Pfizer

mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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.

Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.

fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks. Information on the lot/batch number has been requested.

Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak. Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown. Information about lot/batch number has been requested.

He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pain and pain in his right arm, hand, and wrist area; He also has joint pain and pain in his right arm, hand, and wrist area; Diarrhea; He is also very fatigued and does not want to get out of bed and that he is so tired; off and on headaches; This is a spontaneous report from contactable consumers. A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 11:28 (also reported as about 1130) at a single dose on left arm for COVID-19 immunization. Medical history included pulmonary fibrosis from 2014 and ongoing, ongoing type 2 diabetes mellitus (Diagnosed probably in 1996-1997; under control). The patient previously had pneumonia shot in 2020 and flu shot in 2020 (few months ago in Oct2020/Nov2020) both for immunization. The patient's concomitant medications were not reported. The patient experienced diarrhea, very fatigued and does not want to get out of bed and that he is so tired, and off and on headaches, all on 07Jan2021. He also has joint pain and pain in his right arm, hand, and wrist area on 11Jan2021. He experienced coughing, somnolence, and had aches and pains on an unspecified date. Patient received the vaccine last Wednesday. He experienced diarrhea (on Thursday and Friday, went away then came back on Yesterday), had aches and pains, and severe fatigue (all I wanna do is sleep). Today he said that he wasn't having diarrhea that can be attributed to him not eating much yet, a few aches and pains, very tired, and a minor headache. He was asking how long do these symptoms usually last. Patient received it last Wednesday 06Jan2021 at about 1130. He said that he has been experiencing side effects, not severe, but on Thursday 07Jan2021 and Friday 08Jan2021, he had diarrhea. He said that on Saturday 09Jan2021 the diarrhea let up and Sunday 10Jan2021 was ok, but yesterday 11Jan2021 the diarrhea was bad. He said that he is also very fatigued ("severe fatigue (all I wanna do is sleep)") on 07Jan2021 and does not want to get out of bed and that he is so tired. He has had no fever, but has had off and on headaches. He said that he also has joint pain and pain in his right arm, hand, and wrist area. He said that it is hard to pick up a cup or glass because of the pain. He said that he got the injection in the left arm. He said that he is also experiencing coughing, but stated that he does have pulmonary fibrosis and it could be that. Diarrhea: patient said that his diarrhea is improved as of today 12Jan2021. Fatigued: he said that he noticed it on 07Jan2021, it subsided Saturday 09Jan2021 and Sunday 10Jan2021, but yesterday and today 12Jan2021 it is very prominent and he is very tired. Headaches: He said that the headaches are not severe, but they were there. He said that the headaches are not there today. Pain in the arm, hand, and wrist area: He said that he noticed the pain yesterday and stated that it is slightly worse. Coughing: He said that he coughs due to the pulmonary fibrosis too and sometimes it is a lot and sometimes it is a little bit. He said that he has to get his second dose on 27Jan2021 at 1500. He stated that his brother died of Covid last Thursday. The outcome of event diarrhea was recovering, of "he is also very fatigued and does not want to get out of bed and that he is so tired", "he also has joint pain and pain in his right arm, hand, and wrist area", and "coughing" was not recovered, of "off and on headaches" was recovered on 11Jan2021, of the events "all i wanna do is sleep" and "had aches and pains" was unknown. No relevant tests. No prior vaccinations within 4 weeks. No family medical history relevant to AE.

Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns to bed at least two times per day, feel rested but upon rising to side of bed becomes weak again. Complaining of shortness of breath. Concerned about COVID infection; states had three negative tests with last test being in December. Was evaluated by Dr. with Family Medicine (his primary care provider was not available) and was prescribed Prednisone 20 mg QD x 5 days and Erythromycin 250 mg QD x 5 days; both have been completed. During office visit lungs were evaluated and reported as clear; physician mentioned a COVID test but none was obtained. Has continual cough with asthma, but feels symptoms have gotten worse since the COVID vaccine; "can't get his strength back". States the weakness, cough, shortness of breath, and joint pain have remained the same since first day noticed and has not seen any improvement since completing Prednisone and Erythromycin. Not on O2; states O2 sat is around 98 - 99%; uses a C Pap Machine. Wished to schedule a COVID test; appointment given for 2/3/2021. Denies dyspnea beyond usual SOB; instructed to seek emergency care if symptoms worsen; indicated understood and would do so if needed.

1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process

little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell due to temporal relationship Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.

1. At approx 11PM , Tues. my left arm started to hurt and was a bit stiff. By 6AM, my neck was stiff and I could not move left arm because of pain. I went to bed and when I got up Wed at about 1:30pm, I experienced a lot of pain in my joints and I could not get out bed. I also felt light headed. This lasted the whole day and night. I slept most of the day. The next day, Thur, I was better however, my joints were still hurting. Saturday morning it appears that I was ok.

Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia

soreness on left shoulder; stomach spasm; vertigo; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (lot number: ek4176), via an unspecified route of administration in left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included glaucoma, gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia (Bhp), and cholesterol. Concomitant medications included tamsulosin, metoprolol, and travoprost. Patient experienced soreness on left shoulder, stomach spasm and vertigo started on day 4 of vaccine on 15Jan2021 21:30. Patient went to hospital ER on tenth day after vaccine and released from hospital ER after 2.5 hours. AE result in: Emergency room/department or urgent care. Treatment was not received for these events. Outcome of the events was resolving.

Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired

very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four days later very week and unable to do much activity

dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.

Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered

Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation

Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting for 3-4 days.

No problem at first 9 days after injection I woke up with a very sore spot of the injection/his arm is hurting, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in/could be a sign of an infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El3247; expiration date: unknown) at vaccination age of 76-year-old via an unspecified route of administration in the left arm on 02Feb2021 12:00 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/veterans administration facility. The patient reported that there was no problem at first 9 days after injection. He woke up with a very sore spot on the injection on 11Feb2021. The event did not received treatment for the adverse event. The patient considered the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient further stated that got the Pfizer Covid vaccination on 02Feb2021, but he had no reaction and everything was fine. He mentioned that this morning (11Feb2021) which was 9 days later, his arm was hurting. He stated that it was his left shoulder and arm, the same arm he received the injection in which was given the injection by the employer. The patient wanted to know if it is normal to experience this type of reaction 9 days later. He was wondering if it could be a sign of an infection. The patient was encouraged to reach out to his healthcare provider. The outcome of the events was not recovered.

Swelling of the right foot; joint pain in the right big toe; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9265), via an unknown route of administration on 01Feb2021 at 08:30 (at the age of 76-years old) as a single dose in the right arm for COVID-19 immunization). Medical history included arthritis from an unknown date and unknown if ongoing. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included tizanidine hydrochloride (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) from an unknown date. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 02Feb2021, the patient experienced swelling of the right foot and joint pain in the right big toe. Therapeutic measures were not taken for the events. The clinical outcome of the events peripheral swelling and arthralgia was recovered on an unknown date in Feb2021.

Exacerbation of previously controlled hypertension with blood pressure spiking to 200/100; Had skeletal chest pain; doing well until Covid vaccine; This is a spontaneous report from contactable physicians (one of which was the patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration at the right arm on 22Jan2021 08:30 at single dose for COVID-19 immunization. Vaccination was done in a TN. Medical history included CABG Post op RT CABG (coronary artery bypass; doing well until Covid vaccine) from 11May2020 and hypertension. Concomitant medication included metoprolol succinate (TOPROL), ubidecarenone (COQ10), losartan and Hybrid. There was no other vaccine receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took atorvastatin (LIPITOR) and experienced allergies: Lipitor. The patient experienced exacerbation of previously controlled hypertension with blood pressure spiking to 200/100 on 26Jan2021, went to local ER, BP 180/100 there on 26Jan2021. He had skeletal chest pain which began 25Jan2021 22:00. He stated post op right cabg from 11may2020, doing well until covid vaccine on 22Jan2021. Treatment IV Hydralazine received. The events were considered non-serious by the reporter. On 26Feb2021, it was reported that the patient provided information to another physician regarding the reported adverse events with the use of BNT162B2. The physician did not consider the Pfizer product had a causal effect to the adverse events. Lab data also included Covid test (rapid nasal swab) on 26Jan2021 was negative. The outcome of the events was not recovered. Follow-up (26Feb2021): New information received from a contactable physician in response to HCP letter sent includes: reporter details (added a physician as a reporter), causality assessment and clinical course details. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT62B2 to the events hypertension aggravated, skeletal pain and unwell cannot be excluded. The fluctuation of underlying hypertension may be major cofounder. 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.

Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip strength. Normal range of motion is still present but stregth is significantly diminished and has reurtned only minimally. Right arm is normal.

My body ached everywhere. This was similar to the onset of a cold. The injection site on my left shoulder started to get stiff and aching according to #5 above. This spread throughout my body. The discomfort subsided by 9:00 a. m. on 03/12/2021. The duration seems to have been 36 or so hours. I feel good as of 11:30 a. m. 03/12/2021. I am providing this information if it is useful for any CDC purposes statistical or otherwise.

symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose. The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.

Sore developed under the bandaid placed on injection site; there was a big red dot and it was itchy; there was a big red dot and it was itchy; Also both my arms are stiff and i have some pain.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot #: El9263), via an unspecified route of administration on 28Jan2021 09:30 at single dose at Left arm for covid-19 immunization. Medical history included stents for my heart. Concomitant medication included metoprolol, acetylsalicylic acid (BABY ASPIRIN), furosemide and clopidogrel. The patient previously took gefalexin and levaquin and experienced drug hypersensitivity. On 29Jan2021 08:00, sore developed under the bandaid placed on injection site and the patient reported as, he received first dose on 28Jan2021, right afterwards the next morning I removed the band aid they had placed and there was a big red dot and it was itchy. Also both my arms are stiff and i have some pain. I got the injection on the Left arm but the Right arm feels the same. I spoke with my doctor he told me to put bacitracin on it for few days but it's still there. It's less itchy but the red dot is still there its 2-3 inches from the injection site and also said, I think I'm going to skip the second dose. A red sore developed under the band aid that was applied to cover the injection site. It is under the right edge of the band aid. The area where the exact needle penetrated is healed. Both arms are sore at the top by where they meet the shoulder. Outcome of the events were not recovered.

I received the second Pfizer shot on March 1st. My initial reaction consisted of a couple of days of flu-like systems that abruptly went away. Then a week ago I came down with what appeared to be an intestinal bug. My subjective sense is that my immune system got confused and is now mounting random immune reactions - chills and fever, severe back pain, diarrhea, etc.

Received vaccine on March 18th. Was very tired that day. March 19th slept most of day, had muscle aches. Saturday, March 20th had fever, muscle aches, headache, fatigue. March 21 had all the above but short of breath. March 22, in the hospital with fluid in the lungs, very high blood pressure, short of breath, on oxygen.

Pains in hips and hands, lesser pains and some stiffness in other joints and muscles. This is typical of when I get viral diseases such as colds and flu, except that there were no cold symptoms in my head. First noticed when I awoke the day after my second shot and lasted into late afternoon. OK after that.

Non arteritic ischemic optic neuropathy in one eye; swelling/joint inflammation in one hand. Started several days after 2nd Pfizer Covid-19 vaccination.

Same evening of vaccine injection 3/24 - chills and severe headache and extreme fatigue. Overnight - nausea, vomiting and fever 102.6. Next morning 3/25, woke up and tried to get out of bed. Legs were so weak they gave out and I fell out of bed on the floor. I had no strength to get back up to get on the bed. My wife could not lift me, so she called 911 for a "lift assist". Paramedics were told I received the 2nd dose of the Covid vaccine the day before, so they picked me up off of the floor and put me back in bed. They took my vitals - blood pressure was 116/73 and temperature was still 102.6. Paramedics offered to take me to the hospital but I refused. Paramedics told my wife that if my breathing became labored, she should get me to the ER or call 911 again. I was not able to get out of bed the whole day on Thursday 3/25, because I was so weak I could not stand up, and I also had body aches and had to use a urinal because I could not walk to the bathroom. My wife gave me Tylenol and the fever finally broke late evening of Thursday 3/25 and I started to feel a little bit better. I had not eaten all day, but my wife made sure I stayed hydrated with water. On Friday morning 3/26 I was able to sit up on the side of the bed, and I was able to walk with the assistance of a cane to the bathroom. Extreme fatigue affected me all day Friday, but I did feel better. Fever did not come back after it broke. Saturday 3/27 - still experiencing extreme fatigue, but feel better overall.

12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k

feeling unwell; muscle weakness; excessive tiredness; loss of appetite; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store on 09Mar2021 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and it was unknown if COVID was tested post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]), atorvastatin, and donepezil. On 10Mar2020 at 08:00 AM, the patient experienced feeling unwell, muscle weakness, excessive tiredness, loss of appetite, fever, and chills. The reporter considered the events as serious due to hospitalization. The events resulted in emergency room/department or urgent care. It was unknown if treatment was given for the events. The patient had not yet recovered from all events.

It was itchy like crazy; both of his arms are as stiff and achy at the top; both of his arms are as stiff and achy at the top; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9263) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had two side effects and the second shot would be coming up and he was nervous about what he should do. The main side effect is that they put a band aid on where injection was to protect site. The next morning, he took it off and on the edge of the band aid, there was a red dot about 1/8 to 1/4 inch around. It was itchy like crazy, he did not scratch it. That dot was staying there. The doctor told him not to do anything to it and just put a little bacitracin on it. He did not provide any information for the Bacitracin such as a dose, lot or expiration. The next side effect was both of his arms which was stiff and achy at the top. The injection arm feels exactly like the right, but only the left one got the injection. He would like to know if he should be concerned with second dose or not. The outcome of the events was unknown.

experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; ache all the way around his waist; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration in the left arm on 08Feb2021 14:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient experienced ache all the way around his waist from his front to around to his back and it is pretty intense. After receiving first dose, the next day on 09Feb2021, he experienced pain on hips, trunk, lower stomach and back. He saw on the article not to take ibuprofen, tylenol or advil. He spoke to his Dr. and said never heard about such an article. He wants to check with someone if he can take tylenol because of pain. The reported events were considered as non-serious by the health authority. The outcome of the events ache all the way around his waist was not recovered, for experienced pain on hips, trunk, lower stomach and back was unknown. Information on Lot/Batch number has been requested.

Woke up with very stiff neck Neck sprain, subsequent encounter Breast pain in male Unclear etiology, no obvious mass on exam no axillary adenopathy, mamogram pending Patient's axillary and shoulder pain may be secondary to Covid vaccination.

Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received the 2nd Covid-19 Pfiser Vaccine on Thursday, March 4, 2021. 7 days after second vaccine shot on Thursday, March 11, 2021, patient showed some symptoms of a itchy-horsed throat & a slight dry cough. Called doctors - they said nothing to worry about, drink hot fluids and take couch drops. It went away in 2-3 days. Exactly 4 weeks after second Covid-19 Pfiser vaccine on Thursday, April 1st 2021, patient was sent to the ER for a seizure.

I had the second shot at the same place on 2-11-21. At the time, I only had soreness of the left arm at the injection site and virtually no other symptoms except a mild headache for a few hours. However, during the month or so between the vaccines and post-vaccine period, I developed pain in both shoulders with moderate-severe rotator cuff symptoms. This was pain in reaching in almost any direction. Also, I began to notice heaviness in both upper legs, front and back, which in a week or so progressed to tiredness and then to achiness, and finally to pain when I would squat, bend over, or get up from a chair. I have never had either symptom before.

1st shot, none. 2nd shot, 22Feb21 fatigue joint and wound soreness. Soon diminished.. But, I got shot through my throat and shoulder in RVN ?68 and a deep gash to my inner right forearm 11Sep01 exposing my bones and severed arteries. 2 months later I still feel tightness/constriction, soreness in my lower throat and upper lungs when I breath deeply such as running, exercising or sex to the point I have to slow down. Also my right forearm is no longer sore but still feels a little swollen.

Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.

Sore neck muscles in back for 2 days; Sore neck muscles in back for 2 days; The initial case was the missing following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982) via an unspecified route of administration in left arm on 30Jan2021 at 12:10 (at the age of 76-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. In 2021, the patient experienced sore neck muscles in back for 2 days. The patient was asked if it is possible to take the second dose to different place. The patient did not receive any treatments for the events. There was no admission to hospital involved due to the events. The outcome of the events was resolved in 2021. The patient was scheduled to get the vaccine after 4 weeks. On 26Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration at single dose for Covid-19 immunization. The patient had no discomfort after second dose. Follow-up attempts are completed. No further information is expected.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

3/15/2021: Received first Pfizer COVID-19 vaccination Lot EN6202 3/18/2021: Began experiencing severe widespread aching and stiffness of major muscles upper arms, shoulders, neck, lower back, and thighs. Severely debilitating. Tried over the counter anti-inflammatory medicine were ineffective. 3/26/2021: When into Patient First Clinic with severe muscle ach complaint. They ran many blood tests/results in normal range. Chest X-rays, urine, and an EKG. Referred to the Nova Center for Arthritis; earliest appointment 4/19/2021. 4/12/2021: Returned to Patient First due to no improvement. Chest X-rays taken and Methylprednisolone 4 mg Dosepak. Pain, aching and stiffness completely subsided withing 2 hours of first dose. 4/17/2021: Last day of steroid treatment. Pain returned on the 18th. 4/19/2021: Nova Center for Arthritis appointment diagnosed with Polymyalgia Rheumatica. Prescribed long term steroid treatment (Prednisone). 4/26/2021: Learned from P.A. that assisted on surgery on wife in November that she was out of work for four months following her first Pfizer COVID-19 vaccination. Her symptoms were same to mine and showed up 3 days after shot.

After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain was so bad that my dad went to ER and had a Pulmonary Embolism . He was hospitalized two nights. After the second vaccine: right leg pain, weakness in both legs. Three days after the second dose, my dad had a stroke.

Muscle and joint pain after second shot. Put on diclofenac, topiramate,methoccarbamol,tylenol, and predinsone. Only prednisone works. Still having problems

Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Severe right shoulder joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. Patient was not allergies to medications, food, or other products. Concomitant medication included amlodipine, valsartan, and finasteride. In Feb2021, the patient experienced swelling, redness, hard lump, and a small blister at point of injection in the right arm, severe right shoulder joint pain. Treatment was not received for the adverse event. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Reddness occurred recently, both arms; hard lump at the injection site; Severe right shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in left arm on 18Mar2021 at 10:15 (at the age of 76 years) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included Amlodipine/Valsartan 5/160mg Tab, Finasteride 5mg. Patient was not aware of allergies. The patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number:EN6205) via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 as single dose for COVID-19 immunisation and experienced swelling, redness, hard lump and a small blister. Patient was not diagnosed with COVID-19 prior the vaccination. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, reddness occurred recently both arms, had a hard lump at the injection site and severe right shoulder joint pain. The patient did not receive treatment for events. Patient was not tested for COVID-19 since the vaccination. The outcome of the events was not recovered. No follow up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 19Mar2021, the patient experienced left kneecap went numb/started to come back, but just a little bit around the edge of the kneecap (hypoesthesia); on an unspecified date, the patient experienced knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning, knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning (gait disturbance), back pain, starting in the lower back and it kept getting worse, up my back, pain the size of a dime, like where your kidney is, lasting about 30 seconds, then it would wrap around to my appendix, bothered me all day (back pain), soreness to their arm where the injection was given. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Extremely Swollen and extremely red left elbow; Extremely Swollen and extremely red left elbow; This is a spontaneous report from a non-contactable consumer. This 76-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route in the left arm, on 11Feb2021 12:00 (at the age of 76-year-old) at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included methotrexate and calcium folinate (LEUCOVORINE). On 11Feb2021, the patient developed extremely swollen and extremely red left elbow. The events were assessed as non-serious. Both events required emergency room visit. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. This Consumer reported that a 76-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Jan2021 as 1 ST DOSE, UNKNOWN for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that her husband experienced only shoulder pain. She stated my husband had a sore arm, he (Husband) was fine, he was good with it he just had a sore. The outcome of the events was unknown.

Day #13 following the 2nd shot, patient experienced severe pain in his left knee and began running fevers. Past medical history includes a surgical infection in 1979 leading to 3 knee replacements in this knee. His hardware extends from mid- thigh to his ankle. On 4/21/21 he required a revision of the total knee (the plastic was replaced) after flushing out the wound with antibiotic solution. He is now on oral and IV antibiotics (Rifampin & Vancomycin, respectively). He is being followed mainly by infectious diseases and ortho, but to my knowledge, this has not been reported by them or his PCP.

After the second covid shot I immediately started having having lower back pain. Since I've had this before, I knew it was caused by Inflammation. All I took for it was Acetaminophen. Some days none, some days 1. Never more than 1. Yesterday 5-24-21 it completely quit. I was amazed. Thought you should know. Thank you for your time.

jaw bone like what hooks onto his head gets achy; it gets achy and is weird; terrible muscle pain and joint pain; little shaky when getting out of the chair; terrible muscle pain and joint pain; his hands joint do not work right; This is a spontaneous report received from a contactable consumer or other non hcp (patient himself). A 76-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP7534, Expiration date: Unknown), via an unspecified route of administration in Arm Left on 18Mar2021 10:30 as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks and no adverse events prior vaccination. There was no family history relevant to adverse events. The patient previously received first dose was received in his left shoulder as an injection on 25Feb2021 10:30 and the lot number is EN6200. On 19Mar2021, the patient experienced terrible muscle pain and joint pain, little shaky when getting out of the chair, on unspecified date in Apr2021, experienced jawbone like what hooks onto his head gets achy, it gets achy and is weird and on unspecified date in 2021, experienced his hands joint do not work right.. It was stated that he was calling to report what has happened to him from the second shot. The patient stated he got the shot on 18Mar2021 and when he woke up in the next morning he had terrible muscle pain and joint pain so he decided to call his doctor. The patient stated he could not get a hold of his doctor but the information that was given to the caller was provided from the nursing staff. It was stated that before he got the COVID shot he was working out with weights in the fitness center and doing really good and now he was fighting a battle. The patient stated also his jawbone like what hooks onto his head gets achy. The patient stated that mostly the joint pain was in his shoulders. It was stated he was sitting down on his chair and he used to be able to get up real easy but he now he was a little shaky when getting out of the chair now. The patient stated also his hands joint do not work right but he bought some stuff to rub on them which seems to help a little bit, but he has never had any of this before. It was stated he was working out, handling barbells, and for an old guy people would be surprised what he was lifting and he had no problems and stated for example if he goes to eat a breakfast meal with the egg, sausage, and biscuit he can barely open his mouth enough to eat it. The patient stated this started probably at the end of April. It was stated this is no 24 hours a day but he had it this morning and it gets achy and was weird. It was stated that eventually he will go back to the dentist since the dentist has a machine to take a picture of his jaw since he has not gone yet because of COVID but once he gets all this squared away he will go to dentist so they can take that picture. It was stated he was able to squat down towards the floor and go way down all the way down and pop right up and stated he knows he could not do that in the last couple of weeks anyway but he has not tried it since he has had trouble getting out of chair. It was clarified that this started as an introduction the day after getting the second shot on 19Mar2021 and it was still going on. It was stated he was not sure if it is getting worse or not since he has not followed it like a documentary. It was stated the doctor told him to take Tylenol and he has never had anything like this happen to him. It was stated what the doctor relayed to him was to go get a Tylenol rapid release and he takes two pills which is 1,000mg and he takes this 3 times a day and has a schedule knowing it was not recommended to take more than the 3,000 since the doctor was not wanting him to go over 4,000mg because effect the kidneys or liver. It was stated but he had not talked face to face with his doctor and he needs to get an appointment with his doctor but there is a wait and probably won't be able to see him for about a month. The outcome of the events terrible muscle pain and joint pain, jawbone like what hooks onto his head gets achy were not recovered and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

he did not feel well; he then got tested for covid and tested positive for covid; he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed; he did not want to eat but could smell and taste food but did not want to eat it/ loss of appetite; he started feeling drowsy/ kept falling asleep/ dozing off; the next day started feeling very tired/ tiredness; lost about 12 pounds; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Feb2021 10:30 (Batch/Lot Number: EN5318) at the age of 76-years-old as first dose, single in the left arm for COVID-19 immunisation. Medical history included acute pancreatitis, diagnosed about 10 years ago (2011) and cirrhosis liver, diagnosed maybe 7-8 years ago. The patient's concomitant medications were not reported. The patient previously took Hepatitis A vaccine on 03Feb2021 and has no dosage, lot number, expiry date to provide. The patient stated that he was calling about the Pfizer COVID vaccine and stated that he had the 1st dose on 18Feb2021 10:30 and did not get the 2nd dose; stated that he had the first dose and the next day (19Feb2021) started feeling very tired and thought it was a result of the shot and it lasted until the following Friday, 26Feb2021 and he then got tested for covid and tested positive for covid on Friday 26Feb2021. The patient stated that his healthcare professional (HCP) sent him for an infusion that day and hooked him up to the infusion and said it would help him get better faster and the patient does not know the name, dosage, lot, expiry date of the infusion and has none of that information to provide. The patient stated that he was told he can't get the 2nd shot for 90 days after the infusion and heard that he could get it and the infusion center told him he would have to start all over again with the 1st shot of the Pfizer COVID Vaccine and he does not know but has heard different stories and some say he can get the 2nd dose of the vaccine and others say no he has to wait 90 days after the infusion and he called the facility and the HCP said he would have to wait 90 days after the infusion; states the facility said to wait 90 days and he was told they are going by the agency. The patient stated that his patient card for the Pfizer COVID Vaccine says he was supposed to go back for the 2nd dose on 11Mar2021. The patient also stated that when he went home after the Pfizer COVID Vaccine 1st dose he felt fine and got up and went to work and was fine and then noticed at work he started feeling drowsy (on 19Feb2021) and usually works in the street outside but was in the office that day; patient stated that he started dozing off and then the next day on Saturday (20Feb2021), he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed and he went to go to work the following Monday and Tuesday and Wednesday and kept falling asleep in his office and then it was finally Friday. The patient also stated that he did not want to eat but could smell and taste food but did not want to eat it on 19Feb2021 and the following week he took the whole week off of work and lost about 12 pounds; he also stated that the tiredness lasted into the following week and the loss of appetite, dozing off is not ongoing and lasted probably a good three weeks total until he started feeling from the day after the vaccine on 19Feb2021 for three weeks and then he started feeling more like himself. The patient stated that he was fine up until he did not feel well and it was not probably from the vaccine but was just a coincidence the next day when he started feeling tired and he does not know the results from the vaccine but got worse and worse and could not function normally like he is supposed to and just wanted to lay down. The patient stated that he did not have treatment for the reported events. The outcome of the event "the next day started feeling very tired/ tiredness" was recovered on 26Feb2021, for events: decreased appetite and somnolence was recovered on an unspecified date. The outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

extreme muscular fatigue/discomfort on exercise, "trigger finger" in both hands, diarrhea, sometimes explosive. Course - persisting since mid-April - unresolving muscular fatigue, continuing bilateral joint stiffness in hands, left thumb continues to have trigger finger.

lost strength in left thigh and then all the muscle seemed to melt away in about a week. Still can not support self from left knee, it gives out and I fall

Patient wanted the Shingles shot but unfortunately got the Covid shot. The Immunization Alert system checked before administration showed no records of a previous Covid shot. But after the shot patient presented us with his CDC card showing the Covid series completed in March 2021. He was ok. We informed his doctor on June 10th and upon follow up with patient he said his body temperature was very low and he had pain in his joints.

Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; Herpes zoster right buttock with associated inguinal and penile pain.; This is a spontaneous report from a contactable Physician. A 76-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El9263) via intramuscularly in right arm on 03Feb2021 at 08:30 AM as 2nd dose, single dose for COVID-19 immunization at Clinic. Medical history included crohns, allergic to some seafood, hypertension, hyper cholesterol. Concomitant medication included adalimumab (HUMIRA). Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- El3246) via intramuscularly in right arm on 13Jan2021 at 08:45 AM as 1st dose, single dose for COVID-19 immunization. On 09Apr2021 at 14:00 PM, patient experienced herpes zoster right buttock with associated inguinal and penile pain. Therapeutic measures were taken as a result of the events included Ibuprofen, acetaminophen, lotions. Patient had not been covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible . No further information is expected

Lost weight; He had no appetite; Stomach cramps; Dehydrated; Tired; no energy; Confused; Headache; Diarrhea; Not digesting food; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EL9269), in left shoulder on 13Feb2021 06:30 as dose 1, single for covid-19 immunisation (76 years old when vaccinated). Medical history included damaged his thumb a couple of years ago. There were no concomitant medications. The patient reported that he got the shot this morning. After he got the shot on 13Feb2021 he had to wait for 15 minutes before he could leave. While waiting the 15 minute time period he got a slight headache at that time. He later stared to drive home and realized he was feeling confused. He decided to get something to eat and that did make him feel better. However, he felt like he was not digesting his food all day. He felt like he was still bloated. He was not processing the food he had eaten. He added, the food he did eat he thought the eggs were not done. Normally, he would not eat them, but he was in a hurry. After that he did not eat any food. He was unable to eat any food. Later that day he began to have a bad reaction. He felt extremely tired. He then started to lose his body fluids. He would sit down and it would run out of him. He decided to quarantine himself. He stated he could not use the internet because he lives in a place where they do not have internet. He was tired, had no energy. He just kept losing body fluids constantly. He has lost weight. He felt dehydrated. Stated he did not have a fever. He had a thermometer and was checking it every hour. It felt like at the time when events first started he was getting worse and worse and so he just laid there. He stated he does not know his current weight. He was dehydrated so bad. He lost so much weight his shoes does not even fit his feet. Later, he confirmed he no longer has a headache. He last had a headache slightly yesterday. He added that the headache could have also occurred due to lack of eating. He had no appetite. He was unable to provide if recovered completely or recovered with lasting effects when probed for outcome. He stated he just felt ran down. He clarified losing body fluids as he had like water, like diarrhea, it was running right out like it would out of a body bag. He could not stop it from coming. It would happen every few minutes. He confirmed that he no longer has diarrhea. He had started taking Kaopectate. He reported that he last had diarrhea a little yesterday morning. He does not have it anymore. He just has no energy left. He would lay down because he was so tired and then he started having the diarrhea and it kept getting worse and worse. He ate a little this morning, a breakfast roll. The day he got the vaccine he was so tired. He slept a lot. This was early afternoon. He got up because he realized he had made a mess with the diarrhea. He started having stomach cramps the night of 13Feb2021. He had some when he laid down. He still had some last night when he laid down. He does not know if the stomach cramps have resolved yet, stated he is still waiting to see. He will have to see when he lies down. However, he is trying to get out and about to get some things done and get something to eat. He stated he was taking Tylenol, but the Tylenol was mainly for the stomach cramps. By 14Feb2021 he started to feel dehydrated. He felt that by then he had already stopped up the sewage system. He was taking electrodes from (Pharmacy) due to the dehydration. He knew this was going to be a problem. Therefore, someone went out and got this for him. He stated that he feels better overall. He will truly see when he tries to get something to eat. He stated he does not take any medications whatsoever on a regular basis. He added, the guy who gave him the shot caller does not believe he has given too many shots before. He thought he was a rookie. He stated he went too high to begin with. He said that normally, shots don't hurt with him and this time it did slightly. He reported that he gets the flu vaccine every year. He was supposed to get the second shot 06Mar2021, but he was not sure about if he should get it and has questions about that. The outcome of the event headache was recovered while diarrhea, he had no appetite, lost weight and confused was not recovered. The outcome of the event not digesting food, dehydrated and stomach cramps was unknown while the outcome of tired; no energy was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot. The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered and outcome for other events was unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter

pain in right elbow and both knees; pain in right elbow and both knees; fell down; he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse; had a problem in his left back, and then went to his left shoulder; had a problem in his left back, and then went to his left shoulder; bedridden; knees have gotten weaker; more scared; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical in-formation team. Pfizer sponsored program (CEP ID: 159558). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176) via an unspecified route of administration and administered in right arm on 01Jun2021 10:00 (at 76 years old) as dose 1, single for COVID-19 immunization in pharmacy. The patient medical history included ongoing high blood pressure diagnosed maybe over 10 years ago. The patient concomitant medication include allium sativum (KYOLIC) taken for high blood pressure 2 tablets, formula 100, 600 mg (It was a cardiovascular formula. He substituted this because he did not like what he was taking before); vita-min c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for something i guess for cold (been taking all his life) 500 mg; fish oil (OMEGA 3 [FISH OIL]) taken for something that builds you up (started taking years ago) at 100 mg once daily. The patient did not had any AE(s) following prior vaccinations, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine, no family medical history relevant and no relevant tests. There was no history of all previous immuniza-tion with the Pfizer vaccine considered as suspect. On 02Jun2021 (in the morning when he tried to get out of the bed) patient experienced pain in right elbow and pain in both knees after 1st dose and last-ed days, then weeks, and continues to on and off. Tried getting out of bed and he fell down and went to the hospital. Patient stated that he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse since the vaccine. Reported that on an unknown date in 2021 he had a problem in his left back, and then went to his left shoulder and that he was "practically bedridden for days, and then weeks after the first dose, things have been different since the Pfizer shot and my knees have gotten weaker". Patient provided information that he does take a ginger supplement in the mornings. Next morning patient did not use a full breakfast, he wanted to know if he had done some-thing to make his body feel different. Patient stated that he was more scared now than he was before the shot because he does not know if he was protected. The reporter said that he expects that pain and aches could be symptoms of the Pfizer shot but he did not know if this experience was normal. Patient was supposed to get the second COVID vaccine on 22Jun2021, but he had pain 3 days after the received the first shot. He stated the pain was in his right elbow and both of his knees. He mentioned that he missed his second dose because he went to the hospital to get checked out. Patient wanted to know why he had been experiencing this pain for 3 weeks now and would like to know if it was ok or if he was in danger. Patient confirmed that he went to the hospital because of everything that was hap-pening to him. He stated one night, a Thursday, before he went to the hospital, which was the follow-ing week, all of the sudden woke up and had to go to the bathroom. He tried to get out of bed and he fell. He could not get up off of the floor, because his knees were not strong enough to push himself up. He told the hospital everything that happened to him. Patient stated the problem started after the first shot. They proceeded to give him a scan for his brain and his back. After, they wanted to scan his knees. He told them he came from an (withheld) where he played soccer and rode bikes. He has had problems with his knees bothering him, but not both knees at the same time. He said they wanted to scan his knees. He told them he had problems before and he uses hot water and salt, and his knees were fine. He does not think his knees are the problem, he has a different problem. They said fine, you do not want it, fine. Then they said they would do a chest scan. He has not had any problem for three weeks. No problem with breathing or anything. He wanted to find out what happened after he got the shot. Patient stated he was never in immediate pain. He had pain with movement. For three weeks he was only going to the toilet. He almost fell on the toilet and could not get up because his knees were so weak. He had to take like 10-15 minutes trying to get off of the toilet. Patient stated now he was sitting, his knees have no pain. But when he gets up he knows his knees will hurt. Pain on his right elbow, clarified that the pain in his elbow started on 2Jun2021. Patient was using his elbow to push himself up from lying down, and said very very rarely he has any problem in his elbow. His elbow was okay after a couple of days. If he was in bed he usually uses his elbows to roll over. Stated that he has recovered about 95%. He stated he was 76 years old, he was not young anymore. Patient con-firmed his elbow and knees began to hurt after receiving the first COVID-19 vaccination. He stated it was debilitating when he was trying to get out of bed or sit or stand up. It was immediate, but not the day that he got the vaccine. It was all around him trying to get out of bed and do certain thing that he needed to do and he found that he could not get out of bed; unable to clarify further. Patient unable to provide start date. knee pain: He said it is not causing any irritational pain when he is sitting down. When he tries to get up he can feel the stiffness in his knees. At that point he knows there is a problem in his knees. Patient stated when he went to the hospital they told him they were going to take some blood. He turned away from what they were doing and they gave him some kind of intravenous. He was in the hospital for over an hour. After he questioned them about the first test, and there was no problem. When they said they were going to do his knees and his chest, which was a complete set of tests that they were doing, it has nothing to do with what he was experiencing. He thought he was ex-periencing something from Covid and he was wanting to know if he was going to die. They did not seem to care about what his problem was. He thought COVID had a system where people would be tested for reactions and things like that. Has had problems with his knees off and on maybe once or twice a year but has never gone to the hospital for them. Sometimes his brain does what it wants to do. There was no additional vaccines administered on same date of the Pfizer suspect. Patient visited the emergency room. The patient underwent lab tests and procedures which included chest scan, scan brain on an unknown date with unknown results. The outcome of event pain in right elbow was recovering and pain in both knees and fell down was recovering, outcome of event pain in right elbow and both knees was not recovered, outcome of events had a problem in his left back, and then went to his left shoulder, gotten worse, bedridden, knees have gotten weaker and more scared was unknown. Follow-up attempts are completed. No further information is expected.

moved to lower back pain; joint pain first day; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included barretts esophagus. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccine, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included pantoprazole (PANTOPRAZOLE) 40mg for unknown indication and from an unknown date. On 24Mar2021 at 08:00, the patient experienced joint pain (first day). Went away and next day moved to lower back pain. Continued and seems to be worsened. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of events joint pain and lower back pain was not resolved. No follow-up attempts are needed. No further information is expected.

he got pain on his shoulders; problem on my left shoulder really bad; arthritis/his hands have been arthritic; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. Medical history included Heart attack from 2000 to an unknown date, Blood pressure high from an unknown date and unknown if ongoing. The patient took first dose of BNT162B2 (at the age of 76-years-old) (LOT: EN5318) on 25Jan2021 for covid-19 immunization and experienced my right shoulder was hurt. Concomitant medications were not reported. On an unknown date the patient experienced he got pain on his shoulders, problem on my left shoulder really bad, arthritis/his hands have been arthritic. The patient reported that after the second shot started having problem, on my left shoulder really bad. It occurred after. The patient reported that he had a heart attack back in 2000, might been high blood pressure which he regulates with medications and he takes several medication. He stated that after he received the second dose he got severe side effects, he got pain on his shoulders, he said it was arthritis and his hands his hands have been arthritic ever since. He would like to know if there any other cases like these. The patient underwent lab tests and procedures on an unknown date which included blood cholesterol: all came back good, blood test: all came back good, physical examination: all came back good. The outcome of all the events was unknown.

my right shoulder was hurt it when I rotated cup it was 2 weeks prior and after the second sho; This is a spontaneous report from a Pfizer-sponsored program. A 76-years-old male patient (who is also a reporter) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 25Jan2021 as 1st dose, single for Covid-19 immunisation. Medical history included heart attack in 2000 and high blood pressure which he regulated with medications. Concomitant medications included patient took several medications. On an unknown date, patient reported his right shoulder was hurt it when he rotated cup it was 2 weeks prior and after the second shot started having problem, on his left shoulder really bad. The patient underwent lab tests and procedures which included blood cholesterol which was a normal blood work up for cholesterol and everything just a normal like a check-up for physical whatever all that is and result was reported as all came back good. The outcome of the event was unknown.

within a week of the second shot the patient began to have problems with both legs, such as burning in both legs, continued weakness, and when he walks his feet want to go in one direction and he wants to go in another. It is now July 25, 2021 and his legs are no better.

Chills, low grade fever, generalized muscle aches, headache . Lasted approximately 36 hours. Treated with Tylenol and Inuprofen.

Rather sudden onset of severe weakness of legs and unable to stand up from chair without assistance of wife or walker

Muscle pain from mid back down to hips. Treatment includes Aleve and heating pad without improvement.

The night of vaccination (Sat): Pain at right side hip bone difficulties falling in sleep The next day (Sun): Pain at right side hipbone when I bend to put on socks, sit down, get up, or walk. No pain while sitting in one position. The night the next day (Sun): The pain subsided enough that I could fall asleep. Two days later (Mon): The pain reduced enough that I could put on socks with little difficulties. I could move normally with little or no pain. It is getting better rather quickly.

light headed/ when he got out of bed that he was lightheaded; wobbly on my feet; where he had knee surgery he always has pain but there was additional pain/ Clarified that the pain from knee surgery is joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19. Medical history included knee surgery from 2010. There were no concomitant medications. The patient reported, "After I got my first dose of the vaccine, I felt light headed, wobbly on my feet, and had additional pain where I had knee surgery in the past. Is this normal?" He had a question about vaccine which he got last Monday 11Jan2021. Stated that he had no symptoms when he got the shot. On 11Jan2021, he was light headed and wobbly on his feet. Stated that where he had knee surgery he always has pain but there was additional pain. Stated that the symptoms lasted 4.5 days and went away. Wondered if anyone else had experienced this. Stated that he called his doctor and the CDC. Stated that this is his first shot. Clarified that the pain from knee surgery is joint pain. Stated that he had knee surgery the last time in 2010. Stated that when he got out of bed that he was lightheaded. Stated that it lasted Tuesday into early Saturday. Stated that lightheaded (dizzy) and wobbly on his feet resolved on Saturday morning. No treatment was received for the events. Outcome of the events 'light headed/ when he got out of bed that he was lightheaded' and wobbly on my feet was recovered on 16Jan2021, while recovering for the other event.

starting at the base of head/shoulder pain goes up head, throbbing can not lift head. Taking Tylenol, applied heat pad to back of neck and head

Events: Soar arm, chills, slight fever, aching muscles and joints Treatment: Tylenol Outcome: Resolved in two days

Pain in lower back and hip; Pain in lower back and hip; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes and hip replacement a year prior to the report. Concomitant medication included insulin degludec (TRESIBA) at 16 units a day for diabetes. The patient experienced pain in lower back and hip on 22Jan2021. Patient stated, he had the shot, the virus shot yesterday (22Jan2021). He woke up this morning with severe pain in his lower back and his hip and he wanted to see that can be a side effect, but he was to report it so he was reporting it. Patient stated event start date was last night (22Jan2021). Doctor told him to take Tylenol 500 mg as treatment. He was due to get the second shot on 11Feb. Therapeutic measures taken as a result of the events included Tylenol 500 mg. The patient didn't have any lab tests. The outcome of the events was unknown. Information about lot/batch number has been requested.

moderate pain at injection site rt arm. lots of body/ joint pain. chills. headache. no fever . lasting 24 hrs

RECEIVED BOTH PFIZER COVID VACCINES ON 01/21/21 & 02/24/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF RIGHT SIDED NECK PAIN. DIAGNOSED WITH RIGHT SIDED CERVICAL STRAIN, ACUTE AND DEGENERATIVE DISC DISEASE. INSTRUCTED TO FOLLOW UP WITH SPINE CENTER.

joint pain in his big toe on his left foot; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9262, NDC/UPC number and expiry date were unknown), via an unspecified route of administration in the left deltoid (also reported as the left shoulder) on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the public health clinic/veterans administration facility. Relevant medical history included sleep problem. The patient had no allergies to medications, food, or other products. Concomitant medication included promethazine (strength: 25 mg) for sleep problem. The 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 not been tested for COVID-19. The patient had the Pfizer COVID vaccine shot on Friday morning, on 29Jan2021, and later that day by the evening, he started to experience some joint pain in his big toe on his left foot and the pain had not changed or gone away since then. The patient assessed the event as non-serious. The adverse event did not require any visit to the physician office or emergency room. The patient further stated that he haven't done anything. It happened on Friday and it was there the day prior reporting (yesterday), and it was there in the morning at the time of the report, and the patient was just kind of waiting to see if it would get any better. So, he haven't done anything and was asking what he should do about that. Therapeutic measures were taken as a result of joint pain in his big toe on his left foot, which included that the patient took some paracetamol (TYLENOL), but it didn't really seem to help much, so he didn't take anymore. The patient had no investigation assessment. The patient was not recovered from the event.

Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.

My legs became very weak. After the second shot on Feb 9 I was confined to a wheel chair, unable to walk. I currently am unable to walk.

Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick. Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly. Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck. Size of swelling was easily visible to the eye. Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting. Mass remains soft to the feel, but easily defined in size and location. I have taken OTC pain killers to help with the discomfort. Will continue to monitor its progress, unless notified otherwise. Do not anticipate seeing my physician at this point. Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site. Thought I should report this side effect only because of the size of the swelling that occured.

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Third day weakness and fatigue.

Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time for either). I could barely get out of bed (an awkward rollover did it). My tongue was numb (still is) and raw from the presumed chewing on it. Walking was slow and painful as all muscles hurt. If I sneezed or coughed, my back would hurt. Those last problems are still true. I periodically cough up phlegm and lacking a good place to spit it out, I just swallow it. I have for the first time in my life been using a walker for stability. Right arm is almost useless due to pain.

Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.

Mild fever; muscle and joint pain; muscle and joint pain; malaise; This is a spontaneous report from a contactable consumer reported that a 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; age at the vaccination 77-year), via an unspecified route of administration, in right arm on 02Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included covid-19 (prior vaccination). The patient's concomitant medications were not reported. Patient had allergies to penicillin. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19. On 03Feb2021, patient had Mild fever, muscle and joint pain, malaise. The reported seriousness was non serious. Patient not received treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. 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.

Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.

Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.

I developed severe joint pain in fingers, wrist, elbow, shoulders. I was given a two week prescription of Prednisone which took the pain and stiffness away immediately. Pain came back as soon as the two weeks were over.

his shoulder got a little sore; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9263), via an unspecified route of administration, in the Left arm on 08Feb2021 15:00, as single dose for covid-19 immunization. The patient's medical history included skin cancer, predating treatment with the Pfizer COVID 19 vaccine. Concomitant medications were not reported. On 08Feb2021, the patient's shoulder got a little sore some hours later after the vaccination but it is about back to normal now; he has to raise his arm straight up to even feel it. Caller stated that he received the first dose of the Pfizer covid 19 vaccine on 08Feb2021 and will not be back in the state for the 21-day dosing schedule. Caller wants to know how long he can go and how long can he wait between shots as he will not be back until 04Mar2021 which is longer than 21 days from his first dose. They advised him he could wait 6 weeks maximum and no more. On or after 08Mar2021, the patient was planning to get the second dose. The outcome of event was recovering.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. 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.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Timeline of events: o No concerns in the past month. o Usual state of health on Friday 4/9/2021 o Received Pfizer vaccine at event on 4/9/2021 o Fatigue, poor PO intake and myalgia on Saturday, 4/10/2021; Received Tylenol at 1 pm o Texted Primary Community Nurse (PCN) (not on call), on Saturday, to share above. PCN followed up Sunday morning and reassured them. o Last seen alive Sunday night, not well from vaccine but does not seem like family was concerned enough to page on call team o Monday morning- found dead in rigor mortis o Cause of death: deemed sudden cardiac death. Etiology unclear. o Unexpected death.

Muscle weakness in both arms and shoulders, this has continued for over 2 months. I had the first shot in left arm on 1/06/2021, and the second shot in right arm on 1/26/2021.

The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.

Very sore on my whole left side of my body. Sore and stiff muscels in my back, left arm and left side of my chest.

Chills; legs didn't work; hip sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no.: EL3247) via unspecified route of administration in left arm on 31Jan2021 at 13:00 (age at vaccination 77-year-old) at single dose for COVID-19 immunisation. Medical history, concomitant medications and past drug history were not reported. No other vaccine in four weeks. On 02Feb2021, patient experienced Chills, legs didn't work and hip sore. Reporter states he was calling to report after the vaccine. Three days later, he states he didn't feel good and was starting to have the chill, so he went to bed. After he went to bed he had the chills really bad, even the bed shook, and when he went to get out of bed his legs didn't work. His legs just folded up and he ended up on the floor. He didn't know if he was having a stroke or what. They called an ambulance and went to the ER in (city). At the ER they gave him some fluids and the shakes went down and later his legs came back. Adds his hips, both hips were really sore and he still has a sore spot on one side today. He has never had this problem before. By 14:00 in the afternoon he felt better and he was sent home. The patient adds that they did a CT scan and some other tests. Adds he was told he might have some signs of diverticulitis and he might have bacteria in his blood and he was supposed to call the doctor today to get some medication for that if he does. He was scheduled to receive the second dose on 25Feb2021. Patient mentioned his weight was between 155 pounds and 165 pounds. Adverse event (chills, legs didn't work) resulted in emergency room but not admitted to hospital. The outcome of event for chills, legs didn't work was recovered on 03Feb2021 and hip sore was recovering.

loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The Patient had experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.

Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into chest, down arm and down scapula. Sought treatment Thursday morning around 8:30am at ER in. Patient was admitted. Discharged Tuesday 5-4. Hospital tried pain medications and muscle relaxants (chewable baby aspirin, morphine, benadryl (after reaction to morhphine) norco, dilaudid, toradol, valium, oxycodone and flexeril. Sent home with diclofenac gel, and hydrocodone/apap.

05/03/2021 I awoke and I had multiple joints hurting when I got up at 5:20 to go to work..During the day Monday, I had to take 1 turmeric pill for pain. The pain went away. Monday night I was extremely sleepey, and when I woke up to go to bed about 11:30 I notice some of the joint pain had came back esp the left arm. 05/04/21 , I noticed the area around the v site on the left arm had a red rash about 3x34" and a knot about the size of a golf ball raised and very hard. Joints were hurting in L arm, legs, and right arm and wrist. About 10 AM i took 1 ALEVE and within 2 hours the rash was almost gone on L arm at v site, and the swelling at the v site was also getting smaller. Took 1 more ALEVE at the time point and I felt fantistic. Same as today, great day, no pain.

Massive, severe gout attack (greater than any previously experienced) that lasted for over two months.

shingles; so he thought it was just a pulled muscle; Back pain; soreness in the arm; This is a spontaneous report from a contactable other health professional via the Pfizer-sponsored program. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 77-years-old), administered in Arm Left on 26Jan2021 13:30 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy. It's been 25-30 years ago and he can't take it. He gets swollen and hives and sick. There were no concomitant medications. The patient previously received a shingles shot about 5-6 years ago and flu shot Nov2020. The patient experienced soreness in the arm on 26Jan2021, back pain on 30Jan2021, so he thought it was just a pulled muscle on Feb2021, shingles on 15Feb2021. The patient received the first COVID shot on 26Jan2021 and didn't really have a reaction, but soreness in the arm a couple of days. He then started having back pain and he is a very active person so he didn't think anything of it. Spouse told him that he needs to see the doctor because she thought he had shingles. They do not know if it's associated to the COVID shot or not. They need to also cancel his appointment for tomorrow because the doctor does not want him to get his second COVID shot since he is on medication for the shingles. Mentions again, his arm was a little sore, but then 4 days after that he had back pain. He is an exceptionally active person, and excavation construction worker and still works and so he thought it was just a pulled muscle. Then a few days later, pain was awful and area was sensitive to touch and it looked a little swollen and he had nothing else. A couple days later he kept saying it bothered him and it was all the way around to his side. It was fine at first it started with a little rash and so he went to the doctor today and diagnosed with shingles. Therapeutic measures were taken as a result of shingles which included valacyclovir (Was given Valacyclovir 1 gram tablet to take three times daily to help the shingles). Adverse events required a visit to Physician Office. The outcome of the event "soreness in the arm" was recovered on 28Jan2021, for Back pain and shingles was not recovered, for "so he thought it was just a pulled muscle" was unknown. No other vaccines given the same day or 4 weeks prior. No problem with vaccines in past. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Herpes zoster,sorenessin the arm,backpain,pulled muscle cannot be excluded.But also consider.medical history of allergic drug history and other relevant medical history.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.

flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

Covid test result positive; patient tested positive for COVID-19; Aches; Back ache; All joints hurt; This is a spontaneous report from a contactable consumer. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 at 13:15 in left arm as a single dose for covid-19 immunization. Medical history included atrial fibrillation. The patient did not received any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies were reported as none. Concomitant medications included amoxicillin trihydrate, clavulanate potassium 875 mg, lisinopril, apixaban and diltiazem: all start and stop date was not provided and used for unspecified indication. On 13Mar2021 at 12:00, the patient experienced back ache, all joints hurt, aches, fever, sore throat and cough. The patient took tyneol. The adverse events resulted in emergency room/department visit or urgent care. The patient was quarantined for 10 days and Dexamethasone was prescribed. On 19Mar2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test as positive on 19Mar2021 via nasal swab. The outcome of all events was recovering/resolving. No follow-up attempts are possible. No further information is expected.

Severe clots on right thigh rushed to urgent care and urgent care referred me to emergency Hospital. Was hospitalized for 5 nights with severe swelling on right thigh. The swelling has since abated but has still not subsided. Feel still very heavy on right thigh.

red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.

Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.

Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Muscle soreness; slight headache on top of head; hearing constant high pitched hissing noise/Wheezing sound in head, not ringing but like wheezing sound like hissing; Sore in my left arm where they give me shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's medical history included high blood pressure, high cholesterol, diabetes, gout, sciatica, and penicillin allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9262), via an unspecified route of administration, on 10Feb2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's concomitant medications included telmisartan (MICARDIS) at dose of 80mg per day, insulin glargine (LANTUS), clonidine (CLONIDINE), simvastatin (SIMVASTATIN), gabapentin (GABAPENT) and insulin (INSULIN) taken for diabetes mellitus. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient stated that he had second dose on Pfizer, on 03Mar2021 (on last Wednesday). He was a veteran and had the shot 2 o'clock in the afternoon. Then six hours after his shot, he had the sore in his left arm where they give him shot and then he had sore. He had little bit of headache, but not much so he took some Tylenol as a treatment. The next day, Thursday it disappeared, and he had little bit of sore, but his headache seems like disappeared. But, yesterday around noon time he suddenly heard wheezing sound in his head, he thought it was from his ear, but it was not, it felt like inside his head. It was like a wheezing sound, not ringing but like wheezing sound like hissing, something like that. Sometimes it was little bit higher, sometimes it was low. Right now, it was steady on, the sound was still there but he could hear everything plus the sound that made, therefore he called if it was normal or side effect of what he had. He tried to call his doctor today (on Saturday) but he never answered yet, so he had to call and report. The patient confirmed that it was after the second dose of Pfizer vaccine. On 03Mar2021 16:00, the patient experienced sore in my left arm; slight headache on top of head; hearing constant high pitched hissing noise/wheezing sound in head, not ringing but like wheezing sound like hissing; and sore in my left arm. The patient received treatment for the event headache. The patient was provided with the number of Pfizer Medical Information. The outcome for the reported events was not resolved. No follow-up attempts are needed. No further information is expected.

Pt w/no significant PMH p/w worsening symptoms over 10 days of cough, general malaise, nausea, poor oral intake, and sore throat. On admission, was hypoxic on RA & generally ill appearing. CXR showed poss viral pneumonia consistent w/COVID-19 and COVID test was positive despite having received Pfizer vaccine on 01/15 & 2/8/21. Was admitted for acute hypoxic resp failure secondary to COVID and given 3L O2, dexamethasone and remdesivir. Was ultimately discharged 3 days later w/follow-up.

Patient received Pfizer COVID-19 vaccine on 1/24/21 (first dose) and 2/5/21 (second dose). Patient tested positive for COVID on 5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and passed away on 5/29/21: Preliminary cause of death: Respiratory failure with hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19 vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on methotrexate Anemia Hypertension Obesity

2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can't do flight of stairs without being out of breath, sore joints, fatigue

muscle pain in the right shoulder and its getting worse; muscle pain in the right shoulder and its getting worse; Swelling; Little sensation; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206, NDC number and expiration date: unknown), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 (last Thursday) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing arthritis (probably started off 6 years ago, little by little and got worse over time). Concomitant medication included paracetamol (store brand of TYLENOL 8 HR ARTHRITIS PAIN) taken for arthritis pain (Expiration Date: Jul2022; Lot Number: 81830065M; Count size: 225 tablets, start and stop date were not reported) and CBD oil which helped out with the knees. Patient did not receive any prior vaccine within 4 weeks. The following day on 19Mar2021, patient didn't feel anything but the day after that on 20Mar2021, patient began to have a little sensation and swelling. Patient reported that the little sensation occurred where the Covid-19 vaccine was injected, below the shoulder where they put a shot on a person's arm, and the sensation then moved to the shoulder muscle. Swelling was gone after a couple of days. On 25Mar2021 (from last night), the patient experienced muscle pain in the right shoulder and it was getting worse (myalgia/condition aggravated). Patient was normally hurt everywhere anyway because of arthritis, but the pain in his right shoulder was different now. It was in the muscle not the joint. Patient's second dose was scheduled on 08Apr2021 and he wanted to know should he not take it. Outcome of the events myalgia and condition aggravated was not recovered. Outcome of the event sensory loss was unknown while event swelling recovered in May2021. Investigation Assessment: No No follow-up attempts are needed. No further information is expected.

Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report from a contactable consumer (Patient reported for himself). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 77-year-old), as First dose, single for Age/COVID-19 immunisation in clinic; warfarin, via oral route of administration from an unspecified date since 15-20 years ago (Batch/Lot number was not reported) and ongoing, at 7.5 mg, daily, (7.5mg by mouth daily) for Blood thinner (anticoagulant therapy). Medical history included cardiac disorder(bad heart) ,back disorder(bad back that is full of metal) from an unknown date and unknown if ongoing. No investigation assessment. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date of the Pfizer vaccine received. No history of all previous immunization with the Pfizer vaccine considered as suspect. Vaccine did not administer at military facility. The patient forgot and did not tell vaccine administrator that he was on a blood thinner prior to getting the vaccine and received the COVID-19 vaccine on Tuesday at clinic. He did not read the papers at first. Later he saw on the papers something that he did not tell them. "What does he need to do." On 03Feb2021, the patient had a fever of 100 degrees,It was down to 98.9 degrees ,He was dizzy. The gland under his arm was painful. He had muscle cramping in his legs. Adverse event did not require a visit to emergency room/physician office. The patient underwent lab tests and procedures which included on 03Feb2021, body temperature: 100 degrees and body temperature: 98.9 degrees. No relevant tests were performed. Therapeutic measure the patient took "Tylenol" as a result of fever, dizziness, gland under arm was painful, muscle cramping in legs and it helped. No product complaint was reported. The outcome of the event gland under arm was painful was resolved on 03Feb2021, outcome of the event fever was resolved on 04Feb2021 and outcome of the events dizziness and muscle cramping in legs was resolving. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.

4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; 4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in Left arm on 26Jan2021 13:00 at the age of 77-years-old as 2nd dose, single dose for covid-19 immunisation. Medical history included CHF (Congestive heart failure) from an unknown date and unknown if ongoing, PE (pulmonary embolism) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included unspecified medication, Allioyrubikm; Dabigatran (DABIGATRAN) taken for an unspecified indication, metoprolol (METOPROLOL) taken for an unspecified indication, spironolactone (SPIRONOLACTONE) taken for an unspecified indication on unspecified date received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 05Jan2021 at 13:00 as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Covid test post vaccination was no. On 29Jan2021 at 06:00, 4th day after dose 2 the patient experienced pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain. still have pain 10 days after dose 2. No treatment was received for adverse events. The outcome of event, mobility decreased was unknown and for other events was not recovered. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Pfizer COVID Vaccine EUA Pfizer Vaccine Dose 1 2/5/2021 (lot # not in state registry) Pfizer Vaccine Dose 2 3/6/2021 (lot # not in state registry) COVID Positive 3/27/2021 Hospitalized 3/27-4/2/21 Hospitalized 5/19-5/24/21 6/15/21: Presented to ED. This is a 77 years old gentleman with a history of COPD presents to the emergency department because of shortness of breath and chest pain. Patient states that he was in his usual state of health and suddenly developed shortness of breath and chest tightness. By the time of my evaluation he no longer has chest tightness. He was recently in the hospital and treated with antibiotics for Pseudomonas pneumonia. He is reportedly compliant with his COPD medications at home. He normally wears 2 L nasal cannula at home. Currently he is on the BiPAP and reports feeling better after treatment in the emergency department. He was given IV steroids, bronchodilator therapy. He was also given IV antibiotics given recent history of Pseudomonas pneumonia. Of note patient states that for the past week his bilateral ankle appears to be more swollen and he is on Lasix started by Dr. from pulmonology for this. 6/21/21: This patient with a history of COPD, atrial fibrillation on anticoagulation and chronic dementia, was again admitted 6/16 with increasing shortness of breath and chest pain. It was noted that his COVID 19 test was positive. He was started on IV Remdesivir, but since his COVID 19 test has been positive since March of this year was felt that he did not require additional treatment. We are treating him for an exacerbation of COPD. His chest x-ray was actually normal with COPD but no signs of infiltrate, heart failure or effusions. He is on apixaban for atrial fibrillation and should not have a pulmonary emboli. He was getting IV Lasix, but the BUN and creatinine were rising. We have obtained an echocardiogram to see if there is a degree of systolic heart failure. We will continue the IV antibiotics and steroid therapy. The patient seems comfortable at rest but is on 5 L nasal cannula. The patient reports that he is on 3 L of oxygen at home all the time. I called to talk to the good friend who is listed as the 1st contact and reviewed the situation. He does live by himself but has 24 hour a day care. We discussed that our goal was to get him back down to 2-3 L of oxygen. There seems to be some improvement but if still requires 5-6 L of oxygen, we will ask for a pulmonary consultation. I have talked to the pulmonary team several times unofficially for advice and they seem to have nothing else to offer at this time. Again today the patient seems comfortable and is warning why he can go home.Admitted and treated with bronchodilators, steroids, BiPAP and levaquin. Echocardiogram repeated. By the time of admission, chest pain resolved. Oxygen requirement stay high at 5 liters. Today improved to baseline 2 L. Discharged home.

he received an infusion at a hospital ' to purify' the blood; pain in back; pain in back then his ribs and then travelled to his chest; pain in back then his ribs and then travelled to his chest; virus in his system from the virus as a result of the pfizer covid vaccine.; he was in a lot of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 77-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), (at the age of 77-years-old) via an unspecified route of administration on 06Apr2021 as dose 2 single for COVID-19 immunisation. The patient historical vaccine included received first dose of bnt162b2(Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 16Mar2021 as dose 1 single informed that no reaction on previous exposure to drug. The patient's medical history includes liver transplant about 10years ago. Patient concomitant medications were not reported. On an unspecified date, 3 days after the second shot he developed pain in back then his ribs and then travelled to his chest. He has been to Emergency twice, seen 6 or 7 different doctors; doing testing, had a CAT scan and an echogram. He told this morning that the doctor suspects he has a ' virus in his system from the virus' as a result of the pfizer covid vaccine. Caller asking if we know anything about this and wanting treatment recommendations. Caller unable to clarify what the hcp means. States before he received the vaccine, he was healthy other than a liver transplant about 10 years ago. States he was in a lot of pain-prescribed morphine but did not want to take it. Also states he received an infusion at a hospital to purify' the blood. He felt better after the infusion then 2 hours later it came right back (unclear if caller referring to pain). He was told by his hcp that everything was normal, and they can't find anything wrong. He said he read on the news that people were reporting aches and pains from the pfizer covid vaccine, but he was surprised how long it took for pfizer to acknowledge it. The outcome of the adverse events was unknown. Information about lot/batch number has been requested.

Extreme pain in joints, reduced mobility, inability to move legs, arms, hands; increased white blood count. Was hospitalized four different occasions for 2-5 days each. Various tests and medicines were tried. Pretizone was used for 4 months.

I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the muscles in my body seemed to be vibrating. I could still walk but found a comfortable chair. The shakes would rise and fall in amplitude causing my hands and legs to oscillate then recede after about 30 seconds. This lasted for about 20-25 minutes and simply went away and has not recurred. I have had no other symptoms. As chills were a listed side effect, I assumed at first that it was chills or some variant but I was not cold. It was the chills without an apparent temperature effect although I did not measure my temperature.

Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall. Pt denies any LOC, but states he is currently on Xarelto. Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: "Dizziness, near-syncope: Onset following injection of COVID-19 vaccination.

headache; chills; fever; muscle soreness; injection site soreness; This is a spontaneous report from a non-contactable consumer (wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 14Jan2021 19:00, the patient had headache, chills, fever, muscle soreness and injection site soreness. Outcome was unknown. Information on batch number has been requested.

perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital. Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not 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.

I started having pain in my left shoulder across my back and down my arm into my left hand. It is getting progressively getting worse. both shoulders are so painful and I cannot grip anything in my left hand. My fingers on my left hand are going numb. I've been alternating taking tylenol and ibuprofen but they are not helping at all.

Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered

Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

Tingling and numbness within one hour. That subsided after another 30 minutes but then I lost control of thumb and pointer finger. That loss of control/strength has continued until today(2/11/2021). I tend to drop things from my left hand.

Initially, focal pain in left shoulder, subscapular. In susequent days more diffuse in location and more intense. Distribution shoulders and upper back, greater on left. Exacerbated by motion and pressure. Relieved by acetominophen.

Second day after vaccine, developed mild neck pain but by 3rd day, pain severe enough to limit neck movement (like unable to look up) without pain. Same on 4th day after vaccine, aspirin and heat no positive effect. 5th day took 50mg pill of diclofenac, next day great improvement and mobility almost fine but with some lingering neck pain for a week.

Have constant pain in right upper arm shoulder, have taken Ibuprofen 800mg per day reliefs pain for about 12 hours. My arm movement seems to be good and is not painful when I move it. I have to elevate my arm in a sling type position as the day goes on it gets more painful otherwise. I have called my doctor but have not heard back from him, I am expecting him to call me today, so I can get his opinion on what might be wrong with my shoulder. I have my second virus short scheduled for Feb. 25,2021 at 9:30 am at the same place.

This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient had soreness in the shoulder for only one day and he had bruising. No treatment received. The outcome was unknown.

myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement

The evening of the day of vacination, I had bad headache, body ache, chills and body shivers. By the time I went to bed, I had coughing and wheezing. Took atomizer for that. During the night every joint in my body starting to hurt. Took more tylenol and CBD rubbed on hips, shoulders, knees and wrists. By morning I felt better, but some body aches and headache. Lsted for the rest of the day. Ok by the evening.

shingles on right upper arm which is clearing up now after 2 weeks. Still some aching in right shoulder

Acute gout in left big toe. Treated with Colchicine .6mg tablet (2/day for 3 days, then 1/day for 12 days). Severe pain lasted for 2 days with swelling in big toe and joint.

11 Hours later ambulance called Taken to hospital C/O of left shoulder arm chest pain ,significant dizziness, unable to stand without falling over

Muscle pain - since day after injection. 3 or 4 200mg ibuprofen eases pain, when moving, for 4 or 5 hours.

Severe abdominal cramps/abdominal cramping; Drowsiness; I had a sore shoulder and fatigue; I had a sore shoulder and fatigue; pain; anxiety; small bowel blockage/He had an intestinal blockage; His peristalsis shut down.; bowels are very irritated; He feels bruised; his guts just feel bruised; His blood pressure actually was low while in hospital; Glucose levels were very high while in hospital/when in pain and anxiety his sugar goes up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL3248) injection to upper left arm just below shoulder at approximately on 29Jan2021 10:00 at age of 78 years old at single dose for vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Relevant medical history included: for ongoing asthma and adult onset maybe 25-28 years ago. He did not have when he was a kid. He did not have allergies. Part of problem was lives in an area that had a very high allergy problem; a lot of people in that area have allergies; for sleep apnea, used CPAP machine; for diabetes from 2006 and onset date approximate. A1C is where doctors want it to be. Went through half a dozen pills and stuff for diabetes that worked for short time and stopped: Names/Lots/NDCs/Expiries: Unknown, does not have this information to provide. He was pretty good at judging carbohydrate content in meals to make adjustments to Humalog and Toujeo dosing as needed; for ongoing overweight, weight gain started after oral injectable product for diabetes stopped working, he went on different insulin product and gained 30-35 lbs. Oral injectable product: name/lot/NDC /expiry: Unknown, does not have product or this information to provide. Different insulin product: Name/Lot/NDC/Expiry: Unknown, does not have product or this information to provide; modestly high blood pressure; history of intestinal blockages (occurred quite some time ago, no continuing); had operations in the past. The adverse events (AEs) following prior vaccinations: Adverse Event: He was pretty sure he hit the floor before the needle was even out of his arm when he was administered gamma globulin vaccine which he thinks was around year 1972. The company he worked for at the time had a hepatitis break out, a couple of employees had hepatitis, so they had him receive the gamma globulin vaccine. Vaccine/Brand Name: Gamma globulin vaccine/brand name unknown, whatever it was that was available for hepatitis at the time which he thinks would have been 1972. He is pretty sure in those days they used horse serum in the gamma globulin vaccine; the doctors at the time felt pretty sure that the reaction was to the horse serum aspect of the gamma globulin vaccine. Lot/NDC/Expiry: Unknown, he does not have product or this information to provide. Vaccination Date: Thinks would have been in 1972, further details unknown. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s) was reported as none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He was supposed to have the Shingrix vaccine but decided to hold off on that until after he got the Pfizer COVID-19 Vaccine. He had the Flu vaccine around Sep2020 or Oct2020 when the senior version came out. Ongoing Concomitant medications included: losartan 100mg daily from 2019 for high blood pressure, furosemide (LASIX) 20mg daily from 2019 for high blood pressure causing some fluid buildup, fenofibrate 134mg daily for years for triglycerides, finasteride 5mg daily for years for benign prostatic hyperplasia, multivitamins, boosters of other vitamins (advised by PCP since COVID pandemic started), insulin lispro (HUMALOG) fast acting insulin taken as needed for diabetes, insulin glargine (TOUJEO) slow acting insulin taken as needed for diabetes. It was reported patient stated, he had his first dose of the Pfizer vaccine a week ago Friday 29Jan2021 at 10am. He had a sore shoulder and fatigue. At midnight he suffered abdominal cramping by 7am. He took himself to the ER and called his doctor who met him there. He had an intestinal blockage. His peristalsis shut down. He spent a couple days on an NG tube, had x-rays and imaging study, they found a small bowel blockage. It seemed very coincidental within 18 hours of the vaccine. He had them when he was younger. His physician who was an GI specialist said he had 2-3 other patients with similar reactions. He spoke to the safety team regarding this. He was due for his 2nd vaccine a few weeks. Right now his bowels were very irritated, not consistent to bowel movements. He was still on a low fiber diet. Asked if there was any evidence people are having gastrointestinal reaction. He had had blockages in the past, that was his weakness. Asked what to do about 2nd dose. He had asthma, diabetes type 2, mildly hypertensive. This consumer had his first dose of Pfizer COVID-19 Vaccine 29Jan2021 at approximately 10:00. On 29Jan2021 at about 23:30, he had went through usual drowsiness and took a nap. Around midnight 00:00 30Jan2021 he started having abdominal cramps that became very severe. He was taken to the Emergency Room where he was admitted to the hospital from 30Jan2021 until discharged home evening of 03Feb2021. Severe abdominal cramps: His peristalsis stopped, just shut down. As a result he had an intestinal blockage. He had nasogastric tube placed for 4 days. He was scheduled for surgery with a gastrointestinal surgeon who he happens to know personally. He had called that gastrointestinal surgeon before he was admitted to the hospital. The gastrointestinal surgeon thought he heard some sounds, so he delayed the surgery. That night the intestinal blockage broke up. He was discharged from the hospital before they normally would have released him to get people out as quickly as possible due to risk of contagion in hospitals. Both he and the gastrointestinal surgeon are very concerned about him having the second dose of Pfizer COVID-19 Vaccine as scheduled which is due in like 1.5 weeks. The plan at this time is for him to go on a liquid diet 2 days before the second dose so that there is nothing in him to create intestinal block. Outcomes of events: Bowel movements are irregular because just starting to get back into eating really for a few days. The first few days home he was on a soft diet of basically jell-o pudding and broths. He is on an ultra-low fiber diet right now so it's a different diet than he is accustomed to. Some of what he is eating goes right through, other times there is no bulk to come out; he kind of feels like he is constipated but it is just that there is nothing there. Doctor later this week will determine how much he can normalize his diet. Metamucil which a lot of diabetics do, doctor did not want him to take that until everything settles down. He feels bruised; his guts just feel bruised; he thinks from just the pressure there and getting in and out of the hospital bed was horrible. When he called doctor before he went to the hospital 30Jan2021, doctor told him this is coincidence, that this patient was the third that he has had who in 24 hours has had significant intestinal or bowel reaction; that he is not the first who has dealt with severe gastrointestinal problems following the Pfizer COVID-19 Vaccine. Caller clarified he has no first hand knowledge of those other patients/events/products, this was just mentioned to him by the doctor over the phone. He had no further information to provide for this report; but doctor might be able to provide further information. Relevant Tests: they did a COVID test when he was admitted to hospital 30Jan2021, gave results when he left the hospital-took them 6 days-unknown result. They did X-rays and scan of his abdomen to monitor intestinal blockage-results unknown. Blood work done but nothing remarkable there-results unknown. His blood pressure actually was low while in hospital-specific results unknown. Glucose levels were very high while in hospital which he is sure was because they had him on an IV drip that must have had glucose in it because he was not eating anything and when in pain and anxiety his sugar goes up-further details of results unknown. Patient had no further information to provide regarding testing/investigations/lab work, blood work, imaging, x-rays, etc for this report. Outcome of events were reported as unknown.

2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Feb 21 lost taste Fri Feb 26 extreme weakness in legs Otho has had side effects THAT OTHERS HAVE NOT REPORTED. Otho received the first Pfizer shot on January 28, 2021 and only suffered a small ache in his arm. Otho received the second shot of Phizer on February 1 8, 2021 adminsted at the same location. Day 1 arm a little uncomftable Day 2 6:00 pm extreme chills Day 3 chills gone, tired, weak Day 4 LOST SENSE OF TASTE Day 9 Legs so weak, could not walk without a walker Day 13 TODAY Still very weak and still connot taste. Otho is a male age 78 yrs. Usually very active. He does suffer from Carcinod Caner of many years. We did visit with our doctor. He prescribed to take two Ibuprifen morning and night to help with inflammation. And if Legs weakness increases to get back to him.

Shoulders was all sore both of them; He was sore all over; Chills; Running 101 fever; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included COVID-19 (reported as "has had that virus before"). There were no concomitant medications. On 30Jan2021, in the morning after the vaccination, the patient's shoulders were both sore. By the afternoon of the same day, the patient was sore all over, ran in a 101 fever (unit was not reported), and was having chills. The patient did not receive any treatment for the reported events. The outcome of the events, 'shoulders were both sore', 'sore all over', 'ran in a 101 fever' and 'chills', was recovering; patient was feeling better at the time of reporting. Information on lot/ batch has been requested.

There was a significant drug interaction with Efudex Cream that I was applying topically to a pre-cancerous 2-cm-diameter lesion on my left shin. On the day of my first Pfizer shot, the Efudex treated lesion was progressing normally from the desquamation (scabbing and shedding of epithelial scales) to the erosion stage (starting to form a shallow 2.5-cm-diameter ulcer). Starting about Saturday 30 January (three days after the first Pfizer shot) and slowly increasing for the next four days, the Efudex-treated ulcer became deeper, the peripheral 12-cm-diameter skin became redder, and the left foot and ankle became increasingly swollen. My RN-wife and I (a former medical-research physicist) began research andChronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral. Chronic health conditions: nasal polyps, precancerous bleeding actinic keratoses, Cramp-Fasciculation Syndrome (leg & foot cramps), early macular degeneration bilateral, hearing loss bilateral.DVERSE EFFECTS, TREATMENT, AND OUTCOME: discovered that Efudex should not be given concurrently with any of a long list of immunizations. This is an Efudex problem that should gain another immunization onto that list. Being within a week of finishing the Efudex regimen, we monitored the Efudex-treatment area and the peripheral area carefully. On Thursday 4 Feb (eight days after the first Pfizer shot), the ulcer began unusual drainage, the 12-cm-diameter peripheral area became inflamed, and swelling of the left ankle and foot increased to almost skin-tight - I can upload photos if you need. Time for immediate action. My excellent Dermatologist stopped Efudex and started me on Bactrim by mouth for 10 days, and Gentamicin topical antibiotic on the ulcerated central area and Triamcinolone topical corticosteroid on the peripheral and swollen areas for three weeks. Good choices. Improvement was immediate and continued improving for the next three weeks. By the time of the second Pfizer shot on 24 February, the central area was healing well, in the late-reepithelialization stage (regrowth of epithelial tissue that now formed a completely-covering scar tissue with no oozing), and with all inflammation and swelling completely gone. After the second Pfizer shot (taken 20 days after stopping Efudex), there were zero adverse effects of any kind. NOTE: There were absolutely zero other adverse effects of any kind throughout the entire series: no chills, fever, headache, nausea, vomiting, diarrhea, change in pulse or blood pressure (120/70 range), loss of taste or smell, sore throat, cough, lung congestion, fatigue, feeling of being unwell, shortness of breath, injection-site swelling or redness, hives, swelling of face, decreased kidney function, or other adverse cardiovascular, neurological or pulmonary effects. There was no additional joint pain above my normal osteoarthritis. After both shots, I felt a slight normal-range injection-site soreness for the next few hours, but no site swelling, rash, redness, or other problem. We recommend that this immunization be added to the Efudex ‘proscribed or warned' list.

Next day after shot - legs were very weak and I could hardly walk in a straight line. Went for a routine physical with my Doctor at 1PM and never made it there. I had no idea of where I was going or where I had been. Half hour later I remember being in a store buying lottery tickets and the clerk had to help me in my car. Went to bed for the rest of the day and have been improving little by little each day. Was very, very tired at first and still a little tired now.

Pt had HA and left hip pain after sitting in car. Vitals normal o2 sat 97%, HR 92 BP 121/69 noted. Pt was obs in car 20 minutes with pt calling and wanting to go home. No airway issues . Gave juice and patient felt better

muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; Movement, sleeping, bending, etc.,almost impossible; Movement, sleeping, bending, etc.,almost impossible; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=em9801), via an unspecified route of administration at the age of 78 years old on 12Feb2021 at single dose on arm left for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient received no 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 not been tested for COVID-19. The patient received no other medications within 2 weeks of vaccination. The patient's concomitant medications were none. The patient experienced muscle stiffness and soreness - legs, arms, shoulders, etc.- for the past 14 days or so - since injection. Movement, sleeping, bending, etc., almost impossible. 4- 200mg-ibuprofen helps for about 4 hrs. The onset date for the adverse events was reported as 13Feb2021. The events outcome was not recovered. The seriousness of the events was reported as no.

Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever lasting ~24 hours. Symptoms abated after 24 hours and gone by 48 hours after the administration of the 2nd dose or 36 hours after I became symptomatic. NO symptoms other than a slightly sore arm after the 1st dose.

H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods, 9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities

Very bad muscle and joint pain in my hips, groins, and knees. My shoulders were much sorer than normal as well as I have had soreness in both shoulders which has been ongoing. My symptoms continue. My walking, sitting, and standing up, all are affected.

3 days after second Pfizer shot right foot swelled up with pain. Two days later pain shot up right leg and to hip. Intense pain for about 5 days similar to when I had back surgery about 27 years ago. Since then leg and hip pain subsided but my right foot still feels swollen and painful at night and in the morning. Gets better temporarily walking on it during day but feel like there is a stiff pad below the skin on my foot . Had a similar reaction with second pneumonia shot in October where I got spasms in lower back and then right leg started to collapse but only lasted then for about 5 minutes with no long term effects/

Multiple pulmonary embolism 100 degree fever Chills incontinence Gout Blood Uric Acid Increase Shortness of breath

myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. In the middle of the night on 3/28 he got up to go to the bathroom and was too weak to get off the toilet - to the point where he had to lower himself to the ground, so EMS was notified and reportedly found him with a fever of 104 Fahrenheit. Hospitalization x2 days. Discharge home.

back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

my left shoulder feels like it has what I would relate the pain to as a rotator cuff pain/injury. They gave me the injection at the joint of my shoulder. I could not lift my arm. I have had to go to therapy which is helping.

eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.

pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterday. ? Neck Pain right side. Yesterday noticed a facial droop without any arm weakness or change in gait. No headaches. Using some artificial tears but eye is getting more red and matting of eyelashes. Having more right rhinorrhea, but that's been a chronic issues. Feels like hearing is off in his right ear. More neck soreness on the right.

arm was a little sore; Little rash, red dots on inside of bicep; This is a spontaneous report from a contactable consumer(Patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1via an unspecified route of administration, administered in Arm Left on 25Jan2021 16:35 as single dose for covid-19 immunisation. Medical history included mitral valve prolapse. The patient's concomitant medications were not reported. Had Pneumonia shot and yearly Flu shot. Had no reaction. Has no NDC/Lot/Exp to provide for Pneumonia and Flu shot. On 25Jan2021 in evening patient had a little rash on inside part of bicep. There were little red dots. It itched for a while. Next day was gone. Stated he was shrinking and provided height as 5 feet 11 inches. First time the dots were there it itched a little bit, next morning it was gone. Had no reaction to COVID-19 Vaccine. Had no fever, nothing else. Next day his arm was a little sore. Patient clarified rash and red dots occurred on both arms. Patient thought rash and red dots were something else like detergent or he didn't rinse soap off in the shower. his doctor didn't seem to think it was anything serious. No prior vaccinations within 4 weeks. Had a family medical history of diabetes runs in family, but most other people had that in their eighties and nineties.The outcome of the event little rash on inside part of bicep, little red dots was recovered on 26Jan2021 and for other it was unknown.

Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: S/P PROSTATE CANCER, TAKES LUPON INJECTION EVERY 6 MONTHS AND IS NOT SURE IF THIS DATA HAS SOMETHING TO DO WITH HIS PROLONGED SYMPTOMS, NEXT DOSE OF LUPON DUE IN A COUPLE OF WEEKS FROM TODAY.

severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 05Jan2021 03:30 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Concomitant medications included sotalol (SOTALOL), Olmesartan (OLMESARTAN), Amlodipine (AMLODIPINE), tamsulosin (TAMSULOSIN). On 06Jan2021 at 09:00 the patient experienced severe pain in back and right-side thigh, knee and leg, rheumatism, sciatica. Pain started within one day of shot and has not stopped. I have never experienced this before now. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107296 same reporter/ drug/ AE, different patient

I have developed a very painful region in the left deltoid muscle and the right deltoid muscle is less severe. It prevents me from lifting my arm(s) higher than the elbow, and significant weakness in the both arms, especially the left. My kneecaps also have significant weakness and pains and makes standing difficult. this developed the day after the shot. I also have significant fatigue all the time since receiving the shots. The second shot (Right arm) was given March 5th.

Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10

Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears that patient has had a progressive course of this problem over the last 1 week. His symptomatology is mostly consistent with gait ataxia with some lower extremity weakness. He mentions that his weakness of the lower extremities became more and more pronounced towards the end of the week when he would start trembling in his legs whenever standing for some time. Although he had some numbness and tingling few days ago but that does not seem to be the predominant symptoms. There was no preceding symptoms of any viremia prior to this. Although he has Covid in January, however he did not have cough expectorations upper respiratory infection or any diarrhea in the last 1 month. He has not been exposed to any new pets or any new medications. His clinical exam suggest a lower extremity weakness more proximal than distal although there appears to be some sensory sparing. He has diminished reflexes all over including absent reflexes in his lower extremities and many of the upper extremities. His imaging study did not show any specific etiology for the cause of his problem. He does not have any spinal etiology and his exam does not show any upper motor type of involvement. His spinal fluid shows a high protein with no cells consistent with cytoalbuminogenic dissociation. So he definitely fits with the diagnosis of acute immune mediated demyelinating polyneuropathy or Guillain-Barré syndrome. On IVIG therapy. Overall appears to be some improved however not still able to walk.

muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and a half

lost 10 lbs; I vomited for three nights; lost my appetite; had diarrhea the first week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 02Jan2021 at 08:30 AM (at the age of 78-years-old) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. No other vaccines received in four weeks and no other medications taken in two weeks. The patient lost 10 lbs in 4 days, he vomited for three nights, lost the appetite and had diarrhea the first week, all occurred on 03Jan2021 at 12 AM. No treatment was received for the events. The patient had recovered with sequel from lost 10 lbs on 07Jan2021, from vomited for three nights on 06Jan2021, from lost the appetite and had diarrhea the first week on 10Jan2021. Information on the lot/batch number has been requested.

first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.

Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.

difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown. He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

That evening he called me and told me his groin area was hurting and I went over to his house. He said he was having a hard time standing up. His groin and down his leg. He never had complained about it before. I took him to ER Hospital and they checked him out and verbally talked to him. The doctor told him to take Tylenol and told him to go home. He had that pain for about two hours.

extreme body aches/pain; joint aches; muscle pain; I can hardly function; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6206), via an unspecified route of administration on 09Apr2021 (at the age of 78-year-old), as 2nd dose, single dose in right arm for COVID-19 immunization. The patient's medical history included prior heart attack, diabetes, and neuropathy. Concomitant medications included atorvastatin, clopidogrel, metoprolol, finasteride, all taken for unspecified indications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) on 05Mar2021, as single dose in left arm for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Apr2021, the next day after the second dose of vaccine, the patient experienced extreme body aches, joint aches, and muscle pain all over his body. Patient can hardly function and was in constant pain. Patient received treatment for the events with Predisone, Advil, and Tylenol. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot Number: EN6203) age at vaccination of 78-years-old, as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing (Erythromycin and iodine contrast fluid). Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. After 5 weeks from vaccination the patient still experienced pain in upper arm, severe pain in left shoulder with limited use of arm/inability to freely move arm. Physician Office Visit was required and MD prescribed lidocaine patch (that not help) and now patient was taking Prednisone pack. May require orthopedic intervention. The patient was not recovered from the events.

severe ipsilateral shoulder pain. After second dose developed bilateral pain, then developed migratory polyarthritis. By the time I met him 2 months later he had inflamed joints, ESR 118. Rheumatology eval is in progress, but he has responded to steroids. No prior history of an inflamatory arthritis

had a temperature of 100.4; pain in his shoulders and neck/has joint pain across his neck; he has joint pain across his shoulders and neck and that he cannot turn his head/ pain in his shoulders and neck; he has joint pain across his shoulders and neck and that he cannot turn his head; This is a spontaneous report from a contactable consumer. This 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 05Feb2021 (at age 78-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, Caller stated that he had his first Pfizer shot Friday 05Feb2021. Stated that he had a temperature of 100.4 that went back to normal. Stated that he had pain in shoulders and neck since he got the shot. Clarified that it was for Pfizer Covid 19 shot. Stated that it may be normal or if others felt this way. Clarified that he had joint pain across his shoulders and neck and that he couldn't't turn his head. Wanted to know if this was serious. Patient underwent lab test includes body temperature for which result 100.4 was reported. The outcome of event was resolved for body temperature increased, whereas unknown for all other events. Information on lot/ batch number has been requested.

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; Leg muscle pain and stiffness the day after treatment. The condition has persisted for two weeks.; This is a spontaneous report received from contactable consumer, the patient. A 78-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in right arm on 11Mar2021 at 09:00 (at the age of 78-year-old), as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 15:00, the patient experienced leg muscle pain and stiffness the day after treatment. The condition had persisted for two weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the adverse events. The clinical outcome of leg muscle pain and muscle stiffness was not resolved at the time of report. No follow-up attempts possible. No further information expected.

sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and nausea. Extreme symptoms of gout w/pain and cramping in feet / ankles. Did not eat for 4 days - fatigue, low energy. these symptoms lasted for 4 days. After the second shot on 6-3-21 - Became weak and ill the next day and was taken home from work with extreme pain in right foot and knees. Extensive all over body painful muscle cramping, weakness. Fatigue. To this day has not been able to carry on his normal walking routine. Had consulted with physician.

Weakness of legs; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6199) via an unspecified route of administration in the right arm on 13Mar2021 at 13:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had relevant medical history and was taking concomitant medications within 2 weeks of vaccination, both were unspecified. The patient had no allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 20Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced weakness of legs which got lot worse. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent Doppler study and the result was unknown. The clinical outcome of the event weakness of legs was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Started with severe myalgias, back pain, leg pain and fever T 104 He was taken to Urgent Care with Covid neg, Influenza A/B neg. UA and CXR negative Symptoms lasted 72 hours He has never had fever before and he is 79 years old.

twisted his back a little bit/strained his back; he is having some muscle pain; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he is in good physical health. The patient stated that he is 79 years old, and received his first dose of the COVID vaccine 48 hours ago, on Monday at noon (11Jan2021). The patient strained his back last night (12Jan2021), and he is having some muscle pain, and he would like to know if it is okay to take Ibuprofen, following having received the vaccine. The patient clearly stated that he has had no side effects and he is fine from the vaccine. He also added that it was while he was in the shower last night, he twisted his back a little bit, and that happens to him now and then and that was normally when this happens to him, it takes a few days to get better. But patient stated that this event is totally unrelated to the COVID vaccine. The patient normally just takes a Motrin, and it clears the pain up, it relieves it. But he was just wondering if it is contraindicated to take Motrin after having had the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The events back strain and muscle pain were intercurrent conditions and unrelated to BNT162B2 vaccination.

COVID(+) Narrative: Patient developed COVID-19 symptoms on 1/16, approximately 2 days after receiving dose #1 COVID vaccine. He was admitted on 1/30 with worsening symptoms of fatigue, low grade fever, myalgias, dyspnea, and productive cough and found to be COVID(+) via Cepheid test. Patient was treated with supplemental oxygen and oral dexamethasone therapy.

Myalgia of the left quadriceps and left gluteal muscle starting 3 days after vaccination. This has eased with ibuprofen 200mg daily - BID over the course of 3 additional days to only distal 1/3 left quadriceps and patellar tendon and superior gluteal muscle tenderness. Based on rate of progression would anticipate full improvement by 7-14 days from symptom onset.

having trouble bending his right elbow; swollen right elbow; very painful; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-010782), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021102713) on 26-Jan-2021 and was forwarded to BMS on 02-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful) in 79-year-old male patient who received apixaban (ELIQUIS) tablet for cerebrovascular accident prophylaxis. Co-suspect products included COVID-19 vaccine injection for prevention. Concurrent medical conditions included congestive heart failure, type II diabetes mellitus and hypertension. On an unknown date, the patient started ELIQUIS (oral), 1 tab twice a day. On 21-Jan-2021, the patient started COVID-19 vaccine (intramuscular). On 22-Jan-2021, an unknown time after starting ELIQUIS, the patient experienced arthropathy (having trouble bending his right elbow), joint swelling (swollen right elbow) and pain (very painful). The dose of ELIQUIS (oral) was not changed. At the time of the report, arthropathy outcome was unknown, joint swelling did not resolve and pain was resolving. For ELIQUIS (oral), the reporter did not provide any causality assessments.

Severe pain in right hip, right knee, and the muscles in between. 2 Aleve 220 mg, In the am and pm, walking very slowly. Symptoms improved after 36 hours. By 02/13/21 walk with slight limp, but much better.

I woke up around 2:00am with pain when I inhale. It feels like pleurisy. I can feel the pain in my lungs, upper back/shoulders and neck. I have asbestosis so shortness of breath is always an issue. The pain is not. I am assuming it will pass in the next 24 hours or so.

The normal site pain from the needle stab, and several minutes later a sympathetic pain in the right shoulder. Sounds crazy, but the same thing happened to my sister and one of her friends. Sometime later after arriving home, I developed chills. At 10:30 pm I took two extra strength acetaminophen capsules (500 mg, ea.). That eliminated both the chill and the right shoulder pain by 11:30. Today, the 18th, I am feeling fine except for the injection site pain.

On February 18 or 19, noticed a 5 mm. purpuric skin lesion on right hand, not painful. On about February 19, perhaps in the evening, noted varied perhaps 5 mm discolorations on ankles that in retrospect were probably resolved mild purpuric lesions. On the same evening, noted very mild tenderness in the calf (soleus muscle) regions bilaterally feeling like mild muscle fatigue. On February 21 at about 6 AM, before showering, noted bright cherry red lesions on/under skin of both ankles and more severely on the posterior calf of both lower legs above the calf tenderness. The skin was flat and not tender. Calf tenderness was slightly worse (though still mild). Lesions turned purpuric, fading in hours.

Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.

whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety. Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.

Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.

feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients

After receiving vaccine I felt slow and nauseated, then started having pain in rib cage that lasted a while, i ended up forcing myself to throw up and felt a little better, the pain moved up and i was running a fever. The next day I felt better.

Severe flu like symptoms; fatigue; muscle and joint pains; muscle and joint pains; headache; fever and chills; This is a spontaneous report from a contactable physician (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number LTM 2), via an unspecified route of administration (arm right) on 04Feb2021 00:00 (12 AM) at SINGLE DOSE for covid-19 immunisation, at 79 years old. Medical history included prostate cancer from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. No allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced severe flu like symptoms; fatigue; muscle and joint pains; headache; and fever and chills on 04Feb2021. Treatment was not received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.

23 Hours after the injection, a mild muscular pain started on the mid left arm , within minutes it became evident on the entire left arm and it extended across from to right shoulder arm. The pain included a burning sensation, being extremely intense (using the standard pain scale I was way over 10) At first it appear to be a heart attack. I never had any cardiac issues. The pain lasted approximately 30 minutes. Second event started on Sunday, 7 at 10 : AM same location, and intensity.

About 5 days after the Vaccine shot I noticed that my finger joints were stiff. I couldn't make as tight of a fist, especially my right hand. When I open my right hand my ring finger would hang up and not extend with the others. It would lock up half way open and then extend the rest of the way. The condition has not changed since. I had my second shot on 02/10/2021 at 2pm. I didn't see a doctor about it since it is not critical except for a little lose of dexterity.

When he raises his left arm where the vaccine was given, he feels a twinge of pain/lifts his arm over his head he feels the twinge of pain; When he raises his left arm where the vaccine was given he feels a twinge of pain where that was, and a kind of numbness; when he exercises it and swings his left arm, then he feels a bit tightness; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021, at single dose, to prevent COVID, at a hospital. Medical history included lung cancer (19-year lung cancer survivor), mild heart attack in 2011, aortic valve replacement in 2013 and a heart issue. Concomitant medications were not reported. Historical vaccine included influenza vaccine received on 06Nov2020 for immunization. The patient reported that on he had the first vaccine shot on 19Jan2021 (10 days ago) and on 20Jan2021, when he raised his left arm where the vaccine was given, he felt a twinge of pain where that was, and a kind of numbness, it was nothing that restricts him in any way, but when he exercised in the morning and lifted his arm over his head he felt the twinge of pain, which was something he never experienced with the flu vaccine or any other vaccines. He wondered if it had something to do with this vaccine. He has not treated it, it has not bothered him much. He stated he feels it when he exercises it and swings his left arm, then he feels a bit tightness or a twinge of pain. He says it does not restrict him or cause him to cry out or anything. The patient also reported that he is scheduled for the second dose on 09Feb2021 and stated that he needs to get a dental procedure done on 04Feb2021 and needs to take amoxicillin for it due to past heart issue. The patient wanted to know if it is okay to take amoxicillin and was wondering if this medication will interfere with the second dose. He also asked if he should cancel the dental procedure. The patient mentioned that he had his annual wellness visit on an unspecified date and they did a lipid profile (unknown results) but it was not relevant in his opinion. The outcome of the events was unknown.

MUSCLE TIGHTNESS AND LOSS OF SENSATION IN LEFT ARM FOR LAST 3 WEEKS. SAME ARE AS VACCINATION WAS DONE.

After two days a low grade fever and terrible body aches. My fever has gone but body and joint aches have continued for three weeks. I have been able to some what control by taking a non steroid prescription drug periodically when the pain get bad. It seems to be an inflammation of my nerves. When will this go away?

shot given 2/6/21- next day weakness in left bicep, could only raise empty hand in "curl" motion. Usually exercise with 15 and 10 pound dumbell weights. 2nd vaccine Feb 6 first shot - next day weakness in left bicep, could only raise empty hand in "curl" motion. Usually exercise with 15 and 10 pound dumbell weights. - next day pain in left shoulder joint during any rotary motion. This continued for 4 weeks.

I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown. Information of lot/batch number has been requested.

Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.

sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021. No follow-up attempts are possible. No further information is expected.

he felt drowsiness.; it hurts to turn his head and he cannot drive safely; muscle pain went over to the other shoulder and basically spread out all over his upper body; he's been having muscle pains; This is a spontaneous report from a contactable patient. A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982 and Expiration date not reported), via intramuscular route of administration in the left arm on 28Jan2021 07:30 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not allergic to anything. It was reported that patient was generally in good health in 79. He knows there may be some adverse effects. Last Thursday (on 28Jan2021) he got his first dose of the Pfizer covid vaccine and he's been having muscle pains. The only thing that has happened to him was a lot of muscle pain, quite a bit. Through the day he started to feel the muscle pain and through the night he felt some stuff (referring to the muscle pain), very lightly enough to be a nuisance. States from the waste up he felt drowsiness. The first night he slept some but not much since he could not get in a position where he could sleep very much. The next morning the muscle pain was much more severe, more pronounced on his left-side, which is the side he had the shot, particularly in several areas like right underneath his armpit and between his arm and elbow. By the end of 2nd day, the pain had spread to the right hand and the day after that, it was concentrated on the left arm on the injection site. The next morning the muscle pain went over to the other shoulder and basically spread out all over his upper body. It has since worsened by then. He broke down last night and he took two Advil, and he got a really good night sleep. This morning he got up and the muscle pain gradually came back but not quite a s bad, states maybe the Advil was slowly wearing off. States it was a funny sensation, a lot of them. Patient feels it on the bottom of the side of his rib cage and neck. He was asking how long the muscle pain will go on. He hates to combine anything he will experience from the second dose with what he was currently experiencing. Patients understanding was that the second dose will worse. Patient ask can he take the 2nd dose on his opposite arm (right), he do not want to feel pain on the same side again. He has a card that states when he was supposed to get his second dose. States it hurts, it hurts to turn his head and he cannot drive safely. States his wife got her vaccine two days before him. He puts his glasses on to read the con-tact details from his hcp card. When querying outcome of drowsiness, he reports it occurred a few times off and on and it comes and goes, it does not stay around. Prior to vaccination patient did not take any other vaccines within 4 weeks. The patient experienced he's been having muscle pains, he felt drowsiness, it hurts to turn his head and he cannot drive safely, muscle pain went over to the other shoulder and basically spread out all over his upper body. The outcome of event was not recovered for myalgia, condition aggravated and unknown for somnolence, impaired driving ability. Follow-up activities have been completed and no further information is expected.

Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported.

I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play I have gone from being active and strong to being totally depressed because of the constant pain that I am in

Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........knees , shoulders , hands , fingers , wrists....Have not been seen by Dr...his office told me there was nothing they could do ......situation has not improved and doing normal things hurt like hell ...getting up and sitting down painful, getting in and out of car hurts .......I need and use a cane to walk.......how long does this side effect go on?????

Fatigue; Fever; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19267), via an unspecified route of administration in right arm on 17Feb2021 at 02:30 PM at single dose for COVID-19 immunisation.The patient's medical history included high BP, high cholesterol and diabetes. The patient was allergic to Mobic. It was reported that prior to vaccination, the patient was diagnosed with COVID-19 and the patient did not get tested for COVID-19, since the vaccination. The patient's concomitant medications included celecoxib (CELEBREX), metformin, allopurinol and pravastatin. On 18Feb2021 at 6:30 AM, the patient experienced fatigue, fever and muscle aches for 36 hours. The patient did not received any treatment. The outcome of the events was recovered.

Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis

embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left sided weakness on his leg; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history included transient ischaemic attack (TIA) from 2019 to an unknown date, mild hypertension, idiopathic neuropathy: in the left leg, started in the beginning of the year from 2019, melanoma removed in the 1970s, enlarged prostate, neuropathy, cholesterol and fluid retention. Ongoing concomitant medications included tamsulosin taken for enlarged prostate; gabapentin taken for neuropathy; candesartan taken for hypertension; pravastatin taken for cholesterol; acetylsalicylic acid (BABY ASPIRIN); and furosemide (LASIX [FUROSEMIDE]) taken for fluid retention. The patient has been taking all of his meds for quite some time, over 5 years. The patient did not have prior vaccinations within 4 weeks. The patient received the first dose of BNT162B2 on 09Mar2021 10:30 for COVID-19 immunization. The patient completed the Pfizer COVID vaccine series, the second shot was on 30Mar2021. On 09Apr2021, the patient had an embolic stroke. The patient's daughter stated that the patient has a history of TIA in 2019 and was concerned. She does not know if it was related. She added it might be that if people have previous risk, there may be some precautions, like to take a full dose of aspirin before, a week before. She sent an e-mail last 05May2021 and hasn't gotten a response back. The patient went to the ER due to embolic stroke and was in the hospital Friday (09Apr2021) through Wednesday. The patient went to the stroke rehab center for 3 weeks. The daughter clarified that the patient was in the hospital until 14 or 15Apr2021 before being transferred (also reported as 5 or 6 days and in rehab for three weeks). Then was discharged last 06May2021. The patient's condition seemed to be getting better. His major issue was speech and wasn't able to formulate any words. He was able to speak now. His rehab would be a lot of neurological rehab and speech therapy. The patient previously had left sided weakness on his leg from some random thing that happened. It didn't seem to get worse. It really affected his speech and cognition. The patient's daughter thought that the embolic stroke was related to the Pfizer Covid vaccine and added that thought was in some way but cannot say in what way. She thought that it exacerbated some type of blood clotting. She stated that he never had blood clotting issues before and was the type of person that would take a baby aspirin and get a nose bleed, he was the opposite of a clotter. An MRI in the hospital showed blood clot and stroke. He had blood work but does not know what it showed and presumed he was fine (unknown results). He has never really had any kind of blood work issues and does not know why he was on cholesterol medication. The patient required emergency room visit for embolic stroke. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported "embolic stroke" cannot be excluded. Previous medical history and Old age is a risk factor for the onset of stroke. 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.

right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpal tunnel; feeling anxious; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap/ was hotter than a firecracker; arm was so sore he couldn't pick it up straight in the air; trouble walking; right shoulder was swollen; left knee is swollen real bad; right shoulder was pretty sore and is getting worst all the time; left knee was "sore"; right wrist twice as thick as [his] left one/left wrist then "started swelling and being painful"; This is a spontaneous report from a contactable consumer, the patient. This 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in Apr2021 (at the age of 79-years-old) as a single dose for the corona virus, to get rid of it/ it's supposed to be sure he didn't get it. Patient had no medical history. There was no relevant family medical history. There were no additional vaccines administered on same date of the COVID-vaccine. Patient had no adverse events following prior vaccinations. He remembers his first polio shot he got that back in the early 50's and his second shot was a cube of sugar, called the salt vaccine. Stated he's been getting vaccines for a long time and he never had any trouble with any of them. The patient previously received the initial dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in 2021 (March or April) in the left arm which was deemed invalid by the vaccination provider due to temperature related issues (i.e wasn't cold enough). He explained he received a letter informing him of this incident and recommending a replacement dose (which he thinks was on 06Apr2021). About 2 to 3 weeks before he got his first COVID shot, he got a flu shot in his left arm, about 4 or 5 inches above where he got his COVID shot. The patient's concomitant medications were not specified. He reported that the second vaccine (BNT162b2) caused him problems. On 06May2021, he woke up with his right wrist twice as thick as his left one, it was swollen real bad. The right wrist was quite sore and painful. He didn't know if he was getting carpal tunnel or what it was, so he went to the ER about it and they gave him three different kinds of pills, two of which included tramadol 50mg one every day and ibuprofen 400 mg. The ER couldn't determine the cause for his reaction. About 3-4 days after taking the prescribed medication, his reaction subsided quite a bit and was not nearly as hurtful, but his left wrist then started swelling and being painful/sore. Therefore, he continued to take his medication and it improved. It was like that for a couple/ three days, and it calmed down. He thought he was okay 2-3 days ago, but this morning (14May2021), his right shoulder was swollen and pretty sore and was getting worse; he was in so much pain, so sore he could hardly even move his arm, he couldn't pick it up straight in the air, couldn't get his elbow up past his ear. The patient also reported that when he got off his bed, his left knee was sore and it felt like a fire underneath his kneecap and he was having trouble walking. The left knee was swollen real bad and was hotter than a firecracker. Thus, he went back to taking his pill again. The knee pain started the morning of 14May2021 about the same time it seemed and has worsened, and he took a 400mg ibuprofen and the other pill he's taking, "100 mg doxycycline or something". Patient hadn't been doing much since, he was feeling kind of laid up, he had thought it was all done with yesterday (13May2021). He stated he's been hearing things about allergic reactions to this COVID shot, was sure that a lot of people are having complaints of allergic reactions, and was sure he's not the only one who has had a problem like this. He asked if there was anything he can take to block it because he is sure when this calms down after a week or whatever, it will be his in his right knee or left shoulder or wrists or ankles and he's 100% it's about that COVID shot. He stated he's never had arthritis before. He stated that he has never had any problems like this before. He is supposed to go see his doctor in a week or two. He tried to call the doctor to make an appointment, but he figured he would wait a couple days, but he is hurting bad today (14May2021), and he hasn't been to anybody yet except for the ER. The patient stated it looks like the vaccine is methodically causing this spread into his body. He also reported that it feels warm outside of his left wrist, towards the edge of it and all the way to the joint of the little finger and he thinks the swelling will start again. He expressed feeling anxious about his reactions. He asked if there were any kinds of pills he could take to block the effects of the vaccine from working in his body. He stated it seems like it's going from one area to the next and it seems like it's going through his joints and he doesn't like that. His left wrist still got a little bit of soreness in the back near the joint, but doesn't appear to be swollen. Regarding the right wrist, he has recovered completely, it feels better; doesn't feel any soreness in any place and doesn't look swollen. The clinical outcome of right wrist twice as thick/left wrist started swelling recovered on unspecified date; left wrist painful/sore not recovered; right shoulder is so sore not recovered; left knee was sore not recovered; anxious was unknown; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap was unknown; left knee is swollen not recovered; arm was so sore unknown; carpal tunnel unknown; trouble walking unknown; right shoulder was swollen was not recovered. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551521 same patient/reporter/drug with different AE/time gap.

Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sharp pain in injection arm (left arm: injection site, shoulder and elbow) as well as muscle in opposite leg and hip that prevented him from walking. Pain has minimized since then (report is one week after incident) but patient still feels some minor pain, and says he will report to his primary care provider if symptoms persist for one week. Patient took aspirin for pain, which helped.

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by heart palpitations on day four. Palpitations continued for several weeks and then slowly cleared. BP, heart beat all normal. Palpitations were infrequent, then increased in frequency and the slowly diminished.

Pt had 1st Pfizer Covid 19 vaccine on 3/5/21 and 2nd Pfizer Covid 19 vaccine on 4/2/21. He started to have mild muscle pain just before the 2nd vaccine and continued. Few days after the 2nd vaccine, his muscle pain got worse. He went to a pain clinic from 4/5/21 to 4/9/21. He stopped going there because his muscle pain got worse and he could not walk or move. On 4/16, he made an appointment to see Dr. (orthopedic) and Dr. could not see anything wrong with the X-ray. Dr. said he had a similar case with other patients and pain shots will not fix it. Pt saw PCP (his main doctor) on 6/7/21 and told him he still has muscle pain with muscle spasm and he cannot move or walk. PCP told him to exercise. Pt is still in serious muscle pain and he is homebound from 4/9/21 to now. He cannot walk or move. His symptoms have not improved at all. We do not know what to do because his muscle pain won?t go away for about 4 months now.

he most pain occurred in my left shoulder where I received both covid shots/All of my replaced joints started to be painful on the morning of 05May; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 (at the age of 79 years) as 2nd single dose for COVID-19 immunisation. Patient medical history included O.A (osteoarthritis), joint replacement. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM), meloxicam (MELOXICAM), omeprazole (OMEPRAZOLE) potassium (POTASSIUM) all taken in two weeks for an unspecified indication. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration, administered in left arm on 25Jan2021 as 1st single dose for COVID-19 immunisation. Patient reported that he had O.A. in both of his knees and both of his shoulders replaced. All his replaced joints started to be painful on the morning of 05May2021 at 09:00. The most pain occurred in left shoulder where he received both covid shots. A month later patient was still having pain with no relief. Doctor gave him a steroid shot in his left shoulder with no relief. The doctor and he had no idea what to do next. Patient received the treatment as pain pills, steroid shot, heat for the event. The clinical outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

a shooting pain started up into his knee and it just aches all the time; It is irritated where he cannot wear a shoe now/He cannot get up and out of chair/ He cannot do anything; Everything was normal except for that same mass in his foot; he has a soft tumor on both feet/ the tumor is sticking out; his foot started hurting/his right foot is having pain/ the pain is starting to get worse; now I can't walk; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 09:00 (at the age of 79-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included foot tumor. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 29Jan2021 09:00 as single dose for COVID-19 immunization. The patient reported he has a soft tumor on both feet/ the tumor is sticking out, his foot started hurting/his right foot is having pain/ the pain is starting to get worse, now I can't walk, it is irritated where he cannot wear a shoe now/he cannot get up and out of chair/ he cannot do anything, everything was normal except for that same mass in his foot on an unspecified date in 2021, a shooting pain started up into his knee and it just aches all the time on 26Apr2021. AE resulted to visit physician office. Patient is a consumer, asking what do I do or what can I take to make this pain go away. Patient reported that he received both doses of the Pfizer covid vaccine, his first dose in January and his second dose February 1. Patient reported that around the same time that he got his shots his foot started hurting and now I can't walk. Patient reported that he has a soft tumor on both feet but his right foot is having pain, the tumor is sticking out and the pain is starting to get worse. Patient reported that nothing works to take the pain away. Patient reported that he saw his doctor a while back but reports that back then the pain wasn't as bad, they did x-rays and nothing was wrong. Patient reported that now the pain is terrible. Soon after having the COVID vaccine shot in Jan 2021, patient started having foot problems on his right foot. Patient did have a preexisting soft tumor in that foot. It is irritated where he cannot wear a shoe now. Patient can't stand or walk on it. It is constantly aching. A couple of days ago, a shooting pain started up into his knee and it just aches all the time. Patient was wondering if this is one of the side effects. Patient wants to find out if it is caused by the vaccine. Patient had a x-ray three weeks ago, and there was nothing wrong with his foot. Patient had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Patient thinks the vaccine affected the mass. Patient can't walk on his foot it just aches. Patient foot became irritated in Jan 2021. It was irritating. It has worsened. The shooting pain up to his knee started 26 Apr 2021. Patient just drove to the hospital today to get information and the pain shot up a little bit today. Even when patient is sitting in a chair he has aching and shooting pains in his foot. Patient went to the store in pain. Patient cannot do anything, cannot get up and out of chair, can't turn around with his foot on the floor. The patient underwent lab tests and procedures which included x-ray was normal -he had a x-ray three weeks ago, and there was nothing wrong with his foot. He had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Outcome of the event a shooting pain started up into his knee and it just aches all the time was not recovered, and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Wasn't felling heathy/Wasn't feeling well/not feeling good/Felling ill/Feeling sick; Using a bathroom number 2 four times a day, regular stool not soft; Back hurt; Slightly dizzy; I worry about how I am feeling until I know it is from the shot or not I am not going for another shot; Maybe nauseous; Feeling down; This is a spontaneous report received from a contactable consumer (patient) reported that: A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0123; Expiration date: unknown), via unspecified route of administration on 02May2021 (at the age of 79-year-old) as first dose, single dose COVID-19 immunisation. The patient medical history included atrial fibrillation and the concomitant medications included blood thinner for atrial fibrillation. The patient took pfizer shot 3 weeks ago. The patient experienced was not felling heathy, I wasn't felling a 100 percent; Was not feeling well/not feeling good, using a bathroom number 2 four times a day, regular stool not soft, back hurt, Feeling ill, Feeling sick, Slightly dizzy, worry about how he is feeling until he know it is from the shot or not, patient not going for another shot, May be nauseous, Feeling down on unspecified date in May2021. The patient stated that he got the shot 3 weeks ago and patient was due for second shot tomorrow but he have a concern, he do not think he is going for it, 2 days after he was not well about 8 days and then he felt better and then about 4 days ago he felt the same thing again, The patient stated that "he did not really care to report it but what he was calling to see his second shot is tomorrow and he is not going for it, but he would like get it may be when he feeling mentally after it, Could he take it couple of weeks later, if that ok?" the patient had a reaction to the flu shot (Unspecified Flu Shot) and he was feeling ill for about another 9 days it went away, but then it came back 4 days ago; didn't feel well/ not feeling good. The patient was scheduled for my second shot this morning I did not go because he is not feeling that great. The patient said he got the flu shot 3 weeks ago and 2 days after this shot, he did not feel well for about 7, 8, 9 days and then it went away, he felt okay and then about 4 days ago he got back the same feeling, not feeling good, slightly dizzy, maybe nauseous. Using the bathroom, number 2 frequently 4 times a day and he was scheduled for my 2nd shot this morning I did not go because he was not feeling that great. The patient stated that he took the vaccine three weeks ago and he was scheduled for his second shot this morning, he did not go because he is experiencing some side effects(Further not clarified hence captured as verbatim) and he was concerned to see this is related to the vaccine (confirmed as Pfizer COVID vaccine) or not?" He got this vaccine shot 3 weeks ago two days after he was not feeling well, he was feeling down for about 8 or 9 days and then it passed, the patient felt better then 4-5 days ago the same thing come back, this is 3 weeks now. The patient did not receive any treatment for the events, the outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Burkitt's Lymphoma, Pain in Abdomen, Lethargy, Weight Loss, PET Scan, Chemotherapy, Mass discovered in Lymph Node in abdomen CT Scan - May 18, 2021 Blood Work - May 19 and 27, 2021 Tissue Culture and Biopsy - May 19, 2021 PET Scan - May 27, 2021 Echocardiogram - May 28, 2021 Chemotherapy start date - June 2, 2021

On 03/27/2021 I had the second dose and 3 weeks later I started to have a swollen hand and painful wrist and hand and I was unable to pick up things. I decided to go to the doctor and he gave me injections in the wrist and they did some x-rays. The second time I visited the doctor they diagnosed me with Rheumatoid arthritis in the hand and wrist in the same arm I had the injection. And they put me on prednisone.

pain in the back of neck; pain in left shoulder blade, 1 day later pain also in right shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, 2 days after injection, the patient experienced pain in left shoulder blade and 1 day later pain also occurred in right shoulder blade. On 19Mar2021, 3 days later, the patient experienced pain in the back of neck. It was reported that the pain in shoulders subsided. It was unknown if the patient received treatment for the reported events. The clinical outcome of the event pain in left shoulder blade and also in right shoulder blade was recovered on an unknown date in Mar2021. The clinical outcome of the event pain in the back of neck was not recovered. No follow-up attempts are needed. No further information is expected.

Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.

Have acute pain to both hips that has lingered and is ongoing; Hips both of them at once started aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), second dose via an unspecified route of administration, administered in left arm on 02Mar2021 at 10:30 (at the time of 79-year-old) as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. Family medical history relevant to adverse events was reported as none. No investigation assessment. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), first dose via an unspecified route of administration, administered in left arm on 05Feb2021 at 10:30 (at the time of 79-year-old) as a single for COVID-19 immunisation. Vaccination facility type was reported as hospital, but it was not at the hospital it was a special place set up for injections. Vaccine administered at military facility was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No previous immunization with the Pfizer vaccine considered as suspect. On 09Mar2021, the patient experienced have acute pain to both hips that has lingered and was ongoing, hips both of them at once started aching. It was reported that patient was a patient who received the Pfizer Covid 19 vaccine series and has experienced prolonged side effect. Patient stated that on 09Mar2021, after receiving the second dose of the Pfizer covid vaccine on 02Mar2021, he began to have acute pain to both hips that has lingered and was ongoing although slightly better. Caller inquiry was "Does Pfizer have any update on the length that side effects are supposed to last. Pfizer does not have information on how long what you are experiencing may last. There may be many factors to consider including your medical history and medical condition. Please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Your doctor/healthcare provider was in the best position to advise you about the appropriate action to take as your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient stated he was calling about the COVID vaccine. Caller stated he was wondering if there was any information since after the second shot which was 09Mar2021 a week almost exactly after his hips both of them at once started aching and he did not call in because it was almost impossible to say 100 percent, but he never had problems until after the second shot. Caller asked was there any information of how long it lasts. Caller stated also aside from Aspirin, Aleve, and NSAIDs was there any other way to reduce the effects. Patient clarified the second dose of the vaccine was received on 02Mar2021 and not 09Mar2021. Second dose was suspect product as caller stated his symptom started after receiving the second shot. Patient stated he has taken everything he could possibly think of. No adverse events required a visit to emergency room/physician office. No adverse events following prior vaccinations. No relevant tests. The outcome of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distribution just in the hand initially on 1/16/21. On 1/18/21, patient had symptoms lasting about 4 hours and could not pick up objects. By the time he came to the ER for this, symptoms had resolved. On Tues, 1/19, patient went skeet shooting and experienced an episode of numbness involving the entire left arm from shoulder to fingertips, involuntary hand movements, and left cheek twitching. These symptoms lasted about 10 minutes. Patient also reported dysarthria, slurred speech, strange sensation on left side of face, and facial asymmetry. His wife reports his voice was a whisper and patient's left arm was dangling at his side. Reports voice feeling weak along with these symptoms.

Mild flu like symptoms, slightly elevated body temperature, body aches, tiredness, shoulder ache, first day. 2nd day body aches, tiredness, sore shoulder, administered Tylenol. 3rd day body aches administered Tylenol

Extreme muscle weakness, could not get out of bed unassisted, slight nausea. After 48 hours symptoms went away rapidly. Never had a reaction to a vaccine previously. Have had flu, shingles, pneumonia previously..

he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, "I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?" The outcome of the event chills was resolved, of other events was unknown.

trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.

Later in evening I had intense muscle pain in legs and chills. It progressed later in that day to a piercing headache and 100 degree fever. Ibuprofin helped to lessen the pain. The following day the pain was greatly improved but I was very lethargic and tired.

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

2-22-21 JOINTS ON RT SIDE PAINFUL - NECK, SHOULDER, ELBOW, WRIST, HIP AND KNEE. HAS BEEN TAKING TYLENOL AND USING ICE PACKS WITH TEMPORARY RELIEF - ADVISED TO CALL PCP FOR EVALUATION 2/23/21. 2-24-21 8:30AM TC - PT STATES HE FEELS BETTER TODAY. PCP GAVE HIM A STEROID SHOT AND RX FOR PREDNISONE.

sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or lift right arm and no strength to lift object. Felt swelling in nymph node area under arm and in neck. Totally immobile arm on day 8; improvement and dissipation on day 9. Today, day 10 no after effects; back to normal. Treated the pain and discomfort with Tylenol extra strength.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

1 day after taking vaccine, noted stiffness on left side of the body, beginning on left buttock down left leg to the left foot; leg was swollen and stiff

knocked out due to fatigue; legs were just worked up/area where he had arthritis (knees and wrist) were affected the most/knee joints were so bad/knee joints were so bad that he could barely walk/wrist joints were also bad; This is a spontaneous report from a contactable consumer (patient) reported that an 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis which the patient had for 10 years or so and blood pressure. The patient has a positive COVID test on Sep2020. Concomitant medication included methotrexate (manufacturer unknown) for arthritis, losartan (manufacturer unknown) for blood pressure, hydroxychloroquine sulfate (PLAQUENIL) for arthritis and acetylsalicylic acid (CARTIA, reported as 'kartia') for blood pressure all ongoing and levothyroxine sodium (SYNTHROID) from an unspecified date to an unspecified date. The patient stated that he was okay the first day. Then the next day, it knocked the legs right from underneath him. His legs were just worked up and he knocked out due to fatigue. Mainly the area where he had arthritis (knees and wrist) were affected the most. He was in bed for a couple of days. At one point, his knee joints were so bad that he could barely walk. His wrist joints were also bad as he has arthritis in both knees and wrists. It lasted from the 28Jan2021 to the 30Jan2021. He has recovered from it. His knees are good, and his wrists are back to their normal aches and pains. During the time of the report he was feeling pretty good. He was concerned about the second shot and would like more information. He wanted to know if the second shot will cause more severe side effects. The outcome of the events was recovered on 30Jan2021.

'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.

At 2 a.m.the following morning after the vaccine , my father got up to use the bathroom and realized his legs were so weak he could not stand from the bed. This happened again at 5 a.m.and 7 a.m. when he awakened to urinate. He called his doctor that morning who advised him to go to the ER to rule out a stroke. He was admitted overnight for observation. A CT scan of the head was negative for stroke. He had a follow up MRI head which was also negative for stroke. He will follow up with his neurologist.

79 yo woman received Pfizer Covid vaccine #1 on 2/23/21. She has been experiencing diffuse body pain-especially her hands. Patient had a ground level fall requiring sutures for a head lac on 1/25/21. The diffuse body aches and pains seem to pre-date the vaccine. Certainly, vaccine related reactions such as myalgias can be expected from the vaccine and may have exacerbated her symptoms. MD recommended, based on the above, for patient to receive the 2nd dose of Pfizer vaccine. However, patient can be reassured that she can safely get the second covid vaccine to finish her immunization. She may take pain medication as needed after the vaccine is given to relieve pain.

Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking painful; both legs are hurting; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3242), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 80 years-old) as a single dose for COVID-19 immunization. Ongoing relevant medical history included myopathy, neuropathy, neurological issues, and chronic pain. Additional medical history included the patient also had spinal cord surgery several years ago and sensation issues for a lot of years. The patient's concomitant medications were not reported. On an unknown date the patient experienced muscle ache, muscle spasms, injection site hurt bit, walking difficulty and walking painful. On 10Feb2021 the patient experienced both legs are hurting. The patient reported that they had the first vaccine on the 06Feb2021 and the injection site hurt a little bit and a couple of days went by and then the patient had the muscle aches and all of a sudden it was severe with muscle cramps and spasms from the buttocks down the leg on the left side. The patient stated that now both legs are hurting a lot from about 10Feb2021. The patient stated that he could barely walk and it was very painful to walk. The patient stated he was using a walker, cane, and holding onto objects when walking. The patient said it is a little better, but the patient still has to take baby steps and the patient is currently having a buttock spasms. The patient stated they have the second appointment 27Feb2021 and the patient is leery of taking the second dose as the patient has not been able to function for the last 2.5 weeks and is not sure about getting the second dose. The clinical outcome of the muscle ache, injection site hurt, walking difficulty, walking painful and both legs are hurting was unknown. The outcome of the event muscle spasms/buttock spasms/ muscle cramps was not recovered.

Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through the day and was not feeling well. He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance. He got up at 9pm and fell in the bathroom. He was dizzy. His wife assisted him back to bed. He was not able to sit, he would fall over. On 3/6 his balance was still off. His wife assisted him to the car and took him to the Hospital. They treated him for dehydration and discharged him. On 3/7 he developed a rash over his body, "big red spots". 3/8 his wife called the physician , who saw him the following day, on 3/9. He was advised not to take the 2nd Pfizer vaccine. The rash lasted 5-6 days. At the time of this report, his symptoms have resolved. His wife reports she completed a VAERS. His report number is 346254

Woke up the day after the vaccine was administered (2nd Dose) and legs were weak ("muscles felt like jelly"). The next day I developed aches in lower extremities. The third day, I went to the emergency room and was given a muscle relaxer. This has not relieved the pain. The pain has now moved into my ankle joints and it is very painful to walk. I visited my doctor on the seventh day and was given a pain killer, Meloxicam (15mg), and this is relieving some of the pain when I walk.

Painful and shingle-like reaction. Throbbing pain down the neck and left shoulder. Symptoms persist almost 14 days after vaccine completion.

Received Pfizer dose 2 on 29 Mar. Lot # ER8733 left arm. Did have slight localized soreness initially. But nothing too bad. Then 4 to 5 days later around 02-03 Apr he developed severe left should pain. Pain is constant and rated at # 9. Able to move arm. No hx of injury. Did have surgery on that shoulder in May 2020 but has been doing well. He went to his ortho and he did an xray which was normal. He was told that his exam was normal with good movement. Recommended continued use of his lidocaine patch. Has MRI scheduled for next week. Pt stated he knows the vaccine caused his pain and wants it reported. He had read on the internet about shoulder injury after vaccination and believes that is what he has.

At some time after the vaccines were given I started having muscle aches and pains throughout my body. Thighs, calves, butt, hips, biceps, forearms, and inside area between bicep and lower arm (opposite side of elbow) which would keep me awake at night due to the pain. That pain was only at night, the other pains were during the day and most times would last the whole day, but other times would lessen as the day went on. I still cannot sleep on my left side, due to hip and arm pain, but the very painful left arm pain persists as described above even when sleeping on my right side. I still have these pains as of the date of this writing, April 17, 2021.

shortness of breath; body aches; weakness in arms and legs; headaches; chills; This is a spontaneous report received from a contactable consumer. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shortness of breath, body aches, weakness in arms and legs, headaches, chills on 03Apr2021 with outcome of recovered on 06Apr2021. Therapeutic measures were taken as a result of events included Acetaminophen and Ibuprofen. No follow-up attempts are needed. No further information is expected.

Left hip and joints is bothering me and my left leg is like sore; left hip and the joints, it really hurts; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 10Feb2021 (at the age of 80-year-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included insertion of cardiac pacemaker put into his body on the left side on 04Feb. Concomitant medications were his regular medication and blood pressure pills, which included losartan 50 mg one daily, atorvastatin 80 mg one daily, aspirin 81 mg, carvedilol 12.5 taken 2 daily. The patient took first dose of BNT162B2 (Lot Number: EK4176) on via an unspecified route of administration 20Jan2021) as single dose for COVID-19 immunisation. On an unspecified date, the patient's left hip and joints bothered and his left leg was like sore, left hip and the joints, it really hurts him. The patient enquired if its natural that happens or what's going on because it comes and goes but in his left hip and the joints really hurts.. The patient went for lab work at the hospital where he was two weeks ago, but result was unknown. Outcome of the event was unknown.

Pain in my right arm and shoulder, pain in my right wrist, paiin my my thighs and hanstring, pain in my kness

Reaction was more intense, but of shorter duration than the reaction to the first shot on 4/15/2021 (lot # ER8729) I experienced weakness, dizziness and remained in bed until 5 PM on Saturday 5/8/2021, the day after the shot. This time, there was no pain, swelling, or redness at the shot location on my right arm. I experienced a loss of appetite, slight headache and some groin aches through most of the day on Saturday. I'm feeling much better today, Sunday 5/9/2021. Side effects from the first shot lasted a full two days

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown. Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69. Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.

his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection was given in; I got a lot of headaches and I still have them./unbelievable headaches; More back pain than usual; My blood pressure went up a little bit but not much; This is a spontaneous report from a contactable consumer (patient). Follow-up information received on 17Feb2021 was processed together with initial information. A 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: UNKNOWN), via an intramuscular route on 08Feb2021 (at the age of 80-years-old) as single dose in the left arm for covid-19 immunization. The patient medical history included and back pain. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced blood pressure went up, More back pain than usual and on unspecified date experienced Stiff neck, Headache, pain in arm the injection was given in, pressure on his eyes, cold. The clinical course of the event was as follows: blood pressure went up a little bit but not much. It was reported that blood pressure was up which he was told by the nurse was normal. It was just a little bit high. The nurse at the facility said it was not that concerning and that it was fine. The facility let him stay a half an hour and then he was able to driven home. He hadn't wanted to stayed long because it was very, very cold. He had a lot of back pain. He does have back pain all the time, but not that much. It was more back pain than usual. The pain in his back increased/doubled, and the pain is still high. He clarifies he has had problems with his backed and have had backed pain normally, but after the shot it was liked a lot of pain in his backed and his neck was stiff very, very stiff hasn't knew if it's from vaccine or what. Patient stated that before the vaccine, he was okay and was able to worked in his house and outside. He believes the stiff neck began after 2 or 3 days of receiving the vaccine and it have had worsened. Patient stated that pain in his armed where he received the shot went away completely. He clarifies further the pain in his armed went away the second day. He got a lot of headaches and he still had them. The headaches began right away, and the headaches still c continued. He mentions the headache got a little better last night. He was really worried about it and hadn't knew what to did. It was reported that he told his son everything and his son said to not went to hospital because there was a lot of people that had been in contact with covid and it's going to have been worse. He states his son told him to drink a lot of water and saw if he got better. He did that and he did got a little better but not that much. Patient mentions that he had a lot of pressure on his eyes. The patient did not went to emergency room because he was told it was normal to had headaches but they went away and his should went away in 2-3 days. His armed where he received the vaccine was also okay the next day. The patient did not visit to physician office. Patient mentions that he took blood pressure medication, and everything was under controlled and he took 10mg of a cholesterol medication. Patient declined to include these medications for the report, stating he gave all of this information at the facility he received the vaccine at. He had to filled the paperwork out. He confirms he hasn't had any NDC, lot number or expiry date for these medications at this time. It was reported that patient had a blood tests done about 3 weeks before he received the vaccine and the doctor said everything was okay at the time. The outcome of the events headache was recovering, backed pain and neck was stiff was not recovered and other events was unknown.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Approximately one month after second dose of Pfizer injection patient began to have shoulder joint pain, progressing to hand and then opposite shoulder. Has persisted greater than 3 months. New onset/diagnosis rheumatoid arthritis, connective tissue disorder. Patient states he has had similar pain and swelling in joints in the past that resolves quickly, however states this pain and swelling is severe and persistent now three months

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events. Follow-up attempts are completed. No further information was expected.

Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment

PAIN LEFT AND RIGHT SHOULDER, WRIST AND RIGHT HIP RIGHT HIP STOPED AFTER ABOUT TWO WEEKS WRIST PAIN DECREASED AFTER TWO MONTHS NOW MINOR LEFT SHOULDER DECREASED PAIN AFTER 4 MONTHS RIGHT SHOULDER HAS NOT DECREASED AS OF TODAY

tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well

Wednesday morning he started to feel a lot of muscle soreness in the back of his neck and shoulders and could not put his head back to drink water. Wednesday evening put muscle rub on achy areas and took a couple of Aleve. Thursday morning was feeling better and Thursday evening a lot better. Friday just a slight tight feeling to remind him it is still there.

My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; I'm having trouble walking; got up every 15 minutes after that with frequent urination/ I got up 5 or 6 times and even could not get bathroom fasten up and couple of occasion is very unusual for me; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose in the arm for COVID-19 immunization. Medical history included atrial fibrillation, diabetes and a heart attack 30 years ago. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) for A-fib, empagliflozin (JARDIANCE) for Diabetes, metformin hydrochloride (METFORMIN ER) for Diabetes. It was reported that the patient had no after effects the day he had the shot. In the morning of 16Jan2021, he got some things going on but he was not sure if it is connected with Pfizer or not. Usually he wakes up and go to the bathroom once in middle of a night. Last night he got up 5 or 6 times because he had to go and couple of times, he did not even get to the bathroom on time so he really had to urinate. Stated this is very unusual for him. And when he woke up this morning, her joints do not look physically swollen up but they feel, stated "how do I describe it, they feel very (incomplete sentence)". His knee joints and elbow joints felt very stiff and felt as if they were swollen but they're not. Stated that he's having trouble walking. Stated that it may be totally unrelated. The patient stated, "The only thing I had was, every year they make me go to a lab and make sure I have no issues with Pradaxa because it is a blood thinner. I have that lab. Work done couple of weeks ago. I have not gotten the answers yet". Also stated that he had lab test because he has acid. The outcome of the events was unknown.

not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization. The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.

Sore injection shoulder extending to the other shoulder; 2 degree temperature; chills. Lasted about 24 hours. I also had some scattered, small red bumps over my arms and legs and several tender bumps on my head. The toes on my left foot had a reddish appearance. These symptoms lasted about 5 days and may or may not be related to the vaccination. At my age, random unexplained symptoms are not unusual.

Pain at injection site; muscle pain below injection site; severe bruising below injection site; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982, expiry date unknown) on 16Jan2021 15:30 at a single dose via an unspecified route of administration in his left arm for COVID-19 immunization. Medical history included diabetes, heart disease and arthritis, from unknown date and unspecified if ongoing. The patient had known allergies to penicillin and tramadol hydrochloride (ULTRAM). The patient's concomitant drug included apixaban (ELIQUIS), no other vaccine received in four weeks. The patient had not had COVID prior the vaccination and no COVID tested post the vaccination. On 16Jan2021 (time provided as 22:00), the patient experienced pain at injection site, muscle pain below injection site, severe bruising below injection site. The patient took apixaban and he believed the injection caused severe bruising. The patient received home remedy: elevated arm applied warm compress, as treatment for the events. The patient was recovering from the events.

lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.

I received the vaccine Friday morning, 09:15 AM, (EST) I was woken up at 04:23 AM (EST) by a very loud hissing noise, I thought it was outside, however I soon realized it was in my ears. I was not able to go back to sleep. I realized it was Tendinitis, as I have had systems of Tendinitis, over the years, but it just came and went, and was not loud enough or lasted long enough to be anything but a minor annoyance . In this case while it is not loud, it is loud enough to be annoying, and it still did not go away. (time is now -01:13 PM 2/16, I am hoping it is just the vaccine working its way through my system. I notified my primary care doctor at the VA, as well as audio dept.

Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.

Severe pain and some swelling in Right ankle joint. Started night of injection and progressively improved for three days. Pain was 8 or 9 on scale of 10.

Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. 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.,Linked Report(s) : US-PFIZER INC-2021229604 same patient/reporter, different AE/first dose

2 days after receiving his first vaccine, he developed muscle and bone pain. Symptoms continued and he did get his second vaccination. These were done in in his home state. I am in a different state. I saw him last week and he had muscle pain and arthritic symptoms. Sedimentation rate was elevated. Started on prednisone with some improvement.

4 days after receiving the second injection on Feb20, 2021, I experienced significant weakness in my legs which caused me to be unable to stand upright for any extended period of time and prevented me from taking care of my self. This condition has persisted since then and has not improved significantly.

My RA began to really act up. My whole body stiffened up-(legs, hands, hips, back). Lower back made it hart to bend over, Rt shoulder had a swelling and hurt at a pinch point in shoulder, my rt hip hurt when I walked more than 0.25 miles, my hands swelled and could not use hand well. Did not initially link to Covid shot, so called my Rheumatologist on the sixth day that the symptoms continued. Received prescription to reduce muscle tension and an anti inflamatory. However, a couple of days after talking to my doctor and before taking any of the prescribed meds, the symptoms went away and since that time, my RA is back to typical old symptoms and pain level.

Site: Pain at Injection Site-Mild, Systemic: Severe pain in right arm (non vaccine arm) with sever joint pain also-Severe, Systemic: Joint Pain-Severe, Additional Details: Severe pain in opposite arm with severe joint pain

Lung blood clot found after emergency room visit experiencing shortness of breath 03/04. Tennis ball size neck lymph node swelling starting 02/25. Joint pain and swelling starting 2/22

muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local light pain; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL9261, expiration date: unknown), via an unspecified route of administration in the left arm on 21Jan2021at 12:50 as a SINGLE DOSE for COVID-19 immunization. Medical history included back pain and arthritis. Concomitant medications include propafenone taking for more 5 year still ongoing for indication atrial fibrillation and dutasteride taking for a year and half still ongoing for indication prostate. No history of all previous immunization with Pfizer vaccine and no prior vaccination in four weeks. On 21Jan2021, received first dose of the vaccine about 2 and a half weeks ago. He stated, it went fine but the day after, on 22jan2021 had some muscle tenderness (local light pain) and stiff neck and shoulder developed that was pretty mild but it was still going. It's about 2 and a half weeks now. In the morning it was maybe a tad more stiff mostly on left arm, it improved some when walking around and with exercising so he doesn't have to take medication. He stated, when you don't move it doesn't hurt, it's when you move the neck muscle that it was sore but not much at all. At his age you have back pain and a little arthritis. It was strange that it started the day of or day after. He stated he did report just a bit of local pain but only when you touch the area and a very mild muscle pain, but it has continued and he doesn't know if it was related. He asked if this was related to the vaccine and how long this typically lasts. Mentioned he has had this pain before but he feels that he has avoided exercise or yoga or anything that would cause it now. he does have arthritis in his back. He was scheduled to receive the second dose of the vaccine on 11Feb2021. He didn't receive any treatment for the events. The clinical outcome of the events was still unsure if he had this before vaccine or not and its persisting.The outcome of all events were not recovered.

history is a bit complex. I had had occassional r shoulder pain in the past without a diagnosis or specific Rx. 2 days before 2nd dose, i b raised upper L ulna. 2 days post 2nd dose, rather severe olecranon pain developed dwith expuisite tenderness and mild swelling, but no fever. Subsequently over a period of days and weeks, I developed worsening right and then left shoulder and some neck pain and some additional hip and other pain. Shoulder tyenderness was diffuse and mostly muscular, Siginficant limitations of ROM withinability to raise arms. Pain was worst at night and on awakening with some relief with acetaminophen (no NSAIDS as on Xarelto).

Got worse and the leg swelled and was also having foot swelling because blood flow wasn't there; sore arm; blood clot; pain behind left knee; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right shoulder on 23Feb2021 (Batch/Lot Number: EN6202) (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, stage 3 renal failure (was not bad, was in stage 5 couple of years ago, was a month or so away from full failure, was in the hospital and had dialysis, was able to get reversed with medication and diet), high blood pressure, and blood cholesterol increased/high cholesterol. The reporter stated that with regards to patient's height, he shrunk a little. Patient had no prior vaccinations within 4 weeks, didn't get flu shots. Concomitant medications include about 12 other unspecified drugs, takes statins, has high blood pressure and high cholesterol. Patient started experiencing pain behind his left knee about 6 or 7 days later in Mar2021 (also reported as 04 or 05Apr2021, pending clarification). By that Sunday, it had gotten worse. The leg swelled and was also having foot swelling because blood flow wasn't there. There was no TIA's no stroke, no heart racing, no sweating, was all pain. Got leg up and kept elevated until they could get to the doctor and get imaging. Patient went Monday 08Mar2021 to see the doctor. Patient was brought to the doctor and was then sent to the imaging place. Radiology read the imaging around 5:15pm on the Monday, 08Mar2021. The radiologist said there was 2.5" blood clot behind the left knee. He had never had a blood clot before. Patient was then sent to the Emergency Room at (Name) Hospital, in (Name) where they live. Was kept there several hours. Did a lot more blood tests. He was immediately put on 10mg ELIQUIS 10mg, once in the morning, and once at night. He is now taking 5mg Eliquis in the morning, and 5mg at night. He has not had any of these problems before the Pfizer shot. The reporter knew that not a lot had been reported. It seemed it should be safe. The correlation and timing having the shot on 23Feb2021 and all of a sudden a week and a half later this happened. It was 10 days later. There was nothing they can do about it. Just continuing with the ELIQUIS, trying to dissolve the blood clot, will be staying on it for 4 to 6 months. It was a pretty big blood clot and were worried about it breaking up and traveling. The patient had no other symptoms, had a sore arm, that was it. Patient going back to (Name) 01Jun2021 and he will have another CT scan or ultra sound when they get back. The reporter did not want to need to get the leg amputated. Patient was only in the ER, was not admitted to the hospital. Patient was concerned because of his age. If it doesn't dissolve, they know there will be a lot more trouble. The event of pain left knee, blood clot and sore arm required a visit to the emergency room and physician's office. The patient received the second dose of BNT162B2 on 01Apr2021 (lot number: ER8730) in the right arm. The outcome of events was unknown.

Patient felt significant whole body muscle weakness and has not improved after a month. Also have double-vision.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

Approximately 24 hours after the first dose of vaccine he began to complain of stiff neck and back pain. Reported he was unable to lift his head or get out of bed.

muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.

Muscle aches and weakness progressing over several months since vaccination. Patient is undergoing extensive workup to determine if symptoms are related to myasthenia gravis or polymyalgia rheumatica.

Symptoms of Myasthenia Gravis starting 5 days after vaccine including : -Double Vision treated by corrective lenses -Chronic muscular weakness in legs, back, arms and neck treatment on going with prednisone and pyridostigmine. Throat and jaw weakness affecting swallowing and chewing

continuing hissing noise that is quite bothersome, and does somewhat disturb my sleep; woke up with severe hissing in head and realized it was Tendinitis; woke up with severe hissing in head and realized it was Tendinitis; This is a spontaneous report from a contactable consumer (patient himself). An 81-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm left on 12Feb2021 09:15 am as single dose for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included high blood pressure which is under control and had put two stents in 2003 and concomitant medications (other medications in two weeks) included omeprazole, losartan, atorvastatin, metoprolol and acetylsalicylic acid (ASPRIN). Caller stated that on 14Feb2021 on Sunday morning at 4:23 he woke up with severe hissing in head and he realized it was Tendinitis. He further stated that he has a touch of this over the years, never for long period or continuous. At 08:30 am the heavy hissing noise died down, however he has since then hear a continuing hissing noise that is quite bothersome and did somewhat disturb his sleep. The patient did not receive any treatment. Patient did not received treatment for AE and not COVID prior vaccination. He was not COVID tested post vaccination. He had no known allergies. The outcome of the events was unknown.

1) I had L elbow injury a few days before 2nd injoction (ind 02/26/2021. 2) Some hast history of vague R shoulder pain- intermittent 3) Severe L elbow pain, swelling, tenderness a few days post 2nd shot. Probable olecranon bursitis and bone bruise. 4) Severe bilateral shoulder, neck, arm pain 8/10 most severe at night interfering with sleep and morning. Inability to raise arms. Significant malaise. Some improvement w acetaminophen. Saw dr. Elevated CRP and ESR . Began Prednisone 20mg/day with dramatic improvement within hours.

impacted with fecal matter / Fecal impaction; feelings of heat in the butt area, specifically on the tailbone of his "butt" / Feels like butt is heating up on bottom; numbness / the area also feels numb; feelings of heat in the butt area/ heats up very hot and it hurts; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736; Expiration Date: Jul2021), via an unspecified route of administration, at the age of 81-year-old administered in arm left (reported as left shoulder) on 29Apr2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (diagnosed about 20 years prior to this report), ongoing diabetes (diagnosed about 3 years prior to this report). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included insulin taken for diabetes from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (HYZAAR) taken for high blood pressure from an unspecified start date and ongoing. Prior Vaccinations (within 4 weeks), there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received Flu Vaccine and experienced Shoulder pain for 6 months. The patient asking if the side effects he has been experiencing have been reported. The patient received his first dose of the Pfizer BioNTech COVID 19 Vaccine on 29 Apr 2021. A day after, he gradually became impacted with fecal matter on 30Apr2021. He was taken to the emergency room and was given an enema and stool softener. He mentioned that he was still currently having problems using the restroom. The patient added that he also has "feelings of heat in the butt area", specifically on the tailbone of his "butt" in Apr2021. When he starts walking around, it "heats up very hot and it hurts" in Apr2021. The patient also reported numbness in Apr2021. The patient mentioned that because of the side effects he has been experiencing, he was opting not to receive the second dose. He mentioned that he has been doing frequent visits to the doctor because of his MRI (Magnetic resonance imaging) and colonoscopy." The patient stated he had fecal impaction right after the shot on 29 Apr 2021. Stated it was probably a day or so later. He was gradually becoming impacted. After a week it got so bad he went to the Emergency Room. They gave him an enema and told him to take stool softeners. The patient stated that he still has this problem. He said it feels like his butt was heating up on the bottom, an area about the size of a pie pan, when he was walking around. States that it is the stool building up inside of him and he cannot get it out. Stated the area also feels numb at times. When he walks around a bit it feels like its heating up and started to hurt. He suspected that this was a side effect from the first dose of the vaccine. He stated he was not going to get the second dose. The patient stated he continues to take the stool softeners, Metamucil, and eats a lot of prunes. The event fecal impaction and feels like butt is heating up on bottom required a visit to Emergency Room. The patient stated that if he didn't think it might be required to travel he would not have gotten the vaccine. The patient denied any labs or testing related to these events. The outcome of events impacted with fecal matter / Fecal impaction; feelings of heat in the butt area, specifically on the tailbone of his "butt" / Feels like butt is heating up on bottom was not recovered and others was unknown.

I began experiencing swelling around bone on outside of left wrist bone and after that increasing pain in that area and around the thumb on same hand. After x-ray and MRI on that hand confirmed arthri; This is a spontaneous report from a contactable consumer. A 81-years-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264) via an unspecified route of administration on 13Feb2021 at 11:45 in left arm as a single dose for covid-19 immunization at hospital. Medical history included arthritis in neck, psoriasis and irritable bowel syndrome all from an unknown date and unknown if ongoing, left knee replacement in 2014. The patient previously took celebrex for drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot Number: EL3249) on 23Jan2021 at 10:00 in left arm for COVID-19 immunization. Concomitant medications received in two weeks included finasteride (FINASTERIDE), gabapentin (GABAPENTIN), levothyroxine (LEVOTHYROXINE) and magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced swelling around bone on outside of left wrist bone and after that pain increased in that area and around the thumb on same hand. X-ray and MRI confirmed arthritis that hadn't been evident before Covid-19 jabs. He also experienced some pain in left elbow and outside bone on right wrist and left hip bone discomfort had intensified into sharp pain at times. Bone density test showed normal range. Therapeutic measures were taken, and patient was treated with steroid injection in left wrist (zero help). The patient underwent lab tests and procedures which included magnetic resonance imaging and x-ray which confirmed arthritis and bone density test showed normal range. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.

This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.

Sever abdominal pain extending up center of chest to ears and down center of back. Sever pain if trying to lay flat. Initial occurrence March 31,2021 approximately two weeks after 2nd Pfizer vaccination, Released from hospital same day but unable to lay flat for four days. Same symptoms reoccurred on May 26, 2021 and was admitted to the hospital for three days and it was determined my condition was pericarditis.

I still have uncomfortable feeling in my arm/I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful; I have severe pain in my arm/it started hurting and then it continued to get worse and worse and it was severe; It was the worst pain I have ever had and I could not move my arm; It continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad/I could not sleep on the right side or on a left side; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration (left arm) first dose on 30Dec2020 10:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that I had the vaccine back a week and half ago on 30Dec2020 and was due to get the booster this month and wanted to report severe pain arm for two days. The patient stated that he had many vaccine (Unspecified Vaccine) over the years and have never had anything that hurts so bad after about six hours. The patient just wanted to know that was that normal. Consumer further stated, "I took the vaccine about 10:30 in the morning and about four hours later, it started getting sore but that thing was normal you know some vaccines (Unspecified Vaccine) do that but along with that it started hurting about four hours after the vaccine and it continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad. The patient even have thoughts about getting up and go in to the emergency room. It was the worst pain I have ever had and I could not move my arm. I could not sleep on the right side or on a left side and all I did was take Tylenol as prescribed and that helped a little bit but not much but I did not go to the emergency room, I am not going to do that but I felt like it because it hurts so bad but I made it through the night and next day it continued to hurt really bad. I just keep taking Tylenol every four hours and that continued for two days and then finally I was able to raise my arm up above my head without little pain, it was discomfort, but it was not hurting so bad." The patient stated that the event started about two hours later it started, it started hurting and then it continued to get worse and worse and it was severe, that is the reason why I am calling that it was severe. I wanted a shot or morphine to relieve myself that how bad it was." (no clarified further). The patient stated that the vaccine was given in my left arm only about one inch below the top of my shoulder which I think that might have been the problem, I don't know if you can answer that or not but I have never received the vaccine or shot anywhere near that area, it is always three or four inches down in my muscle, on my arm either on left or right, this was given in my left arm but this was given almost in my joint I am wondering if that would cause pain." The patient stated it was given only one inch below the tip above shoulder may be that is causing so much pain." The patient just wanted to report the severe pain, that was for two whole days and then it was subsided and it lasted for four days and I still have uncomfortable feeling in my arm. I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful." The outcome of the events was unknown. Information on the lot/batch number has been requested.

I was in bed when it happened and it was very sudden. I had a sudden constriction of all of the muscles in my body to where I was frozen and my mind kept saying I have to get lose. This lasted about 30 seconds to a minute and a half and then it went away. I looked on google and decided it sounded like I had an awake seizure so I went to bed. It didn't hurt, there was no pain, it just constricted my whole body, I was alert and I knew I was being constricted and my mind was fighting to try to loosen and finally it loosened. I have never had anything like that happen to me in my whole life, so that is why I assumed it would be considered and after effect of the vaccine.

Vaccinated on Feb 2, slight pain in the side of injection for two days, Then on Feb 9 (5 days after injection) strong gradually increasing pain in R leg at hip and knee (medial side) - these parts were painful previously but not as strong pain as it is now. Using ibuprofen 200mg two tablets (400mg) twice a day with 80 % relief, strong pain during walk, but still worse during the night - difficult to find right position to reduce pain.

right hip was very painful, it killed him/ right hip started to kill him/ couldn't walk without his hip giving way from the pain; hardly could walk on it/ couldn't walk without his hip giving way from the pain/didn't have any problem with walking around until he took the vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration (left arm), on 02Feb2021 09:00, at single dose, for covid-19 immunization. Ongoing medical history included cholesterol, GERD, heart, and prostate. Concomitant medication included carvedilol (COREG) from 2011 and ongoing for heart; lovastatin (MEVACOR) from 2011 and ongoing for cholesterol; alfuzosin hydrochloride (UROXATRAL) from 2011 and ongoing for prostate; omeprazole (OMEPRAZOL) from 2016 and ongoing for GERD; torsemide from 2001 and ongoing for water pill for his heart; and sacubitril valsartan sodium hydrate (ENTRESTO) from 2011 and ongoing for heart. The patient took the first dose of the Pfizer vaccine yesterday, 02Feb2021, at 9:00 and at 15:00 his right hip was very painful, it killed him; hardly could walk on it. His right hip started to kill him. He couldn't walk without his hip giving way from the pain. He didn't have any problem with walking around until he took the vaccine. He wanted to know if it was going to go away. The patient had not recovered from the adverse events at the time of the report. The adverse events did not require a visit to a physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was planning to receive the second dose on 23Feb2021 and mentioned that he was having a heart test later this week.

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

moderate pain in left knee, left thigh, and left hip (the vaccine shot was in my left arm) and the pain continued for weeks and is still happening. Doctor recommended Tylenol, Ibuprophen which did not help. Orthopedist recommended Cortisone injection in 3 weeks from now.

wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown. Information on batch number has been requested.

seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling symptoms worsening each day per patient suspect rheumatoid arthritis even with negative rheumatoid factor will recheck labs today and refer patient to rheumatology for further work up patient to start prednisone 7.5 mg every day x 30 days used in the decision making process Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness pain since administration of Pfizer covid vaccine in January patient agrees to steroid injection to area patient reports improvement post injection used in the decision making process Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects will check lab today continue current treatment used in the decision making process Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process hyperlipidemia denies side effects continue current treatment used in the decision making process celiac disease denies worsening symptoms continue current treatment neoplasm of prostate followed by oncology--reviewed records congestive heart failure followed by cardiology--records reviewed overweight BMI 27.8 + hypertension, hyperlipidemia, CHF weight maintained since last visit continue current efforts--diet and exercise History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking established pt pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free

1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away

At 3:00 pm the following day(03/24/21) after covid-19 vaccine #2 was administered (03/23/21), patient was at grocery store and experienced severe entire back pain that lasted until around 8:00pm, patient was then in bed at 8:00pm, tried to get out of bed, legs went numb and weak and gave out, arms started feeling numb as well. Patient reports his son helped him back to bed and patient fell asleep, slept through the night and the next day 03/25/21 all of patient's reported symptoms were gone.

?Pfizer-BioNTech COVID-19 Vaccine EUA? gout had been quiescent but flared severely beginning about 9 days after second injection, requird Naproxen, and lasted over a week.

10 days after his 2nd Pfizer COVID-19 vaccine, patient developed upper extremity weakness and paraesthesia. From the discharge summary: Pt had his second dose of Pfizer vaccine on 02/18/2021. The patient complained of new onset of bilateral upper extremity tingling, numbness and weakness since 02/28/2021. The patient denied lower extremity paraesthesia or weakness. He has a history of chronic low back pain. He denied any neck pain, back pain or radiation sensation. He has no sphincter dysfunction or incontinence. He has been using walker in the past. Dr. of neurology did a nerve conduction and EMG recently. The study showed the evidence of peripheral demyelination, peripheral neuropathy. The patient was admitted for possible spinal tap and IVIG treatment. The patient had a ground level fall 7 to 8 days ago. He denied fever, chills, headache, dizziness, shortness of breath, chest pain, palpitation, abdominal discomfort, diarrhea, UTI symptoms or coughing. Pt had his last dose of IVIG yesterday. No side effects. Motor weakness improving and UE paresthesia nearly resolved. No side effects to IVIG. BMP normal. Patient symptoms improved after 5 days of IVIG and he was discharged after being in the hospital 7 days

After the 2nd dose my arm was very sore (muscle ache) and fever; After the 2nd dose my arm was very sore (muscle ache) and fever; My arm was very sore; The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that, A 82-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 2 intramuscular, administered in Arm Left on 22Feb2021 15:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) from 2000 and ongoing Enlarged Prostate from 2000. Historical vaccine included bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: EL5982) dose 1 Intramuscular, administered in Left Upper Arm on 02Feb2021 1:10 PM for COVID-19 immunisation. Concomitant medication included tiotropium bromide (SPIRIVA) taken for chronic obstructive pulmonary disease from 2000, salbutamol (ALBUTEROL HFA) taken for chronic obstructive pulmonary disease from 2000 and ongoing, budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease from 2000 and ongoing, terazosin (TERAZOSIN) taken for prostatomegaly from 2000 and ongoing and finasteride (FINASTERIDE) taken for prostatomegaly from 2000 and ongoing. The patient experienced after the 2nd dose my arm was very sore (muscle ache) and fever and my arm was very sore on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included positron emission tomogram: unknown on 22Feb2021 Slightly radioactive spinal fluid culture. Outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

pain in the joints of the feet, ankles, and wrist; pain happened on the right hand and feet; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing gout. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date, the patient reported that in the last couple of days he had pain in the joints of the feet, ankles, and wrist and also mentioned that the vast majority of the unusual pain happened on the right hand and feet. Reporter asked what medication he can take for the joint pain and asked how long the possible side effect would last. The outcome was unknown for the reported events. No follow-up attempts are possible; information about batch number cannot be obtained.

felt very tired/feeling exhausted/tiredness; Headache; muscle and joint pains; muscle and joint pains; Hot Flashes; Chills/cold chills; nauseous; he felt so hot; thought he had a fever; cramping all through the night to the point he wanted to cry; Couldn't Sleep; He specified the pain was in his hands, legs, feet/sore arm; weakness to the point he couldn't get up to go to the bathroom.; Feeling unwell; Dizzy; but everything else was sore too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as "EUO150"/"LU0150"), via an unspecified route of administration, administered in arm left on 13Apr2021 11:15 (at the age of 82-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included blood pressure, allergy, glucose-6-phosphate dehydrogenase deficiency (G6PD), liver genetic deficiency, and had allergy mice, cat, dust and trees. The patient previously took sulphur and aspirin and makes him bleed because his blood was already thin. Concomitant medications included amlodipine taken for blood pressure; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication; all were start and stop date were not reported. An 82-year-old caller received the first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (13Apr2021), around 11:15 am. He added he was monitored for 15 minutes post injection and then used the public transportation to run some errands and return home. He said he received the injection on his left arm had soreness in this arm after vaccination. He explained around 3-3:30 pm he was walking to get the bus and then felt very tired to the point he wanted to sit on the pavement. He also described it as feeling exhausted. He explained he was so tired on the bus that he was falling asleep and almost missed his stop. He said he also began having joint and muscle pain on the bus. He specified he got home around 4 pm and he then experienced tiredness, headaches, muscle and joint pains, hot flashes, chills, and felt nauseous but didn't vomit. He specified he felt so hot, he had to turn off the heat and remove his clothes, but then he had chills/cold chills and had to turn the heat back on and thought he had a fever. He said around 11 o'clock he had appetite. He added he had cramping all through the night to the point he wanted to cry. He couldn't sleep. He specified the pain was in his hands, legs, feet, and joints. He also said he felt tired like he had worked for 12,000 hours and was not able to move. He said he had weakness to the point he couldn't get up to go to the bathroom. He said he had the headaches all through the night. He was feeling unwell, dizzy. He explained he felt like he was going to die; he was worried about his body. He said he still feels tired. They told him he would only have a sore arm, which he did, but everything else was sore too until about 08:00 today (14Apr2021). He explained that he didn't have all these issues before vaccination. He explained how disappointed he was with his reaction to the vaccine given that he was reluctant to the unapproved vaccine at beginning because he wasn't the person that take a lot of injection and medications, and so finally after his primary physician to influence him to get the vaccine. He mentioned he lives alone, healthy, vegetarian, never smoked, never took recreational drugs, does acupuncture, and takes little medications. He explained most people and his acupuncture doctor said he shouldn't get much reaction from the first dose and the reactions to the second dose are more prevalent. He added he was told that people have mainly experienced soreness in their arm after this vaccination with the first dose. He asked if his symptoms were reported after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. Everyone told him the first vaccine is a whiz. That it was easy. The second vaccine is the one that have side effects on. He also stated that he almost called to get an ambulance to take him to the hospital. Said that if he had these reactions with the first one, he does not want to take the second vaccine. Sometimes he regret that he have taken it now because he did not expect all of this to happen to him and they just told him that he will have a sore arm on left arm. He was in kind of shock to experience all of this and he was G6PD (Intent: History). He cannot take Sulfur and Aspirin because that makes him bleed because his blood was already thin but that would be no problem also have a liver genetic deficiency (Intent: History). He was allergic to mice, cat, dust and trees (Intent: History). So, he told all what he had that they knew in the beginning they said none of those things will affect. He take B12 (Intent: History) too once a month, he get injection for allergies for his cats and trees and grass once a month but they told him none of the things will affect him. The outcome of the events was unknown. Information about the lot/batch number has been requested.

3 days after 1st shot: middle finger joint on right hand swollen (from ring size 9 to 11) over night and very sore and still exhists. 3 or 4 days after 2nd shot: wrist joint on right hand very sore like arthritis..very painful and still exhists. Happaned over night. 2nd shot was on 3-11-2021 EP6955 Not sure if these are from vaccination or just coincidence but arthritis does not happen over night. Sent email to doctor concerning these events.

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

bilateral shoulder pain/iliac crest pain started 3 weeks after 2nd COVID-19 vaccine. Noted to have elevated ESR (47). Symptoms improved immediately after starting prednisone. Suspect polymyalgia rheumatica -- ?vaccine related.

Patient hospitalized. Patient died after testing positive for COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested positive on 4/1/2021. Died 4/29/2021

couldn't movelower extremities. Some weakness inarms; No involvement with breathing; This is a spontaneous report from a contactable/non-contactable None[C.2.r.4 (Reporter Type)]. A 82[D.2.2a; age]-Year(s)[ D.2.2b; age unit]-old Male[D.5; gender] patient received BNT162B2[G.k.2.2; suspect product(s) generic name(s) BNT162B2[G.k.2.3.r.1] 1[dose number FDA.G.k.4.r.13] dose:,None[ G.k.4.r.1a; G.k.4.r.1b], None[route(s) of administration or unspecified route G.k.4.r.10.1], administered in Arm Left[add the anatomical location G.k.4.r.11.x1] on 202103171430[G.k.4.r.4; start dates or unspecified date; and time if provided], ER8727[G.k.4.r.7 batch/lot number [Lot #], Expiration date [EXPIRATIONDATE Expiration Date or indicate if they were not reported], [for vaccine indicate the following information] at the age of vaccination 82[FDA.D.2.1a]; as dose(s) with unit] single[DRUGDOSEFREQUENCY], for Covid-19 immunisation[G.k.7.r.1; indication(s). Medical history included [any information regarding past medical history, concurrent conditions, social history, and family history]. Concomitant medication(s) included Suspect[G.k.1 with value of 2: all concomitant medication names] taken for [indication(s) (if provided)] from [start dates] to [stop dates]. The patient previously took [D.8.r.1; past product] for [indication] and experienced [past event]. The patient experienced couldn't move lower extremities. Some weakness in arms,No involvement with breathing[E.i.1.2; AE(s)] and [indicate the appropriate seriousness criterion at the appropriate point in the description] on 202103171630[E.i.4; AE(s) onset date(s)]. The patient underwent lab tests and procedures, which included [F.r.1 ;any information regarding laboratory tests and procedures]. [He/She] was diagnosed as having [provisional/differential/definitive diagnoses]. The [non-vaccine suspect product(s) only do not add this statement for vaccines products] was/were [action taken] on[date of temporary interruption/withdrawn to be included if applicable]. Therapeutic measures were taken as a result of [AE] and included treatment with [treatment product(s)] from [start date(s) of treatment product(s)] to [stop date(s) of treatment product(s)]. The patient recovering/resolving[E.i.7: outcome(s) of the event(s)]/died] on [E.i.5; AE(s) stop date(s)].

Develop rash front of his left arm the injection on the side, the rash is on front kind of even where the injection was given; Pain in his left arm; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Left elbow swelled; This is a spontaneous report from a contactable consumer (patient's wife). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9261), via an unspecified route of administration, administered in arm left on 04Feb2021 (at the age 82-years-old) as 2nd dose single for COVID-19 immunization. Medical history included hypertension (20 Years ago, patient don't know the exact date, at least 20 years ago), cardiac pacemaker insertion from Feb2020, bypass heart surgery on an unspecified date in 2006, neuropathy (patient did not remember its diagnosis date, patient only had bypass and to put in 2 stents). Concomitant medications included hydrochlorothiazide (Tablet) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg (25 mg, 2 tablets per day) daily for hypertension; metoprolol (MANUFACTURER UNKNOWN), orally on an unspecified date at 25 mg twice a day for unknown indication; duloxetine (MANUFACTURER UNKNOWN), orally on an unspecified date at 30 mg once a day for unknown indication; hydralazine (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg thrice a day for unknown indication; furosemide (MANUFACTURER UNKNOWN), orally on an unspecified date at 80 mg once a day for unknown indication; rivaroxaban (XARELTO) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg once a day for unknown indication; ezetimibe (MANUFACTURER UNKNOWN), orally on an unspecified date at 10 mg once a day for unknown indication; clopidogrel (MANUFACTURER UNKNOWN), orally on an unspecified date at 75 mg once a day for unknown indication. Vaccination Facility at the doctor's office. The patient experienced started a lot of pain in shoulder, left elbow and it radiated down into finger on an unspecified date in 2021. 3 days age develop rash front of left arm the injection on the side, the rash was on front kind of even where the injection was given on 14Mar2021 (reporter stated that, read moderna (not clarified) had a problem with rash). Pain in left arm on an unspecified date in 2021. Event start date, it would had couple of weeks after the 04Feb2021 and patient had the rash right now. Probed for events start date, reporter stated, That one was about two weeks ago, everything was in left arm. When probed still having the problems (event), reporter stated, that was better but yes patient had still left, it improved but patient still have it, it progress started about 3 days ago. On an unspecified date, the patient underwent lab tests and procedures which included blood test they were fine, patient was almost fine had routine blood work done but now had not anything. Any treatment for the event, reporter stated, For the rash patient not had any treatment for, the pain in arm and everything the orthopedic doctor gave a shot of cortisone to see if that might have (treatment) and that was on 01Mar2021. When probed for cortisone dose (treatment), reporter stated, I have no idea, I don't know about that. Patient probed for cortisone dose (treatment), reporter had no idea and do not know about that. When probed for cortisone shot (treatment) site of injection, reporter stated, would be on left shoulder and frequency, just once. The clinical outcome of the event pain in arm was recovering and rest of the events were unknown. No follow-up attempts are possible. No further information is expected.

Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; very nauseous; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 04Feb2021 09:15 as 2ND DOSE, SINGLE (age at vaccination 82-years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 14Jan2021 15:30 as 1ST dose, single for COVID-19 immunization. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within two weeks. On 05Feb2021 12:30, the patient experienced that whole body was in pain including my neck it felt like someone beat me up with a baseball bat. I could not even get out of bed in the morning I also became very nauseous and thought I was going to throw up what can I do to get over these side effects. The treatment was not received for the event. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.

Diarrhea; Joint pain; Chills; This is a spontaneous report received from a contactable consumer. A 82-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 28Feb2021 at 13:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. The patient had medical history included diabetes, high blood pressure and stroke. It was not sure if the patient had allergies to medications, food, or other products. It was not sure whether any concomitant medications was taken by the patient. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date of Feb2021 (at the age of 82-year-old) at 13:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Mar2021, at 02:00, the patient experienced joint pain and chills. On 03Mar2021, two days later patient developed diarrhea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of joint pain, chills and diarrhea was recovered on an unknown date at the time of this report. Information about lot number cannot be obtained. No further information is expected.

Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report. Information on the lot/batch number has been requested.

Pt. states about 3 months after receiving second Covid vaccine started having shoulder, hip and thigh pain. Went to several different doctors - orthopedic, PCP and got referred to a rheumatologist. After several months, finally got diagnosed with polymyalgia rheumatica. States symptoms have improved since being on Prednisone 12.5 mg PO daily. Pt. states sister was also diagnosed with same condition after receiving her Covid Moderna vaccine.

issues with his memory and being more confused/Confusion; tiredness/Fatigue; He feels like he is not getting enough oxygen, has had a cough, runny nose, issues with his memory and being more confused; cough; runny nose; Having problems with memory; Not Feeling Right; Muscle pain; Pain areas have been more painful/pain; Sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1685 then says someone changed the 5 to a 6), via an unspecified route of administration in left arm (left shoulder) on 05Jan2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included he had two ablations, close together 4 years ago, blood pressure issues from Dec2020 and ongoing, ongoing thyroid condition from several years, ongoing acid reflux, has been on medication on and off for this condition for 5-10 years. Concomitant medications included levothyroxine sodium, 75 mcg once a day for thyroid disorder taking this medication for several years; losartan, 0.5 mg once a day per for blood pressure abnormal from Dec2020 and ongoing, he used to take half a tablet; started taking a full tablet 08Mar2021; omeprazole, 40 mg twice a day for acid reflux, he has been on and off this medication for 5-10 years. Started taking it regularly in the past year. Also increased it to twice a day in the past year. He was on Eliquis for blood thinning. He was started it 01Mar2021. He had been on hit previously for quite a while and had an ablation and was able to stop taking it. Blood pressure went up so he was put back on it in Mar2021, before then he had taken it about 2-3 years ago. He currently takes 5 mg twice a day. Caller also mentions unspecified vitamins and herbs; no further information provided by the caller. The patient previously received flu and tetanus vaccines in Oct2020 and shingles vaccine in Aug2019. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The month ago (or more) he has been experienced tiredness, fatigue, pain, although he stated that he always has some kind of pain because he was 82 year old but it has been worse in the past 2 weeks. He felt like he was not getting enough oxygen, had a cough, runny nose, issues with his memory and being more confused. He stated that the tiredness and fatigue started out as intermittent about a month ago and said that it would "come and go" but now in the past couple of weeks it has been much more frequent. He also stated that he has been experienced a runny nose, cough and congestion for the past couple of weeks. He stated that since he got it; and for about a month or two, he has not been feeling right. He has tiredness, fatigue, all of his pain areas have been more painful, muscle pain. He doesn't seem to be getting enough oxygen; he really has to suck in air. His overall biggest problem was the fatigue. He stated that right after the shot he had no issues other than soreness in his arm on Jan2021; he has been going down hill since then. Tiredness and fatigue it has gotten worse gradually. It started a month or more ago. It has gotten worse over the last 2-3 weeks. He has pain all the time, he was 82 year old and something that always bothering him. Increased in pains started along with the tiredness and has also gotten worse over the last 2-3 weeks. He stated that his tiredness and fatigue was intermittent, but now it was more frequent. Before he had more good days than bad days. Now he has more bad days than good days. His feeling of not getting enough oxygen also went along with the tiredness. It has also gotten worse over the last 2-3 weeks. Cough and runny nose seem like it started in the last few weeks and has gotten worse. He has difficulty in answering the questions because his memory has been giving him problems and he's been confused more for about a month or so. It was gotten worse. The patient received second dose of the Covid vaccine (Lot Number: EL3249) on 26Jan2021, He was pretty sure that it was given in his left shoulder. He would like to know if he should go back to the VA where he received the Pfizer COVID-19 vaccine to be evaluated for these symptoms. The patient did not visit to emergency room or physician office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of sore arm was recovered on an unspecified date in Jan2021, while with other event was not recovered. Information about Lot/Batch Number has been Requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Crohn's aggravated; Chills; Aching joints; This is a solicited report based on the information received by Pfizer from Manufacturer (Mfr. control no.: 21K-163-3936556-00). A contactable 82-year-old male consumer (patient) and a non-contactable consumer (Patient's wife): A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg, 1 in 2 wk) for crohn's disease.The patient previously received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) vial intramuscular route of administration on 13Jan2021 as dose 1, single for COVID-19 immunization.The patient medical history include hypersensitivity, Crohn's disease, Anxiety, pain, Supplementation therapy. Patient's wife stated that the patient was allergic to two medications to improve his bone density but could not recall the specific medication, bone density abnormal, Abstains from alcohol, Sesame Seeds and Oil allergy manifested by red face and throat swelling and Sulfa Drugs Allergy. The patient was non-tobacco user.Concomitant medication included ciprofloxacin (CIPROFLOXACIN) for crohn's disease, azathioprine (AZATHIOPRINE) for crohn's disease, lisinopril (LISINOPRIL) for crohn's disease, balsalazide (BALSALAZIDE) for crohn's disease, venlafaxine (VENLAFAXINE) for anxiety, oxycodone (OXYCODONE) for pain, betacarotene;calcium carbonate;cyanocobalamin;folic acid;nicotinic acid;pyridoxine hydrochloride;riboflavin;sodium ascorbate;thiamine hydrochloride;tocopheryl acetate taken for supplementation therapy, hyoscyamine for crohn's disease and valsartan taken for an unspecified indication. On 04Feb2021, the patient experienced Chills, Aching joints and Crohn's aggravated.On an unknown date, the patient underwent lab tests which included computerized tomogram: unknown results. The action taken in response to the event(s), for adalimumab was unknown. On 07Feb2021, the patient recovered from chills and Aching joints and had not yet recovered from Crohn's aggravated. Causality as per reporter for event chills and aching joints as probable and for Crohn's aggravated not reportable No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in narrative, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the reported events of Crohn's aggravated ,chills and arthralgia 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.

Feeling tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown. Follow-up attempts have been completed and no further information is expected

LEFT SHOULDER STARTED HURTING ON THE FOLLOWING THURSDAY MORNING, WAS IN UPPER CHEST AREA BY THE SAME EVENING. FOLLOWING MORNING INCREASE IN TEMPERATURE. TOOK TO EMERGENCY ROOM FRIDAY EVENING, DIAGNOSED WITH PNEUMONIA. LEVAQUIN PRESCRIBED. SATURDAY COVID19 TEST NEGATIVE. INCREASE IN CHEST DISCOMFORT NEXT FEW DAYS, NO TEMPERATURE. TEMPERATURE OVER 99 AGAIN ON 1/26/2021, TOP PORTION OF CHEST, NECK AREA HURTING, WOKE AT 10:30 PM COMPLETELY DRENCHED. 1/27/2021 AM FEELING A LITTLE BETTER.

LEFT SHOULDER PAIN STARTED MORNING OF 1/22/21, INCREASED PAIN WITHIN THE NEXT 24 HOURS AND INCREASE IN TEMPERATURE. TOOK TO ER ON 1/22/21 AFTER TEMPERATURE 100.4. DIAGNOSED WITH PNEUMONIA, LOWER LEFT LUNG. LEVAQUIN PRESCRIBED. COVID-19 TEST ON 1/23/21 BOTH RAPID AND PCR NEGATIVE. INCREASE CHEST PAIN OVER NEXT FEW DAYS, NOT TEMPERATURE AGAIN UNTIL EVENING OF 1/26/21. AWOKE FROM SLEEP AT 10:30PM ON 1/26/21 DRENCHED. 1/27/21 FEELING BETTER IN THE AM, BUT STILL EXPERIENCING CHEST DISCOMFORT.

Pulsating muscle back pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 11:00 AM at a single dose for COVID-19 immunization. Medical history included advanced prostate cancer and penicillin allergies. The patient had no COVID prior to vaccination. Concomitant medications included prednisone, amlodipine, losartan, and enzalutamide (XTANDI) given on unknown dates for unspecified indications. Patient has not had other vaccine in four weeks. On 12Jan2021 at 15:00, the patient experienced pulsating muscle back pain. The patient has not been tested for COVID post vaccination. Therapeutic measures were taken as a result of the event which included unspecified OTC medicine. The outcome of the event was recovering.

not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing. The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.

About 6 hours later I fell. My legs could not hold me up. Next day I felt very weak, If I had to walk I had to hold on furniture, a general body weakness. At this time, pretty well recovered. The doctor sent in for full blood workup and chest scan and a brain scan and also the virus test.

Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.

I did not have this reaction with the first dose. On Saturday the 13th, when I walk the groin on both sides (left and right) hurts. When I am sitting it doesn't hurt. It is still happening as of today.

Moderate pain and tenderness at injection site left deltoid area in 4-5 hours, followed rapidly with pain across back of neck to pain and tenderness over right deltoid area., all lasted just short of 24 hours

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

Arm discomfort 2/10, arm and shoulder discomfort 2/11, 12, 13, neck discomfort 2/14, 15, 16, headache neck pain 2/17, 18, 19 worse. Hurts to move head.

slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot. Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot? He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event "slight pain in his arm the shot was given" was recovering, while for the other events was unknown.

Swelling and pain in the arm at injection site, plus Soreness and light pain from shoulder to elbow, now in its second day.

Day 1 Pain Both Shoulders, Neck Only Day 2 Pain Hips, Spine Only Day 3 Pain Both Knees Only Day 4 Pain Both Ankles Only Remainder Time, Ankles Only Second Shot Reaction: Week 1 Very Little Reaction Week 2 Pain Right Ankle, Difficulty Walking, Low Energy Then pain Left Ankle, less Right Ankle Then Significant Pain Left Ankle, Calf Muscles Then Pain Both Ankle, Calf Muscles, Some Thigh Muscle Pain In Legs Would Wake Me up From sleeping One Advil 200 mg Pill Would Reduce pain in 15 minutes, Max 4 pills per day

Arm soreness Joint pain shoulder pain stiff neck involuntary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor apt.

back pain; This is a spontaneous report from a contactable consumer via medical information team. A 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route on 13Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. patient started taking Celebrex about 5 days after the first dose on 13Jan2021of the vaccine for back pain. will be getting second on 03Feb2021. Stated that he has been on Celebrex which is an anti-inflammatory drug. Stated that he was told to get off of it if he wanted the vaccine to work. Stated that she got off it last Thursday. Wanted to know long he has to be off of it before the next shot and how long does he have to be off it after the next shot. Is for Pfizer Covid 19 vaccine. The outcome of the event was unknown. Follow-up attempts are possible. No further information is expected.

had a lot of pain in his left shoulder; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiration date: unknown) via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included psoriatic arthritis and diabetes. Concomitant medication was not reported. Upon Follow-up on 16Feb2021, it was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on adalimumab (HUMIRA) for his psoriatic arthritis, but he didn't take this medication since he had the first dose of the BNT162B2 vaccine. Patient supposed to start adalimumab (HUMIRA) in February. Patient would take the second shot of the BNT162B2 vaccine on 02Mar2021. On an unspecified date in 2021, patient experienced pain in his left shoulder, at first no trouble at all. The last week his left shoulder started hurting, it maybe arthritis. The patient did not have Emergency Room/ Physician Office visit due to the event. The patient also received Humira for Psoriatic arthritis on an unspecified date. The outcome of the event was unknown. Upon Follow-up on 16Feb2021: The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (16Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer included patient's information (age, height, weight), medical history, event, outcome and clinical information. No follow-up attempts possible. No further information expected.

PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday. 03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.

Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; This is a spontaneous report from a contactable other-HCP dentist (patient). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534 and expiration date were not reported) via unknown route in left arm on 17Mar2021 13:30 at SINGLE DOSE for covid-19 immunization. The report is not related to a study or programme. Medical history included high blood pressure unspecified time and was ongoing and hypothyroidism from unspecified time to unspecified time. Patient reported that he does have severe arthritis and that it could be that. There was no relevant family medical history. Concomitantly patient had been taking levothyroxine sodium (LEVOXYL) at a dose of 175mcg tablet once a day in morning for hypothyroid since about 15 years, lisinopril at a dose of 30mg tablet for high blood pressure since about 2-3 years, buspirone as antidepressant at a dose of 15mg tablet twice a day since about 2 years, escitalopram oxalate (LEXAPRO) at a dose of 20mg tablet once a day as antidepressant since about 3 years and trazadone at an unknown dose of for sleep since about an year. Reportedly, all the concomitant medications were ongoing at the time of report. Patient stated that he takes a cataract medicine does not know the name of it, states that it is a large pill and is brown colored. There was no investigation assessment and relevant tests. On Mar2021 (2 days after the injection), patient had pain in joints, muscles, knees, back and shoulders. Patient took Tylenol as treatment for event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of previous vaccinations. There were no other vaccinations administered on same day. Vaccination facility type was pharmacy, it was not administered in military facility. Patient reported that he had vaccination on 17Mar2021 and today is 30Mar2021 and he was still having pain. The event did not require any visit to physician or emergency room. Patient wanted to know why this is happening and if this can happen. Patient was scheduled for second dose on 07Apr2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Had very little pain at the injection site; severe pain in my left shoulder; could not raise my left arm to the side without severe pain; This is a spontaneous report from a contactable consumer patient(himself). A 83-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on left arm on 27Jan2021 04:30 PM as single dose for COVID-19 immunization. Patient medical history included diabetic, high blood pressure, overweight from unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient didn't have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The Patient concomitant medication were not reported. Patient took unspecified other medications in two weeks. The patient experienced very little pain at the injection site on 1Feb2021 at 7:00 AM. After about 3 days he awoke with severe pain in his left shoulder and patient could not raise left arm to the side without severe pain in Feb2021. It seemed to be concentrated in the rotor cuff muscle. Patient not received treatment for the adverse events. The outcome of event was recovering.

Pain commenced in left arm Sunday evening about 7:00 P.M. . Thinking it may be a precursor to a heart attack visited Hospital. Following extensive tests to eliminate a heart problem it was determined the pain may be due to the Covid injection as no other untoward experience had taken place in that arm. Sunday night the pain was so intense the nursing staff administered morphine twice to achieve relief. Pain continued Monday and Tuesday, but is somewhat subdued by Tylenol. . Upon palpation of the left arm at singular site invokes extreme pain. The entire arm aches and feels "heavy."

BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021 Active Hospital Problems Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment. In the emergency department the patient's vital signs were stable. Labs revealed a potassium of 3.3. AST was 52 and ALT 61. White blood cell count was 11.13. Troponin was negative and BNP was within normal limits. Lactic acid was 1.5. UA showed trace blood. EKG showed normal sinus rhythm with PACs. CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes. There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl. Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available. He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months. He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months. He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day. His daughter was updated over the phone.

Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction ABNORMAL LAB BACK PAIN

Arm soreness Joint pain shoulder pain stiff neck involantary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor appmt. Went to ER because of hand and foot swelling. Diagnosed with Poly Myalgia rheumatica or PMR. Being treated at this time by Dr.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were weakness, elevated CPK, anemia, non-traumatic rhabdomyolysis.

Tiredness; feeling unwell; joint pain; chills; muscle pain; This is a spontaneous report from a contactable non-health care professional (patient). An 83 Year(s) old male patient received BNT162B2 (Pfizer-BioNTech COVID Vaccine), batch/lot number# EL9269, via unspecified route of administration on his left arm as first dose, single on 07Feb2021 at 12:45, (age at vaccination 83 years) for Covid-19 immunization. Patient's medical history was not reported. The patient was allergic to Thimerosal, lactose and cucumber. Concomitant medication included lisinopril 10 milligram (mg) for chest congestion relief PE. Patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 09:00, the patient experienced chills, feeling unwell, joint pain, muscle pain and tiredness. He did not receive treatment for the events. The patient was recovering from all the events. No follow-up attempts are needed. No further information is expected.

Chills; Fever; Weakness; I had couple of days when I had cough at night and little bit of this and that; I am worrying about the reaction because I didn't realize that I probably had Covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive; Muscle ache; Tired; I had like laryngitis type like my vocal cords were little bit swelled; Aches; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Apr2021 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure and mild case of COVID-19 both from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date was not reported. On an unspecified date, the patient experienced chills, fever, weakness, i had couple of days when i had cough at night and little bit of this and that, I am worrying about the reaction because I didn't realize that I probably had covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive, muscle ache, tired, I had like laryngitis type like my vocal cords were little bit swelled and aches. It was reported that the patient had his first Pfizer shot last week and Monday, he had quite a reaction about four to five hours later and had chills, fever and weakness and so forth. He called one of the pharmacists about it and was asked if he had COVID before. The patient said that he was checked in for that but last month or so and was not checked down but he had couple of days when he had cough at night and little bit of this and that and he suspected that he might have something. The patient had COVID before he got the first shot within 5 or 30 days and that is why he got that reaction when that shot hit him. Now, the patient was concerned about the second shot, like if he will have a problem with that too, he was worrying to go to from about 2 or 3 days for that shot which was scheduled for next Monday, believed it is 3rd of May. The patient was really bit apprehensive about getting the shot simply because they usually recommend 90 days, in other words, after someone had COVID, to not get vaccination until at least 90 days afterwards. So, he was not sure what to do. The patient took as recommended for the fever, he took Tylenol and it was helpful as far as the aches, muscle ache and all that. Also, he was still very tired and the fever that he got after the shot was only for one day or he got it that night and lasted maybe till the next day and he was sure that it's going to come down and he will feel better. The weakness that linked, had a cough anyway, was going through this cough a little bit and had muscle ache. He also had like laryngitis type like his vocal cords were little bit swelled but was now getting better and it took like a good week like week and a half and that's why he was concerned about the second shot. The patient thought what he was hoping to do, was to stop a week or two and give it a little bit of time because he may be close to the 90 day window, it appeared the best way to do that but he thought that it was what the experts should be able to tell him. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative on 23Feb2021. Therapeutic measures were taken as a result of events fever, muscle ache and aches included TYLENOL. The outcome of the event I had like laryngitis type like his vocal cords were little bit swelled was recovering and the outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Six days after 2nd Pfizer shot I woke at 2:00 am with intense pain in left arm and shoulder. Left arm had very limited motion, could not lift arm . Also had general pain in legs and right arm. Dr. gave me cortisone shot in left arm on May 7th , provided relief for one week. The ongoing pain and restricted motion in my left shoulder have continued for the past eleven weeks. Had MRI scan this week.

Costochondritis/ chest area quite painful/ lower left ribcage; Taking my breath away as I moved; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9809) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), glaucoma, hypertension, and gastrooesophageal reflux disease, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included amlodipine, dutasteride, esomeprazole, and brimonidine tartrate (ALPHAGAN), all from unknown dates for unknown indications. The patient previously received sulfur from an unknown date for an unknown indication and experienced drug allergy; unspecified beta blockers from unknown dates for unknown indications and experienced drug allergy; and the first dose of BNT162B2 (lot number EL3247) in the left arm on 15Jan2021 (at the age of 83-years-old) for COVID-19 immunisation. The patient reported that on days 3-5 following the second shot, his entire chest area was quite painful, taking his breath away as he moved. On days 6 and 7, it was in the left side only, and on day 8 it settled in his lower left ribcage. The patient stated that over 3 months later, it was still there, some days were worse than others. He reported it was diagnosed as costochondritis, stating he visited urgent care, emergency room, two pulmonologists and his primary care physician. No treatment was received for the events. The clinical outcomes of costochondritis and taking his breath away as he moved were not recovered. It was also reported that on 29Mar2021 the patient was tested for COVID-19 via nasal swab, the results were not reported.

For the past several weeks I have been experiencing terrible pain and stiffness in my shoulders and legs. The X-Rays taken show mild arthritis, but I did not feel this discomfort until the past several weeks. Just want to check if the vaccine could have caused it.

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.

painful hip; sore arm; This is a spontaneous report from a contactable consumer (Patient's wife). A 84-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at single dose (Left arm) for COVID-19 immunization (for coronavirus). The patient medical history was not reported. There were no concomitant medications. The reporter was calling about the Covid-19 vaccine. The reporter stated that her husband had a sore arm from the covid-19 vaccine on an unspecified date and that he had a different reaction. She said that he ended up with a painful hip and it was a side effect that was listed on the paperwork. She said that he is in really good shape for his age and that he is much better now. She said that he has very little soreness in his arm still. The pain in his hip has resolved. The outcome of the event painful hip was recovered and sore arm was recovering. Information on the Lot/Batch number has been requested.

Joint pains and muscle aches in upper left shoulder and rear of left knee joint. Shoulder pains on 1/28/2021 and knee joint pains on 1/30/2021. Aches and pains appeared suddenly with no occurrence of stress or injury. Had shoulder x-ray at urgent care center on 1/29/2021. No tests on knee joint which occurred next day. Urgent care referred me to emergency room for heart evaluation at which all tests were okay.

Woke up about 2:30 AM with uncontrollability with bowels and urinary. Black ink like stoll. Chills and Sweating, Joint and Bone pain. Dizziness on arising, unsteady in Walking. Lasted for 2 days before subsiding. Still remain weak on 2//4/2021. Second shot due on 2/16/2021 Same Faculty.

he lost sense of taste and smell; he lost sense of taste and smell; legs feeling heavy and hard to move; restless sleep; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included Patient has recently had a pacemaker implanted. Concomitant medication included potassium Once a day, hydrochlorothiazide (DIURETIC), 20 mg Twice a day, dutasteride (AVODART), Once a day, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg Once a day and a multivitamin QD (Once a day). The patient had the COVID-19 vaccine administered on 14Jan2021. That evening he began waking up several times after a restless sleep approximately six times on 14Jan2021. This lasted approximately two more evenings. On 19Jan2021 he lost sense of taste and smell for approximately three days. As of 20Jan2021 he has regained some sense of taste. The patient's temperature has been normal with no fever and pulse oximetry has been approximately 96%. Lastly on 17Jan2021 patient reported his legs feeling heavy and hard to move which lasted approximately three days. The outcome was recovering. Information on the lot/batch number has been requested.

At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.

not feeling well; tremors (symptom of Parkinson's which he has but they had been under control with medicine); Gout which has flared occasionally but had not caused problems recently; tremors (symptom of Parkinson's but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently; This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included Parkinson's and gout. The patient didn't have COVID prior to vaccination. Concomitant medications were not reported. The patient with other health problems got vaccinated. Next day was not feeling well and the day after was admitted to the hospital complaining of tremors (symptom of Parkinson's which he had but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently. Adverse events started from 30Jan2021. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Treatment received included medication for tremors. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 29Jan2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure and the patient also had PE. No allergies to medications, food, or other products was reported. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included valsartan, metoprolol succinate (TOPROL), doxazosin mesilate (CARDURA), rivaroxaban (XARELTO); all received within 2 weeks of vaccination. The patient had neck pain and can't move head to either side without pain on 31Jan2021 14:00. No treatment was received for the adverse event. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown. Information on the lot/batch number has been requested.

On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.

neck pain has decreased since yesterday. Patient has taken Tylenol to relieve neck pain. Recommended to see primary provider if symptoms worsen.

Caller is a 54 y/o M reporting that he, his 53 y/o F wife and 84 y/o F all received the Pfizer COVID-19 vaccination and have developed symptoms after vaccination. None have ever had adverse reactions to vaccinations. A 400. Advised can have injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever. Swollen lymph nodes and nausea have also been reported. Advised to seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. Cough, shortness of breath, runny nose, sore throat, or loss of taste or smell are symptoms of SARS-CoV-2 or another infection and not consistent with post-vaccination symptoms. Advised PC is available as needed. TR

He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12). Both shots were given into the left arm. He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees. Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees. Some soft tissue swelling was noted around the hand. Simvastatin was discontinued with no improvement in symptoms. Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L. Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare. He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms. Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.

WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

Urinary tract infection; Has been ill; He has been falling a couple times; Had a fracture at the base of his spine; Has gout in one knee; Couldn't walk; In a lot of pain; his knee swelled up, was very hot,the doctor said it was inflamed; hurt his right knee; he has not been eating; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for an 84-year-old male patient (reporter's husband) who received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158) on 10Apr2021 at right arm for COVID-19 immunization. Relevant medical history included ongoing high cholesterol diagnosed a long time ago when he was very heavy at one point he was quite heavier than he was. Now he was skin and bones, ongoing high blood pressure diagnosed 10 years ago or longer and ongoing diabetes diagnosed 10 years ago, ongoing pacemaker and ongoing irregular heart beat and falls. The patient previously had sore arms at site after receiving the flu shot for immunization. Ongoing concomitant drugs included Carvedilol for high blood pressure, atorvastatin calcium for high cholesterol, amiodarone (this is the medication that would cause an issue with the antibiotic if it was taken orally), acetylsalicylic acid (BABY ASPIRIN) to thin his blood, sitagliptin phosphate (JANUVIA) for diabetes, vitamin D3, cyanocobalamin (B12), ubidecarenone (CO Q10), sertraline (generic of an old drug called Zoloft) as something to calm him down. The patient was scheduled to get the second vaccine on 01May2021, however he was in the hospital and did not have his. They rescheduled the vaccine for this coming Saturday because he was still in the hospital. He was actually getting moved to a rehabilitation facility with intravenous antibiotics for a urinary tract infection and will not be able to get it. The patient was on an IV antibiotic which could not be administered orally do to the fact he has a pacemaker and irregular heart beat. The doctor told her that the oral medication would interrupt the spikes of the pace maker, his heart. The reporter was wondering if her husband can still have the COVID vaccine while taking the antibiotic. She asks will it interfere with that medication. Will he have to start all over again with number one of the vaccine because he missed the vaccine in the allotted time span. The last time the patient was weighed he was 155, but he has not been eating since he has been ill. He had so many problems since he has been ill, he has been falling a couple times. The reporter wanted to protect him from the terrible disease, but didn't want the injection into his body creating anymore problems than he already has. The doctor said that she thought the caller could take the patient out of the rehab facility for the day and get his vaccine and then bring him back. The facility said they would have to do research about that and get back to her. Caller states that her husband kept falling and had a fracture at the base of his spine, in addition to other problems, he has gout in one knee. She states that he would be standing up talking to her and the next thing she knew he was on the floor. She states that he has fell six times in a month. She states that she has become friends with the fire department because they came out so much. The falling occurred before he got the vaccine. She states he was fine when he went for the first vaccine and then the following week it started all over again, he couldn't walk. He had a physical therapist helping him strengthen his walking. She states that her husband says he fell and hurt his right knee while working with the physical therapist and the physical therapist said no, no, no, he didn't fall, he had a strap wrapped around him and the physical therapist caught him before he fell. Caller states that the physical therapist is 30 pounds lighter than her husband and doesn't know if he could of grabbed him before he hit the floor. She states that her husband was in a lot of pain and his knee swelled up, was very hot. She states that the doctor said it was inflamed. She states that she brought him back to hospital because they could not get him up and he could not walk. She couldn't pick him up, her son couldn't pick him up, her daughter couldn't pick him up and her son and daughter together finally got him up but he couldn't walk. She states that she called the emergency medical team. They said he has to go to the hospital and that was the last time he was at home. Has a walker and it takes a little while. She didn't know if he got the gout from that knee, but when they took out his fluid the following day you could of heard him screaming in the next county over. They were suppose to have the results but they didn't, they discharged him from the hospital. She states that he hasn't been able to come up with a breather of fresh air and feeling better. Caller states that he was now taking a gout medication at the hospital and that they told her that her husband had a second fracture to lower spine. The outcome of the events was unknown. Information on the lot/batch number has been requested

Day after 2nd vaccination. Legs felt unbalanced (rubbery feelings). Stability compromised - looks like he is drunk when he is walking. 2 days after 2nd dose - fingers became numb both hands. Patient reports he: Called CDC about it. Saw PCP and ran some tests, but no answers. Dr. Called a neurologist - don't want to see him unless referred by a PCP. Seeing another neurologist on 7th of June.

pain in his left wrist; arm pain and swelling to left arm; arm pain and swelling to left arm; swollen under side of his arm where he got the vaccine injected; pain in his left wrist, which was the same arm that he received his injection; This is a spontaneous report from a contactable consumer, the patient. A 84-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, occasionally rapid heart beat, blood cholesterol abnormal, cardiac operation (9 years ago, macular degeneration (in each eye and puts eyedrops in and occasionally they give him injections). Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]; 10mg everyday) taken for blood cholesterol abnormal; estradiol (ESTROGEN; 10mg everyday). The patient did not have any other recent vaccinations or started any new medications. The patient reported practically had no symptoms with either shot. After his first dose he had one day where his blood pressure went very low but by the time he talked to his cardiologist it had gone back to normal and was taking pills, it was under control. Yesterday afternoon he experienced pain in his left wrist, which was the same arm that he received his injection, and describes the pain as not too bad. He states that when he uses his wrist in certain positions, the pain "shoots up." This morning on the lower part of his left arm ("not the top where I got the injection") he has "slight pain." He says this morning his upper arm on the underside where he got it on the left side is swollen. He says he would like to know can it be from vaccine, though maybe he could have strained his wrist, it happened yesterday evening, he had wrist pain and swollen under side of his arm where he got the vaccine injected. He says yesterday late afternoon was the first time, it could be something else, it was the same arm this morning he has a little pain to his upper arm that was not on injection side but below, under it. The patient did not received any treatment, it was not serious pain, it was low level pain, when he uses his wrist and turns it, it comes in more prominent. He says it was not pain that bothers him, if it was not related to the vaccine then he most likely strained his arm. No follow-up attempts are possible. No further information is expected.

Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021

Received Pfizer vaccine 2/2/21 and 2/23/21. Symptom onset 7/4/2021 with cough, runny nose, muscle aches, sore throat, fever and headache. Tested positive for Covid-19 on 7/7/2021

slight chills; diarrhea; sore; heavy mucus/getting mucus in the back of the throat; weight went down; This is a spontaneous report from a contactable consumer (patient). A 84-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route on 09Mar2021 at 13:30 (at the age of 84-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included high blood pressure, high cholesterol. The patient concomitant medications included losartan with dose 100 mg, 1x/day for high blood pressure and rosuvastatin with dose 20 mg, 1x/day for high cholesterol and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced getting a lot more mucus in the back of the throat. Patient stated it had been getting a lot more in the last couple of days. On 10Mar2021, the patient experienced sore the next day a little bit, on 17Mar2021 patient experienced diarrhoea and at 03:00 in the morning slight chills. He said that his weight went down since the diarrhoea. He said that he usually weighs around 220llbs. He said that he had shrunk with his age. Patient stated that he had to get up every hour at night and found a book called Remedies and it said something about carrot juice and also said something about blueberries. He said that he crushed up some blueberries and ate them and it went through him like roto-rooter. He said that he only had one episode of diarrhoea last night. He said that it seems more semi solid now and had slowed down. He said that the mucus seems to have slowed down now. He said that his second dose is due on the 30Mar2021. The patient did not visited emergency room or physician office. The outcome of events getting mucus in the back of the throat, diarrhoea was recovering, chills was recovered on 17Mar2021 and other events was unknown. No follow-up attempts are possible. No further information is expected.

3 days after the shot he started getting flu-like symptoms. This included headache, diarrhea, tiredness, weakness, severe muscle aches, loss of appetite. Contacted his cancer dr. and was told to stop the Calquence for 3 days, drink 8 - 8oz of water a day (which he could not do and threw up after drinking), and to start taking Immodium, which he did.

groin started to hurt; tired; This is a spontaneous report from a contactable consumer. A 85-years-old male patient (reporter's grandfather) received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EL9262, via an unspecified route of administration in right arm, on 01Feb2021 (at 85 years of age) at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. There were no concomitant medications. On 01Feb2021 the patient felt great; on 02Feb2021 he felt ok but was tired; on 03Feb2021 his groin started to hurt, it hurt even to touch it, his leg started to bother him from his groin down and then was unable to be touched; the reporter asked if that could be swollen lymph nodes from the vaccine. At 3 o'clock the patient rushed to the hospital and, on 04Feb2021, he was admitted to hospital due to pain in groin. They thought he had broken something but that was ruled out. The patient underwent an X-ray of his leg and labs. He does not have any infection. At the time of the report the patient was still in hospital and the events "groin started to hurt" had not resolved yet and outcome of the event "tired" was unknown.

headache, severe throat pain/pharyngitis/sinus pain, fatigue, chills, muscle pain. ER admission 2/13. Persistent severe throat pain and weakness thru today (2/19/21); covid test negative; strep test negative

#1 jan 20 2021 #2 2/17/21 pfizer #1 el 3248 #2 en 9581 pain in side near ribs , started on 2/24 comes and goes caller did yard work last Saturday thinks maybe he tweaked something?adv f/u with pcp if pain continues

Within 36 hours, 2/27 my knees swelled and I was unable to walk. On Sunday we went to The ER near where we were and had x-rays and ultrasound of my knee. Dr. took a fluid sample for culture but said it looked clear. I have no history of arthritis nor any injury. I am an avid bike rider and suddenly cannot stand on my feet due to extreme pain.

Patient stated he started having hives, diarrhea and chills 2 days after the vaccine. At the current time, 2 weeks later, he is still having the same adverse events and now has leg weakness.

I experience muscle pain in my upper back muscles, both sides. When I moved my head, I felp sharp stabbing pains which made me shout. I could not sleep much on March 8 evening. The pain persisted all day Tuesday March 9, 2021. I called my ortho doctor and made a morning appointment for March 10, 2021 at 8:15am. I did not sleep much on evening of March 9. On Wednesday March 10 I went to the doctor. On this morning, the upper back muscles were OK, and the pain and spasms wer now in the neck. I could hardly move my head up or down and left and right. Dr. perscribed Methylprednazolone (4mg, 6-5-4-3-2-1 doses) and cyclobenzaprine 5mg (3x daily). after 1 day and 1 dose, I feel I can movemy head a little farther without the stabbing pain.

Patient received dose around 9 AM on 3/16/2021 and felt fine the rest of the day. On 3/17/2021, patient was so weak he fell at home and could not get himself back up. A friend was called who was able to help the patient up off the ground and got him a walker to use. Patient was able to get around using the walker, but then fell again around 20:00 on 3/17/21. He called 911 because he could not get himself up off the ground and EMS brought him to the hospital. Patient denied other symptoms other than new onset BLE weakness. Patient worked with PT/OT next morning and was able to walk 400 feet on level terrain and safely ascend/descend 4 steps with rails.

after 3 days from the first injection diarrhea lasting 72 hours and resulting in 10 lbs weight loss after 2 days from the second shot same result ...took Imodium and it finally stopped

PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.

muscle in upper left arm hurting; This is a spontaneous report from a contactable consumer or other non health care professional (patient). An 85-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9810, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 04Feb2021 08:30-08:45 (at the age of 85-year-old) as a single dose for COVID-19 immunisation in hospital. The patient's medical history and family medical history was reported as none. The initial assessment was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations were not available was reported as none. Concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that the muscle was hurting but has calmed down on 04Feb2021 17:00-18:00. This has bothered the patient on the vaccination day. Patient wanted to know if he can take a muscle relaxer pill. Patient clarified that it was for the Virus 19 shot. The event did not result in Emergency Room or Physician Office. The patient underwent lab tests and procedures which included blood test, the day before he got the shot when he went to the doctor and came up good. The patient has tried to move it around as much as he can as a treatment for the event. The outcome of event was reported as resolving. Follow-up attempts are completed. No further information is expected.

he was 6 feet but had shrunk a little; fever of 100.9; chills; pain around pacemaker in chest; lower back pain; had a sore arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: 3L3246) on right arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included 3 heart attacks in the past and pacemaker from an unspecified date. Concomitant medications were not reported. The patient had a reaction to the Covid vaccine he received on 05Jan2021, stated he had a sore arm the next day 06Jan2021 that had resolved. Stated last night on 07Jan2021, he had a fever of 100.9 and chills and mild pain around pacemaker area in his chest and lower back pain. Stated he treated the fever and chills and pain with Tylenol and stated it had improved. The patient stated he was 6 feet but had shrunk a little on an unspecified date. The outcome of the event had a sore arm was recovered on 07Jan2021, for the event he was 6 feet but had shrunk a little was unknown, while other events were recovering.

right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, "Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema." He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), "It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear." Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)

pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.

For about 12 hours he itched all over. When he got up in the morning his shoulders and ankles also ached. When he moved around the muscle discomfort was relieved, but would come back when he was not moving his joints. Around 10 AM, he sat in a hot tub about 45 minutes, then applied body lotion and was relieved. Neither the itch or muscle aches returned.

RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/03/21. REPORTED ER FALLING ON ICE WITH RIGHT HIP PAIN. ALSO HIT HEAD. IS ON BLOOD THINNER. IN ER O2 SAT DROPPED AND WAS PLACED ON 4L OXYGEN. ADMITTED INPATIENT AFTER BEING DIAGNOSED WITH HYPOXIA, CHF, AND PELVIC FRACTURE

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

Jittery, shaking hands, tight muscles in chest (confirmed that there were no palpitations). Going to take tylenol and call doctor in morning if not feeling better.

her husband's pain is more in his right elbow and right shoulder/pain is more like a joint pain; right arm pain started with the COVID-19 Vaccine injection site/pain is in his right (dominant) arm; husband is experiencing a sore arm, husband's arm has been sore as worsened; This is a spontaneous report from a contactable nurse. A 86-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via intramuscular route of administration, administered in Arm Left on 03Feb2021 14:15 as single dose for covid-19 immunization. Medical history included was none. Concomitant medication was not reported. Upon follow-up (16Mar2021): it was reported that, first dose of Pfizer covid-19 was shot on an unspecified date at 14;15 PM via intramuscular route of administration in right arm of Batch/Lot number: EL9269. She said her husband's arm has been sore for 8 days. Her husband's arm has been sore for 8 days was reported as worsened. She said her husband tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his sore arm, and pain was in his right (dominant) arm, the pain was more in his right elbow and right shoulder, and her husband's pain is more like a joint pain. She said her husband has a high tolerance for pain, and normally doesn't take anything for pain. She said her husband can't put his jacket on because he is unable to lift his arm due to the pain in his right elbow and right shoulder. She said her husband has been trying everything, and nothing seems to help his right elbow and right shoulder pain much. Clarified her husband's right arm pain started with the COVID-19 Vaccine injection site and then the pain moved into his right shoulder and then into his right elbow. Reported her husband had a CAT scan of his head and neck on 01Feb2021 checking for blood clots. She said the results of the Head and Neck CAT (Computerised tomogram) Scan were normal. Reported her husband's second COVID-19 Vaccine dose is scheduled for 24Feb2021. The reporter classified the event husband is experiencing a sore arm and husband's arm has been sore as worsened as disability and other events was not reported and assessed the causality between the event husband is experiencing a sore arm and husband's arm has been sore as worsened the vaccines as Related. Upon follow-up, it was reported that, the patient has a very sore arm for about 8 days but then it resolved and no trouble since then. His second shot did not have much of a reaction and both are fine now. Therapeutic measures were taken as a result of husband is experiencing a sore arm and husband's arm has been sore as worsened and included treatment with ADVIL at a dose of 200 mg (Lot Number: W36210, Expiration Date: Nov2019), TYLENOL, at a dose of 500mg, hot packs and old packs. Upon follow-up (16Mar2021), the outcome for the events were recovered on 11Feb2021. Follow up (16Mar2021): This is a follow-up spontaneous report received from a contactable nurse includes, updated information about the first dose of Pfizer vaccine, route of administration for the second vaccine and the outcome for the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering temporal relationship and known safety profile, the reported pain in arm was likely causally related to the vaccination with BNT162B2. The case will be reassessed should additional information become available. 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.

The first doze made him tired and got back pain. Went to his Primary Doctor to see if it is okay to get the second dose. He got his blood work done, echo Cardiogram and all the necessary test have been done and he is okay to proceed by his Doctor. On the fourth day after he get the second dose of Pfizer-BioNTEch, in the afternoon, he couldn't get up from his bed that he had lay down. He experienced slur, facial droop and left side hand weekness. We called the paramedics right away and they checked him and took him to the nearest Emergency Hospital. They ran tests, did CT scan and diagnosed him with Ischemic Stroke on his right side which has effect on the left side of his body for facial droop and weekness and not being able to get up. He was threated with Mechanical Thromboctomy to remove the blood clot. He stayed in the hospital for 8 days and is bed bound up until now and is transferred to a re-hab. He still can't stand. Today is the 27th day since the adverse reaction started. His left hand has improved a little bit.

immediate soreness at injection site and worsened as time went on. Pain severe on shoulder movements at times, arm feels asleep and a lump developed on the inner aspect of the elbow.

joint pain; This is a spontaneous report from a contactable consumer(patient) An 86-year male old patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) at single dose intramuscular on 23Mar2021 Injected in left arm in the muscle for Covid-19 immunization. Medical history included seasonal allergies started years ago as of 14Apr2021, obesity, endocrine abnormalities (Including diabetes), chromosomal abnormalities, and respiratory illness. He had allergies and sometimes he gets headaches. He had a sinus problem and in the spring he gets migraines. Family medical history was reported as "none". Concomitant drugs included acetylsalicylic acid (ASPIRIN 81) (reported as low dose aspirin) daily, amlodipine besilate (NORVASC), tamsulosin hydrochloride (FLOMAX), and one medication for acid for his stomach every day. He had been these taking for years along with a calcium carbonate, colecalciferol (VITAMIN D 2000). He was taking all prior to getting the vaccine. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. He took first dose was 23Mar2021 and he did not notice the joint pain until the last 3-4 days as of 14Apr2021. Before he got second shot, he noticed it and assumed it would go away. The joint pain did not get any worse. NO ER or physician's office required. It was further stated that adverse event following prior vaccinations was "none". No Relevant test performed. Outcome of the event was not resolved. No follow up attempts are possible, no further information expected.

This is a spontaneous report received from contactable consumer (patient). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, intramuscular, administered in arm right on 12Apr2021 13:00 (Batch/Lot Number: AW0158) as single dose for COVID-19 immunization. Medical history included chromosomal abnormalities, diabetes, obesity, migraines, sinus during spring, allergies, compromised immune status, respiratory illness, endocrine abnormalities, headaches and acidity. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)); amlodipine besilate (NORVASC) taken for acidity; and tamsulosin hydrochloride (FLOMAX RELIEF) taken for acidity and one medication for acid for his stomach every day. He has been these taking for years along with a Vitamin D. He was taking all prior to getting the vaccine. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207), at 86 years old age, Injected in left arm in the muscle on 23Mar2021 for covid-19 immunisation and experienced joint pain. The patient had been experiencing some pretty good amounts of joint pain on his knees, ankles, and lower back. Patient was getting concerned because his joints were bothering him and are painful in his knees and lower back. He also got a headache. Headache started after second shot. He had allergies and sometimes he got headaches. He had a sinus problem and in the spring he got migraines. This was a different type of headache and was a dull headache. The outcomes of events were not recovered. No follow-up attempts are needed. No further information is expected.

In 2017, at 83, my dad was diagnosed with Guillain-Barre. By the time he was diagnosed he had lost all use of his legs. After 2.5 months of physical therapy he walked out of the skilled nursing facility. He continued an active life involved with family, his church and the community. He received his first Pfizer COVID shot 1/27/2021 and noticed a tingling in his fingers shortly after, but thought nothing of it. He received his second Pfizer COVID shot 2/17/2021 and began to notice a marked weakness in his legs. This was reported to Dr., who began diagnostics. He was diagnosed with Chronic inflammatory demyelinating polyneuropathy (CIPD) and IVIG

presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital

Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.

he fallen split his head open and he thought he just would go to the ER; actually fell couple of times and he finally actually fell and hit his head and was taken to the ER; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; he became weaker and weaker and recently he been using walker now; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand/ he became weaker and weaker and recently he been using walker now; This is a spontaneous report from a contactable consumer. A 86-years-old male patient received bnt162b2 (BNT162B2, Lot number: EN6201 and Expiration date: unknown), via an unknown route of administration on 19Feb2021 (at the age of 86-years-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes and hypertension. The patients concomitant medications included 3 pills one was blood pressure, one for sugar, and one for Potassium correct, he took these 3. Patient previously took first dose of bnt162b2 (Lot number: EL8982) on 23Jan2021 and on an unknown date felt very weak and walking slow. Reported said he was just calling to report the side effects that happened to my uncle, after he get the Pfizer vaccine. Well, the first weakness was in January and February they did not think too much about it because it was not one of the side effects that were told to watch out for. So, they noticed, my aunt and my cousin noticed that he was having trouble in walking and he used to walking and drive and to the church on regular basis after his first vaccine he had trouble walking and he started moving very slowly that was unlike him and he became very weak. He always has been a walker and that was not normal for him, he was very healthy. So, that was the first injection and then he got the second injection then nobody realized about you know, weakness was none that, no side effects that we talk about, you know from you providers that you read about and what was on the news. So, he got the second injection, and he became weaker and weaker and recently he been using walker now. His weakness got worsen and he could not even move the walker because he could not grip it with his hand. He could not use his hands and it got worse and he has fallen a couple of times, but they did not take him to hospital as he did not want to go to the hospital it was not until 05Apr2021 that he fallen split his head open and he thought he just would go to the ER. He fell couple of times and he finally actually fell and hit his head and was taken to the ER. From the ER he was transferred to the hospital. He was hospitalized and then they could not find anything wrong with him. He first went to the ER on 10Apr2021 at 21:30. Patient was in the hospital for three days on 14Apr2021 they transferred him to a rehab and he was there for 6 weeks and he was sent home on 01Jun2021, but he still could not walk but they sent him home and he could not even move his hand, so, he got taken back to the hospital at the hospital request on 14Jun2021, and she said to keep him bed rested at home and 2 days to be rested here that he fell or might now fell until we find care for him but we need to go back so she called 911, took him back to the hospital, second rehab and she came back to the hospital and they still could not find anything wrong with him and he got transferred on week later on 21Jun2021. Patient did not receive any other vaccine prior or during the covid vaccine. It was reported that he has both Diabetes and Hypertension but doctor was absent because he has Diabetes for about 25 years and when my aunt told them that she thought that it was related to the vaccines then they just said they have no idea. They just said they had no idea they wished what they knew what was wrong with him, because everything was normal with exception of elevated blood pressure, elevated sugar and elevated potassium. At the time of reporting, he weighed about 139 pounds. Since he has been out of hospital, he has lost about 25 pounds. Reporter stated that, she has to pay out of her pocket for his rehab because they did not know what was wrong with him and her insurance only cover certain amount of days and she was trying to figure out how she can get some assistance in paying for that rehab visit because they paid certain number of days and then she ready to go but he was not ready to come home so she had to pay out of her pocket to keep him there and also trying to see if that is something that pfizer would reimburse for. Reporter stated that, her insurance would not cover all the kind of aiding there and then they sent him home and then he had to back to his status because nurse said he should not be home he is too fragile and that was dangerous for him to keep him in the hospital, if he falls, he falls. She was asking if can either reimburse my aunt for the extra days that insurance did not cover, she had to pay out of her pocket for those because insurance did not cover everything and the doctors, nobody know what is wrong, they just says I wish I knew what was wrong, they can see that he was weak, they can see that he can not walk, he can not feed himself, so he can not be home and yet none of this happened if he did not have these vaccine. Upon follow up, reporter stated that, all events were reported yesterday, first was an ER visit, the doctor said they had no explanation, what was causing this, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things and he fell a couple times, but he got the second shot, he got worse, and he went to ER because he fell and cracked his head on wall and cut it open, so he was taken to ER and admitted. Reporter did not know why the lady last night gave her a number that was not valid. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

ON 1/28 IN THE EVENING, DEVELOPED WEAKNESS IN HANDS AND LEGS. RESIDENT HAD NO STRENGTH AND WAS UNABLE TO WALK. WAS SEEN IN THE EMERGENCY ROOM THAT NIGHT AND RELEASED SAME NIGHT. VITALS WERE STABLE.

Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father. An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of 87-years-old at single dose for prevention because of age group. Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her. This occurred prior to getting the vaccine. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak. Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain. He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor. His legs just continued to get worse. It started on Wednesday night on 13Jan2021. He could not walk in Jan2021. Thursday was the worst. By Friday, it started to get better. He did not get hospitalized. He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the 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.

Knee swelling/has swelling in his right knee as if like water is in there almost; This is a spontaneous report from a contactable Consumer. This 87-year-old male consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11AM at single dose on right arm for COVID-19 immunisation. Medical history included cardiac pacemaker placed about 12 years before. There were no concomitant medications. The consumer previously received the shingles shot in Nov2020 at the age of 87-year-old for immunization and at that time the in Nov2020 fingers were so sore but after a couple days it went away in Nov2020. The patient experienced knee swelling on 22Jan2021. He got up this morning and noticed that he had swelling in his right knee as if like water is in there almost. He had not had a problem with the knee before and all the sudden this morning he saw his knee. The knee swelling looks like its getting better, he did put a gel on it and he doesn't know if that did it or if its getting better on its own. The outcome of the event was recovering. Pfizer is a marketing authorization holder of COVID Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID Vaccine has submitted the same report to the regulatory authorities.

Began having leg weakness 4 days after the vaccine on the evening on 1/29/21. The next day the leg weakness was more significant and went to the emergency room where they found greater weakness in the left leg than the right leg. An MRI showed "Punctate focus of diffusion restriction within the left cerebellar vermis consistent with acute infarct." He was also found to have a critically low platelet level of 30 and then 27 while in the emergency room. He was then admitted to the hospital, placed on steroids to increase his platelet level and given physical therapy following the stroke. He was admitted to the hospital for a total of 3 nights. He was discharged home on Aspirin, Carvedilol, and Atorvastatin, has follow up with hematology to check platelets and physical therapy.

[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.

On 3/5/2021 patients left elbow showed extreme swelling, while the injection was done on the right arm. On 3/14 patients 2 knees down to the ankles showed extreme swelling. By 3/18, patients neck was stiff, and sore created an inability to move and nighttime sleeplessness due to pain/discomfort. By 3/22 patient experienced swelling in the buttocks. Patient visited ER on 3/16/21, Internist on 3/17/21 and internist again on 3/23/21. On 3/23/21 internist referred patient to rheumatologist.

Contact w and exposure to oth viral communicable diseases (Primary Dx); Infection due to 2019-nCoV ED to Hosp-Admission Discharged 3/23/2021 - 3/29/2021 (6 days) INPATIENT DISCHARGE SUMMARY Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Hospital Course Patient is a 87 y.o. male with a past medical history of coronary artery disease, chronic systolic heart failure, hypertension, hyperlipidemia, type 2 diabetes mellitus who was admitted to Hospital with COVID-19 pneumonia. Hospital Course: COVID-19 pneumonia. The patient was treated with convalescent plasma and IV remdesivir and completed the course. He was treated initially with IV Decadron which has been transitioned to oral tablets for discharge to complete a 10-day course. Chronic systolic heart failure. Coronary artery disease. Orthostatic hypotension in the setting of chronic hypertension. The patient does have chronic systolic heart failure with an EF around 20% and is followed closely at the heart failure clinic. He is chronically prescribed Lasix at 80 mg twice daily, however he did have some episodes of orthostatic hypotension during his hospitalization and has been unable to tolerate other guideline directed medical therapy due to his hypotension. He is euvolemic at this time. I have decreased his Lasix dosing to 40 mg twice daily to restart tomorrow morning. His last dose of the 80 mg of Lasix was yesterday morning. I do feel that in the setting of COVID-19 pneumonia and decreased oral intake that he is more at risk for continued hypotension and dehydration aggressive diuresis. He will remain on aspirin, Plavix, and simvastatin. Type 2 diabetes mellitus. His last hemoglobin A1c showed good control at 6.3 on 3/3/2021. His glipizide was held while inpatient. He was on long-acting Lantus insulin 10 units with stable blood sugars in the hospital. He was also on correctional lispro insulin. His glipizide will be resumed upon discharge.

Dehydration; muscle weakness; This is a spontaneous report from a contactable consumer (family member) via Medical Information Team. An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in arm at a military facility on 20Mar2021 (at the age of 87-year-old) (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive other vaccines prior to the vaccination within four weeks. The patient had no relevant medical history. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201) administered in unspecified arm on 19Feb2021 (at the age of 87-year-old) for COVID-19 immunisation. The consumer reported that the patient experienced dehydration and muscle weakness on an unspecified date and was hospitalized for both events from 30Apr2021 to 03May2021. The patient had a negative COVID test about a week ago (30Apr2021), he recently entered the hospital for dehydration and had a whole series of tests, all of which were negative. The patient was in this facility now, mainly he was just convalescing because of the dehydration and muscle weakness. The consumer stated that patient was transferred to this other VA facility, the VA nursing home and that's where he received the third dose today. The events required emergency room visit and did not require physician office visit. It was also reported that patient got a vaccine overdose of Pfizer's COVID vaccine and wanted to know what to do. It was reported that first injection was on 19Feb2021, second injection was on 20Mar2021, and third injection was given today (07May2021). The consumer was informed that the administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. The consumer then mentioned that he was able to find that the booster study will be starting in May on news. The consumer was told that no specific information was found from approved sources regarding the specific date the study on the booster dose has begun. Clarified that booster dose was in regard to a 3rd dose 6 to 12 months after receiving both doses and does not apply to his family member's case regarding 3 doses within the span of 1-2 months. Additionally, the consumer reported that the patient gets his primary care at a medical center. The consumer stated that it was another healthcare professional who administered it. The consumer stated that it was probably in the morning sometime, before noon. The consumer stated that it was given he would presume in one of his arms but he doesn't know which one. The outcome of the events dehydration and muscle weakness was recovering. Follow-up attempts are needed. Further information is expected.

Clouded mental state, very "foggy". Trouble communicating verbally. Muscle weakness, trouble moving and standing. Very tired. Got better after a long night's sleep, mobility retuned as did mental capabilities.

Approximately 1 week after vaccination patient developed swelling and blistering rash overlying left arm. Subsequently developed significant pain and weakness in his arm, with contractures present.

Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and became unresponsive. Patient was lowered to the floor and did not exhibit a pulse. CPR was initiated and 911 was called. An AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.

Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.

chills; stomach problems/ stomach pains; back problems; weakness/low energy; sore arm for a couple of days; aching; upset stomach; lost weights; nasal drip; feeling "miserable"; he was really not well; diarrhea; sick/artificial sickness; This is a spontaneous report from a Pfizer-sponsored program. An 88-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER9231), via an unspecified route of administration on left arm on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure high, diabetic and chronic obstructive pulmonary disease (COPD), he had started no new medications and not had any other recent vaccinations. He took a lot of medications for a lot of things. He was diabetic, had high blood pressure, COPD, a variety of things get over the years, he took medication for these things. He was affected by medications more than most people. No further details provided about his medications. He reacted to medications in general and that because of that he usually took lower dosages. The patient's concomitant medications were not reported. After 2 weeks from the vaccine. Have weakness and stomach pains and diarrhea. The patient had been artificially sick like 4-5 days since 21Jan2021, and had a test done and it didn't show up. He said he hadn't been anywhere to get the virus. He said he didn't have any fever, his oxygen level hadn't changed, he had a testing kit with thermometers, so he knew he never had a fever, but he got chills. He got all the symptoms, the stomach problems, diarrhea, back problems, overall weakness and low energy. He was fine two weeks before this, this started almost two weeks to the day and minute from when he went and got the shot. When he got the shot he had nothing, he waited 15-20 minutes with no problems, his arm was hurting for a couple days, but there was nothing else. Two weeks later he got basically an artificial case and the corona virus test said no, clarified to being negative, but he said it didn't go away, it had been from Thursday to Monday, so 5 days. The big problem was he was supposed to get his second shot Friday, and he had an appointment Wednesday, he would like to ask them too, but he would like to know was it dangerous for him to get the second shot. He didn't think he can get any sicker. He did not do a report online, he tried to get onto the website but nothing told him how to do it or whatever, so he stayed on the line waiting to talk to someone. Height: he was five feet and nine and three quarters inches tall, he had shrunk with age, everyone got smaller. His arm was not sore for very much, he didn't remember how long, he got sick two weeks later, and now he was really not well, though he was better than he was on Thursday or Friday, though he was not 100% yet. He would like to know if he should get the second shot, because he was too old to die from a corona virus shot. Investigations: He didn't know which COVID test they used, they did an instant test with results in an hour. The patient inquiry if he should get the second shot since he had had this artificial sickness for 5-7 days, two weeks after getting the vaccine. He had "sore arm for a couple of days" after the 1st injection, but "nothing more". However, in the last 4-5 days, he's been feeling "miserable". He didn't have fever. But he's been experiencing aching, diarrhea, upset stomach, lost weights and nasal drip. He tested negative to the COVID virus. He has a doctor's appointment scheduled this Wednesday. The outcome of events was unknown.

Pfizer-BIONTECH COVID 19 VACINE EUA 1. MUSCLE PAIN MAKES IT DIFFICULT TO MOVE AROUND 2. JOINT PAIN IN KNEES AND HIPS causes slip and fall issues

Patient became profoundly weak, lethargic, depressed and anorexic. He lives in a retirement community in an apartment alone He became unable to care for himself and was transferred to Skilled Nursing Facility which was onsight. He had a positive PCR test at time of admission on 2/9/2021. He had no respiratory symptoms or hypoxemia. He had 12 lb weight loss. He remained in skilled nursing until 2/25/2021. He looked moribund initially. He was severely depressed, dehydrated and was refusing to eat. He gradually came back to his normal, vibrant self after 13 days.

Patient was a patient on hospice, had terminal dx of frontal lobe dementia. NP visited with patient on 03/10/2021, notable decline/flank pain, fever 101. Patient passed away on 03/12/21, Medical Director wanted this reported to VAERS d/t the vaccination was within 72hrs of the pts death.

This is a 88 yr old male pt with a hx significant for -stage renal disease on hemodialysis, hypertension hypertensive heart disease and kidney disease, CAD, history of acute MI, dementia, GERD, gout, prostate cancer who is admitted with complaints of chest reviewed and back pain. Pr records patient was noted to be grunting and hyperventilating while in the emergency department. Imaging done was negative for a pulmonary embolism, showed minimal interstitial upper lobe and peripheral lower lobe interstitial and groundglass lung opacities which are nonspecific. Patient was tested for COVID-19 and has tested positive.

fever up to 37.8 with sweating; fever up to 37.8 with sweating; CRP 90; Sedimentation rate 70; pain in left groin; This is a spontaneous report from a contactable physician. A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Right on 03Feb2021 09:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation . Age at vaccination :88 years.Medical history included Bilateral inguinal hernia Repair. Facility type vaccine: Unknown;No other vaccine in four weeks; No Other medications in two weeks. The patient experienced fever up to 37.8 with sweating (non-serious) on 03Feb2021 11:00 with outcome of not recovered , crp 90 (c-reactive protein abnormal) (non-serious) on 03Feb2021 11:00 with outcome of not recovered , sedimentation rate 70 (non-serious) on 03Feb2021 11:00 with outcome of not recovered , pain in left groin (non-serious) on 03Feb2021 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 37.8 on Feb2021 , c-reactive protein: 90 on 03 Feb2021 , red blood cell sedimentation rate: 70 on 03Feb2021 . The action taken in response to the event(s) for bnt162b2 was not applicable. The patient received treatments for all events: Acetaminophen and Celecoxib.The adverse events resulted in: Doctor or other healthcare Professional office or clinic visit.Addiitonal information :No covid prior vaccination. No covid tested post vaccination. The patient received dose 2 of bnt162b2 (Brand Pfizer) intramuscular, administered in Arm Left on 24Feb2021 11:00 (Batch/Lot number was not reported) as DOSE, SINGLE, No follow up attempts are possible. Information about lot/batch number cannot be obtained.

brief ache in arm went away overnight, left side from thigh to knee muscles/ joint pain, hard to get up

Patient stated that he was feeling faint, and his body went limp and he became unresponsive. It lasted approximately 15-20 minutes.

1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.

Administered Patient vaccine 01/21/21. Went to ED and diagnosed with the following: 1. Shortness of breath 2. Peripheral edema 3. Hypertensive urgency 4. Weight gain 5. Hypervolemia, unspecified hypervolemia type 6. Atypical chest pain Admitted to inpatient to hospitalist but then signed AMA and left hospital.

Dose #1 on 12/21/20 Dose #2 on 1/11/21 On 1/12/221 He states over the last 24 hours he has developed shortness of breath, chills, extreme fatigue. Patient states he went to sleep fine last night using his BiPAP which she always does for obstructive sleep apnea and woke up today around noon. He states upon awakening he had extreme fatigue and chills and felt short of breath. He states he was breathing "60 times a minute". Patient has not had fever since. Patient states he did have coronavirus in October and had pneumonia with this, states that his pneumonia improved and his symptoms resolved. Patient initially requiring 2 L of supplemental oxygen. Afebrile throughout admission. Was able to be weaned to room air. Patient symptomatically improved in terms of shortness of breath as well as myalgias. Likely the symptoms were secondary to vaccine reaction. Patient stable to be discharged home. No changes made to home medications.

Patient vaccinated 2/21/21. That evening patient had myalgia and chills, and noticed swelling of the R testicle. US performed: acute R testicular epididymo-orchitis. Symptoms resolved without treatment.

5/2/21 Pt was hospitalized for 2 days for COVID is a 89 y.o. male patient of , MD with history of steroid and oxygen dependent COPD with chronic hypoxic respiratory failure on 6 L, coronary artery disease, gout, hypertension, hyperlipidemia, BPH, and recent exacerbation of his COPD who presents with fevers, body aches, generalized weakness for 5 days found to have COVID-19 infection Acute on chronic hypoxic respiratory failure Due to COVID-19 infection. On home requirement of 6L NC. Expect he may have a milder course given vaccinated status (though not fully vaccinated until 5/7/21). Update 05/4/2021 Patient stated that he feels that he is back to his baseline Currently on 6 L nasal cannula oxygen His sats was~98 %t rest, with no evidence of respiratory distress Covid-19 Virus Infection Date of onset of symptoms: 4/28/21, Symptoms present on admission: fevers, myalgias, dyspnea, weakness Date of covid positive test: 5/2/21 Vaccination status: vaccinated on 4/1 and 4/23/21 but had exposure on 4/22/21 Imaging: CXR with low lung volumes with bronchovascular crowing and strandy bibasilar pneumonia with small pleural effusions Oxygen requirements on admission: 6L Current oxygen requirements: 6L Medical therapy: Received x3 doses of remdesivir while in the hospital, will complete total 10 days of dexamethasone treatment Consultants following: pulmonary Anticipated special isolation end date: 5/8/21 Generalized weakness Due to above issues -PT/OT consults COPD with chronic hypoxic respiratory failure GOLD grade 3, group D, follows with Dr. as an outpatient and recently completed a course of prednisone taper and augmentin on 5/1/21.Chronically declines PFTs in the past. He is on chronic prednisone at 5mg daily and uses 4-6L NC continuously at home. Pneumovax 2010, prevnar 2015. -Continue home spiriva, symbicort, singulair, and albuterol MDI 4x daily -ST consulted, recommended chopped/NDD 3, thin liquids -Discharge home to complete total 10 days of dexamethasone -Can restart his home prednisone afterwards

Rash on right leg - calf region; Aching all over especially where he had the surgical hip revision/ sharp pain; Body pain with continued sharp pain in left leg groin area - site of recent hip replacement; This is a spontaneous report from two contactable consumers (one of them was patient himself). An 89-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in right arm on 09Feb2021 at 10:00 (at the age of 89-year-old) as a single dose for COVID-19 immunisation, second dose of immunoglobulins NOS (IMMUNE GLOBULIN, Formulation: Unknown), intravenously from 01Feb2021 at an unknown dose and frequency for CIDP. Patient received IV Immune Globulin within 2 weeks of vaccination. Recent DX and received 2nd IVIG infusion on 01Feb2021. The patient's medical history included ongoing CIDP (he was diagnosed with CIDP which was chronic inflammatory demyelinating polyneuropathy. The treatment for CIDP was IVIg infusion), hip surgery from 14Dec2020 (he had hip surgery on 14Dec2020. The surgery was at (Hospital name)), Sulfur drugs (allergies to medications, food, or other products: Sulfur drugs, known allergies: Sulfur drugs). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID- 19. It was reported that, caller calling on behalf of the patient. She was his wife of 63 years. He has a real problem. It was complicated. His birthday was (DOB) and he would be 90 years old this summer. He had hip surgery on 14Dec2020. The surgery was at (Hospital Name). He was diagnosed with CIDP which was chronic inflammatory demyelinating polyneuropathy. The treatment for CIDP was IVIg infusion. He had infusions for five consecutive days on 24Dec, 25Dec, 26Dec, 27Dec, and 28Dec (unspecified year). He wanted to get COVID vaccine. Pfizer does not have a lot of information for people who get IVIg infusions. On 19Jan2021 he got Pfizer's COVID vaccine and had no problems. On 01Feb2021 he had IVIg infusion because he has to wait 28 days between infusions. They had checked with the neurologist and they said a week then they changed it to 10 days. The neurologist said to go ahead because it was nine days. On 09Feb2021 he got second COVID vaccine. That was Tuesday. He was feeling great and walked into the place to get it. He was ok. He woke up yesterday and he was aching all over especially where he had the surgical hip revision on 10Feb2021 at 07:00. It was six inches above the knee to the top of the groin. It was a sharp pain. When he tries to lift his leg to walk it was especially sharp. He was trying to call the surgeon, but he was in surgery all day. The neurologist said to call Pfizer for any information about people who get IVIg infusion and have chronic inflammatory demyelinating polyneuropathy and the COVID vaccine. He walked into (Name) which was where he got it and he felt great. He walked out and came home. He has had no falls or nothing. He just came home. It was like a mystery. There was not a whole lot of information from Pfizer for people that get IVIg infusions except it started with seven days and now wait 10 days. She was trying to research it on the computer and it only says vaccines in general. It says there might be problem with vaccinations with infusions and she has read the literature that pertained to that. The article she read was from three years ago. It may just be a real unusual kind of thing that a person would have IVIg and get the COVID vaccine. She has been on hold for an hour. She has medical power of attorney for her husband. He had no problem with the first one at all. On the vaccine card she could not read the person's handwriting. Waited to do COVID vaccine on 19Jan2021 when he was in skilled nursing facility. He was in the hospital for 18 days and then went to the skilled nursing facility for 12 days. The only thing that was relevant was did the IVIg have an effect with the COVID vaccine because nothing else had changed. That was the only different thing. Morning after - body pain with continued sharp pain in left leg groin area - site of recent hip replacement on 10Feb2021 at 07:00. Morning of 13Feb2021- rash on right leg - calf region. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The action taken with immunoglobulins NOS for the adverse events was unknown. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

numbness/ his right hand has gotten very numb at times; Began to hurt in his left hip; hand hurts; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reporting for himself. An 89-years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID - 19 VACCINE, Solution for injection, Batch/lot number: EK9231, Expiration date: Not reported), via an unspecified route of administration in right arm on 09Jan2021 (at the age of 89-years old) as single dose for COVID-19 immunization. The patient medical history included left knee replacement in 2005, left hip replacement in 2006, and right hip replacement in 2012. His unspecified medications had not changed in a couple of years. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID - 19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: Not reported), via an unspecified route of administration in right arm on 30Jan2021 as single dose for covid-19 immunization. In mid Jan2021, the patient experienced "right hand has gotten very numb at times", " hand hurts" and "began to hurt in his left hip". The patient stated that he was not sure if he had been having a side effect from the Covid vaccine or not, but he got both doses on 09Jan2021 and 30Jan2021, respectively, both in his right arm. Since receiving the vaccine, he has had numbness in his hand mostly at night and if he raises it, it gets worse. He wanted to know if anyone else had reported this or not. The patient stated he did not think he had any problems with the Pfizer vaccine doses, but now he was going back, and he thought that maybe something triggered a problem that he was having. Both shots were administered into his right arm. After the first shot, his right hand had gotten very numb at times. The patient inquired whether anyone else had reported the same symptoms. He thought that this might or might not be related to the vaccine, or it could be something else, but he was not sure. The patient stated that his symptoms started after the first shot. He stated that he did not realize it at that time, but upon thinking back, he thought it could have been from the shot. He mentioned that he was 89 years old and would be 90 years old soon. He had his left knee replaced in 2005, left hip in 2006 and his right hip in 2012. Two weeks prior, his left leg, when sitting down at the table for breakfast, began to hurt in his left hip. He said this had been happening since then. He stated that for some reason, today it was not hurting at all. He hoped that it had resolved itself. He stated that all of his symptoms started in mid Jan2021. The patient was unsure if he had shrunk at all. He was not sure of the specific start dates of his symptoms. He just knew it started after the first dose, sometime in mid Jan2021. He did not make any correlation between the two at first. He took it as something was just wrong with his hand. He started that it happens more at night, when he is sleeping. If he wakes up the hand hurts and is numb. The worst phase was 2 weeks prior. Since then, it had started to improve. Regarding his "left hip hurting", he was unsure if it was still ongoing or what the outcome was. He knew that this morning it had not bothered him at all. The patient did not undergo any investigation or assessment. The outcome of the event right hand has gotten very numb at times and left hip hurt was recovered on an unspecified date in 2021. The outcome of the event hand hurts was recovering. Follow-up attempts are completed. No further information is expected.