Pfizer

Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1. 0.3 ml given by RN. Patient called his PCP: "... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes: seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a "cardiac alert" was called.

pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days

Low grade fever; muscle and joint pain; muscle and joint pain; mild chills; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm on 04Jan2021 14:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included none. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced low grade fever, muscle and joint pain, mild chills on 05Jan2021 09:00. This case was non-serious. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

Joint pain in both shoulders and knees; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 and first dose on 19Dec2020 08:00 (lot number: EH9899) in left arm; both via at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Dec2020 10:00, the patient experienced flu like symptoms and joint pain in both shoulders and knees that continued until second shot on 07Jan2021 that eventually subsided. The outcome of the events was recovered with lasting effects on unspecified date. No treatment given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

Fever up to 101.1, 2 days after vaccine administration, chills, headaches, moderate to severe body aches and pains, especially to elbow and knee joints. I am now in day 3 and still having low grade fever with continued headache, body aches and pains.

The night of the vaccination I became ill with flu-like symptoms. I experienced muscle aches, chills, a fever, fatigue, and stomach cramping that lasted 3 days.

3h after receiving the first shot, I developed symmetric flank pain in the mid-thoracic area that persisted about 28 hours. No CVA tenderness; elevated BP of 132/85; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on his left arm on 07Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID]) and naproxen. Three hours after receiving the first shot (07Jan2021 at 22:00), patient developed symmetric flank pain in the mid-thoracic area that persisted about 28 hours. No CVA tenderness. The following morning, he had an elevated BP of 132/85 that persisted this morning (120/98). His normal BP is 110/70. Checked a creatinine and metabolic panel on 07Jan2021, all normal. There was no treatment received for the adverse events. The outcome of the events was recovering.

WHEN I RECEIVED THE PFIZER -BIONTECH COVID-19 VACCINE THE NEXT 2 DAYS 12: 45 AM I TOOKA SHOWER AND WENT TO BED THEN I FOUND MY LEFT SIDE OF THE BODY FROM MY AMPIT ALL THE WAY TO MY FEET ARE NAMBED AND ALSO SOMETIMES MY LEFT LEG GIVE UP ON ME FEELS WEEK ON MY KNEE. I WENT TO MY DOCTOR AND ALSO I CONTACTED MY WORK PLACE THAT IS EMPLOYEE HEALTH AND THEY TOLD ME TO CALL THE AGENCY.

MODERATE PAIN IN LOWER EXTREMITIES (FOCUSING ON HIPS/KNEES). TO TREAT: LOCAL WARMTH, FLUIDS, IBUPROFIN.

8 to 10 hours after injection joints throughout my body became very sore, a few days later knuckle on right hand swollen and very sore, i thought it was just coincidental, I did see my Doctor a few days later because the over the counter pain meds were not being very effective, he gave me toradol and told me i could take 10 mg prednisone in am for three days that i had on hand, eventually I got better, i then got my second dose and I had a repeat of the joint pain and swelling of my knuckles on the right hand, this to was better after 3 or four days after using the same treatment, I never felt that it was life threatening but thought I should report it, my joints are still sore but they are debilitating and i am improving each day.

Fever of up to 101.2 Fahrenheit; Chills; muscle soreness; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jan2021 11:00 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history was none. The patient had no known allergies. Concomitant medication included ibuprofen (IBUPROFEN). The Historical Vaccine included product=COVID, brand=Pfizer, lot unknown=False, administration date=22Dec2020, administration time=10:30 AM, vaccine location=Left leg, dose number=1. The patient experienced fever of up to 101.2 fahrenheit, chills, muscle soreness on 12Jan2021 23:30. The patient underwent lab tests and procedures which included body temperature: 101.2 fahrenheit on 12Jan2021 23:30. No treatment was received. The event outcome was recovering. The events reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache, loss of appetite. Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.

Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherwise had no symptoms. By Tuesday 1/19/21, he was having shooting pains through his shoulder and down to his elbow. By late Wednesday, he had started to develop hives on his palm, between his fingers, and up to the elbow. Pt states he has a history of a pinched nerve in his neck and elbow, but this pain is nothing like his usual pain. On 1/22, pt presented to the ED for left uper arm pain and rash. He denied new detergents, foods, clothes, wooded area exposure. Denied decreased ROM in shoulder, but ROM makes his shoulder sore. BP 161/82, otherwise vitals normal. Rash did not apear infectious. No evidence for DVT. Pt received ketorolac 30 mg IM x 1 in ED and was prescribed hydrocodone-APAP 5-325 mg tabs PO Q6h PRN #8. Pt was instructed to follow up with PCP in 1-2 days. By 1/25/21, pt reports the hives have become dark purple, like bruises. He states he has trouble making a fist and is not using his left arm at all - when this writer spoke to him, he said it was "gimpy." Pt stated during the phone call that he was about to call his PCP for a follow up appointment.

Had the shot at 8pm on 1/21. Starting the morning of 1/22 when I woke up, was stiff and achy. As the day progressed got more achy and then started to feel chills. Late afternoon/early evening started to have low level fever. Took Tylenol at 10pm and Advil at 3am (1/23). Woke up on 1/23 at 8am and all symptoms had subsided. Felt fine from then on.

Fatigue and muscle ache morning after. Chills, Fever developing afternoon after injection. Took Tylenol

Back pain/it hurt so bad; could not walk; This is a spontaneous report from a contactable healthcare professional reported for himself. A 60-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscularly on 30Dec2020 13:00 at single dose, left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes and high blood pressure, both controlled. The patient's concomitant medications were not reported. On 02Jan2021, the patient experienced back pain, started slowly peaking on January 7 to where he could not walk, it hurt so bad. Events were non-serious. No treatment received for the adverse event. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name was Nasal Swab.

Fatigue, muscle aches, low grade fever (99.8). Treatment Advil with mild improvement. Outcome continue to work does not interfere with ADLs.

I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches and a low grade fever. Some nauseous. Really vivid dreams.

Few days after receiving the 1st dose, developed tingling paresthesia in both hands. He received his second vaccination despite the symptoms. Symptoms continued to progress to his feet, and also developed weakness, particularly in his legs. Also had some weakness in arm but more so on the left side. He had difficulty climbing ladder when deer hunting due to weakness in his thighs/legs. He ended up falling in his home on Jan 17, 2021 as well, which caused significant hip pain. Had a neurosurgical evaluation- finding lumbar disease L3-4 requiring fusion. Following surgery, paresthesia and weakness persisted and actually worsened, , developed uncontrolled twitching in both thighs. Further developed loss of function in his L-hand. MRI revealed transverse myelitis. Symptoms have improved with corticosteroid therapy. Patient was hospitalized due to these symptoms for two days, discharged on corticosteroids.

This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.

-Sore muscle around injection site lasting for about 24hours -approximately 24 hours after injection I had muscle, joint and skin aching all over my body that lasted about 7 hours

Severe pain from arthritis in left hip developed about four days after injection in left arm. This hip occasionally hurts badly in weather change, but this time was unexpected, much more severe than ?normal?, and was not tied to weather. Pain was quite significant for about 24 hours, then subsided, and was normal again in 48 hours. It hurt like hell for a day( day one being four days after injection), and then hurt a little in the second day, then was gone by day three. On a scale of 1-10, the pain was a 9-10 for a day, then 6-7 for a day, then was fine.

Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.

Gout flare up in Thumb. Never had Gout there before but do have take medicine to control gout. Alopurinol daily. Took extra gout medicine and pain subsiding. Still swollen and tender at this time.

not sure if related. having acute swelling near left knee. after reading side effects include joint swelling decided to report. planning to see a doctor tomorrow to see what they think.

Numbness of left hand fingers; stiffness started 15 minutes after vaccine. BP readings: 141/90 (pulse 86), and 148/89 (pulse, 84). 100% O2 sat.

12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.

fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.

pt. experiencing some lightheadedness. L. sided neck pain and metalic taste in mouth. Medics present. pt. denies any difficulty swallowing &/or other s/s. Resolved with calming / comfort measures. Advised pt. to go to ER via EMS/ have someone come pick him up d/t increased BP. Pt. refused. Pt. asymptomatic prior to leaving vaccination site. Pt. advised to pull over & call 911 if anything changed / symptoms return- pt. agreeable. Advised to f/u with PCP/ Cardo. pt. communicates understanding. BP 216/117 at 1337 HR: 73; SPo2: 93% - smoker- 0.5 PPD x 27yrs. BP: 206/122 at 1443 HR 1443, HR 71; BP 187/112 at 1448, HR :69; BP 180/109 at 1453 HR: 72; BP: 173/103 at 1458 HR: 72; BP: 176/105: HR 71 at 1503.

10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke two hours later with a fever of 102 and severe chills. That lasted 6 hours. Body temp went down to normal. Ate a little breakfast. Tired and achy. Went back to bed. Awoke several hours later. Fever was back. Though not as high, 100. Entire body hurt. Joints, head, abdominal pain, pain in left armpit. Stayed for several hours. Went back to bed about 4:00PM woke up an hour later fever down to 99. Ate a little supper. Acid reflux uncontrollable. Went back to bed. Awoke at 8:00PM . Fever still at 99. Stayed awake until 10:30. Went to bed. Tossed and turned with body aches all night. Had to get up every two hours to urinate. Awoke at 7:30AM. No fever. Feeling somewhat better. Still pain in left armpit. Headache almost gone. Joint pain almost gone, abdominal pain still present. Worst is over.

Muscle pain in shoulders with more extreme pain in the left shoulder, Left wrist. This muscle pain occurred on March 16 and dissipate 2 days later. Then on March 18, 2021 I started to feel muscle pain and swelling in and around my left ankle. On March 20th, 2021 the swelling remain in and around the ankle but the swelling and pain migrated to the first joint of my left big toe. The pain on a scale of 1 to 10 ten is about a 3. The pain elevate to a 10 when touched. Pain is unbearable if I attempt walking on the left leg, as a result I am not able to walk. Swelling has not subsided in 3 days

Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.

Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing , this is the most problematic symptom. Headaches come and go infrequently

Rhabdomyolysis. Persistent muscle aches persisting from time of vaccine to time of presentation and diagnosis 1 mo later. Muscle weakness started 2 wks after vaccination

Fever, joint aches, chills, headache lasting from about 11:00 p.m. the night of the vaccination date through around noon the following day.

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

Severe neck pain on left side on first day of reaction followed by painful swallowing on left side the next day. Both conditions persisted for about 4 days and then resolved itself. Same reaction just 4 days later after second dose with pain more severe and longer lasting. Currently on day 7 after second shot and pain still not resolved.

Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold around 9:45PM. Woke up throughout night with lower back/neck pain and headache. Now (7:18AM) experiencing headache, nausea, neck ache, chills and lower back pain. Feels like a hangover.

Severe hives outbreak all over the body 4 days after second dose of Pfizer vaccine. Hives started in groin and armpit then expanded to forearms, knees, neck, eyes, hips, back, tailbone area, head, and was severe in the hands and wrists. Also -- The evening and through the night after the second dose (given at 8:35 AM) side effects included headache, chills, fever, muscle aches.

Difficulty and painful swallowing on left side of throat + severe neck pain on left side. All symptoms are left side only.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

Headache, muscle aches, chills, high fever, rash,, swollen joints, fatigue, minor chest congestion lasting 9 days. Administered Tylenol, Ibuprofen, Mucous DM. Tested negative for Covid 19 on rapid and lab test.

Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue and loss of muscle strength (I am a hard core cyclist), not detectable during normal activities. A week later it persists. On the fourth evening, I could not stay asleep. As soon as I would drop off I would dream. It would be a violent encounter. I would physically strike out and I would wake up.

Transverse Myelitis; spastic twitching in thighs; severe back and leg pain; severe back and leg pain; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiration date not provided) via an unspecified route of administration, administered in left arm on 07Jan2021 15:00 as a single dose for COVID-19 immunisation. Medical history includes Hypertension, Gastrooesophageal reflux disease (GERD), prostate cancer and broncholith left lung. The patient has no known allergy. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, losartan, pantoprazole, hctz, and acetylsalicylic acid (ASPIRIN). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 17Dec2020 and experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. On 19Jan2021, the patient developed severe back and leg pain resulting in spinal fusion surgery on 25Jan2021. Postoperatively, the patient developed spastic twitching in thighs on 31Jan2021. On 07Feb2021, he woke up with weakness and clumsiness in left hand. At post-op check for spinal surgery on 10Feb2021, the neurosurgeon recommended another MRI and mentioned possibility of Transverse Myelitis. Following this MRI on 15Feb2021, he was again admitted to hospital for more extensive work up and was admitted for 6 days. Diagnosis made of Transverse Myelitis and was started on high dose steroid treatment and was discharged to home on 17Feb2021. Since then have had profound leg weakness, right side greater than left, which severely impairs mobility, especially stairs. He completed 5 day course of 1000 mg methylprednisolone per day as an outpatient on 20Feb2021. He is in PT and is unable to predict date of return to work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment for the events included high dose steroid therapy, PT and exercise. The patient underwent COVID test post vaccination via nasal swab on 24Jan2021 and was negative. The outcome of the events was recovering.; Sender's Comments: Based on available information the reported events are unlikely related to BNT162B2. These are intercurrent medical conditions. Case will be reassessed if additional information is received. 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.

mild numbness and tingling arms and legs; mild numbness and tingling arms and legs; weakness in legs; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), dose 1 via an unspecified route of administration, administered in Arm Left on 17Dec2020 15:00 (at the age of 60years) as single dose for Covid-19 immunization. Medical history included hypertension, GERD (gastrooesophageal reflux disease), prostate cancer, broncholith left lung; all from an unspecified date. Concomitant medications included amlodipine, losartan, pantoprazole, hydrochlorothiazide (HCTZ), and acetylsalicylic acid (ASPIRIN (E.C.)); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020, the patient initially experienced mild numbness and tingling in arms and legs following first dose of vaccine, followed by progressive weakness in legs. The patient was hospitalized for 6 days from an unspecified date to an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, and Disability or permanent damage. The patient was tested for Covid-19 post vaccination (Nasal Swab) 24Jan2021 with negative result. The outcome of events was recovering.

First injection: Sore arm that received initial injection for about one day. No treatments. Second injection received on other arm (right): Sore arm. The next day arm was sore, perhaps sooner. Also, the next day I was lethargic/sleepy, had a slight chill and was sore in at least some joints, including ankles. No treatments other than staying in bed. The second day I was close to back to full energy. Now a month later I'm occasionally naps these days, which I wonder whether are prompted by the vaccination.

On March 30th, the first skin rash / bump appeared on my right wrist and was very itchy. It expanded to an area about 1 inch x 2 inches and a week later continues to be itchy. Zyrtec helps reduce the itching (I only take 1/8 of a pill because a whole pill is too strong for me) On April 4, three additional spots about 1/2 inch in diameter appeared on and around my right nipple. Later that day, three other spots about 1/2 inch in diameter appeared on my LEFT shoulder. I got the short in my right arm. The chest and shoulder spots are only slightly itchy. I took pictures - hopefully later in this interview, I will be able to upload them.

lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood pressure 199/98.; nausea; Arm pain first day.; fatigue; palpitations; shakes; joints and muscle pain; joints and muscle pain; headache; Chills; night sweats; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (Batch/Lot Number: EN6199) as SINGLE DOSE (at the age of 60 years) for covid-19 immunisation . Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , covid-19 from Mar2020 to Sep2020, (COVID 19 Long-Hauler from Mar-Sep2020). Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); simvastatin (SIMVASTATIN). The patient previously took aspirin [acetylsalicylic acid] and experienced anaphylactic reaction, zantac and experienced rash and experienced peripheral swelling. The patient experienced feeling like fainting (medically significant) on 13Mar2021 14:30 with outcome of recovering , that happened parallel to erratic high blood pressure 199/98 on 13Mar2021 14:30 with outcome of recovering , palpitations on Mar2021 with outcome of recovering , lightheaded on 13Mar2021 14:30 with outcome of recovering , stomach pain on 13Mar2021 14:30 with outcome of recovering , shakes on Mar2021 with outcome of recovering , joints and muscle pain, headache on Mar2021 with outcome of recovering , chills on Mar2021 with outcome of recovering , night sweats on Mar2021 with outcome of recovering , nausea on 13Mar2021 14:30 with outcome of recovering , arm pain first day on 09Mar2021 with outcome of recovering , fatigue on Mar2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 120's-30's/70's, blood pressure measurement: 199/98 on 13Mar2021, platelet count: 99, sars-cov-2 test: Several negative tests on unspecified date. The patient went to Urgent Care twice. The patient took no other vaccine in four weeks and the patient was not COVID tested post vaccination.

Starting Monday at work I began to feel very tired, my muscles started aching across my back at shoulder level, and my hands went numb. I went home and took Tuesday off to rest. Wednesday this has continued and I may leave work again. I have also had some very sharp pains in my joints.

Pain at injection site. Progress to under the arm. Also lymph nodes under arm are noticeable to the touch and water build up on the right under arm chest wall. Some coldness in hand and occasional tingling. Shoulder area feels heavy.

My husband wore a t-shirt to the vaccination appointment at the mass vaccination site. Upon rolling up his sleeve to uncover the standard shoulder injection site, the person administering the vaccine asked him to roll up his t-shirt further and administered the vaccine very high and close to the shoulder bone. About 30 min after the vaccination, he started experiencing severe shoulder pain which has shown no improvement as of today (vaccine 4/7, reporting 4/9). He is unable to move his right arm without extreme pain. So far he has not sought medical care and is treating the shoulder with ice and over the counter medication. Currently ongoing with no improvement. So far too early to determine if this will lead to disability and permanent damage.

weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-dependent enhancement

Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.

After receiving the 1st vaccine I experienced pain in my arm, chills and swelling of both hands and both knees After receiving the 2nd dose I experienced the same symptoms except the pain in my arms and the chills. I'm still experiencing swollen hands and knees. Not able to make a fist and lot's of pain in both knees and both hands especially the mornings. Joint pains and swelling in my hands are affecting my ability to hold things firmly without dropping everything.

Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.

Gout in the second toe on my left foot. I had NO alcohol, or shell fish. I have had gout 2-3 times in my life, mostly in my fingers

Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.

Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.

Acute onset left foot pain (5th metatarsal protuberance), lasted six days, resolved with ibuprofen, colchicine, Keflex. Prompted urgent care clinic visit on 4/13/2021 where x-rays showed no abnormalities. Diagnosed as probable gout flare (my first first diagnosis of gout, but second episode of this type of pain).

pain and swelling in right arm with severe swelling and severe pain in right hand and wrist. pain and swelling appears to affect joints as lower back and fingers on left hand has become swollen and painful several days after injection

numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering. Information about Lot/Batch number has been requested.

Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail hammered into the skull pain), back pain, check tightness, and upset stomach.

Several minutes after injection patient began feeling hot and fainted - Patient never lost consciousness, breathing remained regular, but complained of neck pain

Day after 2nd injection extremely sore right shoulder. Extreme headache. Very fatiqued for two days.

Flu like feeling very bad for 2-3 days - fever over 100. muscle aches and pains- still occurring now.

Bony pain; night sweats; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 20Feb2021 12:45 (Lot Number: EN6201) at the age of 60 years old as single dose for covid-19 immunisation. Medical history included Covid prior vaccination, Hypertension, Diabetic, No Known allergies. The patient's concomitant mediations received in two weeks included medications for Hypertension and Diabetic Medication. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Bony pain and night sweats on 21Feb2021 at 11:45 AM. No treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. The report was serious per the reporter.

Large swelling in and around my left armpit with soreness. Appears to look like a lump under my left armpit with veins visible with the eye. Swelling appeared after within 36 hours of receiving the 2nd Pfizer Covid-19 vaccination shot.

My left arm is painful above the elbow, arm is very weak, trouble carrying things. Joint pains, stiffness, extreme pain in my knees, painful to the touch, sharp pains when I step or turn wrong.

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the top of his left shoulder down to his fingers. He says it hurts from the skin to the bone. He cannot lay down, he has to sleep sitting upright. he said the pain is constant but is not as bad when he sits up and when he lays down the pain is so bad he has to get back up. He is taking aspirin for his pain.

I experienced a very sudden and intense Gout flare up that caused and is still causing an unbearable swelling in my right foot and ankle. I have not had a flare up of this intensity and severity for over 12 years. My Gout has been successfully managed by Allopurinal for over 12 years and I have not experienced any significant events during this time. This time includes over 20,000 miles on my road bicycle and dozens of days over 100 miles. Never have I had a problem. Last Tuesday, I received the second dose of the Pfizer vaccine and I have yet to be able to walk or sleep through the night for six days and counting. This adverse effect should be followed and researched. I also will be requesting reimbursement for out of pocket expenses due to this event.

On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.

Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days. Did not seek treatment since I knew these were normal reactions that would subside. Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.

Sudden bilateral leg weakness a little over 2 weeks from vaccine dose. Also had the inability to walk. Bilateral increasing numbness to both arms and legs. Progressive weakness. Admitted to hospital. Had CT scan, MRI scan, LP puncture, blood work. Findings/lab work state GBS (Gillian Barre syndrome)

Severe muscle aches, severe headaches, sever joint pain, low grade fever and hyper fatigue. All of these symptom's occurred the next morning after the shot on April 18th.

chest pressure; shingles/rash; itch and rash and tenderness on his rib cage; itch and rash and tenderness on his rib cage; chest pain; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 10Apr2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing Cholesterol. Concomitant medication included ongoing atorvastatin taken for blood cholesterol. Patient investigation assessment was No. The patient developed a rash from 16Apr2021. They figured out in the hospital that it was probably shingles. It had developed even more. They want to give him Valacyclovir. He came down with an itch and rash and tenderness on his rib cage from 16Apr2021. He slept on his chest and had pressure on his chest from 18Apr2021 to 19Apr2021. He went to the hospital to rule out a heart attack. The patients father passed away a long time ago of the heart attack and thought it was that as well. He went to the emergency room and was brought in the hospital under observation status. He was diagnosed with shingles at the hospital from 19Apr2021. They were on the right side. The itching, tenderness and pain got worse on Sunday with chest pain from Apr2021. Patient has not received Valacyclovir yet. The hospital was waiting to give it until after caller speaks with Pfizer. The patient was currently waiting to get the antiviral medication for shingles. The outcome of the event chest pressure was recovered on 19Apr2021, of shingles/rash was not recovered, of other event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. I had violent & severe neck pain and severe headaches. Also an extremely stiff neck where I couldn?t turn it 1/8th oh an inch to either side. It all got so severe that I didn?t eat for days at a time and was literally not with it. Couldn?t respond when spoken to, and became excessively weak where I couldn?t walk w/o help, and speech was slurred. It all lasted 5 days where it was so severe. With medication it slowly began to back off.

Pain, stiffness and sometimes very restrictive movement in left rear neck area. Upper back and pain and some stiffness seems to have lessened.

soreness in muscle in right arm with movement.; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 17Feb2021 02:15 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Other medical history: mild hypertension. Concomitant medication(s) included ibuprofen. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and the patient did not tested for COVID 19 post vaccination. No known allergies reported for the patient. On 18Feb2021 07:00 the patient experienced soreness in muscle in right arm with movement. The outcome of event was not recovered.

Losing strength in his right leg; Muscle pain; Joint pain; Muscle spasms in his neck because he has neck pain too; Muscle spasms in his neck because he has neck pain too; His leg kept getting worse; He just cant walk anymore; Leg is swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: ER6208) as single dose at the age of 60-year-old for COVID-19 immunisation. Medical history included disability. The patient's concomitant medications were not reported. The patient experienced losing strength in his right leg in Mar2021, his leg kept getting worse in 2021, he just can not walk anymore in 2021, leg is swollen in 2021, muscle pain in Mar2021 with, joint pain in Mar2021, muscle spasms in his neck because he has neck pain too in 2021. The events losing strength in his right leg, his leg kept getting worse, he just can not walk anymore and leg is swollen were assessed medically significant. The patient underwent lab tests and procedures which included magnetic resonance imaging: leg is swollen in 2021, X-ray: nothing showed up in 2021. Therapeutic measures were taken as a result of losing strength in his right leg, muscle pain, joint pain. The course of events was as follows: Around 21 Mar2021 or 22Mar2021, he had problems with his leg. Patient was experiencing muscle pain and joint pain, losing strength in his right leg. Patient stated that was a problem. Patient had an MRI and X-ray that looked to see what the problem was. Patient received second dose on 14Apr2021. Patient hasn't even seen his prescribing Healthcare Professional yet, until Monday. He hasn't worked in five years, he's been on disability. He wanted to get off disability so he went and got a job. He started the job 28Mar2021 and everyday, his leg kept getting worse. He had to leave the job the other day because he just cant walk anymore, he has to do a lot of walking on the job. He called the doctor and told them something was wrong with his leg, they took an x-ray and nothing showed up. They did an MRI and all it shows was that his leg was swollen, no bones or nothing is broken. He was looking at Pfizer paperwork that a facility gave him and the two of symptoms are on there, so this problem was related to the vaccine. He never hurt his right leg, never had a problem until he got this shot. He was losing all his strength in his right leg, all the pain. They have been giving muscle relaxers and ibuprofen and they did not seem to work or be doing anything. First, he went to the emergency room and they gave him Ibuprofen 600 mg tablets and they gave him Cyclobenzaprine 10mg tablets. They said that he was experiencing muscle spasms in his neck because he has neck pain too. So he made an appointment with his family doctor, which there was no openings and had to see another PA. He did not know the HCP last name, but he/she was a PA in the office and he saw him/her, who requested the x-ray, and he had the x-ray done and saw him/her again and nothing showed up so he/she requested an MRI. He went to the hospital to have that and nothing showed up except his leg was swollen. Now they are going to send him to a bone specialist, but there was no reason to because now he stated he knew what was causing this. Patient took Cyclobenzaprine, 10 mg, three times a day by mouth. He states it did not seem to do nothing. Patient verified it was a prescription from the pharmacy: NDC: 0137517-19674, unsure of LOT, expiry date. The quantity of the first bottle was 15 but he went through that already and he got a new bottle that has 42 in it. This current bottle he has 12 or 13 left. The first bottle was completely gone. Patient took Baclofen 5mg tablets, three times a day: morning, noon, and night. They were not doing anything either, well he did not think they are. Patient provided NDC: 0135391-19674. The first muscle relaxer they gave him, the 10mg one, he took it that day, it knocked him out. Caller states when he saw his doctor, he said he can not take that one while he works, he will take it at night time, so that is why the doctor gave him the other muscle relaxer, Baclofen, to take while he worked during the day. He took one muscle relaxer at night of one kind and the other kind he takes the ones that won't take him out as much. Patient stated that he had to leave his job because he cannot do it, he cannot walk. Patient took Ibuprofen (NDC: 0139246-19674, to use before 22Apr2022) 600mg, by mouth, three times a day. He took one with the muscle relaxers. Patient took verified all medications Cyclobenzaprine; Baclofen; Ibuprofen were prescriptions from the pharmacy. The outcome of muscle pain and joint pain, losing strength in his right leg, his leg kept getting worse, was not recovered of he just can not walk anymore on, leg is swollen, neck pain was unknown. Reporter seriousness for muscle pain and joint pain, losing strength in his right leg and neck pain was unspecified Patient received his second dose of Pfizer Covid 19 Vaccine (LOT: EW0161, unsure if ER or EW) on 14Apr2021. A Product Complaint was filed. No follow-up attempts are needed. No further information is expected.

Per Client, received second COVID 19 on 4/22/2021, in the left arm. Client C/O that in 2-3 days started having joint and muscle pain throughout body. On the sixth day, joint and muscle pain worsen, and now for eight days pain is still present. Per Client, by the seventh day, started taking Ibuprofen, now having itchiness throughout body, and very fatigue. Client has not followed up with PCP, but has an appointment already scheduled in two weeks to see PCP. PHN suggested that Client try following up with PCP sooner than two weeks, to go into Urgent care, ER, and with medical emergency to call 911 if needed. Client verbalized understanding information provided.

Within 30-min: Muscle pain across shoulder and arms. Joint pain: shoulders, elbows, fingers, knees, and toes. Mild swelling and redness in hands. Next day; mild swelling of face.

Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering. Information about lot/batch number has been requested.

leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from a contactable consumer (patient's sister). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer said the patient took the COVID shot, and has taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him. She said that with the first shot he had some leg cramps at the top of his legs at night and that was it. He had it for like 2 nights and then it went away. She stated that she didn't know his age when he got the 1st vaccine because she didn't know when he got it, but that it was sometime in March (Mar2021). She stated he did receive the vaccine at hospital. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.

This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.

Onset of bad body/joint aches about 20 hrs post-vaccine, worsening for about 6-7 hours and dissipating over following 2 hours.

At approximately 9 AM the following day, it seem like all my joints are very achy and sore. All liquid ingredients that I tasted seem to taste very strange Seems to have cleared up by the third day. Other than taste buds.

On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bear weight on right leg. Reduced to crawling around house on hands and knees. Went to former Primary Care Physician on 4//14/21, where I was treated for Sciatic Nerve flare up. Returned to Dr on 4/19/21 in severe severe pain. Dr referred me to hospital where I was again treated for Sciatic related symptoms. Symptoms worsened daily. On April 28, 2021, I crawled into Hospital, was admitted. Received injection in spine. Symptoms worsened. Changed Primary Care Physicians to Dr on 4/11/21.

Called health system call center to report the following symptoms post vaccination on 4/30/21: fatigue and minor sore throat since 5/2/21, Joint pain and muscle aches since 5/1/21. No fevers or respiratory symptoms. Pt scheduled for urgent care visit on 5/4/21. Pt was advised to go to ED if worsening of symptoms. Pt verbalized understanding.

High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to kidney and liver

severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (COMARNITY; Lot/batch no: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 09:00 AM (at 60-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included many food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included fluticasone propionate (FLONASE) and essential amino supplements (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if ongoing. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 09:00 PM, twelve hours after the injection, the patient had severe pains in abdomen with severe muscle pain in back and legs. The patient experienced some chills, headache and fatigue which were mostly over in 24 hours. The patient did not receive any treatment for these adverse events. At the time of this report, the patient was recovering from the events abdominal pain, muscle pain, chills, headache and fatigue. No follow-up attempts are possible; information about lot number cannot be obtained.

On 5/18/21 AM, woke to pain in my right side under my shoulder blade. Went to ER. They performed many blood test, chest Xray, Chest CTA. Determined Pulmonary embolism and infarction. I was admitted, more blood tests, Echocardiogram, Venous Doppler study( No evidence of DVT). Released 5/20/21. Prescribed Eliquis to thin blood for easier natural clot dissolve. No Known cause of PE, yet. Follow up scheduled with my PCP.

Left arm, Epilepsy (Parkinsons) Can?t lift arm, muscles cramp, hurts under his arm, never had this problem before, Received Moderna May 20th. Takes blood thinner depakote and triacetone,. Being seen by Health Department.

Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date. Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

headache; muscle aches; sore achy muscles; fatigue; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2(COMIRNATY, solution for injection, Batch/Lot number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing pancreatitis, asthma from an unknown date and unknown if ongoing, overweight from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included hydralazine (HYDRALAZINE) taken for hypertension from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus from an unspecified start date and ongoing; insulin human (HUMULIN R) taken for diabetes mellitus from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 for covid-19 immunisation, keflex [cefalexin monohydrate] and experienced drug hypersensitivity. The patient experienced headache, muscle aches, sore achy muscles on 05Mar2021 04:00. Outcome of headache, muscle aches, sore achy muscles was unknown. No follow up attempts are possible. No further information is expected.

On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.

Pain at injection site, sore muscles, headaches, painful and swollen lymph node on left side of neck under left ear -- still painful and swollen after 3 months since injection

Fever; chills; headache; muscle aches; joint pain; fatigue; pain in injection area; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:15, as single dose for COVID-19 immunization. The patient's medical history included hypertension. The patient had COVID-19 prior vaccination. Concomitant medications included chlorthalidone, hydralazine and losartan potassium. On 06Mar2021 08:00 AM, the patient started experiencing fever, chills, headache, muscle aches, joint pain, fatigue and pain in injection area. No treatment was received in response to adverse events. The patient was not COVID tested post vaccination. The outcome of the events was reported as not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

PT REPORTED OF MUSCLE PAIN THAT RADIATED FROM LEFT ARM (WHERE HE WAS GIVEN THE SHOT), TRAVELLING TO LEFT SHOULDER, THEN TO LEFT CHEST MUSCLE. INJECTION OCCURED AT AROUND 1140AM, PT REPORTED PAIN TO PHARMACIST AT 1151AM. WHEN I EXAMINED THE INJECTION SITE, THE AREA DIDN'T LOOK RED OR SWOLLEN. I CHECKED BP AT 1153AM AND IT WAS 152/81. I CHECKED BP AGAIN AT 12:10PM AND IT WAS 155/85. AT 12:10PM, PT WAS STILL REPORTING CHEST MUSCLE PAIN ON THE LEFT SIDE OF HIS TORSO. PT WAS ALERT AND WAS ABLE TO TALK TO ME.AND TELL ME HIS SYMPTOMS. EMT WAS CALLED AT 1214PM. 911 OPERATOR INSTRUCTED ME TO GIVE HIM 4 TABS OF 81MG CHEWABLE ASPIRIN (NDC 00904-4040-73) AT 1231PM. EMT ARRIVED SOON AFTER. PT WAS TAKEN TO HOSPITAL AT AROUND 1245PM.

Developed shortness of breath and high blood pressure within 48 hours. Chest pain and back pain. Shortness of breath when working out slightly.

POLYARTICULAR REACTIVE ARTHRITIS, swollen and extremely sensitive and painful joints, affecting all fingers in right hand, right wrist, right elbow, right knee, left big toe. Treatment with Prednisone, initially 40mg daily, boosted to 50mg, partially effective after 2 weeks

bulging veins in wrists and hands; Neck pain; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for patient (husband) that a 60-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient had no medical history. Concomitant medications included fluvoxamine (FLUVOXAMINE) taken for obsessive-compulsive disorder (Has been taking over 20 years); clonazepam (KLONOPIN) taken for obsessive-compulsive disorder, anxiety (Has been taking maybe about 5 years). On 18May2021, the patient experienced bulging veins in wrists and hands; while on 17May2021 neck pain. Patient was treated with Tylenol. Patient taking Pfizer COVID 19 vaccine because he wants his mask off. Consumer reported that patient know about his feet or legs, he was sleeping. She noticed his hands this morning. It was reported that patient had the neck pain last night and woke up with it this morning. Everything has now gone away. He took a Tylenol this morning. It was reported that vaccine scheduled around 10:30 am, was probably around 11:30am. History of all previous immunization with the Pfizer vaccine did not considered as suspect. Additional Vaccines was not administered on Same Date of the Pfizer Suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not had any illness at the time of vaccination. Patient did not had any family medical history. Patient did not performed any lab test. The outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested

Sharp chest pain, neck pain, difficult/painful breathing, emergency room trip, diagnosis of Pericarditis

A few days after his second dose he developed left neck, left arm, and left thigh pain. He described it as a burning pain and a poking pain. It felt exactly like his post-herpetic neuralgia from 2019 - which he developed after herpes zoster.

Severe shoulder pain vax site spreading to other shoulder. Numbness right side of face. Large swelling left shoulder below vaccination site.

Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet and back. Also pins and needle feeling. Started taking Advil and Benadryl. Helped a little. Moved to Advil and Zyrtec during the day. The intensity varies during the week. To a little sunburn feeling to more intense on other days. Been doing on for two months now.

Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore arm; started taking Ibuprofen throughout the day. Tuesday 6/15 experienced fever, chills, still aches and pains, headache.

Chest pain in heart region at night progressing to pain radiating down left arm and up left side of neck and slight nausea. Symptoms similar to beginning of heart attack, so went to emergency room for observation. No signs of heart attack were detected and emergency room doctor suggested follow up with heart specialist. Follow up also showed no heart attack occurred. Pericarditis not detected with stethoscope but was suspected. Pain in heart region was not severe, ~level 2, but was persistent. Heart doctor said that was not consistent with heart attack which tends to be severe but episodic. Slight pain noticeable in heart region for weeks afterward and still evident but now very slight. Not acute, but joint pain seems slightly increased after the vaccine.

Pain in the thighs and legs, in the lower part of the buttocks; Pain in the thighs and legs, in the lower part of the buttocks; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 10:00 (Lot Number: EN6207) as single dose for covid-19 immunization at the age of 60-year-old. The patient medical history and known allergies were none. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; verapamil taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in the thighs and legs, in the lower part of the buttocks on 20Mar2021 01:00 and resulted in visit to doctor/other health care professional (HCP) office. The outcome of the events was not recovered. Therapeutic measures for events included Prednisone. The patient further received second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Apr2021 11:15 (Lot Number: EW0179) as single dose for covid-19 immunisation. The patient underwent Covid Test post vaccination (polymerase chain reaction: Nasal Swab) which was negative on 07May2021.

1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.

Patient had a Non-STEMI MI on 6/24/21 with new onset A-Fib also. Pt arrived to ER from clinic with c/o chest and Left shoulder pain for 2weeks. Arrived to ER with HR in 150s that converted with IV Diltiazem. Pt showed s/s of MI with elevated Troponin. IV Heparin drip and IV Heparin bolus was given. Pt was transported by helicopter to hospital for further treatment and studies.

Elbow and ankle joint pain; Skin tenderness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6205) via an unspecified route of administration in the left arm on 07Mar2021 at 12:00 (at an age of 60-year-old) as a single dose for COVID-19 immunisation. The patients medical history included acid reflux, Chronic obstructive pulmonary disease (COPD), Kaposis sarcoma and unspecified allergies. The patient was allergic to nonsteroidal anti-inflammatory drug (NSAID). Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, has the patient was not tested for COVID-19. On 09Mar2021 at 09:00, the patient experienced elbow and ankle joint pain and skin tenderness. 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 elbow and ankle joint pain, skin tenderness was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tired, fatigued, no energy. Symptoms worsened. Started to experience bilateral numbness in both legs, gradually moving up into arms. 4/30-5/3 developed coordination issues,. Stated, "I wouldn't be able to pass a field sobriety test." Tripping, stumbling, dropping items. 5/3 had a CT scan of brain (did not show history of stroke) Early am on 5/4 fell and lost all movement on left side. MCA occlusion removed/stent placed/brain swelling worsened. Informed by neuro team that he was experiencing more brain swelling in 24 hours than a stroke victim had in 4 days.

Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wrist, hands; Infrequent headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm, on 19Mar2021 at 15:30 (at the age of 60-years-old) for COVID-19 immunisation. Medical history includes Barretts esophagus and crab allergy (seafood allergy). The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:00 patient experienced numb tingly fingers, upper body joints ache, neck, shoulders, elbows, wrists & hands, infrequent headaches. The patient described numb tingly fingers as worst. Therapeutic measures and treatment were not received as a result of 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 numbness in fingers and tingling (in fingers), joints ache and headache were not resolved. No follow-up attempts are needed. No further information is expected.

About 35 days later I woke up early morning about 4:30 a.m. with a sharp pain in my left underarm. I felt a lump about the size of a quarter in my left armpit. Contacted doctor's office and went to see the my primary care physician the following day who determined or believes I had a infection possibly of the glands and wanted to wait a week before doing anything. After 7:00 or 8 days the pain subsided and the lump was smaller. Today July 2nd 2021 the lump is gone down considerably and there is no more pain.

Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours

I started having pain in my lower back and shoulder. I had SOB. Pain in back that went up to my jaw. I went to the hospital. They did a cardiac work, came back negative for heart attack. The COVID-19 test came back negative. They did a chest CT scan to rule out PE. They show the I had COVID-19. I got swab the next for COVID-19, was negative. I still having SOB that is getting worse. They said I had a mild carditis.

Fatigue; Headache; Muscle pain; Nausea; Feeling unwell in general; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to CEFTIN. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within the 4 weeks prior to the COVID-19 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 25Mar2021 at 11:00, the patient experienced fatigue, headache, muscle pain, nausea and feeling unwell in general. 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 any treatment for the reported events. The clinical outcome of the fatigue, headache, muscle pain, nausea and feeling unwell in general were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.

Numbness in upper extremities and hands. Numbness and lack of power in hands and arms. Numbness and lack of power in legs oh my God I'm ready to get you medical testing laboratory results related to the

injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from a contactable other health care professional, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 19.00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) 20mg on every other day for an unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 19.00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 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 not received any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 15:00, the patient experienced injection site pain, fever, entire body joint and muscle pain. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care 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 events vaccination site pain, fever, body joint pain and muscle pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot. Thought I just pulled a muscle some how but the next day I sneezed and the pain was incredible.; I'm in severe pain.; cough; sneeze; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732, Expiration date: Not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 18:30 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes, asthma, glaucoma, tinnitus, Known Allergies: raw apples make my mouth itch. Concomitant medication(s) and received within 2 weeks of vaccination included solifenacin, losartan, tadalafil, atorvastatin. The patient had allergies with raw apples makes mouth itch. The patient had no other vaccine within four weeks. 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 filed this information in the initial report but got the vaccine on 26Mar2021 Friday and maybe 1-2 hours after that he thought he pulled a muscle somehow under his ribcage area and the next day on Saturday he still felt it but it was not a big deal. States then he sneezed while he was driving his car and almost crashed and the pain was incredible and was one of the most painful things he has had happen. States he couldn't believe this and then when he went home and bought Salon Pas which are those heat things that heat up and he is using so many of them but they are causing skin irritation. States he went to the emergency room on Monday but according to him people showed no interest and was not quite alarmed of the situation even though they do not know what is it specifically. His physician, prescribed him with the cough syrup because if he coughs or sneezes was when it really really hurts him and hurts more when he sneezes and oxycodone for the pain which he didn't took. He also mentioned that physician requested for a CAT Scan which didn't show anything on the results Normal. He is also scheduled for his second shot tomorrow. The adverse event resulted in emergency room/department or urgent care visit. The patient did not receive any treatment. Outcome of the event skin irritation was unknown, while that for other events was not recovered, at the time of this report. Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.

Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high degree of pain occurring one week after 2nd injection.

Extreme joint pain lasting; Chest painful with every breath; Could not sleep even; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included lung cancer and diabetes. The patient did not have allergies to medications, food, or other products. Concomitant medications included chemoradiation, metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. The patient had not received 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 11Mar2021 at 15:00, the patient experienced extreme joint pain which lasted for 15 hours. The patient also experienced chest pain with every breath and was not able to sleep with Tylenol PM, had to sit up in the chair for five hours, could not stand pain lying down and hence took 3 more Tylenol regular strength 4 hours after first dose. The chest pain then moved to neck area lasted rest of the day with Tylenol helped. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of joint pain, chest pain, sleep difficult and included treatment with TYLENOL. The clinical outcomes of the events joint pain, sleep difficult and chest pain was resolved in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.

After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a night, but took 2 and it did not. Told to take Benadryl by cardiologist, which helped sleep. Extreme stomach cramps, nausea, joint pain, sprained ankle flared up again, fatigue. Went to work, but had to leave early because of symptoms.

Shingles flank pain followed by typical left flank rash with resolution over 4 week time course. Neurasthesias resolved over 7 weeks

heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 02Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and seasonal allergies, and the patient was allergic to dyes, and a kind of antibiotic. Concomitant medications included bisoprolol celecoxib (CELEBREX), amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate (ADDERALL), esomeprazole magnesium (NEXIUM), and multivitamin (MANUFRATURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 at 03:00, the patient woke up with heavy wheezing and a lot of coughs. He had tried and breathed shallow to not cough. Coughing lasted about an and couldn't controlled it. He took an over-the-counter allergy pill that seemed to help after about 40 minutes. He had to call in sick to work because excessive movement would get coughing again. It was reported that, at 11:00 he was breathing better. His left side of back was hurting from all the coughing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. As the result of adverse events an unknown over-the-counter allergy pill was taken as therapeutic measure. The clinical outcome of the events wheezing, coughing and back pain were recovering. No follow-up attempts are needed. No further information is expected.

Pain started at the left shoulder and kept like traveling through the elbow to the side left to little finger and pounding of heart

Left wrist began to hurt and swell around mid April 2021. I went to Medical Office Building where it was discovered through ultra sound I had blood clots in my left wrist. I was immediately sent to the Advanced Care where I was told that I would not be able to go home and to call a family member because I had to remain for treatment which was an intravenous treatment then had to start immediate injections and medication. My wrist is in constant pain and I am unable to work due to the adverse reaction to the COVID 19 vaccine. Follow up appointment with Oncology 5/19/21, Follow up appointment with Primary Care Physician 6/17/21, US DVT Bilateral with Ultrasound-7/19/21

My left elbow swelling, collecting fluid.; collecting fluid.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient previously had no known allergies. Medical history included plaque psoriasis. Concomitant medications included secukinumab (COSENTYX) 150 mg/ml 2 pen from unknown date, for unknown indication. 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 24Mar2021 at 18:00 the patient experienced, left elbow swelling and collecting fluid (bursal fluid accumulation). It was unknown if the patient received any treatment for the reported adverse events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event elbow swelling and collecting fluid (bursal fluid accumulation) was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. gone in buttock on day 3, gone in hamstrings day 4, still slight in calves.; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2, lot number and expiration date unknown, at the Hospital, via an unspecified route of administration on 23Dec2020 at 11:45, at a single dose for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included psoriatic arthritis from an unknown date, for which patient took Enbrel 50 3 weeks prior to injection (in 2020). The patient had no known allergies. Concomitant medications included propranolol hydrochloride (INDERAL LA, 60 mg) and olmesartan medoxomil (BENICAR, 40 mg). In 26Dec2020 at 04:00, the patient experienced strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. Gone in buttock on day 3, gone in hamstrings day 4, still slight in calves. The event was reported as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering. Information on the lot/batch number has been requested.

tested positive for COVID-19; tested positive for COVID-19; Headache; feeling unwell; muscle pain; This is a spontaneous report from a contactable nurse reporting on himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:15 AM (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced mild side effects consisting of headache with feeling unwell and muscle pain. The patient reported this happened on 01Jan2021, and 02Jan2021 and on 03Jan2021 and later, the patient did not experience any side effect. Since the vaccination, the patient was tested for COVID-19 on 02Jan2021 with a Nasal Swab Rapid Test and tested positive for COVID-19. The adverse events resulted in Emergency room/department or urgent care visit. The patient did not receive any treatment for these events. The outcome of the events headache with feeling unwell and muscle pain and tested positive for COVID-19 was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.

Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day

Patient experienced weakness on lower legs post 3 hours of receiving COVID-19 first dose that lasted for a few minutes. The weakness subsided after 15 minutes of resting and only complaint of mild headache. Patient has a medical history of HTN and type II diabetes. The facility called 911 and the paramedics crew took patient with them to monitor the vital signs.

Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hours. Took 2 Tylenol. All symptoms gone after 30 hours.

5AM: TEMP 101.7, HEADACHE, CHILLS, LOWER BACK PAIN, LETHARGY. SYMPTOMS PROGRESSED THROUGOUT THE DAY. SYMPTOMS STARTED ABATING 1/8 TIME 2100. 5AM TOOK 2 EXTRA STRENGTH TYLENOL. 8AM- 2 EXCEDRIN. 1300 - 2 ADVIL; 1600- EXTRA STRENGTH TYLENOL. 01/0 0700 - 2 EXTRA STRENGTH TYLENOL FOR HEADACHE.

Right Brachial plexopathy. Began with right periscapular muscle spasms x 5 days followed by right arm paresthesias on day 6 followed by right wrist and hand weakness on day 7 of adverse event.

Some injection site soreness; Joint pain; Muscle aches; A little temporary nausea; This is a spontaneous report from a non-contactable consumer. A 61-years-old male patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number FL1284, via an unspecified route of administration on14Jan2021 09:00 at SINGLE DOSE for COVID-19 immunization. Vaccine location: Left arm Medical history included cardiovascular disorder, colitis ulcerative and depression. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), colecalciferol (D3), fluoxetine (FLUOXETINE), mesalamine (MESALAMINE), rosuvastatin calcium (ROSUVASTIN), ubidecarenone (COQ10 [UBIDECARENONE]). On 14Jan2021 19:00, patient experienced injection site soreness with outcome of recovered, joint pain with outcome of recovered, muscle aches with outcome of recovered and a little temporary nausea with outcome of recovered. The action taken was not applicable. No follow up attempts are possible. No further information is expected.

Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.

felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; achy arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team a Pfizer-sponsored program, Pfizer First Connect. A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization administered at the hospital. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number and expiration date unknown) on 22Dec2020. Relevant medical history included high blood pressure and diabetes; both were diagnosed in 2006 and ongoing conditions and were under control. Concomitant medications included metformin, lisinopril for high blood pressure, and semaglutide (OZEMPIC, injection), which was a once a week injection kind of like "Trulicity" that encourages his body to make more insulin. The patient said that when he got the second dose of the vaccine on 12Jan2021, he got an achy arm and it went away. At the time of the report on 18Jan2021, almost a week later, he felt like he got the vaccine in his arm again and it was going into his shoulder. The patient was asking if it was normal. He was driving at the time of the call. The patient had been a scrub technician (tech) and an endoscopy tech for 20 years. During the first surge, when they shut down the outpatient surgeries, he went and worked as an aide in the COVID ward. He was glad to get the shot. He did what his kids would do when they were young and would get a shot. He took ibuprofen. Later that evening for the achy arm, he took more ibuprofen. The achy arm lasted only a day. He thought he wasn't going to have any side effects at all. It felt like a flu shot. The patient clarified that at the time of the report (18Jan2021), his arm felt achy like it was the day he got the shot and the day after. He got the vaccine as he was in the first bunch in the city and he works in healthcare and the fact that he was over 60 years old. The patient stated he could live through it and he was just curious. The reporter assessed the events as non-serious. The events did not require any visit to an emergency room or a physician office. The patient had no relevant tests. Therapeutic measures were taken as a result of achy arm, which included ibuprofen. The patient recovered from the event "achy arm" on 13Jan2021, while the outcome of the event "felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after" was unknown. Information on the batch/lot number has been requested.

I have been have contact with my primary care doctor because of the reaction with the first dose. He advised me to take Benadryl 15 minutes before receiving the injection. I stayed at the vaccination site for an hour instead of 15 minutes. I left the vaccination site and went home and went to sleep, I worked over night. I did not sleep well that day. I got up around 6pm and I went to work at 10pm and I was extremely anxious and tired all night. I was a little confused while at work. I got off work and went to my chiropractor who noticed and my wife also noticed that I was extremely pale, after the appointment I went home and went back to bed. When I woke up I was still exhausted that I ended up calling out out of work that night. I went back to bed and slept all night till 9am this morning. The next morning my color was back and I was looking better. My energy level is slowing improving but still feel tired even when I got a good nights of sleep. I don't know if it related, but I went and brought some new shoes and then my hip started hurting. It is to the point where I set up a doctor's appointment on Monday to have my hip looked at. See VAERS report 906796 for first dose reaction.

Polyarthritis involving the proximal interphalangeal joints of the 5th and 4th fingers and distal joint of the 3rd finger of the left hand. Swollen and painful and still persisting.

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. 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.

Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy

Patient stated that they had quite a bit of pain in his shoulder, had some bruising that spread down his arm, and what looked like red blood vessels visible on his right shoulder. He had no pain for the first injection. This occurred about a month ago, but the patient is still experiencing intermittent pain/soreness on and off.

the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.

Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 days beginning approximately 48 hours after first shot; almost constant Fever; Body Aches; Strong lower back and hip pain; Bilateral pedal edema; dehydration; inability to absorb fluids for 5 days; arm, ankle, hip, back, shoulder, and wrist joint pain; difficulty getting out of bed in the morning, or getting up from the stationary position. Symptoms finally resolved day 7 just before I anticipated going to ED in local hospital, and were gone for two days. Symptoms returned on day 9 following vaccination and lasted 5 additional days, with symptoms resolving for good only on the 15th day after the initial injection.

Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and intermittent chills)

I had a severe case of COVID in October, with over 4 weeks in hospital. After first dose, I experience severe muscle and joint pain for 3 days

Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore. Mind somewhat clouded. Modest temperature, 101. Chills. Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad. Very minor nose congestion and sore throat. Symptoms all ended by 36 hours after 2nd shot

Shoulder Pain starting 48+ hours after injection. Initial arm soreness went away in less than 24hours. At time of injection the shot was given high on my shoulder and sent pain through my back an up my neck. The shot was administered into my shoulder not my muscle This is problem from the injection not the vaccine. SIRVA type injury

After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took a shower, and when he went to wash under his armpit was very swollen, and very tender. He put some ice on it which did not help the swelling. It bothers him when his T-shirt touches the area, so he tried to wear a regular shirt. He also had achy pain in his back, weakness in his arms, sore throat and a little cough, no fever. The armpit still hurts and is still swollen. Other than the ice he did not take anything else as he takes a lot of medications as it is. He has not called his doctor because it happened over the weekend, but is going to call her today. He did have a COVID test yesterday drive through facility at the community hospital as he has a surgery coming up, and they were going to call him if it was positive. He is scheduled for surgery on his right knee on Thursday.

Very tender area around injection site developed on second day and resolved about 36 hours later. Noticeable joint pain developed after 24 hours in shoulders, knees and hips. This resolved about 24 hours later. One instance of "Covid toe" developed on the small toe of my right foot about 48 hours after the vaccine. This has not yet resolved.

This came on gradually over a period of about 5 hours: headache, aching in the joints, abdominal cramping, lethargy.

Chilling, shivering, muscle and joint ache, fatigue for about 24 hours, then tapered off. Lymph node under left arm swelled and pain for about a week.

significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced "significant redness" and swelling at injection site with minimal pain. He described it as "Out of proportion to what should be expected". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events "swelling and redness at the injection site with minimal pain" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the product. 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.

45 minutes after injection slight lip swelling and swelling in left cheek hei 's and years took 20 Tech and histamine and symptoms subsided in a few hours. *Important, 30 hours after injection the following night at 11:00 p.m. began to experience pronounced generalized Fasciculations - Similar to those I experienced After receiving the 3rd of 5 doses of the rabies vaccine in 2008. Strong , generalized muscular Fasciculations are now persisting 7 weeks after receiving the 1st dose of the Pfizer Covid vaccine.

Client stated after receiving his vaccine he had shoulder pain leading from the injection site. Vital signs O2 sat 99%, BP 137/71, HR 78.

Gout in my left foot at the base of the big toe has flared up. Some swelling and redness in the area, was warm to the touch when it started. Significant pain and lack of flexibility in the joint. Has persisted for four days.

migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive

Fever within 12 hours reached 102.5. Within 18 hours, fever subsided to near normal levels. Severe chills. Ongoing fatigue and muscle soreness and stiffness. Still mild fever after 30 hours.

immediately after vaccination, patient developed arm numbness and weakness. he was monitored at vaccine site x15-20 min and was sent home. when he arrived home about 35-40 minutes after vaccination, that sensation traveled throughout his body. he described feeling weak all over, had lightheadedness, and tingling on his lips and tongue.

Patient started with pain in his lower back thought it was muscle spasm .Kept working with the pain rash started still didn?t think anything about it March 29 he went to family doctor said it was a muscle spasm gave him muscle pills March 29 he was taken to the emergency room in excruciating pain emergency room doctor did test bloodwork CT scan urine sample came back that he has shingles he has the rash. His wife also had the same shot and she also has rash on her side no pain.Do not know if this has anything to do with the shots but wanted to report us because he never had it before he got the shot or neither did she

Injection site is sore, my body feel achy. 101.2 temp. It is down to 99.6 at 2:00 pm My joints feel like a dull pain.

On my first visit on 3/4/21 I was given the Moderna lot number 025A21A......When I went in for my second series on 3/29/21 I was given PFIZER lot number ER8732. Prior to getting this second shot I had been verified several times and my wife was there at the same time at the same table also getting her second shot. When I went to sit and wait the 15 minutes, a representative came to me and ask to speak in privacy. She advised me that there had been a mistake and you were given PFIZER not MODERNA. I need your card to mark it right. I advised her that I was extremely upset and confused since all of this is so new.....I then asked her if this had ever happened before here and she advised me yes it has happened to a total of 3 people. i was shocked to hear this...i am experiencing left buttocks and left leg discomfort.....After my first shot I had NO side effects......Am I worried, yes.

Low grade fever, headache, joint pain began about 28-24 hours after injection and lasted for about 18 hours and resolved.

Tinnitus in left ear. Soft high-frequency crickets when my throat gets stressed, including hiccups, burping, stretching, sometimes yawning, muscle tensing, sometimes swallowing, stretching to wake up in the morning. Last for the duration of the stress, a few seconds. Left eustachian tube slightly sore, slight earache. Has gone on for almost a week now. Best guess is nerve is pressured or damaged? Will try hydroxide in ear next, in hope it kills whatever's going on. Whether this will go away or not is unknown at present.

sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medications included losartan (LOSARTAN)m colecalciferol (VITAMIN D), vitamin b complex (VITAMIN B-COMPLEX) and magnesium (MAGNESIUM) all taken for unspecified dates and indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive the vaccine on 18Mar2021 and he was okay on Friday. By Saturday morning (20Mar2021 9:30), he felt pain in upper left buttocks like someone sticking with knife followed by muscle contractions in same area that would repeat 2 to three times but was intermittent for 4 hours. He felt ok with no symptoms rest of Saturday. Then on Sunday morning around 4 a.m., the same feeling came back and lasted until Sunday noon (21Mar2021). Then, his whole-body muscle aches that lasted whole Sunday along with headache. On 22Mar2021 (Monday), the patient had still intense whole-body muscle aches all day headache but no buttocks contractions. By night, he slight fever took paracetamol (TYLENOL) and also had sweat fever. By Tuesday morning, the patient still had faint muscle aches slight headache. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient did not receive treatment for the events of pain in upper left buttocks like someone sticking with knife followed by muscle contractions, whole-body muscle aches, headache and sweat fever. The patient was recovering from the events and was feeling much better No follow-up attempts are possible. No further information is expected.

by Sunday afternoon my left shoulder was in agony. On a scale of 1 to 10 probably a 9. This lasted until the middle of the night Tuesday/Wednesday when the pain went almost entirely away.

tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me. I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue

Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain

Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.

Lower back pain and stiffness. Pain in left hip. Pain has been continuous for 8 days following second shot.

After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours. Then it went away with mild fatigue for a couple days.

Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 hrs after vaccine administered). Arm pain lasted a day, fatigue about 12-18 hours.

He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down. He has thrown up 3 times. His bones are aching and light headed. He has not taken anything for the reaction, just trying to stay hydrated, very little appetite. Does have an appointment to see his doctor today at 4:20 PM.

Bells palsey on left side. Had stiff neck several days before with first shot and more with second shot that escalated to bells palsey.

Joint pains. 1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint. 3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior

Headache, body aches, joint aches, fatigue . Majority of pain subsided within 24 hours, fatigue and a mild headache with mild sinus congestion persisted for about 48 hours. Fully subsided within 3 days.

found a deep blood clot.; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 61-years of age), dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 12:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included blood clot after a back fusion about 16 years ago (2005), and had a knee replacement 3 months before the vaccine (Dec2020). The patient's concomitant medications were not reported. The patient previously took ANCEF [cefazolin sodium] and had allergies; and oxacillin which the patient had allergies and hepatitis. The patient was not diagnosed with Covid prior to vaccination nor was he tested for covid since vaccination. The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. It was reported that the day the patient received the first vaccine his calf, foot, and knee swelled up by evening. It stayed swollen for a week and he went to see his doctor. He did an ultrasound on his calf and found a deep blood clot. He was now on blood thinners. He mentioned that he had a knee replacement 3 months before the vaccine but it was progressing fine. Usually blood clots occur after surgery within a 2 week period. He had a blood clot after a back fusion about 16 years ago. He was reporting this because his doctor was not sure why he got the blood clot and it coincided with the vaccine. The patient underwent lab tests and procedures which included ultrasound scan: found a deep blood clot in Mar2021. The events started on 17Mar2021 18:30 with outcome of recovering. The events resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events with LOVANOX and PRADAXA. Follow-up attempts are completed. No further information is expected.

About 12 hours after the vaccine (2nd dose) I developed fever, chills, teeth chattering (rigors), sweats, muscle aches and dry cough. Other symptoms have resolved after 2 days - but some muscle ache persists - along with a dry, non-productive cough (worsened upon deep inspiration). Although my overall sense of well being has improved over the few days since vaccination, the cough is persists and not improving.

Started the day after the second injection. Feeling very tired, most of the day. Fall asleep on my couch. Flu like muscular pain in back and legs. Sometimes my legs feel very weak. I will call my Doctor if I am not feeling better by tomorrow the 20th of April.

Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nausea or vomiting Diarrhea

I DEVELOPED RED BLOTCHY SORES / ITCH/ 2 ON LEFT LEG/1 ON RIGHT LEG/ AFTER MORE THAN A WEEK WITH NO RELIEF, I VISITED URGENT CARE (03/29/21) / DR DIAGNOSED WITH SHINGLES. I ALSO EXPERIENCED UNEXPLAINED BACK PAIN WHICH WAS EXPLAINED TO POSSIBLY BE SHINGLES ALSO. TREATED WIT VALACYCLOVIR HCL 1 GM TABLETS FOR 10 DAYS. SORES ARE NOW DRY BUT STILL ITCHY. NOTE: I WAS VACCINATED AGAINST SHINGLES AT THE END OF 2020 ( 2 SHOT DOSE) I HAVE NOT SOUGHT FURTHER MEDICAL ATTENTION AS OF THIS DATE.

Starting 3-4 days after injection, began to have increasing pain in buttocks. Pain became more severe, spread to hips, then to knees/quadriceps over next 3 days - during this time, pain was relieved with Tylenol for 2-3 hours, then the pain would "break through" the Tylenol. Three days after onset pain was unbearable and consistent for 2-3 days. The pain slowly subsided over next 3 days without intervention. Morphine and Valium was required to manage pain in ER.

left knee started to ache/ bend my left knee fully without it paining.; Swelling/swelled up; was not able to bend the knee/cannot bend my left knee fully without it paining; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm as single dose for covid-19 immunisation, dose 1 on 28Feb2021 13:45 (Lot number EN6198), dose 2 on 21Mar2021 14:00 (Lot Number: EP-7534). Medical history included allergic to shell fish and pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 1st dose (outside the normal side effects), his left knee started to ache, swelled up and he was not able to bend the knee. Did not effect his right knee. The patient took Ibuprofen and iced to reduce swelling. The ache reduced but was still persistent. After the 2nd shot the situation worsened a bit and was still there. The patient could not bend his left knee fully without it paining. No treatment was received for the adverse event after second dose. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain. I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.

Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.

Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.

Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis. Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER). On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix. Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known. The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.

On 4/14/2021 patient developed pain in left shoulder blade with numbness in the front of chest and under left arm and biceps, and broke out rash on Sunday 4/18/2021 and on Monday, 4/19/2021 he developed blisters and he went to Urgent care and was diagnosed with Shingles. He received a prescription for the rash, (Valacyclovir TID x 7 days), but he used Calamine lotion and applied that to the rash which improved. . Went to see his health care provider a week later on 4/26/2021. and received pain medication Tramadol, which was very helpful with reducing the pain. He was advised to get the 2nd dose of Pfizer vaccine on 4/29/2021. As of this date no complaints. He was encouraged to use V-Safe and he is being followed by them at this time.

He is complaining of rhinorrhea, nasal congestion and a dry cough. He denies any fevers or chills. Patient said that he felt off yesterday. Since getting up today patient has felt more short of breath on exertion. He feels like he is breathing heavy. He is denying any chest pain or pressure. Patient did feel some pain behind his left knee over the last week, but has none at this time. He is also felt some mild right ankle discomfort, but that has resolved as well. He denies any recent COVID-19 exposures. Treated with heparin and catheter directed alteplase

Vaccine injected into right arm too high/too forceful. High level of pain at time of injection in shoulder. Experienced patient in receiving injections, Dr. did not properly identify location markers. Shoulder pain (not arm) still exists. Dr (who administered vaccine) needs to measure twice before injecting.

The second dose of the vaccine triggered a moderately severe RA flare lasting from 28 April to 29 April. Significant flu-like full-body joint pain, moderate fever (100.5 F against a normal base of 97.3), and light nausea. Joint pain continues as is usual for such flares, since some light damage likely occurred in my joints. I was unable to take NSAID or Prednisone (as I normally would for a flare) due to the vaccine. Acetaminophen taken but ineffective. NOTE: My RA is being treated with Rituximab, two doses every 4 months. Next dose scheduled 11 May 2021. Prior dose completed 12 January 2021.

Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions. Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib). Pain came on 5-10 minute intervals for 4 hours. Day 4 was at a hotel in another city. Pain was gone by Day 5. Neck was sore throughout the 5 days post vaccine.

fatigue; myalgias; Mild nasal congestion; Headache; This is a spontaneous report was received from a contactable physician (patient). A 61-years-old male patient received 2nd dose bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient medical history included BPH. The patient had received unspecified concomitant medications. The patient had no history of allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 in right arm on 18Dec2021 at 8:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications the patient received within 2 weeks of vaccination. On 09Jan2021 at 11:00, 28 hours after injection, the patient developed fatigue, then myalgias, lasted about 44 hours, mild nasal congestion, and headache briefly. The patient did not take treatment for the adverse events. The outcome of the fatigue and myalgia was recovered on 11Jan2021 while for the events headache and mild nasal congestion was recovered on an unspecified date in Jan2021. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

lower back pain for last 2 weeks since taking vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 06May2021 at 14:00 (Lot Number: er8736) as single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy and barretts esophagus. The patient did not received 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. Known allergies was none. Concomitant medication was reported as: The patient received the list of any other medications within 2 weeks of vaccination. On 11May2021, the patient experienced lower back pain for last 2 weeks since taking vaccine. The patient aware of no other activity or event that would be a cause. No treatment received. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extremities, joints, ankles, wrists, knees, neck pain, high fevers and intermittent sweating. Something that triggered me and that I had never suffered before was ALLERGIES TO POLLEN. Today a week later I still feel sick from it. A lot of headache, runny nose, and sneezing. I assume they are allergies to pollen because I took some pills for that {CLARITIN} and I calm down and we feel them a bit, however I do not take it off.

Pain at inject site; Myalgia at the injection site; This is a spontaneous report from a contactable physician (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at 09:30AM as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient did not receive other vaccinations with 4 weeks of COVID-19 vaccine. The patient did not undergo any lab test. On 09Jan2021, the patient experienced injection site pain and myalgia for three days. The patient did not require a visit to physician or ER (emergency room). The outcome of the event was resolved on 12Jan2021. The reporter assessed the events injection site pain and myalgia as related. Follow-up attempts are completed. No further information is expected.

He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine. He also has had numbness in his hands. He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing. He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him. He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe. He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil. They told him to take Advil. The cardiologist has not given him any results yet. He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.

I had a flare up of Gout; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6198) via an unspecified route of administration on 03Mar2021 at 02:45 on left arm, single dose for COVID-19 immunization. The patient's medical history included gout immediately following surgery on her foot 5 years ago. It was reported that the patient did not receive any other vaccine in four weeks, he did not have covid prior to the vaccination, he did not test for covid post vaccination and had no allergies. The concomitant medication of the patient included pravastatin taken for an unspecified indication, start and stop date were not reported. The historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on 03Feb2021 at 10:15 AM on left arm as 1st dose, single dose for COVID-19 immunization. On 04Mar2021 at 1800 hours, one day after second dose of vaccination the patient experienced a flare up of gout. No treatment was received for the event.The outcome of event was reported as recovering. No follow-up attempts were possible; information about lot/batch number could not be obtained.

Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.

First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.

I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.

Sudden onset of right upper back pain with radicular symptoms radiating to right pinky on afternoon of 3/5/2021. Discovery of right pinky weakness in extension and abduction with EMG confirmation of Parsonage Turner Syndrome on 6/8/2021

Joint pain in thumbs, with limited bending and pain when bending thumb to grasp or even shake hands. Taking Ibuprofen and Asa po prn

A VERY, VERY minor neck ache started the day after my 2nd Pfizer injection (4/30/21), on right side of neck, below right ear. Ache continued to get worse VERY slowly on almost a daily basis. About 2 weeks after that 2nd injection, my neck started popping/cracking when I moved it around. Pain continuing to get worse (but very slowly). On 6/10/21, (with pain continuing to slowly get worse, but at a pretty high level by now) I finally went to see a doctor. He checked for serious conditions and concluded it wasn't anything 'serious' and suggested a few sessions of physical therapy. The earliest I could get physical therapy would be almost 2 months away, so I have not had physical therapy yet. On 6/11/21 I took an Ibuprofen and played racquetball. The neck pain was completely gone for about 11 hours and then slowly came back. I have been taking 2 Ibuprofens a day since then and even if I don't take an Ibuprofen for a day the neck pain seems to be easing. It feels like it may be slowly getting better, although there is still some pain and cracking/popping when I move my neck.

Irritation of joints on same arm as injection: elbow, wrist and middle finger. No signs of irritation in shoulder of this arm or other parts of the body. Irritation is constant and ongoing, without decrease since its onset. This irritation leads to limitations on use of the arm for weighty objects (5 pounds or more) and any major pressure down onto the arm.

arm discomfort; This is a spontaneous report received from a contactable consumer (patients' wife). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151; Expiration Date: 01Jan1900), via an intramuscular route of administration, administered in Arm Left (non-dominant, upper arm, closer to shoulder) on 09Apr2021 (at the age of 61-year-old), as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (onset of symptom occurring after the first dose), the patient experienced arm discomfort and the reporter stated that the symptom seemed to have gone away 24 hours after the first dose and her husband did not take any medication to treat this symptom. There is no product complaint associated with this case. The outcome of the event arm discomfort was resolved on 10Apr2021.

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

shoulder muscle pain that has not resolved I did two weeks of tylenol as prescribed by my doctor to no avail It is difficult to lift my arm out from my side which is paunful and makes it difficult to lift items at my work (farming) there is a knot in the shoulder muscle(s) first dose March 10, 2021 second dose April 8, 2021

I developed tinnitus in left ankle, right wrist and right shoulder with rupture of two tendons in my right shoulder. Which lead to surgery 06/18/2021.

Presented to ED on 6/21 w/ left knee pain. Doppler demonstrated DVT in left gastrocnemius veins. Discharged from ED on apixaban and to f/u with PCP.

Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. 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 event extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.

began having some neck tightness. I figured it was a side effect. It continued on and got noticeably worse. When walking I noticed if i increased my stride the tightening would get worse. This continued on until 6/5 when I went to the emergency room. My heart enzymes were increasing, indicating that I was in pre-heart attack. I had 3 stents put in on 6/7 into what was a perfectly healthy artery as of 9/13/2019.

Barely able to walk; Pain in both knees; Both knees swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 61-year-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0151)via an unspecified route of administration, administered in Left arm on 06May2021 at 08:30 (at the age of 61-year-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included high triglycerides, mild arthritis in back. The patient had no allergies. Since the vaccination, the patient has not been tested for COVID-19.Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS), vitamin D nos. On 13May2021,the patient experienced pain in both knees. Both knees swollen. Barely able to walk, gotten better but had to take ibuprofen for pain and am taking glucosamine sulfate. The patient was not tested positive post vaccination. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0165)via an unspecified route of administration, administered in Left arm on 27May2021 at 08:30 (at the age of 61-year-old) as Dose 2,Single for COVID-19 immunization. No treatment mentioned for all the events. The patient reported gotten better but has to take ibuprofen for pain and am taking glucosamine sulfate. The outcome of the events was not recovered/not resolved.

It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; Pain in arm; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533), via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications of the patient included atorvastatin (MANUFACTURER UNKNOWN) 20 mg and acetylsalicylic acid (ASPIRIN) low dose for unknown indication from an unknown date. The patient did not have allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced pain in arm, loss of strength, pulled muscle, pain upon movement. The patient reported pain in the left arm which persisted until the day. It felt like he had pulled a muscle and noticed pain in movement and lack of strength and felt like someone had repeatedly punched his upper arm. The pain was persisted for 6 days so far. The patient did not receive 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 pain in arm, loss of strength, pulled muscle, pain upon movement was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.

Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The 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 medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep. The adverse events did not result in a visit to the doctors 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 the events dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.

This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, aortic valve replacement and allergy to statins. Concomitant medications include metoprolol (MANUFACTURER UNKNOWN), desipramine (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), ezetimibe (MANUFACTURER UNKNOWN) and acetyl salicylic acid (ASPRIN). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. 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 01Apr2021 at 15:00, the patient experienced severe headache, muscle aches, chills, sweats and fatigue. 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 any treatment for the events. The clinical outcome of events severe headache, muscle aches, chills, sweats and fatigue were resolving at the time of report. No follow-up attempts are needed. No further information is expected.

Did well with first shot. Second shot was okay, pain and tenderness in shoulder. Did not worry about it at first, figured it was vaccine related. 2 weeks later i was still having issues, noted weakness when reaching up and out to pick up things. Got to point I was reaching across body with right arm/hand. 2+ months later still having issues reaching for medicine in medicine cabinet, keys in closet, soap dispenser at work. Got to point i was dropping things. Thinking i somehow unknowingly injured myself and needing to get better quickly (ice, heat, Tylenol, limited use was not working), went to orthopedic 7/19/21.

first dose: upper right arm muscle was very sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FW0171, Expiration date was not reported), dose 1 intramuscularly, administered in upper right arm muscle on 29Apr2021 (age at vaccination 61 years) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced first dose: upper right arm muscle was very sore on 06May2021. He was unable to get second dose as scheduled today on 20May2021. Reporter stated, when he got the shot, he was fine except for his arm, right arm. they gave it to him in his upper right arm muscle and it was very sore for a week. his wife got the same shot on the same day right after him and she had no symptoms whatsoever. Caller asking does he have a time frame, today is two weeks, that he had the first shot. It was also reported that caller confirms he received his first dose of the Pfizer Covid vaccine on 06May2021 at 1555 and it began hurting later that afternoon towards the evening. Caller states he has an appointment today at 1555. Caller states he's going to try to call and try to get it for Sunday, he just needs to know if that's going to change the potency of the shot. The outcome of upper right arm muscle was very sore was recovered on 13May2021, missed dose outcome was unknown. Follow-up attempts are completed. No further information is expected.

My upper arm at the area of vaccine site has been sore, throbbing aching with mild pain. Its bearable but not normal and comfortable. I had a scan of my upper are near the shot and they say that my veins look clear. But it don't feel its my vein. It feels like my nerve muscle tissue has been irritated. Something don't feel right

Kind of tired after first shot; Stomach was kind of irritated; Back hurts a little bit more; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 12May2021 (age at vaccination: 61 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pain pump which was removed on an unknown date in 2015 at hospital. It was 16.5mg per day plus outside medicine. They were supposed to remove pain pump, but they let it run dry, he was regurgitating for 5 days, every 30 minutes. They got the pump out because he started getting tremors, and that's what gave him the memory loss. It was helping the pain quite a bit that's the only thing it was doing in the back. When they took the pump out, they left a piece of the catheter in one of the discs, he could feel that more than ever. They had him in like an outpatient for people that abuse drugs, he was just there to get the pump out. The patient had dementia, but he was surprised that he can remember his address and driver's license; that his memory is coming back quite a bit. Surgery on shoulder, fell right on that shoulder a week after surgery on shoulder, allergic to about 15 different medicines mostly the heavier ones like the muscle relaxants, 100 percent disabled, had 8 ulcers, stomach sometimes flares and back pain. Some of the shots he had from pain management were like epidural. The patient's concomitant medications were not reported. On an unknown date in May2021, the patient experienced kind of tired after first shot, stomach was kind of irritated and back hurts a little bit more. He didn't have blood work. He said he would have to terminate pain management if he was not comfortable with this. The patient said that he was unsure if this was related to the shot. It might not have been the shot. The kind of tiredness was more the issue because he already has back problems before, has a compression, broke. The outcome of the events was unknown. Information on the lot/batch number has been requested.

knee pain; This is a spontaneous report from a contactable physician (patient). This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK5730), via an unspecified route of administration, on 20Dec2020 at 07:15 AM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. No other vaccine was received in four or two weeks. Medical history was unknown. Concomitant medications were none. Th patient developed left (L) knee pain (7/10) on 23Dec2020 which has not yet resolved as of 28Dec2020. No treatment was administered for the event.

Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM. Since morning no additional symptoms including no tiredness/lethargy. I currently feel completely normal. Last dose of naproxen was at 6:00 AM and no symptoms since. Currently 1:45 PM.

Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again. I had no reaction to 1st dose.

Patient stated his arm from his elbow to his shoulder was warm for 1 hour. He also stated he was achy and he had joint aches more then usual.

Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. Lasted until about 2am. Anxious because concern about being cardiac. Next day very tired and headache.

On Jan 12th developed sever left upper abdominal pain or left lower rib pain. After Ct scans left lower lung atelectisis and splenomeglia . Also enlarged Lymphnodes in the Mesentergic areas.

On January 18, 2021, I experienced extreme weakness of both legs to the extent that I was unable to stand. I experienced an exacerbation of baseline numbness over many areas of my body. I had an elevated resting heart rate of over 108 bpm. I was transported by ambulance to that afternoon. I was admitted in the early morning hours of January 19, 2021. I was diagnosed with, "Exacerbation of multiple sclerosis; SIRS (systematic inflammatory response syndrome). I was given multiple intravenous antibiotics. I had a CAT scan. I had a chest x-ray. I had many blood tests. The adverse event resolved on its own. I was discharged January 16, 2021.

Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pain, fever, nausea. Rough night and still had symptoms all day Sat 1/23/21. By Sunday morning only headache remained, mild compared to day before. Now Monday, and still have light headache and tired.

fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch

1/25/2021- Presented to ED with chest pain which radiated up his right shoulder, right armpit and across his chest. The EKG showed a STEMI [acute inferior]. He was transferred to other Hospital.

Generalized muscle aches; lethargy; This is a spontaneous report from a contactable physician. A 62-year-old male patient received first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the left arm, on 18Dec2020 12:45 at a SINGLE DOSE for covid-19 immunization. Medical history included hypertension (HTN). 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 hasn't been tested for COVID-19. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCT), amlodipine and aripiprazole (ABILIFY). On 19Dec2020, the patient experienced generalized muscle aches and lethargy. The outcome of events was not recovered. Therapeutic measures were taken as a result of events included OTC motrin and Tylenol. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5             Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.

Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done

muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. 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. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.

Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well

woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events. The outcome of the events was recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21. PT did not knowingly have COVID prior.

After my vaccine, experienced Covid-19 symptoms for ten days. I was exhausted, had a small fever, had muscle aches, headaches and extreme fatigue. I was in bed for seven days. I had a Covid test performed which was negative.

Since the injection, I've had ongoing tingling and weakness in my arm. Unable to open a jar with my hands, which I could do previously. I feel a bit off and this has been going on since I received the shot 2 weeks ago. Concerned about getting the second dose, which is due 3/15 - I don't want these symptoms to worsen and need guidance.

64-year-old male with a history of hypertension, melanoma, vasovagal events from previous needles presenting to the emergency department today for vasovagal episode. Patient was across the street receiving his first dose of Covid vaccine. At that time patient had a syncopal episode. According to EMS they indicate that nursing there was unable to feel pulse and began CPR. They did multiple rounds of compressions and patient woke up. They are bringing patient in today for further evaluation of syncope versus cardiac arrest. Patient does endorse that he has chest wall pain from where they were doing compressions.

Severe pain in lower right back, will last 1-2 hours as pain subsides, dry heaves begin. This has happened on 3/8, 3/9 and 3/10.

Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.

Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during night 2nd time (5 am). Fell once. In the morning (about 7:30) I noticed a rash all over his trunk (small pink spots) As the result of the falls, he hit chin and cut it. Hit left temple and bruised it. Back is very sore and painful. May have cracked rib(s). Currently 2:20 pm on March 14. He is no longer experiencing the dizziness. The rash seems to be clearing up (brownish spots instead of pink spots on trunk). He's resting.

Yesterday evening he was lifting some boxes and moving them to the right and started to experience left-sided upper chest pain. It is described as "tightness" and is constant, radiating to the shoulder with movement. He denies cough, fever or shortness of breath. Ibuprofen taken this AM has helped and over the past couple hours the pain has resolved completely. No recent prolonged travel

Second COVID vaccine received 01/06/21. Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea. Duration 8 hours, clinical dehydration, missed one night ED shift(HCP). 5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21. Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional. 02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo. 03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis. Continue high dose aspirin, colchicine, metoprolol, flecanide. Have not returned to work.

PT PRESENTED TO ER 3/12/21 FOR COMPLIANT OF 3 DAYS WORTH OF SHOULDER PAIN. PT RECEIVED COVID VACCINE 10 DAYS PRIOR AT VACCINE FACILITY. PT STATES PAIN IS MADE WORSE BY FLEXING HIS SHOULDER, MOVING HIS SHOULDER IN ANY WAY AND HAS ELBOW PAIN AS WELL.PT WAS ADMITTED TO HOSPITAL FOR CARDIAC MONITORING. PT WAS SCHEDULED TO HAVE SECOND DOSE OF VACCINE 3/24/21 BUT WAS STILL HOSPITALIZED SO DID NOT RECEIVE. SECOND DOSE.

Headache; Muscle and body aches; Muscle and body aches; This is a spontaneous report received from contactable consumer, the patient. A 62-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EL3247expiry not provided) as a single dose via unspecified route in the left arm on 19Feb2021 at 12:00 (at 62-years-old) for COVID-19 immunisation. The patient reported no medical history and denied any allergies to medications, foods or other products. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (lot EL3247) in the left arm on 29Jan2021 at 12:30 (at 62-years-old). The patient denied receiving any other vaccination within four weeks prior to the COVID vaccine. The patient also denied being diagnosed with COVID prior to the vaccination. On 21Feb2021 at 08:00 the patient began to experience headache and muscle and body aches. The patient denied being tested for COVID since being vaccinated. There was no treatment received. The outcome of the events, headache and muscle and body aches was recovered on an unspecified date in Feb2021.

Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus." Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.

Patient experienced severe arm pain in his shoulder at 8:00am. Blood pressure at 8:00am was 151/80 (normal for patient) and heart rate was 79 beats per minute. At 8:15am pain was radiating down the patient's arm. At 8:40am the patient was feeling better and felt comfortable leaving with his wife because she is a nurse

Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder. started on 6th day with max pain on 8th/9th day. pain subsiding on day 10. treated with Advil/Acetaminophen Dual-Action and lidocaine medicated rub.

A few minutes after receiving the vaccine felt tongue "thickness" but only lasted about a minute. Then about 4 hrs later felt headache, dry throat and sore arm. At about 7 hrs after injection noticed pain in the left wrist, same side as vaccine. Went to bed and all symtoms were resolved this morning except sore arm.

Pt. has a swollen spot under his left arm pit the size of a small apple, and it is sore to touch, and feels like an achy muscle. This was noticeable after the second injection of the Pfizer vaccine.

sore muscles. arthritis flare up Gout in my foot swelled up like a balloon (extremely painful). all symptoms are receding as of 4/2/2021 8:30

Considerable pain developed at injection site 6 hours after injection, then extended to pain in neck and lower back. All persisting 10 hours later, but possibly starting to fade. About 10 hours after injection, faint nausea noted for about 2 hours. No treatment sought or administered. Patient is doing physical activity and excercise, and symptoms seem to be fading.

Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to the left and couldn?t raise my arm. Had both shots in the left arm. Still have slight pain in those areas.

Headache first day, headache & fatigue second day, headache, severe fatigue, muscle aches, nausea and diarrhea third day, fatigue and slight headaches Fourth day, mild fatigue fifth day.

About 10 days after the injection, I experienced severe joint swelling and pain in my shoulders, neck, wrists, hands, hips and knees. The knee and hip pain made walking difficult. My doctor ordered blood work that showed my CRP marker at 57.6 and she diagnosed polymyagia rheumatica. I am on a six day regimen of prednisone. Swelling and pain have decreased.

Fever and chills 36-48 hours after the second vaccination. Sore arm, sore muscles and fatigue 6 days later.

Delirious fever; temperature was high enough to where he got delirious; Headache; Muscle aches; he was just tired a little early; Swollen joints, possibly hands, knuckles, arms, shoulders; This is a spontaneous report from a contactable consumer. A 62 years old male consumer reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8733), via an unspecified route of administration, on 26Mar2021 at 12:00 in Arm Left (at the age of 62-years-old) as single dose for covid-19 immunisation. The first dose of bnt162b2 was received on 05Mar2021 (Lot: EN6205). Medical history included diabetes mellitus, hypertension from, gastrooesophageal reflux disease from 1977, sleep apnoea syndrome from 2000, pain from 2017, blood cholesterol increased from 2013, vitamin D deficiency from 2013, depression from 2000. Concomitant medications included glipizide for diabetes mellitus; lisinopril started about 1982 or 1983 for high blood pressure; metformin hcl for diabetes mellitus; terazosin hydrochloride from 1987 prescribed for Benign hyperplasia of prostate (BPH) but it turned out to be something else, but he still takes this medication because it helps with his urination; famotidine for acid reflux; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy; oxycodone for pain from 2017; VITAMIN B12 for vitamin deficiency from 2016; calcium citrate from 2019 for blood in his urine; fish oil for blood cholesterol from 2013; colecalciferol (VITAMIN D3) from 2013; ketamine hcl for depression, and CANNABIS he used it recreationally and probably medicinally too because it helps him sleep. He is not a daytime stoner, he just uses it at night to relax and go to sleep. He started about 2009, when he got a medical card. Caller reported had his vaccine shot at noon on 26Mar2021. He stated he felt fine, he was just tired a little early and went to bed at 10. He woke up at midnight with a headache and a delirious fever. He didn't test his temperature or anything but it was high enough to where he got delirious, but he doesn't know how high that was. He took Tylenol 2500mg capsules which helped with the headache and not the fever, so 4 hours later, he took Ibuprofen 800 mg which seemed to helped with the fever. He stated the headache is gone. Caller stated delirious feverish was gone but then clarifies he doesn't know if he has recovered completely actually, it feels like he has, but these things are funny sometimes. Caller reported muscle aches started around midnight on 26Mar2021, and were gone by 27Mar2021. Further Caller reported he had swollen joints- his hands, knuckles. He adds his arms and shoulders, but he doesn't know if that was from laying on them all night for as long as he did because he slept all the next day, too. The swollen joints seems to be resolved at this point. He clarifies all the symptoms started around midnight on 26Mar2021, about 12 hours after the shot. He confirms that he did not have swollen lymph nodes. No follow-up attempts are needed. No further information is expected.

About 1 day after vaccination, there was pain in the muscles around the right hip joint to the extent that I had difficulty walking up the staircase. It lasted for 2+ days and gradually diminished. Then, sporadic pains appeared in the right collar bone for a day, then in the left collar bone for a day or 2; and then intermittent ache in the left elbow and left hand; and then soreness in finger joints of both hands, especially in the morning; and, beginning 5 days ago and ongoing, RA-type pain is felt in the left shoulder, especially when I try to lift the arm or holding something with the left arm stretching out. this pain seems to be growing. Sometimes, tingling sensation in the toes and soles of both feet.

Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight) Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately) Overnight Tue/Wed upset stomach

Patient received dose #2 of Pfizer COVID-19 vaccine. Injection was given too high (left bursae area). Patient reporting neck pain and stiffness yesterday.

Started afternoon of Apr 16. 100.2 F fever, chills, aches in joints, tiredness, really sore left arm at injection site. Most symptoms gone by afternoon Apr 17.

Calf soreness; stiffness; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer reported for himself that: A 62-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:30 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity; drug hypersensitivity the patient's concomitant medications were not reported. The patient experienced calf soreness and stiffness on 28Mar2021 and the events were assessed as Non serious by health authority. and outcome of the events was Not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Acute pain radiating up the neck on the same side as the injection, beginning 30 minutes after jab and continuing. It has now been almost 9 hours. Soreness where the injection was administered beginning 6 hours after the jab.

Pt C/O feeling dizzy, light headed, and muscle pain in the neck. Tingling in the fingertips ( not new, this is ongoing). Pt placed in trendelenburg on stretcher. Vital signs x3., Pt also given juice and crackers. Pt stated didnt eat or drink in a few hours. Dr. spoke with pt's mother of symptoms and she was able to retrieve pt from site to home for pt's safety. Dr. informed pt to inform family dr. of incident and to schedule a follow up. Also informed pt if symptoms get worse to go to the nearest ER. VS: 1342 HR 78, Resp 20, BP 136/77, O2 sats 98%, / 1352 HR 79, Resp 20, BP 138/86 O2 sats 99%/ 1406 HR 75, Resp 20, BP 120/78, O2 sats 98%

Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.

Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.

The first Pfizer shot was on 4-1-21, and I had no reactions to that. The second Pfizer shot was on 4-22-21, and a few hours after, I started feeling soreness in my arms, shoulder, neck, armpits and had chills (although no fever). Throughout the next couple of days, the chills and body aches went diminished and/or went away--except for my left armpit. My left armpit is still sore and it is swollen (now at 52 hours).

while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00 (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.

Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.

Muscle weakness, Hypertension that is not controlled with his regular antihypertensive meds, and light headedness (comes and goes). States that he has an appt with his doctor on the 5th. Recommended: he needs to be evaluated by a health care provider today. Can not wait for the 5th. 4/27-4/28 unable to reach

his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; his arm is "going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling; This is a spontaneous report from a contactable consumer reported for himself. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller reports that his arm was going back and forth with a tingling feeling, like when you cut off blood circulation to a limb, you get the tingling feeling. Reporting that his arm was going through that constantly back and forth even when doing nothing reporting that at one point its good, then the next minute it felt like the circulation was off. The patient was asking if his symptoms are normal and if he should get the second dose with these symptoms. Patients query was responded as he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider would know his health situation and had access to information that could better help inform this decision.The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

At 0947, patient reported headache rated 5/10 on the pain scale and chest pain radiating to left shoulder (patient received vaccine on left arm). EMT assessed patient vitals: blood pressure 158/90 mmHg, heart rate regular 69 beats/minute, and SpO2 96%. Patient denied difficulty breathing, difficulty swallowing, itchiness, hives and rashes. Patient reported history of atrial fibrillation, pulmonary embolism, and surgeries on elbows, ankles and esophagus. Patient denied taking current medications. Patient offered 911. Patient declined 911. Patient given water and advised to wait for further observation. Patient reassessed at 1005. Patient vitals were blood pressure 149/90 mmHg, heart rate 67 beats/minute, and SpO2 97%. Patient reported headache decreased to 2/10 on the pain scale. Patient reassessed at 1015. Patient vitals were blood pressure 144/88 mmHg, heart rate 65 beats/minute, and SpO2 97%. Patient stated his headache was gone and he felt fine. Lead nurse educated patient on communicating with primary care provider about his reactions to the vaccine and seeking emergency care if symptoms worsen or has difficulty swallowing/breathing. At 1018, patient left facility to self with steady gait and unlabored breathing.

Patient presents with a potential reaction to the COVID19 vaccine. Patient-reported vague symptoms of some RUE tingling and R-sided facial tingling after RUE injection along with some neck tightness. The patient also reported mild generalized itching without rash, which he felt may be due to seasonal allergies. He requested 50mg oral Benadryl. Oral Benadryl given per request. Returned to baseline with monitoring.

Fever (101.2), chills, malaise, muscle ache, headache lasting over 24 hours no appetite swollen lymph glands in armpits lasting 48 hours +

Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking fluids. Lasted about 24 hours; felt fine the next day. Note: no reaction to first COVID vaccine injection 3 weeks earlier.

Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep.; The pain runs to my chest and behind to the back of my ribs.; The pain runs to my chest and behind to the back of my ribs.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old male patient received 2nd dose of BNT162B2 (lot_number EP6955) on 25Mar2021 at single dose on Left Arm for COVID-19 immunisation. Medical history was heart attack and was hospitalized to rule anything out, Hugh blood pressure, Cholesterol. Historical Vaccine was 1st dose of BNT162B2 (Lot number=EN6199) on 04Mar2021 on Left arm for COVID-19 immunisation. No other vaccine in four weeks. Left arm is in a lot of pain. It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep. The pain runs to my chest and behind to the back of my ribs. I have a history of heart attack and was hospitalized to rule anything out. Events started from 08Apr2021. Events results in healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (3 days), disability or permanent damage. Treatment was Pain meds. Outcome of the event was Not Recovered. No covid prior vaccination. No covid tested post vaccination. No Known allergies. No follow-up attempts needed. No further information expected.

After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse. Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician. The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks. Being advised to move and rest moderately. Received again information about Deep Vein Thrombosis. Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021. Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check. Another blood clot had developed. Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks. Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave. Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.

Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!

Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams

Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COVID vaccine. Symptoms continued and worsened over next two weeks. Went to ER on April 11th, 2021, due to immense head pressure, BP over 200, and ringing in ears. My blood pressure and heart rate were checked at ER and were high, but came down after laying down for a while. I was given blood pressure medication, Amlodipine, 10 mg tablets. Medication had minor positive effects but symptoms continued to get worse. Returned to ER on April 14th, 2021. Same diagnostic testing was performed. I was given more BP medication and recommendations were made for how to lower blood pressure with diet and exercise.

This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported. The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021. No follow-up attempts are needed. No further information is expected.

After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.

Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.

- Instantaneous sharp pain throughout the shoulder region (not experienced during initial vaccination shot, 3 weeks earlier in same shoulder). - Subsequent loss of use of left arm for 2-plus days (any motion caused inflammation to spike in shoulder, centered on one muscle but radiating throughout). - No treatment other than limitation on use of arm, very gradual reintroduction of usability. - Gradual recovery over several weeks. Now 18 days out from second shot, about 98% recovered from shoulder injury.

Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae. Follow attempts are needed. Further information is expected.

past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19. Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell. He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results. On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough. The patient then developed complaints of chest pain and rib discomfort. He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9. Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia. At time of admission he was given IV Lasix and started on Rocephin and Azithromycin. The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.

pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in throat only

4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squeaking sounds 3 different occasions. Thought I might have an ear infection and called Teladoc was prescribed Oxi Clav 825 mg . 2x day. 4/25-4/26 significant temporary loss of control of left arm and left leg felt wobbly but intensity subsided to minor loss of mobile control.4/27 Left leg went totally numb from the knee down with no control couldn't wiggle toes , Left should went numb 2x left face went numb 1x Stroke, total blockage of left corroded artery

Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.

3/26/21 After Pfizer vaccine noticing hives on chest and left arm as well as facial tingling and slightly left eye itchiness. Received 2 dose of Epinephrine during ED visit. 5/13/21 After Janssen vaccine he received at this morning around 8:10 AM. After that he had almost the exact same symptoms with a shooting pain in the left arm and neck some left hand tingling and swelling to the point where he can't get his wedding ring off and a sensation of pressure/tingling/fullness in the left side. Given Benadryl and steroids, initially there is no airway concerns or compromise. However after a period of time, he thought his voice was different. He did sound just slightly raspy, though I did question whether this could be related to dryness from the Benadryl. Regardless given that he did note a change, we opted to go ahead and give a dose of epinephrine, which did resolve his symptoms

Since 5/10/21 (through today 5/29), Left Shoulder / Arm soreness and swelling especially in left elbow which spread to lower left leg especially in left knee.

Developed gout in right hand and right foot. PCP prescribed Indomethecin. Condition continues after multiple weeks.

pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.

I've had Covid (01/2021) and Monoclonal Antibodies (01/2021). Was told to wait 90 days before vaccination (04/29/2021 and 05/20/2021). After Covid I began experiencing severe tiredness, headache, brain fog and muscle pain. No issues after 1st vaccination. About 10 days after 2nd vaccination, the muscle pain started becoming severe. Getting up in the morning, muscle pain in legs (mostly things) started mildly, then became so severe it was impossible to put my full weight on my legs. Am able to "walk it off" after an hour or so. NSAIDS are somewhat effective. Other symptoms include tiredness, headache, muscle pain, generally feeling unwell, joint pain, diarrhea.

6 years ago I had chip in L elbow, pain. could not bend elbow in comfort, to touch face difficult to dress etc. 2 days after vaccine I had the same thing happen; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (Pfizer BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EN6206 and Expiration date: unknown), dose 1 via an unknown route of administration in left arm on 04Mar2021 11:45 as single dose for covid-19 immunization at facility. Medical history included Aspirin Reyes syndrome as child. There were no concomitant medications. The patient has not tested positive for covid prior and post vaccination. No other vaccine in four weeks nor Other medications in two weeks. On 06Mar2021 09:00 (2 days after vaccine as reported), the patient experienced the same thing which happened 6 years ago, he had chip in l elbow, pain. could not bend elbow in comfort, to touch face difficult to dress etc. First time in 6 years. Possible coincidence, possible side effect, better: not well yet. It was unknown if patient received treatment. Outcome of event was not recovered. No follow up attempts are possible. No further information is expected.

having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; The pain is increasing it is really getting worse; I cannot eat from my hand at the back, I cannot lift anything; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration Date: 31Jul2021) via intramuscular route in the arm left on 10Apr2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included diabetes and Blood pressure high. The concomitant medications included metformin hydrochloride 1000mg, sitagliptin phosphate monohydrate 50mg (Janumet XR) and Glimepiride 1mg tablet (taking half because diabetes was not that high) taken for diabetes mellitus the morning and in evening and taking for 7 years, lisinopril taken for High blood pressure taking for 3 years, tadalafil; the patient went in surgery in 2020 (start feeling the excursion) So that time the patient was taking medication so would say 3 months and having appointment to continue or discontinue. After that the only thing the patient was taking tadalafil. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6207 and Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization and experienced no adverse event and in 2008, flu shot (lot number and expiration date was unknown) for immunization and experienced was sick, got sick and flu or fever or headache (After that did not take the shot again). On 10Apr2021 after the 3 weeks of first dose the patient received second dose of vaccine and waited for like 20 minutes before leaving the facility, the hospital, and like on third day (may be on 13Apr2021) the patient experienced having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain. The patient reported that, the pain was not that severe and did not have fever, headache and any other side effect at all. It was just the pain 3 days after, and then it did continue to increase and maybe like one week of joint pain because of that injection and it continue. The patient was feeling pain and then by May2021, the pain was like most and stated that I cannot eat from my hand at the back, I cannot lift anything, so that was new problem, the patient cannot lift anything and cannot turn hand at the back. The patient reported, it was not that very severe that I cannot eat and not that harsh, it was just in the joint and in the muscle. The patient reported, the first day and second day was not that much, the third day was when he started really experiencing and one week after he really feel it. The patient reported that, the pain was increasing. The patient was trying to see maybe within 1 week, within 2 week and within one month but now on 02Jun2021, it was really getting worse, and this was his experience. The patient started really feeling it and thought maybe after 2 weeks it will be going to be over, but it continued, so when it continued, he decided to go to the hospital and so they told me that. The patient took Tylenol and then kept taking Tylenol until for one month after it was lie if he was taking Tylenol it not really hurt maybe it was coming back, he cannot lift of his hand at back and cannot lift anything, the pain was not that kind of pain that it why I was taking. The patient reported that, the pain was continued. On 23Feb2021, the patient underwent laboratory tests, it was a general check-up for Diabetes to check it once and see the kidney, the blood pressure, everything the doctor was checking and then the physician said that that they wanted to check his system the blood work, they did find out that he had COVID 19 symptom on it. Physician told it was not positive. The physician told that, the patient has a strong immune system and if he tested positive, he would not feel anything, and physician told everything was excellent. The patient reported that, he took Tylenol 500mg, and that medication he always takes if he has too much pain. The patient reported that, he takes 2 tablets twice a day and sometimes 3 times in a day, sometimes 2 times in a day. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Headache; Sore muscle at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old adult male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 17Mar2021 at 11:30 (at the age of 62years) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and blockage, major depression, posttraumatic stress disorder (PTSD), sleep apnea, tinnitus. The patient did not have any allergies to medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medication was not reported. On 17Mar2021, the patient experienced "sore muscle at injection site. Started developing a headache around 3pm, continued worsening. Around 8am it began to subside. Around 9 it was gone". The clinical outcome of the events sore muscle at injection site and headache was recovered. No follow-up attempts are needed. No further information is expected.

42 days post immunization, pt still experiencing sore shoulder with a swollen "bump" at injections site

Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain. 7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc. The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced. Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between. By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.

hands and feet swelling; headache; back starting hurting; This is a spontaneous report from a contactable consumer (patient's spouse) A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included prostate cancer, surgery for prostate cancer about 4 months ago, tooth extraction on 09Mar2021. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, diphenhydramine hydrochloride (BENADRYL), amoxicillin. On 12Mar2021 the patient experienced hands and feet swelling, he started getting body aches and a really severe headache. All events were assessed as non -serious. It was also informed that on 09Mar2021 he was at the dentist for a dental procedure and they give him amoxicillin. By Friday evening his hand was completely swollen, his legs were swollen a little bit and then his back starting hurting, had a headache so is that may be a combination of amoxicillin and the Pfizer shot (as reported). At the time of the reporting the patient was recovering from the events. No follow-up attempts are possible. No further information is expected.

Injection site pain; Severe chills; Joint pain; Muscle pain; Low grade fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced injection site pain, low grade fever, severe chills, joint pain and muscle pain. The patient reported injection site pain for 3 days, low grade fever for 2 days, severe chills for 3 hours occurring approximately 14 hours after injection, joint and muscle pain for 2 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site pain, severe chills, fever, joint pain and muscle pain was recovered. No follow-up attempts are needed. No further information is expected.

stiff painful frozen shoulder symptoms quickly developed with second covid shot in left arm, seen primary care doc/steroid shots,,,,got mri, seen Orthopedic doc/thearpy better but still sore and catching/popping

Pain in finger joints when waking up in the morning. My wife got the vaccine the same day and we both developed the same finger joint pain

Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter). A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered. Follow-up attempts completed. No further information expected.

Patient has been diagnosed with polymyalgia rheumatica. States symptoms began after vaccination. Patient also reports a flare of his dermatitis immediately post vaccination

Aches; Headache; Chills; Joint pain; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via unspecified route to left arm on 15Mar2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Ambien and multivitamins for unspecified indications received on unknown dates and unknown if ongoing. On 15Mar2021 at 21:00, patient experienced headache, chills, aches, joint pain and tiredness. The patient did not receive any treatment for the events. The clinical outcome of headache, chills, aches, joint pain and tiredness were recovered on unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

I had pain in my injection site and it has subsided but literally for 4 months from march until early June I had pain at the injection site. I had an acupuncturist come and massage the injection site. I went to my doctor and she took an MRI and my whole left hand tingles. I still have a slight tingle now. I had to get a pain killer because I had to take the MRI and I lay on my left shoulder and I could not move but it was painful so I took the pain killer. As the pain has subsided the tingling has increased. What my doctor said is that I was injected in my rotator cuff.

On the first day after taking the shot: couldn't walk well; very dizzy; loss of balance; blurry vision; couldn't focus; difficulty riding my bike. I went to the doctor and I was recommended to see a neurologist. I gradually got better over time. I still have soreness in my ribs and I can walk somewhat normally. I feel like I have 90% recovered.

Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative

Nausea, vomiting, pasted out twice at the pharmacy, Dizziness, Muscle Weakness, Shortness of breath, chest pain and tightness.

INJECTION SITE PAIN & REDNESS, ARM PAIN. TIREDNESS, HEADACHES, MUSCLE + JOINT PAIN. CHILLS, FEVOR, NAUSEA, VOMITING, FEELING OFF/UNWELL.

I had rusty joints in both shoulders with muscle pain and fatigued. I was modern pain. Seen doctor, after the second shot. They did blood test. There was 5 out 13 abnormal results in the blood test. They believe it was due to inflammation that was from the vaccination. They started me steroid (Methprodnazoe) for the inflammation and joint pains. I was a one-week treatment. That was very affective. After the treatment stopped, the symptom came back, it was about 80% more that traveled down my body. It was more mild pain. I am still having these symptoms. I am going to contact my doctor to get back on a low-level steroid treatment pain. The more I exercise the worst it gets.

Severe swelling in right knee; unable to walk.; This is a spontaneous report from a contactable consumer, the patient. A 62-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 right arm on 19Mar2021 at 11:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history and allergies to medications or foods or other products were reported as no. Concomitant medications received within 2 weeks of vaccination included WELLBUTRIN, CRESTOR from an unknown date for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 00:00, the patient experienced severe swelling in right knee and unable to walk. Adverse 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 any treatment for the reported events. The clinical outcome of the events severe swelling in right knee and unable to walk was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. 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 shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

When doing minor routines, like washing dishes, pain in all my bones. Doctor says it is muscle pain as bones hurt that don't have joints. Started about 2 weeks after the second shot and continues to this day. Doctor wanted me to report it to you IN CASE it is a reaction to Covid shots. So pain since end of April.

This is a spontaneous report from a contactable consumer. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 62-year-old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as single dose for Covid-19 immunization. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. On an unspecified date in Apr2021, the reporter stated that the patient experienced sore sensations in his joints after dose 2 of the Pfizer Covid 19 vaccine. The event assessed as serious (medically significant). The reporter stated the event result Doctor or other healthcare professional office/clinic visit. It was unknown if patient receive any treatment for the event. Outcome of the event was not recovered. Information about lot/batch number requested.

Violently Sick; Throwing up/ Violent vomiting to Biel for 6 hours straight; cannot drink fluids or foods for 12 hours plus.; Chills; Joint pain; barely able to move or walk; Fever/Fevor 101; barely able to move or walk; Muscle pain; Nausea; Feeling unwell; Injection site pain; Tiredness; arm pain; Headache; injection site redness; injection site redness & swelling; He has minor discomfort; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 02Jul2021 at 10:30 AM (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included valtrex for infection in right eye, known allergies: mold, mildew, blue grass, dust, mites, cockroaches (start - 10 to 15 years). The patient concomitant medication included valaciclovir hydrochloride (VALTREX), allergy shots taken for allergy (patient stated it changes based on vials). Patient did not receive any other vaccine within 4 weeks prior vaccinations. Patient was not diagnosed with COVID prior vaccination. Patient was not tested COVID post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Jul2021 at 05:45 PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced he has minor discomfort, diarrhea on an unspecified date in 2021; injection site pain (the date patient received the vaccine), tiredness, arm pain, feeling unwell (subsided from feeling violently sick yesterday), headache, injection site redness, injection site redness & swelling on 02Jul2021; nausea on 04Jul2021; violently sick (It started at 5am (67 to 68 hours after vaccination). It has mostly subsided, gone away. Patient stated he has recovered with lasting effects because he was so beat up from throwing up) on 05Jul2021 at 05:00 AM, throwing up/ violent vomiting to biel for 6 hours straight (at 5 or 6 am yesterday. It lasted around 6 hours until noon), cannot drink fluids or foods for 12 hours plus, chills (around 5 or 6 am), joint pain (5 to 6 am), barely able to move or walk, fever/fever 101 (5 to 6 am, patient temperatures are normal now), muscle pain (around 5 or 6 am) on 05Jul2021. Adverse events did not result in emergency room, physician office visit. Adverse event: 12 of the 17 listed side effects on fact sheet revised 10May2021. injection site redness and swelling, arm pain. Feeling unwell, off. Joint and muscle pain, barely able to move or walk. Chills & Fevor 101. Violent vomiting to bile for 6 hours straight. cannot drink fluids or foods for 12 hours plus. Patient is calling about the vaccine, stated covid 19. He got the vaccine, his second shot and had a reaction that is on the paperwork. The patient underwent lab tests and procedures which included fever was 101 on 05Jul2021. The patient received tylenol, advil and pepto-bismol as treatment medication for the events joint pain, nausea, headache, fever/fever 101, muscle pain. Outcome of the events violently sick, feeling unwell, he has minor discomfort, diarrhea was unknown; tiredness, arm pain, cannot drink fluids or foods for 12 hours plus, joint pain, headache, injection site redness, muscle pain was recovering; injection site pain, throwing up/ violent vomiting to bile for 6 hours straight was recovered on 05Jul2021; chills, barely able to move or walk, nausea, injection site redness & swelling, fever/fever 101 was recovered on 06Jul2021. Follow-up (PRD/SRD 08Jul2021): Follow-up attempts are completed. No further information is expected.

Leg pain, hips and waist later moved into shoulders and arms Dr. visit June 2021 PMR returned and diagnosed July 2021

Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up. I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist. The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping

Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest

Pinched nerve in neck, knee cap was blown out, pinch nerve in lower back, pinched nerve in neck again causing a shoulder injury. Inflammation of the joints was diagnosed by chiropractor.

Chills; Tiredness; Headache; Muscle pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications included salbutamol (ALBUTEROL) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), both for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent nasal swab test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 15:45, the patient experienced chills, tiredness, headache, fever and muscle pain. The clinical outcome of the events of chills, tiredness, headache, fever and muscle pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Joint pain; I started feelings like I am having flu like symptoms like chills; Body fatigue; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported ), via an unspecified route of administration on the upper arm on 23Dec2020 at a single dose for COvid-19 immunization. Medical history included triglycerides (abnormal). Concomitant medication included eicosapentaenoic acid ethyl ester (VASCEPA) for triglycerides. The patient is a dialysis technician in a dialysis Unit. The vaccine was given in a facility. The patient got the Covid Vaccine on 23Dec2020 and its like more than a week now, on an unspecified date, he felt joint pain, body fatigue and two nights ago, he started feelings like he was having flu like symptoms like chills he took his temperature and its normal so he doesnt know if there is a reported reactions like this that he was feeling and he would like to know what does he needs to do, to know anything and an advice. He was scheduled for the blood work done at this month. The patient was taking only paracetamol (TYLENOL) for his joint pain, and chills and that's the only thing that he is experiencing right now. The consumer did not undergo emergency room or physician office. Outcome of the event chills was not recovered, while for the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.

COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "COVID-19 PCR test/he was positive per the PCR test" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded

About an hour later, slight headache. Around 2am on 1/12, woke up with hip joint pain. On 1/13 slight injection site pain and continued hip pain, and around 11am had slight nausea that went away. 1/14 still have hip pain.

LOW GRADE FEVER, JOINT AND MUSCLE ACHES, PAIN AT INJECTION SITE, SLEEPINESS FROM LATE EVENING ON 01/07 TO EVENING OF 01/08. ABOUT 22 HRS TOTAL. TOOK EXTRA TYLENOL. ONE PILL TAKEN TWICE DURING REACTION TIME.

MUSCULAR MILD ACHES GRADUALLY DEVELOPED TO STRONG ACHES TO PAIN AND MUSCLE TIGHTNESS BY 3 HRS OF SYMPTOMS ONSET.(ARMS AND THIGHS). TENDERNESS AT LYMPH NODE AREAS OF AXILLA AND GROIN. LIGHT SWEATING W/O FEVER BY 8 HRS OF SYMP ONSET. GENERALIZED MALAISE AND TIREDNESS FOR 15 HRS FROM SYMPS ONSET. TOOK TYLENOL 650 MG PO., Q 4HRS WITH IBUPROFEN 800 MG

Severe join Pain/ all over/ groin pain/ muscle pain/ night cramps/headaches/ injection pain/ feel unwell/ like sinus infection/ fatigue/ fall asleep midday. 3 weeks later. Still have some body pain/ still fatigued/ unwell and headache. Dizzy sometimes. Not my normal/ alert athletic self. Haven?t felt like exercising since took shot.

Severe shoulder ache followed by muscle tightness in neck, lasting several hours. On subsequent days muscle pain continued sporadically in neck, mid-back , and chest. Hot/ fLushed feeling accompanied back and chest pain but no elevated temperature was observed. On day 5 the left shoulder pain returned with a vengeance for about 4 hours, centered at the injection site.

pt states he started feeling pain in the left arm about one hour after the vax. He had a little back pain that night but could not get out of bed the next morning. He said it feels like the pain is all over his lower back and in the kidneys. Pt will contact his PCP.

Fever, soreness at site of vaccine and headache were only present early on and resolved in 48 hours of the vaccine. Then after a few days, these symptoms started (below): PAIN in every joint, large and small, including vertebral spine, shoulders, hips, knees, elbows, hands and feet, fingers and toes, as well as costochondral joints in the ribs; SWELLING and REDNESS in many joints including most of right foot, some of left foot, knees, hips and sacroiliac joints. On and off headache. Slight reduction, but still present after 3 weeks.

This was my first COVID-19 vaccine. Second is scheduled for 2 March. Soreness developed at point of injection that evening, but not unusual. I felt pressure in head/neck area and had dry cough that evening. Took Advil PM before going to bed. About 2am that night I started having severe chills. I took temp at 5am and it was 101.7. Took Tylenol and temp went to 99.8 by 7 am. Temp went back up to 101.5 by noon. Had called my workplace medical and they want me to stay out for 3 days due to the reaction.

Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia; 36 hours duration Ibuprofen; hydration; bed rest; Work absenteeism x 3 days

Day three mild swollen tongue that lasted 5 hours, day five mild swollen upper right lip that lasted 5 hours, day six moderate swollen left face/cheek that lasted 24 hours, day seven swollen left hand/wrist that was extremely itchy that lasted 24 hours and counting.

Body aches, chills, muscle soreness, fatigue, GI upset for 48hours, no measurable fever but feeling feverish, lack of appetite, severe back soreness which has escalated in the last 5 days to severe back pain, severe insomnia, fatigue is severe.

Right shoulder pain, right flank pain, midback pain, right knee pain. Started AM on 2/19/2021. Worsened, unable to move right arm ,pain hindered mobility for walking, unable to bend sue to back pain.

Light headedness, 100° temperature, lethargic, pain at injection site, tight muscles across shoulders & neck

My ankles became swollen, became so bad that I could not walk. Eventually swelling decreased by 1/3/2021/

Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events. Information on lot number/batch number has been requested.

The vaccine was given in the left arm. The left arm began to tingle and get heavy as expected. However, during the 15 minute waiting period after receiving the vaccine, the left side of my face began to feel ever so slightly thick and numb. It felt as if I had been to the dentist for a filling a hours ago. I never lost speech or had a discernable facial deformity, but the numbing caught me off guard. The facial feeling faded in about the same manner as the arm recovery.

8 years ago I had a chip in my left elbow. Some constant pain, Could not bend without massive pain, could not touch face, dress myself etc. Saw physician, lasted two weeks. 2 days after vaccination in left shoulder similar symptoms again in left elbow for the first time since the 8 year old event. Getting better on tumeric and ibuprofen, not well yet. Will visit DR if trend worsens.

Joint and Muscle Pain, Tiredness, Headache, Extreme Chills, Fever (102), Neck Pain, ...in that order over the past 24 hours

48 hours after first dose - extreme chills, joint and muscle aches, rash on legs. Felt like symptoms of Covid. (I have never had Covid)

Constant pain on the bone area on top of the left eye and makes the left eye watery. This symptoms is soothed by taking one tablet of a Regular Strength Tylenol a day in the morning. With this I can sleep well at night and ok when I wake up but the pain start like an hour after I got up from bed.

First: Site swelling & pain (about a week - 03/04 to about 03/10/21) Second: Headache, muscle pain, joint pain, tired (started day after - 03/05 to 03/06/21 - about 1-2 days) Third: Serious pain in left arm (mid-upper arm & lower arm down to the hand). Bones hurt, muscles hurt, and joints hurt. Rash on upper and lower left arm. Sensitive to touch and slightly red. Serious diarrhea just after arm started to hurt. (started 03/17/21). Still on-going.

Guillain-Barre Syndrome- prosimal upper limb malgias, followed by progressive 4-limb (prox>distal) weakness, hand paresthesias, bifacial weakness, areflexia, over 4-5 days. Course complicated by SIADH and hyponatremia. Currently treating with plasmapheresis.

Neck, shoulder, arm, trunk pain. chills. neck and axilla adenopathy. possibly related to using NSAIDS around vaccination

Head ache, severe at times. Stiff neck and shoulders. Flu like symptoms runny nose, sneezing, slight cough. Fatigue.

Approximately 5-10 minutes after first covid vaccine, patient was witnessed to become pale, eyes roll in the back of head, become stiff, and fell backwards in chair and onto floor. Patient hit back of head after fall. Patient was laying supine on floor and lost consciousness for approximately 30-60 seconds. He did not respond to name or place when asked. He had a strong pulse and was diaphoretic. After approximately one minute, patient opened eyes and stated his name and where he was. During this event, Code Medic was called by another staff member. Patient continued to talk to writer while waiting for code team to arrive. He stated that he had no pain and was starting to feel better. Report given to code team and care transferred. Patient taken to ED for further evaluation.

Twenty-Four Hours after the vaccine I experienced severe headaches, muscle aches, and fatigue including fever 101-102, reducing to moderate levels after 6 hours but persisting for 7 days. Symptoms varied in severity over days but significantly impacted ability to work.

Decedent began noticing symptoms on 3/17/2021. He c/o worsening back pain, joint pain, headache and stiffness last Sunday (3/21/2021). Today (3/25/2021), he c/o chest pain. The decedent received his COVID-19 vaccine on 3/16/2021.

could not move; fever went to 102.3; shaking so bad; my legs felt like rubber and every time i would try to get up i would fall down; terrible pain; serious discomfort; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer reported that he received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6208) on 15Mar2021 02:00 PM at right arm for COVID-19 immunisation. Medical history included kidney disease, known allergies: Penicillin and high blood pressure. The patient had received other medications in two weeks. The patient reported everything was going great. He took a nap 15 hours after shot, woke up hour later and could not move. Fever went to 102.3 and he was shaking so bad and his legs felt like rubber and every time he would try to get up he would fall down. He was so scared he called somebody to come be with him, things got better about 28 hours of terrible pain and serious discomfort. He was in such pain and he need to know if he should arrange someone to be with him for second dose. Event onset date was reported as 16Mar2021 10:00 AM. The event resulted in: Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment was received as paracetamol (TYLENOL EX). Outcome of the event was not resolved.

mucsle aches, nausua, night sweats, chills, cough, major fatigue had 2 telehealth conversations with 2 drs through primary care In the meantime doctors encouraged and strongly supported receiving second vaccine - symptoms continues and primary care presecribed antibiotic (arithomiziathan) or possible pneumonia, tylenol PRN for bilaterl lowert extremity pain follow up call a week later -f/u call-with another general practicioner - rx antibiotic (levofloxacine750mg x 7 daye) ) CC- same syptoms, dr said to "follow the course", eventually sent ED at local hospitalwent to Hemotologist = Blood cultures, stool cultures, and on the verge of bone marrow biopsy

Low grade fever, lethargy, muscle aches, chills, sleepy, mild headache; lasted about twenty hours. No treatment other than sleep. Symptoms gradually disappeared.

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient came to our pharmacy to pick up prescriptions for Diclofenac 50 mg and Norco 5/325, and informed me that ever since he received his Covid vaccine, his right shoulder has been in pain to the point that he could no longer sleep at night. I have called Store 4742 and informed the pharmacist on duty about this report from the patient the same afternoon.

back pain; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer (patient) reported that he received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL9263; Expiration Date: May2021) as SINGLE for covid-19 immunisation. Medical history included intervertebral disc degeneration from 2013 to an unknown date, arthritis and arthralgia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced back pain, has been getting pain in his back since 3 hours after the shot. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.

Received vaccination on Saturday night, 3/13/2021. On Tuesday developed headache, fever( highest recorded was 101.2), chills and body aches, with most sever pain left side mid-back. Treated with Tylenol and it lasted about two days. On Friday developed a rash on my right foot, that by Sunday had spread to the other foot, both hands and arms, and around my waist and partially down my legs. Bright red and itchy. Still have splotchy rash two weeks later. Due to get my second shot tomorrow, Saturday, April 3rd.

Woke up on Sunday 3/28/2021 with a sore neck and back of the head, sore arm, underarm, and shoulder. At first, I thought I had just slept wrong but the symptoms did not decrease for a couple of days. On Tuesday 3/30/2021 I began taking a stress dose of Hydrocortisone (I have Adrenal Insufficiency due to surgery to remove a Pituitary Tumor). I contacted my Primary Care the next day, by phone and after discussing my symptoms he diagnosed me with lymphadenopathy. I continued the stress dose until Saturday 4/3/2021 when I began to taper off. Symptoms are considerably decreased but not completely gone, nevertheless I intend to get the second dose on Tuesday 4/6/2021 based on my discussions with my PC.

Head ache, irritated sinuses, fatigue, sore muscles, pain at injection site, for 3 days. Treated with acetaminophen on 3rd day.

1. Peripheral neuropathy in arms and legs, no treatment, perceived same day as getting the vaccine, symptoms continue. 2. Arthritis in neck, shoulders and hips, no treatment other than ibuprofen , perceived same day as getting vaccine, symptoms continue. 3. Metallic taste on tongue and tingling of tongue, no treatment, perceived same day as getting vaccine, symptoms seemed to have subsided. 4. Stomach muscle fatigue, no treatment, perceived same day as getting vaccine, symptoms including burning sensation continue. 5. Itchy head, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 6. Stuffy head - unable to clear ears, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 7. Generalized sore muscles, no treatment, perceived on same day as getting vaccine, symptoms continue. 8. Generalized aching joints, no treatment, perceived on same day as getting vaccine, symptoms continue. 9. Enlarged or swollen lymph nodes, no treatment, perceived a few days after getting vaccine, symptoms have lessened over time. 10. Testicular pain, ice pack as needed, perceived a few days after getting vaccine, symptoms continue.

Flu type feeling a few hours after injecting but went away within two hours. Exhaustion following morning. Swelling of armpit area of injection arm feeling like there was a tennis ball in armpit, along with moderate to severe tenderness, still continuing.

After about 6 or 7 days of receiving dose #1 of Pfizer vaccine in my left arm, I experienced sharp/severe left-chest and upper left-back pain for a few days and the pain gradually decreased until it was finally gone as on 04-07-2021.

Headache and neck pain on left side for nearly three weeks; it is debilitating unless I take 3 ibuprofen twice and day, and shows no sign of relenting; exhaustion.

within 20 minutes after shot the left side of my face felt light the dentist shot me with a light does of novocaine . the left eye feels tired, tongue and lips feel slightly numb, left side of face feels strange along with a headache

I received the shot around 9am, That evening my left arm was a bit sore as well as my neck muscles. The next day I had several of my old Shingles symptoms return, weird feeling in my left eye, itchy eyebrow muscle, itchy skin on left side. (I had the shingles about 15 years ago, LEFT side, not too bad, mostly itchy, with recurring odd things just mentioned maybe once a year) The the 2nd day I got a weird tingling, buzzing feeling in my left upper back above shoulder blade, like those TENS device electric muscle stimulators. This is similar to my shingles twitches, but different and NEW. Maybe I should have taken the shot in my right arm? I may take the second shot in my right arm.

Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury.

I received the COVID-19 shot on 03/24/21 at 1:30 in the afternoon, perfect health at the time, not even a headache, then 24 hours later my entire left ankle was swollen from the COVID-19 vaccine shot. I contacted my primary care doctor, and was looked at and was verified as being swollen. I was referred to a foot doctor who did verify the foot was swollen. The foot doctor gave me a steroid shot in my left ankle, and the foot was still sore. I was back at his office after my appointment on 4/9/21 to get a foot boot. It was suggested about being in a boot to keep my foot off the ground, Today the swelling comes and goes and is really painful

patient stated his daughter found him ?unconscious and he was rushed to the hospital, he stated he still has facial paralysis and is experiencing difficulty eating?. I attempted to contact patient and voicemail was full. Alternate number was given and wife answered the phone. interpreter use during call. Wife reported her experience with vaccine and reported husbands as well. States, her husband is at work and cannot talk on the phone, he may be home late?. Wife states her husband received Pfizer vaccine on a Friday 4/9 and then woke the following Monday with a ?crooked mouth, migraine headaches, very sleepy and heavy arm?. Wife states he did not loss consciousness but was take the Hospital on Monday 4/12/21 and was not given an answer to what was wrong with him. Advised wife I cannot share any medical information about her husband with her, that he could return my call.

The first day after the vaccine I felt a total lack of energy as well as muscle soreness and general aches. By the second I was pretty good. On the 11th day It all came back and more. Dry and soar throat, headache , total loss of energy, no apatite, muscle aches. This has gone on now for 5 days. On the 2nd day I had a covid test- came back negative. On the 4th day I had another at a different facility, came back negative. Could this still be a reaction to the first vaccine and should I have the second?

he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently. He does not know if it just the progression of the pain or if it is coming from the injection. The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe. He added that he has had nausea with the cancer, so this nausea would be very light. But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works. The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this. He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice. He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

left shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunization at a public health department. Medical history included diabetic and blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first dose, the patient had left shoulder joint pain for about 10 days. The event resulted in emergency room/department or urgent care visit and hospitalization. The event was not treated. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Could not stand; Piercing pain in middle of spine to tailbone; Piercing pain in middle of spine to tailbone; Walking was very difficult; Left arm injection site sore; This is a spontaneous report from a contactable consumer(spouse). A 63-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8729), intramuscular at Arm Left on 06APR2021 10:45 at the 63 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were none. The Historical Vaccine was BNT162B2 first dose on 16MAR2021 at 63 years old for COVID-19 immunization (Lot ER2613; Injected in left arm given in the muscle).The reporter was calling on behalf of her husband who had the second vaccine yesterday. He had an odd reaction and was not good. He had to go to work after getting the vaccine and was at work for an hour. He could not stand and he is a chef. She had to go pick him up. There was a piercing pain in the middle of his spine to his tailbone. The patient experienced Walking was very difficult and Left arm injection site sore. He has been on the Tylenol which is the protocol. All of the events happened on 06APR2021 12:30. This morning on Day 2, it was not much better. She would like to know if there have been any reports of this and what Pfizer recommends for this. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Patient's shoulder joints began hurting after vaccine. It kept getting more and more severe, up to the point where he couldn't raise his arms. He also had some pain in thigh muscles but not as severe. Pain got so severe he went to ER - who did labs and told to see PCP. PCP gave naproxen for pain, which helped some. 3 days later - he went back to ER and he was given a muscle relaxer and IV morphine. He returned back to PCP and was given steroids and 2-3 days later had complete relief but still being treated on steroids.

Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness With my first shot, all I had was a sore arm for 4+ days. The second shot I has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM, By Noon that day, I was fatigued but able to go to work. A week later, I had chills again and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.

Brain Bleed.; Pain in back of neck; BNT162B2 in right leg; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date not provided), via an unspecified route of administration, in right leg, on 26Mar2021 17:45 (at the age of 63-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure. Patient had no known allergies. No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV6206, expiration date not provided), via an unspecified route of administration, in right arm, on 03Mar2021 17:45 (at the age of 63-year-old), at single dose, for COVID-19 immunization. On 27Mar2021 03:30, the patient experienced pain in back of neck and brain bleed. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient was hospitalized for 19 days. The patient underwent lab tests and procedures, which included COVID test was negative in Apr2021. Therapeutic measures were taken as a result of events and included treatment with observation intensive care unit (ICU) 7 days, tube feed and medication. The outcome of the events "pain in back of neck and brain bleed" was not recovered.

Started walking to my bedroom in the rear of the house and my legs began to get weak and I lost my balance and had to lean against a bookcase with the help from my wife

Started with moderate arm pain about 11 hours after injection. Progressed to fatigue, moderate muscle and joint pain and slight fever over the next 12 hours. Felt terrible for about 24 hours and slowly began to feel better within 48 hours.

help knock pain down for joints hurt like heck; a pinching like pins and needles trying to get out on your stomach area, it comes and goes; first time the rash itched underneath; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes; Started freezing all over the place, hands are ice cold; Starts effecting different joints in the body, hit the muscle or joint; Starts effecting different joints in the body, hit the muscle or joint; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit; Started freezing all over the place, hands are ice cold; a little pain in the muscle; A paramedic gave vaccine and hit an artery; bleeding underneath skin above injection site, 7 droplets of blood above injection site; When stood up couldn't breath and throat was like closed off; When stood up couldn't breath and throat was like closed off; Severe sharp pain in your head that comes and goes each day to this day; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6208 and expiry date not provided) via intravenous, in left arm in shoulder area on 18Mar2021 (at the age of 63-years-old) as a single dose for covid-19 immunisation at hospital. Appointment was for 8:40, told facility he had allergic reactions to allergies. Medical history included patient had life and death lung surgery in 1997, lost bottom lobe on lung, less breathing capacity than normal person. There was no relevant family medical history. Patient was told by family doctor, should get the Covid shot. Concomitant medications were none. Patient did not have prior vaccinations within 4 weeks. No additional vaccines were administered on same date of suspect vaccine. There was no investigation assessment. AE(s) following prior vaccinations: Patient stated it was not like this, usually just sore arm where put needle in, never had blood fly out of arm on rubber glove, or bleeding, after pulled syringe out, kept pressure on arm. Patient has never had anything like that happen. Patient did not provide NDC/lot/expiration for vaccine that made arm sore where put needle in. Never happened again after that. On 18 Mar2021, a paramedic gave vaccine and hit an artery, and injected the vaccine into his blood stream, when stood up patient couldn't breath and throat was like closed off and bleeding underneath skin above injection site, 7 droplets of blood above injection site. Patient still has one today that didn't go away yet. Patient stated that he suggested to the Paramedic that he pull out the needle and put it in the right arm and start over. Paramedic was just staring at the blood coming out underneath the syringe and continued to shoot the first dose Pfizer Covid Vaccine into the blood stream. After a few seconds caller's throat opened back up. States it was freaky. Never had that happen before. Throat opened back up, but scared patient real good. Just happened for a few seconds after standing up, maybe patient stood up too fast and that caused the problem. When patient got home he had blood on his arm and shirt. On 29Mar2021 11th day after first dose Pfizer Covid vaccine, patient experienced like a warm, hot forehead, gets warm and then gets hot like running a fever to the touch burning on forehead comes and goes, also patient started freezing all over the place, hands are ice cold, was wearing long johns two sweatshirts and a winter coat in house to be warm. Patient puts hands in coat pocket to warm up. This is still going on every day, still going on this morning. It started effecting different joints in the body, hit the muscle or joint, joints targeting on and off, still happening every day, No effect on joints yet. Patient hopes does not have anymore.. First symptom started after first dose Pfizer Covid vaccine, for seven days underneath the muscle. It was that 20 minutes one time it showed up. Patient clarifies that this began on the 7th day after receiving the first dose Pfizer Covid Vaccine. Patient had a little pain in the muscle. Felt something in the muscle are for about 20 minutes. It was ongoing and persisting. Also had a rash on right chest but it wasn't itching, it was just burning, strip of red rash going down left side of neck that went away and another rash started under left armpit. It was a pinching on the inside trying to come out through the skin. That's what the rash feels like. Reports this was still coming and going. Clarifies the rash underneath the right arm and on the chest is what patient was referring to. Last night for first time the rash itched underneath patients right arm in the muscle, it started to itch, still hot. It was never itching before but started itching last night, 20Apr2021. Rash came back on right arm between elbow and shoulder in muscle area. Red rash came, felt the pinching like trying to come out from under the skin. Patient went to the bathroom and looked and it was itchy for the first time. Patient didn't want to itch it, rubbed lightly with flat hand so nothing would happen. Improve a little bit, not all over chest like it was, going on in different locations of the body. On 20Apr2021, patient having a symptom from yesterday and today a pinching like pins and needles trying to get out on your stomach area, no rash there but it comes and goes. Patient pushes finger on it and it seems to calm it down a little bit. Reported this was another symptom that was appearing. Patient states he was still having these symptoms. On an unknown date in 2021, patient experienced severe sharp pain in head, he has a stabbing pain in forehead that comes and goes each day to this day. After that started experiencing, never had headaches before, that was a severe sharp in your head that comes and goes each day to this day. Treatment received ibuprofen 300mg once in a while to help knock pain down for joints hurt like heck. Patient doesn't know when he began taking, after symptoms occurred he began taking. Other than that the patient did not take it. Patient was not a big fan of taking medication. No relevant tests were done. Patient visited emergency room in a hospital due to events 01Apr2021. Patient was discharged from emergency room. Pleaded with emergency room to give patient an epi pen to stop the side effects from occurring to get back to normal life and not deal with problem. Emergency room refused to give patient the epi pen, saying the epi pen would give the caller high blood pressure. Patient does not have high blood pressure. Patient thought that would be better than the reactions he was having. Patient stated that gave him a steroid. Patient was hoping there was an anecdote to stop the side effects to not continue going through this problem. Shot was not designed for where it was put, guess have to deal with unless answers. Patient asked what are the long term effects to the brain at end of blood stream? Have any idea? Nobody has answered. Vaccine should have been aborted, not injected into blood stream. Patient underwent EKG (Electrocardiography) in emergency room on 01Apr2021 and result was unknown. Patients second dose was scheduled for 27Apr2021, 41 days after first dose Pfizer, not 21 days. The seriousness for all the events was unspecified. The outcome of event paramedic gave vaccine and hit an artery was unknown and for other events was not resolved. No follow-up attempts are needed. No further information is expected.

1. Sever hemi hyperesthesia R arm/chest/back which lasted about 72 hours. 2. Edema R arm & hand which lasted about 24 hours. 3. Fatigue which lasted about 1 week. 4. Pain & weakness in R shoulder which has not resolved.

Patient is a pleasant 63-year-old gentleman who came to the hospital originally on 4/10/2021, refer you to the H&P done at that time by Dr. Comes in with a diffuse rash over his torso and his legs. He did get COVID vaccine, his first one (4/1/21 at Imaginetics) about a week to a week and a half before admission. He said shortly thereafter is when his symptoms began. The rash is pruritic. He had no breathing troubles whatsoever. No throat closing or tongue swelling, etc. No mouth lesions and in fact the rash over his torso and his back is pretty minimal, looks more like a sunburn type appearance. In any case, also had a petechial type of purpuric rash on his legs and I did show this to Dermatology who felt that it did look like vasculitis. He was placed on steroids. He did SOLU-MEDROL while here and this was converted to prednisone on discharge for which he will continue with for the next few weeks. Slow taper. Rash had improved over his stay here. His LFTs were also up somewhat as well, but these did improve while he was here and multiple imaging studies were done including ultrasound, CAT scan and abdominal Doppler all were negative for any kind of pathology. Suspect probably these elevated LFTs could have been from vasculitis and that is also improving now with the steroids. He is tolerating diet well. He has no abdominal pain. Okay to be discharged today. We will continue with prednisone taper. Follow with PCP in 1 week. Also know, there is an ANA pending as further workup for vasculitis. We will defer to PCP on follow up for that. 4/21/21 Follow-up with PCP: 63-year-old male here for a hospital follow-up. He was hospitalized for rash suspected to be vasculitis and elevated LFTs-started 2-3 days after his COVID vaccine. Etiology of elevated LFTs unclear. Liver US and CT were negative. Hepatitis, viral testing, and ANA negative. Received his first COVID vaccine on 4/1. Still on prednisone taper for rash. He is feeling better, still somewhat tired. Rash is almost resolved. Current complaints sore on the left side of his tongue for the past 11 days. Initially hurt when he would eat, is better now. Is back at work. Denies abdominal pain nausea, vomiting, stool changes, dark or light stools, yellowing of skin, swelling in abdomen or legs. Does not use tobacco, alcohol, or drugs. No history of liver issues. Normal LFTs 7 months ago. Follow up appt at Allergy/Immunology on 4/29/21: Plan: Patient had a delayed reaction to his 1st dose of Pfizer vaccination that included symptoms of arthralgias, rash as well as elevated liver enzymes. His symptoms don't meet criteria for type 1 IgE mediated reaction so skin testing would not be beneficial. His symptoms required hospitalization and improved with tapered steroid course. His symptoms did not fit DRESS syndrome criteria as he did not have peripheral eosinophilia, fevers, sloughing of skin/oral mucosa or blistering. We discussed how there is not much data or case reports about how to proceed with completing vaccination for COVID. I would recommend he get Johnson & Johnson vaccination since it is a different class of vaccine and he may not have the same reaction but again this is not guaranteed. There is a small chance of clotting with Johnson & Johnson vaccine as well. He should pre-medicate with cetirizine 20 mg po qday for 1 week before vaccination and 2 weeks after. I would also suggest he get a steroid course to have on hand from his PCP in case rash starts again after vaccination. It may be beneficial to have him get lab work several days after vaccination as well (U/A, CBC, CMP) to evaluate for any inflammation.

Severe left first toe/hallux pain, patient unable to bear weight, intermittent without redness, warmth, swelling. Morning stiffness. No risk factors, personal history, or family history for gout.

The very next day after my second dose, Left hand pointing finger, primarily joint between distal and middle phalanx became swollen and very sore. Felt like I had sprained the finger. Then, on 05/03/2021 I had a blood test for my annual exam and my ESR and CRP levels are elevated, and my hemoglobin was low.

Extreme flare up of gout. The worst gout I ever experienced. I can be prone to gout so am familiar with the issue. This began immediately the following morning after the first dose and is still a problem now 3 weeks later. My entire foot, ankle and lower calf were completely swollen and the foot turned blue. Finally now 3 weeks later the swelling has reduced to the big toe but I am still limping. I was schedule for the second dose yesterday and we cancelled. I am very concerned about taking the second dose, especially since we have a wedding trip planned in early June. I can not suffer with this again during that trip and not sure if a 10% increase in immunity from Covid is worth the risk of another major gout flare up like that. Naturally I am concerned about permanent joint damage also.

First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm. My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much. Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor. Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.

Severe arthritis pain in hands and back for about 2 weeks, Severe sinus paid over left eye that started day after shot and lost 6-7 days Tightness is chest that started say after shot and lasted 5 days Tinnitus that started on approx 5 days after shot and still exists as of today (May 9th)

Received first vaccine on 3/17/2021 - had mild shoulder pain. Received 2nd dose on 4/6/2021. After second dose I have had severe shoulder pain - both shoulder and mild hip pain on both sides. The shoulder pain is severe enough that I can't put on my own shirt, coat and trouble with putting on socks due to shoulders leaning forward. Shoulder pain is in the area where shoulder and upper arm connect. I saw a internal medicine physician on 5/7 and he is sending me to sports medicine physicians 5/14 - my pain is not due to an injury, it was mild after first vaccine but has been severe after 2nd vaccine. I am taking no medication besides Aleve before bed but in pain while sleeping and when I get up. Pain is constant when moving shoulder or hips. If I drive for more then 1 hour, my hips are in pain and I need to get out of car and walk around.

Gout attack; This is a spontaneous report from a contactable consumer (patient's wife) via a medical information team. A 63-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (at the age of 63-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, caller and her husband was scheduled to receive the second dose this afternoon. Caller states that her husband had a gout attack this morning in which he took his treatment medication of Colcrys and Allopurinol. Caller states that he probably should not have taken the medication this morning and asked if these medications are going to interact with the vaccine or not. Referred to healthcare professional. Caller asked if her husband was able to take the vaccine at a later time or not. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

feels like a neuropathy, a nerve pain; nerve pain in the right leg; Right Leg weak and painful when he stands; Right Leg weak and painful when he stands; Has been in bed for two weeks; This is a spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date was unknown), via unspecified route on 17Apr2021 at 13:00 (patient was 63-year-old at the time of vaccination) at a single dose for COVID-19 immunisation. The patient's medical history included bad back which was ongoing he had this issue since he was 20. He has been going on for about 45 years. The patient received first dose of BNT162b2 (Lot number: EN6200), and patient didn't have any problems with the first dose of the Covid Vaccine. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient had not received any additional Vaccines on Same Date of the Pfizer Suspect. On 27Mar2021 The patient's concomitant medications were not reported. On 17Apr2021, 8 hours after vaccination, the patient experienced right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before, he has been in bed for 2 weeks now. He can get up, but if he does he will have about an hour of pain afterwards. He was putting ice on his leg for about 2 hours at a time but he doesn't have to do that anymore. He can walk for about 2 minutes, then has to lay down, Then he will feel back to normal, then he can walk two more minutes, then he has to lay back down. Reporter stated the pain is only in his right lower leg and good. Reporter stated it feels like a neuropathy, a nerve pain. Reporter stated that 8 hours after his second dose of the Covid Vaccine his right leg went very weak and became very painful when he stood up. He stated this is something he has never felt before. He has been in the bed since then. His right leg went numb and is very painful when he walks but not as much when he in bed; he never experienced this before. Reporter wanted to know about any reports of neuropathy or autoimmune disease reported with the covid vaccine and how it might be treated. On an unspecified date, the patient visited physician's office. Reporter stated that his doctor doesn't know what is wrong with his leg. He also stated he had a MRI yesterday, no results from that known yet. The patient asked has anyone else reported neuropathy. Offered transfer to and initially declines. He doesn't think they can help him. When asked what kind of help he was looking for states that he wants to know if anyone else has reported neuropathy. Informed to reporter that has the most recent product information for the Vaccine. The patient was referred for hcp for further guidance. The outcome of the event muscular weakness and bedridden were recovering, while outcome of the other events were unknown. Follow-up #1 (30Apr2021):This is a Follow-up spontaneous report received from a contactable 63-year-old male consumer (Pharmacist). This consumer (patient) reported for himself that: Relevant medical history (Historical vaccine, medical history), suspect details, new events (neuropathy and neuropathic pain), outcome and lab data added. Follow-up attempts are needed. Further information is expected; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Muscular weakness, bedridden, neuropathy and nerve pain 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.

You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.

Client stated after 1st dose Pfizer COVID vaccine received in Right arm 04/07/21 (LOT ER8729) at vaccination site he gradually developed Left hip pain rated a 9.5/10 and stated he had to use a cane to walk. The pain lasted 36 hrs and then resolved. Client took Motrin to help manage the pain. Client denied shortness of breath, chest pain, dizziness, headache or tingling in mouth, face or throat. Denied pain anywhere else and denied trauma to the area. Client denied any allergies to medication/food/environment and denied any other medical history or medication use. He stated he did not consult with a PCP because he is newly moved to the area and has not yet established care.

DOSE 1 ON MARCH 16, 2021; DOSE 2 ON APRIL 13, 2021; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING FIRST INJECTION.... MUMPS-LIKE SYMPTOMS... PAIN FROM INJECTION SITE , UP NECK, BACK OF HEAD... TOTALLY DEBILITATING PAIN WORSE IN EVENINGS AND PAIN "MOVING" FROM ARM TO NECK TO HEAD AND BACK...WORSE AT NIGHT.... SAME SYMPTOMS WITH EACH DOSE... 2 MONTHS NOW! PAIN LASTED 4 WEEKS AND WAS REMITTING AT TIME OF SECOND INJECTION; SEVERE PAIN STIFFNESS, TETANUS, ACHES, FATIGUE, MORE PAIN SAME DAY FOLLOWING SECOND INJECTION (I WAS ALMOST BETTER AND THEN BACK TO WORSE THAN FIRST DOSE! WAY WORSE! PAIN LASTED 4 WEEKS AND IS CONTINUING NOW

Client complained of dizziness, little shortness of breath shortly after receiving his 2nd Pfizer vaccine. BP=100/60, 98%, 89 RR. Complain of pain in left hand rating it as 5/10 d/t gout. States that he stopped drinking 5 days ago (ten beers a day).

Office Visit 5/5/2021 Dx Fever ? Generalized Body Aches ? Fatigue Reason for Visit Progress Notes PA Encounter Date: 5/5/2021 Signed Cosigned by: MD at 5/12/2021 8:00 PM Assessment/Plan PT was seen today for fever, generalized body aches and fatigue. Diagnoses and all orders for this visit: Viral illness - COVID-19 PCR; Future History Chief Complaint Patient presents with ? Fever Started yesterday ? Generalized Body Aches ? Fatigue had cvoid vaccine last wednesday HPI Patient is a 63-year-old male presenting today for evaluation of fever and body aches that started last night. He states that he received his first Pfizer Covid vaccination 1 week ago, no significant reaction or side effects. He reports now having fever up to 101, body aches and muscle pains, fatigue. No congestoin, rhinorrhea, cough, V/D. He has taken some Tylenol 500 mg, LD was this morning. No sick contacts. No hx of asthma. No rashes. Nonsmoker. ED to Hosp-Admission Discharged 5/18/2021 - 5/19/2021 (24 hours) Hospital DO Last attending Treatment team Chest pain Principal problem Discharge Summary (Physician) Internal Medicine Inpatient Discharge Summary Brief Overview Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 5/18/2021 Discharge Date: 5/19/2021 Presenting Problem/History of Present Illness/Reason for Admission Chest pain [R07.9] Acute chest pain [R07.9] History of coronary artery disease [Z86.79] Hospital Course HPI: PT is a 63 YO M admitted with chest discomfort in the setting of asymptomatic COVID 19 infection. His chest pain was associated with troponin elevation prompting admission and cardiac stress testing. His troponins peaked at 0.09. His PET stress test was negative. Therefore he was discharged to home without medication changes.

Severe stiff neck, locked up completely, extreme pain lasting for 30 hours so far. No left, right, up or down movement.

He got his vaccine, immediately where the needle went in he had a bruise and just stayed the same. Then a few days later he started feeling stiffness and pain in his right neck and shoulder area. He did not have any rash, fever or other symptoms. He does still have the swelling at the injection site. He has taken Aleve for the discomfort. He has not called his doctor. He is able to work, but is having the pain in the neck and the shoulder every day.

Sudden on set of Severe joint pain in shoulders,hips,hands,knees,forearm,elbow On going testing ,diagnostics,treatment Saw family dr & orthopedic specialist both recommend seeing rheumatologist

weakness in the legs; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 06Apr2021 (Batch/Lot Number: ER8734) as 1st dose, single (at the age of 63 years old) for COVID-19 immunisation. Medical history included ongoing high blood pressure diagnosed 4 to 5 years ago, ongoing diabetes diagnosed 10 years ago and ongoing bone cancer diagnosed about 2 years ago. The patient's concomitant medications were not reported. The patient experienced was in and out for different things. He was hospitalized for weakness in the legs on 28Apr2021. Patient was supposed to get second COVID19 vaccine on 28Apr2021 but was hospitalized for unrelated issues. The patient wants to know where to get second dose. The outcome of the event was unknown.

Please refer to the H&P for full details. This is a 63 y.o. male with PMHx of HTN and HLD who presented to the ED with chest pain NSTEMI Type 2 Myocarditis Patient was seen by her PCP on 5/12 with c/o chest pain found to have elevated troponin 0.06 (0.03 upper limits of normal) otherwise EXG and CXR nl and was recommended to come to the ED. Patient reports the chest pain started ~1.5 weeks ago, initially resolved, however began to have discomfort again 4d PTA. She describes the sensation as a dull ache with radiation to the neck and her right shoulder. No history of heart disease. Risk factors for this pt include HTN, HLD and tobacco use. On admission HS-Tn elevated at 230 and EKG shows NSR, no ST/Twave changes. ECHO shows EF 60%. Received ASA and nitro in the ED. -monitor on telemetry -cardiology consulted, angio on 5/14 showed normal coronaries, cardiac MRI with evidence for myocarditis per discussion with cardiology - final read is pending at dc - colchicine started Moderate aortic stenosis Noted on ECHO, no significant change in the aortic valve pathology or aortic root dimension compared to prior in 2017 HTN Normotensive in the ED -continue amlodipine and lisinopril HLD Last lipid panel on 12/1/2020 with LDL 109 -continue statin - increased to high dose 80 mg Tobacco abuse Current everyday smoker of at least 1 ppd -cessation discussed Tremor: Continue home med Aortic root dilation - 4.0 cm. Monitor.

Patient reports week-long, not yet resolved, numbness in fingers, pain in elbow of injected arm. Also ?hard to bend? and injected arm ?darker than other arm?

Arthritis pain in back, hips, shoulders and hands; Sore arm; He is not doing anything to cause the pain; This is a program spontaneous report from a contactable consumer or other non hcp (patient himself). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0185; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 19May2021 08:00AM as 1st dose, single for covid-19 immunization and would scheduled to receive the second dose on 10Jun2021. The patient's medical history included bad Arthritis, Allergic to Penicillin from an unknown date. The patient's concomitant medication included Apixaban (ELIQUIS) 25mg tablets a day patient was taking blood thinner this since he was 48-year-old. On 19 May2021 after the vaccination the patient experienced with a Sore arm, on 20May2021 then the second day after the vaccination the arthritis started for no reason and had more pain in back, hips, shoulders and hands and prior to vaccine he would had minor pain here and there, every day, but now his arthritis had really flared up badly, had to take the pain medication every day. Patient stated that He was not doing anything to cause the pain. It had stayed the same since the pain started, since patient got the vaccination, his arthritis had been getting worse. could not take arthritis medications because he had 2 blood clots for that he was on blood thinners. Patient had a type of arthritis called DISH, which was in his back and was the worst rheumatoid arthritis and osteoarthritis a person can have. Patient was in a lot of pain and took just pain killers and pain medicine as treatment as prescribed Norco by his doctor, 7.5-325 tablets to take as needed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event pain in back, hips, shoulders and hands was not recovered, and the other events was unknown. Follow-up (24May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable 63-year-old male consumer (patient) reported that included patient weight, age, concomitant medication, treatment received, outcome of events. No follow-up attempts are needed. No further information is expected.

Left arm was very swollen from shoulder to his neck; Stiff arm and stiff neck; headache; dizziness; muscle and joint aches; muscle and joint aches; Everything hurt; Thought he had the Flu/ flu symptoms; Couldn't lift left arm; Chills; Temperature got up to 99.2; Bed sweats; Nauseous; This is a spontaneous report from a contactable consumer. A 63-year-old male consumer (patient) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the left arm on 28Feb2021 16:30 (at the age of 63-year-old) as single dose for COVID-19 immunisation. The patient medical history included type 2 diabetic. Concomitant medications were not reported. The patient reported that he was calling to report a reaction to his first vaccine dose. He had no medical questions at this time and requested to be transferred to safety. 30 calls ahead, caller was agreeable to holding for the safety department. Got COVID-19 vaccine on Sunday afternoon 28Feb2021. Was okay after the fifteen-minute waiting period. Got home and took a nap. On 28Feb2021, the patient woke up at around 6:30 PM, he was feeling a bit nauseous. He drank ginger ale and went back to bed. On 01Mar2021 at around 01:30, he reported of everything hurt and thought he had the flu/ flu symptoms, could not lift left arm, chills, temperature got up to 99.2 and bed sweats where he had to change his bed and t-shirt twice. Never had a fever, but his temperature got up to 99.2. Last time he had the flu was 10 years ago, which was why he thought he must have the flu. Thought it was a coincidence he received his COVID-19 Vaccine and then got the flu. That morning, 02Mar2021, he felt great. On an unspecified date, he reported that his left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness, muscle and joint aches. Did not know what that was, but glad it was gone. His left arm was the injection arm. Arm was very swollen from his shoulder to neck. He felt his armpit and did not feel like his lymph nodes were swollen. Felt like a stiff neck and stiff arm. Did not have any trouble breathing. Did not have heart palpitations. No prior vaccinations within four weeks. He tested positive for COVID-19 Virus on 01Feb2021 around 4:30PM. Believes it was a PCR COVID-19 test. End of his isolation was 11Feb2021 and he tested negative. Was getting tested for a procedure that was scheduled for 03Feb2021. However, the procedure is now moved to 15Mar2021. No further details provided. Last vaccination was a Tdap and he did not have any problems with that. Tdap was forever ago and has no NDC/Lot/Exp to provide. Would like to speak to a consulting Nurse. Had first dose of covid vaccine and had bad reaction. Has surgery scheduled very close to second dose appointment of vaccine. Clarified surgery was scheduled before first dose of vaccine. Wants to know with having reaction to first dose and being close to surgery, should he get second dose. No unaddressed medical questions referred or forwarded to Medical Information. He was having surgery (hip replacement) on 29Mar2021 and was scheduled for his second Pfizer vaccine on 30Mar2021. Since he had several side effects with the first vaccine dose, he enquired that should he not get the second vaccine dose the day before his scheduled surgery. He was having a heck of a time getting scheduled for his second dose, window was supposed to be 20-25 and he was able to get it scheduled on the 28th, he had a severe reaction to the first dose, night sweats, no fever, but classic flu symptoms, lasted about 24 hours, started on 1:30am Monday morning is when he started having the symptoms. Had shot Sunday afternoon 28Feb2021. He was having a hip replacement on 29Mar2021, will it be a problem if he has another reaction, cannot cancel surgery. First surgery was cancelled because he tested positive for Covid on 01Feb2021, prior to vaccine, tested negative for covid on 11Feb2021, hip issues and surgery were scheduled prior to vaccine. Was it okay for him to get his hip surgery the day after his second dose of the vaccine. Investigation assessment was unknown. Outcome for the events left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness and muscle and joint aches were unknown. Outcome for rest of the events was resolved. Follow up (02Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics, relevant medical history and concurrent conditions, vaccine details, case narrative information. Follow-up (11Mar2021): This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported which included verbatim and event description, medical information. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included event details (no new events). No follow-up attempts are possible. No further information is expected.

The first time that I had this feaccion was after the influenza vaccine, one year after the H1N1 EPIDEMIC. In which I was diagnosed with RA. Now a few days after reciving this vaccine for COVID-19 my joints started to swell and became painfull, the swelling have been control with the increase of prednisone but there has been an increase of joints affected, in other words, my RA is now worse. We did a blood test to measure if I have created any antibodies and it came back None reactive (0). So I dicided not to continue with the vaccination.

feel a little arthritis pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Programme Covax US Support. A 63-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: EN6198) via unspecified route of administration in left upper arm received on 22Feb2021 at 11:30 hours (at the age of 63-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included arthritis and allergy to eggs. Concomitant medications were not reported. Patient did not receive any other products. Patient doesn't get the Flu vaccine because he has an allergy to eggs. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On unspecified date of Feb2021 (two or three days after the first vaccine), patient feels a little arthritis pain after the first vaccine. Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees. Patient states that he has been getting a needle, with medication, in his hand, for the pain, and it was not working. Patient could not tolerate the pain of his arthritis, and the needle, with medication, did not helped his pain. Patient states he does not know what medication he was injected with. Patient had physician office visit. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; Sciatic pain, worsened, after second vaccine; Swelling of left foot and numbness of toes on left foot, after second vaccine; Swelling of left foot and numbness of toes on left foot, after second vaccine; Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; Arthritis pain has doubled, increased and skyrocketed: arthritis includes pain and swelling of hands, thumbs, right shoulder and knees, after first and second vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 11:30 (Batch/Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunization. Medical history of the patient included ongoing arthritis and egg allergy. Concomitant medications were not reported. Patient did not receive any other products and doesn't get the Flu vaccine because he has an allergy to eggs. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 11:30 (Batch/Lot Number: EN6198) as 1st dose, single dose for covid-19 immunization and felt a little arthritis pain after the first vaccine.On an unspecified date in Mar2021, after the second dose at night, patient's arthritis pain was doubled and it had increased, skyrocketed, his arthritis included pain and swelling of hands, thumbs, right shoulder and knees. Patient stated that, he mentioned his increasing pain to his pain management doctor twice, and his doctor told him to call Pfizer. His sciatic pain kicked up, and clarifies as worsened, after the second vaccine. Pain went higher than an 8, sometimes from a 7 to a 9 on the pain scale. Patient experienced swelling of left foot and numbness of toes on left foot, after second vaccine and the swelling goes down, and results in numbness of patient left foot toes, swelling was off and on, and the numbness was more frequent. Reportedly, patient would normally feel the arthritis pain a day or two before bad weather, and his usual pain would elevate. The patient felt the same way after his second shot, as if it was a day or two before bad weather. He experienced this after the first and second vaccine, but worse, after the second vaccine. Patient states that he has been getting a needle, with medication, in his hand, for the pain, and it was not working. Patient could not tolerate the pain of his arthritis, and the needle, with medication, did not helped his pain. Patient states he does not know what medication he was injected with and cannot provide any specific details about this medication. Outcome of events Sciatica aggravated Numbness in toes, Swelling of feet were not resolved and outcome for rest of the events were unknown. No follow-up attempts are needed. No further information is expected.

63 y.o. man with hx of prediabetes, diverticulosis, and family hx of CAD who presented on 4/12/21 with chest pain.(Pt had first dose of Pfizer Covid Vaccine on 3/25/21, with no causative factors for Pericarditis). He developed sternal CP radiating to both shoulders while working in the garden on 4/11. The pain improved with acetaminophen and sleeping overnight, but still was present in the morning, prompting him to go to the ED. EKG showed diffuse 1-mm ST segment elevations, prompting emergent cardiac catheterization + coronary angiography --- > no obstructive CAD. cTnI and CK-MB were normal. He had WBC 14.1 & CRP 9.3, which raised suspicion for acute pericarditis, although his symptoms were not typical. Overnight 4/12-4/13, he developed new-onset rapid atrial fibrillation which was treated with IV diltiazem and metoprolol tartrate. He is discharged with colchicine and metoprolol tartrate. The CP resolved postprocedurally and did not recur.

Joint pain, unable to raise arm over head, then some improvement, now seeming worse- pain sleeping on shoulder, pain using shoulder, limited range

Sore joints and muscles; Sore joints and muscles; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:00 (Batch/Lot Number: ER2613) (at the age of 63-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergies: penicillin. The patient had no COVID prior to vaccination. Patient had no other vaccines in within 4 weeks prior to COVID vaccine. Concomitant medication included sertraline taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6199) on 15Mar2021 at 16:00 (at the age of 63-years-old) in the left arm for COVID-19 immunisation. In Apr2021, patient reported sore joints and muscles. The events appeared the week of second injection and then went away and reappeared on 05May2021 and is continuing. It was unknown if treatment was given to the patient. Patient had not tested for COVID post vaccination. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

worst case of the flu; Shakes; aches; headache; muscle pain; Still had a mild temperature; This is a spontaneous report from a contactable consumer, the patient. The A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6225) solution for injection, administered on the arm left on 15Mar2021 19:00 (at the age of 63 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) solution for injection, administered on the arm left on Feb2021 14:00 as a single dose for COVID-19 immunisation. Patients medical history included blood pressure, prostate and cholesterol medications. Concomitant medications were not reported. The patient does not had any allergies to medications, food, or other products. At other facility the most recent COVID-19 vaccine was administered to the patient. The patient does 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 has not been tested for COVID-19. The lab test includes body temperature and the result was max 100.2 degrees. On 15Mar2021 at 22:00, he experienced worst case of the flu. First 24 hours, he felt like the worst case of the flu he has had in decades. Shakes, aches, headache, muscle pain and hard to concentrate. Absolutely miserable. Still had a mild temperature. The patient does not receive any treatment for the adverse event. The clinical outcome of worst case of the flu was resolving. No follow-up attempts are needed. No further information is expected.

COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT. CANT SLEEP AT NIGHT AFFECTING MY JOB . MISSING TIME FROM WORK. NECK PAIN LEFT SIDE. PAIN IN MY CHEST LEFT SIDE. PAIN IN LEFT SIDE ARMPIT.

On the week of March 14, symptoms started mild and by the following week they were unbearable. On both legs, my muscles from my hips to my ankles became fatigued and got burning sensation when I was just standing up or sitting down. The pain was mostly relieved when laying down. I did not sleep well. Also, I got fevers only at night when asleep. Measured about 101 degrees temperature. Got up with tee shirt wet with sweat. On March 22, I went to my doctor and did some blood work and was told I had a lot of inflamation. Started on Prednisone. Went to RA doctor at Rheumatology on March 30, and went to an infectious disease doctor. I was told that I had an auto-immune response. I was on Prednisone from March 25 to May 16.

It started to ache on April 3 in arm and shoulder and progressed, and on the 4th I went to ER because I could get comfortable and it raised my blood pressure. ER doctors gave me ibuprofen and Percocet.

This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 63-years-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus diagnosed decades ago and wasn't feeling good from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 AM as 1st dose, single for COVID-19 immunization and no reaction on exposure to vaccine. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he went to the hospital because he wasn't feeling good in Dec2020 of last year and all the test results were fine, so he got his first vaccine, believes it was, 05Apr2021 for the first dose and 27Apr2021 for the second one. After that, the patient had extreme itching in his body and his liver enzymes are off and he just wanted to report what was going. The itching began after the first shot in Apr2021. He had to go to the hospital one time, and he had to go to the doctor 3 times, they say liver enzymes are off. He has a copy of the test. The patient stated prior to that, they were way higher when he went to the doctor. The patient's blood urea nitrogen (BUN) was 25 high, Aspartate aminotransferase (AST) was 100 high, Alanine aminotransferase (ALT) 176 high, alkaline phosphatase was 318 high, albumin was 3.2 low. He was also lost like 30 pounds. He has been experiencing extremely dizzy. Sometimes he stands up and he feels very dizzy and sometimes he feels strange, he has no other way to explain. He doesn't feel himself. He stated 8 days after the shot, he started feeling bad. It all started all together. The patient stated Pfizer can get that information from the doctor, he doesn't feel so good to keep up with that. The patient stated the extreme itching and extremely dizzy was worsened, that's why he had to go to the emergency room on 11Jun2021. Regarding the liver enzymes were off the patient stated, Pfizer can speak to the doctor. His doctor knows who he was and will give specifics. According to his doctor, the doctor was going to report it wherever it has to be reported to. He doesn't feel good, he was itching, and he doesn't know what to do about it. The event extreme itching and extremely dizzy required emergency room and physician office visit. The outcome of the events extreme itching and extremely dizzy was not recovered. The outcome of the events liver enzymes are off, lost like 30 pounds and he feels strange was unknown.

Fever; chills; pain at injection site; headaches; muscle pains; joint pains; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 20Mar2021 at 15:00 (at the age of 63-year-old), as an unknown single dose for COVID-19 immunisation. Medical history included hypertension and colon cancer. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 1300, the patient experienced fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell. The patient received other medication within two weeks of vaccination. Tylenol and Motrin was taken as therapeutic measures as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered. Information on the lot/batch was available, Additional information has been requested.

Injection site pain; Upper body muscle crumps/severe pain - most around neck area; Swollen lymph nodes; Headaches/ Any body movement causing head pain; neck pain/ Any body movement causing neck; Tiredness; Felling unwell; Dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. This report received from a 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 11Mar2021 (at the age of 63-years-old) at 11:30 as a single dose for COVID-19 immunisation. The medical history reported that the patient had two ablations, otherwise regular exercise, active living style. The patient had not received any medications within two weeks of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. On 13Mar2021, the patient experienced vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as results of events and included the treatment with naproxen 500mg, baclofen 10mg. The clinical outcome of the events vaccination site pain, upper body muscle crumps mostly around neck area, swollen lymph nodes, severe constant headaches with neck pain, tiredness, felling unwell, dizziness and weakness and any body movement causing neck to head pain were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Since May 2021 have developed right shoulder tendonitis which has gradually progressed to bilateral medial epicondyle elbow tendonits follwed by bilateral radial wrist tendonitis. Symptoms have remained mild but persistant and are bothersome when doing tasks typically considered routine.

- Severe lethargy - Chills - Dehydration - Limited torso flexibility - Rash - Swollen back of neck - Weight loss (20 pounds)

Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, stomach pain. severe joint pain that moves all over my body. 5 plus nights get chills and bad head fever. My breathing progressed worse as time went on and was hospitalized 7/1/21 with covid pneumonia, they worked hard and got it controlled fast and was released late 7/2/21. Now I am working from home on oxygen and quarantined.

Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection. Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).

Felt like punched in arm; Some soreness and some stiffness at the injection site; stiffness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 at 16:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included mild obstructive sleep apnea. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) 40 mg and omeprazole (MANUFACTURER UNKNOWN) 20 mg daily; both for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 19:00, the patient experienced like punched in arm, some soreness and some stiffness at injection site. The patient used an ice pack and once taken 800 mg ibuprofen helped reduce this no worse than mild pain or soreness. Moving left arm overhead with a back-and-forth motion also provided relief. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events felt like punched in arm, sore injection site and injection site stiffness were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Extreme vomiting; stomach pain; back pain; Loss of appetite; fatigue; chest pain; This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose via an unspecified route of administration in her right arm on 20Mar2021 at 16:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included kidney stones. The patient had no allergies to medications, food or other products. The patient received hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 21:00, the patient experienced extreme vomiting later same day of vaccination, chest pain, stomach pain, back pain, loss of appetite and fatigue. The patient did not receive treatment for the reported events. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events vomiting, chest pain, stomach pain, back pain, loss of appetite and fatigue were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Left arm between shoulder and elbow has become very weak and painful. It is difficult to raise my left arm (or extend it to close a car door for example).

I got symptoms like allergies but I don't know if they were allergies or not. Nothing that I thought wasn't more seasonal than anything else. The worst was extreme macular aches and pains and severe join paints. Muscles spams and cramps to the point of muscle tearing. Nothing has changed for me and time has gone on and I'm not getting them muscle spasms or pains. I'm not sure if the headaches I was getting was in relation to it or not.

discomfort in left shoulder blade area. pain in taking breath in back. tiredness, sweats, and discomfort in both kidney areas.

On the morning of April 2 I awoke with pain in every joint in my body. The worst was my left ankle, which was sprained badly when I was 12 years old. My right knee which has been diagnosed with mild arthritis was also particularly painful. The pain was bad enough that I could not walk without a cane. I took 600 mg of ibuprofen and had a cup of coffee. About 30 minutes later the pain had largely subsided, but I was somewhat sore for the rest of the day. I felt much better the morning of April 3.

SHOULDER PAIN IN BOTH, GENERAL MALISE PAIN IN MY LEGS, MY HAND SWELLED UP, MY KNEE SWELLED UP. THE PAIN COMES MORE WHNE I RECLINE IN A CHAIR OR LIE IN BED FEELS LIKE THE BLOOD IS POOLING IN MY ARMS.

severe swelling in both hands; moderate joint pain; moderate muscle pain; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0259, expiration date: an unknown date in Jul2021) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included osteoarthritis. Patient did not have any allergies to food, medications or other products. Concomitant medications included sildenafil citrate (VIAGRA) 100mg from an unknown date for unknown indication, bupropion XL 400mg (MANUFACTURER UNKNOWN) from an unknown date for unknown indication, and vortioxetine hydrobromide 10 (TRINTELLIX) from an unknown date for unknown indication. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 03Apr2021, the patient experienced severe swelling in both hands, moderate joint pain, moderate muscle pain and fatigue. Therapeutic measures were taken as a result of adverse events and included treatment with Ibuprofen (MANUFACTURER UNKNOWN) 600 mg x 1 time. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe swelling in both hands, moderate joint pain, moderate muscle pain and fatigue were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Sore shoulder; general malaise for the next two days; strange smelling urine; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30(at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. 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 31Mar2021 at 20:30 the patient experienced sore shoulder, general malaise for the next two days with strange smelling urine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event shoulder soreness, malaise and urine odour abnormal was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

acute inflammatory demyelinating polyradiculoneuropathy (AIDP, aka Guillain-Barre Syndrome) treated with IVIG 5/14-5/17/21: sudden onset noting numbness in fingers and toes around 4/13/21 and 4/14/21 and about 10 days later saw Primary Care for evaluation, but since this time notes progression of symptoms up to knee and forearm level. He also notes loss of fine motor abilities due to reduced sensation, and also has difficulty holding a pen to write. He notes development of loss of reflexes over this time period. Notes tingling sensation in hands and feels as if walking on rocks on feet and feels as if everything is tight, also notes burning pains and discomfort even with touching keyboard. No diarrheal illness, no change to bowel habits.

SECOND SHOT: He felt nauseated; His hiatal hernia had gotten worse since his car accident; Reported his neck was injured; my head just Spun; I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up; might have messed up my certain position of my neck and I had neck issues; SECOND SHOT: he had gotten real dizzy; SECOND DOSE: He passed out behind the wheel of his 2015 Mitsbushi Eclipse the day after he had his second Pfizer COVID-19 Vaccine; SECOND SHOT: he felt antsy after he got the vaccine shot; FIRST DOSE: with his first Pfizer COVID-19 Vaccine shot, he was down for a week; FIRST SHOT: he felt antsy after he got the vaccine shot; SECOND SHOT: He felt really weak now; This is spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0161 and expiry date 31Jul2021) via an unspecified route of administration on 15Ap2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0176 and expiry date 31Aug2021) via an unspecified route of administration on 06May2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 2, single for COVID-19 immunization. The patient's medical history included Stomach cancer, 14Feb2021 after being exposed to heavy metals. The patient's concomitant medications were not reported. Reported he had an adverse reaction to the Pfizer COVID-19 Vaccine. He said it had been one heck of a ride, and he felt like the Pfizer COVID-19 Vaccine almost killed him. He passed out behind the wheel (of his 2015 Mitsubishi Eclipse) the day after he had his second Pfizer COVID-19 Vaccine, and he knew it was the Pfizer COVID-19 Vaccine shot because he felt antsy after he got the vaccine shot. He said he felt antsy after his first Pfizer COVID-19 Vaccine shot, too and with his first Pfizer COVID-19 Vaccine shot, he was down for a week. Reported his doctor seemed to be the least concerned about him being knocked out. His doctor did not appear to be receptive to what his complaints were after he received his second Pfizer COVID-19 Vaccine shot. His insurance company was aware he was going to change doctors. The patient reported that he collapsed on 14Feb2021 after being exposed to heavy metals, and was hospitalized, stating his primary care doctor had not helped him at all. On an unknown day he felt nauseated. It was reported on 07May2021, the day after his 2nd Pfizer COVID-19 Vaccine injection, he felt antsy by the time he got home, threw his body in bed, and was down for a day. He felt nauseated, but (on 07May2021) did some sheets at the laundromat. While coming home he had gotten real dizzy, and passed out. He ended up flooring the gas pedal on his car, and bounding over the curb in his apartment complex's parking lot. He bounced his head on the front passenger side seat. He clarified he passed out over the center console of his car, and his rib cage went over the car's center console. His head bounced off of the passenger seat. He said his rib cage was pushed up inside him when it hit the car's center console, and had to do something to his insides. He said it was a one car accident, and his apartment manager may have the car accident on film. He was looking in three directions and my head just Spun, I get the sick feeling. Reported his car accident caused a tear in his hiatal hernia in his stomach and he needed surgery. Reported his neck was injured. He had follow ups with his doctor since then, and his neck had been getting worse. He felt like something foreign was stuck in his throat, so he went to the Emergency Room (on 22Jun2021). The patient needed to see an endoscopy doctor to be ruled out for stomach cancer. He was told by the Emergency Room doctor that he had a mass in his stomach, and his hiatal hernia needed repair. His hiatal hernia had gotten worse since his car accident. He stated that he went home and laid down after his car accident. He said he felt ok and had his own pain medication to take to help recover from the car accident. He clarified he took Hydromorphone that was prescribed by his pain doctor. He did not have the Hydromorphone , Lot, and Expiry Date. He had an appointment on 23Jul2021 to see doctor for a new Hydromorphone prescription. No further details provided. The patient reported he was concerned about the stomach thing. He recalled his stomach swelled up after his car accident. He tried to take oxygen through a CPAP machine after the car accident to help him feel better and using the CPAP machine was not normal. His CPAP machine worked perfectly before the accident, but now he had a problem, and could not take the CPAP machines pressurized breathing. He now fought to get a breath while the CPAP machine was pushing oxygen in because he was trying to push his breath out at the same time. He felt really weak now, and the CPAP had helped all along. I did passed out behind to wheel of my car and 'it doesn't stopped'(Further not clarified) and I didn't have any information to you because all the information I had is in back of my car. The first shot I was given 09Apr2021 no 15Apr2021 looks like, I think this was she said worked down 15Apr2021 (Further not clarified), second shot I received on May 6, but on 07May2021 at 5 pm I just passed out upon pulling into my Apartment complex and the snakes you known 'just slow you down'(Further not clarified) you know of course I didn't have any problems to slow down but there were 4 cars behind me, I am looking at the cars, I am looking at the rare view and I am looking ahead of me to make sure , you know I am following 'snake' and everything's being cool and I am been forced to go fast what I mean I was driving car but I was looking to those 3 different areas my head just Spun, I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up and I think I might have messed up my certain position of my neck and I had neck issues, that happened on 07May2021, the day after the second Covid shot, I think if I had not gotten, if I stayed down may be the thing better but First time I got the first shot, it was 3 months the same thing I felt the same like I have to be really careful you know what I did, if I did it (Further not clarified, hence event not captured ). The second one I didn't feel that way. The patient required emergency room and physician office visit. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has severe pain in area. This limits pt's mobility.

small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report. Follow-up attempts are completed. No further information is expected.

Received vaccine in the morning 08:00 am, took acetaminophen 1 GM at 09:00 am due to pain in arm. By 10:30pm, I began having flu like symptoms, (aches, low grade fever, sinus symptoms) took another acetaminophen 1 GM. At 11:00 pm, developed severe rigors that lasted for approximately 2 hours. I am an RN and I have seen many cases of sepsis and felt like I was experiencing similar symptomatology. By 1:45 am, the rigors finally ceased and the body, muscle and joint pain became severe (on a pain scale of 1-10, it was an 8). At 7:00 am, I took another acetaminophen 1 GM, the body pain became much less and I was experiencing a global headache. I do not get headaches, so this was unusual. By 10:00 am, the headache was minimal, body aches were gone, only sinus symptoms persisted.

Headache; I got small fever like 99.9; Muscle pain; Feeling unwell; Difficult breathing just a little bit just like a cough a little small cough; Difficult breathing just a little bit just like a cough a little small cough; Dizziness; Cold; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included diabetes, high blood pressure, and cholesterol. Concomitant medications included diabetes medication, medications for high blood pressure and for cholesterol. The patient stated that he got the Pfizer vaccine on Christmas eve that would be the 24th and today (30Dec2020) he was getting just small things like headache, fever (small fever like 99.9), muscle pain, feeling unwell, difficult breathing just a little bit just like a cough a little small cough, dizziness, and probably just a cold. There was no injection swelling, fast heartbeat, and rash. He doesn't know if he should go get tested for COVID or not because he just took the shot. The patient stated that he got to get the next dose of the vaccine on the 14th of January. The outcome of the events was unknown.

Myalgia, Diarrhea, pain at injection site Narrative: Myalgia and inection site pain/myalgia and diarrhea by 9pm on date of injection 12/29/20. Myalgias continued for 2 days and resolved by day 3.

Headache, Myalgia, injection site pain Narrative: Side effects began the day after Injection: site pain, significant myalgia and arthralgia, could not walk his dogs, rigors without fever, chills-has to take Acetaminophen every 6 hours, frontal headache. States fatigue is "disabling" Has had to take time off of work.

I did my Injection Friday 1/15/2021 at 09:00 PM and woke up Saturday feeling unwell, chills and muscle pain all day. Sunday 1/17/2021 I awoke at 6:00 AM with my Right ear swollen at least three times normal size. The ear has visable sores and is extruding a clear liquid all day Sunday 1/17/2021 and today Monday 1/18/2021. I made an appointment for 4:30 PM today with NP

Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats

I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of my chest; hip joint pain sever enough; This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREH9899), via an unspecified route of administration at left arm on 29Dec2020 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing Chronic hip joint pain. Concomitant medication included celecoxib at 100mg once daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020 at 16:30, after patient left the observation tent, while walking to his car, He felt slightly lightheaded. Upon reaching his car he felt a slight disorientation and a very heavy feeling in the center of his chest. These symptoms lasted until he reached home which was about a 15 min drive. Once at home he experienced hip joint pain sever enough that he had to stop being mobile. All symptoms disappeared within 1-2 hours except for the heaviness in the center of his chest. This lasted for about another hour. After that no more issues. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.

From about 9:30pm Saturday 01/23/2021 till approximately 11am Sunday01/24/2021 I experienced serious diarrhea (8 times), accompanied by muscle pains and chills. Thirst. I had no difficulty in breathing.

Fatigue; fever 99.6 F; headache; myalgias; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 19Dec2020 08:45 at single dose, and then second dose (lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. On 03Jan2021 11:00, the patient experienced fatigue, fever 99.6 F, headache and myalgias. Therapeutic measures were taken as a result of the events that included Rest Tylenol Motrin. Clinical outcome of the events was recovered on an unspecified date.

fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one. He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.

Report of left shoulder pain with swelling started the next day post vaccination. Treatment: Advil and ice. Outcome: No improvement with pain, ice helped with swelling. Continues to work, no interference with ADLs. Consulted his primary doctor via telemedicine.

Extreme joint pain/achiness over entire body; extreme fatigue; fever that ran from low grade up to 101.5; cloudy peripheral vision (cloudy vision only lasted about 30 minutes). Fever does respond some to ibuprofen, but ibuprofen does not help joint pain or achiness.

Body aches, fever, chills, joint swelling gradually worsened until had to miss work on 2/9/21. Symptoms persisting. Sudden onset dermatomal type skin rash 2/12/21. As of 2/16/21, starting to resolve. Diagnosed as atypical shingles because other than rash, no pain or itching associated with this.

Patient is a 64-year-old male who has received 2 doses of the pfizer coronavirus vaccine. He received his last dose last week and started having pain in the shoulder which gradually spread to include the upper back and neck region. The pain would radiate down into the arm. he describes the pain as a very deep constant ache with no real aggravating factors. The pain is worse when he is lying down at night. It is best when he is up and active. He has no specific pain with movement of the neck, back, or arms/shoulder. He denies any lumps or bumps at the injection site. He denies any color changes in the overlying skin or swelling. He feels numbness in the entire hand in a stocking glove distribution.

Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered. No follow-up activities are needed. No further information is expected.

Sore throat; chills; headache; lower back pain; muscle pain; sinus drainage; severe cough; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9262), via an unspecified route of administration on the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunisation. Medical history included hypertension. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, atenolol, and atorvastatin. The patient experienced sore throat, chills, headache, lower back pain, muscle pain, severe cough with thick yellow phlegm on 29Jan2021 13:00. It was reported that the patient had sinus drainage on 29Jan2021 13:00. There was no treatment for the events. The patient has not recovered from the events yet.

Less than one hour after shot - extreme sense of needing sleep. Took 30 minutes nap in car after stopping at convenience store. Over the next 36 hours, loss of strength, extreme aches and joint pain, fever up to 101.2, fatigue,

Arm soreness at injection site Temp 102 F for 48 hrs Severe shaking chills, rigors for 48 hrs Headache 72 hrs Severe myalgias for 72 hrs Joint pain 72 hrs Sweats, particularly at night for 72 hrs Fatigue for 96 hrs Took multiple doses of Tylenol 1000mg over course of 72 hrs.

I had no adverse effects at the time of the vaccination and the day was uneventful but I got a small headache early in the evening on the left side of my head/neck. I ignored it. By bedtime 10/11 PM Thursday night I had pain in my neck on the right side that felt like I had been in a bad car accident. By 4 O'clock in he morning the pain was almost unbearable. I got up and did an hour of stretching and it became bearable. I had finally taken a 8 MG HYDROMORPHONE tablet just before 4 AM that the doctor had given me last summer for falling over a pile of lumber and landing on my back on a 4 x 4 board. That helped some. Ever since then, the pain in my neck has gone from a 4/10 to a 9/10 in pain and the headaches have clustered on the left side of my head. The worst ones are just below my left ear. It is now Saturday night and the neck pain is not as bad but it is not gone either, It still hurts to turn my head, cough or when I get up or down. I did not do anything physically to cause this.

Terrible cramps diarrhea nausea vomiting constipation a high fever of a 103 or more Muscle aches sore skin joint ache Worse than the flu

SORE LEFT ARM AND NECK, LETHARGIC, LIGHT HEADNESS, HEADACHE, SOME SOB TX- SLEPT/ REST MORE AND DRANK EXTRA FLUIDS

Extreme muscle weakness beginning 48 hours after second Pfizer shot. Confusion and slurring of some words. Difficulty walking. Still experiencing mild symptoms almost one week after the second shot.

Immediate onset of uncontrollable chills and fever of 100.8. Muscle aches and major malaise. Later chills/hot flashes occurred.

Injection site soreness x 3 days, Myalgias and fever (99.2 -100) for three-four days, headaches, fatigue, arthralgias.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: initial dizziness, loss of consiousness for roughly 30-60 seconds, body rigidity before waking up-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: 4-5 minutes after vaccinating patient he reported feeling dizzy, when accessing patient he became unresponsive and breathing became louder, he became pale and lost consciousness. 911 was called. His face began turning red and with the help of 2 individuals we lowered him to the floor, his arms became rigid for abotu 5 seconds, and upon trying to wake him/checking for vital signs, he came to and was aware of where he was and that he had just got a vaccine. he did not recall the event post dizzine

Fever of 104F, arthralgia, nausea and vomiting, extreme fatigue. N&V last ~24h and other symptoms lasted three days

63yoM with PMH Anxiety, Depression, GERD, Arthritis here for evaluation of rash x 2 days. Pruitic in some spots. Started on L wrist yesterday. Awoke with red spots on face today. Got 2nd COVID19 vaccine (pfizer, with Norton) 48 hours ago. Called hotline and they advised coming for evaluation. Has applied no therapies. Took a single benadryl last night for pruritis. Denies chest pain, dyspnea, wheezing, dizziness. Did yard work 4 days ago and history of contact derm to plants, otherwise no prior history of rash like this.

lightheadedness, weakness, Pain Narrative: A 63yo male with history of tobacco use, Cocaine dependence in remission, PTSD, Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he received Covid-19 vaccine on January 11, 2021, per protocol, without complications and was advised to stay on site for 15 minutes. Instructions about side effects and ADR reporting were also provided. He called hospital advice line on January 12, 2021 to report ADR symptoms of having LT arm pain that radiates to his back and chest which started on his way home after he received the vaccine. Also reported he felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the call documenting nurse, to go the hospital ED, for evaluation. Per telephone note - Physician A/P documentation included that symptoms were discussed with the patient on January 12, 2021 @13:01 PM, patient was assured what he experienced was an expected reaction from the vaccine and it'd be safe to get his second scheduled shot On January 14 the patient called back to report feeling a little light headed, having muscle/ body ache and feeling weaker after the Covid-19 vaccine. Recommendation was made to go to the ER by the call taker Patient called on January 15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17, 2021 the patient presented to the ED with chief complaint of Chest pain, was hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained in MICU and passed away on February 4, 2021

Dehydration, muscle soreness (slight, e.g. after exercising too much), elevated temperature up to 101.7 F. Drank water, took a nap, and took 500 mg of Tylenol when temperature reached 101.7 F. About an hour after having taken Tylenol, temperature was back at 99.8 F. No further muscle soreness.

Vaccine received 10:30 am Monday 3/22. Headache, muscle and joint soreness, very tired starting 4:30 pm Wednesday 3/24. Slight elevated temperature 3/24. Continue through Friday 3/26. Starting afternoon of Thursday 3/25, skin sensitivity on upper body, front and back. Feels like a sunburn to touch. Ongoing.

I had the Pfizer vaccine, 1st and 2nd. The first one gave me the reaction most people say the 2nd one gives, although not quite as bad as what others have described. HOWEVER, the 2nd dose in my case, cause a severe flare-up of arthritic type symptoms in my joints, mostly both knees but no feverish reactions. When I say severe arthritic flare up, I mean debilitating to the point where it almost hurts too much to walk. I had the shot on a Friday, the arthritic pain began late that night and became worse on Saturday. It is now Monday and the pain has only subsided a little bit. It's still difficult to get up from a sitting position and to walk or stand for longer periods of time.

sore shoulder starting 7 hrs after injection. Woke up to 102 F fever and chills at 2 am. Symptoms slowly dropped away to just balance issues as of morning of 03/29.

Systemic: Joint Pain-Severe, Additional Details: Pt states that the day after the 2nd dose he has full body ache which was expected. But, the next day and 2 days after, the pt states that the pain, along with noticable swelling localized in his left knee.

Patient presented for Second dose vaccine and was vaccinated without incident. During 15 minute observation time patient complained of chills, body ache and stiff neck. BP at 12:45 was 180/100; HR 76. Patient states he is anxious, worries about side affects from vaccine. Denied SOB, no diaphoresis. Patient denied history of hypertension. BP at 12:50 200/100, HR 76, R 18; 12:55 pm BP 180/100 and EMS was called despite patient denying SOB or dizziness. 1:10 PM EMS arrived. BP 176/100, HR 80. Declined transport to hospital and left site at 1:15 ambulatory.

I have had on and off serious muscle soreness for 3 weeks now. comes and goes. will last 2-3 days, lessen up for a couple days and come back. hurts and sore to get out of a chair, walk around. hamstrings extremely tight. metabolism in overdrive, have lost 3-4 pounds. begging to become concerned how long this is going to last. my wife had nothing. best friend nothing. I have had flu shots for 14 years straight and no side effects. I am scheduled for my second shot in two days on monday 04/05/21 DO I Go ?

sore arm; general muscle soreness; slight nausea; lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER8732) via an unspecified route of administration, in Left arm on 26Mar2021 at 11:00 (at the age of 64-year-old) at a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration, in Left arm on 02Mar2021 at 15:00 at a single dose for COVID-19 immunization. The patient was vaccinated at hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient did not have allergies to medications, food or other products. The patient medical history was not reported. The patient received unspecified concomitant medications. The patient experienced sore arm, general muscle soreness, slight nausea and lethargy on 26Mar2021 at 21:00. The events were reported as non serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Trigger finger - Left Middle Knee joint pain - Right Foot Patience has taken Tylenol and Aleve prior to visiting his doctor. Doctor prescribed Meloxicam.

SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite, difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected. LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.

CLIENT REPORTS THAT HE WOKE UP 4/4/21 WITH PAIN IN HIS RIGHT KNEE AND SWELLING IN HIS RIGHT CALF, WHICH HAS INCREASED FROM HIS RIGHT KNEE DOWN TO THIS DAY. HE ALSO HAS NOTICED IT IS WARM TO THE TOUCH TODAY. CLIENT CALLED HEALTH DEPT TODAY TO REPORT THIS SYMPTOMS. PUBLIC HEALTH NURSE CALLED CLIENT FOR INFORMATIION AND ADVISED HIM TO SEE A MEDICAL PROVIDER TODAY REGARDING HIS SWOLLEN AND PAINFUL R LEG/CALF. CLIENT AGREEABLE. CLIENT STATES HE HAS APPOINTMENT TODAY AT 2:45 WITH A PROVIDER.

Started with soreness in arm and expanded to shoulder joint the next morning. This persisted an got worse for each of the next three days. Muscle soreness then began to abate on the fourth day, but shoulder and elbow got more sore and stiff. Now, 11 days after the vaccine, most general soreness is gone, but shoulder remains stiff with a loss of full motion without causing pain.

On Sunday, April 11, 2021 morning, I noticed that my left side towards the back was hurting. I normally have a cup of tea and do some mild calisthenics and walk around the house. The pain escalated over time. The next day, April 12, I called my primary care physician and we had a zoom health care visit. My primary care provider and she prescribed 800 mg ibuprofen, I told her that I had taken the covid vaccine on April 2, 2021. The pain subsided temporarily but came back once the meds wore off. It's 4 days now, and the right lateral right side towards the back (approximately where the Kidneys are is still tender and hurting once the meds wear off. I am waiting a urine analysis results to confirm if this an infection or a kidney stone.

Symptoms began roughly 15 hours from the injection with severe headache and body aches. That continued to progress to include a 102 fever, aggressive chills, nausia, no appetite and muscle weakness. The symptoms continued, especially the muscle weakness, to the point that by the afternoon of the 12th, I was unable to get up from a chair or navigate stairs on my own. I was really unable to sleep. By the afternoon of the 13th, the muscle weakness subsided to the point that I could get out of a chair and navigate on my own, not well, but on my own. Symtoms continued to decline by the afternoon of the 14th. Symptoms continued to improve by the afternoon of the 14th that I could return to computer work.

Noticed around 13:30 hours: Swelling and moderate pain around injection site, slight headache; Noticed around 14:30 hours: numbness in forehead, nose & cheeks; drowsiness; Noticed around 16:00 hours: pounding headache requiring ingestion of Tylenol, fatigue; Noticed around 18:30 hours: aches & pain in joints, primarily ankles, knees, fingers, wrists, elbows, and shoulders; Noticed around 03:30 following morning: cramps in right calf muscle lasting for approximately two (2) minutes. As of 04/16/2021 at around 10:54: slight headache, some fatigue, aches & pain in joints still exist but diminishing with worst pain area in knees, elbows, and wrists.

Two reactions, one severe, one moderate. Moderate: My arm starting hurting three days after the first shot, a dull pain at the site of the jab. The dull pain has not gone away. I can feel it right now as I type this. Severe: One week after the first shot, my varicose vein problems re-emerged. I had vein surgery in 2018, and my problems vanished until the first shot. My calf muscle swelled and became very painful; my lower leg was covered with black and blue bruises; my varicose veins reappeared. These problems diminished slowly throughout February. I saw a specialist at the Vein Clinic in March, who determined that I needed additional surgery this summer. My leg has almost returned to normal, but I have intermittent heaviness in the calf muscle and pain in the quads, like a weaker version of what I had before the first vein surgery in 2018. Additional comments: I had a bout of powerful fatigue following the first shot. I slept 14 hours straight the day after getting it. For the second shot, the fatigue was less severe, coming in waves. However, I felt weak for more than two months, which I noticed since I go to the gum regularly. My strength has still not returned to where it was previously.

Tested Positive on January 6th, 2021 Bad headache, I hurt all over just like when I had the Covid Virus, Joints were the most painful, My body had hives on all places I was able to see, Eyes were very red with red rings around the outside of my eyes and eye lids, Nausea, my skin had a red look and there were red lines on my arms and legs, Every vein on my limbs were very pronounced, I had a "restless" arm and leg" vibrations and I had to get up and walk to make the feelings stop. I fought against the symptoms.

Gout; Swelling of Ankle; Headache; This is a spontaneous report from a contactable consumer reported for himself. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, in arm on 24Mar2021 00:15 am (at 64-years age) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. The patient experienced gout, swelling of ankle and headache on 25Mar2021 12:00 pm. Patient was not allergic to any medications, food, or other products. No treatment received for any reported adverse event. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

not sleeping on that shoulder; Sinus infection/Head Congestion; Bronchitis; Positive Covid Test; Positive Covid Test; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03Feb2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included raynaud's phenomenon from 1992 and ongoing, chronic obstructive pulmonary disease from 1998 and ongoing, anaemia from 1986 and ongoing, renal transplant from 2014 to an unknown date, stated it started during chemo in 1986 and comes and goes but he never gets better than borderline; states since his kidney transplant it happens less, lymphoedema from 2010 and ongoing, hypertension from 2000 and ongoing, ongoing dry mouth, stated he has had his whole life because of Sjogren's, mycobacterium chelonae infection from 2014 to an unknown date, stated it was a cousin to Leprosy and a type of TB. Stated the infectious disease doctors presented his case to the CDC and he was on antibiotics for 2 months to get rid of that, one cost $5000/day. States he was getting cellulitis in both legs every week until they took care of that, sleep apnoea syndrome from 1998 and ongoing, ongoing peripheral venous disease, blood clot in lung and DVT in leg, stated he has thrown blood clots that lodged in his lung and had a DVT in his right leg--during chemotherapy, gout from 2005 and ongoing, advanced neuropathy and ongoing, advanced neuropathy all over his body for 25 years. Stated he has had finger nails torn out and it doesn't hurt. Leg ulcer from: 1987 and ongoing, reoccurring leg ulcers mainly around his ankles. Stated his skin was so thin that it breaks open and forms ulcers. States he got out of the hospital in Nov 1986 and they showed up next summer 1987. States he has been wearing compression support hose since 1988 all the time, ongoing Sjogren's syndrome, Sjogren's Syndrome which is a lesser degree of Lupus. States he has had it for 6 years. States the clinic missed it on him. States he was diagnosed in the air force and it has advanced now to the point that they are calling it Lupus like. State he is a 100% disabled. Caller states he had a kidney transplant in 2014 and he has been on immunosuppressant drugs for 18 years. Mainly Prednisone, CellCept and Tacrolimus. Historical vaccine included BNT162B2, Lot: EK4176, on 13Jan2021 for COVID-19 immunization. Concomitant medication(s) included prednisone taken for transplant suppression and sjogren's from 1998 and ongoing; allopurinol taken for gout and ongoing; amlodipine taken for raynaud's phenomenon; bisacodyl (DULCOLAX [BISACODYL]) taken for an unspecified indication and ongoing; hydrofluoric acid (HYDROFLUORIC ACID) taken for moisturizing legs for skin and ongoing; losartan taken for hypertension and ongoing; magnesium oxide taken for supplement magnesium levels are low and ongoing; mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]) taken for Kidney Transplant Suppression and Sjogren's for 18-20 years and ongoing; rosuvastatin taken for blood cholesterol abnormal and ongoing; tacrolimus taken for kidney suppression anti rejection and ongoing; tiotropium bromide (SPIRIVA) taken for lung problems copd; states he has had 8 pneumonias and bronchitis and ongoing; valaciclovir (VALACICLOVIR) taken for outbreaks of shingles in mouth herpes simplex and ongoing; vitamin d ongoing; vitamin b12 taken for supplementation, ongoing. The patient experienced positive covid test on 27Mar2021 11:00 with outcome of recovering, not sleeping on that shoulder on an unspecified date with outcome of unknown , head congestion on an unspecified date with outcome of unknown, sinus infection on an unspecified date with outcome of recovered, bronchitis on an unspecified date with outcome of unknown. Stated he had his second shot on 3Feb2021 and on 27Mar2021, he was diagnosed with Covid. Caller stated on Saturday 27Mar2021, when they found out, the emergency room was really startled [that he tested positive for Covid after being fully vaccinated] and the hospital is a good size. Stated he was the first person that has been fully vaccinated that has caught Covid at the hospital. States he may have caught the virus earlier. States it started with head congestion that lead to a sinus infection and he was put on a Z-pack. States the sinus infection went away but he started having lung trouble so he went back and they said he had bronchitis, his lungs looked fine, and they put him on a different antibiotic. States they said lets do a Covid swab to make sure but they really doubt he would have it and the Covid test came back positive and boy were they surprised. Clarifies the antibiotic didn't work on the Covid. States it was Levofloxacin, dosage unknown. States the Hosptial is normally good about putting the dose on there but they didn't put the dosage and they kept the bottle at the emergency room on Saturday. Caller states that he is also on these other medications; however he doesn't think they were taken within the 2 weeks before the vaccines. Acetaminophen as needed, albuterol as needed, Refresh Eye Drops as needed, Guaifenesin as needed uses when he gets a chest cold and gets them fairly often, and Sudafed as needed. States a surgeon once told him he had the worst bronchitis that he has seen in his career. States he has had a collapsed lung. States during therapy they were putting in a subclavian line and nicked his lung. States boy does that hurt getting a line put in. Caller states he had a kidney transplant in 2014 and he has been on immunosuppressant drugs for 18 years. Mainly Prednisone, CellCept and Tacrolimus. Treatment was gaving him a boost of dexamethasone, simply relying on the vaccine to help him get better. States he had no adverse reactions, other than not sleeping on that shoulder, that is all he had. Emergency Room visited on Saturday 27Mar2021 and 23Mar2021. States they did X-rays and blood tests and that is when they told him on 23MAR2021 that he had Bronchitis and sent him home on the antibiotic. The patient underwent lab tests and procedures which included blood test: unknown result on 23Mar2021, sars-cov-2 test: positive, x-ray: unknown result on 23Mar2021. Therapeutic measures were taken as a result of positive covid test, sinus infection, bronchitis.

Headache; fever 103; muscle aches; This is a spontaneous report from a non-contactable consumer (Patient). A 64-year-old male patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an intramuscular route of administration at left arm on 23Mar2021 15:30 as single dose for COVID-19 immunization. Patient had historical vaccine (at 64-year-old) first dose of BNT162B2 at left arm on 02Mar2021 03:30 PM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included Cancer. Past drug event of patient was allergies with Penicillin. Concomitant medications included pembrolizumab (KEYTRUDA). On 24Mar2021 17:00, the patient experienced headache, fever 103, and muscle aches. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included fever was 103 on 24Mar2021. Treatment was not received for adverse event. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

back and knee pain every hour woke up at 0600hrs. my joints were very sore and it was very hard to get out of bed. it progressed all day and as I went to bed at approximately 22:00hrs. I woke up with severe joint pain almost every hour (knees and back, from my waist to my neck inclusive. as I type this report I am still in severe pain although not as bad.

I submitted. received error. Submitting this again. Previously I reported stiffness in the hands and developed a trigger finger. These occurred began on Feb 19th. See report 330994. I have had a cortisone shot in both hands. This has relieved the stiffness somewhat, but not entirely. No relief for the trigger finger. The new adverse event is a ear ache and tinnitus. These started about a week ago. They are continuous. I have tried sudafed and zyrtec to no avail. I will be seeing doctor shortly.

Increased joint pain in knees, shoulders and hips. Approximately a month after second dose I began to have significantly increase in joint pain.

Experiencing chills, fever over 101 degrees, soreness and redness just above left leg ankle area. Also soreness/ pain in upper inside thigh area Just took 3 ibupropen about 11 am

Day after 2nd dose, 4-15, experienced fever, headache, muscle ache, and tiredness. 2nd day after 2nd dose, had slight fever and slight headache. As of 4-17, have been experiencing mild headaches every day, from mid morning to early evening. Rarely if ever had headaches prior to 2nd covid-19 vaccination.

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Felt \"unwell\" for 4 days-Medium, Error: Incorrect Reconstitution, Additional Details: Patient states that his right arm feels weaker than normal and is impacting him at this job.

Injection was given on top of shoulder instead of back of arm. Shoulder joint and arm started hurting 30 minutes after injection radiating down arm. Extreme exhaustion and sleepiness but unable to sleep due to pain. Nausea and stomach upset.

all of a sudden a pain shot through knee; he can't put any weight on it; This is a spontaneous report from a contactable consumer. A 64-year-old male patient (reporter's boyfriend) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunization. Medical history included his weight is too much, maybe 210 pounds or something around there. The patient's concomitant medications were not reported. The patient experienced all of a sudden a pain shot through knee in Mar2021, he can't put any weight on it in Mar2021. Clinical course as reported: Reporter is a consumer reporting her boyfriend received the first dose on 24Mar2021 and is reporting pain in his knee. Reporter said the boyfriend's knee pain 'comes and goes really quickly'. Her boyfriend went golfing and he was getting ready to swing and getting set and all of a sudden, a pain shot through his knee and he couldn't put any weight on it. Patient said this knee pain was happening every one in a while but not often. Patient is running around like crazy person, he never sits still. Reporter stated she would have to check with her boyfriend to say when the pain began, she thought boyfriend stated it was the same day he received the first dose of Pfizer Covid 19 Vaccine on 24Mar2021. Also said it was the same day boyfriend received first dose of Pfizer Covid 19 Vaccine or the next day, within a couple days. Happened again the other day and it seemed to be sporadic and not as intense. Reporter reported her boyfriend received his vaccine at the same place as the reporter. He got his vaccine at the same place as reporter at a different time of the day around noon. Reporter said boyfriend was supposed to go back for the second dose of Pfizer Covid Vaccine the same day the reporter was scheduled to do so. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

2 days after first dose pain and swelling in rt knee resolved after 2 weeks. 2 days after the second dose had sever incapacitating pain in rt knee again. Pt does have thallasemia minor

8 to 12 hours after my first COVID-19 shot on 3/11, the outside of my left (non dominant ) wrist started to hurt. I had not injured or overused it. It has never hurt without a reason before. It has continued to hurt ever since (47 days). That was the only side effect I had other than a sore upper left arm (several days). Nothing changed after my second shot (lot #EP7533) on 4/11 (just a sore upper left arm again for several days). The pain has spread to the inside/underside of my wrist in the last week or so.

Swelling and fluid on left elbow. The fluid decreased by 70% within 3 or 4 days but is still some fluid left. It is small mass on corner of elbow slightly sensitive to pressure. Is this a side effect and should I be concerned?

Dizzy, muscle aches, joint pain, nausea, flu like symptoms for 3 1/2 days Rather severe Same problems on second shot but less so.

low fever (100F); headache; muscle ache; This is a spontaneous report from a contactable consumer. A 64-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 on 16Feb2021 09:00 as single dose for covid-19 immunization. Patient was 64-years-old at the time of vaccination. Vaccination facility type was workplace clinic. The patient medical history and concomitant medications were not reported. No Known allergies. On 26Jan2021, the patient received other pfizer vaccine within 4 weeks. No other medications in two weeks. No prior covid vaccination. No covid tested post vaccination. On 17Feb2021 at 01:00, patient experienced Low fever (100F), headache, muscle ache. The events assessed as non-serious. No treatment received. The outcome of the events was unknown. Information about lot/batch number has been requested.

He got the vaccine on a Friday, and felt sore after. On Monday he still felt pain on his back, but thought it was because of the vaccine. He also felt warm and itchy on his back and under arm as well. It started as a small patch that looked like a rash, and was very painful and itchy. By the end of the week he decided to go to the doctor because he couldn?t take the pin anymore and it was spreading and blistering. He was given Ibuprofen, and acyclovir ointment. The second visit on April 5th they gave him Gabapentin 100 mg.

Started with a stiff neck turning to the right, then two days later woke up with a feeling of concussion syndrome, vertigo, head nausea, brain fog and then buzzing in both ears, this has been on going since the first vaccine, it got worse after the second vaccine on February 21st . I have had a brain MRI, and Neck MRI both appear normal, I have been checked by ENT for ear issues none noted, being treated by neurologist now for all the head symptoms

Six days after pfizer shot #1, I noticed that my little finger and ring finger had no strength on the arm with the shot. I also had arm. pain since the shot as well on that arm.

After the COVID vaccine, it started numbness in hand fingers while sleeping, slowly, slowly and day by day it become more. Last four days I could not able to sleep, whole body getting numb while sleeping, and it getting all blood to the hands, legs and hand figures, foot fingers are becoming numb. And also getting pains in the bone joints, specially in fingers. Getting Itchy, eye pain due to no sleep. Some one should call and provide remedy immediately, otherwise I may die, this responsible is control organization. This I am entering at May 4th 2:00AM CST. I already registered online, no responded.

fever 100.8 severe pain head ,neck, back, shoulders ,back arms hands hot cold sweats, lungs , weakness

Patient presented to nurse A&O x3, with calm affect. No history of reactions to vaccines. After prescreening patient the vaccine was given. Immediately, the patients eyes rolled back and he went limp. RN supported patient in chair until paramedic took over quickly..

16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 04Feb2021 at 11:00 AM (batch/lot number: EM9810) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clindamycin and experienced allergies; and BNT162B2 first dose on 14Jan2021 at 10:30 AM (batch/lot number: EL3248) administered in the right arm for COVID-19 immunisation. Facility type vaccine was public health clinic/administration facility. No other vaccine in four weeks. No COVID prior to vaccination and was not COVID tested post vaccination. On 05Feb2021 at 03:00 AM, 16 hours after the vaccination, the patient woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours. Treatment was received for the events which included over the counter acetaminophen. The outcome of the events was recovered on Feb2021.

SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermittent L side "ache" (feels like a pulled muscle) Pneumonia due to COVID-19 virus - carvediloL (COREG) 3.125 mg tablet; Take 1 tablet (3.125 mg total) by mouth 2 (two) times a day - HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet; Take 1 tablet by mouth 2 (two) times a day as needed for moderate pain or severe pain

Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.

Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out. Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19. Follow up needed, further information has been requested.

pt states his left arm was tender and next day he began to develop soreness in all joints. He started taking over the counter aleve and tylenol. The joint pain continued to progress. He has constant pain. He contacted Labs to have blood work. The blood work showed the protein levels at 48% which is why he was having so much inflammation in his joints. The RA test was normal. Pt will be going to an Urgent Care since he is still in so much pain and the symptoms are not getting any better. He was very active and now has trouble moving around. Mobility is down 25 to 30% compared to 100%.

within a few days of the first vaccine shot I had pain and stiffness in my right hip.. over the course of a few weeks that pain and stiffness gradually went to my other hip and then to both hamstrings, then my right knee. there was a great deal of swelling in the right knee. I also have pain and stiffness in my shoulders. I have now been diagnosed with possibly polymyalgia rheumatica. I have been on oral steroids (prednisone) since May 4. I have improved significantly but remain with some level of swelling, stiffness and pain in a all areas.

he's not doing well/ he felt so sick that he could not walk to go to work this morning/ Still can't function well; I can hardly move/ took him 20 minutes to get out of bed and get dressed; couldn't move and struggled to get through work; he felt so sick that he could not walk to go to work this morning/ Could hardly walk, it took over his whole body, back, legs, and speech; nausea; head, back pain/ Headache; head, back pain; stiffness in his legs; Fever; like the flu, worse than the flu; fatigued; fell asleep; This is a spontaneous report from a contactable consumer and other hcp from a Pfizer sponsored program Pfizer RxPathways. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 64 years, on 04May2021 14:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing single functional kidney. The patient's concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 13Apr2021 for COVID-19 immunization and experienced pain in arm. The patient received the 2nd dose of the covid vaccine yesterday and said he felt so sick that he could not walk to go to work this morning, fatigued, nausea, head/ back pain and stiffness in his legs which were categorized as severe on 05May2021. The patient's wife called and stated "My husband got the Pfizer vaccination, the second dose yesterday and he's not doing well." The patient than got on the phone and stated "I had an adverse reaction, I can hardly move." He also stated he could hardly walk, it took over his whole body, back, legs, and speech; still can't function well and been in bed since he got home. The patient was calling about the Pfizer Covid Vaccine and stated he received his second shot yesterday, 04May2021. He stated after he received the shot, he felt fatigued (04May2021) and fell asleep (May2021). He stated he works nights and when he got up at 02:00, it took him 20 minutes to get out of bed and get dressed. He stated he was home now, and he has a headache, fever, he still can't function well, and it is like the flu, worse than the flu. He stated at 02:00 a.m., he couldn't move and struggled to get through work and he still has a fever and is fatigued. The outcome of the events back pain, stiffness in his legs, fell asleep and nausea were unknown while other events were not recovered. No follow-up attempts are needed. No further information is expected.

passed out; dizzy; cannot raise my arms above my waist; neck is stiff; limited rotation of my head; tired; aches and pains and severe reduction in range of motion in all of my joints and muscles; aches and pains and severe reduction in range of motion in all of my joints and muscles; aches and pains and severe reduction in range of motion in all of my joints and muscles; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 64-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 PM (Batch/Lot Number: ER8730) as 2nd dose, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 AM (Batch/Lot Number: EN6202) for covid-19 immunization. The patient experienced passed out (medically significant) on an unspecified date with outcome of unknown, aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , dizzy on an unspecified date with outcome of not recovered , cannot raise my arms above my waist on an unspecified date with outcome of not recovered , neck is stiff on an unspecified date with outcome of not recovered , limited rotation of my head on an unspecified date with outcome of not recovered , tired on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on unknown date, electrocardiogram: unknown results on unknown date, sars-cov-2 test: negative on 21Apr2021. Therapeutic measures were taken as a result of the events. Facility where the most recent COVID-19 vaccine was administered was Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. The clinical course was reported as follows: I have aches and pains and severe reduction in range of motion in all of my joints and muscles. I also got dizzy one day and passed out. I have been put on a 6 -day steroid pack twice already. The steroids help greatly but once the pill pack was complete the symptoms came back. I cannot raise my arms above my waist. My neck is stiff and I have limited rotation of my head. I'm tired most of the time. I have had many blood tests, (2) EKG tests and my blood pressure is being monitored. So far nothing. My doctor is going to send me to see a rheumatologist. I was very healthy before receiving my 2nd shot of the vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. The adverse event resulted in Emergency room/department or urgent care. Treatment was received for the adverse event included Put on a 6-day steroid pack twice so far. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Batch/Lot number has been obtained. Further information has been requested

bilateral subsegmental PTEs; right flank pain under ribs; This is a spontaneous report received from a contactable HCP. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route, on 30Apr2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. The patient was not diagnosed with COVID-19 before vaccination. Relevant medical history included hypertension (HTN), gout and osteochondritis dissecans (OCD). No relevant concomitant medications were provided. The patient did not have allergies. No other vaccine was received in four weeks. The patient presented to the emergency room (ER) with right flank pain under ribs. Found to have bilateral subsegmental pulmonary thromboembolisms (PTEs). The onset date of the events was provided as 20May2021. Both events were reported serious because requiring hospitalization for 3 days (admission date not provided) and as life-threatening conditions. The patient was treated with enoxaparin then apixaban. Nasal swab was done on 21May2021 and resulted negative. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0172) on 21May2021 for COVID-19 immunisation. The patient was treated with enoxaparin then apixaban. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of all reported events cannot be totally 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.

having a heavy headache continuously...include when I sleep/continuous and severe headache; having problems concentrating on my job, read, work on the computer; Neck and back pain; Neck and back pain; Fever; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW5318, Expiration date not reported), via an unspecified route of administration in arm left on 30Jan2021 18:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history allergies to medications, food and other products was reported as none. The 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. Concomitant medication(s) included fish oil (FISH OIL) and tocopherol (VITAMIN E [TOCOPHEROL]) both taken for an unspecified indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date not reported), via an unspecified route of administration in arm left on 09Jan2021 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Beginning (24/36hs), after the vaccination the patient experienced neck and back pain, neck and back pain and fever on 31Jan2021 22:30, (01Feb2021) Monday, Tuesday, Wednesday, Thursday I'm having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer on 01Feb2021. The patient received Tylenol for 24 hs as treatment for neck and back pain and fever and no treatment received for having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer. The seriousness of all the events was reported as non-serious. The outcome of all the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

Left calf and ankle swollen after 2nd dose on 5/2, d-dimer blood test 0.54, ultrasound found a Baker's cyst. No treatment yet and left calf is still swollen after 4 weeks.

One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972. Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016. Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks. He was having leg spasms, severe back pain, and all kinds of side effects. He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted. He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

ankle was swollen; muscle being swollen; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient 4 days later he experienced ankle was swollen, He had a walk on the park and he had felt his muscle being swollen too on an unspecified date. He mentioned that he was afraid that side effects after his 2nd dose would be much worse. In line with this, he would like to know if he needs to reschedule his second dose following the side effects he experienced. Response received as Spoke from FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v1.0). As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. He also wanted to know How long side effects last final (v3.0) for the following points, Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: muscle pain, joint pain. The Centers for Disease Control and Prevention (CDC) provides information regarding "Possible Side Effects After Getting a COVID-19 Vaccine". The response below was copied on 23Apr2021. COVID-19 vaccination will help protect you from getting COVID-19. You may have some side effects, which are normal signs that your body is building protection. These side effects may affect your ability to do daily activities, but they should go away in a few days. Some people have no side effects. 3 If you received a second shot Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Referred to HCP for further clinical recommendations. Also, mentioned that should they decide to re-schedule their 2nd dose, they would need to contact the vaccination center where they had the first dose. The outcome of both event was unknown. Information on the lot/batch number has been requested.

had the typical left arm soreness for about a day or two and then nothing; had muscle stiffness and soreness that was around his buttocks and his thighs; had muscle stiffness and soreness that was around his buttocks and his thighs; felt "soreness for a few days afterward; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0162, expiration date unspecified), dose 1 via an unspecified route of administration on 26Apr2021 (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included atypical pneumonia from an unknown date (twice as reported) and atypical flu from an unknown date. The patient's concomitant medications were not reported. On an unknown date in Apr2021, post vaccination the patient had the typical left arm soreness for about a day or two and then nothing. On an unknown date in May2021, (third week before getting his 2nd dose) the patient had muscle stiffness and soreness that was around his buttocks and his thighs. On 18May2021, the patient reported that his neck pops and he has never had that happen before. He was really healthy for 64 years old and he had no medical or health issues and he worked out all the time. Then he got the 2nd dose and within a day or two he was sore The outcome of the events was reported as unknown at time of report. Information on Lot/Batch number was available. Additional information has been requested.

Weakness in all muscles especially extremitie,. Extreme jpint pain in hips, elbows shoulders and knees.

sore arm; Discomfort in arm after first shot; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 64-years-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced sore arm and discomfort in arm after first shot. After 6 hours of the first shot, arm discomfort started and lasted for 3 days. Regarding treatment of events, the patient stated that he did not do anything. The outcome of the events was recovered on an unspecified date of Apr2021. No follow-up attempts are possible. No further information is expected.

Arm hurts where shot was administered. (Like muscle pain). Two days later, tiredness and occasional light stomach ache. Four days later, slight back pain on both sides like punched kidneys that continued for a week. Rash developed on ankles of both feet that has continued till present. (applying Hydrocortisone with slight success) Have an appointment with dermatologist 6/17. Joints started aching all over with 2 areas (left Ankle and right elbow) continues to have pain. These were areas that had old injuries but had no prior pain before the vaccine 2nd shot.

Had no decent sleep for the last few nights; His mouth wide open which then makes him dehydrated of course; His mouth wide open which then makes him dehydrated of course; Moving so slow and had lower back and thigh tightness; shoulder aches like someone took a bat and hit it/ feels like he was 80 years old/ it looks like it is something with air in his bloodstream; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/it hurts from his elbow down to his shoulder and it aches; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/his shoulder area on the right side is a little bit in pain; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; he has some pain and there was pain in his triceps, he also has pain between those muscles, it hurts, and It was maybe where he had the COVID vaccine; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He rotates his head and looks around, neck pops frequently; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on 17May2021 (at the age of 64-year-old, Batch/Lot Number: EW0177) as a single dose for COVID-19 immunisation. Medical history included was walking pneumonia twice and other than that just a typical flu. The patient races dirt bikes so he was tough. Also, he had carpel tunnel from his job, and he had left over pain pills from that, and he had been taking them to help reduce the pain since he cannot really do anything about his side effects. Concomitant medication included pain pills, no other products reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EW0162) as a single dose for COVID-19 immunisation and on an unspecified date in Apr2021, experienced muscle stiffness and soreness that was in left arm and around his buttocks and his thighs and reported felt soreness for a few days afterward. This report is not related to study or programme. It was reported that, honestly, he wishes he never got it because he cannot do anything. He was on the fence about getting it since we are at the end of the pandemic and the hospitals are not as overwhelmed anymore. Everyone thinks that he was still in his 50's, he was very healthy, and he has no medical or health issues and he works out all the time, which was why he was so concerned about why it was affecting him like this. He has had his second dose of the COVID vaccine, and he wanted to report what was going on with his body. It was reported that, then he got the 2nd dose and within a day or two he was sore, and he was at the 11th day of experiencing this. He was sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him. He had his 2nd dose not last Monday but the Monday before that. It did dissipate during the day. He jokingly said it was like the Pfizer vaccine retreats and hides during the day. Because of this he has had no decent sleep for the last few nights. His shoulder aches like someone took a bat and hit it. It feels like that on his left arm too but a little less pain. He was a side body sleeper, and he cannot sleep on his side because of this so then he ends up sleeping on his back with his mouth wide open which then makes him dehydrated of course. he has no energy, and the pain was like it was hitting a nerve where he barely can pick up 5 pounds. This was an extending issue and he just wanted to report and see if anyone else has had this before. The hospital said that they have not had anyone else report this before. It was slowly dissipating but he did not understand why it reinforces itself in the evening. Yesterday, he had to go service a customer and he was moving so slow and had lower back and thigh tightness. His upper body was sore and tight so when he got home, he was walking around trying to get his blood flowing and stretching some but then in the middle of the night those reserves came out and he gets attacked. The stiffness, soreness and pain were all concentrated mostly on his upper body. Also, his neck pops and he has never had that happen before. He looked it up and it looks like it was something with air in his bloodstream or something and when he rotates his head and looks around it makes a pop sound, and it has been doing it ever since his 2nd shot. He says this started probably on 18May2021 right after the vaccine. The patient clarified that for the side effects after his second dose that began soon after the COVID vaccine and he states that it was like all hell broke loose. This has gotten a little bit better but not a lot. Maybe 10% better or maybe 15% better. As he was sitting there his shoulder area on the right side was a little bit in pain. He feels like he was 80 years old, he was walking slow, and his body was stiff. No further details provided on the pain pills. He says he was flexing his bicep and he has some pain and there was pain in his triceps. He also has pain between those muscles, it hurts. It was maybe where he had the COVID vaccine. He also has this same pain on the left side except his bicep doesn't hurt but his tricep does and it hurts from his elbow down to his shoulder and it aches. On a scale of 1-10 his pain was at a 3-4 but at night it was worse. The patient and health care professional consent to be contacted was reported as yes. Investigation assessment was reported as no. The outcome of the events Sleep deficit, oral disorder, dehydration, hypokinesia, feeling abnormal was unknown and for all other events recovering. Information on Lot/Batch number was available. Additional information has been requested.

hot and cold with sweats; hot and cold with sweats; Shortness of breath; Eyes ache and itch a little bit; Headache, like stuffed up, sinus headache; Rattling in chest at night like fluid/ whistling sounds; whistling sounds; A lot of mucus in lungs; got real sick with flu-like symptoms; got real sick with flu-like symptoms; coughing up a lot of; heat flash; feeezing; cold, flu, and pneumonia feel like; chills; joint pain; Severe pain in left bicep; pulled muscle; muscle was tight; Eyes ache and itch a little bit; he was 215 and now 223 lbs. Seems like he gained weight; This is a spontaneous report from a contactable consumer (patint). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 21May2021 13:00 (Lot Number: EW0168) at the age of 64 years as 2nd dose, single dose for COVID-19 immunisation. Medical history included arthritis and pneumonia, had not been diagnosed with COPD, but took a lung test, and was prescribed this symbicort 3 months ago. During the pandemic he was never sick and never had symptoms of COVID, was never hospitalized or none of that. Patient was tested and was negative. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT). Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 30Apr2021 (Lot Number: EW0171) at the age of 64 years as single dose for COVID-19 immunisation. Within seven days of taking second shot, patient began to get real sick with flu-like symptoms, started 5 days after he took second shot. Was feeling fine, usually did an hour walk every morning. And 5 days ago, did an extra 30 minutes on his walk to boost himself and that's when he began to get sick. Confirmed date as 26May2021. Still came and went. Stated he developed mucus in his lungs began 27May2021, on 28May2021, got more mucus in his lungs. This past Saturday, didn't buy Mucinex, but got something for severe cold and chest to break up mucus from forming. Patient stated today he was able to start back walking and gradually coughing up mucus. Improving slowly, but surely. Denied shortness of breath. Has rattling in chest at night like fluid, which began on 27May2021. Hot and cold with sweats began on 29May2021 and were not as bad as they were. Stated women should have not men. Shortness of breath began on 28May2021. Not to the point of having to call emergency services. Stated it all came down on him at once. Stated he started to call for ambulance but didn't most emergency rooms sit there for 11 to 12 hours before looking at you or fall out dead. Reported slowly getting better. No sneezing, just felt like he was feverish, but did not have a fever, didn't have a thermometer so he could only go by sweat that he had and the chill he has. Patient stated joint pain that normally didn't bother him. Stated the first shot didn't affect him the way the second shot had. States he now had a little joint pain, like pulled muscles around his lungs, around biceps, sharp pains around biceps. Severe pain in left bicep on 27May2021. His friend thought he was having a heart attack, but wasn't. It was up above heart more like a pulled muscle than a heart attack pain. Patient stated this morning while outside after his walk, all of a sudden a pulled muscle pain in bicep on right side. Stated was this thing moving around on me since started on left side now on right side. Pain had stopped was just a sharp pain, muscle was tight. Stated has never had sharp pains to hit him like that since he was alive. Patient stated he did not have a runny nose, his eyes may ache and itch a little bit, but was coughing up a lot of, had whistling sounds and had a lot of mucus in his lungs. Patient had rattling in chest at night like fluid on 27May2021. Hadn't had runny eyes or stuff in the corner of his eyes. Patient felt like he has gained weight since taking the shot. He was 215 and now 223 lbs. Seems like he gained weight. Patient had headache, like stuffed up, sinus headache from 27May2021. Patient was taking generic brand Tylenol for joint pain. When having chills, he would take 2 in the morning and drink hot coffee. Then all of sudden, went along with joint pain and chills, after moving around and walk outside, broke out into a heat flash. Stated this was irritating. He's freezing one minute and about to burn up the next. Vicks Dayquil pill form for severe cold and allergy to help mucus in chest. Stated he was not able to make it that far to a drug store or Walmart and got from service station. Stated he had had a cold and knew what cold, flu, and pneumonia feel like, what he used to have before this Covid thing. Stated he knew how to recognize some things and not put himself to point of not getting any help. The Symbicort Budesonide didn't do anything to release the mucus. It seemed like it just bypassed that. AEs did not require a visit to emergency room or physician office. Outcome of events got real sick with flu-like symptoms, a lot of mucus in lungs, headache, like stuffed up, sinus headache, hot and cold with sweats, shortness of breath, eyes ache and itch a little bit was recovering, joint pain, muscle pain, pulled muscle, muscle was tight, was recovered and the other events was unknown.

Approximately 3 1/2 weeks after vaccine- increasing neck pain on right, enlarged lymph node right axilla, then pain in wrists, right > left, painful to do pushups or turn lids, red and swollen. LN resolved with zpack. Still some pain in wrists and swelling in fingers, pain in right side neck.

one week after the 2nd shot of Pfizer vaccine, I developed stiff neck such that I cannot turn my head beyond my shoulder and have difficulty to turn my head when driving and changing lanes. two days later, my lower back pain re-occured after being pain free for more than a few years. I let the both pain to recover by itsself but the recovering process of the back pain is quite different from my past experience; the back pain last for more than 3-4 weeks until I feel freely to move around.

I had somewhat sore arm later that day and overnight. I then had an episode where the ball of my right big toe on the morning of 4/10. It wound up being gout. I have never had gout before. I went to the doctor on Saturday. I was prescribed antibiotics thinking it could be a cellulitis infection. The pain went away a few days later. I went to the foot doctor who said it was gout, not an infection. This lasted about 7-10 days.

After taking the shot, I could barely walk up and down the stairs. I couldn't bend my knees. I was having difficulty walking because I was in so much pain. I was having a lot of joint related issues. I received cortisone shots in my knees from my doctor. Within a week, things started to get a little better. I still have some difficulty walking, but I could currently stand without help.

Acute respiratory failure with hypoxia; Acute respiratory failure with hypoxia; Couldn't breathe; Pneumonia due to MRSA/Ground glass pneumonia; weak; lost 20 pounds; fever; Cough; This is a spontaneous report from a contactable consumer (the patient himself). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208, Exp 30Jun2021) via an unspecified route of administration in arm left on 16Apr2021 11:00AM (at the age of 64-year-old) at single dose for COVID-19 immunisation. Relevant medical history included heart disease ongoing from 1997 (this happened in 1997 and the patient had been living with it for a little while), heart attack, pacemaker defibrillator because of cardiac arrest (in 2011), atrial fibrillation (diagnosed a little while, he was not sure and had been in and out of the hospital and to heart doctor quite a bit) and hypertension. The patient was administered with first shot of BNT162b2 (Lot number EW0153) in left shoulder on 16Mar2021 11:00AM (at the age of 64-year-old). Concomitant medications were not reported. On 16Apr2021 after the second dose, the patient was fine. There were no reactions after the first dose, but the second dose two days after he started developing a cough and fever. He thought it was a side effect but then ended up in the ER with pneumonia. They gave him antibiotics and sent him home. He went through the antibiotics and went back because he was still sick and not responding. They gave him more antibiotics and sent him home. He went through that batch and ended up really bad so he had to call an ambulance a few weeks later. He was diagnosed with MRSA Pneumonia and stayed in the hospital for 5 days. Then, he was discharged. He went back to the ER again a few days later because he did not seem to be improving. He was coughing and was weak. He was given another batch of antibiotics. He did not know if it was from the shot or what - he was healthy until then. The patient added that she lost 20 pounds and confirmed that it was following the vaccine. Two days after the vaccine, maybe it was 19Apr2021, he had a fever and it was now gone (exact dates were unknown). Cough happened at the same time of the fever but it was not as bad, and then progressively got worse. His lungs started filling up. They thought it was COVID. by the x-rays it looked like COVID lung but they took a sample and it was MRSA (exact dates were unknown). His admission was 18May2021 and was for acute respiratory failure with hypoxia. Discharge paperwork said acute chronic combined systolic diastolic congestive heart failure but he has had that for many years. It also stated primary hypertension but he has had that. The paperwork sayid pneumonia due to MRSA and pneumonia due to unspecified organism. He was hospitalized 18May2021 through 23May2021 with pneumonia and the reason he was hospitalized was because he could not breathe. Lost 20 pounds: after he started getting sick from the beginning of it all, he was coughing and losing weight and all that. It may not be quite 20 pounds, maybe 17, but he just knew that he was down quite a bit. He was 160s now, he was high 170s before (as reported). Treatment included Lasix and all kinds of different antibiotics. They were giving him, he did not know what it was, at first. Then, they narrowed it down and once they found out it was MRSA they gave him Clindamycin he believes. Investigations: they did CT scans, chest X-rays, and labs but he does not know any information. Each time they did a chest x-ray, when he went to get a chest x-ray, each one was worse all the way up to when he was admitted. When he went, they did a bronchial scope or whatever, he was not sure, and they saw lots of swelling and infiltrate. He did not know what this meant, stuff was infiltrating into the tissue and it was not just in the airways. He added it looked like ground glass pneumonia is what they said. The patient added that he was usually pretty active and cannot do anything anymore. He had three or four Covid tests, all negative, no additional details provided. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

I am suffering from extreme pain in all of my joints; I am suffering from extreme pain in muscles also; I am suffering from severe exhaustion; I am suffering from headaches; I am suffering from nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration on an unspecified date, at the age of 64 years as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension and gastroesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), hydrocortisone (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN). The patient suffered from extreme pain in all of my joints (joint pain) and muscles (muscle pain). The patient also suffered from severe exhaustion (exhaustion), headaches and nausea on 12Mar2021 at 12:00. The patient cannot do any day to day activities. The patient did not receive any treatment for events. The clinical outcome of events joint pain, muscle pain, exhaustion, headache and nausea were not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I began to experience acute joint pain that progressed over a period of weeks until I finally went to my orthopedics. I got an injection in my knee that was marginally effective another consult for ankles and physical therapy.

getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.

Systemic: Body Aches Generalized-Medium, Systemic: lower back pain-Medium, Additional Details: Patient called on 6-29-21 complaining of lower back pain that started and has continued since receiving his first dose of pfizer vaccine.

swollen glands in arm and neck; the glands were very uncomfortable under his left arm; This is a spontaneous report from a consumer (patient) via Pfizer COVAX support. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8729 and Expire Date: unknown) via unspecified route of administration, in left (upper) arm on 07Apr2021 13:45 in the afternoon (age at vaccination: 64 years) as DOSE 2, SINGLE for Covid-19 immunisation. Patient's medical history included diabetes and immune system disorder (immune system is not the same) from an unspecified date and unknown if ongoing. Since he was diabetic so he was skeptical to get the vaccine because he knew his immune system is not the same as most people. Concomitant medications were none. Patient previously received first dose of vaccine (Lot no: ER2613, expiry date: unknow) via unspecified route of administration, in left (upper) arm on 17Mar2021, as single dose for Covid-19 Immunisation. There were no other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine. After second dose, on 08Apr2021 the patient reported he had swollen glands under his arm and neck. It was reported that when it first started swelling, it wasn't extremely painful but the glands were very uncomfortable under his left arm and then after a few days it got better but then on the 5th or 6th day all the glands got swollen. He confirmed that was still ongoing, it had pretty much been persisting the same since that 6th day after the shot. He said it had been almost 10 weeks. He went to his GP and they took one look and did a blood test and a urine test and it was all normal and because this was such a new thing no one knows what to do. Since the blood test and urine test was negative the patient was sent to the ENT and he looked at his under arm and neck and said come back in a month if he still has it, this is why he was calling because no doctor knows what to do with it. The patient underwent lab test on 30Apr2021 which included CNC, CMP and urine test, results of which were negative. The sample was collected on 30Apr2021 the report was given on 01May2021. The adverse event resulted in visit of physician's office. Patient believed that his other 2 sisters got the Pfizer shot, and they had no reactions and they also have immune compromised systems. The outcome of the events was not recovered.

Occurred all at once: muscle ache stiffness in both shoulders (partially frozen), legs (knees), hips, back, arms, elbows. Severe limitation on mobility especially after sitting or laying down for a period of time. Still have, recently prescribed Meloxicam 7.5 mg, once a day, which is relieving symptoms about 80%.

I started feeling pain in my lower back and my piriformis and ouside of my shin on the right side at about the time of my 1st Pfizer shot. I also started having tingling sensation in my right foot. I do not know if it is related to the shot or if it is something else. I called my insurance remote doctor for consultation about 2 weeks after I started having the symptoms and followed that up a week later when the pain and discomfort still persisted. About another week or 2 later I went to see my primary physician. After 3 weeks of no improvement, I was referred to a Physical Therapist and after 8 sessions I still have the same pain.

Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.

Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had the feeling of being tired; blockage in the lower intestines.; Hard time going to the bathroom; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot number:ER8732) via an unspecified route of administration administered in left arm on 16-Apr-2021 at 10:30 (at age of 64-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient underwent lab test and procedures include cholesterol and result was unknown on unspecified and colonoscopy on 10May2021 result was unknown. It was reported that the patient received the first dose of the Pfizer covid vaccine and was in the hospital for blockage in the lower intestines on 17Apr2021. The patient wanted to know if that is associated with the Pfizer covid vaccine. He stated his nephew was a police dispatcher and got a call where someone else have reported similar issue what the patient has experienced. The patient did not know what vaccine that person had or age and gender of that person. The patient wanted to know about if Pfizer was going to get the FDA approval for the Covid vaccine. The patient reported that he had both doses and he was fine right now but when he had the first dose he was, he got it 16Apr2021 and he had some side effects the next day, on 17Apr2021 he was having cramping and he woke up and was feeling hot and cold and ended up in the hospital with a blockage in his intestine and he was wondering if that could have been anything that was related the vaccine. The patient has lost weight in the hospital, he thinks he was about 145 lbs now. It was reported that the patient was fine the whole day he got the vaccine, he ran errands and did things he needed to do, he went to bed and woke up and felt hot and cold and on 17Apr2021, he was having hard time going to the bathroom. He called his son and told him he wasn't feeling well on an unspecified date in Apr2021 and his son came over and called his other son who is a fireman and he told them to call the ambulance so they did and they took him to the hospital and they couldn't figure out, he was asking them and they had no answer, he just seen on the website and he has been wanting to call but he wasn't going to but he did so that they would have it documented. He confirms when the cramping and feeling of hot and cold and difficulty using the bathroom began it was after midnight and the date was 17Apr2021. When asked if the feeling of hot and cold is ongoing, he says he was in the hospital for 8 days. When asked if the feeling of hot and cold is ongoing or has it recovered, he says he just had the feeling of being tired on an unspecified date in Apr2021 and out of it even after the fact. He does not if it had to do with vaccine or if it was something, he had going on prior to that. The ER doctor told him it was possible that when he got the vaccine whatever could have been going on and put his system in overload. He confirms he was admitted to the hospital due to blockage in the intestine supposedly, the lower intestine. He says that is recovered, everything got taken care of, he had to schedule a colonoscopy after he got out of the hospital. He does not know why they couldn't have done it there while he was in the hospital. He was contemplating the second dose; it was scheduled on 07-May-2021 and he had his scheduled colonoscopy for 10-May-2021 and he didn't know what he should do. People were telling him do it or not to do it but his doctor told him to go ahead and get it so he followed what he said and he did get it. The hospitalization dates were from 17Apr2021 until 24Apr2021 was the day that he got out. He had blood work done for cholesterol in the hospital and he sees a cardiologist doctor for the cholesterol. They did blood work in the hospital every day, he has no idea what the results were. The events feeling hot and cold, cramping and hard time going to the bathroom after midnight and the middle of the night lead the patient to emergency room visit. He didn't know whether to call but it has been playing on his mind. He is sure they have given millions of doses and he did not know if it could be anything to do the vaccine. The outcome of events blockage in the lower intestines, feeling of hot and cold was recovered and outcome of other events was unknown. Follow-up attempts are needed: Further information has been requested.

Flu-like symptoms; Stiffness; Mental fogginess; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable company representative, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no allergies to medications, food, or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); both were taken for unknown indications from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 20:00, the patient experienced flu-like symptoms, fatigue, stiffness, body ache, headache and mental fogginess. 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 any treatment for the events. The clinical outcome of the events flu-like symptoms, stiffness, mental fogginess, fatigue, body ache and headache were resolved on an unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.

Pain around injection site; stiff shoulder; left muscle sore; This is a spontaneous report from a contactable consumer (patient himself). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: en6198), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (lot number: er2613) on 22Mar2021 administration on left arm as dose 1, single for COVID-19 immunisation. The patient received other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. 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 23Mar2021, 08:00 AM, the patient experienced pain around injection site, stiff shoulder, left muscle sore. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

he is having trouble moving and getting up and walking; he is having trouble moving and getting up; he has never had the back pain before with the pain in the muscle; Sick; My husband experienced lower back pain, well today the back pain is really severe; This is a spontaneous report from a contactable consumer. This consumer (patient's Wife) reported for a 64-year-old Male patient (Reporter's husband) that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW017A and expiry date was not reported, at the age of 64-year-old), via an unspecified route of administration, administered in Arm Left on 25Jun2021 08:00 as dose 1, single for covid-19 immunisation. Medical history included ongoing splenectomy. The concomitant medications were not reported. Patients wife reported that her husband experienced lower back pain well today the back pain is really severe, he is having trouble moving and getting up and walking on 25Jun2021. She states she took him to the ER, and they gave him a muscle relaxer and a pain pill, which didn't help at all. She states they were there for about 4 hours and sent home with some more pain pills and still is not helping; when he left the hospital, he was still in pain. He has never had the back pain before with the pain in the muscle. She states he had no soreness in his left arm. She states she told the ER nurse this as well, but he doesn't have a spleen and she doesn't know if the shot affected him worse because of the immune system to fight it. She remarks her husband is having regrets taking the vaccine because he is so sick. She states the second shot is scheduled for 16Jul2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. The patient underwent lab tests and procedures which included urine analysis and x-ray both negative on 26Jun2021. The outcome of event low back pain was recovering and for all the events was unknown.

Vaccine #1. Headaches for 2 days, that would jump around in my head. These started occurring within 1/2 hour of the injections. Nothing I would even take an aspirin for, but as soon as it occurred, I recalled the same thing for a few days about 2 months earlier. Does this mean I had Covid already and was essentially asymptomatic? Would have been nice to have been tested for antibodies prior to the first injection. Vaccine #2. About an hour after the vaccine was administered, I was very fatigued. This fatigue has lasted ever since. The first 2 months, I could not do much without laying down after about 2 hours. The fatigue then started subsiding, but I am still not at my normal energy level. I have also had lower body muscle soreness, which is still occurring.

Patient recieved the first pfizer vaccine on 3/15 and tolerated without side effect. On 4/5/21 he recieved the 2nd vaccine and 72 hrs later he felt extremely weak sweaty had some nausea and then developed the swelling over the temples on 4/12 he had no visual loss he had no headaches he had no PMR type symptoms. He developed neck pain shoulder pain or hip girdle pain. He had no visual changes. he was referred to our office with a high sed rate and elevated glucose. Saw Dr 4/26/21 for initial evaluation. pt was started on prednisone, temporal swelling had already resolved.

Joint aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Mar2021 12:45 (at the age of 64-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. The patient has not tested for COVID-19 since the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 20Mar2021 18:00, the patient experienced joint aches. Patient has not received any treatment for the event. The clinical outcome of the event was recovered on unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked since reporter is not patient, reported for the patient added in narrative and final sentence was updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained".

One week after first Pfizer shot, had bad heart palpitations, thumping and very noticeable. After two weeks, immediately before second shot, got slightly better. Went forward with second shot. Still have mild heart palpitations ever since, but more like a flutter. But it has been continuous and it's now two months after. Also, extreme fatigue, shortness of breath and mild joint discomfort.

Profuse sweating without fever; Severe muscle pain; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the right arm on 27Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included gabapentin (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), carbamazepine (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN); all for unknown indication on an unknown start date and unknown if ongoing. On 27Mar2021 at 20:00, the patient experienced profuse sweating without fever, severe muscle pain and joint pain, fatigue. 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 any treatment for the reported events. The clinical outcome of the events profuse sweating without fever, severe muscle pain and joint pain and fatigue were recovering. No follow-up attempts are needed. No further information is expected.

Monday 22-Mar Rec'd 2nd vax shot Thurs 25-Mar 1st reaction, feeling cold & sore back Tue 30-Mar 2nd rxn milder effects Sun 4-Apr 3rd rxn, sore back & chills Mon 5-Apr spasums, 6pm to 4am Tues 6-Apr vomitting 7pm to 3am Thurs 15-Apr 4th rxn Fri 16-Apr cont'd 50% sore back Wed 21-Apr 5th rxn, noon started feeling minor effects` Sun 2-May 6th rxn. started feeling effects around 5pm (Just tired) - mild, & chills Mon 3-May just minor effects, feeling chills Wed 19-May 7th rxn woke up feeling chills / minor effects Fri 21-May 8th rxn, woke up started feeling minor effects` sore back & chills Tues 25-May 9th rxn, started after midnight started feeling chills, no back pain. 26-May lower back pain & chills Fri 4-Jun 10th rxn, started at 8pm chills Sat 5-Jun lower back pain & chills Wed 30-Jun 11th rxn, started at 12am-midnight chills Thurs 1-Jul lower back pain & chills Wed 7-Jul 12th rxn, started at 10.:30pm chills Thurs 8-Jul mild lower back pain & chills

About eight hours after I got my vaccine, I had an acute event and a chronic event. Acute, I developed a very high fever and chills for 48 hours. A week or so after that, I had a severe reaction of my arthritis. My arthritis gotten times worse after receiving the vaccine and is still the same level of pain. It has crippled my hands and I have had to start an immune repressive medication.

New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thighs developed stiffness (R>L) in morning with AM stiffness for 1/2 day, and finally wore off day before second shot. Then, got 2nd shot 5/17/21, with fever first day, body aches starting the next day. After few days, felt better. However, Friday morning 5/21 woke up with pain in biceps, triceps, could not abduct arms above 7 o'clock position due to severe pain -- bedridden 4 days, felt like someone beat him up or got hit by a car, then improved sligthtly. 1 week later, developed stiffness in low back, hips, and thighs. Also with night sweats few nights.

got tired; On 01Jul I got one the size of a silver dollar (hematoma). It does not hurt and I did not bump ag; have been getting these like blood bleed under my skin on my arm; blood bleeds under his skin on his arm; began getting red spots (like a blood spot) on my arm. On July 1st I got one the size of a silver dollar (hematoma). It does not hurt and I did not bump ag; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 64 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EW0153) as single dose for COVID-19 immunisation. It was reported that after receiving the Pfizer Covid vaccine the patient on 13May2021, the patient began getting red spots (like a blood spot) on arm. On 01Jul2021 he got one the size of a silver dollar (hematoma). It did not hurt and did not bump against anything. He would like to know if this a side effect of the Covid vaccine. Have others reported this symptom, How many? The patient was not on any blood thinners and a very healthy adult male. He has become large, blood bleeds under his skin on his arm; this has happened 4 times now. It was reported that last Thursday he couldn't go to his work, got tired. The patient was a very healthy old man and ever since he got the vaccine, he started to have this, under the skin bleed and spots, red spots and bleed on arms. The adverse event resulted in Doctor or other healthcare professional office or clinic visit on 12Jul2021 and received treatment. The outcome of the events was not recovered and fatigue was unknown.

extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; heart attack; Myocarditis; Heart racing; 20% loss of memory; light chest pain/pressure; foggy; severe headache; light chest pain/pressure; ill; horrible cough; Dizziness; High temperature; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for himself. This 64-year-old male patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right shoulder on 20Apr2021 at 12:25 (Batch/Lot Number: ER8735) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. There was no additional vaccines administered on same date of the Pfizer suspect. The patient received the first dose and after he had a horrible reaction and he had to go to the hospital. By 03May2021 he was in the ER and they were saying he had a heart attack; they were going to do emergency surgery to place a stent in his heart; but when they did the tests they found that a virus had caused the heart attack; he had myocarditis. Add then he had various medical care to keep him alive those two days. The doctor confirmed that he had myocarditis from a virus. He was still on mediation for his heart. The patient also mentioned his memory comes and goes now. Mentions the beta blocker his is prescribed is Metoprolol 25mg. Adds he was instructed to take one half of a 25mg tablet and then move up to 25mg, but he blacked out for a day when he took the 25mg, so he had to go back to one half of 25mg. Adds his heart races really fast and he has to have this medication to control it. He is also taking 81mg ASPIRIN. He was taking Atorvastatin 20mg once daily, but the other doctor told him to stop it because it is not doing him any good. The patient states he kept a journal of his symptoms after the vaccination on 20Apr2021. From 20Apr2021 to 22Apr2021, for two days he felt tired, slept all night on 21Apr2021, awake for two hours then back to sleep. From 22Apr2021 to 27Apr2021, he felt fine. On 28Apr2021 he was tired. On 29Apr2021, tired, dizzy, horrible cough, fever of 100 / high temperature. On 30Apr2021, the patient took off work, bad cough, resting, dizzy, ill. On 02May2021, ill, temperature. On 03May2021, ill, temperature 100, when he got out of bed at 05:00AM he had extreme pain in his head, back, shoulder, arms, and lungs feeling crushed so he went to the emergency room. The did two COVIDs tests that were negative. Blood tests that showed the heart attack need for a stent; but when they got in there with the camera it showed he had a viral attack on his heart that caused the blood flow to slow; EKG abnormal, mentions an MRI; and troponin level off the charts. The priest came in to talk to him and he had a horrible cough that has now gone away. He was in the hospital overnight and discharged 04May2021 at 15:00. After that he noticed he feels light chest pain/pressure all the time on 04May2021; the first week he was foggy on 04May2021 and had severe headache on 04May2021 and noticed about 20% loss of memory. The patient mentioned he made medical heart parts at work and he went back to work on 10May2021 but he just sat at his bench and examined the parts. He thought the vaccine activated his really good immune system and caused it to attack his heart. He had another EKG and the doctor said his right ventricle is damaged in his heart last week. Mentions he has had at least 30 different blood tests. Everyday for three weeks he thought he was going to die but his doctor did give him some hope. The event was hospitalized for myocarditis from a virus, heart attack and extreme pain in his head, back, shoulder, arms, and lungs feeling crushed from 03May2021 to 04May2021 at 15:00. Treatment received for myocarditis from a virus and heart attack. The outcome of tiredness, light chest pain/pressure was not recovered, of horrible cough was recovered. The outcome of other events was unknown. Heart racing results in Physician Office visit with follow up. Follow-up attempts are completed. No further information is expected.

hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; not been able to use hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. can't grip anything; not been able to use his hands; wrist to hurt; peripheral vision bad, his vision was bad; visual distortion; peripheral vision bad, his vision was bad; visual distortion; given a drug to take when they flared up (migraines); pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything was worsened; hardly walk/ lower back got so painful; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG206), via an unspecified route of administration in right arm, on 17Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. Medical history included heart attack from 1994, left side kidney removed in 2015 and single functional kidney on right side from 2015. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG202), via an unspecified route of administration in right arm, on 24Feb2021 at 13:00 as dose 1, single for COVID-19 immunization and experienced headache, stiff neck, peripheral vision was bad, migraine and swelling of hand and feet. The patient previously took (UBRELVY) for migraine and visual distortion. The patient had a headache and stiff neck really for no apparent reason and they continued. Then he noticed that his peripheral vision and vision was bad with visual distortion in Mar2021. He called his primary care provider and told him about this, and he was prescribed a steroid pack and for 2 months he was provided a muscle relaxer to help. They provided some relief but didn't get rid of it. Believes the steroid was a Zpack for inflammation and was unable to provide the name of the muscle relaxer or the NDC, Lot, or expiry for either Zpack or muscle relaxer given. Eventually, they continued and after he had the visual distortion, he went to an eye doctor to make sure nothing was wrong like a tumor that was causing the headaches or stiff neck. Eye doctor told him nothing wrong with his eyes and they were fine, not tumor, he just had migraines and he never had migraines before. He saw a neurologist and was diagnosed with migraines. On the first neurology appointment, they gave him an injection in the stomach, but he does not know the name of it. The second visit was given shots in the back of head and back of neck. On that next visit, he got a shot in the stomach and most of it was quiet down with the migraines and the visual distortion and he still had them. The patient was then given a drug to take to help when they flared up, for break through migraines in 2021. It was 100mg. He was given the free ones and he could only take up to 10 in a month. He was given 4 of them and only had to use 2 of them and the migraines and visual distortion has gone away. Provides NDC, lot number 1843724 and expiry of Jul2022. He started this in Apr2021 or in May2021 after his first visit with neurologist, (withheld). During the same time, he had the migraines and also started having pains in his upper thighs, felt like in his muscles. States imagine little bubbles like they are going to pop was how it felt in 2021. They went away and stopped. He then started to have back stuff, pains that started in Mar2021 or Apr2021. They stopped after 7-8 days later and then they were gone. He was then sent to a nerve specialist and they did a conduction nerve test to see if what happened affected his nerves and the test was fine. Then all of a sudden, after one thing happened and went away another one would start and then his lower back got so painful so that he could hardly walk and went to an orthopedist thinking it could be a pinched nerve in 2021. They did x-rays but could not see anything that caused this kind of pain. They didn't give him anything, but 7 days after that he was fine ever since, and it just went away. He also had pains in the upper arms that felt like someone was giving him shots at the same time in both arms and also a kind that hurts and stays hurting. Felt like they didn't pull out the needle, like someone was pressing the needle in the arm, directly in the area you are getting a shot, but this feeling lasted much longer. Had this very same feeling in the top of both shoulders and they were intermittent. One minute he would have them and the next they could last about 5 minutes, or it could be gone for 5 hours and show up again in 5 minutes. It was not consistent and happen every hour. This also resolved in May2021 along with the migraines. Patient had pains at top of shoulders fell in line with his neck, where the soft spot between the collar bone is which was like getting a shot in his arm. Again, he no longer has these symptoms and no problems with vaccines in the past. Provides he had second dose on 17Mar2021 in left arm and lot number of ENG206. No further details provided. Started in the beginning of Jun probably, it's been about two and half weeks. He had not been able to use his hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. He can't grip anything in Jun2021 and also got worsened in 2021. Extending from the tip of his fingers all the way up to the shoulders, in his left arm especially causes the wrist to hurt in Jun2021. It hurts all up to the left shoulder. In the right arm it only goes up to the bicep and these have gotten worse and are continuing to get worse. The patient was given tramadol for that pain and unable to provide NDC, Lot, or expiry from orange pharmacy for tramadol bottle. He takes 50mg, 1-2 tablets by mouth four times daily. It was prescribed 16Jun2021 and expires 16Jun2022. These pain pills help some, it takes the pain away, but does not allow him to grip with his hands or anything else. Now it may sound crazy, but when he coughed it would make him feel like the inside of his biceps were going to explode. It went away and only lasted a week. After a week this went away, but to touch it hurts after he coughed. Still had tenderness in both sides in the muscles, but at that time it felt like they were exploding outwards. Again, mentions he no longer has this. His feet are swollen up and he has never had that before now. Went back to see his heart doctor. He had gone to have a Covid test and heart test in Jan2021. With the swelling in the feet, he felt it had something to do with the heart and he went to see the cardiologist where they asked about testing which was done by primary care provider and also had antinuclear antibody testing done with primary care and that test came back with no arthritis in the hands on an unknown date. The patient mentioned he had a heart attack at age 38 before he had COVID vaccine, since he is 64 now. He didn't have any chest pains and didn't fall under those heart symptom questions asked. None had anything to do with his heart and the provider felt symptoms probably due to with the vaccine, but there is not enough information out there on it yet. He saw about 6 specialist and they all say the same thing. The patient still had his feet and hands swelling. He had a heart attack in the past or how it will affect his muscles in his heart because he does not want to find out later that it had affected his heart, and nobody knew. The patient also had an magnetic resonance imaging (MRI) of the brain, blood vessels and nerves ordered by his Neurologist as well. The outcome of peripheral vision bad, his vision was bad; visual distortion was recovered in Mar2021; pains in upper thighs was recovered in May2021; lower back got so painful so that he could hardly walk was recovering; felt like bubbles in muscles like they pop was unknown while the other events was not recovered.

Chills; Headache; Arm pain; Shoulder pain; Neck pain (left side); Stiff neck (left side); Joint pain knees; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 01Apr2021 at 11:45(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included heart failure and emphysema. Concomitant medications included dutasteride (AVODART), rosuvastatin calcium (CRESTOR), enalapril maleate, hydrochlorothiazide (ENALAPRIL H), metoprolol succinate (TOPROL XL) and acetylsalicylic acid (ASP); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 13:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. 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 01Apr2021 at 11:45 the patient experienced Chills, Headache, Arm pain, Shoulder pain, Neck pain, Stiff neck all left side and Joint pain knees. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events Chills, Headache, Arm pain, Shoulder pain, Neck pain, Stiff neck and Joint pain knees was unknown. No follow-up attempts are needed. No further information is expected.

On 07/18/2021 late that night my right knee swollen rapidly, about 1:30am called EMS, Xrays indicated fluid, Blood testing said my INR 7.1, the DR took my off Warphrine and bed rest. I was in the hospital for 6 days.

woke up from sleep with stomachache, which spread and stayed inribs, both sides, front, in the middle ofthe rib cage.; woke up from sleep with stomachache, which spread and stayed in ribs, both sides, front, in the middle ofthe rib cage.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), atorvastatin (LIPITOR), acyclovir (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN). 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 04Apr2021 at 04:00, the following night (36 hours post shot), the patient woke up from sleep with stomach ache, which spread and stayed in ribs. Ache in both sides, front, in the middle of the rib cage. It got better in the morning and started up in the next night, but less severe. The pain was diffuse and strong. Adverse 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 woke up from sleep with stomach ache, which spread and stayed in ribs, both sides, front, in the middle of the rib cage was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Congestive Heart Failure; Blurred vision; The caller was concerned the brother may have had an emboli,; Dizziness; Flu like symptoms; He had difficulty breathing/couldn't breathe; Headache; Cardiac issues; Fatigue; The blood pressure keeps spiking; Unable to stand very well; muscle & joint pain; muscle & joint pain; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in deltoid muscle in Jul2021 (Batch/Lot number was not reported, expiration date not provided) at age of 64 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestive heart failure on 10Jul2021, blurred vision (Life-threatening) on 10Jul2021 19:30, the caller was concerned the brother may have had an emboli, dizziness (Life-threatening), flu like symptoms (medically significant), he had difficulty breathing/couldn't breathe (medically significant), headache, cardiac issues, fatigue, the blood pressure keeps spiking, unable to stand very well, muscle & joint pain, all in Jul2021. The patient was hospitalized for congestive heart failure from 10Jul2021 to an unknown date. The patient underwent lab tests and procedures which included blood pressure: keeps spiking in Jul2021. The outcome of the events was unknown. Clinical course: The caller was a pharmacist calling in regards to her brother. The caller did not know if this has any correlation. The callers brother received the first dose Pfizer Covid Vaccine, a day later all the typical side effects of flu like symptoms occurred. Had to get up in the middle of the night to raise arms because couldnot breathe: The caller's brother had to get up in the middle of the night to raise his arms because he couldnot breathe. The caller states this occurred the second night after the caller received the first dose Pfizer Covid Vaccine. The caller did not know specifically what time this occurred. The caller told her brother to go to a hospital. The callers brother had every excuse not to go the hospital. Later that evening, the caller called her brother to check on him. The caller's brother was having more symptoms, the brother had dizziness. This was not just typical Pfizer Covid Vaccine symptoms. Ended up in the hospital with congestive heart failure: The patient ended up in the hospital with congestive heart failure. The hospital is still having trouble, this is the patient's second or third day in the hospital. The hospital is having trouble maintaining the patients blood pressure, the blood pressure keeps spiking. This could be coincidental. The caller is asking if anything different is presenting after receiving the Pfizer Covid Vaccine? The caller would like to present this information to the doctor if so. Is there any correlation at all? The caller states she knows there have been incidents of myocarditis, but the caller's brother is not a youngster, the patient is going to be 65 in less than a month. Received first dose vaccine, a day later all the typical side effects of flu like symptoms occurred: The caller states this occurred after the patient received the first dose Pfizer Covid Vaccine. The symptoms have gone away after the third day. The caller has not asked the specific question if the patient recovered with lasting effects or recovered completely and does not know. Had to get up in the middle of the night to raise arms because couldnot breathe: When asked when this began the caller states her brother must have had the first dose Pfizer Covid Vaccine on Friday, 09Jul2021, or it could have been Thursday, 08Jul2021. The caller called the patient on 10Jul2021. When asked if this was ongoing or went away, the caller replies the patient continued with other symptoms that happened. The caller was concerned the brother may have had an emboli, all sorts of things. The caller advised the brother to go to the hospital. Had dizziness: When asked when the patient's dizziness began, the caller states she can not answer that exactly. The caller clarifies the dizziness occurred after the patient received the first dose Pfizer Covid Vaccine. The patient had only received one dose of the Pfizer Covid Vaccine so far. The caller is not sure if the patient has been advised to receive the second dose Pfizer Covid Vaccine or whether this is something totally different. When the patient was having flu like symptoms he was also having dizziness. The dizziness became different the second day at night time at 1930 pacific time, the patient told the caller he went out to the car and got so dizzy and light headed and couldn't breathe. The patient was bringing groceries inside and got winded. It was not normal. Ended up in hospital with congestive heart failure: The caller states the patient was hospitalized yesterday 12Jul2021, the caller then clarifies, no it was Saturday night, 10Jul2021 the patient was admitted to the hospital. The patient is still hospitalized at this time. The caller states she asked the cardiac nurse at the hospital and the cardiac nurse says she thinks this has nothing to do with the Pfizer Covid Vaccine. The caller is not sure and has heard so many different reports. Causality: When asked causality for each symptom, the caller replies, she certainly thinks the flu like symptoms are related to the first dose Pfizer Covid Vaccine. The caller does believe something must have happened to cause his condition to spiral down hill. The patient had some symptoms prior to receiving the first dose Pfizer Covid Vaccine but these were all manageable and not a problem. The caller doesn't know if the patient having the flu like symptoms may have put extra stress on the patient's heart. Had to get up in the middle of the night to raise arms because couldn't breathe: The caller considers this life threatening. Had dizziness: The caller states when the patient had dizziness at night, the caller considered it life threatening. The patient had other dizziness and blurred vision and inability to breathe and it was clearly cardiac issues. blurred vision: The caller does not know when this began. The caller states when her brother called at 1930 on 10Jul2021, that is when he had the blurred vision, the caller does not know if the caller had the blurred vision before and can't answer that question. The caller does not know if the blurred vision is ongoing at the moment. The caller knows the blurred vision had mostly gone away, the caller does not know if any of the blurred vision has come back, she believes it is gone. The caller considers the blurred vision life threatening. Date of first dose: The caller is unable to provide the date the patient received the first dose Pfizer Covid Vaccine. The caller states she would have to be in touch with the patient. It was either 08Jul2021 or 09Jul2021. ~ Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event headache, fatigue, joint pain, muscle pain and the suspect drug BNT162B2. 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.

Felt extreme soreness in both shoulders; Radiating down to my arms, elbow, joint areas / radiating pain in the shoulder and elbow joints.; This is a spontaneous report from a contactable healthcare professional, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Jan2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and reported as otherwise in good health. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), vitamin D nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously took bactrim and sulfur drug and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021, the patient experienced extreme soreness in both shoulders radiating down to arm, elbow, joint areas. It had been over three months since those shots, and she continued to have radiating pain in both shoulder and elbow joint areas. She had a full physical about two weeks ago from the time of this report and was in good health, except for the radiating pain in the shoulder and elbow joints. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the events extreme soreness in both shoulders radiating down to arm, elbow, joint areas were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

injection site pain; facial swelling; fever; joint pain; chills; aches; feeling unwell; This is a spontaneous report from a contactable physician who reported for himself. A 65-year-old male patient received the first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at left arm at 05:00 PM 02Jan2021 for Covid-19 immunization in his workplace clinic. The patient had a medical history of controlled hypertension. The patient had no known allergies to medications, food, or other products. Concomitant medications included telmisartan for blood pressure. The patient had not received other vaccines within four weeks. Commencing exactly 24 hours after vaccine received, on 03Jan2021, the patient developed facial swelling, fever chills aches joint pain feeling unwell, injection site pain lasting for 18 hours. The patient had not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All the events resolved. The patient considered that the events were non-serious. Information on batch/lot number was requested.

Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.

Two days after receiving the second dose I experienced numbness and weakness in my right hand, especially the pinky finger. The numbness has improved, but the weakness and decreased range of motion hasn't improved.

Received the covid vaccine on 1/12/21 started having symptoms evening of 1/15 including stomach upset, chills, muscle and joint pains headache and overall feeling Blah........on Saturday afternoon started feeling much better. Over all symptoms lasted less than 24 hours slight headache after that but relieved with medication.

Sore neck for 3 days now. Have tried getting ahold of somebody but am getting no responses to my calls. Have been getting text checks daily but still no call as requested.

had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement; had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0149), via an unspecified route of administration in arm left on 22Dec2020 09:45 at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Medical history included known allergies: Sulpha, PCN. Concomitant medication included famotidine (PEPCID). The patient had cramping, pinching pain in his left superior trapezius/supraspinatus thinking brachial plexus involvement on 23Dec2020. The patient did not received treatment. Duration 10 days. Resolved without intervention. The outcome of events was recovered on 02Jan2021.

Back pain in the muscle; Back was swelled up; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose (lot number: EL3249) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced back pain in the muscle and back was swelled up started yesterday 12Jan2021 in the evening. Treatment included Advil. Outcome of events was recovering.

He has had gout at other times, but he has never had it as hard as this/awaken with pain in the middle of the night; He was awaken with pain in the middle of the night; This is a spontaneous report from a contactable consumer (wife) who reported for her husband (patient) that a 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration on 05Jan2021 08:40, at single dose for COVID-19 immunization. Medical history included gout, using timolol maleate to control the pressure in his eye. Concomitant medication included ongoing timolol maleate (5ml eye drops) to control the pressure in his eye. He uses eye drops that are prescribed. He keeps them on the counter to remember to take them. He has been using it for 3 years. Patient previously had the shingles vaccine on 14Dec2020 for immunization at the age of 65 years old. It said as long as the vaccine was given two weeks prior. The patient received COVID vaccine at outdoor park on 05Jan2021. The wife reported that the next day after the first dose of the vaccine (06Jan2021), her husband developed gout. He got it at the same time she did. He has had gout at other times, but he has never had it as hard as this. He awaked with pain in the middle of the night, it started from 06Jan2021 and is ongoing, slight improvement. She was not sure if that was reportable. Patient did not visit emergency room or physician office for any adverse events. Outcome of the events was recovering.

Jan 3 vaccine administered, jan 4 started headaches, vomiting, pain in the back of the neck, Headaches, chills, loss of speech,

About 25 minutes after vaccine a pain started at the injection site and went to left shoulder and up the left side of my neck. I had a lot of pain for about 10 minutes. Most of the pain went away about 10 minutes after it started.

injection site pain, headache, muscle pain, chills, joint pain, and nausea. Started 0300 02 Feb 21, ended 1000 02 Feb 21.

Pfizer-BioNTech COVID-19 Vaccine EUA Monday February 1, 2021 Injection in left shoulder was at 1 PM Monday. First noted slight pain at injection site about 12 hours after injection. Tuesday February 2, 2021 Shoulder pain at injection site increased to moderate level, slightly more than fall flu shot . Noted some body and joint aches. Wednesday February 3, 2021 First noted left lymph node under left arm (armpit area) was swollen approximately 43 hours after injection of vaccine after waking up on Wednesday morning. Shoulder pain at injection site is still considered to be moderate.

Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM Fitful Sleep.Extreme soreness at injection site. Awoke with fever (100.7), joint pain, nausea, lethargy. Took 400 mg of ibuprofen. Took "Nyquil" the next evening to help with symptoms. Fitful sleep and extreme sweating. Awoke Saturday feeling a bit better. Temperature (98.6) Rested all day. Better sleep Saturday night. Did not take any medication. Some sweating overnight. Awoke Sunday feeling better. Still not 100 percent Temperature 97.4.

Joints hurt and achy; wondering if his joints hurting and achy was an allergy; body ache (muscle pain); body ache (muscle pain); This is a spontaneous report from two contactable consumers (one was the patient). A 65-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, Expiry Date: 31May2021), via an unspecified route of administration on 20Jan2021 09:45 to at a single dose on left arm for COVID-19 immunization. Medical history included cholesterol, glaucoma, COVID-19, blood thinner, pressure, allergies, Acid Reflux/Stomach. Concomitant medication included atorvastatin calcium for cholesterol, clopidogrel for Blood thinner, amlodipine besilate for Pressure, lisinopril, flunisolide for Allergies, latanoprost for Glaucoma, famotidine for Acid Reflux/Stomach, alprazolam (XANAX). The patient previously received flu vaccine for immunization three months ago in Oct2020. Patient received the first dose of the vaccine yesterday 20Jan2021 9:45AM and between 6:00-7:00PM he started experiencing body ache (muscle pain), he's still achy and he would like to know what should he take, if he can take Tylenol. He mentioned him and his wife got the COVID Vaccine yesterday 20Jan2021. However, he is calling today because his joints hurt and achy. He initially stated he noticed his joints hurt and achy last night on 20Jan2021 around 7PM or 8PM, later stated like 6PM or 7PM. He also mentioned he told the lady yesterday a few months ago he tested positive for COVID. He was told he probably came in contact with it for a brief moment. He stated they could tell he had it in his blood and the antibodies not the first set, but second set was working. He later added, he took a blood test for COVID and was positive. He confirmed this was all prior to getting the COVID Vaccine, it was a few months ago like 3-4 months ago. He mentioned he was really calling because he is wondering if his joints hurting and achy was an allergy. He mentioned he has gone through this before with this allergy. Stated he has gone through these symptoms before. He wants to know what he can take for it. He did not do anything. He did not have a fever or anything. Stated he did not even take his nasal spray because he was unsure if he could. No treatment received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. Vaccination Facility was Hospital. The adverse events did not require a visit to Emergency Room or Physician Office. No Prior vaccinations within 4 weeks.

Approx 16 hrs after injection, low fever, chills, fatigue, and muscle aches set in. Took two tylenol and symptons lessened. About 6 hrs after taking tylenol, fever and chills started returning. Took 2 more tylenol went to bed and woke up fine. But the symptons I experienced after the injection was similar to my symptons during the time I had Covid.

there is a risk of being exposed for Covid; General malaise; muscle aches and pain; This is a spontaneous report from two contactable consumers A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), intramuscular in the right deltoid on 18Dec2020 07:15 at a single dose to prevent covid. Medical history included hypertension, stage 3 renal failure and his creatinine level was elevated ( and now it was under control since he was not taking nsaids and changed his medications around; he cannot take nsaids; and his creatinine was 1.6 and now it was 1.27 (dates unspecified)). Concomitant medication included unspecified medication for hypertension. Patient had no prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. He got the local flu shot a few months ago as it was required by his employer. He received the mmr v vaccine about 4.5 years ago and he had a terrible reaction for a week: he had muscle aches, pain and joint pain and everything hurts and it eventually went away. He does not have the exact name, lot, ndc, or expiration date to provide. It is on record at his employer. On day 4, 22Dec2020, after the first dose of the vaccine he had generalized malaise, muscle aches and pain, it was painful to put a pair of socks on and it went away within 24 hours. He sees covid patients everyday at the hospital. He does echocardiography and he is close to the patients for 20 minutes and there is a risk of being exposed for Covid. He clarified he is a registered diagnostic licensed medical sonographer, not a hcp. The outcome of the events general malaise and muscle aches and pain was recovered on 23Dec2020. Information on the Lot/Batch number has been requested

Severe loss of muscle strenth in waste, legs, knees, ankles......difficult to stand and walk. Severe joint pain in both knees and ankles. Extreme swelling in both ankles and feet.

arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.

Low grade fever; severe chills and shaking; severe chills and shaking; severe joint pain for 5 hours; sweats; Post fever fatigue; other vaccine same date vaccine date=21Jan2021; other vaccine same date vaccine date=21Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 65-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. Concomitant medication included irbesartan. 3 days post-vaccine on 24Jan2021 19:00, the patient experienced low grade fever, severe chills and shaking, severe joint pain for 5 hours and then sweats, post fever fatigue. No treatment received for these events, and these events were recovered on Jan2021. The patient received other vaccine on the same date 21Jan2021. The patient received COVID test post vaccination via Nasal Swab on 25Jan2021, COVID test result was Negative. Information on the Lot/Batch number has been requested.

Patient had vaccine on 1/29/21 and had STEMI on 2/4/21, started with back pain symptoms on 1/31/21 requiring hospitalization and MI occurred in the hospital

lower back muscle twitching; At 20Jan2021 04:30 woke up with his left lower back muscle twitching; back and neck stiffness; soreness in left arm (injection arm); This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL8982), via an unspecified route of administration at Arm Left on 19Jan2021 08:45 at the 65 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. At 19Jan2021 13:45 the patient experienced soreness in left arm (injection arm) and took 800 mg Motrin. At 19Jan2021 20:00 developed back and neck stiffness. Took another dose of Motrin. At 20Jan2021 04:30 woke up with his left lower back muscle twitching. He felt back asleep and woke up at 20Jan2021 8:00 will all symptoms resolved. The outcome of the events soreness in left arm, back and neck stiffness, lower back muscle twitching was recovered on 20Jan2021 08:00, the event woke up was recovered on 20Jan2021.

Stabbing pain over the right first metatarsophalangeal joint. Intermittent. No relation to activity. Progressed to nightly burning over the area, waking me up from sleep or preventing me from falling asleep.

I was working and around 10 o'clock my back started aching a little bit, and then mild body aches spread all over my body. I started feeling weaker. When I got home I was weak, and I had chills and fever and I was tired. I woke up a few times in the night with night sweats and chills. I was short of breath.

Swelling, pain and weakness of left wrist and hand. I have had this to date since adverse reactions started.

This is a spontaneous report from a contactable consumer reporting for her husband. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Jan2021 at 05:44 PM or 05:45 PM (at the age of 65 years old) as a single dose in the arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. The concomitant medication included acetylsalicylic acid (ECOTRIN) 81mg, potassium chloride (KLOR-CON M10) 750 mg, 2x/day, olmesartan 40-25 mg, 1x/day, rosuvastatin calcium 5mg and other non-prescribed supplements. On 24Jan2021, the patient experienced bump in his arm and was a little stiff and sore. The patient did not receive any treatment for these events. The outcome of the events bump in his arm and was a little stiff and sore was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Tremendous fatigue, slept for 12+ hours, followed by overall general achy back, joints, some light headiness, unstable when standing at times.

loss of muscle tone of my cheek and inability to smile on the left side; Loss of sensation of my left cheek from under my eye to my mouth; loss of muscle tone of my cheek and inability to smile on the left side; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration in the left arm, on 29Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included hypertension, diabetes, increased cholesterol and COVID-19 prior to vaccination. The patent has no allergies to medications, food, or other products. Concomitant medication included enalapril, hydrochlorothiazide, atorvastatin (LIPITOR), and metformin. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient was not tested for COVID-19 since the vaccination. The patient experienced "loss of sensation of my left cheek from under my eye to my mouth. My wife noted loss of muscle tone of my cheek and inability to smile on the left side" on 29Jan2021 at 08:30. Symptoms started about one hour after the injection and resolved after 3 hours. No treatment was received for the events. The outcome of the events was resolved on 29Jan2021 at 11:30. The reporter assessed the events as non-serious.

One hour after the vaccine I experienced loss of sensation of my left cheek from under my eye to my mouth. My wife noted loss of muscle tone of my cheek and inability to smile on the left side. Symptoms started about one hour after the injection and resolved after three hours.

Tachycardia, joint soreness on March 5th. Low grade fever (100.5), severe headache, nausea, whole body ache on March 6th. Severe shaking on the evening of March 6th, duration over 60 minutes. Night sweats, nausea, headache that night.

muscle soreness throughout body and at injection site, lethargy, slight headache - appears to be resolved after 1 day.

Side effects began almost 1 week after 1st dose. Patient had severe motion sickness and nausea resulting in vomiting, sporadic moments of fever chills and muscle aches. Symptoms persisted for 2 days, tapering off on the 3rd day. Side effects for 2nd dose appeared night of injection, include fever chills and muscle aches. Symptoms disappeared the next day.

Upset stomach / nausea started just a few minutes after the vaccination then upon waking the next day headache, muscle aches, fever came on in addition to nausea.

Left shoulder injection site sore and tender. Stiff-tightness associated with movement. Hot shower directed at injection site reduced symptoms. Symptoms remain 48 hours after injection. I run at night, usually 3 miles or more. 7 hours after injection no problem running. 31 hours after injection running was much more difficult, similar to fatigue.

One week after getting the first Pfizer vaccine, my superficial vein thrombosis returned with a vengeance. I had gotten the vein ablation treatment several years ago for varicose veins, and the problems I had went away, but one week after the first shot, my calf muscle was swollen and felt sore and aching, and the rest of the leg was in pain, just like it was before getting the vein operation. The varicose veins returned and my leg now has prominent black and blue areas on it, like it had before my surgery. I'm returning to the vein clinic in two weeks for them to look at it. My leg still hurts. I should also add that my arm is still sore where they gave me the shot. My strength has not yet fully returned, even though I work out in the gym regularly.

About an 1 1/2 hours after getting my first shot I had what I can only describe as a RUSH/High energy feeling along with a soreness in my chest around my heart area. Lasted for about 2 hours and that was it no other symptoms that I noticed. Then after getting my second shot had the same thing only much more intense to the degree I was worried I may be having the start of a Heart Issue. This last for a couple days. And now I?m about 14 days after my second shot and my heart area feels much better but my whole back from my neck almost to my waist feels like sore and achy. Never had fever chills shortness of breath or anything really other than what I?m describing above. I?m starting to feel a little better each day. I just boy wanted to report this because I could not find anyone else who had felt like this after the shot. Thank you

Patient developed fevers the day after vaccine, arthralgias/myalgias. daily fevers persisted, and he was eventually admitted to the hospital for FUO workup. fevers finally stopped after prednisone initiated on 3/11 (3 weeks after vaccine) presumed Still's disease type phenomenon from vaccine (has high ferritin, high WBC, low albumin, mild LFTs abnl, persistent fevers), never had rash

2 days after receiving 2nd COVID 19 vaccination, woke up with pain, tenderness, and swollen left armpit. Received vaccination on left arm

Chills; fever 100.4; joint pain; mild headache; This is a spontaneous report from a contactable consumer for himself. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 09Feb2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included arthritis from an unknown date and unknown if ongoing. The patient had casein and dairy allergy. The patient's concomitant medications included Levothyroxine sodium (Levothyroxine), Amlodipine, Metoprolol and Omeprozole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 19Jan2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. On 09Feb2021 20:00 the patient experienced chills, fever 100.4, joint pain and mild headache. The events were assessed as non-serious by the reporter. The patient received Advil and Tylenol as treatment medications. The outcome of the event was recovered. Information on the lot/batch number has been requested.

areflexia throughout/decreased sensation to pinprick; B/L CN 7 weakness; areflexia throughout/decreased sensation to pinprick; Bilateral lower extremity weakness and pain/patchy weakness in RLE > LLE; Bilateral lower extremity weakness and pain; paresthesia in bilateral hands and legs; acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre syndrome); lumbar puncture showed no WBC and significantly increased protein to 107; lumbar puncture showed no WBC and significantly increased protein to 107; This is a spontaneous report from a contactable physician. A 65-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261), intramuscular on 24Jan2021 at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included 'Cryptogenic cirrhosis s/p liver tx 20Jun2020, T2DM on insulin, Factor V Leiden, CAD s/p stent x3 (2008), hyperlipidemia', NSAIDS allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine, acetylsalicylic acid (ASPIRIN), bupropion hydrochloride (WELLBUTRIN), carvedilol, citalopram, ergocalciferol, insulin glargine (LANTUS), melatonin, metformin, omeprazole, senna alexandrina (SENNA). The patient previously took atorvastatin and experienced Allergies to Atorvastatin, promethazine and experienced Allergies to promethazine, tolmetin and experienced Allergies to tolmetin, INSULIN for T2DM (Type 2 diabetes mellitus). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Bilateral lower extremity weakness and pain and paresthesia in bilateral hands and legs on 26Jan2021. Symptoms began two days after first dose of the Pfizer vaccine (received on 24Jan2021) and have continued to progress over the last 2.5 weeks. His neurological exam now (10Feb2021) includes areflexia throughout, patchy weakness in RLE > LLE, decreased sensation to pinprick and B/L CN 7 weakness. His lumbar puncture showed no WBC and significantly increased protein to 107 in 2021. This is all consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association in 2021. The patient underwent lab tests and procedures which included lumbar puncture: no WBC and significantly increased protein to 107 in 2021, neurological examination: areflexia throughout, patchy weakness in RLE > LLE and B/L CN 7 weakness on 10Feb2021, Rapid SARS-CoV-2 (COVID-19) by PCR Nasopharyngeal swab on M4 (NASO): negative on 06Feb2021, skin test: decreased sensation on 10Feb2021. The adverse events result in Emergency room/department or urgent care. Hospitalization for all the events. Therapeutic measures were taken as a result of events (IVIg). The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, patient developed signs and symptoms which were consistent with acute inflammatory demyelinating polyneuropathy (AIDP or Guillain Barre Syndrome) likely secondary to COVID vaccination given temporal association. In addition, a contributory role of patients co-morbidities cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

A couple of days after the vaccine, back muscle (upper back, left side- the same arm of vaccination) started hurting. Since then, the pain is constantly there BUT it moves to various locations, only on the left side, sometimes in muscles, sometimes in shoulder joint and often at the site of vaccination. The pain, while it moves around, is only at one location, often in addition to the vaccination site. Thus it can be in left shoulder joint and the site. Or it could be the site and at the shoulder- neck joint. Never has the pain migrated to the right side and is confined to the left arm, shoulder, upper back area. Naturally the pain dulls upon taking a couple of Tylenol?s or Advil?s but otherwise has been there no -stop for about two weeks, shortly after the vaccination. Avery slight swelling can be felt at the injection site.

Fairly severe joint pain started on 06Feb, worse today, esp. in shoulders which are quite arthritic; This is a spontaneous report from a contactable consumer (patient herself) A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN53.8),via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation .Medical history included osteoarthritis from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing ,obesity from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported. The patient experienced fairly severe joint pain started on 06feb, worse today, esp. in shoulders which are quite arthritic on 06Feb2021 07:00 with outcome of not recovered.I would have been happy to help had you bothered to generate a fillable .pdf but I'm not going to try to hand write everything. This is the 21st century, time to get with the program.The events were considered as non-serious by the consumer. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.

101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatigue for first 10 days. As soon as eat breakfast have to go back to bed for 1-3 hours. Same with lunch, eat, go back to bed about 3 hours and same with dinner. Then go to bed for evening. Extreme brain fog and forgetfulness. Can't think of words or make sentences. Can't remember anything. Feels like a very heavy feeling in head like head weighs a lot and very cloudy. Pain from shot in arm moved up to neck, ear and jaw the day after shot. Arm quit hurting but couldn't lift it. Pain stayed in neck, ear and jaw for a week and now is a stiff feeling. I think the lymph nodes are swollen. Effects eating, hard to keep food down. Nausea and stomach pain. I have appetite but have to eat while nauseous and pain. Still severely fatigued every day and have to sleep most of each day or at least sit and rest. So exhausted. Also night of shot started getting hot and cold chills. Still have them over 2 weeks after shot. Bad tinnitus started night of shot and still have it over 2 weeks after shot. Very loud and nothing makes it go away. Bad headache started morning after shot. I have had a headache pretty much everyday, all day since the shot over 2 weeks ago. I feel sick like I have flu.

Initially a low-grade fever but after a few days, my arthritis in my hip became very painful radiating to my knee and lower back to the point where I could not sleep or walk very well. I am still experiencing pain and difficulty walking or standing for more than a few minutes.

Sharp lower back pain with lumbar inflammation. Pain radiated down both legs with intensity that impacted mobility. Pain has subsided after four days but remains present after 10.

Pain in right shoulder x3 days; tiredness x1 day; increase in volume of Tinnitus in Right ear-continuing; stiff neck and headache-continuing; Advil x2 day for stiff neck and headache-continuing.

Day 8 thought I was getting a urinary tract infection. Started experiencing chills. The next day same symptoms. A couple days later went on for a week with fever and muscle ache.

Infection after hernia surgery; respiratory infection; swelling was from the trauma of the procedure; pain; aggravates the arthritis; aggravates the psoriasis; stress; Felt like he was getting a cold; Little cough/He was not coughing up green or red, just light brown; Tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 09Feb2021 13:00 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. Medical history included ongoing bronchitis chronic, pneumonia, ongoing back issues, which has been suffering from back issues for 20 years, ongoing psoriatic arthritis, ongoing psoriasis, liver transplant from 29Oct2013 to an unknown date, muscle spasms, heart rate, depression, anxiety attacks, blood pressure and hernia. Concomitant medication included amlodipine for blood pressure and ongoing and he began taking years ago, carvedilol for heart rate and ongoing that he began taking over 10 years ago and stated that it is to keep his heart rate between 70 and 80 beats per minute; pravastatin and ongoing that he began taking about 5 years ago; sertraline hydrochloride (ZOLOFT) for antidepression and ongoing that he has been taking for 2 or 3 years; alprazolam (XANAX) for anxiety attacks and ongoing that he has been taking for over 10 years; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for he didn't cramp up and ongoing that he has been taking for 5-10 years; mycophenolate and everolimus both from 2013 and ongoing for anti-rejection since his liver transplant in 2013. While providing concomitant medications he mentioned details about a historical medication. He was on bupropion hydrochloride (WELLBUTRIN), but was switched to Zoloft. He was switched because he had built a resistance to the bupropion hydrochloride and had to move up in the class. The patient experienced tired on 10Feb2021, felt like he was getting a cold on Mar2021, little cough on Mar2021. The patient was hospitalized for infection after hernia surgery (infection) from 22Feb2021 to 24Feb2021. For chronic bronchitis, patient stated that he was never really diagnosed, that it's just like having a cough all the time. It felt like his lungs are not big enough for his body and that he got winded quickly. He was strong and could do manual labor, even after the liver transplant, but that he has noticed the last couple of years that the cold felt like it's freezing his skeleton. He has had pneumonia 3 times altogether. He was unable to specify dates but he knew that he had it post-transplant in 2013. There isn't a test for psoriatic arthritis so he was unable to provide a diagnosis date. He had been experiencing this for the last 10 years. He was diagnosed with psoriasis when he was 25. He had his first shot done, clarified as the Pfizer Covid-19 vaccine. He was supposed to go back to get his second dose of the Covid-19 vaccine but was hospitalized briefly after hernia surgery with complications and got an infection. Therefore, he didn't make his appointment. Patient stated that his second dose of the Covid-19 vaccine is now scheduled for 21Mar2021 but he would like to schedule it for somewhere closer. He was a liver transplant patient and that the hospital where he received the transplant likes to keep things in house. After the hernia surgery he couldn't drive or sit down because it was uncomfortable and that the jostling of the car was too much. Patient reported that he would see his physician who recently retired once a month for a prescription for pain meds that he needs for back issues, psoriatic arthritis, and scar tissue from being operated on 4 times. He has had about 10 Covid tests. It made people feel more comfortable when he shows them the negative results. He has been stressed over waiting for the Covid test, that the stress then aggravates the psoriasis which aggravates the arthritis. After the vaccine he clarified he did not feel right. He said that he didn't feel sick, just wasn't 100%. He was tired and felt like he was getting a cold after receiving his first dose of the Covid-19 vaccine. Which he did, he had a cold/cough. He felt tired the next day and only for a couple of days after. He confirmed the tired feeling has resolved completely. Patient stated that he thought the hernia surgery was already scheduled, and stated that the liver clinic called him and said that he had to come in a certain day at a certain time. He received the first dose of the Pfizer Covid-19 vaccine 4 days before surgery. For infection after hernia surgery, patient reported that he couldn't remember the hospital dates but that he was admitted for 2 days and received IV antibiotics. He was hospitalized on 22Feb2021 or 24Feb2021. His doctor had told him that the swelling was from the trauma of the procedure. For little cough and felt like he was getting a cold, patient reported that he had been on oral antibiotics after his surgery and his doctor increased the dosage to help with the respiratory infection, it was a cough. Feeling like getting a cold started like a week ago. He was not coughing up green or red, just light brown. Patient unable to provide NDC number or expiration date as they were not listed on his card. He was a liver transplant patient so he's on immunosuppressants. He stated that he is 65 and if he gets Covid he's a dead pigeon and that he doesn't see himself surviving the pulmonary aspect. Mentioned he has had pneumonia a few times in his life, post transplant, and has bronchitis. Patient stated that Micophenylate/ Everlimus were actually poison that fool body into thinking that's liver. Caller stated that they lower immune system so didn't fight it. He got more colds and if he got a cut on hand it would get infected. Patient stated that he had labs done and a CT scan and labs when he was hospitalized for the infection after his hernia surgery and that everything came back normal. He was just having pain. Vaccine administered was not at facility and vaccination facility type was hospital. Nonadditional administered vaccines. No AEs require a visit to emergency room but physician office was required. He went to the doctor for the little cough that he experienced. He was hospitalized for the infection following his hernia surgery. Patient hospitalized for 2 days was the hospital stay. No prior vaccinations within 4 weeks and no ae following prior vaccinations. The outcome of event tired was recovered on unspecified date in 2021 (as reported), the outcomes of events felt like he was getting a cold and little cough were recovering, while other events were unknown.

Received second COVID 19 vaccine in left arm on 03-08-2021. Woke up on 03-09-21 with pain under my left arm pit. Looked at my arm pit in the mirror. My lymph node was swollen approximately the size of a tennis ball and hanging down approximately 4" under my left arm pit. I tucked the lymph node back under my arm and squeezed my arm against my side for approximately 1 hour. The lymph node no longer hung under my arm pit. I then used ice pack and a heating pad to for the next 5 days aid in reducing the swelling. As of this date (04-02-2021) the lymph node is still slightly swollen approximately 1" to about 1 1/2". A little tender when pushing on it, but not painful. This was the only side effect I had after receiving both Pfizer Covid 19 vaccinations.

No reaction to first dose. Second dose no immediate reaction. 3 days after 2nd shot swelling in the both wrists, at the time I thought it was tendentious. 4-5 Days after, stuffy nose and cold symptoms. 7 days, asthma symptoms began to get worse. Day 9-12 asthma attacks became severe leading to lung congestion, heavy mucus production and intense wheezing and coughing attacks. Treatment during the attacks was FloVent 110 2 puff 12 hours apart. As attacks grew worse, use of Ventolin rescue inhaler had to be used to control severe bronchial constriction and build up of thin mucus causing breathing congestion and more coughing. The coughing and difficulty breathing meant using the Ventolin every hours. The

Fever, chills, muscle contractions in lower back and stomach for two days. Loss of appetite, lower back pain. My urine was deep orange in color and bowel movements were very loose (not formed). Extreme fatigue for almost 8 full days before I felt any sense of feeling normal.

bodychills; headache; heavy sweats; low fever; no appetite; losing weight; lethargic; heavy head; tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (Lot number: En6205), via an unspecified route of administration, administered in left arm on 08Mar2021 11:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. No Covid prior vaccination. Concomitant medications included amlodipine besilate; benazepril; and gemfibrozil. No other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced body chills, headache, heavy sweats, low fever, no appetite, losing weight, lethargic, heavy head and tired. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized due to the events on unspecified date. There was no treatment given for the events. The outcome of the events was not recovered.

excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

EXTREME muscle pain in legs starting 4 days after the injection - 4/3/21. The pain started the day after a routine 5 mile run. By routine, I mean a run that I have done thousands of times without muscle soreness. At first, the pain was treatable with a 400mg dose of Ibuprofen but gradually worsened to the point where over the counter NSAIDS were no longer effective. Moving to 200mg Celecoxhib 2x day was only modestly effective. The pain was so intense that I am unable to get adequate sleep and has consolidated in the left leg.

Starting on or about 4/5/21 severe headache that I treated as a sinus infection from seasonal allergies. Stayed inside. stopped smoking (marijuana), nasal mist. Very dry sinuses and eyes especially the left eye. The pain proceeded to worsen and I rinsed my sinuses with nasal mist which eventually relieved the pain. At one point during the rinsing I had a short flow of blood from my sinuses. I used eye drops for the dryness in my eyes. I had occasional pain in my legs during the week of the 5th followed by extreme back and leg pain on the 11th. This pain and spasms mainly effected regions where I have had long term weakness. I still have minor pain as is typical.

slight fever 99.7 early evening 07Feb; lower abdomen pain thru to back; lower abdomen pain thru to back; then woke to cold and shivering lasting 2hours that night; then woke to cold and shivering lasting 2hours that night; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 06Feb2021 at 03:45 AM as single dose for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. Allergies included shellfish allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 07Feb2021 at 19:00, the patient experienced slight fever 99.7 early evening, lower abdomen pain thru to back, woke to cold and shivering lasting 2hours that night. The clinical outcome of the events slight fever 99.7 early evening, lower abdomen pain thru to back was unknown and the event woke to cold and shivering lasting 2hours was recovered. The patient underwent lab tests and procedures which included body temperature: 99.7 on 07Feb2021. No follow-up attempts are possible and no further information is required.

First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks. ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.

mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, intramuscular in right arm on 26Feb2021 10:15, at 65 years of age, (Batch/Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included knee surgery on 23Jan2019, some tiredness, disability (reported 40% on back and 30% on mental) and mental depression since 1978 and ongoing. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 05Feb2021 at 10:15 AM (Batch/Lot number: E23247), via intramuscular route in left arm and one dose of Flu vaccine on 14Jan2021 in left arm. Concomitant medications included acetaminophen 500 mg twice daily for back pain, lithium carbonate 1 tablet 300 mg for depression and lamotrigine 25 mg 1 tablet daily for depression, all taken since an unknown date and an unspecified medicine for Disability 40% since an unknown date. On 26Feb2021, 8 hours after the second vaccine dose, the patient experienced tired and sleepy "skeleton" and back pain got worse and shoulder pain and, on an unspecified date, he experienced mind and memory depression. No treatment was administered to the patient for the reported events. The events tired and sleepy resolved on 28Feb2021, the event shoulder pain was resolving, whereas the outcome of the events back pain got worse, mind and memory depression was unknown at the time of the report.

development of severe neck pain leading to acute quadriplegia over the course of 24 hours Patient was intubated, started on high dose steroids and had an emergent C3-C7 decompressive laminectomy, medial facetectomy Extubated in ICU and now recovering.

While in monitoring room client noticed red blotches on arms. No other signs or symptoms noted. b/p 168/98 patient reported that it would be high before b/p was taken, stated he has high blood pressure. PSO2 97 % pulse 59. Skin pink warm and dry. Respirations even and unlabored. Client monitored until 2pm, stated he was going to see his friend who is an ER doctor for a follow up. Informed to seek medical attention if any other symptoms or shortness of breath occurred at any time.

65-year-old man with PMH significant for hypertension, who began to experience neck pain shortly after he had his second dose of the Pfizer COVID-19 vaccine on 4/14/2021. He reports pain started out as aching in his neck and down into his back. His pain got worse and he went to see a chiropractor the next day, where he had massage and neck manipulation which temporarily provided some relief but then the pain worsened. He was seen in ER that night for neck pain and spasms. He was treated with Valium and DC with Rx for Flexeril. He took several doses but pain persisted. This morning, he noticed tingling in bilateral hands, as well as tingling and inability to move his legs. He called EMS and was brought to ED for evaluation. Pt was evaluated by neurologist, was found to be quadriplegic. He was immediately ordered for CT head, CT cervical spine as well as MRI of cervical and thoracic spine. Imaging is notable for enlargement of the spinal cord from the C2 down to C7-T1. Felt to be likely transverse myelitis. Pt also noted to have superimposed cervical spinal stenosis, most significant at C5-6. The patient was then taken for emergency neurosurgery for a C3-C7 decompressive laminectomy, medial facetectomy on 4/16/2021. Due to lab work findings an infectious workup was completed, patient noted to have MSSA positive blood cultures, and subsequent ECHO demonstrated mild to moderate aortic valve calcification and mobile strands of the aortic cusp. Treatment was begun for endocarditis.

Per pt's caregiver, he had chills, hives, itching, fatigue, swollen joints, an irregular EKG and PVC (premature vascular contractions). The irregular EKG & PVC is what I wanted to report since this is not considered typical with the Pfizer vaccine.

I was unable to perform any usual daily activities. I had a severe headache, joint aches, chills and extreme fatigue. I slept for 36 hours. I'm reporting this because I had the same reaction to my first dose. I had COVID in December but I'm otherwise very healthy. I would not be willing to receive another dose of this vaccine.

Fever up to 102 degrees; muscle pain all over; Chills; sweats; Headache; tiredness; feeling unwell; injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN 62 OV, expiry date 30Jun2021) at right arm via an unspecified route of administration, on 20Feb2021, 11:45 at SINGLE DOSE for COVID-19 immunization. Patient was diagnosed with COVID-19 Prior to receiving vaccination. The concomitant medications were not reported. On 21Feb2021, the patient experienced fever up to 102 degrees, muscle pain all over, chills, sweats, headache, injection site soreness, tiredness, feeling unwell. Since the vaccination, the patient not been tested for COVID-19. It was reported that the patient not received treatment for the events. At the time of this report event outcome was recovering.

History of hypertension and COPD presents to the ED 4/23/21 with complaints of fever, nausea, dizziness, muscle aches, diarrhea, urinary urgency, and shortness of breath that started 4/20/21. SARS-CoV-2 COVID-19 resulted positive 04/22/21 23:40 on PT admitted 4/23/21. PT received dose 1 Pfizer vaccines on 2/25/21 LOT EN6200. Pfizer dose 2 received 3/18/21 LOT EN6207. PT discharged 4/25/21.

Severe leg (confined to the thigh/quad area) muscle pain; This is a spontaneous report received from a non-contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7534) via unspecified route of administration in left arm on 30Mar2021 at single dose for COVID-19 immunization. Medical history included strong seasonal allergies, eosinophilic esophagitis. No known allergies to medications, food, or other products. Concomitant medications were not provided. On 04Apr2021, the patient experienced severe leg (confined to the thigh/quad area) muscle pain following a routine run 3 days after the injection. The intense pain worsened over the subsequent days peaking at about 6 days from onset when the right leg suddenly got better leaving the left still in extreme pain. At 8 days from onset the pain slowly started to subside. Patient was still in moderate pain at day 10 from onset. Over the counter pain meds were not effective, so patient tried 50mgs tramadol, also not effective, 200mgs celecoxib 2x/day brought some relief. This report was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

crawling sensation in his face and head; pins and needles in his hands and feet really bad; lower back pain; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8737) at right arm on 16Apr2021 14:00 at single dose for COVID-19 immunization (reported as because everybody is saying that we should; because he is 65). Medical history included ongoing Diverticulitis, ongoing Tinnitus, Stroke (About three years ago, he woke up one morning and started seeing two of everything and when he went to hospital they stated he probably had a slight stroke and was started on aspirin), bolt and screw in his neck due to a spinal injury, the disc collapsed, Cholesterol, acid reflux and thyroid. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW) from 2018 and ongoing because had a slight stroke, omeprazole from unspecified date (started taking at let 15 years ago) and ongoing for acid reflux, levothyroxine from unspecified date (started taking about 7 years ago) and ongoing for thyroid and atorvastatin from unspecified date (been taking about 10 years) and ongoing. 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) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. Family Medical History Relevant to AE was None. Relevant Tests was None. The caller stated she and her husband, got the first dose of the vaccine on Friday 16Apr2021. On Saturday (17Apr2021) her husband started having pins and needles in his hands and feet really bad and lower back pain, and this morning (19Apr2021) is having a crawling sensation in his face and head. She asked if he should get the second dose. No Investigation Assessment. Caller states patient is currently not taking any medication for these events. Events were not required a visit to Emergency Room or Physician Office. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions. Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction

the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) 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 the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Headache; sore muscles; sore joints; chills; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown), via an unspecified route of administration, in Left Arm on 11Apr2021 at 08:30 (at the age of 65 years old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 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 and since the vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration, in Left Arm on 14Mar2021 at 10:00 at single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at hospital. The patient experienced headache, sore muscles, sore joints and chills on 11Apr2021. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Right after the injection, I felt flushed. For the following 2 days, I felt: chills, headache, a light/dry cough, light nausea, balance was off, concentration was off, fatigue, and joint pain (esp. in hands and fingers). Symptoms cleared by 2/15/2021 except for headache, which remained present every day and Intesified. i told my wife for the first time about it on 2/22/21, then told her that I worried it was a symptom of a stroke on 3/1/2021 and she told me to call my doctor. I met with PA on 3/3/2021 and had a CT scan on 3/9/21. I met again with PA on 3/9/21 and was told that my CT scan indictate normal brain abnormalities due age and an inflamation in the sinuses.

Approx 3 weeks after the second shot the same leg I had a blood clot in 5 years ago in 2016 had my ankle puffed up with soreness in the calf. I knew it was another blood clot, took almost one week to get a doppler scan and they confirmed that I had another clot. I was put on Eliquis the same day.

Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive. Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.

Rash on upper right arm and shoulder( Opposite injection Site).; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on his left arm on 05Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included peripheral arterial disease (PAD), chronic obstructive pulmonary disease (COPD) and hypertension. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN); all for unknown indications form unknown dates and unknown if ongoing. Patient was allergic to pseudoephedrine hydrochloride (SUDAFED). 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. One week after vaccination on 12Mar2021 at 06:00, the patient experienced rash on upper right arm and shoulder (opposite the vaccination site). It started as muscle pain, which was not itchy. It was just uncomfortable muscular pain. He did not receive treatment for the events. The clinical outcomes of the rash and muscular pain were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Guillian barre Syndrome ~2 weeks following second shot of Pfizer vaccine ; ultimately resulting in intubation and invasive ventilation

Extreme pain in shoulder, interrupted sleep, chest heavy, left side. pain spreading spreading left to right

Chill, headache, dizziness, sore muscles, nauseated, tired. for 2 days. Milder headache & dizziness for 2 more days so far

There is pain in his shoulder; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; But his knees, bigger joints, was 2 days; Even up in my jaw bone. It hurt so bad I couldn't eat soup.; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them.; I had arthritic pain, on my thumb - like I broke my thumb; It started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows; Even up in my jaw bone. It hurt so bad I couldn't eat soup.; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them./I can't lift my left arm (injection arm); Excruciating joint pain after receiving 1st dose Pfizer vaccine; I had arthritic pain, on my thumb - like I broke my thumb; The next day my left foot (I put on aspercreme and took Advil), then moved up to my right wrist same thing excrucitating pain, hardly move them.; This is a spontaneous report from a contactable consumer. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration (by injection), in left arm on 14Jan2021 (at 65-years age) as 1st dose, single for covid-19 immunisation; and ibuprofen (ADVIL [IBUPROFEN]), via an unspecified route of administration from an unspecified date (Batch/Lot Number: EC3203; Expiration Date: May2023) to an unspecified date, at unspecified dose for joint pain. Medical history included he sees a lung specialist for the last 5 years, he had pulmonary fibrosis, he was dyslexic. There were no concomitant medications. Patient experienced excruciating joint pain and it would move around on 17Jan2021 after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Three days after receiving the first dose patient had arthritic pain, on thumb - like he broke my thumb (put on aspercreme and took Advil) but night it went away. The next day my left foot (put on aspercreme and took Advil), then moved up to his right wrist same thing excrucitating pain, hardly move them. Pain in the joints even up in my jawbone. It hurt so bad he couldn't eat soup. He was into 16 days and could not lift his left arm (injection arm) for 4 days could not lift it. He went to see his rheumatologist. On the 04Feb he had his second dose, he did not want to go through all this pain. Caller wanted to know if he needed to get 2 doses again if he missed his scheduled second dose or delayed it. Patient having excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he was not able to move his left arm for 4 days. There was pain in his shoulder, he could move his shoulder, but to do the chicken wing with his arm, he could not do it. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints were there one day and gone, he puts Aspercreme on and took Advil, and by nighttime the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you could not drink soup. His left arm was going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4th. The doctor said he would call. he had a hard time getting around with oxygen. Patient received Aspercreme and Advil for joint pain, he puts Aspercreme(expiry AUG 2022, lot is 19H122) on and took Advil, and by nighttime the pain was gone, but the next day it was somewhere else. The outcome of the events was unknown. Follow up (02Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: patient information and dosing date. Follow-up attempts are completed. No further information is expected.

flu-like symptoms; joint and muscle pain in hips and back of thighs; joint and muscle pain in hips and back of thighs; headache; bodyaches; fever; lack of appetite; fatigue; weakness; light headedness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 65-years) as 1ST DOSE, SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: known allergies: Minor Adverse reaction to Yellow Fever Vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Prior to the vaccination the patient was not diagnosed with COVID-19. On 09Feb2021, the patient experienced 5-7 days of flu-like symptoms: headache, bodyaches, fever, lack of appetite, fatigue, weakness, light headedness. Additionally, the patient had 5-7 days of joint and muscle pain in hips and back of thighs interfering with sleep at night. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 12Feb2021, post vaccination the patient had nasal swab test (SARS-CoV-2 test) and the result was negative. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

I first noticed an increase in my Heart-Rate about 15 seconds after the injection. I also felt an unusual pain in my lower back area, down to the end of my spine. During my 30-minute waiting period after the injection the symptoms did not subside. Since I am allergic to Insect Stings, I had 25 mg Diphenhydramine Tablets and my Epinephrine Injector with me at the clinic. I took one 25 mg Diphenhydramine Tablet orally with water. My symptoms subsided after about 30 minutes. I waited an additional 30 minutes at the clinic. My wife and I left after that time period. I presently feel normal at this time.

Headache; Neck Pain from top of shoulder to neck on left side; Neck Stiffness; Really Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via intramuscular, administered in left arm on 03Mar2021 at 09:30 (at a age of 65-year-old during vaccination) as 1st dose, 0.3ml, single dose for covid-19 immunisation. The patient's medical history and family medical history were reported as none. The patient's concomitant medications were not reported. The patient had not undergone any investigation assessment prior or post vaccination. The patient had not taken any other vaccine 4 weeks prior to Covid vaccine. The patient no adverse events prior to Covid vaccination. On 03Mar2021, the patient almost immediately within 5 mins of vaccination experienced headache. He stated that he went home, and headache still lasting and then within a half hour after the vaccination the patient had neck pain from the top of his shoulder up to his neck and his neck was really stiff, and really dry mouth. He wanted to report his effects, he assumes he had a reaction to the shot. He stated that he was finally starting to feel better. He stated that he has his next one shot in three weeks. The patient had neither visited emergency room nor physician. He stated that his doctor may tell him to go to the ER if events worsened and it was not. The patient took Tylenol as treatment medications for the resulted events. The outcome of the event headache was not recovered and for the rest of the events was recovering. No follow-up attempts are possible. No further information is expected.

left shoulder and upper arm pain; left shoulder and upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left (left shoulder) on 29Mar2021 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 01Mar2021, with lot number EL3302, in his left shoulder and experienced pain in his left shoulder. The patient received the second dose at the end of Mar 2021, on 29Mar2021. Since the second dose (29Mar2021), he experienced left shoulder and upper arm pain for two months and the pain has not gone away. Caller states that he received the injection in his left arm. He had consulted with his HCP in which they advised him to perform stretching exercises and states that the exercises have not helped. Caller states his doctor said the pain must be from him having a strong immune system. It was reported that after the second dose, he had less pain in his shoulder, but it hasn't gone away. He did not have a prescribing doctor. He had not received treatment. He didn't go to the doctor or ER. He did talk to his doctor, and his doctor said people are reporting all kinds of weird stuff. He did ask him if he was working it out. The caller was stretching every morning, and that was when he felt it. Patient wanted to know if he should be concerned about this side effect, what he should do and there is any treatment recommendations to provide. He also asked if anyone else has experienced this side effect and what could cause this pain in his arm and shoulder. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

pain in his left shoulder; This is a spontaneous report from a contactable consumer. A 66-years old elderly male patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL3302), via an unspecified route of administration in left arm on 01Mar2021 as FIRST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccination, the patient experienced pain in his shoulder for a couple of days and then the pain subsided. Caller states that he has consulted with his HCP in which they advised him to perform stretching exercises and states that the exercises have not helped. The Outcome for the events was recovered. Information on Lot/Batch number was available. Additional information has been requested.

Since March 2021, I am experiencing discomfort in the upper abdomen area, just under the rib cage. At times the pain is in the rib area. On a scale of one to ten and ten the worst, it is about a one. I have undergone several tests, a stress test, and two ultrasounds, one with contrast. Still, the discomfort persists. The only change in my routine was the administration of the vacation.

Several days after the shot I had severe, crippling pain in both hands, wrists, shoulders, elbows, knees, upper arms that migrated from place to place. It lessened somewhat over the next couple of weeks but did not fully resolve before time for the second shot. After the second shot the symptoms came back even worse, to the point I had to seek medical care. The doctor prescribed Prednisone, which has helped some, but has not resolved symptoms. I have had increased swelling in feet and ankles, so a diuretic was prescribed. The pain has affected my ability to work, activities of daily living, ability to sleep at night because of pain. At times I need help to dress. I am in the process of being referred to a specialist. I also have fatigue and tire easily.

Site soreness; Generalized muscle soreness; This is a spontaneous reporter from a contactable consumer. A 65-year-old male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201) via an unspecified route of administration on 04Mar2021 at 01:15 PM (age at vaccination: 65 years ) on left arm at single dose for COVID-19 immunization. The patient's medical history included hypersensitivity(allergies) to sulfa drugs. 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 Concomitant medications were not reported. It was reported that patient received other unspecified vaccine in four weeks but did not receive other medications in two weeks. On 05Mar2021, the patient experienced site soreness and generalized muscle soreness. No treatment was received for the events. The outcome of events was resolving. No follow-up attempts were possible. No further information was expected.

tired; sore shoulder; headache for only one evening; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in left arm on 04Mar2021 at 08:30 as a single for COVID-19 immunisation. The patient's medical history included allergies to any cillin. Concomitant medications were not reported. The patient has not received any other vaccinations in four weeks nor other medications in two weeks. The patient was not diagnosed with Covid prior to vaccination and has not tested for Covid post vaccination. After first dose, on an unspecified date the patient experienced tired, sore shoulder and headache for only one evening. No treatment received for the adverse events. The outcome of the events was reported as recovering.

After 10 hours extreme pain left arm bicep; This is a spontaneous report from a contactable other HCP (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6199), via an unspecified route of administration on 05Mar2021 at 02:15 pm (65-year-old at the time of vaccination) on the left arm as a single dose for COVID-19 immunisation. The patient had no known allergy. The Patient's medical history included Type 2 diabetes, prostate cancer 2019 (no signs of cancer 2020). COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's concomitant medications were not reported. On 05Mar2021, at 09:00 pm, the patient experienced extreme pain in the left arm bicep. The patient did not receive any treatment medication for the events. The outcome of the events was unknown. No follow-up attempts are Possible. No further information is expected

Inflammation of left calf: 5/27 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Ultrasound on June 2 for possible DVT was negative. Exam by orthopedic provider on 6/4 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 5/28 began experiencing swelling and tenderness in ankle, groin area, and testicles. Has continued to present. Ultrasounds on 6/8 confirm no clots in leg. Also confirm fluid retention in leg, groin, and testicles. Cough: Have experienced persistent slight cough from 5/28 to present. No sputum or nasal congestion. Treating with over the counter cold remedies with no change. Chest xray and CT scans on 5/8 reveal no fluid in lungs or heart Night Sweats and fever: Extensive night sweats and low grade fever 5/28,29,30,31. .Other information: Had COVID February 17- March 5 Received monoclonal antibody therapy on 2/24 ( casirivimab and imdevimab) Had recovered from Covid and was in good physical health exercising daily prior to vaccination. Had no previous injury in left calf preceding the vaccination.

lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.

On 3/28/21 I decided to get the Covid vaccine ?PFIZER ER8733 after my first dose I started to have joint pain in my left foot of which I thought was the onset of a gout attack. I increased my intake of POM juice and it did not make much of a difference and really no difference at all. I treated the pain with Motrin IB 200mg, four or more pills at a time or whatever was needed to relieve the pain, the pain never went away. I received my second dose of the PFIZER 0162 vaccine on 4/18/21 and then the pain and swelling attacked my left ankle and foot and the pain became unbearable. ?I was in tears? could barely walk and thought it was a gout attack. Unbearable pain!!!!!

Muscle pain in both legs in the upper legs and butt/getting bad muscle pain in back of my legs up to buttocks muscle; Had leg pains and could not walk; could not walk; Muscle pain in both legs in the upper legs and butt; This is a spontaneous report from a contactable consumer (the patient). A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: El3302) via an unspecified route of administration in Arm Left on 09Feb2021 at 12:00 PM (65-years-old age at vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included Copd, both knees replaced and both hips replaced from an unknown date and unknown if ongoing. Concomitant medications included theophylline, prednisone, losartan, pravastatin and allop. 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 the vaccination, the patient had not been tested for COVID-19. The patient did not had allergies to medications, food or other products. On 20Feb2021 at 16:00, a week or so after the first shot patient started getting bad muscle pain in back of his legs up to buttocks muscle and could not walk. It was stated that now it was only the right side now (so it seemed). Previously the pain was on both sides. The doctor prescribed him 800mg of Tylenol and he also had diclofenac. Therapeutic measures were taken as a result of the events. The outcome of the events were reported as not recovered. The events were reported as non serious. No follow-up attempts are needed. No further information is expected.

Approximately one week after first vaccine, I experienced difficulty standing and loss of strength in my legs. (Both legs felt heavy) I also had increased pain in my lower back.

Symptoms: Numbness in fingers and hands; pain in arms, shoulders, lower back, hips, buttocks, and legs; sharp, jagged pain in hands and inability to form a fist in both hands; inability to walk, stand, sit for more than 15 minutes, dress self, inability to wash and groom self; total body weakness Treatment: Two one-week treatments of Medrol, pack of 21, Lioresal EQ 10 mg, Tramadol 50mg; one week treatment of Prednisone pack of 78, ortheses bilateral hands for carpal tunnel syndrome Outcomes: Some relief from hand and wrist pain

Received Pfizer-COVID-19 vaccine on 5/18/2021 and 4/27/2021 (lot number EW01562). Presented to ED 6/19/2021 with painful mass in inguinal area thought to be a hernia. CT scan with contrast showed occluded main portal vein, masses throughout liver and kidney suggested of spreading hepatocellular carcinoma, no inguinal hernia.

Symptoms (24x7, for last 15 weeks) o Feels like pressure inside my head. Occasionally headaches, but mostly pressure. o Best description is that I feel slightly "hung over" every day. Or like I have the flu or some other virus o Constant light headed, balance issues – Worse in morning , a little better later in the day o No dizziness, no vertigo o Memory and cognitive skills not at 100% (forgetful, using wrong words occasionally, foggy) o Ringing in ears; vision changes o Exhausted, weak o Get car sickness which has never been a problem before o Stiff, painful popping neck o Nagging cough for months o Possibly increased nasal congestion o Occasional palpitations – seem slightly more frequent than before but unsure o Occasional headaches behind my eyes

Back pain, discomfort, and possibly sciatica pain; Back pain, discomfort, and possibly sciatica pain; Back pain, discomfort, and possibly sciatica pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received BNT162B2,(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as Ist dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced back pain, discomfort, and possibly sciatica pain, back pain, discomfort, and possibly sciatica pain on an unspecified date. Therapeutic measures were taken as a result of back pain, discomfort, and possibly sciatica pain, back pain, discomfort, and possibly sciatica pain. Outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered. Follow-up attempts completed. No further information expected.

can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his arm/ the whole arm itself just hurts; pain at the top of his arm going down his arm/ arm hurts/when he turn had pain up his armpit; when he turns his neck to the right he has pain up his armpit; This is a spontaneous report from a two contactable consumer (patient and his wife). A 65-year-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Jan2021 (age at the time of vaccine 65-year-old) as 1st dose, 0.3 mL, single dose on right arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not specified but taking for blood pressure unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the pfizer suspect. On 01Feb2021, the patient experienced pain at the top of his arm going down his arm/ the whole arm itself just hurts/when he turns his neck to the right, he had pain up his armpit. On an unspecified date, the patient could not really sleep and had injection site pain on his right arm had kept him awake. The patient stated he was calling about the Pfizer BioNTech COVID19 vaccine and stated he had been having a reaction of side effects and asking how long the side effects could last. The patient stated that for the first couple of days after getting the vaccine he had nothing and then the pain started a little bit on Monday and then on Tuesday the pain got a little worse; stated that last night the pain was beginning to keep him up from sleep. The patient stated all the adverse events are ongoing. The patient's wife stated the indication for which the patient received the vaccine was they are trying to be safe, and the patient's HCP called him and asked the patient if he wanted to take the shot. The patient's wife stated they both received the vaccine. The patient stated he was given paperwork down at the site location where he got the shot but was given the paperwork after he was administered the shot and the paperwork was a list of side effects; stated if he had seen the list of side effects before, he was administered the shot, he probably would not have taken the shot. The patient's wife stated the patient received no testing or treatment for the reported events. The patient did not visit emergency room. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Patient hospitalized for left hip pain & total hip replacement within 6 weeks of receiving COVID vaccination.

So, I started to have some epidermis outbreaks about a week after the second vaccine. Shortly, after that I had a poison ivy reaction, but this reaction was different in which it started to go, which is odd for poison ivy. I was having an overaction to certain irritants as well. I also would have an abnormal amount of warts that were showing up. I have a lot of epidermis outbreaks. I also have had terrible joint pains also which started a week after the second dose. I was not able to lift things or do normal activates. I am still having trouble with my joints.

Only slight injection site pain for first shot. With the 2nd shot, I had pain at injection site that radiated into my shoulder 8-15 hours after initial injection. Noticed swollen lymph glands in armpit of vaccinated arm after 24 hrs. All these particular symptoms disappeared after 36-48 hrs. Along with these symptoms I began to have very loud tinnitus which I have suffered from for years but nothing to this volume. Approximately 11 days after the 2nd dose I came home from working a short day and after a meal began to feel like my blood pressure was up because my head felt pressured and I could tell my heart was racing. Checked my blood pressure and it was at rest 140/105 w/ 96 bpm. I am not on any bp meds because I have never been prone to high blood pressure. Bp prior to this occurrence has always been in the 117-120/76-80 range with a bpm of around 64-70. Chest pain radiate from front to back to front and stayed that way until I went to emergency room 3 days later believing I may have had a heart attack. I was administered an EKG, had blood serum tests and a CT scan - all of which were normal and or showing no signs of a heart attack. I was kept overnight for observation with blood being drawn middle of the night and vitals being monitored. The morning of the next day I was administered a stress test which I apparently passed no problem.

diarrhea; Severe joint pain in knees; lower back pain kidney area; kidney pain; pain in his thigh muscles and buttocks; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6205) via an unspecified route of administration on 10Mar2021 at 02:00 pm on the left arm as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications patient received within 2 weeks of vaccination included : Lisinipril, coreg hydrocodone, Cialis and sertraline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 10Mar2021, at 09 30 pm, the patient experienced severe joint pain in knees, lower back pain and kidney area. The caller also stated that he experienced severe pain in his thigh muscles and buttocks. He had terrible pain in his knees. He also had pain in his kidneys for 4 days. The patient took Meloxicam for inflammation, Hydrocodone for pain and Flexeril for a muscle relaxer. The caller stated that he can deal with his muscle and joint pain but is concern was about the kidney pain and he didnot want kidney failure. The caller stated that he also had diarrhea on the 5th and 6th days. The caller stated that he was scheduled to get the second shot tomorrow. caller has read that the second dose was worst than the first. The caller stated that he doesn't know whether he should get the second dose and his doctor advised him to speak with Pfizer or where he received the first vaccine or to go to the emergency room. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Back pain; Leg pain; Right knee swelling; foot numbness in both left and right feet; Light headed; Felt odd; Tired; Queasy; Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route of administration in right arm on 12Mar2021 at 13:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The medical history included lower back disc surgery on 12Mar2014 was successful but had low level pain on right side and constant slight numbness in right foot 3 small toes and high blood pressure. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril (MANUFACTURER UNKNOWN) 20 mg daily for high blood pressure. The patient received no other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 13:15, the patient felt light headed and felt odd initially after injection. At 1-3 days felt tired , queasy and experienced sore arm. On 15Mar2021, at 3-4 days the patient experienced back pain and leg pain, right knee swelling, foot numbness in both left and right feet which made the patient difficult to be active and experienced continued same symptoms as day 1-3. At 7-10 days, the patient was mostly back to normal. The patient did not receive any treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of light headed, feeling abnormal, tiredness, queasy, painful arm, back pain, leg pain, swelling of right knee, numbness in feet was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Exhausion; back ache; lightheaded; injection site pain; This is a spontaneous report from a contactable consumer or other non health care professional (patient himself). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration , administered in right deltoid on 05Feb2021 08:45 (at the age of 65-years-old) as a unknown dose, number, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included received within 2 weeks valsartan taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (CCB) taken for an unspecified indication, start and stop date were not reported. The patient had 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. No other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, the patient experienced exhausion, back ache, lightheaded, injection site pain. The patient did not receive any treatment for the adverse event. Seriousness of the case reported as No. The outcome of events was not recovered. Follow-up attempts completed. No further information expected.

2 weeks after the 2nd shot I woke up with a pain going from my left armpit, along my collarbone to my neck under my jawline. It felt like a string from my armpit to my neck was too short and tight. I also felt slightly ill with pain behind my eyes for the 1st 2 weeks when pain began. I assumed it was my lymph nodes on my l eft side that was affected and not a muscle issue since rubbing it made it hurt more. By the 3rd week I was able to go back to swimming and other activities. It's 8 weeks now but still slightly tender on collarbone and neck.

Arthritis; pain down to the knee and lower back; pain down to the knee and lower back; hardly sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on 04Mar2021 at 09:15 hours (at the age of 65-years-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension (controlled), cholesterol (controlled) and allergies to intravenous pyelogram (IVP) contrast dye (iodine based). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included ezetimibe (ZETIA) 10mg once and omeprazole (MANUFACTURER UNKNOWN) 20 mg once a day; both from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Mar2021 (after four days), the patient experienced a serious arthritis episode in the right hip with radiating pain down to the knee and lower back which as of this submission was still giving him problems. For a week, the patient could hardly sleep. The patient reported that even now (as of report), it hurts just lying on the bed. The patient had a doctor's appointment but cannot get in until 29 March (after the second shot). The patient did not receive any treatment for events. The clinical outcome of events arthritis, knee pain, lower back pain and sleep unwell were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

I had the second dose on 03/27/2021. I got the main symptoms of headache, body aches, pains the following day. I went to urgent care 3 days later, Tuesday 30th. Went in for pain I thought I had a rib out, they had a chiropractor checked me out, he did not do anything, I went to urgent care twice. Both times my lungs were clear. No pneumonia. They did an x-ray which was clear. I had nebulizer treatment, and then it came back to the same. I went to the doctor the following week on 04/13/2021 and he checked me over and could not find anything. He heard some crackling in the lower part of my lungs, which he found interesting but he could not find out why I was having that pain. I left there. Before getting home he called me and said that it could be a sign of a blood clot. He had me get a CT scan, I got it in 06/14/2021. They found that I had 1 blood clot on each lung. The biggest one on the right one. They gave me blood thinners. I had fluids on my lungs. They were not able to take it all out so I might have to have surgery. The blood clots have resolved themselves with the medication.

On the same day as dose one-pain and lose of range of motion. A month later on May 5th I went to see my primary dr.-he prescribed PT and I still have the pain and lose of motion. Dr stated the condition is Subacromial Bursitis/SIRVA-Shoulder Injury related to vaccine administration.

My problems began with a bad case of diarrhea, fever and high blood pressure of 170. I could not walk and unfold my hands. I lost strength in my legs , arms, and hands. My most severe problems lasted for two weeks. I laid in bed and took aspirin. After about two weeks , the most severe problems subsided. I currently fill weak and stiffness., and tightness in my chest.. My doctor has taken me off the blood pressure medication because pressure is down. My doctor has advised me to report problem to VAERS. I'm waiting your response.

Numbing sensation from the neck to the left pinna occurred, I could not feel my ear. It has subsided, however, numbness and tingling sensation still present in the external ear. After that, I started feeling symptoms similar to those in the disease ALS; ie, extreme fatigue, weight loss due to loss of muscle mass, especially in the legs and buttocks, muscle weakness, edema in the lower extremities and face, blurred vision, imbalance, clumsiness, and lightheadedness/dizziness.

Patient presented to the ED on 5/2/2021 for left ankle swelling. Patient presented to the ED on 5/10/2021 for diabetic ulcer of right midfoot and pneumonia and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.