=== SYMPTOMS MOST CLOSELY MATCHING MINE === Pfizer, 3 months painful right arm for a few weeks, then lesser pain burning forearms, hand numbness arms, shooting pain arm (vax 2021-01-07, report 2021-04-24) 1259976-1 aching pain on forearms; wrist splints; injury; nerve pain; shooting pain; burning sensation; fatigue; inflammation; feeling ill; pins and needles; high fever; three days after the vaccine; swelling; paralyzed with pain; thursday just gone; over the next few days; unable to bend my fingers; Condition worsened; sleep on my back; felt a strange; irritation shooting down the inner side of my left arm; funny-bone (this is the main site of the pain).; wrist is painful; Aching pain on forearms, upper arms, hands, wrist and fingers/Pain in fingers/During the worst period it was extremely painful; my arms would go numb/Wrist, fingers and base of the hand are sometimes numb; pain in my armpit; Peripheral neuropathy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID- 202103172023335890, Safety Report Unique Identifier GB-MHRA-ADR 24966931. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 07Jan2021 at 19:00 for COVID-19 immunisation. Medical history included bone pain from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing, suspected covid-19 from 09Mar2020. It was unsure when symptoms stopped and pain. Concomitant medication included ibuprofen (IBUPROFEN) taken for pain, start and stop date were not reported; diclofenac sodium (VOLTAROL [DICLOFENAC SODIUM]) taken for pain, start and stop date were not reported. Patient has not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant, Patient was not currently breastfeeding. On an unspecified date, the patient experienced aching pain on forearms, wrist splints, injury, nerve pain, shooting pain, burning sensation, fatigue, inflammation, feeling ill, pins and needles, high fever, three days after the vaccine, swelling, paralyzed with pain, thursday just gone, over the next few days, unable to bend my fingers, condition worsened, sleep on my back. On 10Jan2021, peripheral neuropathy. The event reported in the last few months were as stated by the patient patient had suspected Covid in Mar2020 last year. I've not had an antibody test, but my partner has had a positive antibody test and had the same illness as mine at the same time. I had my first dose of Pfizer vaccine at 19:00 on 07Jan2021 (three days after I came back to London after 4 weeks holiday). I started feeling ill about 14-20 hours after I'd gotten the shot and it gradually got worse. High fever, muscle aches, fatigue. The patient was reported that, was completely out until the morning after. Three days after the vaccine, I felt a strange light nerve pain/irritation shooting down the inner side of my left arm (the arm I had the shot). It lasted for a couple days. Eight days after the vaccine, I was unable to use a knife to cut cheese with my right arm. It was paralyzed with pain. 10 days after the vaccine, I was painting our living room wall with a roller and had been putting a lot of pressure on my right arm. I started having severe pain and was again paralyzed with pain. I was only able to finish the job by using both arms. Over the next few days, I worked relentlessly on a project both in and out of work hours - mainly writing on a computer. My desk had not been set up properly, and the positioning of my elbows, wrist, arms were not ideal. A few days later, I was working from home and my right arm started aching quite badly. The pain got increasingly worse and I tried to stop using my right arm. In order to finish my work I switched over to my left arm. Soon the left arm got the same reaction. At the beginning it would stop as soon as I stopped doing the activity that I was doing, but for a few weeks I started having sustained pain even when I wasn't doing anything. It was severe for a few weeks and then it calmed down gradually. I have scaled back on work tasks and this has made the injury go down quite a bit, but not completely. When the injury was at peak I took ibuprofen regularly for almost week (I stopped when the pain became manageable). Whenever it flares up I take ibuprofen for a couple days. I used elbow and wrist splints for a while to stop myself from bending my arms and wrists. It helped a lot, but it's quite inconvenient so I've stopped using the elbow splints, and use the wrist splints occasionally - mainly when working. I've stopped bending my arms at night because this makes it worse. I try as much as possible to sleep on my back so that I don't put any pressure on my arms. I used the elbow splints at night for a while but stopped last month. I ice my arms most days to calm down inflammation. Thursday just gone, I strapped the ice-pack a bit too tightly and my whole hand got swollen - I was unable to bend my fingers. I released the pressure expecting the inflammation to go down within a few minutes, but it didn't go down at all even after 1.5 hrs when I went to bed. The swelling had mostly gone down the following morning, but not completely. I started taking ibuprofen over the weekend and it went completely down, but now my arms are achy and painful. The pain keeps changing, and is present in both arms around the funny-bone (this is the main site of the pain). The wrist is painful most days during/after working on a computer. Shooting pain down the forearm. During the worst period it was extremely painful. Also, randomly quite severe burning sensation on both topside and underside of forearms and the back of my hand. Aching pain on forearms, upper arms, hands, wrist and fingers. Sometimes my arms would go numb with pins and needles for no apparent reason. Sometimes the pain shoots down the sides of my fingers. Sometimes have a dull, bone pain in my forearms. Wrist, fingers and base of the hand are sometimes numb. I have light shooting pain on the inside and outside of the upper arm sometimes. Sometimes I can feel the pain in my armpit. My friend has inquired on my behalf with a neuroimmunologist about my injury and he said that due to the temporal relationship with the vaccine and the rather rare clinicap picture, it is relatively likely that this is a consequence of the vaccine. That these symptoms are not uncommon after Covid-19. He recommended that I quickly run a neurological exam and nerve function test, if unclear immediately followed by an MRI of the neck spinal cord and spinal tap. He further recommended not to wait until my scheduled appointment (23Apr2021- more that 3 months after the onset of the symptoms) to be seen by a specialist. He also said that treatment with IV. immunoglobulin might be required. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events aching pain on forearms, wrist splints, nerve pain, injury, shooting pain, burning sensation, fatigue, inflammation, feeling ill, pins and needles, high fever, three days after the vaccine, swelling, thursday just gone, over the next few days were recovered on unspecified date, and remaining all other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. (vax 2021-03-01, report 2021-07-15) 1474352-1 (Janssen) Ongoing arm pain in the area of the shot (deltoid muscle) continuous for 6 months since the shot Moderna "1788611-1" "1788611-1" "3 months of persistent arm pain in the deltoid muscle" neuropathy of radial nerve, pain, spasms, 2 months "1934220-1" "1934220-1" ""Drooping wrist//can't move the fingers of my hand//can only partially close them towards the palm; Tingling; patient can't sleep more than 2/3 hours at night/countless sleepless night; Cramps in my arm; nausea; Motor deficit; Pain burning; Pain in arm/stabbing pain in my arm; Mononeuropathy; Hyposthenia; Vaccination site pain; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: IT-MINISAL02-812276 (MINISAL02). A 27-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 14Sep2021 (Lot number: FF2382, Expiration Date: 31Dec2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOTOR DYSFUNCTION (disability) with onset 14Sep2021, outcome ""not recovered"", described as ""Motor deficit""; PAIN (disability) with onset 14Sep2021, outcome ""not recovered"", described as ""Pain burning""; PAIN IN EXTREMITY (disability, medically significant) with onset 14Sep2021, outcome ""not recovered"", described as ""Pain in arm/stabbing pain in my arm""; MONONEUROPATHY (disability) with onset 14Sep2021, outcome ""not recovered"", described as ""Mononeuropathy""; ASTHENIA (disability) with onset 14Sep2021, outcome ""not recovered"", described as ""Hyposthenia""; VACCINATION SITE PAIN (non-serious) with onset 14Sep2021, outcome ""recovered"" (17Sep2021), described as ""Vaccination site pain""; VERTIGO (non-serious) with onset 14Sep2021, outcome ""recovered"" (17Sep2021), described as ""Vertigo""; MUSCLE SPASMS (non-serious) with onset 18Sep2021, outcome ""not recovered"", described as ""Cramps in my arm""; PARAESTHESIA (non-serious) with onset 28Sep2021, outcome ""unknown"", described as ""Tingling""; RADIAL NERVE PALSY (non-serious) with onset 05Oct2021, outcome ""unknown"", described as ""Drooping wrist//can't move the fingers of my hand//can only partially close them towards the palm""; INSOMNIA (non-serious) with onset 21Sep2021, outcome ""recovered"", described as ""patient can't sleep more than 2/3 hours at night/countless sleepless night""; NAUSEA (non-serious) with onset 14Sep2021, outcome ""not recovered"", described as ""nausea"". The event ""pain in arm/stabbing pain in my arm"" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (21Sep2021) clean; (Oct2021) normal; electromyogram: (05Oct2021) the radial nerve is indeed the only one that, notes: responds very little to impulses, and as a result they confirmed the diagnosis of mononeuropathy of the left radial nerve (the nerve in question starts from below the elbow to the wrist, then the forearm; neurological examination: (21Sep2021) indicated a probable mononeuropathy, notes: of the left radial nerve; (30Sep2021) unknown results; physical examination: (28Sep2021) unknown results; quality of life decreased: (unspecified date) 10/10; ultrasound scan: (Oct2021) normal; x-ray limb: (21Sep2021) fine. Therapeutic measures were taken as a result of motor dysfunction, pain, pain in extremity, mononeuropathy, asthenia, muscle spasms, paraesthesia, radial nerve palsy with Oki, 50 mg of deltacortene, brufen, tiobec 800, lenizak, lyrica, laroxyll and cortisone. Additional information: I decided to go for a run and do some physical exercises (push-ups, abdominal exercises etc...), in the evening I came home and without any kind of pain I went to bed. 19Sep2021: I called the doctor in the morning because of the still present pain, and they indicated tacchipirina. 20Sep2021: the tachipirine had no effect and I called the general practitioner as he is on duty on Monday, and he prescribed oki assuming that the nurse has injured/inflamed my arm nerve with the vaccine shot (on enquiry most doctors tell me this is very unlikely). 21Sep2021: neurologist prescribing me 50 mg of deltacortene a day, some brufen/oki to contain the pains and a nerve supplement tiobec 800. During this week 28Sep2021: I'm following the treatment with almost no improvement, I can't sleep more than 2/3 hours at night. I tried lenizak as a painkiller on a prescription from the general practitioner, but after taking it one night and having no benefit apart from nausea, vertigo, weakness the next day I decided not to continue and kept the pain until 28Sep. Also, on the 28th, a doctor from the outpatient clinic examined me and prescribed 75 mg of lyrics in the evening as a painkiller. 30Sep2021, Visit to the neurologist: I arrived after countless sleepless night with a stabbing pain in my arm and the neurologist prescribed 75 g of lyrica in the morning, 150 g of lyrica in the evening plus 5 drops of laroxyll (to compensate for the strong pain) and he raised the daily dose of cortisone to 75 mg. 05Oct2021 my arm is a little better (less cramps, even if they are still present, but at least I can sleep for 7 hours, even if I then wake up with stronger pains that subside when I start to warm up my arm and take 75 mg of lyrica). They don't know the recovery time and they don't know if my hand/arm will return to the way it was. Throughout the month of October and up to the present day, 15Nov2021, I have been undergoing physiotherapy, although the recovery is incredibly slow. No one knows the cause of my problem and consequently the physiotherapists don't know if the hand will return and if it will return at 100%.) - Impact on quality of life (10/10)"" right shoulder pain, range of motion decreased, not sure how long (report 2021-12-31) "2013267-1" "2013267-1" ""right shoulder pain / Right deltoid muscle pain; Difficulty lifting right upper limb; right shoulder pain / Right deltoid muscle pain; vaccination site pain; This is a spontaneous report received from a contactable reporter (Physician) from Regulatory Authority. Regulatory number: v21132146. A 41 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 16Sep2021 (Lot number: FD0349, Expiration Date: 31Jan2022) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient didn't have concomitant drugs taken within two weeks before the event onset. The patient didn't have any medical history. Vaccination history included: On 21Aug2021, Comirnaty (dose 1, single, Manufacture: Pfizer, lot number FF3622(expiration date: 28Feb2022), via Intramuscular route, at right deltoid), for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees Centigrade on 16Sep2021. The following information was reported: ARTHRALGIA (disability), MYALGIA (disability) all with onset 16Sep2021, outcome ""unknown"" and all described as ""right shoulder pain / Right deltoid muscle pain""; INJECTED LIMB MOBILITY DECREASED (disability) with onset 16Sep2021, outcome ""unknown"", described as ""Difficulty lifting right upper limb""; VACCINATION SITE PAIN (non-serious) with onset 16Sep2021, outcome ""not recovered"", described as ""vaccination site pain"". The events ""right shoulder pain / right deltoid muscle pain"", ""difficulty lifting right upper limb"", ""right shoulder pain / right deltoid muscle pain"" and ""vaccination site pain"" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (16Sep2021) 36.3 Centigrade, notes: before vaccination. The course of the events was as follows: After received the second dose of Comirnaty, the patient experienced right shoulder pain (vaccination site, as reported), and pain gradually increased. Because it became difficulty lifting right upper limb, the reporter referred the patient to a nearby Orthopedic Surgery. There was no possibility of receiving examination at reporter's hospital. The reporter classified Right deltoid muscle pain and Difficulty lifting right upper limb as Persistent / Significant disability / Incapacity. The reporting physician classified vaccination site pain as non-serious and assessed that all the events were related to BNT162b2. There were other possible causes of the events such as any other diseases, but detail was not reported. No follow-up attempts are possible. No further information is expected. Follow-up (24Dec2021) This is a spontaneous follow-up report from the same contactable physician, response of follow up letter. Updated information: Historical vaccine ""COVID-19 vaccine"" updated to ""Comirnaty"", other details also updated; Concomitant Therapy selected as none; Disability ticked for event ""Arthralgia"", Myalgia and ""Injected limb mobility decreased""; Outcome and treatment for event ""Arthralgia"" and ""Injected limb mobility decreased"" updated; Narrative updated. Follow-up attempts are completed. No further information is expected."" 7 month pain at injection site "2086037-1" "2086037-1" ""kind of ""infarction"" of the deltoid muscle on the opposite side of the body; persistent pain at the injection site; kind of ""infarction"" of the deltoid muscle on the opposite side of the body so to speak, with persistent pain and numbness.; kind of ""infarction"" of the deltoid muscle on the opposite side of the body so to speak, with persistent pain and numbness.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier: AE-000465 (Biontech), AE-000664 (Biontech ticket reference number). A male patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE INFARCTION (medically significant), outcome ""not recovered"", described as ""kind of ""infarction"" of the deltoid muscle on the opposite side of the body""; VACCINATION SITE PAIN (non-serious), outcome ""not recovered"", described as ""persistent pain at the injection site""; MYALGIA (non-serious), HYPOAESTHESIA (non-serious), outcome ""not recovered"" and all described as ""kind of ""infarction"" of the deltoid muscle on the opposite side of the body so to speak, with persistent pain and numbness."". The event ""persistent pain at the injection site"" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain. Additional information: After the basic immunization with Comirnaty, the patient had pain at the injection site and near it for about 7 months. On the instructions of his general physician, he carried out treatment with heat- unfortunately without success. His general physician was at a loss. The pain first occurred as a reaction at the puncture site and then subsided. However, they come back regularly and now affect a somewhat larger area. He underwent heat treatment. After the first immunization, the patient, also had a kind of ""infarction"" of the deltoid muscle on the opposite side of the body, so to speak, with persistent pain and numbness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200181217 same product/patient, different dose/ events"" burning pain, swollen muscle, not sure how long, narrative indicates about 3 months (vax 2020-10-04, report 2022-02-02) "2091195-1" "2091195-1" ""Ulnar neuritis; The pain continued and was described as burning, shooting; deltoid muscle swelled up; radiational pain; induration; This is a spontaneous report received from a contactable reporter(s) (Physician). A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 04Oct2020 (Lot number: FF2389) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: ""IBS-C"", start date: 01Jan1989 (ongoing). Concomitant medication(s) included: LINZESS taken for irritable bowel syndrome, start date: 01Jan2020 (ongoing); MIRALAX taken for irritable bowel syndrome, start date: 01Jan2019 (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Time (24hr): 18:00, Anatomical site of injection: left deltoid, Route of Administration: Intramuscular, Batch/lot number: FF2787), administration date: 13Sep2020, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): ""severe pain and swelling at the injection site"", ""severe pain and swelling at the injection site"", ""pain radiating down the posterior aspect"", ""burning sensation"". The following information was reported: ULNAR NEURITIS (medically significant), outcome ""not recovered"", described as ""Ulnar neuritis""; PAIN (non-serious), outcome ""recovering"", described as ""The pain continued and was described as burning, shooting""; VACCINATION SITE SWELLING (non-serious), outcome ""recovering"", described as ""deltoid muscle swelled up""; INDURATION (non-serious), outcome ""recovered"", described as ""induration""; RADIATION ASSOCIATED PAIN (non-serious), outcome ""recovering"", described as ""radiational pain"". The events ""ulnar neuritis"", ""the pain continued and was described as burning, shooting"", ""induration"" and ""radiational pain"" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ulnar neuritis, pain, vaccination site swelling, induration, radiation associated pain. Vaccination Facility Type: Doctors office/urgent care: Pharmacy or Drug store. Treatment: Methylprenisolone gabapentin. This patient complained that her deltoid muscle swelled up, was very tender to touch, and was indurated to palpation. Although the induration resolved after 48 hours, this patient complained of worsening of the radiational pain down the ulnar distribution Of her left upper arm. The pain continued and was described as burning, shooting, and continued to be triggered by the previously described motions, but now began to be triggered by pressure over the triceps and lateral aspect of her upper arm, such as while laying in bed, being hugged or applying any pressure to the area. Since the burning pain did not improve spontaneously, she was given 2 courses of Medrol dospak with minimal improvement. She was then placed on a month-long Medrol taper, from 24 mg down to O mg, reducing her dose every 3 days by 4 mg. She was also initiated on a up-titrating dose of gabapentin, beginning on 100 mg TID, and titrating up to 300 mg TID over the course of 2 weeks. This provided her with moderate to significant relief, but she had to discontinue the gabapentin after 2 weeks due to a viral gastroenteritis, and is slowly being up titrated again. At the present time, she has experienced mild improvement in her symptoms as compared with the initial presentation, but continues to be unable to use her left upper arm in the previously described movements as those movements trigger her burning, radiational pain. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported events Ulnar neuritis , Pain , Vaccination site swelling , Induration , Radiation associated pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate"" Janssen pain 3 months "2091543-1" "2091543-1" "Pain started at the injection spot in my left deltoid approximately 24 hours after injections. Approximately two weeks later, the pain had spread to the triceps brachii and upper brachioradial is muscles. Over three months later, the pain has subsided somewhat, but definitely persists causing me to use my right hand/arm for any heavy lifting." Moderna pain 3 months "2092920-1" "2092920-1" "I had no reaction with the first dose of Moderna, a sore arm for a couple of days with the second dose of Moderna and with the third dose, I had muscle soreness and weakness - was afraid I?d drop the gallon of milk as I was taking it out of the refrigerator. The muscle soreness, which I would rate at a 3-4 on a scale of 1-10, persists almost three months post last injection. The ?discomfort? seems to migrate from central deltoid at the injection site to the right side of the deltoid, to the left side of the deltoid and even up into shoulder muscles and is present all day, every day. Arm movement is uncomfortable. Taking Ibuprofen does nothing to eliminate or relive the discomfort." arm pain 10 months, lymph node swollen, numbness "2106510-1" "2106510-1" ""muscular pain; Lymphangitis; Swollen arm; Muscle weakness; injection site on deltoid muscle was still inflamed; injection site on deltoid muscle was still painful; arm also went numb at night; arm also went tingles at night; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority and Healthcare products Regulatory Agency. The reporter is the patient. Regulatory number:-202201291829015080-VFYPQ. Other Case identifier: ADR 26535871. A female patient received BNT162b2, administered in arm, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Patient had not had symptoms associated with COVID-19. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (disability, medically significant), outcome ""recovering"", described as ""muscular pain""; LYMPHANGITIS (disability, medically significant), outcome ""not recovered"", described as ""Lymphangitis""; PERIPHERAL SWELLING (disability, medically significant), outcome ""not recovered"", described as ""Swollen arm""; MUSCULAR WEAKNESS (disability, medically significant), outcome ""not recovered"", described as ""Muscle weakness""; VACCINATION SITE INFLAMMATION (disability, medically significant), outcome ""not recovered"", described as ""injection site on deltoid muscle was still inflamed""; VACCINATION SITE PAIN (disability, medically significant), outcome ""not recovered"", described as ""injection site on deltoid muscle was still painful""; HYPOAESTHESIA (disability, medically significant), outcome ""unknown"", described as ""arm also went numb at night""; PARAESTHESIA (disability, medically significant), outcome ""unknown"", described as ""arm also went tingles at night"". Clinical course: The patient had her vaccine first dose on 23Apr2021 and it's been almost 10 months and her injection site on her deltoid muscle was STILL inflamed and painful. The pain came and went on waves. It's a shooting deep muscular pain that's localised in her Injection site and muscle. She can't lift anything heavy. It's always sore. Her lymph node in her armpit was also swollen and painful and it swelled up in waves. It's forever painful! Her arm also went numb and tingles at night she can't sleep on it. Details of any relevant investigations or tests conducted: ""Ultrasound of underarm"". The patient underwent COVID-19 virus test: no - negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected."" burning pain, muscle spasms at 3 months "2121131-1" "2121131-1" "Patient came into pharmacy on 2/17/22 stating he wanted to report issues from his first Pfizer covid 19 dose on 11/23/21. Patient originally called to report but they directed him to come to pharmacy store level and they asked patient to get a claim number which he did not have. Patient stated 3 days after receiving 1st Pfizer dose he had burning/stinging pain, deep soreness, pulsating pain, and muscle spasms. Patient stated no issues with 2nd dose of Pfizer which he had administered in right arm.Patient followed up with physician who told him nerve was struck possibly during vaccine administration causing nerve pain. Patient was prescribed muscle relaxers and physical therapy by physician which patient states is still ongoing as of 2/17/22. Patient states left arm where area of vaccination occurred starting to heal with range of motion getting better with physical therapy but they are continuing to work on building strength back in his left arm. Patient stated left arm is his dominant arm and he had no issues with mobility or pain in his left arm prior to getting the vaccine. Patient wanted to report to us but did not state any legal action or requesting compensation or treatment compensation. Patient was thankful he received 2 doses of Covid vaccine prevented him from getting covid during December and at work when it was going around. Patient inquired when he was eligible for a booster vaccine which HCP wrote down date in 5 months from 2nd dose of Pfizer on her business card and gave to patient. Also offered to mail patient gift card for customer loyalty for using our pharmacy for vaccines for customer service." Janssen arm pain at 5 months "2230382-1" "2230382-1" ""off label use; interchange of vaccine products; Booster; pain in vaccinated arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority-WEB. Regulatory number: FR-AFSSAPS-AM20220829 . A 62-year-old female patient received BNT162b2 (COMIRNATY), on 23Oct2021 as dose 2 (booster), single (Lot number: FG7911) at the age of 62 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine janssen (Dose 1, Single, batch/lot: 21C10-02, Route of administration: left deltoid), administration date: 11May2021, for COVID-19 immunisation, reaction(s): ""without adverse effects"". The following information was reported: IMMUNISATION (medically significant) with onset 23Oct2021, outcome ""unknown"", described as ""Booster""; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome ""unknown""; OFF LABEL USE (medically significant) with onset 23Oct2021, outcome ""unknown""; VACCINATION SITE PAIN (medically significant) with onset 23Oct2021, outcome ""not recovered"", described as ""pain in vaccinated arm"". The event ""pain in vaccinated arm"" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: no joint, tendon or muscle abnormality. The patient reports a few hours after the injection, the occurrence of muscle pain around the injection point of the left arm, without any other associated symptoms, which persists at 3 months, from mechanical time to mobilization of the arm, motivating the consultation with the attending physician. Patient not recovered at 5 months (symptomatology unchanged). Persistent left arm pain 5 months after D2 COMIRNATY. No follow-up attempts are possible. No further information is expected."" (vax 2022-02-03, report 2022-05-09) "2267687-1" "2267687-1" "I have swollen arm and pain on the day of vaccination. Pained continued to be focused on the injection site for about 3 days after which my whole arm started to feel painful. The pain was not specific to the injection site after almost a week on the shot. The pain was not specific to one area. My whole arm was painful and it did not feel specific to the muscle. Even with extensive rest the pain won't go away. using my arm for daily activities (washing dishes, writing/typing) was causing a little more pain. Wearing Backpack was causing more pain. My arm also felt numb, and heavy. I still feel the same pain, numbness and heaviness. Numbess is not continuous (i.e not all the time). I do not sleep on my arm and it still is painful. Sleeping on it will cause more pain. There are times when I feel burning sensation that almost feels that it is within my veins. The pain and heaviness are still persistent at the same level. These symptoms are intefereing with my daily activities since my right arm is the dominant one." (vax 2021-11-30, report 2022-06-11) "2316655-1" "2316655-1" "Left arm has been affected including ongoing pain from shoulder to forearm. At first, I felt general soreness and discomfort, and after a few weeks pain and/weakness when lifting small (coffee mug) and medium sized objects. Sometimes feels like nerve injury connecting deltoid, bicep and muscles of my forearm, even into my fingers. More recently, the pain feels focused in my shoulder. I have a general sensation of mild discomfort with shooting, stabbing pain when i try to perform certain actions. These flares are quite intense and I'm unable to carry on with what I'm doing until it settles back down." Total: 14 === SYMPTOMS OTHER THAN ARM/SHOULDER PAIN === feet burning "1869607-1" "1869607-1" "Symptoms began with intense burning in the feet, gradually spreading to the calves and minimally into the hands. There was also a very annoying continuous buzzing/tingling sensation in foot/toes that progress up my leg into my arms and fingers. The tingling was like electrical shocks that occurred several times a night, waking me up from a sound sleep. No problems before the second Moderna dose. No prior Covid-19 exposure. The symptoms eventually faded after several months. On 10/28/2021 I received my Moderna booster. The side effects included chills, aches, muscle pain. Two days later, the symptoms described above reappeared. Feels like neuropathy and electrical shocks but not as intense as the second dose." severe pain, arm, neck, face, vision disturbances "1981089-1" "1981089-1" "Within 15-20 min L face began to tingle, while driving home. Once home, I observed that the vaccine location was given at the lowest and most medial edge (and nearly off of) L deltoid muscle. Within 5-8 hours whole left arm with tingling sensations followed by excrutiating nerve like pain shooting up and down arm most severe at medial L arm running up through axilla and into shoulder. Entire left arm, shoulder and up into neck/face in severe pain (near inability to move or touch arm). This subsided some after 1 week and was left with tingling sensations in Left>R hands and some in left arm as well. 2 months later tingling sensations began in feet. Saw NP at Medical Clinic in Location who ran some generalized labs and was started on Gabapentin 100mg BID. This improved symptoms and after 1 month of taking medicines stopped them and symptoms increased exponentially reprising initial post vaccine symptoms of tingling sensations in left face and whole L arm and leg. Then increased muscle soreness and fatigue started particularly at joint areas on left side but also throughout Left shoulder, arm and Leg. At this time Left eye also began to become blurry with difficulty focusing. Saw NP again on 7/15 who ordered MRI of brain. Then was referred to neurologist at Clinic (first appointment 9/23) where further testing was completed until final follow-up visit on 11/30 where Doctor concluded Symptoms most likely the result of the vaccine and told me to fill out the VAERS." muscle spasms, pain, legs, burning (vax 2021-01-12, report 2022-02-02) "2091175-1" "2091175-1" ""felt like my legs were burning; so much physical pain; severe muscle spasms; twitches; Anxiety; depression; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2021 08:30 (Lot number: EJ1686) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: ""Migraines"" (unspecified if ongoing); ""PCOS"" (unspecified if ongoing); ""chronic pain"" (unspecified if ongoing). Concomitant medication(s) included: METHOCARBAMOL; GABAPENTIN; VENLAFAXINE; BUTALBITAL. Past drug history included: Zofran, reaction(s): ""Zofran: Drug Allergy"". Vaccination history included: Bnt162b2 (Dose Number: 1, Pfizer EH9899, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: BURNING SENSATION (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""felt like my legs were burning""; PAIN (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""so much physical pain""; described as ""needed a walker to walk or a wheelchair at stores/prolonged events""; MUSCLE SPASMS (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""severe muscle spasms""; MUSCLE TWITCHING (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""twitches""; ANXIETY (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""Anxiety""; DEPRESSION (disability) with onset 12Feb2021 19:00, outcome ""not recovered"", described as ""depression"". Reported that she had severe muscle spasms, constant pain, twitches/spasm that are visibly seen. Anxiety, depression from the result of the constant pain and spasms. They have not figured out something that helps them. The events ""felt like my legs were burning"", ""so much physical pain"", ""needed a walker to walk or a wheelchair at stores/prolonged events"", ""severe muscle spasms"", ""twitches"", ""anxiety"" and ""depression"" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: antibodies: (04Jan2022) positive, notes: Blood test; PCR: (04Jan2022) negative, notes: Other; Nasal Swab: (04Jan2022) negative. Therapeutic measures (pain medicines, muscle relaxants, nausea medicine) were taken as a result of burning sensation, pain, muscle spasms, muscle twitching, anxiety, depression.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Depression, anxiety, muscle twitching, muscle spasms, pain, burning sensation, and the suspect drug ""BNT162B2"" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate."" Janssen, small fiber neuropathy 2 months after vax - paresthesia, palpitations, twitching for > 1 year (vax 2021-03-01, report 2022-04-03) "2213344-1" "2213344-1" "Initially just had a sore arm and some muscle pain for 24 hours. 2 months later started having altered sensations (tingling, burning, electric shocks, vibrating) along with internal shaking, internal vibrations, heart palps, muscle twitching, insomnia, panic attacks. This has continued to this day. Was diagnosed with small fiber neuropathy on March 29, 2022" history of tingling/numbness 2nd vax: muscle pain, head/neck pain, tingling, numbess arms/legs/face 3rd vax: burning pain muscles, heaviness in muscles, muscle shaking, mild nausea, mild dizziness "2109457-1" "2109457-1" "My main symptom is exercise intolerance, muscle soreness, severe muscle fatigue and feelings of muscle ?heaviness? that can last 3-4 days after even very light exercise. This seems to have started shortly after my last COVID boosters. I am a 50-year-old woman and I work as a consultant for various humanitarian organizations, most recently in other Countries. In the past I have been in good health, and it has been my habit exercise vigorously. I have participated in half-ironman competitions and have usually exercised 5 or 6 days/week with combinations of running (as far as 10 miles), biking (as far as 50 miles), and swimming (over 1 mile). I enjoyed these activities until December 2021, when my muscle symptoms started. During the past two years, and especially the last three months, I and my family have had many negative COVID PCR and rapid antigen tests in the course of traveling. I haven't had any of the common symptoms of COVID infection, and I have been very careful to wear NK95 masks and follow appropriate COVID precautions. In April 2021 while in a Country I received my first dose of Astra Zeneca COVID vaccine. In May after returning, I received 1 PFIZER dose, and in June 2021 a second PFIZER dose. I had mild arm achiness for one or two days after these with some body aches, but I did not have any more general symptoms. (At that time it was not clear whether airlines and border-control agencies would accept doses from 2 different vaccine manufacturers as fulfilling two-dose travel requirements, so I opted to take 2 PFIZER doses after the Astra Zeneca dose.) On December 13, 2021 I received a COVID booster. This dose was administered at a mass vaccination center and was said to be PFIZER vaccine. However, I could not read PFIZER on the label. A colleague who was vaccinated at the same vaccination center said that when she asked to see the vial used by the health worker, the vial said ?sodium chloride?. Whatever it was, I doubted if the vaccine had been properly refrigerated or if the dose was correct. After the December 13 booster I had mild arm soreness for a day or two, and around December 20 I developed over 1 or 2 days general muscle soreness and low-grade head and neck aching along with a recurrence of peripheral neuropathy-type symptoms, including tingling and numbness of my arms, legs and face (See previous medical history below). Initially the muscle soreness seemed relieved when I drank 2 liters of an electrolyte and glucose solution over 24 hours. However, during subsequent days my leg muscles became even more sore, especially 8-10 hours after exercise. I sometimes had stabbing pains in my thighs. Because of these symptoms I progressively reduced my exercise from running 9 miles in the hills (late Dec 2021) to walking slowly and for short distances (2-3 miles) on level ground (early Jan 2022). In mid-January I returned to another Country. After 24 hours sitting on a plane and in airports and another 2 days of quarantine at home upon arrival, my symptoms had abated. However, they returned when I engaged in even light activity. On Jan 13, 2022, because I wasn't sure of the provenance or dosage of the vaccine I had received in December, I elected to take a Moderna booster. This vaccine was delivered by air-freight under proper refrigeration, and was administered at another country. (At that point I had received 1 Astra Zeneca, 2 or 3 PFIZER, and 1 Moderna vaccine.) On January 14 I participated in a one-hour yoga classes with bodyweight strength training exercises. My muscle strength seemed normal although I was slightly sore afterwards. The following day I attended another yoga class. My muscle strength was normal, but within 15 min after the session, I developed nausea, a feeling of shakiness and an increased heart rate. That night I developed marked muscle soreness, and the muscles in my shoulders, back and legs felt like they were in fire. This was not relieved by Ibuprofen or Celebrex. For several days thereafter I felt like I had run a marathon. At this point my symptoms of peripheral neuropathy also significantly worsened. The muscle soreness was aggravated by even minimal effort like lifting a backpack, climbing stairs or walking at a slow pace, and was accompanied by a feeling that my limbs were very heavy. Although I was engaging in only light physical activity (no more than 10-20 minutes at a time of slow walking or light household chores), my ability to walk or stand continued to deteriorate over the next 3 days. Standing or slow walking for more than a few minutes caused my legs to shake and gave me mild nausea and dizziness. I saw an physician who was unsure what was wrong, and on January 20 I returned to see physicians at. The results of their tests have been normal, and no one has been able to come to a diagnosis regarding my muscle symptoms. Currently, my maximum exercise tolerance is 3-4 miles of slow walking, but even this leaves me very sore. Muscle soreness peaks during the 12-24 hours after even very light exercise (10-20 minutes of walking). At times I also notice a faster heart rate, increased from my usual 50+ to 80-90 even when I am not engaged in any physical activity. I cannot go on walks for 2 or more consecutive days without developing tremors in my thigh muscles. Even very limited strength training (without weights) causes immediate muscle fatigue and weakness, followed by soreness within 6-8 hours. I do not feel tired or need to sleep more than usual. I have had my CK enzymes checked twice (both during bouts of muscle soreness post physical activity), but the levels have been normal. I have not had a fever, rash, joint symptoms or change in the color of my urine. Previous medical history Along with my recent muscle symptoms I have also had numbness and tingling. This seems to be a recurrence of symptoms that first occurred and disappeared while I was living in another Country in 2019. At that time I had tingling in my fingers and toes which would wax and wane and last several hours. Over time the episodes involved my hands and feet as well, in a stocking-glove distribution. In 2019 several hours after strenuous exercise in a hot environment, I had an episode of more intense tingling that involved my distal extremities, face and tongue, and was accompanied by marked nausea. These symptoms lasted about 6 hours and seemed to clear as I drank fluids. During the next 3 to 4 weeks, however, the tingling continued on and off, with fleeting feelings of head pressure or fullness and a metallic taste in my mouth. I had no weakness, fatigue or muscle pain. The symptoms were not precipitated by identifiable factors. I was not worried about anything, or under significant stress. I consulted a neurologist in the other Country, and his examination and nerve conduction studies on my arms and legs were normal. He discussed the possibility of peripheral neuropathy but did not make a specific diagnosis. About three months later (December 2019), while visiting, I saw M.D. for neurology consultation. At that time I had been free of symptoms for one or two months and was following my usual exercise routine without trouble. Dr, neuro exam and blood tests were normal. She did not think I had an auto-immune disorder and we discussed the question of small-fiber peripheral neuropathy (SFPN). She thought that a skin biopsy to evaluate this possibility was not warranted. In mid December 2021 a few days after my PFIZER booster, I began to have along with my muscle symptoms a recurrence of tingling in the same pattern as in 2019. It lasted hours and sometimes was accentuated by exercise, becoming a burning sensation in my feet after running. I developed headaches and momentary electric sensations in my scalp and extremities. In January 2022 before returning to other Country I had a tele-visit with a neurologist who recommended I have a brain and spine MRI for MS, and blood tests for possible causes of peripheral neuropathy. These tests were normal. In February 2022 a different neurologist raised the question of an auto-immune condition possibly linked to my COVID boosters, but did not recommend any treatment. At this time my neuropathy type symptoms have largely abated. They flare up to a very limited extent with tingling in my feet and fingertips and face if I engage in physical activity. My muscle symptoms continue, however, and are disabling. Feelings of muscle fatigue and ?heaviness? can continue 3-4 days after very light exercise. It is impossible for me to overstate what a huge change this represents in my health and quality of life." === SHORT DURATION OR LONG AFTER VAX === muscle pain 3 weeks 1315860-1 Pt developed muscle pain about 3-4 days after vaccination. She didn't feel pain initially but started feeling pain and pain still persists after 3 weeks. She cannot move her arm. The location is not where she got vaccinated but below. There is no lump or redness. Pt still wanted to get 2nd dose and got vaccinated on right deltoid on 5/12/21. pain arm, only 19 days 1476914-1 Peripheral nerve disorder; Left arm pain; This is a spontaneous report from contactable physicians via COVID-19 Vaccine Adverse Event Reporting System (COVAES), and from the Regulatory Authority. Regulatory authority report number is v21116105. The patient was a 68-year and 10-month-old male. Body temperature before vaccination was 36.7 degrees Centigrade. The patient had nothing in particular family history. The patient was taking DIOVAN 80 mg 1 tablet once a day for the treatment of hypertension. The patient had no medical history of allergy or past side effect. During last a month, there were no pathological changes of disease. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received DIOVAN within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension. On 05Jun2021 14:45 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EX6564, Expiration date 31Aug2021) intramuscular in the left arm as DOSE 1, 0.3 ML SINGLE (at the age of 68 years old) for COVID-19 immunization. On 06Jun2021 at 09:00 (1 day after the vaccination), the patient experienced Peripheral nerve disorder. The event onset date was reported as 06Jun2021 (1 day after the vaccination). On 24Jun2021 (19 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: On 05Jun2021, the patient received Comirnaty 0.3 cc via intramuscular injection on the deltoid muscle of left shoulder (first dose). On 06Jun2021, the patient experienced left arm pain after vaccination. Body temperature was 36.3 centigrade on 06Jun2021. After observation, till 14Jun, the symptom still did not relief. Therefore, the patient visited the reporter's hospital. No vaccination site swelling, or pain was observed. General Body status was well. No palsy or Muscular weakness of the left arm were observed. There were no other symptoms. On 19Jun2021, the patient visited the reporter. The patient had experienced pain in the left upper limb while getting up from the bed. Acetaminophen was prescribed and the patient was under observation. Analgesics was administered and the symptom relieved. However, in the next morning, the pain appeared again. During examination, the symptom was recovering. No pyrexia. There was no vaccination site redness or vaccination site swelling. No palsy or Muscular weakness. Under the instruction of Orthopedics, Roentgen scan was performed on the shoulder. No abnormality was confirmed. Now, the symptom still did not change. The outcome of the event was not recovered with treatment including Analgesics. The reporter stated the event results in doctor or other healthcare professional office /clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter commented as follows: After vaccination, only left arm pain persisted. The reporter did not know further information. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. pain ~4 months after 2nd dose, range of motion limited (duration 6-8w) (vax 2021-03-05, report 2021-09-16) "1705752-1" "1705752-1" "Muscle pain; inappropriate schedule of vaccination administered; arm ache/ Pain in arm; This is a spontaneous report from a contactable consumer (the patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109031801027430-NDEET, Safety Report Unique Identifier GB-MHRA-ADR 25893817. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8713), via an unspecified route of administration, in the left deltoid, on 05Mar2021 (at the age of 44-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included pain in arm, hayfever and headache. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EJ1688), via an unspecified route of administration, in the left deltoid, on 05Jan2021 (At the age of 44-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The usual expected arm pain after 1st dose of Pfizer COVID vaccine. This lasted about 2 days where patient couldn't lift arm above the horizontal position and it was painful to lie on. This resolved. Concomitant medications included codeine taken for headache and paracetamol taken for headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. The patient experienced arm ache/ pain in arm on an unspecified date in 2021; muscle pain on 01Jul2021 and inappropriate schedule of vaccination administered on 05Mar2021. After the 2nd dose of Pfizer COVID vaccine patient had slight arm ache for a day which then resolved. Both doses were in the left deltoid. Now months after that 2nd dose, patient had pain in that same arm in the deltoid area and patient cannot lift arm above the horizontal without being in a lot of pain. Patient had not sought any treatment for this yet as patient was hoping it might get better but it has been approximately 6-8 weeks since this started and was ongoing. The patient underwent lab tests and procedures which included sars-cov-2 test/ COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). Outcome of the events arm ache and muscle pain was not recovered and other event was unknown. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : GB-PFIZER INC-202101167752 same patient/same product, different dose/events." burning arm, fatigue, only 3 weeks confirmed "1937290-1" "1937290-1" "Body temperature increased; Armpit pain; Muscle ache; Coldness; Pelvic pain; Chest pain; Tingling feet/hands; Lightheadedness; Painful arm; Vaccination site pain; Arm discomfort; Fatigue; Burning sensation; Joint pain; Administration site bruise; body felt extremely weak; swelling arm; dose 1 on 29Jun2021/dose 2 on 19Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the United Kingdom's Medicines and Healthcare products Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202110052248469850-VNDY1 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26041034 (MHRA). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2153), via an unspecified route of administration administered in arm left on 19Sep2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included suspected COVID-19 from 01Jan2020 (ongoing); bowel disorder psychogenic, energy decreased, damage liver all from 2020 (ongoing); vomit bile (not ongoing), unintentional weight loss (not ongoing), loss of taste to Jan2020, pain in arm (ongoing), chest pain (ongoing), weakness (ongoing), and severe constipation all from Dec2019; repetitive strain injury (RSI) (ongoing); bloating; heartburn; fatigue; stress (notes: due to personal issues). Concomitant medications included vitamin d [vitamin d nos] and vitamins nos taken for supplementation therapy; aluminium hydroxide;calcium carbonate;sodium alginate;sodium bicarbonate (GAVISCON) taken for thermal burn, dyspepsia, nausea to 2021; plantago ovata (FYBOGEL) taken for constipation. She was not taking any other medications at the same time as the vaccination. However, she do take vitamin D supplements as well as regular vitamins to boost her health; and sometimes drink plantago ovata to deal with her persistent constipation issues. The patient previously took metoclopramide (PRIMPERAN) for gastric disorder; teprenone for gastroenteritis and gastric ulcers; domperidone for nausea; miya-bm fine granules for abnormal intestinal flora; phelloberin tablets for diarrhea; bio three; laxido; ohta's i-san to Aug2020 and received the dose 1 of bnt162b2 (lot number: FC9001) on 29Jun2021 for COVID-19 immunisation and experienced burning body temperature and lightheadedness. Her first vaccine resulted in her having symptoms of lightheadedness and burning body temperature on the day, but it disappeared the next day. Patient caught an unexplained health condition in 2020 and have been gradually recovering ever since. It affects the bowels and her energy levels. Not had a COVID-19 test. Over the past two years, she have regularly visited the doctors due to gradually recovering from an unexplainable chronic illness that she caught from Dec2019 (but it grew serious in Jan2020). From Dec2019 to Apr2020, the patient was ill with an unknown condition in which the patient vomit bile, had very low energy, lost 5 kilograms in a matter of weeks (from 64 to 59), lost her sense of taste for a month, had aching arms and aching chest pains, had severe constipation and was very frail and weak. This condition has gradually improved to being somewhat stable; however she have not fully recovered yet. Many doctors tested the patient and gave her medicines however they did not help much. She had an x-ray and blood test in Jan2020 but it was all clear. She took many medicines that she kept on having to take over and over again. They were a mixture of tablets and powder: metoclopramide for stomach problems, teprenone (acute gastroenteritis, exacerbations of gastric inflammation, and gastric ulcers), MIYA-BM fine granules (used to improve diarrhea, soft stools, constipation, abdominal distention, etc. caused by abnormal intestinal flora), phelloberin tablets (treat diarrhea), domperidone (for nausea), Bio Three; as well as 5 other medicines whose names she can't translate. She also was recommended to drink health drinks such as Pocari Sweat to keep my energy levels stable. From Apr2020, the patient had one blood test in mid 2020 and had an abnormal liver reading in terms of the part of the liver that is damaged after heavy alcohol consumption and drugs. However, the patient do not consume alcohol, nor drugs. She only took medicine in Japan. She have had to contact the doctor many times and have taken laxido on numerous occasions. She had a colonoscopy on 15Oct2020. Her results were clear. Before this, she had a few stool tests due to spots of blood and yellow mucus appearing in my constipated stool on many occasions. Now, she only get yellow mucus sometimes but she was still easily constipated. She used to take Ohta's I-san until Aug2020, and was regularly consuming aluminium hydroxide;calcium carbonate;sodium alginate;sodium bicarbonate until early 2021 to deal with her heartburn and nausea after eating certain foods. She had a bladder test in early 2021 as well as a result of struggling to pass urine. Her results were clear, however it took a full month for her urine to return to normal. She was easily fatigued and have low energy as a result of the illness she suffered in 2020. She have had to rebuild her stamina gradually. She have RSI in her right wrist. Her chronic condition means that she will get serious bloating and heartburn from eating very greasy/ oily foods, fizzy drinks and rich creamy foods as well, so she eat them in moderation. Fizzy drinks and oily foods make her feel very sick, same for when she eat large portions of food. Some meats also have a negative aftertaste. She have to avoid many types of rich dishes and her appetite is gradually returning to normal. She also have much lower stamina than before and get easily fatigued. She was also regularly constipated. If she don't consume plantago ovata her constipation makes her severely ill. However, her symptoms can vary by the week- some weeks and months she've felt almost back to normal only then to relapse once exerting herself as much as she used to before she became ill. Other contributing factors may be stress due to her personal issues. On 20Sep2021, the patient experienced burning sensation, joint pain, painful arm, vaccination site pain, arm discomfort, fatigue, administration site bruise, body felt extremely weak, and swelling arm. On 21Sep2021, the patient experienced coldness, pelvic pain, chest pain, tingling feet/hands, lightheadedness, armpit pain, and muscle ache. On an unspecified date, the patient experienced body temperature increased. The clinical course was as follows: A day after the patient's covid injection, she suddenly lapsed into severe muscle/ joint pain; lightheadedness; pelvic/bum pain and tingling fingers paired with coldness. Her body felt extremely weak. However, after taking paracetamol, most of her symptoms gradually decreased. Despite this, three weeks after her covid injection; her pelvic pain, as well as her arm pains/ swelling still persist. She was worried that her left arm may never return to normal again. In addition to that, it has a burning sensation in her arm (as well as occasionally in her finger). As for her second vaccine, she arm had pains from the first day, however her strongest symptoms happened on the 20Sep2021. Most symptoms disappeared after taking paracetamol and resting for the night. However, symptoms such as burning sensation in the arm, fatigue, pain in her arm that sometimes stretches to her armpit and random pelvic pains have persisted ever since. The biggest issue is the pain at the site of injection (left arm). Typically, it just feels a bit dull but she can move it easily, and the pain is almost unnoticeable once its rested. However, the way it aches once she use her left arm for certain activities is a cause for concern, it feels like a muscle bruise. And it burns, usually at night. The treatment on the day of the event was fine, however she was still recovering from the vaccine. Her left arm aches and burns at minor exertion and her fatigue has increased more than usual. Recently, her pelvic aches seem as if they may subside entirely soon. She have not had a similar reaction from any other vaccines or medicines. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the burning sensation, painful arm, vaccination site pain, arm discomfort, armpit pain, fatigue, vaccination site bruising, and swelling arm was not recovered; of the joint pain, chest pain, and body temperature increased was recovered; of the tingling feet/hands, lightheadedness, and muscle ache was recovered with sequel; of the weakness generalized and inappropriate schedule of vaccine administered was unknown; while of the remaining events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Follow-up (13Oct2021): The significant information was received by the MHRA from a contactable consumer which included: Product start date and stop date, batch /lot number for dose 1 and dose 2 was updated, new event fatigue and Body temperature increased was added, concomitants vitamin d Gaviscon, Plantago ovata was added, Anatomical Location was added, paraesthesia, dizziness, myalgia outcome updated, chest pain outcome date updated, all event onset dates were updated, as per the FU. Relevant medical history in 2020 was found bowl disorder psychogenic, on 2020 was found energy decreased, on dec 2019 was found vomiting, on an unspecified date found unintentional weight loss, on dec2019 was found loss of taste, on dec2019 found pain in arm, on dec2019 found chest pain, on dec 2019 was found weakness, on 2020 was found damage liver, on an unspecified date found repetitive strain injury, on an unspecified date found bloating, on an unspecified date found heartburn, on 20Sep2021 date ground fatigue, on an unspecified date found stress, past drug was given metoclopramide for gastric disorder, past drug was given teprenone for gastroenteritis, past drug domperidone for nausea. Blood test done on jan2020 was found clear, on jun2020 found abnormal liver reading, colonoscopy was found clear on 15Oct2020, urine analysis was found clear, on jan2020 X-ray was found clear. Stool analysis showed yellow mucus and easily constipated on an unspecified date. Event body temperature increased was found with outcome of recovered, lab data and complete clinical information was updated. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Follow-up (25Nov2021): This is a spontaneous follow-up report received from the same contactable consumer (patient). Updated information: patient details, medical history details, laboratory data, concomitant drug details, and reaction data. The case was upgraded to serious." (vax 2021-05-20, report 2021-12-15), says burning sensation "not recovered", but doubtful "1953383-1" "1953383-1" ""palpitations; burning sensation in the arms; ectopic heart beats; severe lightheaded 1 week following first dose; Severe panic and anxiety; Severe panic and anxiety; Tingling sensation; Muscle pain; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112021526416450-QOVI0 (RA). Other Case identifier(s): GB-MHRA-ADR 26281744 (RA). A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20May2021 (Lot number: ET8885) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient's last menstrual period date was on 03Nov2021. Patient had no symptoms associated with COVID-19, was not enrolled in clinical trial and was not breastfeeding at the time of report. The following information was reported: PALPITATIONS (disability, medically significant) with onset 2021, outcome ""not recovered"", described as ""palpitations""; BURNING SENSATION (disability, medically significant) with onset 2021, outcome ""not recovered"", described as ""burning sensation in the arms""; EXTRASYSTOLES (disability, medically significant) with onset 2021, outcome ""not recovered"", described as ""ectopic heart beats""; DIZZINESS (disability, medically significant) with onset 2021, outcome ""recovering"", described as ""severe lightheaded 1 week following first dose""; PANIC ATTACK (disability, medically significant) with onset 2021, outcome ""recovering"", ANXIETY (disability, medically significant) with onset 2021, outcome ""not recovered"" and all described as ""Severe panic and anxiety""; PARAESTHESIA (disability, medically significant) with onset 2021, outcome ""recovering"", described as ""Tingling sensation""; MYALGIA (disability, medically significant) with onset 2021, outcome ""recovering"", described as ""Muscle pain""; NAUSEA (disability, medically significant) with onset 2021, outcome ""not recovered"", described as ""Nausea"". The patient underwent the following laboratory tests and procedures: three blood test: unknown results; electrocardiogram (2x static ECG): unknown results; electrocardiogram ambulatory (24hr ECG): unknown results; sars-cov-2 test: negative. Clinical course: Severe lightheaded 1 week following first dose, along with severe panic and anxiety, palpitations, burning sensation in the arms. Ectopic heart beats where never had any heart issues prior. Patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : GB-PFIZER INC-202101737285 same patient/different dose/different event"" "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Adverse Event Description: muscle month soreness deltoid; muscle week soreness deltoid; muscle month soreness arm burning;" "muscle week soreness arm burning; muscle month sore deltoid; muscle week sore deltoid; muscle month sore arm burning; muscle" "week sore arm burning; muscle month pain deltoid; muscle week pain deltoid; muscle month pain arm burning; muscle week pain arm" "burning; muscle month painful deltoid; muscle week painful deltoid; muscle month painful arm burning; muscle week painful arm" "burning" "Event Category: Permanent Disability; Hospitalized; Existing Hospitalization Prolonged; Emergency Room / Office Visit **;" "Emergency Room *; Office Visit *" "Recovered: No" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: VAERS ID" "Show Totals: False" "Show Zero Values: False" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Aug 21, 2022 2:48:48 PM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Aug 21, 2022 2:48:48 PM" "---" Messages: "1. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "2. These results are for 582 total events." "3. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "4. Click on a VAERS ID to see a report containing detailed information for the event." "---" Footnotes: "1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse" "event (possible side effect)." "---" Caveats: "1.

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine" "manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports" "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain" "information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they" "are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports" "should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope" "and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to" "post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events," "also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as" "the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have" "the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine." "

Key considerations and limitations of VAERS data:

" "2." "3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more than 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "4. Data contains VAERS reports processed as of 08/12/2022. The VAERS data in WONDER are updated weekly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or" "reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting." "5. Values of Event Category field vary in their availability over time due to changes in the reporting form. The ""Emergency" "Room/Office Visit"" value was avaliable only for events reported using the VAERS-1 form, active 07/01/1990 to 06/29/2017. The" """Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit"" values are available only for events reported" "using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be considered when evaluating count of events for" "these categories." "6. About COVID19 vaccines: "