Pfizer

Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain in the vaccinated arm. 1/13: I had trouble sleeping; left arm was in immense pain. 07:00: experiencing arm soreness, muscle pain, nausea, hot flashes; temperature = 99.5 08:20: experiencing arm soreness, muscle pain, hot flashes, chills, sensitivity to light; temperature = 100.6. Took 650mg acetaminophen. 09:00: experiencing arm soreness, muscle pain, sensitivity to light; temperature = 100.8 10:30: experiencing arm soreness, muscle pain; temperature = 99.2 11:15: experiencing arm soreness, muscle pain; temperature = 99.0 12:20: experiencing arm soreness, muscle pain; temperature = 98.0 Extremely fatigued; took nap (13:00-17:00) 17:00: experiencing arm soreness, muscle pain, headache; temperature = 99.3 18:00: experiencing arm soreness, muscle pain, headache; temperature = 99.2. Took 650mg acetaminophen. 19:00: experiencing arm soreness, muscle pain, headache; temperature = 100.8 20:00: experiencing arm soreness, muscle pain; temperature = 98.3 21:00: experiencing arm soreness, muscle pain; temperature = 100.6 21:30: experiencing arm soreness, muscle pain; temperature = 99.2 22:20: experiencing arm soreness, muscle pain; temperature = 100.1. Took 400mg Ibuprofen. 1/14: 07:00: woke up experiencing pain at the injection site, neck pain, headache. These events continued throughout the day. No temperature over 99.5. 18:30: Took 650mg acetaminophen for headache.

Severe arm tremor from elbow down to hand; significant nerve pain and muscle weakness. This tremor was severe Monday, Tuesday. Still experiencing muscle weakness and nerve pain 6 days post shot only in right arm that vaccine was injected into.

On 4/16/21, the day after receipt of the second SARS-CoV-2 vaccine the patient developed new headache, fever, malaise, and myalagias. on 4/17/21 the patient then developed chest pain which worsened over time and lead to diagnosis of myocarditis with decreased left ventricle function of 44-47% and with troponin I of 1.58 ng/mL.

16 y/o VR present with father received vaccine and approximately 1 minute later became unresponsive, falling forward and hitting his face on the carpeted floor. VR became rigid with posturing that lasted one minute. VR regained consciousness. VR had a 2.5cm laceration to the left eyebrow and abrasions to the left face. Hemostasis is achieved with pressure. NIHHS is 0 at the time VR regained consciousness. CN exam intact as tested. Cerebellar exam is intact – gait is deferred. VR had been fasting. BP 90 /50, HR 50, 99% on RA, RR 16. Sitting causes lightheaded/dizziness. Ambulance was called and VR transported to Emergency Department. Father present throughout the likely multifactorial syncopal event.

5 minutes after dose while standing and watching sister receive dose of vaccine, patient experienced presyncope. Patient started to sway and lost muscle control. I helped to the floor and laid him out. Patient conscious whole time and never stopped breathing. Did not lose cognizance. Had momentary feeling of nausea that immediately passed. Did not believe necessary to call 9-1-1 as patient did not exhibit any allergy symptoms of any distress during the whole episode. Allowed to lay on floor for about 5-10 min. Supplied patient with bottle of water to help with dry mouth and he drank and felt better. After another 10 minutes patient was up on feet and feltmuch better. Mother called an hour and a half later (about 5 min ago as I prepare this form) to inform me that he was back to 100%.

Extensive hives, joint swelling; swelling over left eye. I saw him on 4/26/21. He had some minor hives. I prescribed an epiPen, prednisone (40 mg daily), and benadryl (25 mg tid prn rash, hives). He came back on 4/27/21. He had more hives, swollen left upper eyelid, joint pain, difficulty walking because of hives on soles of feet. He had no respiratory distress. His chest was clear. I admitted him on 4/27/21 to the Hospital.

Aching in joints; This is a spontaneous report received from a contactable consumer. This consumer (parent) reported for 16 years old male patient that received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 12Apr2021 15:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) 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, Lot Number: EP6955) on 22Mar2021 at 03:30 AM in Arm Left for covid-19 immunisation. The patient experienced aching in joints, continuing for 18 hours on 12Apr2021 18:00 with outcome of recovered. Therapeutic measures were taken as a result of aching in joints included Tylenol and Advil. No covid prior vaccination. No covid tested post vaccination. Known allergies was none. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

MYOCARDITIS. Patient is a 16 year old boy with ADHD who presented with fever and myalgias for 3 days, that progressed to sharp parasternal chest pain and some SOB. Patient received second dose Pfizer COVID-19 vaccine on 4/26, and after that shot experienced fever to 102 at home and myalgias. Subsequently his symptoms of chest pain have occurred. He underwent workup revealing of elevated Troponin, and EKG with some ST segment elevation, a slightly elevated CRP at 32, and a normal ECHO. Admitted for observation and concern for infectious myocarditis vs MIS-C. Cardiac MRI was done confirming Myocarditis, Troponin I was elevated and peaked at 23, 325pg/mL. Workup unrevealing of SARS. Other testing showed Resp virus panel negative, blood pcr for EBV, CMV, Parvovirus B19, enterovirus, and adenovirus all negative, HIV antigen/antibody testing negative. Patient treated with Ketorolac with steady improvement in symptoms over several hospital days. Discharged home 5/2 with Troponin I well down and symptoms resolved. Given reports in lay press regarding other cases of COVID-19 MRNA vaccine associated myocarditis, we are reporting this as a vaccine associated adverse event.

Previously healthy 16 year old young man presenting with chest pain admitted for myopericarditis. He was in his usual state of good health until 2 days ago when he experienced fever, chills and myalgias after receiving his 2nd dose of COVID pfizer vaccine. He improved until 5/2 when he developed a crushing, non-radiating, substernal chest pain which was waxing and waning in nature without specific alleviating factors. He had shortness of breath, but no palpitation, dizziness, or changes in pain on exertion vs rest. Family activated EMS who gave 325 mg of aspirin en route to the ED. In the ED, he was afebrile and hemodynamically stable. He was mildly diaphoretic, but otherwise, unremarkable on physical exam. STAT EKG showed ST elevations in V5 and V6 and ST depressions in V1 and V2 as well as PR depressions, which persisted on repeated EKG. Given concern for myopericarditis, they ordered labs including CBC, CMP, troponin and inflammatory markers which were only remarkable for troponin of 1.94 and CRP 3.5. Chest x-ray was normal. Cardiology was consulted and they recommended transthoracic echo which is pending. Cards also recommended starting Ibuprofen 600 mg q8 hrs and admission to cards for further management.

My son woke up with a upper backache in the middle of the night (5/3/21) and shortly after that he said that it felt like someone was squeezing his heart. We called the pediatrician on call who recommended I take him to the ER. At the ER, they performed two EKG's, a chest x-ray, bloodwork and an echocardiogram. We were discharged from the ER 7 1/2 hours later with the following diagnoses: acute chest pain and acute pericarditis. His treatment consists of taking 600 mg of Advil every eight hours for at least the next, laying low and not exerting himself for the next and following up with his primary care provider and seeing the pediatric cardiologist later this week.

My son since started with pains at the vaccination site, headache, chills, muscle pain, fatigue, little of nausea, thirst, body temperature of 99.1 degrees Fahrenheit at 10:00 pm. Tomorrow medications acetaminophen

Itching, hives and pain around injection site. Pain in injected muscle. Pain in shoulder joint. Heat and redness around injection area. Finally, nausea and arm pain. Nausea may be unrelated to vaccination.

Too trashed to train for his sport/described as too weak to train; Swelling; Loss of taste and smell to some extent; Brain fog; Swollen glands; Loss of taste and smell to some extent; Leg pain; Joint pain; passed out/hit the floor, put a big bump on his head; passed out/hit the floor, put a big bump on his head; Redness; Chills; Fever; Too sick to get out of bed; Shortness of breath; Headache; Muscle pain; Tiredness/Fatigue; Pain in the arm; 2 inch diameter raised circle at injection site; could not barely remember his name; tried to study but just wasn't there, head on desk. Still has difficulty focusing; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER2613 and expiry: Jul2021), via an unspecified route of administration in right arm on 31Mar2021 14:30 (at the age of 16-year-old) as single dose for covid-19 immunisation. Vaccination was taken because he was going back to school. The vaccine was not administered at a military facility. No additional vaccines administered on same date of BNT162B2 and no prior vaccinations (within 4 weeks). The patient received first dose of bnt162b2 (Lot: EN6199, Expiry: Jun2021) on 10Mar2021 at 13:30 in right arm (at the age of 16-years-old) as single dose for covid-19 immunisation and experienced loss of taste and smell and joint pain, all events started in Mar2021. Medical history included mild allergy to Birch pollen (which everybody has, but nothing else/patient tested for allergies, and had no significant allergies, they thought he might be because he spilled a sugared soda behind his bookcase in his room and there was mold growing so they thought he might be allergic to mold, so they tested for allergies and he has no allergy to mold) and ongoing vitamin supplementation. Family Medical History included Sarcoidosis with mother. Concomitant medications included vitamin d3 for vitamin supplementation from 2020 (about a year ago) and ongoing; ascorbic acid, rosa canina fruit (VITAMIN C) for vitamin supplementation from an unspecified date (several years ago) and ongoing and an unspecified ongoing multivitamin from an unspecified date (several years ago) at 1 taken daily for vitamin supplementation. On 31Mar2021, the patient experienced pain in the arm at 17:30, tiredness at 20:30, shortness of breath, headache at 22:30 and muscle pain at 22:30. On 01Apr2021, the patient experienced fever at 00:30, chills at 01:30, redness at 02:30, leg pain at 08:30, fatigue (ongoing) at 02:30, joint pain at 08:30, too sick to get out of bed and passed out and hit the floor, put a big bump on his head at 05:30 (about 15 hours after second dose, patient was at the kitchen table with his head between his knees trying to breathe, passed out, hit the floor and put a big bump on his head). On 02Apr2021, the patient experienced brain fog at 14:30, swelling at 14:30, swollen glands at 02:30, loss of taste and smell to some extent at 14:30 and too sick to get out of bed. On day 2 (02Apr2021) and was still about pushing 100 degrees Fahrenheit and on 21Apr2021 (after 21 days) sometimes over sometimes less. On the following Monday (05Apr2021), he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hadn't trained for 3 weeks. He still has a fever. His local doctor did not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. In 2021, the patient experienced 2-inch diameter raised circle at injection site and disappeared after 10 days and there was a time he could not barely remember his name, tried to study but just wasn't there, head on desk. Still has difficulty focusing and doing his calculus. It was reported that the time to recover from any exertion seems to be longer by a lot. On 01Apr2021, body temperature reached 103 degrees Fahrenheit. The patient tried to do a few things like a week ago just because he couldn't stand to be in the house anymore he took a bike out for about 15 minutes and was just trashed from that experience and took 3 days to recover. The events did not require emergency room visit nor physician's office neither hospitalized. The outcome was recovered from loss of consciousness, head injury on 01Apr2021; from illness on 02Apr2021; from headache on 04Apr2021; from chills on 06Apr2021; from pain in arm and fatigue on 07Apr2021; from erythema on 11Apr2021; from ageusia and anosmia on 14Apr2021; from lymphadenopathy on 16Apr2021; from arthralgia on 17Apr2021; from myalgia on 18Apr2021; from leg pain on 21Apr2021; from vaccination site swelling in 2021; then recovered with sequel from dyspnoea on 05Apr2021 and from swelling on 07Apr2021; then recovering from pyrexia, feeling abnormal; then not recovered from asthenia and unknown for the remaining events.

seizure; passed out; light headed; fell out of chair and hit floor; making a gurgling/growling sound; his right arm was contracted and tight; his right arm was contracted and tight; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8736), via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 16-years-old) as a single dose for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 23Apr2021 at 09:45 (reported as 13 minutes after the vaccine), the patient said he was lightheaded and then fell out of the chair and hit the floor. He started making a gurgling/growling sound. After the nurses flipped him over, they noted that his right arm was contracted and tight. They were unable to determine if he had passed out or had a seizure. He had no seizure history. He regained consciousness after about 45 seconds to a minute. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of passed out was resolved on 23Apr2021, while of seizure, lightheaded, fell out of chair and hit floor, making a gurgling/growling sound, his right arm was contracted and tight was resolving.

Patient is a previously healthy 16 year-old M presenting with acute onset chest pain, shortness of breath, nausea, vomiting, malaise, fever and myalgia to ED on 5/6/2021 at 20:44. He started experiencing symptoms on 5/6/2021 morning a t06:07 AM. He received his second dose of Pfizer COVID-19 vaccine on 5/4/2021 10:: AM. In the ED, CBC, CMP and UA was within normal limits. EKG at 20:46 and again at 21:14 showed ST segment elevation in inferolateral leads with possible myocardial injury, ischemia or pericarditis. Troponin 0 hour was 835 and at 2 hours 1674. Patient was admitted to the PICU for further evaluation and management. Echo on 5/6/2021 showed normal LV systolic function with SF 31% . Cardiac MRI on 5/7 showed contrast enhancement of inferolateral wall consistent with myo-pericarditis with small pericardial effusion. Troponins were trended every 12 hours and plateaued in the 1800's on 5/8/2021. Patient was diagnosed with acute myo-pericarditis. Respiratory viral PCR and COVID-19 PCR on 05/06/2021 were negative. Thyroid studies were normal. ANA titer is pending. Viral serology for HbsAg was negative and HIV was non-reactive. Results for additional viral serologies for Coxsackie viruses, EBV, CMV and HHV6 are awaited. Patient was treated with NSAIDs and Colchicine. IVIG was not given based on clinical judgement. Pediatric Cardiology was involved in patient's care and clinical decision making. Patient remained hemodynamically stable on room air throughout his PICU course. He was discharged on 5/9/2021 with Pediatric Cardiology outpatient follow up in 2-3 weeks. He will continue Ibuprofen 600 mg every hours and Famotidine 20 mg 2 times daily until his follow up.

presented to outside ED with complaints of new onset chest pain that radiated to the back and down his arms with concurrent nausea. Patient was sitting in the living room around 2030-2045 when he developed midsternal and epigastric region pain. Pain radiated to his upper middle back and down both left and right arms. There were no notable exacerbating or relieving factors. Pain was a 4-7 in severity. He was also nauseated. He was given tums by his mother without significant change in symptoms. After 45 minutes they decided to go to the ER. At ER labs were notable for elevated troponin (2-- >15-- >9). EKG with J-point elevation. Non-contrast CT chest/abd/pelvis was unremarkable. He was given ASA 325 and famotidine in the ED. Pain eventually subsided around 2345. He was transferred to another hospital for further evaluation of troponinemia.

Patient is a 16-year-old male patient admitted with seizure like activity. One day prior to admission patient received his second COVID vaccine, Pfizer brand. On the day of admission Patient woke at 0200 with pain in the left side of the chest, mid-axillary per patient's description it was cramp-like pain and he was able to go back to sleep. At 0500 he got up to use the restroom and went into the kitchen. He told his mom he didn't feel well and fell forward making a gurgling sound, arms rigid, was unresponsive, and this lasted 1.5minutes according to mom. Mom called EMS and when he awoke he stated he was nauseous. After EMS arrived it was 2-3 minutes and he did not feel well again, he stood up and head fell back, eyes open, he was shaking, and making a gurgling noise again, this episode lasted 30 seconds. Upon awaking he was disorientated for a few minutes then back to baseline, he was nauseous again and very tired. He came to the ED where EKG (pending), CBC (normal), PT/PTT/INR (slight elevation), CMP (normal), TSH (normal), Ethanol (None), Troponin (normal), Head CT (normal), and chest xray (normal) were done. He received a NS bolus was given. He was admitted to the pediatric hospitalist for further evaluation and management. This is where he had a 24hour Video EEG with normal EEG he was discharged home.

This is a spontaneous report from a contactable reporter reporting for her son, via Pfizer sponsored program. A 16-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose at the age of 16-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After 24 hours from vaccination, on 25Apr2021, he felt pain on the injection site. For that, the mother gave her son Tylenol to treat the symptoms. Then after 24 hours, on 26Apr2021 he felt fine. However, 2 days after, on 28Apr2021, he felt pain underneath the left side of his armpit, had a fever with a temperature of 102.8 F, and the right side of his neck was swollen. In addition to this, he was experiencing a lot of body aches, headache, and pain on his neck. They already contacted their HCP and prescribed him with antibiotics in Apr2021. He was tired and almost lethargic in Apr2021. Reporter wanted to know if her son should still receive the 2nd dose. The reporter was invited to consult her HCP. The outcome of pain on the injection site was recovering, of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; 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 serious events Neck swelling, Armpit pain, and Fever cannot be excluded. The case will be reassessed if additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On 05.17.21 patient received his first dose of the Pfizer Covid-19 vaccine (lot # EW0182 exp. 08/2022). Client's mother signaled to EMT that they needed assistance. EMT and RN responded. Client was a 16-year-old male found sitting upright and leaning forward while alert and tracking. Client had a chief complaint of ringing ears and uneasiness. Client stated that he began to notice his ears ringing a few minutes after observation began. Client's mother was unable to console the client prompting her to calmly wave for assistance. This was the client's first dose of the Pfizer vaccine. He and his mother both deny any medical history, allergies, or regular medication use. Assessment revealed no hives, rashes, discoloration, swelling, shortness of breath or other signs of anaphylaxis. Client complained of unspecified uneasiness while leaning forward but exhibited no accessory muscle use. Client denied any pain throughout his body. Airway, breathing and circulation were intact. Client stated that he was "nervous" before receiving his vaccine today due to stories he had heard from his peers. Client then stated that he felt like he "couldn't move [his] hands" despite there being no obvious range of motion compromise. Vitals at 1332 were pulse 76, O2 100%, lung sounds clear bilaterally, alert and oriented to person, place, date and event, respirations 20. Client and mother both consented to an additional 30 minutes. Client was assisted from his observation chair to a bed by EMT and mother and stayed there for the remainder of his observation. After approximately five minutes of lying down, the client stated that he felt "much better." Remaining vitals: 1337 - 118/78, O2 99%, Resp. 16, HR 76, 1349 - 110/76, HR 72, O2 99%, Resp. 16. 1402 118/78, O2 100%, HR 72, Resp. 16. Client's mother was provided with all relevant vaccine information and instructed to seek medical attention if further concerns arise in the evening. Client denied EMS transport. Client completed his observation at 1402 and departed with his mother at 1402 in positive disposition with steady gait asking his mother if he could go out and "skate".

Patient notes that he about 3d PTA he had his 2nd Pfizer Covid vaccine (received on 5/12/21) after which he had about 24 hrs of myalgias, low-grade fever, headache that all resolved. Patient was admitted to the hospital on 5/15/21 with likely post-viral myocarditis.

back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent's room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, 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 recovering.; Sender's Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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.

Patient developed dull R chest/axilla pain "around the time of vaccine". On 5/11/2021 diagnosed with spontaneous pneumothorax. s/p 10 day hospital stay including pleurodesis

Patient is a 16yo girl admitted on 5/19 with sepsis secondary to myocarditis and pneumonia, s/p IVIG, after presenting with fever, myalgia, sore throat, hypotension, elevated troponin, elevated CRP, and leukocytosis with left shift. Sore throat has been present for about a week and fevers began on 5/17 with a Tmax of 103. On 5/18, she began developing shortness of breath and upon evaluation by the PCP on 5/19, she was admitted. During initial workup on 5/19 upon admission, hospitalist was high concerned as she developed hypotension of 91/48 on 5/20 at 08:35am. CT of chest on 5/20 showed patchy consolidation of the posterior lower lobes bilaterally. At that point, I was contacted and recommended broadening regimen to clindamycin , ceftriaxone, and azithromycin. Upon transfer to Hospital, further serologies were collected which showed leukocytosis with left shift, highly elevated CRP, elevated troponin, elevated IL-6, elevated ferritin, negative Covid abs test, negative RVP, and negative Covid PCR. IVIG (2grams/kg) started on 5/20 at 22:57. Cardio and ID on board and all regular myocarditis infectious workup has been collected. ID consulted for workup and management. Of note, patient received the Covid vaccine on 5/1/21

Not sure if seizure; body muscles started shaking; Pain in lower spine on back; Pain in lower spine on back; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in Arm Right on 07May2021 13:00 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunization. Medical history included type 1 diabetic, allergies to severe peanut, "tree but", shellfish. Concomitant medication included insulin lispro (HUMALOG) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in right arm on 16Apr2021 13:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. The patient experienced Pain in lower spine on back and body muscles started shaking uncontrollably, not sure if seizure on 08May2021 02:00. No treatment received for the events. The outcome of the events was recovered. The event seizure was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was Hospital. 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 has not been tested for COVID-19. Information about lot/batch number is requested.

Day after vaccine patient went to er with cp, cough, myalgias and fever, he was sent home. (No known covid exposure) The following day sent to the er with same symptoms and bedside echo normal. the third day came back to the er and labs were done with an elevated troponin to 2.7 increased to 12. Still currently monitoring.

One week after 2nd dose, developed extreme fatigue, numbness and weakness in both legs, aching/pain in legs, loss of feeling in feet and occasional pins and needles feeling in feet. Some numbness/tingling in hands as well. Difficulty walking, just needs to sit. Difficulty raising arms. Complaints of legs and arms feeling very heavy. Shortness of breath.

Developed arm soreness 1 day after vaccination, then developed axillary soreness and swelling 2 days after vaccination which progressed overnight before mostly resolving 3 days after vaccination. No systemic symptoms or injection site swelling/reaction noted.

Patient was seen by me via telehealth for follow up after ED visit to Hospital on 5/26/21. On 5/26/21 patient was riding his bike, felt like his legs were heavy and lost consciousness. He said that prior to losing consciousness his vision was blurry and sounds sounded distant. Mother witnessed event and stated he had shaking of his upper extremities for a few seconds woke up and then had repeat shaking and loss of consciousness with eyes rolling up. He was taken by EMS to Hospital where evaluation per report was normal (labs, CT head, EKG)

c/o chest pain began 1 day (may 26) after2nd pfizer vaccination (May 25). Patient came to ER on 5/27. C/o chest pain. Physical exam shows chest wall Tenderness to palpation.

16 yo M w/ no known chronic medical conditions (but s/p ASD and mitral valve repair in 2015), presents w/ constant R-sided CP since yesterday; woke up w/ R shoulder pain that radiates to his R pinkie. The CP is worse w/ movement of the torso, specifically while bending forward. No shortness of breath, DOE, leg swelling, LH, diaphoresis, n/v/d, abd pain. No recent illnesses, fevers/chills, cough, nasal congestion. No h/o similar sx. No family h/o cardiac disease. He had congenital mitral prolapse and ASD that were repaired in 2015; he was told by his interventional cardiologist that the repairs were successful and that he does not need regular follow-up. Worked out heavily 2 days ago (mostly chest/arms weightlifting

16-year-old male with no significant past medical history, now presenting with chest pain. Patient had 2 episodes of left-sided mid-chest pain. The initial episode was at ~ 3 am on 5/18 when the pain woke him up from sleep, lasted for ~ 20 minutes and he was able to fall back to sleep, he did not mention it to his parents at that time. Then it recurred at 2.30 pm - pressure-like pain in the same area, which radiated to his left shoulder. There were no significant worsening or alleviating factors. No change in pain quality or intensity with position. No shortness of breath, near-syncope or syncope, no palpitations. Upon his second pain episode, he called his parents on video chat and they instructed him to take 81 mg of aspirin and the pain subsided after 30 minutes. His parents promptly took him to the urgent care where he was found to have ST elevation and elevated troponin. He was transferred to CICU for further management. Admitted for myopericarditis with ST elevation and elevated troponin. On motrin q8h ATC, 12 lead EKG and troponin levels q6h. Underwent cardiac MRI on 5/20 which confirmed the diagnosis.

16-year-old male with no significant past medical history who presented on 5/25/2021 with 2-day history of chest pain. Patient had his second dose of Pfizer Covid vaccine on 5/22/2021 and on 5/23/2021 he developed headache and body aches. In the afternoon of that same day patient developed retrosternal chest pain that he described as a pressure and radiated to the back. He took 2 Tylenols and went to sleep and he reports improvement of the pain. He woke up the next day on 5/24/2021 without any pain and was most of the day doing well but in the afternoon early evening the pain returned stronger. He describes as at least 5 out of 10 in severity, no shortness of breath but the pain got worse when yawning or taking a deep breath. The pain would improved if he lay on his left side. Given the symptoms he was taken to outside hospital where he was found to have ST segment elevation and elevated troponin concerning for myo/pericarditis he was transferred from this facility for further management. He was given 2 aspirins and the pain improved down to a 1 out of 10 and has remained the same. Interval history 05/26/2021: No acute events overnight. Denies chest pain, SOB, or headache. Eating well. VSS. No emesis. Almost back to baseline very minimal residual discomfort

Swelling and tenderness under right armpit the morning after the administration of the vaccination. Swelling is slightly larger than a golf-ball.

two days of recurrent sudden, severe, crushing right sided chest pain lasting 10 min to 3 hrs that occurred 2 days after second dose of covid vaccine. pain radiation to back presented to ED, found to have elevated troponin and d-dimer. also endorsed emesis and diaphoresis. Denies sob. discharged two days after hospitalization.

patient began having chest pain on 6/10 that progressively worsened over the past 24 hours. He was diagnosed with pericarditis and costochondritis. We have started colchicine and ibuprofen and will monitor overnight.

seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shaking almost fell of the chair; his arm is so hard and straight (on the left arm where the vaccine was injected); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old male patient received the 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 26May2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunization. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications the patient received within 2 weeks of vaccination. After seconds of injecting the vaccine, on 26May2021 at 10:00, the patient passed out or fainted. His father slightly slapped his face to keep him awake. The patient responded slightly and his face and lips became so pale. His father thought he was okay, then he fainted again and the seizure happened. The father was holding his body and his arm is so hard and straight (on the left arm where the vaccine was injected). His body was shaking, almost fell of the chair. Then they called for emergency assistance from the hospital. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was to schedule a visit to the primary doctor. The clinical outcome of the events passed out or fainted, face and lips became so pale, seizure, arm is so hard and straight, and body was shaking was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

No immediate reaction. Starting around 48 hours after vaccination (Saturday 6/5), client noted swelling, redness and pain at site of injection that spread to left axillary and breast area. Swelling was significant enough that mother described it as "he looked like he had a breast". They sought medical attention on Monday 6/7 at pediatrician's office. Swelling had decreased but was still present. Pediatrician advised ibuprofen. Symptoms resolved within 5 days post vaccination.

16 year old male with no PMH who presented with chest pain. Initially on 6/10-6/11 had expected myalgias and headaches post vaccination similar to dose #1, but later 6/11 developed chest pain that made it impossible for him to sleep. It was waxing and waning but continued through 6/12 which after discussion with PMD ultimately led to referral into our facility for further evaluation. Received a dose of ibuprofen with marked symptomatic relief. No further medications given during his time, his chest pain had resolved after that ibuprofen dose and was at clinical baseline until discharge on 6/15. Prolonged hospital course was to arrange for cardiac MRI to be done for comparison. Otherwise had serial labs (documented below) which had trended in the right direction.

loss of taste and smell; loss of taste and smell; joint pain; This is a spontaneous report from a contactable consumer (patient's father) reported. A 16-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in arm right on 10Mar2021 13:30 as first dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no allergies reported. Concomitant medication included MULTIVITAMIN, VITAMIN D3 and VITAMIN C. After Received the first dose of Covid Vaccine, the patent had every side effect on the list plus those not listed, loss of taste and smell to some extent and joint pain. He missed 5 days of school. He got it on a Wednesday, 31Mar2021 and was too sick to get out of bed on Thursday, 01Apr2021 and Friday, 02Apr2021. Thursday morning, 01Apr2021 he passed out and hit the floor. On the following Monday, 05Apr2021 he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hasn't trained for 3 weeks. He still has a fever. His local doctor here does not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. The patient was administered his second dose of Pfizer Covid Vaccine on 31Mar2021. After the 2nd dose of vaccination, the patient experienced Pain in the arm, Redness, Swelling, 2 inch diameter raised circle at injection site, Tiredness, Fever, Shortness of breath, Passed out, Hit the floor, Put a big bump on his head; Chills, Headache, Muscle pain, Leg pain, Fatigue, Too trashed to train for his sport, Joint pain, Swollen glands, Loss of taste and smell to some extent, Brain fog, The time to recover from any exertion seems to be longer by a lot. Onset time after receipt of second dose of Pfizer Covid Vaccine: 3 hours. When patient experienced peak expression of adverse event after receipt of second dose of Pfizer Covid Vaccine: 48 hours. No other vaccine within four weeks prior to the first administration date of the suspect vaccine. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Fever 18 hours after second dose injection. Stiff neck, tightness in chest approx. 30 hours after second dose injection.

also been experiencing a migraine which doesn't seem to be going away/ Intractable migraine, pain in his head; pain in his head and neck; Fever; chills; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old male patient received second dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in deltoid left on 04Jun2021 at 10:25 (at the age of 16-years-old) as single dose for COVID-19 immunization. The patient did not had ant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), administered in left deltoid muscle on 14May2021 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any additional vaccines on same date of the Pfizer suspect. On 04Jun2021 at 18:25 (within 8 hours of being administered the second dose of Pfizer Covid-19 Vaccine), the patient experienced fever and chills. On 05Jun2021 at 20:00, the patient been experiencing a migraine which doesn't seem to be going away/ intractable migraine, pain in his head, and pain in his neck. The patient received treatment for the fever and chills which included Tylenol. The patient was also treated for the migraine and pain in his head and neck. Duration of the fever and chills was about 36 hours, after which patient recovered completely. The consumer explained that the fever and chills were the normal, expected side effect. The intractable migraine, pain in head and neck was persistent. The patient did not require a visit to emergency room or physician office but they were waiting to hear back from his doctor. The patient was not hospitalized and did not underwent relevant tests. The consumer wanted to know if that was normal and how long she should expect the headache to last. The outcome of the events fever and chills was resolved on 06Jun2021, and migraine and pain in his head and neck was not resolved.

Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient). A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.

6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering, imbalance, and right sided facial droop. He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits. Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis on 6/28/21.

Patient has developed shingles. He had chickenpox as a child, where they didn't vaccinate against it. He has a bad rash on his scalp, at the back of his head, slight ringing ears and aching neck. Doctor said outbreak will probably increase around neck before scabbing over and healing.

Patient received his 2nd dose on Thursday 7/1/2021. He had flu-like symptoms the next two days (fatigue, fever, headache, myalgias). On Sunday morning (7/4/21), the patient woke from sleep with sharp, stabbing left sided chest pain that did not relent. He was taken to the hospital where he was found to have sequential troponins of 6.6 and 8.12. He was started on fluids and underwent EKG and Echo which were unremarkable. He also had repeat labs. Serial troponins downtrended on 7/5/2021.

Chest pain, shortness of breath, severe myocarditis, rhabdomyolysis developed 2 days after his second shot.

I got the Flu A with throbbing head pain almost constantly in the right side of my head and neck. No stuffy nose or anything like that. Just general pain and feeling terrible. I was bed ridden from Friday 25th June to Wednesday 30th June. My fever was up to 102 and was generally high throughout that time as well. I took ibuprofen and ate healthily, when I could eat though I had no appetite. I went to the DR and got a flu test on the 29th or 30th of June.

Patient received vaccine on July 5 and had just a sore arm for 30 hours then began having headache on evening of July 6. July 7 headache worse and nausea. July 8 headache so severe could not walk without pain shooting down back and pain with neck motion. Vomited 4 times and had to wear sun glasses even inside due to eye sensitivity. Patient had no fever no sore throat or cough. When he presented to the ED his neurological exam was normal but had mild nuchal rigidity/photophobia/and moderate severe headache. As we worked him up the consideration was vaccine reaction versus viral meningitis. We gave him Toradol and Compazine as we awaited his test results and he felt significantly better. I was going to do a lumbar puncture if he was not improved. He ate and drank gatorade with no nausea and was discharged with orders to return if symptoms worsened. He was instructed to see his doctor if not well in 3-4 days.

After completing the immunization, the patient stated he needed a moment because he felt dizzy. Within seconds, his head fell back and his eye had rolled to the back of his head. The patient was caught by the administering pharmacist and asked for assistance. The patient was placed on his back and allowed to gradually get his bearings. The patient's mom states he has experienced fainting following or during other medical treatments since the age of 6. The patient was given water, and after about 30 minutes felt well enough to leave the store with his mom.

patient initially had myalgias and then 5 days after second vaccination patient had acute onset of burning, numbness and tingling of his feed and legs.

Pt c/o lightheadness and nausea. vs 98.4, BP 102/74, HR 82, Bld sugar 115 evaluated by Physician and Nurse Practitioner; sent to the Clinic for further evaluation; given fluids. Pt emphasized some change in mental status and sent to the Hospital for evaluation; evaluated treated with fluids and released back to the clinic. 7/15 vital signs stable, c/o slight pain at injection site; no other c/o any issues Later on 7/15 pt c/o sl chest pain and discomfort-examined. vital signs stables dx with controchondritis-treated. No further c/o any problems after COVID injection 7/8 left the clinic and reunified with family

(mother positive first), Sx onset 7/18/21 cough, runny nose, chills, headache, muscle aches, loss of smell & loss of taste.

Reaction to second vaccine (7/10/2021) -Vomiting -Fever for 24 hours -Pain; on vaccine site, entire right arm and right side of back Took 4 doses of Tylenol (every 6 hours)

Patient is a 16-year-old boy with no significant past medical history presents to the emergency department with concerns for chest pain and shortness of breath. Patient had his second dose of the Pfizer Covid vaccine 3 days ago. Initially after the dose he did experience some myalgias, fatigue, and a sore throat. The symptoms lasted overnight and into the following day. They then remitted. Yesterday, patient was feeling well in the morning, however, in the evening he began to experience significant shortness of breath. This shortness of breath along with some anterior throat and upper chest discomfort with deep respirations. He denied any associated nausea, vomiting, or sweating. With these symptoms he went to hospital. There he was evaluated and a chest x-ray was performed. Patient's chest x-ray did not show any concerning findings. Patient was discharged in stable condition with albuterol and encouraged to follow-up with his primary care physician. Today, patient's shortness of breath and chest pain returned. He states that it is in the center of her chest with occasional radiation to his jaw. He denies any associated nausea, vomiting, or diaphoresis. His pain was initially severe in route to the emergency department, however, it has lessened and is now 4 out of 10 in severity. Patient otherwise denies any other fevers, lightheadedness, change in vision, abdominal pain, constipation, diarrhea, or dysuria. Medical Decision Making: Pt presented for chest pain. EKG was given to me shortly after obtaining it. This showed ST elevation inferiorly and laterally with possible reciprocal change in I, aVL & V1. Troponin was markedly elevated. I discussed case with our interventional cardiologist initially who wanted to take pt to the cath lab. However, pt is a minor and he noted that he couldn't cath a minor. This decision was made after the patient was already in the cath lab. Therefore, I contacted Hospital and discussed this case with the on call cardiologist. He recommended pt be tranferred to the ED where they will evaluate him and possibly do an echo of his heart. I discussed this with the ED physician at hospital who agreed to see pt. He was then tranferred via ambulance for further care.

Red round bump under his left armpit that is painful to the touch Currently using Ibuprofen and ice packs to help

about 30 after vaccine, patient starts to feel weakness on his legs, dizzy and when turn had side to side, pt noticed delayed reaction (delayed fuison)

20 min after the injection, patient started to develop itchness on his arms and back. for the next 48 hours the itchness came and went. small rash (raised red pimps) around the injection spot. I have treated the itch with allergy meds and the rash with hydrocodone cream 4 days later, he still complains of sore arm, periodic metalic taste when he eats, sore joints and arm muscles. Saturday evening he had brief chills, and sunday reported sore throat.

Pt is an 17 year old male who presents with a history of left shoulder pain since 3/25. He has recently been vaccinated for SARS Co-V2 (First dose on March 5th with second dose on March 27). He is currently hospitalized for elevated troponin and working up for myocarditis.

April 2- woke up with extreme fatigue, achy, headache, had trouble sleeping. In afternoon had 100 fever. April 3 - woke up with migraine type headache; fatigue; lack of energy; had trouble sleeping; had weird dreams. April 4 - work up with same headache; had trouble sleeping; had a neck ache and sore throat. Overnight, 230 am April 5, had severe stomach pain, breathlessness, pain in left elbow. Had headache after waking up, missed school, still feeling drained.

Shot given around 1125 am. Pt and pt's mother went to sit in front of pharmacy. At around 1135, pt fell out of chair, sounded/looked like he may have hit his head on blood pressure machine that he was sitting near. We thought he had fainted. Pt woke within 10 or so seconds after fall and was confused. Said his head didn't hurt. His skin did lose it's color and he was looking "white as a sheet". We had pt lie on floor and elevated his feet. After a few minutes he was feeling better and was able to sit in a chair. Pt and his mom left the pharmacy area about 15-20 minutes after pt fainted. Upon looking at video of the event, it appears that before the patient fell out of his chair that his right arm raises up and his elbow is bent in a very stiff way. A split second later his whole body appears to stiffen and bend to the left, then he falls out of the chair and is lying on the floor. When on the floor, his legs appear to be fairly stiff as well. This whole episode seems to last about 10 seconds or less. The video makes it look more like a seizure than a case of syncope.

Throat had sensation of closing up and sore arm yesterday evening. Took Benadryl. Today muscle and body aches, low grade 99.9 fever, dizziness.

Starting around noon of the fourteenth, had flu like symptoms including headaches and sore muscles. Woke up the fifteenth feeling better but not 100 percent.

Injection was in left arm. A few hours later, left armpit/gland began hurting and was sore. Armpit felt swollen. Lasted 3 days. Ibuprofen given prn. Resolved.

Day 1-- shot, nosebleed 8 hours later Day 2-- feels gross, sore throat, 2 more nosebleeds, stays home from school, fatigue, chills around 7 pm, complains of nausea Day 3-- feels grosser, stays home from school again, another nosebleed, fever 99.2, fatigue, still sore throat, weak muscles, gets winded if he has to walk gave him advil, vitamins, lots of water, emergen-c, ice packs, hot water bottle, tylenol, room humidifier, tea w/ lemon & honey, cough syrup for throat, afrin to clear up nose when it was stuffed closed (after the nosebleeds, afrin did not cause them) Nothing has helped him, he felt worse with each passing day. Tomorrow is day 4.

1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed their another medic. Two other EMT arrived at car at 1022. 1022: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Pt also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. Mother stated no food or medication allergies but pt had previous anxious reaction to Hep B two years prior. Initial vitals on arrival: BP: 80/52 SpO2: 89% Resp: 26 1025: 0.3 mg Epinephrine administer into left vastus lateralis by emt overseen by another emt 1026: repeat vitals BP: 111/57 Sp

3 min after receiving the vaccine pt verbalized feeling faint. Staff offered pt a cool pack for his neck. Patient accepted. Pt reported not having had breakfast and leaned back into the chair and became pale. PTA eyes were noted to be rolled into his head. Pts body became rigid. Staff assisted pt to the floor to a supine position. Staff obtained baseline vitals (127/75, HR 66) while simultaneously dialing EMS. Pt a color retuned within approx 2 min and pt was talkative. Dad reports pt with fear of needles with hex of syncope in past. Pt reported feeling fine upon EMS arrival. Pt declined EMS transport. Tolerated water and muffin without difficulty. Pt without injury. Self ambulated out of clinic after additional 15 min observation period.

SEVERE FLU LIKE BODY PAIN IN ALL PARTS, SEVERE HEADACHE, SEVERE NECK PAIN, SEVERE CHILLS, FEVER, SENSITIVITY TO LIGHT/ SOUNDS/ SMELLS/ twitching/ shakey, extreme fatigue

Severe vomiting 12 hours post 2nd vaccine. Chills, high fever (102.1) for 26 hours. Diarrhea on day 2-4. Stomach ache , loss of appetite for 4 days. Lost 8 lbs. Doctor prescribed zofran.

Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Mild tingling in the arms 15 minutes after vaccination along with feeling uneasy. Benadryl given, pt felt well enough to leave store. Followup phone call on 4/28/21, pt had recovered fully.

History of Present Illness: This is a 17-year-old male with history of asthma brought in by his mother who presents to the ED after an allergic reaction. The patient was receiving his first dose of the Pfizer vaccine at the vaccine clinic here approximately at 1:15 PM. He then started to develop left-sided neck tightness, throat pain, and tongue swelling 30 minutes afterwards and brought here. Currently, the patient's symptoms are constant, moderate in severity, and has no alleviating or aggravating factors. The patient has significant allergies to cats, grass, and dust but no known drug allergies. The patient also received a meningitis vaccine 1 month ago. The patient's parents are both fully vaccinated.

pt received injecton and immediately he advised it was alot more pain the the last one. Said he felt alittle dizzy but said he felt he could make it to chair. On the way to chair walking with RN on one side and father on other side pt had a sycopal episodes. legs gave way. EOA was a few feet away and assited pt to cot. directly upon being laid on cot pt was A&Ox3, V/S B/P 90/60, pulse 78, 02 sat 98%. at that time stated he remember getting dizzy following the painful injection. Father, mother and sister all have this same reaction when receiving injections. Pt observed for 30 min no problems noted. denies any problems. Pt sat on end of cot. Denied any dizziness. stood up no problems V/S retaken 90/70, pulse 84, O2 sat 98%, Instructed mother good idea to take to primary MD for check up. Pt stable released home.

17-year-old male who presents with 8 days of headache. He received his first dose of the Pfizer vaccine on 4/21. He felt like he had the flu after getting the vaccine and developed right-sided neck pain and a temperature to 100. The patient did endorse being elbowed in the neck playing basketball during this time as well, as he played in a basketball tournament in right after this. He got his Covid vaccine in his right deltoid. He saw his pediatrician on 4/26 and a CT scan of his neck with IV contrast was done and this showed significant diffuse right-sided deep spatial neck edema and right-sided adenopathy. The pediatrician discussed the findings with ENT who recommended augmentin and a medrol dosepak. The patient developed a headache several days after this and went to urgent care for evaluation. There was concern that the augmentin and steroids had caused the headache, so the steroids were stopped and he was switched to keflex on 4/30. He was given phenergan and toradol at Urgent Care and discharged home. His mom notes that several days ago he had fevers of 101-104. He has not had a fever for several days now. His headache continued and he felt unwell at basketball practice so he returned to urgent care on 5/4. A CT scan of his head was done which showed right sigmoid and transverse sinus thrombosis as well as thrombophlebitis of the right IJ. He was sent to ED for further management at that time. In the ED, the patient was hemodynamically stable and well-appearing. The CTs were overread by our radiologists here. The patient had some labs done at the outside urgent care but PT/PTT/INR and a CRP were drawn here, which were unremarkable. A Covid PCR is negative. Neurosurgery, neurology, and hematology were consulted. Neurology recommended heparin and a hypercoagulable workup and hematology agreed with this plan. The patient was admitted to the ICU for neuro checks and monitoring during initiation of heparin.

HI, couple days after my son (17 years old) got the 2nd shot he was heaving a pressure in his chest and left arm so we rushed him to the hospital. When we got to the hospital with his level of 26 (normal 1) and blood test show also lever inflammation they hospitalized him right away. He was there 3 days and just got released. now he need to be under care with medication and visit to a heart cardiology doctor every few days for tests. he cannot do any activity (per to the doctor including computer games that can raise his heart rate)

Intense headaches the day after taking the shot, back pain from the waist up. 2 days later I woke up with chest pain and the lingering headache, my chest feels heavy and maybe shortness of breath. I did a bunch of research however I did not find anything about chest pain related to the second dose of Pfizer. I am not sure if it is some type of tissue or muscle pain or something more serious. When I massage my chest it does not ache like the muscle pain from my shoulder so id assume it has to do with maybe my lungs or heart.

came to see me 3 days after his first Pfizer Covid vaccine and had been having a subjective fever, bad headache and stomach ache since the day the vaccine was administered. He incidentally had some weight loss noted at the visit over the previous 6 months for which I did some lab work. The lab work was normal except for his platelet count which was 111,000. A repeat platelet count done a week later was normal at 273,000. Because of the transient decrease in platelet count and the 3 days of bad headache after the vaccine, I decided to hold off on getting a second Covid vaccine. Additionally and possibly of no significance, his mother apparently had a history of ITP during her childhood.

Pt was seen at ED on5/8 for L sided weakness in the setting of a headache. Pt?s mother reports that these symptoms began 2 days after receiving second dose of Pfizer COVID-19 vaccination in R deltoid. She says that on 5/6, pt complained of L arm weakness during cooking class at school, which was followed by a mild L sided headache later in the day. Symptoms resolved without intervention but recurred on 5/8 with associated L sided facial droop, slurred speech, L arm spasms, and L foot drag. Pt was seen at ED for this and had a HA (5/10 in severity) at that time -- workup was unremarkable with a normal head CT, laboratory workup, and resolution of symptoms. Pediatric Neurology evaluated the pt, deemed no further workup necessary, and advised outpatient follow up. Pt presented again to the ED on 5/10 with concern for full tonic/clonic seizure, witnessed by pt?s mother. Mother reports that she heard pt fall and went upstairs to find pt seizing on his bed -- says that pt had shaking of bilateral upper extremities (in flexed position close to chest) and symmetric lower extremity shaking; eyes were closed without clear focality or eye deviation. Also some drooling, though no incontinence or tongue biting. Episode lasted for approximately 2 minutes; pt was confused and did not recall what happened immediately afterwards but improved within the next 8 minutes. He was taken to the ED by EMS. By the time he arrived in the ED, he had left sided weakness again. He was given Keppra 1g, placed on EEG, and was admitted. EEG overnight was read "normal" and additional workup was unremarkable. Pt had MRI brain completed showing cortical abnormalities in the R parietal lobe, suspected to be related to recent seizure. MRA showed patent intracranial cerebral vasculature. MRV showed no evidence of dural venous sinus thrombosis. Weakness resolved by the morning and pt was back to baseline on morning of 5/11/21. However, around 9 AM, L sided weakness (face, arm>leg) with associated headache recurred. Mom says that this event was captured on EEG. He was then transferred to our facility. He was placed on pEEG and had repeat labs, imaging completed. Pt did have L sided facial droop, L arm weakness, and slurred speech on arrival, but this resolved within 24 hours. Pt had one additional episode of "wave" of L sided weakness including L sided facial droop and slurred speech at one other time during the hospitalization, but no additional seizure like activity. He was discharged on 5/14 with a normal neuro exam-- some labs (including labs of Rheum and Id workup were pending at time of discharge.) Primary and consulting teams elected to forgo steroids but reconsider should symptoms worsen or return. Pt was readmitted on 5/16-- had an episode of expressive aphasia + headache while at a social gathering; states that he became overwhelmed by the noise. No additional seizure like activity.

17 y.o. male with non contributory PMHx presents with chest pain. Patient began not feeling well on Monday May 3rd with muscle aches, sore throat, dry cough, and headache. Received COVID vaccine on Apr 30. He woke up Friday May 7 he developed a fever to 102F. Went to urgent care yesterday was diagnosed with strep based on suspicion (negative rapid, culture pending) and started on amoxicillin. Rapid covid was negative at that time as well. Now presents for chest pain. He has woken up that last two mornings with chest pain (worse when laying flat), pain is substernal, sharp/throbbing, radiates to the left arm. Belching a lot. Palpitations and one episode of emesis prior to arrival. Suspected symptoms were from gas so took charcoal tablets prior to arrival without relief of symptoms. Has been taking ibuprofen for discomfort (400 mg every 4-6 hours for > 7 days). No shortness of breath. No abdominal pain. No diarrhea. No hematuria or dysuria. No family history of sudden cardiac death or significant for CAD. No known tick bite. Of note, received Pfizer dose 2 3d prior to symptoms starting. Presented to ED earlier tonight where exam was notable for: Low-grade temp, mildly hypertensive with otherwise stable vitals, appears uncomfortable, belching, neck is supple without meningismus, bilateral tonsils 1+ with exudate, oropharynx is erythematous, uvula midline, no trismus, no swelling, lungs clear, regular rhythm mild bradycardia, no murmurs rubs or gallops, abdomen is soft and nondistended with mild tenderness in epigastrium and right upper quadrant they did ECG, bedside Echo, Strep PCR, zofran, maalox, pepcid, IVF, tylenol, and labs which were notable for elevated troponin -> 13.58 d/w YSC Ped ED and tx Assessment: Patient is a 17 y.o. male previously healthy who presents with 1 week of malaise, and 3 days of intermittent substernal chest pain (now resolved), found to have elevated troponin and ST segment elevations in I and lateral leads c/f myopericarditis. Etiology is unclear at this time, likely viral vs post-vaccine. Exam notable for exudative pharyngitis, however Strep and CMV neg. EBV serology with positive EBNA only. Labs otherwise notable for elevated CRP 180, ESR 38, some transaminitis, ferritin/D-dimer wnl. COVID RNA neg, spike Ab positive c/w recent COVID vaccination. Normal function on ECHO. CRP continues to downtrend. Troponin has started downtrending again and pt remains asymptomatic. Plan Plan: #Myopericarditis - Repeat echo today - q8 troponin, AM CBC, CRP, ferritin - Motrin 400mg prn - steroid taper per Rheumatology recs 30mg PO BID for 7 days 30mg PO qday for 7 days 15mg PO qday for 7 days 7.5mg PO qday for 7 days 2.5mg PO qday for 7 days Off - f/u ID and rheum labs - continuous telemetry: patient at high risk of arrhythmia #FEN/GI - Regular diet - strict I/O - Pepcid 20mg BID #dispo - steroid taper sent for delivery to bedside - upon d/c start ASA - f/u cardiology - If echo today reassuring and troponin continuing to downtrend will plan for discharge this afternoon

17 y.o. male who presents with chest pain, elevated troponins and diffuse ST elevations concerning for pericarditis vs myocarditis admitted for cardiac monitoring and evaluation. Pt states he has had 1 day of sudden onset L shoulder pain and chest pain. Endorses dyspnea due to pain with deep breaths, denies tachypnea, nausea/vomiting, diaphoresis. Endorses mild chills and aches after COVID vaccine 3 days prior to onset of symptoms, denies any fever, URI symptoms, diarrhea, rash, known COVID contacts. Pain continued to worsen and spread across his chest, causing presentation to ED this afternoon. No history of PE, DVT, long travel, recent surgery, malignancy, alcohol or cocaine use. Significant cardiac history in family: dad with CAD w/LAD blockage, both parents with hypertension. At ED, labs notable for elevated troponin 0.456, repeat 0.67 and diffuse ST elevations on EKG concerning for pericarditis. COVID neg, CXR unremarkable, blood cx drawn, no abx started. Patient was given toradol for pain with minimal improvement. Peds cardiology was consulted and patient was transferred to different ED for further care. At different ED, repeat EKG showed similar diffuse ST elevations in I, II, aVL. Repeat troponins uptrending (4.91), proBNP 562, ESR 43, CRP 18. Mildly tachycardic but otherwise hemodynamically stable. Given tylenol for pain. Cardiology recommended admission for trending troponins, echo and cardiac monitoring. CV: Troponins were trended every 12 hours with a max of 4.91. His last troponin checked on the morning of discharge was 0.41. He had an echo that showed normal cardiac function, an MRI that indicated normal ventricular size and function, with minimal or healing and inflammation or mild myocarditis. During his admission, he had continuous cardiorespiratory monitoring, that did not show any arrhythmias. Resp: On 2L NC for comfort, no respiratory distress or hypoxia. FENGI: Regular diet Neuro: Ibuprofen scheduled and tylenol PRN for pain. He was initially started on ibuprofen 800 mg every 8 hours, but was starting to have pain prior to being due for medicine every 8 hours so his regimen was changed to 600 mg every 6 hours which controlled his pain adequately. ID: Myocarditis panel sent with some results still pending. Thus far, he is CMV negative, EBV IgG was positive but not IgM. RVP was negative. This all occurred in the setting receiving the Covid vaccine 3 days prior to presentation, which has been reported as a rare reaction to the Covid vaccine. At the time of discharge, labs pending results include mycoplasma pneumonia, coxsackie, parvovirus, enterovirus. Etiology of myocarditis remains unclear at this time, could be related to infectious etiology not yet clear to us, vs related to his COVID vaccine prior to admission.

Symptoms began around 10 hrs after administration of shot, first a racing heartbeat for a few moments followed by an intense ringing in the ears and legs felt wobbly, quickly progressed to chills feverish for 9 hours. Headache then began for several hours. Tylenol administered by parent/guardian. General malaise and bed rest followed by congestion. Malaise and some nasal congestion lasted for additional 24 hrs. Thirst treated with electrolyte based-drink and water.

Presented on 5/15 with chest pain and diffuse ST segment elevation consistent with perimyocarditis. He received his second COVID vaccine (5/11) 4 days ago- reports 3 days ago feeling sinus inflammation, throat felt swollen, and laid in bed all day, 2 days ago- he reports just having sinus inflammation sensation, 5/10- he reports feeling like every muscle including his neck hurt. No headache, vision changes, weakness, tingling. No cardiac history, leg swelling, rash, rhinorrhea, or recent illness.

Patient is a 17 yo male with no hx asthma who presented to medical center ED as transfer from facility with pleuritic chest pain and fever x1 day. Recent history of second covid vaccine on Friday (5/14). Patient reported associated fatigue, headache and muscle aches late Friday into Saturday (5/15). Sunday patient reported a fever (101 F) and chest pain with deep inspiration. No associated SOB, increased work of breathing or abdominal pain. Was seen initially at urgent care and then referred to facility for "an abnormal EKG." Pertinent findings at facility: troponin 0.31, EKG wnl, rapid covid negative, ESR 9, CK 134, D-dimer <150, WBC 12.4 w/ left shift. Transferred to medical center for further workup. While in medical center ED, troponin 1.59. EKG rSR' leads V1-V3 w/o ST segment elevation. MISC tier 1 studies drawn. Cardiology consulted - admit for observation, myocarditis infectious workup, echocardiogram and During his time in the ED, patient continued to have pain with deep inspiration as well as when he had to yawn. He other wise felt fine. Vital signs normal throughout out time in ED. His troponin continued to rise, with max of 14, so decision was made to start IVIG and steroids. His troponin fell over the next day. He remained stable from a clinical standpoint, and symptoms had resolved by the morning of 5/18. At time of filing, patient is still hospitalized at medical center, with further labs and imaging pending.

Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events. Information on lot/batch number was available. Additional information has been requested.

Chills, Muscle Soreness, fever and Severe Headache from about 5:30 p.m. 05-19-2021 - 1:30 p.m. 05-20-2021. Less severe chills, fever, and severe headache from 1:30 p.m. 05-20-2021 - 6:30 a.m. 05-21-2021. Less severe headache continues after shower finished 6:30 a.m. 05-21-2021 until present 05-21-2021.

5/13 began as flu like , 5/14 6:00 pm couldn?t get full breath, went to Patient 1st, chest X-ray nothing , 5/15 4:00 am shoulder pain, couldn?t get full breath, Went to Hospital ER, Ekg progressively abnormal, Troponin and C reactive values increasing, transported to Medical Center ICU pediatric cardiology, physician and cardiologist, she diagnosed myocarditis and pericarditis. 5/18 discharged and home improving.

Patient was fine until sometime in the morning hours, approx. 12 hours after receiving vaccine. Began with a fever of 100.7, nausea, leg pain/joint pain. Patient took Motrin but fever rose to 102.5, continued with nausea, and leg pain. This lasted two full days.

Chest pain (midsagittal), feeling similar to heartburn, pain felt midsagittal throughout chest, but especially immediately below heart. Diaphragm movements when breathing increased severity of pain. Symptoms subsided within 12 hours with use of Kwan Loong Pain Relieving Oil. Unlike heartburn, nothing worked to relieve pain immediately. This was in addition to known side-effects that were present including: fatigue, slight fever, headache, muscle pain, and soreness at injection site.

Patient presented with one week of back, right leg and right groin pain. Right lower extremity swelling and was diagnosed with deep vein thrombosis from right popliteal vein into IVC involving a renal vein. He is on anticoagulation currently and going for catheter-directed thrombolysis today. Patient has been in hospital two days and hospitalization is ongoing at the time of this report.

Patient received his first dose of the Pfizer vaccine on 5/7/21. On 5/13/21 he began to feel feverish (unsure Tmax, never took temperature) and was intermittently febrile until hospital admission on 5/20/21. On 5/18/21 he was seen in the ED for fever and tested positive for strep throat and started on amoxicillin. His inflammatory labs were elevated at this time and did not notice improvement on amoxicillin. He returned to the ED on 5/20/21 at which time patient reported headaches on the right side, sharp 7/10 pain which come and go with the fevers as well as fatigue, muscle/body aches, and sweats in addition to persistent fever. He also noticed maculopapular rash on palms and soles and on distal extremities which was not pruritic or painful on day of hospital admission. All infectious workup was negative and patient did not improve on broad spectrum antibiotics. Given his persistent fever, hypotension, and inflammatory labs without other cause, patient was empirically treated for MIS-C and was given IVIG and methylprednisolone as well as being started on prophylactic dose enoxaparin for his elevated D-dimer. Repeat echocardiogram identified a new coronary aneurysm, supporting the diagnosis of MIS-C. Following IVIG and steroids patient remained afebrile and inflammatory markers down trended, however liver enzymes remained elevated at time of discharge. He improved and was discharged to finish steroid course at home with close follow up.

BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered. Follow-up attempts are needed. further information is expected.

Arm pain, runny nose, fever, muscle aches, headache. Second dose symptoms were less severe than first dose. He had a severe headache after the second dose but not the first. All symptoms resolved within 24 hours, however first dose symptoms lasted longer than the first dose. He had a more severe reaction and longer duration to the first dose than he did the second dose.

Patient hospitalized for overdose. Patient found to have potential myocarditis. Patient overdosed on antihistamines loratadine and doxylamine. Found to have rhabdomyolysis. CK levels have been trending downward. Patient found to have elevated troponin and ECHO showed decreased EF raising concern for myocarditis. Also with EKG changes. Patient is asymptomatic without chest pain or palpitations. Cannot differentiate cause of myocarditis, can be due to over dose and related to rhabdomyolysis or other causes.

When patient arrived his guardian was not here so he sat and waited. When dad came, we registered patient as normal asking if he feels ill or not and he stated no. When I brought him back to the room we were talking about school and activities he is in and he seemed normal and answering normally just tired. I cleaned his arm and talked him through things that can happen with the second dose of Pfizer. He seemed just fine and once I injected and bandaged him he went stiff and I tried to talk to him and he did not respond. I called for help and they got his dad. he finally started coming too and was extremely warm. I sat with him for 10 to 15 minutes and rubbed his back and we got him water to drink. we started an incident report right away while talking to the dad. nothing further happened and he was told to go straight to the clinic to be checked out.

Patient evaluated at local hospital for concern for meningitis / encephalitis, transferred to our facility and was able to get studies (detailed below some of which are still pending). Initial symptoms presented with rhinorrhea, then severee headache, neck pain, and fever (tactile). Had sweats and chills. Began to experience diarrhea, dysuria, diffue body aches and myalgias. Severe pain in his neck / posterior occiput. Denied any mental status changes at the time. Studies largely negative for an identifiable bacterial process so presumptive diagnosis is aseptic meningitis. Unclear if from vaccine or other etiologies. Outside hospital had started antibiotics but this was stopped and patient symptomatically recovered with only symptomatic care.

He had normal - tired, kind of sicky feeling when he woke up on Thursday. At 07:00pm, he had pain behind his right knee. I told him to drink more water and I gave him some Tylenol. I told him to keep me posted as to how he felt. The next morning, he said he hadn't slept all night - he had a dull pain that didn't go away when he moved. It traveled up his upper leg and up to his right hip. Moving and stretching didn't make it go away. Constant dull pain. I took him to ER. It took 36 -48 hours before it faded. He didn't wake up with it on Saturday.

Day 2 - fever and muscle aches Day 3 - chest tightness and discomfort; tingling and numbness in both arms and hands

5/2/21: After playing soccer, got home, ate dinner, then ~9p had sharp left chest pain and pain above clavicle with deep breatning. Took one 500 mg Tylenol, then 10 mins later took ProAir (albuterol) 2 puffs felt better 10-15 mins after, so unsure which helped, or if resolved spontaneously 5/3/21: ~7p c/o fast heart rate (mom read 72 bpm on home BP monitor). Took ibuprofen 200 mg and 2 puffs ProAir, felt somewhat better, and went to evening soccer practice. When picked up, c/o occipital headache and chills (which he experienced post-exercise for weeks prior to vaccination, calls it his "normal chills"). Took Tylenol 500 mg and Advil 200 mg, went to bed, felt better in am.

not able to function; sleeps all day; lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend; chest hurt; Shortness of breath; fatigued and very weak; fatigued and very weak; Headache; cannot focus on school online; blood pressure goes up and down; heart rate goes up and down; Dizziness; muscle mass depleting; This is a spontaneous report from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the right arm, at age 17 years, on 12Apr2021 (Batch/Lot Number: EW0158) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included pressure in his eye from an injury, asthma (diagnosed when the patient was about 2) and has family members with asthma and heart conditions. Patient is in perfect health, he works out 6 days a week, and does football conditioning 5 days a week. 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. Concomitant medication included timolol taken for pressure in his eye from an injury from an unspecified start date to 20May2021. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient historically received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EP7534) at the left arm at age 17 years on 22Mar2021 for COVID-19 immunization. The patient got his second dose of the vaccine on 12Apr2021 and shorty after on 19Apr2021, he became very fatigued, very weak, his chest hurt, and he had shortness of breath. On Apr2021, patient had dizziness. The patient used to have bulky arms and now you can see his muscle mass depleting in Apr2021. The patient cannot focus on school online because of the headaches from 19Apr2021. The patient's blood pressure goes up and down from 19Apr2021. For days from 19Apr2021, the patient's heart rate will be fine in the 60s and it goes up to 120 or 130 with chest pain, it fluctuates depending on the day. The patient visited the emergency room on 05May2021, but was not admitted and no one knows what was going on with the vaccine. It was also reported that the patient lost 14 pounds on 25Apr2021 since the second dose of the vaccine. They knew the patient has already lost 10 pounds and then yesterday, 25May2021, the patient weighed himself and noticed he has lost another 4 pounds over the weekend. Patient had bloodwork on 20May2021 and it was all negative. The primary care provider was concerned about the weight loss so she ran a bunch of blood work. The patient is negative for COVID test and chest x-ray on 21May2021 and he has had multiple tests done. The patient went to his primary care provider on 25May2021 (yesterday from the time off reporting) and the reporter mentioned that maybe can they look at this as being a side effect from the vaccine. The patient's doctor laughed and said nothing has been proven yet about this. The reporter felt that this is a reaction to the vaccine. At the time of reporting on 26May2021, the patient was not able to function and sleeps all day. The patient also underwent lab tests and procedures that includes being tested negative for mono twice now (on unspecified dates). Clarified that they have not filed a safety report with Pfizer on the patient's events. The outcome of the events 'dizziness', 'lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend', 'muscle mass depleting', 'cannot focus on school online', 'not able to function' and 'sleeps all day' was unknown; while for the other events, it was not recovered.

He had sharp chest pains that would come and go in left side near ribs beginning around noon on 6/17/2021. They seemed to worsen throughout day & with laying down. Then, increasing pain along left side of body into hip and leg around 5:30pm. He experienced very "bad, cramp-like" pain in left calf area around 6:30pm. Sharp Chest pains intermittent at "10 pain level" & lower left leg at "8 pain level". Some nausea and vomited once at this point. We called the urgent care line for our doctor's office and spoke with nurse who instructed us to go to the ER. They performed ECG and Chest XR. Labs were BMP, CBC, CK, D-dimer (quantitative), & Triponon-I. They gave 800mg Motrin, IV fluids and keterolac in IV. They said they "did not identify a specific problem" but to rest, take ibuprofen, and follow-up with doctor and cardiologist. They said it was most likely related to the Covid-19 vaccination but could not give causation. Patient seems fine so far today, but still has medication in system.

night sweats; different things like that, joints; The initial case was missing the following minimum criteria: adverse event NOS. Upon receipt of follow-up information on 11Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (Patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose (17-years age at the time of vaccination) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, Consumer reported that patient received his first dose. Consumer does not remember the date. On an unspecified date, patient had symptoms (night sweats, different things like that, joints). Patient was sensitive to a lot of things, so consumer is nervous. Consumer heard of healthy people getting the vaccine and dying shortly after. Consumer further wanted to know if he should get the second dose. Consumer indicated he was to have his second dose on Monday but awaiting blood test from HCP, delayed until 14Jun2021. On an unspecified date, the patient underwent lab tests and procedures which included blood test with unknown result. The outcome of events was unknown. Information lot/batch number requested.

c/o "feeling sick for a week"; treated at clinic Saturday, 6/19, for UTI and prescribed antibiotics; c/o generalized muscle pain/aches since 6/16/2004; positive for diarrhea and fever. Received an EKG, labs, and chest Xray. Diagnosis of Obstructive jaundice and SIRS. Transferred to higher level of care with specialty in house.

Continuous lumbar pain. Xrays show inflammation. Treatment is physical therapy and anti inflammatory meds for 2 weeks.

initially numbness of right arm reported on day of second vaccine. noted to have muscle aches and pains on day one after second vaccine dose. two days after vaccine, was complaining of severe chest pain, so was taken to ED.

Constant headaches mainly frontal headache that is sharp and horizontal between the ears at times; Muscle aches; Tail bone pain; Back pain; Significant fatigue; lymphadenopathy in neck; This is a spontaneous report from a contactable other health care professional. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), intramuscularly in the right arm on 11Mar2021 at 20:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Prior to vaccination, the patient had 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 COVID-19 vaccination. On 13Mar2021 at 15:00, the patient experienced constant headaches for the last 11 days. Mainly frontal headache that was sharp and horizontal between the ears at the time. The patient experienced muscle aches, tail bone pain, back pain, lymphadenopathy in neck and significant fatigue on 13Mar2021 at 15:00. Therapeutic measures were taken as a result of events constant headache, muscle ache, tail bone pain, back pain and lymphadenopathy in neck and included treatment with TYLENOL and ibuprofen. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events headaches, muscle aches, tail bone pain, back pain, lymphadenopathy in neck and significant fatigue was not recovered at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

On 06/02/2021, (23 days after vaccine) the patient and his identical twin brother were at dinner when patient had shortness of breath and chest pain. They brought the patient to Medical Center where a CT of the chest was performed to rule out a pulmonary embolus. No pulmonary embolus was identified and patient was transferred the patient via ambulance to Hospital to the intensive care unit. He was noted to have an elevated troponin, an elevated BNP and a left ventricular ejection fraction of 35%. He underwent a cardiac MRI on 06/04/2021 documenting delayed enhancement in the inferior and inferolateral walls of the left ventricle consistent with myocarditis. The patient's chest pain was quite severe and was only relieved once he was in the intensive care unit at Hospital. He did well for 2-3 days and did not require inotropes but his troponin vacillated and his ejection fraction remain low. He was given IVIG non 06/05/2021 after his echo showed an ejection fraction between 37 in 45%. He subsequently developed headache emesis and neck pain. On hospital day 5, the father was quite concerned for his son and thought ?he was going to die?. The father shared pictures of the edematous, pale son that he took with his phone. He improved over the next 1-2 days and was discharged from the hospital with an ejection fraction on 06/07/21 of 62%.

Patient is 17yo previously healthy male that presented to the ED due to a 3-day hx of chest pain in the setting of acutemyopericarditis secondary to the second dose of Pfizer COVID vaccine. On Friday, patient was vaccinated with the second dose of Pfizer COVID vaccine. On Saturday night, he started presenting with headaches, myalgia, a temperature of 100.0F, and chest pain. Such pain is sharp, mid-sternal, non-radiating, a 7/10 at it's worse, and worsened by lying down. For the chest pain he has been taken Tylenol 500mg and Ibuprofen 400mg as needed, with minimal improvement. The next day, his headache, myalgia, and high temperature resolved but he persisted with the chest pain. Today, he took Tylenol 500mg at 7:20am with minimal improvement. Due to persistent chest pain, he presented to our ED. Overall, he denies any UR sxs, trauma, SOB, emesis, diarrhea, abdominal pain, sick contacts at home, and known COVID-19 exposure. Denied any family history for sudden cardiac death, congenital heart disease, or arrhythmia. Currently not taking any medications. No known allergies. VUTD. In the ED, CXR normal. Troponins elevated to 2.8. EKG with sinus rhythm, ST elevation with normally inflected T wave, and normal axis, intervals, and voltages. COVID ID now negative. He was given one dose of Ibuprofen at 11:30am with chest pain improvement to 2/10. In CICU, the patient arrived at RA, hemodynamically stable, with good pulses, cap refill less than 2 secs, and chest pain 2/10. During his hospital course, troponin uptrended to a maximum of 5.09. Repeat level in the afternoon with consistent downtrend at 2.86. EKG with ST elevations consistent with pericarditis but hemodynamically stable, with good pulses, cap refill less than 2 secs, and no chest pain. Echo with no structural abnormalities, no significant valvar dysfunction, and normal LV systolic function. CXR on 06/14 normal and in no respiratory distress. Pain management controlled with ibuprofen 600mg q8hrs and Tylenol PRN. Currently with no chest pain. Mycoplasma IgM and IgM and RPP pending and will be followed as an outpatient. Physical exam unremarkable. Will follow up with Dr. on 06/25/2021. Advised patient and family to refrain from strenous exercise for 2 weeks and no sports for 3-6 months.

Patient presented on 6/30 to the ER after going to PCP for chest pain and neck pain. Had received second dose of Pfizer vaccine on 6/27/21. Was found to have a troponin of 6 and echo with normal cardiac function.

fever and chest tightness. Onset yesterday. Began after he received the second dose of his pfizer covid vaccine. He has generalized malaise and myalgias. Chest tightness with sob. Ed medications- Ns bolus 1000 ml, toradol 15 mg IV

History of Present Illness 17-year-old male who denies any major medical problems presents to the ER concern for chest pain. The patient states that he stayed up all night and he woke up this morning around 12:30 p.m., around 1 hour prior to arrival and he was having a tightness in his chest. The tightness is constant, seems to go down his left arm. He has never had this happen before. He received his Pfizer vaccination for COVID-19 on Friday of last week and he feels like he has had some aches since that time. He has been taking Motrin for this and this morning he also took Motrin but there is no significant relief. He has no significant shortness of breath, no nausea vomiting, no diaphoresis. I spoke with him privately and he denies any history of cocaine abuse. Per his mother he has healthy, no major medical problems. He has not recently had any other concerns or recent review systems. No history of having blood clots or DVTs. Medical Decision Making: History examination as above. Patient presents our concern for tightness in his chest with some radiation to his left arm over the past 1 hour. His EKG does show J-point elevation but he has no risk factors, he is hemodynamically stable well-appearing on examination. He has no shortness of breath, nausea, diaphoresis. Differential includes myopericarditis, early repolarization. Feel that the likelihood of STEMI, ACS is low. Will obtain a troponin as a part of his workup, chest x-ray for evaluation of cardiac silhouette size, bedside ultrasound. I do not suspect that he has a PE. He has no tachycardia tachypnea hypoxia. No external findings of suggest a DVT on examination. I do not suspect that he has cardiac tamponade, CHF, pulmonary process such as pneumothorax, pneumonia based on his history. Do not suspect a GI etiology. Will monitor closely here in the ER and re-evaluate. Time 2:30 p.m.. The patient's troponin is elevated at 7. I consult with Cardiology and I spoke with Dr- we reviewed the patient's EKG, his presentation, his history. He feels this is secondary to myocarditis from likely the COVID-19 vaccination. I have added a viral PCR as well as a part of his workup. He does not recommend activation the cath lab, he does not feel this is a STEMI. I do agree based on the history and the patient's appears this time. He recommended a formal echocardiogram as well. -I spoke with the ultrasound technician at bedside and there is no evidence of wall motion abnormality. This is consistent with my examination. -given the patient's elevated troponin we do not have capabilities of caring for him here. Not have Pediatric Cardiology, we do not have a PICU if the patient's condition were to worsen. There for the patient requires transfer to tertiary center. -will consult with another hospital for transfer. Time 3:22 p.m.. I spoke with Dr, he accepts for transfer. No recommendations for medications at this time. The patient is chest pain-free, hemodynamically stable. Spoke with the ultrasound technician there is no evidence of cardiac wall abnormality, pending official interpretation with our cardiologist. -asked for emergent transfer because I do not want the pain to be waiting here in the ER with possible worsening condition, worsening troponin elevation without cardiology consultation at a pediatric specific hospital. I do not want him to have the chance of deteriorating at this facility and therefore I do feel that he warrants emergent transfer as opposed to routine where he could wait here in the ER for hours. I do feel that benefits outweigh the risk and I spoke with the patient and his family about this and they agree. Critical Care: 55 minutes. Emergent evaluation on presentation given his EKG showing STEMI per computer interpretation. Time spent for multiple re-evaluations, discussion with Cardiology and outside hospital consultants, time spent with documentation. Time spent with family. Complex medical decision making. Serious life threatening disease process. Potential for death and increased morbidity. Exclusive of procedure time.

Patient is a 17 year old male with only past medical history of anemia at 1 year of age (resolved with iron and vit C supplementation), who presented to an Hospital on 7/7/21 with 2 days of chest pain radiating to his L arm, generalized upper extremity weakness, SOB, vomiting, found to have an an elevated troponin level of 0.626 with ST segment elevation on EKG, echo reportedly normal. Patient reportedly tested positive for COVID-19 on 6/6 and subsequently went into quarantine, was re-tested on 6/21 and tested negative. He arrived on 6/28 and received his 1st dose of Pfizer COVID-19 vaccine on 07/03/21. Of note, he was told he might feel dizziness and arm achiness after the vaccine but denies he was informed about possible inflammation of or around the heart after the vaccine. On 7/5 he was awakened in the morning by chest pain 6/10 and shortness of breath that started in the right lower sternal border and progressively moved to the left lower sternal border and then to his L shoulder and arm which he describes as feeling like he had been "punched" or a constant achy feeling. He took Tylenol x1 on Monday with minimal improvement. He initially thought it was reflux pain and took tums but it did not improve. He had one hour of relief but then the pain returned. He reportedly felt dizzy Monday evening as well. The pain was absent on Tuesday, but he woke up this morning again with the same chest pain and shortness of breath, prompting him to seek medical attention. In the outside ED, he had one NBNB emesis that was not preceded by nausea. En route from Hospital to Hospital he complained of chest pain 7/10 for which he was placed on 2L O2 which reduced the pain to 4/10. During his admission his troponin levels initially up trended and peaked at 5.67 before beginning to downtrend. He was diagnosed with myopericarditis and started on ibuprofen three times a day around the clock. He was discharged home on 7/8 with specific return precautions, follow-up appointment with cardiology, and strict instructions to avoid exercising and strenuous exercising until cleared by cardiology.

PT is a 17 y/o previously healthy boy who presents with 3 days of moderate-severe, substernal chest pain, dyspnea, and nausea 2 days after receiving the 2nd dose of the Pfizer COVID-19 vaccine. On Tuesday (7/6), PT received the second Pfizer COVID-19 vaccine. The following day (Wednesday 7/7) PT had "flu-like symptoms" with chills, subjective fever, and a sore arm that resolved by Thursday (7/8). He was back to his baseline state of health on Thursday (7/8) and felt fine that whole day. On Friday afternoon (7/9) when he was at work washing dishes where he had some physical exertion he began to notice at 16:30-17:00 that he developed substernal, sharp, 7/10 chest pain that did not radiate, improve/worsen with deep breaths, sitting up, laying down or with movement of his upper extremities. It worsened towards the end of the night and peaked at 8/10 by 22:00-23:00 that same evening. His sister picked him up from work per his regular routine and he went home and took a shower which improved the pain to a 5-6/10 when he went to sleep. He woke up at 3 AM on Saturday (7/10) AM and had one episode of NBNB emesis associated with the chest pain. When he woke up later that morning he felt improved until 10-12 AM he developed mild chest pain again which he took Tums for. He also tried Motrin which did not help his pain at all. On the morning of admission (7/11), he woke up at 6-7 AM with upper right back pain, dyspnea, and nausea along with the persistent chest pain which prompted him to present to MFSH. He does endorse mild sore throat but denies any fevers, recent sick contacts, known COVID-19 exposure or previous history of COVID-19. There is a family history of cardiac disease including a fatal MI in his father. His mother's family also has a history of heart disease and both sides have a history of high cholesterol. He did add Whey Protein recently to his diet to for muscle building, but he DENIES any drug, alcohol, tobacco, vaping, marijuana, THC use. He does not play any sports regularly. He also denies any recent bug/tick bites or rashes.

A few hours after the vaccine he got chills and muscle aches. This continued into the next day and he got a bad headache and couldn't go to school. Went to school Wednesday and came home with a migraine. He had migraines, congestion and extreme fatigue for next ten days. He was diagnosed with a sinus infections but could not break migraines so ended up in the ER and had an adverse reaction to Compazene. His heart rate dropped to below 42 beats per minute and his blood pressure was all over the place. He was basically sick for 6 weeks after getting the vaccine.

Immediately after administration, he started taking deep breaths and holding his chest with chest pain. He then lay down on the exam table and symptoms improved in a few minutes. 14 days later, on 6/17/2021, he developed severe muscle pain and was hospitalized two days later on 6/19/2021 for rhabdomyolysis. Discharged 6/22/2021 from Medical Center. He is an active athlete, plays alot of basketball and lifts weights. This was his first episode of rhabdomyolysis.

Intense left arm pain; Intense left arm pain resulting in aninability to move it; Body aches; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 17-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 24Mar2021 at 15:45 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. The patient was only allergic to Hazelnuts. Concomitant medication included sarecycline hydrochloride (SEYSARA) for unknown indication from unknown date. 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 25Mar2021 at 08:00, the patient experienced intense left arm pain resulting in an inability to move it or else there was excruciating pain. The patient also experienced full body aches and upset stomach. The patient did not receive any treatment for the events. 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 intense left arm pain, intense left arm pain resulting in an inability to move it, body aches and upset stomach were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

So right after getting the shot, within an hour, he complained of a pain in his back and I thought it was left over from the arm pain from the shot. But then he complained of stomach ache as well. We went to the hospital in June and they have done so many tests on him though and he was referred to a GI DR as well. He gets a stomach ache after having full meals, like anything normal size he used to eat, he gets nausea. He passes stool that is yellow in color. The DRs are still working on him currently though. He has some sort of bug or something. We have tried Pepto bismol and other over the counter medications but they have not helped.

Ongoing dizziness, fog brain, weakness, fatigue, poor appetite, loss 7 pounds, heartburn, increase of anxiety, no motivation to do the things he once enjoyed

Mother positive, Sx onset 7/14/21 cough, sore throat, muscle aches, headache, fatigue, loss of smell & loss of taste.

Pt describes falling with onset of weakness below the hip level about 6 inches above the patella with missing clonus reflex. The pt cannot squat down with associated observable loss of strength, pt is not able to stand up. The pt has fallen 7 times since symptom onset around lunchtime between 1200 and 1300. Pt denies LOC.

Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent with aches and chills. Near 22:00 I had developed a headache, one of a dull nature, with Sharp throbs. Between 22:00 and 00:00 01/11/:12 I had developed tinnitus. Near 01:00 01/12/2021 I had developed swelling of the injection sight with contralateral numbness on the left arm and leg. Near 02:00 01/12I had loss sensation In my left arm and developed numbness in the face. From 20:00 01/11 to 22:00 01/12 I had developed episodes of tachycardia with a peak resting heart rate of 143bpm measured via Watch. Between 15:00 01/12 and 22:00 01/12 I had experienced terrible non radiating angina proximal to the sternum. I had developed pain while urinating at around 21:00 01/11 my last urination was at 23:00 01/12, I did not go again until 16:00 01/13. I had experienced lower back concurrent with that. From 22:00 01/11 to 23:00 01/12 I had terrible SOB, and chest pain upon exhalation. Fever and body aches did not subside until through the night of 01/12:13. I had not experienced any symptoms as the night of 01/12. I had developed a rash across my chest near 18:00 01/11 though it has subsided it is still present.

Pt woke up 2 days later with excruciating pain in the knee throughout the day that has been semi relieved by ibuprofen 600mg TID. His knee buckled twice while walking. 1st time the knee collapse and he fell backwards. The 2nd time his knee froze with excruciating pain and had to fall over because it locked. Tonight, he is resting with his knee elevated and will schedule an appointment with his primary for further evaluation. (Only on the right knee.) (Today is day 2 of the symptoms of the knee buckling and pain. Day 1 was the arm pain, slight headache, weakness.)

The adverse event started with discomfort in the arm, body aches, then progressed to headaches, more severe body aches, and chills. Later in the day of 3/12/21, Patient began to spike a fever which eventually went to 102. He continually suffered from headaches, fatigue, body aches, and chills. We attempted to control the symptoms with Tylenol. All symptoms continued on Saturday. There was some minor control with Tylenol. At approximately 9:30 am patient had discomfort in his left underarm, when he lifted his arm, he became aware of a tennis ball size lump under his arm. Patient was suffering from severe lymphadenopathy in his left underarm and down the left side of his neck, with less severe but significant lymphadenopathy in the right underarm and down the right side of his neck. Patient's fever continued to hover around 101 to 102 Saturday and Sunday. There were times, within an hour of taking Tylenol that it might drop to 99, but would go right back up. He continued to experience fatigue, chills, etc... His fever finally broke on Monday morning and he is still experiencing some lymphadenopathy, but the lymph nodes are starting to reduce s of 3/17/21.

Mild soreness when using shoulder on vaccine arm (left) at 7:58am Sudden headache, at 9:45pm Arm soreness increases substantially (cannot comfortably raise whatsoever) 9:45pm Chills at 9:50pm Fever 100 degrees F at 10:30pm Fever broke and chills stopped at around 3:00 am on 3/31 (the next day) Headache where it hurts to look to the side persists until 4/2 after which it gradually goes away becoming negligible by 4/4

feeling unwell; sick to stomach; vomiting; chest pains; hard to breath; chills/freezing; weak; 104 fever; sore arm; sore muscles; This is a spontaneous report received from a contactable consumer (patient's mother). A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 14:00 (02:00 PM) (Lot Number: EP6955) at the age of 18 years old as single dose for covid-19 immunisation. Medical history included Known allergies Morphine and sulfa antibiotics; Marphans syndrome, autistic, severe scoliosis & kyphosis. The patient's concomitant medications received within 2 weeks of vaccination included too many to put down here not enuf room. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother took care of the patient due to his sever disability iam filling this out for his as he was unable so he received shot (pending clarification), registered with v-safe, 22Mar2021 2pm. Fine, health check next 23Mar2021 day sore arm, kinda sore muscles, 24Mar2021, sore arm still sore muscles, 25Mar2021 13:00 (1pm), feeling unwell, sick to stomach started vomiting, chest pains, hard to breath, called 911 EMS advised him to stay home after vitals ok due to not wanting to expose the patient to actual Covid virus. At the time no fever 30 min after EMS left 104 fever sever chills, freezing coming in waves so weak. He can't get up to go to the bathroom. The reporter was worried and closely monitoring him. Treatment was received for the adverse event included Medication for vomiting, doctor apt in morning. The events were non-serious per the reporter. The patient underwent lab tests and procedures which included body temperature: no fever 25Mar2021, 104 30 min after EMS left on 25Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Pt mother stated pt was nauseous and then that he was passing out. RN ran over to check on pt as pt eye rolled back and pt limbs fell limp. Pt moved to the floor by RN, rolled to the side by RN. Pt regained consciousness almost immediately and was laid on his back with feet elevated. Pt stated he felt fine, did not recall exactly what happened. Pt helped up into chair, given water and crackers. Pt stated he felt fine, observed by medical personnel for 30 min and pt was able to ambulate off site.

Day 1 Wed a.m. vaccination Day2 Thurs - nausea/dry heaves briefly in morning around 10am Day 3 Fri - actual vomiting around 11am; son said feeling nauseated all morning up to that point Day 4 Sat - woke up with a stiff neck (back of neck) and low grade fever and chills with intermittent nausea - came and went similar to when had COVID last November but not as bad as the real thing but similar pattern Day 5 Sun - same as Saturday but sore neck went away Day 6 Mon - same up until around mid day; later that day had a headache -took Advil and cleared Day 7 Tues - woke up with a headache; took Advil and cleared Day 8 Wed - threw up again in the morning but thought that might not be related to COVID vaccine; in his mind, his symptoms related to the vaccine ended Monday early afternoon so 6 days including the day of the vaccine (no side effects on vaccine day - Wednesday), but really can't tell for sure one way or the other whether connected. Question is whether he should get the second shot or not. Is 6 to potentially 8 days of side effects a concern? Also, parent has been curious as to whether son was a long hauler from covid for brain fog but son thinks it could be burnout from school. Strange that had such a long lasting reaction compared to to others his gneral age, including those who had covid after he had it so longer ago.

At approximately 1342 HRS, patient and father presented to observation RN stated, "My arms feel heavy." Patient denied shortness of breath, chest pain, itching, or difficulty swallowing. Respirations even and unlabored. Oral mucosa inspected, appeared pink and moist. Patient smiling during assessment. Pulse Ox 99% on room air. Pulse 95 BPM, even in rate and rhythm. Patient was observed for 10 minutes. Released from observation tent. Ambulated from area accompanied by father without assistance. Gait appeared steady.

Patient states Saturday 4/17/21 he noticed "normal Pfizer symptoms" of fever, chills, "shakes," muscle pains, especially in joints including shoulder and back, they got better after several hours, except that about midnight Saturday he still had the back pain, in the upper back, noticed severe chest pain in front and back, it hurt "with every heart beat," "like a heart attack," sometimes would have "attacks," sometimes better, sometimes worse, and it hurt in chest to breath, took Nyquil about 3am, was able to go to sleep, Sunday-Monday it was "pretty bad," but came in "attacks," sometimes it felt worse than others. Monday chest still hurt, went to urgent care, had EKG and scan, went home and did some school, that evening chest pain was severe "I froze," went to ER, was diagnosed with pericarditis. given an IV and Toradol. Was discharged home from ER with OTC Ibuprofen 200mg, to take 8 times a day. Patient states it is getting better, still continues to have some pain, taking ibuprofen daily at this point.

Around 10:30 I began to feel tired and a little sick. I went to sleep and at around 2 or 3 am I woke up freezing cold and sweating, with my left arm (arm I got the shot in) hurting a ton. I didn?t fall asleep for a few hours and couldn?t get out of bed due to coldness, lethargy, and muscle soreness. Next day had a moderate headache throughout the day that Ibuprofen didn?t help with. By 10 pm Friday all symptoms other than arm soreness had disappeared.

I had a 102°F fever from 9am to around 6pm (9 hours). Along with that the normal headache and muscle pain. After 6pm, everything went back to normal and I?ve felt fine

white tiny bumps on both arms (thousands of bumps) and inflamed (painful) right armpit lymph node, over 28 hours since injection

18M with no PMH s/p pfizer vaccination dose 2 on 5/4/21 who presented with chest pain. He initially had chest pain the day prior to admission with pain in his back and down his left arm. This improved with Tylenol and resolved prior to bed. On the morning of 5/6 the chest pain returned and was so severe it woke him from sleep. He was difficult for him to characterize, but he said it was all over his chest, sometimes sharp and pressure-like, most severe in mid substernal region and was so substantial that he had difficulty speaking properly. He feels that the pain is most severe when lying flat and is best managed when he is resting at a 45 degree angle. Patient was at ED he was found to have an initial ECG with ST depressions in aVR and elevations in II, aVF, and V2 through V6 raising suspicion for pericarditis/myocarditis. Initial troponin was elevated at 4.35 as well. Cardiology Dr. was contacted by ED physician, case discussed, and EKGs reviewed and felt this was more likely pericarditis, but not STEMI. Of note, he reports a family history significant for his mother having a?hole in her heart.?He was given Toradol with improvement in his pain and upon arrival to hospital his chest pain was markedly improved. He was noted to have troponins peaking at 39.415 that down trended and an elevated CRP of 4.8 on admission. D-dimer was 0.26. Covid PCR was negative. He was evaluated by cardiology again here who upon review of his ECG and cardiac enzymes as well as presentation was consistent with pericarditis. Echocardiogram showed normal LV systolic function with trace posterior pericardial effusion and telemetry was monitored without any arrhythmias. He was started on low-dose beta-blockers, aspirin 650 mg 3 times a day, and colchicine 0.6 mg every 12 hours for 2 doses followed by 0.6 mg daily. He is planned to continue this for approximately 3 months and will need to follow-up with cardiology in 1 to 2 weeks for repeat monitoring and management with plan to taper off aspirin once his CRP normalizes. Later that night, he even had a similar episode of sudden onset chest pain for which she received IV Toradol with minimal relief and oral Tylenol with relief of symptoms after that. No telemetry abnormalities were recorded at that time. ECG the following day showed improving ST changes and troponin of 26.328 with CRP 4.2. He had no further symptoms for over 24 hours and is responding well to treatment. He is advised to take Tylenol as needed in addition to the above-mentioned medicines should he have any recurrent chest pain.

per mother, pt splayed out chair and body was shaking, which lasted a few seconds. Pt reports, that it felt like he was dreaming. Mother informed me immediately. Pt was oriented by the time I came. EMT was called and they took vitals. Pt was bradycardic and hypotensive. He also reported neck pain. He was then taken to the hospital.

Lack of energy- Attempted to sleep off with limited success Major pain in joints- Took Ibuprofen, mostly ?treated? Still need to take it, or pain returns Stiffness- No actions can be taken to alleviate that I am aware of. Still present, but improved from yesterday and the night before Headaches- Took Ibuprofen, surprisingly ineffective . Relatively new symptom, just started today. Coughing- Did not treat, mostly disappeared by the next day. Only a very minor and sporadic cough still remains. Minor feeling of congestion- Did not treat, not serious enough to warrant action. Still present today.

5/7 PM: c/o sore throat 5/8: starting having tactile fever, chest pain, sweats, nausea 5/9: continued with above plus vomited once, dizzy, shaky, neck and back pain 5/10 and 5/11: same 5/12: fever to 103, went to the PMD and referred to the ER.

Patient's mom called about 40 mins after receiving dose and said that patient's right hand (vaccine was in right deltoid) felt tight and was red. She said that he did NOT have any redness or swelling at injection site. She said that he is on the spectrum, so complicates asking him about symptoms. She confirmed that he was NOT experiencing any lip/tongue swelling or trouble breathing. She said he was running hand under water because it "felt tight". After counseling, I followed up with her 40 mins later and she reported that his symptoms were much improved without any treatment.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost conciousness a few minutes after dose was given. Patient was unresponsive for approximately 2 minutes. Neck felt tight, difficulty breathing, was not alert/oriented when finally awoken. Patient was given 1 shot of epi 0.3 due to a temporary interuption in breathing that lasted seconds. By the time paramedics arrived, he was becoming more alert. Was taken to the ER and discharged.

18-year-old healthy man received his second Pfizer COVID-19 vaccine on Sunday, may 16th. He had generalized muscle aches and mild flu-like symptoms which were not unexpected on Monday the 17th. On the 18th, he reported dyspnea on exertion, some chest tightness, and his throat felt like it was "closing". He also had tender anterior cervical lymph nodes and a fever to 100.8 °F. He came into the ER for further evaluation. After evaluated by cardiology, given his stability, felt appropriate for discharge with immediate outpatient follow-up.

Patient has pain that started 1 week after vaccine, pain in deltoid- when reported to doctor had been 3 weeks, harder to lift things, painful. pain radiates from deltoid towards shoulder and down into forearm

Patient is a 18 y.o. male who witnessed syncopal episode at 1605 yesterday s/p COVID vaccine. Patient says that he received a COVID vaccination yesterday at 1601. Per mother, the patient had a syncopal episode at 1605, he was sitting down and slid out of his chair with full extension of bilateral arms and legs, lasting about 30 seconds. Witnesses deny headstrike or shaking during syncopal episode. The patient denies pain. He states that he only ate cereal yesterday morning and has experienced similar symptoms in the past while receiving other shots. Patient denies recent trauma or fall. HA, confusion, changes in vision/speech, changes in gait, fever, chills, n/v, abdominal pain, chest pain, SOB, palpitations, cough, hemoptysis, back pain, neck pain, dysuria, hematuria, recent sick contact or travel. Otherwise has no complaints at this time. Patient was discharged at 16:54 and given educational materials on understanding vasovagal syncope

Patient presented to urgent care with 3 days of pleuritic chest pain. He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED. Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago. About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder. No associated cough, dyspnea, sputum production, hemoptysis. Chest pain is not associated with activity. He does not describe chest pain with the positional change or laying down. no fever or chills. He had 3 episodes of emesis this morning. No abdominal pain, no diarrhea.

Severe fatigue; Right hand started twitching uncontrollably; Had pain but it did not go across chest like after first dose vaccine; Had numbness down arms and legs; Had vertigo really bad; Was very hot, no fever, but radiating heat; Muscle pain; Mind numbing migraine pain in the caller's son's head; Body was hot allover, and his skin turned red; had periodic pins and needles with the numbness; Dizziness; Difficulty sleeping; Chest tightness periodically, but not consistently; Chest pain; Ear ringing; General malaise; Can't walk to the end of the block without coming back in pain; Found it hard to concentrate; Cloudy head; This is a spontaneous report from a contactable consumer (patient's mother). An 18-years-old male patient received of bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in left arm on 07May2021 12:10 (Lot Number: EW0183; Expiration Date: 31Aug2021) as 2nd dose, single dose for COVID-19 immunisation. Medical history included lyme disease ongoing from 2013 and it was reported that her son had no tick bite & was diagnosed through a blood test. Her son had fatigue, migraines, lethargy & the doxycycline made him sick as a dog. A chiropractor had success using various tinctures & after 1 to 1-1/2 years, her son went into remission. Her son has a low degree of pain & soreness & has learned to deal with the pain. When his immune system is triggered, his Lyme disease comes back & he takes tinctures for a week or 2 & his symptoms goes away. No further details provided. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EW0164 and Expiry date: 31Aug2021) administered in left arm for COVID-19 immunisation and experienced chest pain, headaches and light-headed. Patient also had his first HPV Vaccine, laid out flat for a week and had no problems with the meningitis. On 07May2021, after second dose of vaccine administration, the patient had pain but it did not go across chest like after first dose vaccine, numbness down arms and legs, really bad vertigo, was very hot, no fever, but radiating heat, muscle pain, dizziness, mind numbing migraine pain in head, body was hot allover, skin turned red and right hand started twitching uncontrollably. On an unspecified date in May2021, the patient had periodic pins and needles with the numbness, difficulty sleeping, chest tightness periodically, but not consistently, chest pain, severe fatigue, ear ringing, general malaise, can't walk to the end of the block without coming back in pain, found it hard to concentrate and cloudy head. It was reported that the caller's son had the pain but it did not go across his chest like after the first dose Pfizer Covid 19 vaccination. The caller's son had numbness down his arms and legs and her son's legs were real heavy. The caller's son had to help life his legs to get his legs to move. The caller's son had vertigo really bad. The vertigo was so bad the caller's son had to lay down on the stretcher as the vaccination site. Even sitting up, the caller's son's world was spinning. The caller's son had to lay down. It was very hot, no fever, but radiating heat: The caller's son was very hot, no fever, but radiating heat. Part of that was the vaccination centre was not air conditioned and the caller's son was already a little uncomfortably warm when he went in. Dry ice packs were placed on the caller's son's head, went through three dry ice packs melting on the caller's son. The dry ice packs were on the caller's son's forehead and back of his neck and the injection site. The caller was trying to give her son coolness the best she could. He stayed about 30 minutes at the vaccination site and nothing improved or got worse. He was still very heavily dizzy or whatever and got in the wheelchair and got home. The caller's son did nothing for the rest of the day or weekend. The caller's son was just in so much pain and so much dizziness, it was just too much to do anything. The caller's son's symptoms gradually improved but very minute. The amount of dizziness the caller's son had was a little less so he could sit up at the computer, but even that the caller's son had to take breaks and couldn't do it for more than 30 minutes before laying back down. Had pain but it did not go across chest like after first dose vaccine: The caller's son's pain was a little less intense. The caller's son's numbness by Monday, 10May2021, had subsided for the most part. The caller's son is still having numbness down his arm, the opposite arm the caller's son received the second dose Pfizer COVID-19 Vaccine. The caller's son is also having numbness in his thighs sometimes, but not constantly. Clarifies the thighs or upper legs. The caller took her son to a Chiropractor and the Chiropractor gave her son a couple supplements to detoxify. That seemed to actually make things worse. The caller also took her son to the doctor's office. The caller took her son to a Chiropractor and the Chiropractor gave her son a couple supplements to detoxify: The caller states these were Charcoal and Magnesium combination and Turmeric root extract. Reporter made her son hydrate and use the generic Acetaminophen 500mg Caplets, along with a pain tea. The pain tea was loose herbs of valerian root, peppermint, and skull cap and pain tea seemed to help her son more for his pain, and mask some of the general malaise, and allowed her son to study for his AP Calculus exam. Patient's pain went from an 11-12 and was now at a 6 or 7. patient had a high tolerance for pain, and could cope with the pain, but the pain made it difficult for him to concentrate. Patient's migraine pain was unbearable at times and made it difficult for him. The generic Acetaminophen 500mg caplet with the pain tea helped to manage so his migraine pain was not so extreme. Therapeutic measures included Liposomal Resveratrol 38mg Curcumin from turmeric root extract 100mg, dietary supplement (Lot: 00728B or 007288). She has reported that she had been giving her tylenol for muscular pain and migraine. Other treatment included: alternating between Advil (Liqui-Gels) and Tylenol (generic acetaminophen 500mg caplets), Advil Liqui-Gels 200mg Ibuprofen (UPC Number: 0573176914, Lot Number: R77157, Expiration Date: Mar2022), Generic Acetaminophen 500mg Caplets, NDC Number: 21130-111-90, Lot Number: 1AV1505 and Expiration Date: Nov2022). Reported in the evenings her son would take Advil PM (200mg Ibuprofen with Diphenhydramine Citrate 38mg), NDC/UPC Number: Unknown, Lot Number: EG1024 and Expiration Date: Jun2023. Reporter said that Advil didn't seem to work on her son's migraine headache like the Advil usually does. Outcome of the events pain but it did not go across chest like after first dose vaccine, numbness down arms and legs and vertigo really bad, muscle pain, mind numbing migraine pain in the caller's son's head, periodic pins and needles with the numbness, right hand started twitching uncontrollably, chest tightness periodically, but not consistently, chest pain and ear ringing as recovering, outcome of the event body was hot all over, and his skin turned red was recovered, outcome of the event difficulty sleeping as not recovered and outcome of the events dizziness, severe fatigue, general malaise, can't walk to the end of the block without coming back in pain, found it hard to concentrate and cloudy head as unknown. Information on Lot/Batch number was available. Additional information has been requested.

The morning after my shot maybe 12 hours later I woke up with a 104.5° fever and my right armpit was the size of a tennis ball and hurt a lot. I was extremely tired I could not go to work. I did not eat all day but I did take a lukewarm shower and some Tylenol.. About 5 PM my fever broke and it still took another 24 hours for me to feel myself again. It has been five weeks and I still have a golf ball sized lump in my right armpit even after massaging it and exercising and sweating every day.

Pt was in usual state of health until 6/2/21 and experienced fevers, chills, sore throat, shortness of breath, chest pain, erythematous rash on trunk and limbs, arthralgia inthe ankle. Presented to ED on 6/4-febrile, tachycardic and mildly tachypneic. Pt is still currently admitted in Unit. left axillary adenopathy

Patient experienced fatigue and muscle aches immediately following the vaccination. His symptoms became progressively worse as time passed and by the next day he was experiencing chills, fever, tachycardia, shortness of breath, and excruciating chest and upper back pain. He described the pain in his chest as "stabbing" and also had a small and painful protrusion from his chest wall that was determined to be a lymph node.

5/4/21 Pt had first covid vaccine to right arm and aprox 5-6 hours later pt c/o sharp left upper back pain the proceeded to radiate to right arm and chest, causing some sob due to pain with breathing. Pain cont. throughout night. Seen in office 5/6/21 for symptoms that persisted, but improving. Denied swelling, n/v/d, palpitations. Pulse ox 97% on RA, RR 20, HR 88. No acute distress. EKG and CXR done, no abnormal findings. Advised motrin for pain, f/u if worsening of symptoms occur.

Myocarditis/Pericarditis. Prior to hospitalization for Myocarditis/Pericarditis the patient had severe headache, fever/chills, temperature ranging from 100.8 to 104 degrees, right side mid back pain, brief moments of random intense pain in other parts of the body, lack of appetite and excessive fatigue.

After receiving vaccine patient stated they did not feel well (complained of nausea/light headedness), before I could ask if the patient was okay the patients entire body stiffened, his eyes got very big/wide, and they started to roll back. At that point I stayed with the patient and called for my pharmacist. The patient lost consciousness, and by the time my pharmacist got there he was stable and coherent. Once my pharmacist assessed the situation she had me call 911 for paramedics. We had him lay on the floor with a pillow under his head, feet elevated. We provided ice water, nuts as a snack, and I dabbed sweat from his forehead while holding an ice pack to his forehead. I stayed with the patient and patients girlfriend until paramedics arrived for transport.

This is an 18-year-old male here complaining of pain in the left chest wall just inferior to the axilla. Patient states it started 3 days ago 1 day after the Covid vaccine of Pfizer was given in the ipsilateral arm. Patient states he feels swollen with some numbness and tingling in that area and also in the left forearm. Mild tenderness to the left chest wall that is improving. Instructed patient to use anti-inflammatories as needed.

Chest tightness, shortness of breath, tight jaw, tingling left foot, racing heart rate/arrhythmia, irritability, inability to sleep more than 1 hour a night, excessive thirst? still waiting on treatment

Pain around injection site; Severe fatigue; mild muscle/ joint pain; mild muscle/ joint pain; Mild nausea; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6995), via an unspecified route of administration in the right arm on 25Mar2021 at 08:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was 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. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications received within two weeks of vaccination included methylphenidate hydrochloride (RITALIN), Sertraline hydrochloride (ZOLOFT) and testosterone (MANUFACTURER UNKNOWN) for unknown indications from unknown date. On 25Mar2021 at 12:00, the patient experienced pain around injection site, severe fatigue, mild muscle/ joint pain and mild nausea. The patient did not receive any treatment for the 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 vaccination site pain, severe fatigue, muscle pain, joint pain and mild nausea was unknown. No follow-up attempts are possible. No further information is expected.

Rash near the site of the shot; Swollen neck; Swollen neck that led to pain when moving; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the right arm on 31Mar2021 at 13:30 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive other 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 tested for COVID-19. On 31Mar2021, the patient experienced rash near the site of the shot, swollen neck that led to pain when moving and swallowing, chills and fever for the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as the result of rash, swollen neck, neck pain, chills and fever. The clinical outcome of the events rash near the site of the shot, swollen neck, neck pain, chills and fever were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

18 year old male started experiencing lightheadedness, muscle stiffness, sweating profusely within 10 minutes of his first dose of Pfizer vaccine. Patient was made to lie down on the ground with ice applied to back of neck and forehead. His blood pressure reading was 77/64. Patient was coming in and out of consciousness for about 60 seconds then became alert and regained full consciousness. He also appeared to be experiencing an episode of muscle tightness (possibly a seizure) for a few seconds while he was unconscious. His mother who states that she is a nurse, was present with him as he experienced unconsciousness and prevented him from falling to the ground. She states he does not have a history of seizures or other conditions and has never had a reaction after an immunization. Paramedics arrived within 15 minutes, EKG and BP, blood glucose appeared normal. Patient was alert and able to stand unsupported prior to being taken to the hospital.

Received vaccination on Jan. 20th 2021. No symptoms till two days later on Jan 22nd 2021. Symptoms include achy muscles, redness, and quarter sized hives all over body. Main location of hives were located on L and R shoulders and back. Symptoms continued for three days then stopped completely. Redness and hives symptoms then reappeared on Feb 4th 2021. Continuing off and on till Feb 9th 2021.

Muscle soreness, achey feeling all over body, chills, migraine, and a lack of appetite paired with slight upset stomach.

Pt had a seizure at 9:10 that lasted about 10 seconds. Pt.'s upper body stiffened and he turned pale. After the seizure pt. reported hx of seizures after vaccines that was not reported to the vaccinator. Pt was observed for an additional 30 minutes and left the observation area.

Per patient he received his second Covid vaccine 3 days prior to arrival and immediately following developed myalgias, subjective fevers and " viral symptoms" which she managed with ibuprofen 2 tabs q6h some improvement. On the day prior to arrival he developed increasing shortness of breath particularly with talking and with ambulation. He also describes chest tightness with deep inspiration, the tightness radiates to back, no radiation to left arm or jaw. Chest tightness is non-positional, but does feel worse immediately after he lies down from ambulation and then slowly dissipates. His last subjective fever was yesterday evening. He has never had a reaction to the vaccine before. He has no allergies. No prior medical conditions he is aware of, and takes no medications. He did not experience any of the symptoms following the first vaccine. He has h/o asymptomatic COVID infection in November 2020. Cardiology consulted for concern of pericarditis post COVID-19 vaccine. He does not have significant ST elevation or PR depression. He also does not have evidence of significant pericardial effusion at this point. The high sensitivity troponins are mildly elevated. He does have viral syndrome. Is unclear if Covid vaccination was causally related to his symptoms. We would like to improve his medications for better chest pain control and to prevent recurrent pericarditis in the future.

19 year old male with cognitive delay presents with both parents for vaccination. Vaccination received in left deltoid and client had subsequent event with momentary loss of consciousness and muscular rigidity, followed by wakefulness and stated lack of discomfort or dizziness. Vital signs stable; HR 75, BP 117/75, Respirations even and unlabored. Client experienced nausea with emesis of approximately 30 cc after a sip of water. Client declined ER visit. Client monitored for an additional observation period and returned home.

Pain left axilla developed evening of vaccine given date, next day developed pain over left side chest with fluctuating heart rate. Per patient he went to ERD on 3/15 where he had a chest xray and ekg with normal results, advised to take pain meds and follow up with PCP. On 3/16/21 pt seen via call advised to take anti inflamatories and labs ordered. Follow up OV on 3/22/21 CT chest ordered, prescribed pain med and anti inflammatories. 3/29 follow up visit- symptoms unresolved, 4/5 sympt unresolved, 4/15 4wks post injection sympt continue order Ultra sound left extremity

Pruritic round lesions along left leg, left side of torso, and back. First happened the night of vaccination on 21 APR with a few round lesions on the left leg. The following morning the patient noticed more lesions on the left side of his back and torso. Patient seen here in clinic on 23 APR for concerns of these lesions.

Swollen Lymph node in arm pit. Minimal discomfort and soreness in armpit/lymph node. No pain. Swelling seemed to start around a week after 1st dose. Swelling has subsided in the past few days.

Patient had first dose of Pfizer vaccine for COVID 19. He had the COVID-19 infection 2 months prior. He was found to have fevers, chills, myalgias 12 hours following vaccine and then 24hrs after vaccine administration, developed chest pain and found to have a troponin elevation to 31 and EKG consistent with pericarditis. Found to have mildly reduced EF with mild global hypokinesis, suggesting viral myocarditis.

Sharp chest and back pain that gets worse with any movement and hurts to breathe. Hot flashes, nausea, fatigue, joint soreness, shortness of breath. All these symptoms started 2 days ago and have not subsided.

Heavy pressure in chest area, causing difficulty breathing. Also caused headaches that caused blurry vision, and muscle tightness in shoulders and back on side of injection.

Chills; aches in bones and muscles; aches in bones and muscles; fatigue; This is a spontaneous report from a contactable consumer (parent) reported for his/her son. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 09:00 AM (Lot number: EP6955) on the right arm as single dose for covid-19 immunization. Medical history included depressed left ventricular function due to COVID-19. Prior to vaccination, the patient had diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); metoprolol tartrate; probiotic; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); that patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 09:00 AM (lot number: EP6955) on the right arm as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, aches in bones and muscles, fatigue; that the symptoms started late evening 09Apr2021 at 23:00. Treatment of Tylenol received for the adverse event. The outcome of the events was recovered on 11Apr2021. No follow-up attempts are needed. No further information is expected.

Nausea, dizziness, light-headed, muscle ache, ear ache, stomach ache, exhaustion, fever, chills, sensitivity to light, headache, restlessness

I first experienced a headache ~20 minutes after vaccination (11:15 AM). It faded, and I felt generally unwell and tired throughout the afternoon. Around 10:30 PM, I experienced serious chills and generally felt like I had a fever. These symptoms worsened into the night, as did the fever (measured at 102 degrees F, possibly higher at the peak). I also experienced a headache, mild nausea, joint (knee) pain, although some symptoms may have been due to dehydration. Despite being very tired, I was unable to really fall asleep. At around 6 AM the fever finally dropped substantially, and as of 8:30 AM is currently only 99.4 degrees. I am still experiencing a bit of a headache as well, but the other symptoms are gone.

Felt like I had the flu, back pain, headache for over 12 hours Tylenol did cure. Muscle soreness all over as well.

Fever about 10 hours after vaccination, hot flashes, chills, headache, muscle pain mostly in arm. This continued through the next evening as well

Patient is a 19 y.o. male with a variety of minor past medical problems but without any significant PMH who presents with 24h of acute onset chest pains. He reports yesterday morning he was woken from sleep at 3-4 am with severe substernal chest pains that radiated to his arm and neck. This was worsened by laying flat and better if he waked around/pacing. He took ibuprofen and it got better so he went back to sleep. The pain returned about 6 hours later and was getting more severe so he went to see his doctor. There an EKG was abnormal so he was referred to the ED where a work up showed ST elevations c/w pericarditis and an elevated trop I of 24. The night prior, he reported a low grade temperature. He has not had any more fevers for the past 12-18 hours. He denies any other symptoms such as palpitations, shortness of breath, cough syncope. He denies sick contacts but did have a sore throat 4-5 days ago without any other associated symptoms. He has had recent negative COVID tests while at college. Of note he did receive the 2nd dose of Pfizer on 5/15 about 24-36 hours before onset of symptoms. Of note, he does boxing at school and has been participating in work outs until about a week ago. ED course: EKG w/ diffuse ST segment elevation in V3-V6, I, II, II, AVF. Troponin I 24. Creatnine 1.2 with baseline of 0.5 but BUN WNL (11). CBC WNL, CRP mildly elevated to 3.1, Transferred to another ED. Second ED Course: BP 120/64 | Pulse 83 | Temp 36.7 °C (98.1 °F) (Temporal) | Resp 18 | Wt 76.3 kg | SpO2 97% exam non-focal, COVID ab notable for +spike neg nuclear capsid consistent with vax but no infection, D-Dimer, procal, ESR, ferritin, Coags all WNL, Trop T elevated to 1.46,, ECG with consistent diffuse ST seg elevations, seen by ped cards who did echo in ED and notable for EF ~50%, admitted to PCICU for further management and treatment Admitted to the PCICU in stable condition. Placed on telemetry monitoring for the duration of the admission. Started on IV steroids and given IVIG on hospital day 1. Continued on toradol which was switched to motrin on hospital day 2. Cardiac MRI did not show signs of fibrosis. Troponin downtrended throughout his stay. At the time of DC echo showed normal function, ekg showed T wave inverions, and troponin was down trending to 0.57. Pt to be restricted from physical activity until cleared by cardiology. Infectious workup also sent, most of which was pending at time of discharge.

19 y/o male with no past medical history who presents with dizziness post vaccination. Patient states that this is his first vaccination in a two-dose series. Patient denies previous reactions to vaccinations in the past. Patient denies headache, vision changes, sore throat, difficulty breathing, shortness of breath, itch or rash. NP and Paramedics at patient side. Patient states that he has not had anything to eat since 1 am and drank only a small amount of water. Patient provided with water and a protein bar. Glucose was obtained and measured 225. Patient denies increase thirst, hunger but states that he has lost some weight recently (patient pushes carts at the supermarket sometimes in the sun). Mother states that patient went for a physical today and pending blood work. Patient vitals within normal limits, 133/89 BP, 98% RA, 77 HR, Resp 12. Patient physician office called and notified of elevated glucose here at the vaccination site. The RN states that patient will be seen tomorrow am to obtain further labs. Prior to discharge patient glucose rechecked x2 and measured 99 and 98. NP still instructed patient to keep tomorrows appointment for labs. Patient was monitored for 30 mins with resolution of dizziness. Patient discharged home in stable condition.

cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; shaking; muscle pain; This is a spontaneous report from a non-contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)(Batch/ Lot Number: Unknown), 2nd dose, via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included BNT162B2 (Lot/batch no: Unknown), 1st dose, via an unspecified route of administration on an unknown date for COVID-19 immunization. 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 4 weeks prior to vaccination. On an unknown date in Mar2021, the patient experienced shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity. The patient did not received any therapeutic measures for the adverse events. The clinical outcome of the events shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity were recovering at the time of reporting. No follow up attempts are possible, information about batch number cannot be obtained. No further information is expected.

Started with small headaches, then I got a fever, chills, muscle aches, and severe headache. Over the counter medication made most of it go away, but I still had a light headache.

Constant headache from Monday to Wednesday night, with fever, chills, body aches, and a large rash that broke out on the left side of my neck and shoulder. This rash tensed my neck muscles and had a sunburn like sensation on the skin. Medications were taken throughout, like excedrin migraine, ibuprofen, and benedryl.

Received 2nd dose of Pfizer-BioNTech Covid19 vaccine on 5/9/2021. The following day developed substernal chest pain radiating to neck and left shoulder and arm. Also reports fever of 101 degrees on 5/10/2021. Used Tylenol, initially with some reloief, but symptoms worsened over the course of the next few days. Then presented to ER on 5/13/21 because of worsening pain. EKG showed diffuse ST elevations c/w pericarditis. Initial Troponin 11.1, ultimately peaking at 13.67, c/w myopericarditis. Admitted to hospital for supportive care, and treated with PO colchicine. A transthoracic echocardiogram revealed normal LV function without segmental wall motion abnormality and no pericardial effusion. A Cardiac CT showed normal coronary arteries. The patient's symptoms improved with colchicine. He was discharged home with a course of colchicine on 5/15/21. A subsequent outpatient Cardiac MRI did show epicardial and mid wall late gadolinium enhancement involving the basal to mid lateral and inferolateral walls, and a mid wall stripe of distal anteroseptal, septal and inferoseptal segments, c/w myocarditis, idiopathic cardiomyopathy or sarcoidosis. The pericardium was borderline thickened at 3 mm.

The following morning after I got my second COVID shot, I experienced extreme nausea, sweating, high-fever, weakness in my legs, lack on night vision (everything was unusually dark), light headedness, trouble hearing, extreme ringing in both of my ears, and trouble balancing. I felt like I was blacking out. I was treated by laying back in bed and I felt much better after about 20 minutes. 4 days later on May 26th at about 3:00 am, I experienced severe diarrhea (15-20) bouts for an entire day, I vomited 3 times by 9:00 am, severe dehydration, sweating, nausea, and stomach cramps. I was treated with 2 full bags of Iv's and nausea medication.

My son developed severe fatigue, muscle aches, fainting, headache, tachycardia for 1 week (up to 164 in the ED), fever, feelings of chest heaviness.

The patient was given the vaccination and told to wait 15 minutes in the recovery area to observe for signs of adverse reactions. The patient had syncope about 2 minutes after sitting and fell from a seated position on his chair to the ground. He had a brief seizure (unresponsive, tense muscles, open eyes) for about 2-5 seconds. He then became responsive and was able to respond to prompts and questions. He was given water. an ice pack (for injured spot on forehead), and told to wait for 30 minutes for further observation. He arranged to have a friend pick him up to take him home from the pharmacy and was told that he could not drive himself home after this adverse reaction. The patient stated that he otherwise felt normal afterwards (aside from some ache from the forehead after falling).

wrist and ankle pain; heel pain; bump re appeared however only on ankle and heel; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 28Apr2021 (at the age of 19-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history was reported as none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 01Apr2021 at 11:15 (at the age of 19-years-old) at 1st dose, single dose for COVID-19 immunization. On 06-08Apr2021 after the first dose, he experienced low grade fever, chills, and body ache. On 14Apr2021, he began to complain about chest pain. He went to a hospital in which he was told he has environmental pneumonia on right lung and was given antibiotics. On 17Apr2021, he went to the emergency room due fever at 104.3 and chills which were high, and he had difficulty breathing. He was admitted to a hospital and was eventually transferred. He was given antibiotics (ZITHROMAX) and IV fluids. The patient was discharged on 21Apr2021. Later that night, they noticed bumps that hurt in front of his legs. He went to the doctor and they indicated he had erythema nodosum and was prescribed prednisone 2 a day for 5 days. He took an X-ray that showed he had hilar lymphadenopathy on Apr2021, and they will go and see a pulmonary specialist. The patient was told it was ok to take the second dose of the Pfizer vaccine. He received the second dose on 28Apr2021 and on 01May2021, bump re-appeared however, it was only on his ankle and heel. On 15May2021, new symptoms he experienced were wrist, ankle, and heel pain. He was waiting to see a specialist. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient underwent lab tests and procedures which included nasal swab for COVID-19: negative on 12Apr2021, 15Apr2021, and 17Apr2021; body temperature: 104.3 on 17Apr2021; and X-ray: hilar lymphadenopathy on Apr2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient presented for his first dose of Pfizer Covid vaccine. Immediately after administering shot, patient lost consciousness, fell to the floor, and hit his head. Loss of consciousness lasted approximately 3-5 seconds. Upon waking, patient was alert and oriented x4. Vitals upon waking: BP 75/35, P: 62, O2 Sat: 90%. Water was administered orally. Patient c/o neckache 6/10 and headache immediately upon waking. Vitals continued to be monitored frequently and BP continued to be 80's/40's. Blood sugar 76. EMS called and arrived. Patient's blood pressure increased to 130/80 for approximately 10 minutes and then dropped again to 78/45. Patient taken to local hospital for further evaluation accompanied by parents.

armpit on the side he got the vaccine is swollen and sore; armpit on the side he got the vaccine is swollen and sore; This is a spontaneous report from a contactable consumer (patient's mother). A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (Batch/Lot Number: EW0187) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Family medical history relevant to AE(s) was reported as none. There were no concomitant medications. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Patient's mother reported that on 10Jun2021 her son's armpit on the side he got the vaccine was swollen and sore. She asked if this was normal. The caller stated her son got the vaccine on Wednesday and asked how long he should wait to go see the doctor about this symptom? The event armpit swollen and sore was reported as worsened. The seriousness of the events was assessed as non-serious. The patient did not undergo any relevant tests. Caller stated he (patient) has not gone to the doctor and has been putting it off and wants to know if she should go. The outcome of the events was not recovered. Additional information has been requested

Pt developed pericardial tamponade after 2nd dose. Pt reports intermittent symptoms that started about 2 weeks after 2nd dose. He was hospitalized about 6 weeks after and initially thought he had a pulled muscle.

Vaccine #1 5/27/21. Vaccine #2 6/17/21. On 6/19/21, he was working at a climbing wall and his shoulders were sore. He rubbed them and noticed 2 small lumps in the supraclavicular area. He presented today for evaluation. A quick pubmed search revealed case reports of same (but not many) . I wanted to report this. https://pubmed.ncbi.nlm.nih.gov/33685772/ Supraclavicular lymphadenopathy is rare in children and young adults.

Severe pain in left shoulder within an hour of recieving vaccine, and weakness in left arm, for 6 days has become progressively worse.

day 0: deltoid soreness day 1: tactile fever and general malaise day 2: pressure like chest pain, non radiating, 2/10 in AM and 8-9/10 PM. fevers resolved. acetaminophen did not improved symptoms day 3: chest pain continued day 4: chest pain continued (ER visit)

FLARE UP OF ULCERITIS COLITIS AFTER 7 MONTHS FREE. BLEEDING IN STOOL, PAIN ON LEFT SIDE OF ABDOMEN, HEART PALPITATIONS, INTENSE TINGLING IN LEGS ESPECIALLY IN LEFT LEG, INTENSE PAIN THROUGHOUT ENTIRE BODY, BACK PAINS, DIZZINESS, LOSS OF FOCUS, FATIQUE, NAUSEAU, SENSITIVITY TO LIGHT AND SOUNDS, DIFFICULTY BREATHING WHEN INTENSE FLARE UP OF NERVE SYSTEM, LOSS OF BALANCE, TREMOURS THROUGHT BODY DURING FLARE UPS. INABILITY TO CONTROL MUSCLES, MUSCLE TWICHES/SPAMS, INTERMITTENT HEADACHES, SWEATY PALMS WITH INTENSE PAINS, "CHARLIE HORSE" CRAMPS IN MUSCLES AFTER MUSCLE SPASMS, WEIGHT LOSS. BEGAN FEELING EFFECTS APPROXIMATELY 26-27TH JUNE 2021, ADMITTED 7/9 & IS CURRENTLY AT HOSPITAL AS AT 7/17/2021.

General weakness, intermittent numbness (especially bil hands), muscle twitching, dizziness, headaches( general), diarrhea, back pain.

Fever that went up to 103.5; Severe headache; Couldn't sleep through the nights.; Tons of sweating.; Muscle pains; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955), via an unspecified route of administration in the left arm on an unknown date (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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, the patient experienced fever that went up to 103.5, severe headaches, couldn't sleep through the nights with tons of sweating, muscle pains and a sore throat. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Medicine was taken as a therapeutic measure for the reported events. On an unknown date, the patient underwent nasal swab and the result was negative. On an unknown date, the patient underwent lab test which included body temperature and the result was 103.5 (units unspecified). The clinical outcome of the events fever that went up to 103.5, severe headaches, couldn't sleep through the nights with tons of sweating, muscle pains and a sore throat were resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered to the writer at 0800 on 1/5/2021. No immediate reactions were noticed for the 30 minutes observation period immediately after. The writer's muscle that received the vaccine began to become increasingly sore throughout the day; however, that was similar to the first dose of the same vaccine a few weeks prior. The pain was described as constant (2/10) but aggravated with motion. The pain did interfere with the writer's normal range of motion (specifically raising the writer's arm above shoulder height). From 0800-2200 on 1/5/2021 no noticeable symptoms except for the injection site pain occurred. At 2200, the writer rapidly developed chills, body aches, a headache, fatigue, and a fever of 100.8. These symptoms were left untreated and continued through the night (the symptoms did not interfere with sleep). The writer woke up at 1300 on 1/6/2021; all previous symptoms had resolved by this time except for the injection site pain. By 1400 on 1/6/2021, the writer noticed pain near the right axillary lymph nodes. The pain can be described as moderate (1/10) and generally occurred only with motion. The writer was unable to palpate any swelling in the area. Around 1800 on 1/6/2021, the writer noticed it felt weird to swallow. Specifically, it felt as if there was a slight internal swelling 1-inch subhyoidally and 1-2 inches laterally within the right side of his neck when he swallowed. The swelling was not palpable from the skin's surface. The writer did not seek medical attention as breathing/eating/drinking were not made more difficult but monitored this closely. The swelling in the neck resolved by 2000 on 1/6/2021. The lymph node pain in the right arm resolved over the course of a few days and was no longer present by 1/9/2021 at 1300.

Developed fever within 12 hours. Severe head ache and muscle aches within a couple hours. Mild cough in 10 hours.

Following second vaccine, about 12 hours after vaccine. Sever levels of fatigue, nerve pain, joint and muscle throbbing, convulsions, fever of 102.4

I had all of the common side effects of getting vaccinated, headache, muscle pain, drowsiness etc. Then around 12hrs later I started having a light allergic reaction. I got hives on the right arm (injection arm) and itchiness around my whole body (top of head, arms, legs) I took a Benadryl and put some Benadryl anti itch cream on the hives and all symptoms stopped.

Muscular pain on left arm and ribs muscles while having a deep breath. Very light fever. Took1g of paracetamol every day to help. (Doliprane) Fatigue. Left arm pain started 3/4 hours after injection the rest came the morning after.

Patient stood up and went to seated waiting area while I finished filling out his COVID Record Vaccine Card. I walked over to him within 60-120 seconds after the vaccine administration and found him to be in a stiff full body extended position while sitting on a chair. I asked him if he was ok. He did not respond. Called over the nurse and we were about to bring him down to the ground after suspecting a seizure. Patient "came to" after about 90 seconds of no movement. Patient became alert and orientated. When asked about prior seizure history, patient stated they had a traumatic injury to their back within the last month which resulted with spontaneous seizures throughout the past 2 weeks. Patient was asked to follow-up with primary care provider or seek urgent care/emergency care if it happens again. Patient observed for 30+ minutes until his girlfriend came to pick him up.

Patient called into Services on April 6 to report a suspected "allergic reaction related to his Covid19 Vaccine received March 30. He said that beginning 24-48 hours after his vaccine he began to experience "a sore throat, swollen lips, conjunctivis in both eyes, pain and muscle aches, and hives/boils all over his body. He asked if he should go to an urgent care center. His mother had suggested an urgent care. He wanted us to complete the form and was going to the Urgent Care. Couldn't find his vaccine card, so called him with Lot # and expiration of dose. Advised to call us back after being seen to update his condition.

No symptoms from first dose. Immediately after second dose, injected arm felt numb/tingly. When seated at observation area, began to feel nauseous, dizzy, and began sweating. Rose to ask site staff for help, felt very uneven. Taken to back observation room and laid down on a cot. Blood pressure observed at 85/30, significantly lower than normal. Rested for approximately 15 minutes, then sat up. Nausea and blurry vision returned. No change in blood pressure. Blood was drawn, sugar and other indicators normal. Sat up again, feelings returned. Drank two water bottles and began to feel better, blood pressure returned to low end of normal after around 15 minutes. General weakness persisted throughout day, along with mild pain at injection site and in neck.

Extreme sweating and discomfort, muscle pain. Nausea and headache day after vaccination. Arm sore during day of vaccination, adverse effects worsened overnight causing loss of sleep

Patient experienced vaso-vagal response immediately following injection. Eyes rolled back and he slumped over in chair. Made snorting sounds. Some tremors. Sweating. Legs elevated. Chair reclined. Aroused after about 45-60 seconds. Alert and appropriate responses to questions. Acknowledged that he had not had anything to eat recently, nor had he had fluids. Ice chips offered. Assisted to wheelchair and transported to Obs for VS. Ice water and coke offered.

Patient received his second dose of Pfizer COVID Vaccine on 13 Apr 2021 at about 9:30 AM. That afternoon, he began to experience chills, body aches and back pain. Later that night, unable to sleep, he began to experience visual hallucinations, to include a demon to his immediate left, a candle in his far left periphery, shackles, the room going dark and feeling like he was stuck in a time loop. In addition he experienced auditory hallucinations, to include a demon yelling and people whispering. He took ibuprofen that afternoon for his chills. No known psychiatric history or drug use. He denied suicidal ideation. Has a history of back pain for which he has been seeing physical therapy for several months. Enjoys his job with no identifiable unique stressors. Work up in the Emergency Department included CBC, electrolytes, Urine drug screen, ETOH, procalcitonin and urinalysis. All were normal, with the exception of an elevated neutrophil count and low lymphocyte count. Head CT was normal as well.

Tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swollen throat, dizziness and weakness.

I felt muscle aches and pains about 6-8 hours after I received the vaccine. I had COVID-19 in late January 2021, and these symptoms from the vaccine felt about the same as the COVID symptoms I had, they just didn't last as long. However, around 36 hours after I received my vaccine, my armpit area started to become sore. It has felt swollen and sore for the past 36-48 hours. I also developed a fever of around 100.5 degrees Fahrenheit today, so around 72 hours after I received the vaccine. I have also been fatigued for the past 3 days.

It feels like I have the flu. I have a fever of 100.3. I have a headache, nausea, chills, and every joint and muscle in my body hurts to articulate. This started at around midnight in my bed while I was asleep the same day I got my shot. I'm autistic, and I?m in a therapy program with other autistic 20 year olds and those who also got the shot were likewise experiencing the same symptoms as me. I have yet to recover.

Bedridden all day, severe joint pains especially in right knee. Sustained efforts of walking led to almost passing out. Was difficult to breathe effectively and found myself breathing in an abnormal pattern

High fever, chills, splitting headache, muscle aches, tiredness, cold sweat, congestion. Treatment: Lots of water, rest, and Tylenol

04/29/2021 5:30pm - chills, pins & needles, soreness 8:00pm - 100.8 degree fever, chills, soreness, joint pain; two 200mg ibuprofen tablets take & cold wet towel placed on forehead 9:30pm - 101.2 degree fever, chills, soreness, joint pain 11pm - trouble sleeping, confusion, chills, soreness 04/30/2021 1:00am - fever, chills, soreness; two 200mg ibuprofen tablets take & cold wet towel placed on forehead 7:00am- 98.0 degree temperature, soreness, slight joint pain; one 200mg ibuprofen tablet taken 11:30am~5:00pm - slight occasional chest pain (around sternum) 7:00pm - soreness in arm only, headache

Initial presentation Patient was in his usual state of good health until 4/19 when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. He awoke the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. The next day he began to experience gross hematuria and presented to the ED with a temperature of 98.9, blood pressure of 100/69mmHg, heart rate of 110bpm, respiratory rate of 18 breaths per minute and an O2 saturation of 97% on room air. On examination, patient was ill-appearing with diffuse pustules on his face, chest and back, periorbital edema, and leukoplakia of the tongue and buccal mucosa. His abdomen was soft and tender to palpation in the suprapubic area and at both costovertebral angles. Hospital course In the ED the patient was found to have a metabolic acidosis of pH 7.33 with an anion gap of 16, lactate 2.6, neutrophilic leukocytosis (22k), acute renal insufficiency with a BUN of 45 and creatinine 3.81 (baseline is 0.76). The patient?s urine demonstrated packed RBCs and 5-10 WBCs. He was admitted to the medicine service for further management. On the medicine floor he was initially found to have rhabdomyolysis (CK 584), worsening renal failure (Creatinine 8), follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. CT A/P without contrast showed increased attenuation of renal pelves and ureters consistent with hemorrhage, but no renal stones or hydronephrosis was seen. The patient was treated with pulse dose 500mg IV Methylprednisilone for 3 days and then transitioned to 60mg Prednisone. The patient?s pustular rash and oral leukoplakia greatly improved while on pulse dose steroids, but his kidney function continued to decline (Creatinine rising from 8 to 11), and the patient?s bilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. Bilateral hearing loss prompted an MRI of the brain which identified several punctate infarcts across multiple vascular territories in bilateral cortices and left cerebellum. The patient?s kidney function has continued to decline, with progressive hyperkalemia and hemodialysis was begun.

At 6 minutes post vaccine, while in the observation area, patient had a vasovagal episode. He fell to the ground from the observation chair and immediately came to. Patient has small abrasion under right eye, some right shoulder pain. Prior to vaccination, patient disclosed fear of needles. Patient arrived around 2:30p initially, vaccinator prepared him to be vaccinated laying down on cot. Patient was nervous and decided to reschedule. Patient returned at 4pm and decided to receive vaccine. Patient did not want to be vaccinated laying down. Patient refused EMS and refused to be evaluated by physician in Emergency Department and stated he would follow up with his physician. Patient observed for extended period and released.

weakness under his shoulder; pain under his shoulder; Parson Turner Syndrome (neuritis); Parson Turner Syndrome (neuritis); experience arm pain; difficulty moving his arm; This is a spontaneous report received from a contactable physician. The physician reported similar events for two patients, this is the first of two reports. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at 20 years old on 17Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Caller reported that he had a patient who received his Pfizer vaccine, second dose last Saturday (17Apr2021). He reported that on Monday (19Apr2021) he continued to experience arm pain followed by difficulty moving his arm. Now he was requiring a sling, had been prescribed Toradol and Steroids but was not doing any better. He was having continued weakness and pain under his shoulder. Caller was asking for documentation or studies that have been done to determine if the vaccine has any relationship with Parson Turner Syndrome (neuritis) and recommendations for management. He asked to speak with a Pfizer Neurologist. Caller reported that the patient was being seen by an orthopedist, MD. Caller was requesting urgent escalation of his inquiry for further investigation into a relationship between the covid vaccine and Parson Turner Syndrome (neuritis). The outcome of the events was unknown. No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441207 Same reporter/drug/AE, different patient

worsening renal failure/kidney function continued to decline; gross hematuria; follicular conjunctivitis; a low CD3/CD4 count (CD4 91, CD347, CD8 258); a low CD3/CD4 count (CD4 91, CD347, CD8 258); The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; pustular rash on his chin forehead, chest and back; nauseous; diffuse myalgia; vomited; suprapubic pain; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old male patient first dose of received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 19Apr2021, at the age of 20-years old, (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. It was reported that the patient was in his usual state of good health until 19Apr2021, when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. On 20Apr2021, he woke up the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. On21Apr2021, he began to experience gross hematuria and presented to the Emergency department. On the medicine floor he was initially found to have worsening renal failure, follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. His kidney function continued to decline and hemodialysis was begun on 27Apr2021. His kidney function continued to decline on hemodialysis, becoming so he was transferred to the MICU for CRRT. The patient was hospitalized for 12 days due to the events, the events were also assessed as life-threathening. The patient been tested for COVID-19 post vaccination with unknown result. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events. Information on Lot/Batch number was available. Additional information has been requested.

Patient during his observation period @1010 reported symptoms of HA, lightheaded, joint pain, and shortness of breath following Pfizer vaccine administration. Patient was provided 25mg Benadryl @1018 and legs elevated for possible allergic and syncopal symptoms respectively. After no immediate clinical improvement, patient was transferred to ED via EMS . Patient did not require any interventions in ED and was diagnosed with Anxious reaction to vaccine. Patient released to home.

Day of dose 2: fatigue Day after: fever, chill, headache starting around 12:00 and lasting around 12 hours. 2 days after: soreness in and around right armpit. Upon palpation I found a lump in my right armpit.

20 YO patient with no significant PMH who presents with headache, back pain, and chest pain. He received 2nd Pfizer COVID19 vaccine dose 5/8/21. Later that day he felt very tired. On 5/9/21, he developed a headache that worsened throughout the day, was felt over whole head, but more painful in temporal areas, and he became nauseous. On 5/11/21, he developed back and chest pain and had 2 episodes of NBNB emesis. The chest pain is sharp, located over the whole chest and extends to axillae. The back pain is worse in the right shoulder. The back and chest pain are worse with inspiration, movement, and supination. CMR confirmed myopericarditis. Patient treated with colchicine and NSAIDs and IVF, has cardiology f/u on

After the vaccination, there was no chair in pharmacy so that he could sit and wait the 15 minutes inside the place, so we had to go to the car to wait the 15 minutes, that was when the person began to feel very cold and lost consciousness for about 2 minutes. His head fell and also his upper limbs stiffened with twisted hands as if it were a convulsion, as if it were a tonic phase. His skin turned white and he didn't react. I put alcohol gel all over his face and body, then he began to react, little by little his body color returned but he does not remember anything that happened in those minutes.

Sore vaccine site first 2 days, had sore joints next day, woke up the third morning and vomited every 20-30mins. Was too dizzy to walk or move , lost sense of taste and smell, headache, cough, tiredness, high fever of 104, and chills. Had redness and pain at injection site the whole time and other symptoms lasted 3 days.

Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: CHEST CRAMP, JOINT PAIN IN RIGHT ARM, PAIN ON RIGHT SIDE OF BODY, SYMPTOMS LAST 1 DAY

Migraine headache, nausea, vomiting, diarrhea, muscle aches, fever of over 101 but under 102 - all happened the day after the 2nd dose. He felt a little better for a few days but still struggled with nausea, some vomiting and diarrhea (and weight loss). It's been a month and at this point the nausea is limited to the morning.

Please see housestaff note for full details. In brief, 20-year-old neurologically normal man with history of asthma now presenting with new onset fever, headache and then status epilepticus. On 5/25 the patient received his second dose of COVID vaccine and then started to have intermittent fevers up to 102.5. This was associated with malaise, nausea, fever, headache, myalgias. He came to ED on 5/30 and had IVF, analgesics and a cardiac workup that was unremarkable and was discharged with diagnosis of possible pericarditis/myocarditis. He then had ongoing worsening headaches and increasing fevers and was unable to get out of his bed, and so his wife called 911 and he came to ED on 6/3. There he had vomiting and transaminitis and was diagnosed with gastroenteritis treated with flagyl. Headaches progressed and were associated with dizziness; he had HCT read as unremarkable but then while awaiting MRI had convulsion. He was returned to his room and had two more and thus was intubated, placed on propofol/versed, Keppra, dilantin, and broad-spectrum antibiotics and acyclovir before transfer to UCSF. on 6/5/2021 found to have reduced urine output, and serum creatinine found to be 1.72 and climbed >7 in days later normalized spontaneously with fluid support to 4.26 with continued improvement. LFTs were also found to be elevated. Was acutely encephalopathic. Seizures resolved on Keppra treatment though had acute agitation for several days. Slowly returning to neurologic baseline. with AKI and LFTs slowly normalizing.

The patient became very weak, unable to follow commands and was alert and oriented x1. Within 1 minute of the event the patient became very stiff, his eyes started to roll in the back of his head and he was unresponsive. Pt was placed in a wheelchair, full set of vitals obtained,sternum rub performed, cold compress applied to the forehead, and the nurse begin to ask a series of questions to try and keep the patient conscious. Patient begin to respond, no food or drinks given, EMS arrived and took control of the scene.

Around 8-10 hours after my second shot, I started to get joint pain in the arm I got the shot. It worsened over time as I was working the night shift and using the arm. Nearing midnight that same day, I started feeling feverish, and when I got home at 1:15am I got some water and tried to sleep, but it's 6 hours later and I haven't been able to sleep at all.

Headache; Soreness at vaccine site; Fever; Myalgias; Mouth ulcers; This is a spontaneous report received from a contactable consumer, the patient. A 20-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on18Mar2021, at 08:30 AM as a single dose for COVID-19 immunisation. Medical history included ADD and genetic inflammatory fever syndrome. It was reported that no allergies to medications, food or other products. Concomitant medications included FOCALIN and LEXAPRO. It was reported that, 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. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:00 the patient experienced mouth ulcers, headache, myalgia, fever and soreness at vaccination site. Therapeutic measures were taken as a result of mouth ulcers, headache, myalgia, fever and soreness at vaccination with mortin (MANUFACTURER UNKNOWN). The clinical outcome of the events mouth ulcers, headache, myalgia, fever and soreness at vaccination site was resolving. Information about lot/batch number cannot be obtained. No further information is expected.

Pt is a 20 year old male with history of myoclonic epilepsy presenting with chest pain. Per Dad and patient received his 2nd Pfizer covid vaccine on Friday 6/25. On Saturday, he had fever, fatigue, myalgias and chills which resolved within the day. On Sunday he awoke with chest pain. He reports that chest pain is diffusely through chest, and is not associated with nausea, shortness of breath, dizziness, LOC.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Tachycardia-Mild, Additional Details: pt mom called 4 days post vaccination. i recommended going to urgent care or er. she said chest and armpit swollen with pain and pt thought heart was beating faster than normal.

Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Muscle ache; Joint pain; Extreme cold like fever; Extreme cold like fever; This is a spontaneous report from a contactable consumer reporting for himself. A 20-years-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 22Jun2021 as single dose (at age of 20-years old) for covid-19 immunization which was administered outside of the range 19 - 42 days after the first dose. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after getting the second dose on 22Jun2021 (yesterday), he experienced a side effect like muscle ache, joint pain and extreme cold like fever on unspecified date in Jun2021. Consumer added, he was just trying to figure out symptoms were that he was experiencing if he needed to go to the ER or not. The outcome of all events was unknown. Information regarding the lot/batch number has been requested.

Left sided chest pressure (concern of myocarditis); Left sided chest pressure (concern of myocarditis); Left sided chest pressures, like a chest pain on the left side; Shortness of breath; Chills; Wasn't feeling good with joint pain; Wasn't feeling good with joint pain/Wasn't feeling good after he received the vaccine; Not feeling well; Whole time from the time he got the dose till now he is been not feeling good; Fatigued/Still feeling fatigued; A lot of congestion; Sick; Muscle injection site was painful, arm was sore; Arm pain, the site of injection was really painful; Muscle injection site was painful, arm was sore; Arm pain, the site of injection was really painful; He didn't looked good at all, he just looked white; Ear infection; This is a spontaneous report from a contactable other healthcare professional . A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left (at the age of 20-years-old) on 02Jun2021 as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and ongoing. Concomitant medication(s) included salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported. Nurse stated, Initially when he has a dose of the first dose like two three days after he was experiencing, he also had a muscle that was given, he had a muscle injection site was painful, that arm was sore that was given, but he also started experiencing shortness of breath and same left sided chest pressure and I called his pediatrician and that's why we are just watching him because it wasnt to the point where he was full blown shortness of breath, full blown chest pressure stayed last for a couple of days then getting it worst. But he had the chills, he had fatigue is still there and it started to subside and then couple days after since it subside, fatigue never left but then he started to get chills again and fatigue was even more pronounce and then started more congestion and then he has ear infection, which we took him to doctor 2 days ago and he has started antibiotics. So the whole time from the time he got the dose till now he is been not feeling good, so now with the antibiotics he is feeling a little better and on 04Jun or 05Jun, like Friday to Saturday he was expecting little shortness of breath and then he was having a little bit of left side chest pressure, he had the arm pain initially and the site of injection was really painful and then the fatigue probably started the same time Friday Saturday he just, he didn't looked good at all, he just looked white. The patient experienced left sided chest pressure (concern of myocarditis), like a chest pain on the left side, shortness of breath, chills on an wasn't feeling good with joint pain wasn't feeling good with joint pain/wasn't feeling good after he received the vaccine; not feeling well; whole time from the time he got the dose till now he is been not feeling good, fatigued/still feeling fatigued on an unspecified date, ear infection on 19Jun2021 and a lot of congestion, muscle injection site was painful, arm was sore; arm pain, the site of injection was really, muscle injection site was painful, arm was sore; arm pain, the site of injection was really painful, he didn't looked good at all, he just looked white on an unspecified date. The patient was treated with antibiotics for ear infection. The patient underwent lab tests and procedures which included sars-cov-2 test result: negative. Caller stated His sons next dose (of Pfizer COVID vaccine) is due Wednesday. But until now he has not been feeling good. I don't want to give him the vaccine when he's sick. Does that make a difference with the effectiveness if I delay the second dose and she heard people had worse side effects for the first few days with fevers, body aches, nausea, fever and subsided and then they take their 2nd dose and are better after the 2nd dose, also stated her sons symptoms were not acute, but is not sure if it is coincidental if his ear infection was due to the vaccine. The outcome of the events were reported as unknown.; 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 event myocarditis 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.

Intense neck pain; Upper back pain; soreness in the arm where I received the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had not received any concomitant medications within 2 weeks of vaccine. The patient had no known allergies to medications, food, or other products. The patient had 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. On 29Mar2021 at 08:30, the patient woke up with intense neck and upper back pain, in addition to soreness in the arm where he received the vaccine in the next morning. That was still ongoing. 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. Therapeutic measures and treatments were not taken as the result of adverse events. The clinical outcome of neck pain, upper back pain and vaccination site pain was not resolved. No follow-up attempts are needed. No further information is expected.

Symptoms started during bedtime and woke me up. Began with severe full body chills and full body muscle shaking and weakness during the night of 1/5 and early morning of 1/6, around 1000 to 0200. Slight headache began during that time as well. Upon waking at 0900 on 1/6, chills and shaking decreased to mild severity, muscles still felt moderately weak and shaky, headache had increased in severity to a severe throbbing pain that worsened upon standing and walking, and moderate visual photosensitivity began. The headache persisted until I took 2 tablets of ibuprofen 200 mg, which is when the severity decreased to moderate after a few hours and then mild by bedtime. The photosensitivity persisted through the day and did not decrease much by bedtime. Upon waking 1/7, there was only a mild headache and mild photosensitivity that faded completely within a few hours, no medication required. No more symptoms in the afternoon.

headache; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (right deltoid) on 05Jan2021 at 13:00 at a single dose, for COVID-19 prophylaxis. Patient has no relevant medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left deltoid) on 15Dec2020, at 13:00 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient received the second dose of his COVID-19 vaccine yesterday on 05Jan2021. He said that he had no side effects with the first dose except for injection site pain. He received the first dose on 15Dec2020. After receiving the second dose, he has a headache, chills, and muscle aches. He had more symptoms than he had with the first dose. His symptoms started last night and continued this morning. Headache started around 02:00 06Jan2021 while chills started around 22:00 on 05Jan2021. He stated that the chills resolved sometime in the early morning 06Jan2021. Muscle aches started around 22:00 05Jan2021. Patient reported that both of his COVID-19 vaccines had the same lot number. The patient did not require emergency room visit. Patient received ibuprofen, naproxen, and acetaminophen for his headache and muscle aches. Outcome of the event chills was recovered on 06Jan2021, while for other events was not recovered.

Fatigue - Presented 12 hours after and persistent for 2 days. Diarrhea- Presented 12 hours after and resolved after 24 hours. Severe muscle aches- Presented 4 hours after and persisted for 2 days. Numbness in face- Presented 12 hours after and resolved 32 hours after. Numbness in injection arm- Presented 2 hours after and resolved after 24 hours. Swollen lymph nodes- Presented day after and still unresolved. Headache -Presented 12 hours after and persisted for 24 hours. Chills- Presented 4 hours after and persisted for 24 hours. No medical treatment by provider. At home treatment with NSAID?s and rest.

Patient admitted to hospital for progressive bilateral lower extremity weakness, sensory changes and inability to ambulate. Neuroimaging with significant degenerative disc disease with disc protrusions throughout the lumbar spine, greatest L3-L4, and with severe central stenosis. Question of radiculopathy vs peripheral neuropathy at admission, but no acute findings such as cauda equina syndrome. EMG consistent with atypical variant of GBS--acute motor sensory axonal neuropathy.

high fever (102.3), muscle aches, local injection site reaction, head ache and shortness of breath and chest discomfort

Muscle ache and tenderness; Joint pain; I even ran a low fever like a 100.5; Chills; This is a spontaneous report from a contactable consumer reporting for himself. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 14Jan2021 10:00 at single dose intramuscularly in right arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient started experiencing muscle ache and joint pain around 21:00 or 22:00 on 14Jan2021 and then he ran a low fever like a 100.5, and had chills pretty much all throughout the night. The patient noticed that those are common side effects but he had main concern on his work that he was unsure if he was okay to work on 15Jan2021. The chills and fever were gone on 15Jan2021 but he still had the muscle ache and tenderness. He stated that on 15Jan2021 the muscle ache and joint pain was about the same, it'd gotten a little better compared to what it was throughout the night, mild. The patient took two ibuprofen (ADVIL). The patient was recovering from the muscle ache and joint pain. The events low fever, chills were resolved on 15Jan2021. Information on the lot/batch number has been requested.

Patient experienced muscular rigidity and carpal pedal spasms. He had increased DTRs and clonus on exam.

Tingling sensation down right arm (arm of injection) into fingers. Had sensations of hitting funny bone in elbow. We gave apple juice. Started to feel light headed and escorted to emergency room.

Trouble breathing; Lightheaded/dizzy; Chills; Sore all over; Weakness in legs; Chest pain; This is a spontaneous report from a contactable consumer (patient). This 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 12Jan2021 at a single dose on the left arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. No known allergies. Pre-vaccination COVID test was not performed. On 13Jan2021, at 05:00 PM, the patient had lightheaded/dizzy, chills, sore all over, weakness in legs, chest pain and trouble breathing. On 14Jan2021, COVID test (Nasal Swab) was done and resulted negative. The events required an emergency room visit. Then, the patient was hospitalized for 3 days due to the events. Therapeutic measures taken as result of the events included ibuprofen and 2 other medications. The patient was recovering from the events.

Patient developed typical fever, myalgias, body aches in the days after his vaccine. He would describe them as severe. This was followed by chest pains. These chest pains prompted him to seek care in the ER. Upon workup, I found the patient to have developed myocarditis with a significantly elevated troponin prompting hospitalization.

Swollen lymph node under left deltoid. Severe pain in chest, back, elbow, underarm. Day number 5 and counting.

ED Visit 3/11/21 History of Present Illness 21 year old man pmhx of autism, recurrent abscesses, presents with complaint of L axilla swelling and drainage. Pt received COVID vaccine in L arm on 3/1. Pt did well until 3/5 when he started to complain of pain in the L armpit. Mother examined the area and did not see anything concerning. The pain continued through the weekend, no fevers. Pt felt warm on Monday, no temperature taken. Mother then noted a few "bump" near the L armpit. The bumps continued to swell and be painful on Tuesday, went to pediatrician and was prescribed Keflex. Pt has been taking Keflex but continues to spike fevers, Tmax 102F on Wednesday. Pt had fevers yesterday and today of "about 100." Pt took a nap today, and woke up with the area draining. Mother states that the drainage was smelly pus. Called PCP who recommended evaluation. ED course: Patient observed in the emergency department of antipyretics and did not have any further fever. I will switch his treatment to clindamycin and provide topical bacitracin and provide strict criteria to come back if pt became febrile instructions provided to mom. Patient safe for discharge to home. Discharged in improved condition. Written instructions reviewed with family. 3/18/2021 Discharge Summary History of Present Illness 21yo man with h/o autism and multiple soft tissue infections including cellulitis and pilonidal cyst who presented to the ED 3/13/2021 after axillary drainage and fever. He had been treated outpatient with keflex, but continued to have fevers at home. Re-evaluated at ED and placed on clindamycin. Cultures from outpatient showing skin flora. Mother has been doing several dressings of drainage at home and ongoing fevers up to 102 so was brought to the ED for evaluation. No cough, rhinorrhea, diarrhea, recent travel, known sick contacts. Summary of hospitalization: He re-presented to ED on 3/13/2021 and was started on vanc/cefepime/flagyl. A CT scan with contrast done to determine extension of abscess, which was fortunately limited to the subcutaneous plane (no infiltration near bone or into muscle fascia). In the ED, patient's creatinine was 1.5. Patient received IVF and his creatinine downtrended to 0.75 on 3/18/21. The surgical course was uneventful. Successful debridement of the left axillary abscess was performed on 03/4/21. Wound cultures grew Actinomyces Europaeus and S. Epidermidis and Infectious Disease was consulted. Their antibiotic recommendations to discontinue the cefepime/flagyl and start vanc/CTX were followed. Sensitivity analyses showed S. Epidermidis was sensitive to linezolid, tetracyclin, tigecyclin, bactruim and vancomycin. The Actinomyces Europaeus sensitivities have not yet resulted at time of discharge. Per ID recommendations, the vanc and CTX were discontinued and oral doxycycline was started, which should be continued for 6 months. It could be considered to switch to PO amoxicillin after 2 weeks and finish the 6 month course with amoxicillin. This will be discussed during outpatient follow-up. Per ID recommendations, the following labs should be checked 2 weeks after discharge (on 3/29/21) and could be spaced out to every 4 weeks thereafter if normal: CBC with differential, CRP, ESR, BUN, creatinine, AST, ALT. The patient is scheduled to see (ID) on 5/5/21. Dermatology was consulted per ID recs for evaluation of spots on the chest and back. Per dermatology these spots are keloid, not suspicious for hidradenitis suppurative, there is no need for biopsy. For pilonidal cyst spot dermatology recommends rec hibicleans cream. Immunology was consulted for recurring abscesses and recommended the following tests, which were ordered, in addition to outpatient followup: IgG, IgA, IgM, IgE, specific Ab titers: for strep pneumo IgG (23 serotypes) and tetanus IgG, lymphocyte subsets, T cell memory panel, B cell memory panel, neutrophil DHR, CH50. A wound VAC was placed on the left axillary wound bed on 03/15/21 and exchanged on 3/17/21. Patient tolerated the wound vac changes well with 5mg of oxycodone taken 1 hour prior to the vac change. On 03/18/21 patient was discharged with a home wound vac and VNA. At the time of discharged patient was afebrile, his pain was well controlled, his oxygen saturations were >94% on room air, he was tolerating a regular diet and voiding/stooling without issues.

Extremely sore right arm, long-lasting headache, achiness, fatigue, sore shoulder muscles. Headache and achiness began overnight, fatigue set in about 24 hours after vaccination.

Patient states that on day of vaccine, after receiving vaccine he felt tired, didn't feel well. Around 8pm that evening, he began having chills and didn't sleep well. On 19MAR, patient states he felt tired and vision got blurry while driving. Last thing he remembers is EMS personnel in ambulance stating that BP was very low. Patient states that while trying to brake prior to accident, he felt like he couldn't move his foot and stayed on the accelerator because he couldn't move his foot. MVA 19 Mar 2021. States following his COVID vaccination on 18 Mar, he had fevers, chills, and body aches that night and into the next day. While driving to work on 19 Mar at 0900, he struck another vehicle from behind while traveling 40mph. States his vision went blurry and he was unable to move his leg off the accelerator. He was wearing his seatbelt and the airbags deployed. Denies any LOC. He was taken via ambulance to. Imaging performed, as above, unremarkable. SM denies any issues today and feels well, besides neck pain. Unremarkable neurologic exam in clinic, no focal neuro deficits. MACE completed and showed a 2 point improvement from yesterday. Discussed importance of physical and mental rest, limit caffeinated products. Light indoor duty and no PT for next 3 days. Will f/u on Friday, 26 Mar 21.

First dose: Dec 16 Symptoms spanning 36 hours after injection as well as occasional joint pain in left elbow, wrist and knuckles. 36hr symptoms included: Fever, fatigue, muscle and joint pain in legs and arms, chills. 2nd dose, jan 6: Symptoms spanning ~60 hours (two days following vaccination + day of vaccination)Symptoms included: headache, low grade fever, muscle and joint pain in legs and both arms, chills. Symptoms almost completely resolved after that period, occasionally had some very mild joint pain still.*Note after both doses, pain in left arm was more severe than right arm* Starting the night of Jan 22 (fri) started having light leg pain, which carried into the 22nd. Dismissed it as too much walking the next day.Jan 24: leg pain a bit more severe, from a 1-2 to a 2-3. Included joint pain in left knee and ankle. Jan 25: pain in both legs at a 3-4, also mild pain in left arm (1-2) as well as joint pain. Jan 26: pain in left arm more severe, leg pain similar in severe. Very mild pain in right arm starting that evening, though only in upper arm. No joint pain in right arm Jan 27: pain in left arm similar in severity, slight increase in right arm pain, would rate 2-3 in right arm, 3-4 in left arm, 3-4 in legs. Muscle weakness in legs (legs shaking when walking down stairs for example) Jan 28 (Thurs):Symptoms started fading. Arm pain lowered in severity in both arms, as did leg pain. By Saturday all that remained was mild leg pain (1-2 in severity)Since then, leg pain has persisted. Week of Feb 14, leg pain increased in severity back to a 3-4. Visited the doctor on the 17th and had blood-work done on the 23rd after severity didn't decrease. Blood-work was normal other than slightly elevated lymphocyte % (50.8%)Visited a specialty medicine doctor on 2/25 and had x-rays done of legs. Results normal. Thought to have developed Achilles tendinitis. Possibly attributed to inflammation in legs, doctor wasn't sure. Rough quote "could it be from the vaccine, possibly, we just don't know." Have been doing stretches since which has helped the leg pain. Starting on March 12, I began to have pain in my left arm again, and ended up getting vertigo that evening. The arm pain persisted on and off from then on out, as well as occasional dizziness, which I treated with Dramamine. I did get an appointment scheduled with a neurologist in May that I still have. On March 25, I began to feel unwell, with a fever, dizziness, and a headache. That worsened into the evening, and I woke up at around 3 am with a high fever, that ended up going to about 103 F, and began vomiting around 4:30am on Friday, which persisted into the evening. On Saturday evening I began to feel better. With that recovery, the constant leg pain and frequent arm pain seemed to be gone, and has yet to return to the degree that it had been prior to that bout of sickness. I do still occasionally get arm or leg pain, but it's minor and only lasts about 20-30 minutes at a time.

Muscle ache manifested ~11 hours after initial injection, Temperature increase as well. Temperature subsided within an hour, muscle ache persistent

I got the Vaccine over a week ago and now I'm experiencing pain in my shoulder that radiates down my arm theny wrist is tingling and my hand is numb

Patient rec'd Pfizer COVID vaccine at 1438. Reported he felt "slight discomfort at the back of his throat" at 1451. VS WNL. Denied dyspnea. Water given. Denied difficulty swallowing. AT 1457, patient stated his "throat felt tight". Denied allergies to any medications and stated he has taken benadryl in the past. 50 mg PO Benadryl given. VS remained WNL. Stated throat "felt better" shortly after. Then c/o SOB and "feeling like he had to cough, but couldn't". Discussed treatment options and need for evaluation. States understanding. Consents to EMS being called. EMS called and patient monitored while waiting. C/o continued s/s and feeling "jaw tremble and chills, as well as back pain".

Chills and cold sweats the night after receiving the vaccine. Next day had fatigue and soreness in the left shoulder. Also had swollen lymph nodes under my left armpit which led to an inflamed lump there.

Patient received Pfizer Covid19 vaccine on April 9, starting having symptoms of fever (101 degrees F), chills, body aches, muscle soreness. On April 13 experienced throat soreness and called/saw personal physician. Physician prescribed Amoxicillin 500mg tabs for 7 days. On Wed. Apr 14 got blister on lip. On Apr. 15

Shortly after second dose, patient experienced myalgias, fatigue, but 3 days later, developed chest pain with troponin elevations and was found on MRI to have myopericarditis. He is otherwise stable, He is being treated with antiinflammatories with good response

started with soreness/stiffness in injection site, which I expected as it was how I reacted with the first shot. however, I then started experiencing mild dizziness/visual impairment (feeling like my vision was shifting or "glitching") that started around two hours after the shot, slow onset of sore/achy back muscles that hit peak pain at around 3am, and intense chills/shivers that started around 11pm, getting progressively worse as the night went on. Attempted to stop the chills by wrapping in several blankets, but only continued to feel colder and colder. Despite the chills starting around 11pm, fever did not present itself until around 1am, hitting 99.8°F by 1:30am. It was around this time that I took an ibuprofen and acetaminophen, which did not kick in until around 2:30am. Once the chills stopped, my hands and feet only got hotter, keeping me awake for an additional 2 1/2 hours.

Myalgia for ~2 months since getting first dose. Am a college tennis player, but am unable to perform essentially any exercise more intense than a few miles of walking and biking for 10 minutes.

patient was nauseated 10 minutes after dose, proceeded to have tingling in feet first, then legs and arms that moved into abdomen as well. Pain and extreme heaviness in arm shot was administered in. Ice packs were placed on arm and back of neck. Patient then stated after another 10-15 minutes that breathing was becoming labored and then both hands drew in and locked unable to move them. EMS was called at this time and EPIPEN was readied but not administered. Patient continued to communicate tingling was coming and going and after another 10 to 15 minutes breathing eased up and tingling in lip and body was fading along with able to move fingers but not thumbs. EMS arrived and took all vitals and cleared patient. About 15 minutes after patient was able to leave on own accord.

All Symptoms Arose When Awoken The Next Morning ?Migraine ?Bone Pain (Like Shin Splints) ?Swollen Lymph Node Under Left Armpit ?Dizziness ?Brain zaps (a symptom of Lexapro Withdrawl, although I did not discontinue or change my dosage)

Headache (ongoing), Muscle soreness (ongoing), Swollen lymph node in left armpit (started on 5/9), nausea (when I woke up on the 8th), chills, elevated resting heart rate (around 100 BPM)

Rhabdomyolysis (CK > 22.000); Elevated LFTs; This is a spontaneous report from a contactable physician. A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 21-year-old on 24Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was School or Clinic. Medical history included asthma. Concomitant medication included ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced rhabdomyolysis (CK > 22.000) (hospitalization) on 24Apr2021, elevated LFTs (hospitalization) on 24Apr2021. The patient underwent lab tests and procedures which included blood creatine phosphokinase: > 22.000 on 24Apr2021, liver function test: elevated on 24Apr2021, SARS-CoV-2 test: negative on 25Apr2021 (Nasal Swab). Therapeutic measures were taken as a result of rhabdomyolysis (CK > 22.000), elevated LFTs. The outcome of events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rhabdomyolysis and Elevated LFTs. 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 Committees, and Investigators, as appropriate.

Uncontrollable shaking, chills, swollen lymph node within armpit of vaccinated arm, fatigue, aches throughout body, joint pain, fever, dehydration. Drank water consistently and switched between Tylenol and Ibuprofen every 6 hours to reduce fever and pain. Bed rest for entirety of symptoms.

Unknown vaccine clinic site. Patient was seen at Per internal reported event: 21 y.o.male with PMH significant for asthma who was admitted 5/15/2021 with CP. Pt had Pfizer COVID vaccine #2 on 5/12. He developed fever and myalgias on 5/13. These had recovered by 5/14 - only complaint was sore arm and underarm swelling on the L. By 5/15, pt had severe CP with dyspnea. Taken to ED - noted to have elevated troponin and ST elevation on EKG. Now s/p LHC today - coronaries clean. Echo without wmas. Cardiology suspects acute myocarditis. No pericardial effusion to suggest pericarditis.

The following 2 days after second dose with malaise, fatigue, myalgias, subjective fevers, third day post vaccine with chest pain consistent with myopericarditis after evaluation. Echocardiogram pending, elevated ESR, CRP, Leukocytosis, elevated CPK level, Tropnins uptrending from 8, EKG with diffuse ST segment elevation and PR interval depression, clear CXR.

day after second vaccination I experienced fever, migraine, Chills, muscle soreness, chest pains , fatigue, loss of appetite.

Pericarditis diagnosis: This is a 21 year old male who presented to the emergency department on 4/27/21 with a two-day history of chest pain. He was seen in a emergency department on 4/26 and reported a normal EKG, blood work, and x-ray. He was discharged home. His was worsened so he reported to an urgent care in . That team had a concern for pericarditis, so referred the patient to the emergency room. He had a reproducible pain over the costal margin but did describe a positional component. Provider felt they still had to consider pericarditis as well as costochondritis. The suspicion for pulmonary embolism or acute coronary syndrome or very low. The suspicion also for myocarditis was low. His EKG did show some J-point elevation versus ST elevation in the anterior and lateral leads. There was no evidence of reciprocal depression. His troponin test was normal. His CBC and metabolic panel were normal. He had had CRP which was mildly elevated at 4.6. A bedside point-of-care ultrasound showed no evidence of a pericardial effusion. Provider felt it was reasonable to treat him for pericarditis although his EKG is not classic for this. It was recommended he use his scheduled ibuprofen 600 mg 3 times a day. He was also given a 1 month course of daily colchicine 0.6 mg. It was recommend he follow closely with his PCP to see if he needs to have this colchicine course extended. He will follow-up with his primary doctor in 1 week for repeat check.

After receiving vaccination, pt reported heaviness in R arm that went over to the left arm. Provider was sent for at this time, and patient was placed in supine position. VS at 1629 119/70; 96;18;O2sats 97% on room air; pt denies shortness of breath, chest pain. After VS check pt reports R arm heaviness has resolved. At 1641 pt sat up and reported that he was "twitching" and was purposefully moving both right and left shoulders at this time, and was able to stop movement indepedently. Pt then ambulated to waiting room and was dismissed after 15 minutes provider observation.

Extreme weakness, myalgia, pain in body, headache, fever, chills, high blood pressure lasted for approximately 2 weeks.

Patient presented to ED with c/o body aches, cold sweats, night sweats, coughing, weight loss, and fevers that have worsened since onset around 2 weeks ago. Patient states his symptoms started after receiving the second Pfizer COVID-19 vaccination on 5/22/2021. Presents with fever of 101.4. Patient was transferred to the hospital for a higher level of care. ED Diagnosis : Leukemia, acute

Patient started to be unconscious and not alert 5-10 minutes after vaccination. Patient was twitching, clenched hands, stiffness of muscles for <1 minutes. 911 was called but patient denied ems assistance.

21-year-old male with no significant past medical history who received his second vaccine of the Pfizer COVID series on Wednesday, 16JUN21. Afterwards, he developed myalgia and chest pain that began on 17JUN21, which worsened prompting his arrival to ED. His troponin was found to be elevated and there were non-specific ST elevations on his electrocardiogram so he was admitted for observation while starting colchicine for myocarditis. His chest pain resolved in the emergency department prior to admission and did not return during his stay. His troponin peaked and down-trended. The findings on his electrocardiogram resolved. A formal echocardiogram was performed on 21JUN21 with no significant findings. He is to continue on colchicine 0.6mg PO BID for 3 months (END 8/11/21) and then follow up with cardiology for possible further workup if needed.

Stabbing heart pain. Shortness of breath. Weakness in right hand (opposite the arm vaccinated). Extreme joint pain to the extend of difficulty walking. Symptoms abated strongly after 48 hours with the exception of tightness in chest.

Discharge Summary Risk of unplanned readmission within next 30 days: N/A (0-12 low risk, 12-21 moderate risk, 22-28 high risk, 29+ extreme risk) Reason for Admission: Present on Admission: ? Acute chest pain Final Diagnosis: Acute chest pain Myopericarditis Hospital Course: Patient is a 21 y.o. Caucasian male who presents with acute onset of fever, headaches, chest/back pain and rapid heart rate after having received second dose of Pfizer Covid vaccine on 5/21/2021. Chest pain with oppressive character (pressure-like, squeezing) that is associated with palpitations, sweating, SOB, not nausea, exertion, dizziness. +cardiac risk factors (smoking, and +FH). Patient evaluated by cardiology. Echocardiogram with normal left ventricular ejection fraction no pericardial effusion. Troponins downtrending. Patient diagnosed with myopericarditis pericarditis as per cardiologist: "discharge him home with plans for a repeat echocardiogram in 1 month and follow-up with a cardiologist. I do not feel strongly that we need to start cardioprotective medications or any anti-inflammatory medications as he is feeling better." Once symptomatically improved and repeat troponin downtrending patient was cleared for discharge by cardiology in stable condition Significant Medication/Changes this Admission: See MAR Follow Up Recommendations: PCP Problems Addressed During this Admission: Acute chest pain Elevated troponin Engages in vaping * No resolved hospital problems. * Consults: Consultants below were obtained for their respective expertise as needed (Please refer to their consult and progress notes for details). Discharge Disposition: Condition at discharge: Stable. Discharged to Home

Fever; Chills; Sweating; Body aches; muscle fatigue; Very rapid heart beat. Myresting is in the 60s, today is the 80-90s. I have stood up, walked a fewfeet, and sat back down and my heartrate was 110.; Lethargy; This is a spontaneous report from a non-contactable health care professional, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 AM (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any concomitant medication. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced lethargy on 22Mar2021. The patient experienced fever, chills, sweating, body aches, muscle fatigue and very rapid heartbeat on 23Mar2021 at 03:00 AM. It was also reported that usually when the patient woke up, his heart rate was at 40s and the morning was at the 60s. Resting heart rate was 60s, but it was at 80-90s following vaccination. When the patient stood up, walked a few feet, and sat back down the heart rate was 110 (unit and reference range was not provided). The events resulted in a visit to the doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the events. The clinical outcome of lethargy, fever, chills, sweating, body aches, muscle fatigue and rapid heartbeat was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.

After a couple days of symptoms That had subsided , developed a quick headache, light headedness with shoulder and chest pain on the left side. The pain was radiating toward the breastbone area. Waves of chest pain.

PER MEDICAL RECORDS RECEVED FROM THE HOSPITAL- PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AFTER RECEIVING HIS SECOND COVID VACCINE THREE DAYS PRIOR. COMPLAINED OF NECK PAIN AND HEADACHE IN THE DAYS AFTER HIS SHOT. ON 7/7 THE PATIENT DEVELOPED CHEST PRESSURE IN THE RETROSTERNAL AREA. MEDICATIONS GIVEN INPATIENT: ASPIRIN, 81 MG = 1 TABS, ORAL, DAILY. LOPRESSOR, 12.5 MG = 0.5 TABS, ORAL, Q12H. SODIUM CHLORIDE 0.9% BOLUS, 1000ML, IV BOLUS, ONCE. SODIUM CHLORIDE 0.9% FLUSH, 5 ML, IV FLUSH, Q8H. PER MEDICAL RECORD, PATINET WAS DISCHARGED 07/10/21 AND WAS TO FOLLOW UP OUTPATIENT WITH 2 DIFFERENT DOCTORS

swollen lymph nodes (lymphadenopathy) in left arm pit (arm of injection), swollen breast area,, lump in arm pit; sore

Hours after the dose: right arm tingle and soreness, hard to lift objects with that arm. Next morning: Total body Soreness (neck to legs) and some feverish chills began, not strong enough to stop activity Sunday 7/25: Soreness/chills felt like they were going away Today 7/26: Total body soreness and chills returned stronger, hard to get out of bed/walk without shaking too much or having to stop because of pain.

Headache; Joint pain/ache; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 30Apr2021 at 15:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 09Apr2021 at 15:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021, the patient experienced headache, joint pain/ache, chills, fatigue (but not debilitatingly so). 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. On 01May2021, patient underwent lab test which included nasal swab for SARS CoV-2 test and the result was negative. The clinical outcome of the event headache, joint pain/ache, chills, fatigue were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Injection site pain - present Tiredness - 24hrs Headache - 24 hrs Muscle pain - 24 hrs Chills - 24 hrs Joint pain - 24 hrs Fever (101.2°f) - 24 hrs Nausea - 24 hrs Malaise - 24 hrs Swollen lymph node (left armpit only) - present

Patient got his 2nd shot around 1:15pm. About 10 minutes later patient started feeling like his joints are on fire with some stiffness. Came to report around 1:50pm. Checked injection site area, no signs of allergic reaction, anywhere. Gave him 50mg of Benadryl at 1:56pm. Patient also stated that the next day after his first dose, he felt the same way and it took 3 days to feel better. He also said heat makes his joints feel better, cold makes it much worse. At 2:28pm, patient said he felt better but still feels "tight". At3:30pm came back saying he felt worse. Had him take 800mg Ibuprofen. At 3:58pm patient told me in addition to the ibuprofen, he also took 1000mg acetaminophen around 3:35pm, and that he isn't feeling any better. 4:22pm, patient still not feeling any better.

I took both doses of the pfizer vaccine and noticed that my thumb joints and my right wrist started to hurt. It hasn't resolved and it seems to not be getting any better

On the 1/15 I noticed swollen lymph nodes. One on my right shoulder and base of the left side of my neck. The one on my right side went away in about two weeks and the one on my left side is still here till this day. I made appt. with my PCP and he ran some blood test with no abnormal findings. I also have thalassemia trait. The day after I had a fever of 99 and back muscle pain due to those two I left work for the day.

Fever; Headache; Joint pain; Chills; Vomiting; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 23Jan2021 at 12:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 02Jan2021 at 04:45 PM for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. On 23Jan2021, the patient experienced fever, headache, joint pain, chills, vomiting, and fatigue. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

fever, headache, full-body muscle aches, generalized joint pain, injection-site pain, chills, purple, speckled rash bilateral arms, eczema flare on left arm around injection site

Started with soreness in the arm; Turned into horrible muscle and joint aches; Turned into horrible muscle and joint aches; pounding headache; an immense amount of pressure behind the eyes; uncontrollable body aches; This is a spontaneous report from a contactable other hcp (patient). A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=En5318), via an unspecified route of administration on 29Jan2021 11:30 (at 22-year-old) at single dose (Right arm) for COVID-19 immunization. The patient medical history was not reported. Patient had known allergies. Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine was administered in four weeks. No other medications in two weeks. Patient had no covid prior to vaccination. The patient was covid tested post vaccination. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El3248), on 08Jan2021 12:00 (at 22-year-old) on Right arm for COVID-19 immunization. It was reported that it started with soreness in the arm. Turned into horrible muscle and joint aches, pounding headache, an immense amount of pressure behind the eyes, and uncontrollable body aches. This lasted from about 12 hours and then got progressively better. By hour 48 he was totally fine. Events started on 29Jan2021 22:00. No treatment was received for events. The patient underwent lab tests and procedures which included covid test: Nasal Swab: negative on 31Jan2021. The outcome of the events was recovered.

SARS-CoV-2 / COVID-19 mRNA IM (Pfizer-BioNTech) Date Status Dose VIS Date Route Site Manufacturer Lot# Given By Verified By 3/13/2021 Given 0.3 mL EUA 12/2020 IM RD Pfizer, Inc EN6208 RN --

Back was itchy, normal for him, no hives visible. Allergy to grasses, normally itchy with runny nose and eyes. Itchiness deteriorated after sitting. released at 5:05pm

swollen lymph nodes around my neck; diarrhea; severe headache; chills; fever near 102; muscle aches; profuse sweating; felt freezing cold; inability to sleep; This is a spontaneous report from a contactable other hcp, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 25Feb2021 at 10:00 (at the age of 22-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 on 04Feb2021 at 10:00 (Lot Number: UNKNOWN; at age of 22-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Feb2021 at 16:30, the patient experienced in order, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating although felt freezing cold, inability to sleep. The headache has lasted 3 days now as well as swollen lymph nodes around his neck. The patient did not receive any treatment for the events. The patient was recovering from the events, swollen lymph nodes around his neck, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating, felt freezing cold, and inability to sleep. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Approx. 30 minutes after vaccination the joints in my left shoulder froze up and felt like a lump of concrete for 20-30 minutes total. Approx 3 hours after vaccination intense waves of nausea set in and have been coming and going since and currently is still active. Very shortly after the nausea began my left arm began experiencing, excruciating muscle spasms and cramps those are also still active and come and go. Approx. 4 and a half hours after vaccination I began feeling extremely fatigued and started experiencing chills and the sensation of being cold despite my apartment being at the typical temperature I keep it at.

My arm went completely numb immediately and then it started itching and then about an hour later my throat started to close and I could see my heart beating out of my chest and I ended up having to go to the emergency room and then over the next three weeks I have experienced every side effect that is listed With the worst being fatigue muscle ache and abdominal cramps

Patient reports receiving second dose of COVID vaccine on Saturday (Pfizer) and that night experienced fever and chills. When patient awoke in the morning he reports neck stiffness and left sided chest pain. The neck stiffness has since mostly resolved although chest pain has been getting worse. Patient reports it is localized, sharp, non radiating, constant, 6/10 in severity and exertional. pt admitted at Hospital ++ marked troponin leak and cardiac cath which revealed non obstructive CAD, elevated LVEDP (30) and transferred to another facility . Pt started on milrinone drip and had a endomycocardial biopsy on 4/22/21 : no lymphocytic myocarditis pt discahrgedon 4/23 with outpatient fu and metoprolol succinate and spironolactone for 3 months if tolerated to minimize myocardial injury from resultant inflammation + cats at home

Pt was standing at check out when he became dizzy. He was sat in a chair and conversing with the nurse. His eyes rolled back and his head bent forward. Suddenly his head went back and his body was rigid and began to shake violently for approximately 20 seconds. He became conscious but disoriented about 45 secs after episode. EMS intervened and patient was assessed and monitored. Patient refused transport to hospital but said he would contact his physician.

Developed pruritic hives on buttocks, thighs, and arms, with bilateral hand swelling over 72 hours after vaccine administration. Hives resolved with Benadryl administration. Had temperature of 99/100F and myalgias for 48 hours after vaccine administration which resolved prior to onset of hives.

Woke up with pain and swellig base of left neck with a firm, slightly cystic feeling, rounds and slightly tender mobile mass (3 cm) anterior to left clavicle

States felt fine until that evening and then developed muscle aches and felt somewhat short of breath. Thought these were both side effects so went to bed. The muscle aches have resolved but is still short of breath, reports hard to take a deep breath today although he sounds fine on the phone as he speaks calmly and in complete sentences. He has no mouth swelling, there has been no rash or hives at all. He has no hx of asthma and doesn't believe anxiety is playing a role. Pt concerned he may have gotten COVID from the vaccine.

Diarrhea, blood in stool, grabbing at groin area (patient is nonverbal). Increased ulcerative colitis meds, had stool tested and the result was severe inflammation of the intestines. Patient is on steroid currently for this condition.

Severe headache started at 5:00 pm post vaccination. Lasted 24 hours. Moderate, lower body muscle cramping and pain started 24 hours post vaccination. Lasted five days.

Shoulder pain; Neck pain; Pulled a muscle; Blisters appeared on the arm; Shingles; Some residual pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9266; Expiration date was not reported) on the upper right arm on 13Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included acid reflux, anxiety, insomnia, and was stressed out. Concomitant medications included pantoprazole for acid reflux; and hydroxyzine HCl for insomnia and anxiety. On 21Feb2021, the patient had shoulder pain; neck pain; had pulled a muscle; blisters appeared on the arm; had shingles; and some residual pain. The patient had received prednisone and valacyclovir as treatment for shingles. The outcome of the evens was recovering for blisters; was recovered on an unspecified date in 2021 for shingles; and was unknown for all the other events. The patient wanted to make sure if it would be safe to receive the second dose of vaccination.

Client presented to 2nd dose appointment for Pfizer COVID vaccine and reports she experienced swelling in right inner elbow, forearm, and wrist about 1 week after first dose Pfizer COVID vaccination to right arm. Client reports she followed up with her PCP regarding symptoms. Client reports she was prescribed a topical steroid of unknown name, but reports she did not use the steroid as the swelling resolved before she was able to pick up the prescription from the pharmacy.

myocarditis; Strange weird bilateral wrist pain severe; Pericarditis/inflammation around the heart; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00, as 2nd dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487544 same reporter, suspect drugs and events; different patients

Chest Pain, Myopericarditis; From EPIC: From cardiologist healthy man who comes to the ER with left anterior chest discomfort for the last 36 hours or so. Symptoms are made worse by deep inspiration. Were improved following self administration of 600 mg of ibuprofen earlier today. 2 days ago he received his second COVID-19 vaccine (Pfizer). Following day he experienced arm pain muscular aches and pains severe discomfort of the right arm (injection site) later in the day there was nausea and vomiting on one occasion (nonheme). By last night he was able to eat dinner but subsequently felt short of breath with worsening chest discomfort morning the left arm continued to ache with musculoskeletal pains. Developed more discomfort in the left anterior chest radiating to the throat made worse by deep inspiration. Does not describe typical sharp catching pain of pericarditis. No cough sputum bruising bleeding abdominal pain change in color or character of bowels. Sign in the emergency room he was hemodynamically stable, in sinus rhythm with a normal EKG.Torrey work-up notable for an initial troponin of 1.28 and a follow-up troponin of 2.14. Chest x-ray perfectly normal. Elevated d-dimer. CT angiography negative for pulmonary embolism vascular injury, cardiomegaly, pericardial effusion but the radiologist did note thickening of several right posterior and lateral axillary lymph nodes raising a question of recent right-sided vaccination or injury/infection to the right arm. Presently he is perfectly comfortable able to take a deep inspiration with mild chest discomfort, breathing easily. I met him in July 2018He came to the emergency room with a 3-day viral syndrome manifested as headache nausea vomiting diarrhea and abdominal discomfort and then developed chest discomfort. He was found with diffuse mild J-point elevation on EKG consistent with a viral type pericarditis with troponins which rose to a maximum of 10.4. Work-up for myocarditis was negative. Echocardiogram perfectly normal. Symptoms responded to a course of nonsteroidal anti-inflammatory agents and colchicine. Seen in follow-up of repeat echocardiogram was perfectly healthy. Our diagnosis was myopericarditis. There is no history of shortness of breath dyspnea on exertion decrement of exercise capacity peripheral edema orthopnea PND palpitations lightheadedness syncope or collapse. No ill contacts. He works in a high security position and therefore qualified for early administration of the Pfizer COVID-19 vaccine. Graph past medical history notable only for the episode of myopericarditis and a remote tonsillectomy. There is no significant family history of sudden cardiac death or unusual heart disease. He takes no medications. Patient was recommended to take 4 weeks of ibuprofen and colchicine if needed for worsening chest pain. Patient was recommended to follow-up closely with his primary care doctor and check ESR, C-reactive protein as well as renal function. Needs close follow-up with cardiology as an outpatient.

Within minutes of receiving covid-19 vaccine, I became very excessive sweaty (my shirt was wet), felt eyesight was dimming, space perception was completely off, very pale, dizziness and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt heavy and then became completely numb and I was unable to move to either arm for approximately 45 minutes. Movement slowly came back throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy. I felt like I was doing to die. Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.

Red sore arm with the bump 22 hours after the shot he went from a normal temperature to chills and 103.4 instantly temperature headache aches pains

This is a spontaneous report from a contactable consumer (patient's mother) and a contactable other healthcare professional. This consumer reported similar events for two patients (twins). This is the first of two reports. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00 (at the age of 22-year-old) as 2nd dose, single dose for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered. Follow-up (14May2021): New information received from a contactable other healthcare professional includes: reporter details (other hcp added as a new reporter). Follow-up attempts are needed. Further information is expected.

Patient received first dose of COVID 19 vaccine at 1:30 pm on 5/4/21, at 11:00 pm on 5/4/21 patient was at home sitting on couch when his body went stiff, eyes rolled into the back of his head, legs began shaking for about 20 seconds, once patient came to he was extremely nauseous and vomited. Patient did not seek medical attention that evening, called his PCP next day and was advised to follow up. Two days later patient still experiencing some headaches and nausea, advised to go to local ED (hospital) patient had labs drawn and received a CT scan, reported all were unremarkable. Patient is in the process of following up with Neurology and undergoing and EEG for suspected seizure.

This is my 2nd dose of Pfizer. I got sick both times. After my fever was gone, still have stiff neck for a few more days. Today is 2 weeks after the second dose, I feel like I got covid all over again but only feeling shortness of breath for a number of times a day for everyday. I had to inhale long oxygen to feel better every time .

2 days after second dosage the patient began to experience chest pain and shortness of breath at rest and worse with minimal activity-body aches--myalgias--headache

Patient present to ER on 6/19/2020 with 2 day history of fever to 103, bilateral pleuritic chest pain, back pain and fatigue.

Felt fine throughout the day after the shot but woke up around 2:30 AM shaking uncontrollably/having muscle convulsions. Moderately painful and lasted for about 20 minutes before subsiding. After the convulsions ended I felt very feverish. Woke up feeling mostly better but felt sore from the shaking and have a considerable headache.

fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown. Follow-up needed. Information about batch/lot number has been requested.

Elevated heart rate within couple of minutes of receiving vaccine and extreme fatigue. Visited emergency room 4 times within two months after receiving vaccine and had abnormal EKGs. Followed up with a neurologist, cardiologist, gastrologist, and primary care physician to receive more follow-up tests but have not received any official diagnoses yet. As of July 7th, I still have rapid heart rate, low blood pressure, shortness of breath, bone cracking, and back & stomach & neck pains that all started since receiving the second dose of vaccine.

Symptoms began between shoulder and neck. High sensitivity to noise in the left ear. Discomfort behind left ear for 2 days. 3rd day, tongue and lips were numb. 4th day left facial paralysis. Went to Urgent Care. Diagnosed with Bells Palsy.

6/10 chest pain and pangs around 36 hours after 2nd Pfizer dose (Saturday night). Shortness of breath, potential heart flutterings, and chest pain that comes and goes. Intensified around midnight. Sunday, increased around noon. Decided to get checked out at ER. Doctor said no evidence of a blood clot, and diagnosed me with ******"costochondritis"****** has not gone away, although slowly subsided by day 4. I still have shortness of breath, inability to breathe deeply, bend over. Got intense saturday night but is mild now.

increasingly pale; discomfort bilaterally in his hands and forearms; tingling; inability to move his hands; discomfort bilaterally in his hands and forearms; feeling weak/ weakness; sweating; This is a spontaneous report from a contactable other HCP. A 22-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0177) via intramuscular on 20May2021 at 14:20 (at the age of 22-years-old) in left arm as a single dose for COVID-19 immunization. Medical history (including chronic or long-standing conditions) included COVID-19 (mostly asymptomatic) from Feb2021 to an unknown date. It was unknown if the patient received prescriptions over the counter medications, dietary supplements or herbal remedies at the time of vaccination. Allergies to medications, food or other products, other illness at time of vaccination and up to one month prior were reported as none. It was unknown if the patient had an adverse event following previous vaccine. The patient concomitant medications were not reported. It was reported that the patient was very nervous when checking in for vaccine. On 20May2021 at 14:23, after administration he experienced sweating and became increasingly pale. He then reported discomfort bilaterally in his hands and forearms. He described it as weakness, tingling and inability to move his hands. This lasted for 30-45 minutes and then seem to start to ease. Patient was released to his mother. At 20:30 his mother reported that he felt weak but seemed ok otherwise. Adverse reactions to the vaccine, especially after a recent case of COVID were discussed in detail with the patient and mother. Due to the reaction, it was recommended that they talk to patient's doctor before getting second dose. Medical tests and laboratory results related to the adverse events were not reported. The outcome of the events was unknown. Follow up attempts needed. Further information is expected.

I started feeling flu-like symptoms around 14 hours after the second vaccine. Each symptom occurred at the same time at 03:37 AM on July 14, 2021. The symptoms included achiness, cold shivering, slightly elevated temperature (100.8 °F), and almost complete muscular tension in arms and legs. It made it difficult to walk. I took a mixture of Tylenol (acetaminophen) and Advil available in one tablet. I took 2x of these, drank plenty of fluids, and went to bed around 05:15 AM on Wednesday, July 14, 2021. I had a heating blanket along with a microwave bean bag to keep myself warm. I woke up at 1:45 PM with most side effects subsiding, besides vaccine injection site still remaining sore.

arm felt sore; muscle aches; fatigue; feeling an itching sensation under myskin around my torso; slight cough; soreness all over; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWOISO) via unspecified route of administration in the right arm on 31Mar2021 at 12:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient was allergic to any and all molds, molds in food, medications such as penicillin, augmentin, etc. and latex. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), salbutamol (ALBUTEROL), vitamin D (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. 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 for COVID-19. On 31Mar2021 at 16:00, patient experienced sore arm, muscle aches, fatigue, soreness all over, itching sensation under skin around torso, and a slight cough. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm, muscle aches, fatigue, soreness all over, itching skin, and cough was resolving. No follow-up attempts are needed. No further information is expected.

Received Pfizer vaccines on 5/18/21, 6/8/21. Began feeling ill on 7/21/21 w/ cough, sore throat, vomiting, nausea, myalgias, chills, H/A. Tested positive for COVID-19 by PCR on 7/23/21.

At 2:00am 12/19/20 I woke up to an episode of diarrhea and was left feeling nauseous. I woke up again at 4:30am with another episode of diarrhea and severe nausea which led me to throw up. I feel better after throwing up and proceeded to get rest before going to work at 6:00am. By 8:00am I had developed a severe headache, severe nausea, muscle fatigue and overall felt bad. When I got home I had become extremely nauseous and developed severe muscle fatigue and severe arthralgia and my headache had increased and became sweaty and dizzy. I slept from 9:00am to 2:00pm where the symptoms had gotten no better and the headache had gotten worse. I slept from 3:00pm to around 6:00pm with the same symptoms but managed to eat some soup and kept it down. I slept from 10pm to 12pm the next day 12/10/20. My fatigue and joint pain had somewhat dissipated but I was still experiencing severe nausea and a severe headache. By the end of 12/10/20 around 8pm my joint pain and muscle fatigue had gotten better but the nausea and headache were still there. 12/11/20 I was well enough to drive and receive a covid test. My nausea and headache did not go away until the end of day 12/11/20

Starting ~10PM: fatigue, muscle soreness. Overnight, fever (99.8), chills, aches, Headache, sore throat, fatigue and mild diarrhea.

I had injection site pain about 4 or 5 hours after my injection. Around 9:15 at night I felt slightly warm and could tell that I was becoming febrile, but I wasn't completely there yet. Around 12:45AM on January 9th, I had massive chills and uncontrollable shivering and muscle aches. I took 1000 mg of acetaminophen. I took another 1000 mg of acetaminophen at 6:00AM when my chills came back. At 10:45AM I was feeling febrile again, and took 600 mg of ibuprofen followed by an hour and a half nap. I had slight malaise afterwards but did not feel febrile. By 5PM, I was feeling almost completely normal and was fever free. On the morning of 1/10, I am completely recovered.

loss of smell; Loss of taste; feeling like a sinus infection; pain at the injection site; muscle pain; Headache; Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, expiration date: Nov2021), via an unspecified route of administration on 11Jan2021 at 11:00 AM in the left deltoid at single dose for work as behavioral technician. Medical history included Chronic headaches predates his treatment with bnt162b2. Family Medical History was none. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Patient reported he got the first dose of the bnt162b2 on 11Jan2021. He noticed one and a half hours later (12:30) pain at the injection site and muscle pain; then 12Jan2021, the next day lost his sense of smell and taste and it felt like a sinus infection. Added he didn't know exactly what a sinus infection felt like but he felt like he had jumped into a pool without holding his nose. Added twelve later (on 12Jan2021) the muscle pain resolved; his injection site was still a little painful and he still couldn't smell or taste. He was planning to get the second dose of the vaccine on 03Feb2021. Added he took ibuprofen for a headache later the night of the vaccine 11Jan2021. He had headache multiple times a week. This headache started that day. After taking the ibuprofen his headache resolved that same day. There were not any events require a visit to physician or ER. Therapeutic measures were taken as a result of events headache. No investigation assessment. The outcome of the event headache was recovered on 11Jan2021, muscle pain was recovered on 12Jan2021; outcome of events pain at the injection site and feeling like a sinus infection was recovering; outcome of the other events was not recovered.

Day of 2nd vaccine dose 25JAN21 patient reported muscle aches and chills, the day after 2nd vaccine dose 26JAN21 patient reported fever 102.5 and headache, 2 days after 2nd vaccine dose patient reported loss of taste.

No adverse affect after 1st dose. After second dose, no arm pain was felt, but joint aches and a fevers were prevalent around hour 8 after injection. Around hour 10, a fever of 100° F set in and quickly rose to 102° before hour 12. Fever reached 103° by hour 12.5 and broke by hour 13. After fever broke, vomiting/dry heaving occurred for roughly 2 hours. Lethargy/ LOC set in around hour 16 and the former remained until around hour 48. After the course, I began to feel fine, I just wanted to report how adverse my side effects were compared to those of my coworkers.

Pfizer COVID-19 Vaccine EUA 1-12-21 Pfizer Covid 19 vaccine given left deltoid Seen at Employee Health on 1-21-21 Pfizer initial dose given on 1-12-21 56-60 hrs later, bilateral cervical adenopathy incl. submandibular. Then 6 hrs later, awoke with constitutional symptoms of myalgias, felt feverish/chilled, headache, night sweats, fatigue, thinks had some arthralgias when symptoms were peaking late on 1-15-21 or early 1-16-21; currently sx improving but persistent. Arm was sore at vaccine site, but no localized itching type reaction noted. Additional symptoms are pharyngitis/expectorate yellow phlegm. No h/o Covid 19. Has enrolled in the V-safe CDC monitoring program Rapid strep/rapid mono/Covid 19 PCR/Flu PCR negative. Throat culture negative for strep. Diagnosis: Adverse reaction to vaccine, moderate 1-26-21: symptoms are resolving. There is no contraindication to booster vaccination. Patient needs to decide if risks of adverse reaction to booster outweighs benefits of vaccination to determine if he will proceed with booster.

fever; Headache; Chills; First dose: it was 3 weeks ago from 20Jan2021/ her son thinks it was 05Jan2021; pain under the arm; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 20Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received first dose of BNT162B2 (3 weeks ago, thinks it was 05Jan2021) for COVID-19 immunization. The reporter stated that her son worked in a doctor's office and got the second COVID 19 vaccine on 20Jan2021. Her son has a fever (started about 4PM) and she wanted to know if her son was contagious because he has a fever. He was experiencing quite a few side effects: headache and fever on 21Jan2021; and on 20Jan2021 chills and he started last night with pain under the arm. Outcome of the events pain under the arm and headache was not recovered, fever and chills were recovering. Information on the Lot/Batch number has been requested.

1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic, 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently invo 1/11/21 COVID Pfizer vaccine #1 = no issues (given at Clinic = screening form marked all no but had a 30 min watch post vaccine 1/29/21 Covid Pfizer vaccine #2 EL0261 left arm at Clinic - no c/o reported 2/20/2021: medical sent to local ER on 2/20 for 2 day c/o worsening left hand/forearm numbness, coldness, discoloration to left hand and pain (purple appearance). Was seen at clinic with negative DVT r/o US, nl imaging and labs. 2/21 sent to ER c/o UE pain and weakness x 5 days (woke up with bicep pain that progressed to numbness, tingling, swelling and discoloration of hand (cyanosis pallor and cold LUE x 3 days). Severity is moderate. Quality dull pain. Currently involves entire left arm (arm, elbow forearm wrist hand).. Did have some swelling and motor loss, NO CP, SOB or sensory loss, no redness, no injury, no fever, chills, ha, depression sore throat, cough, rash, lymphadenopathy, abd pain, GI distress, no trauma or recent illnesses. 2/21: admitted clinic w/rhabdomyolysis: no preceding workouts, increased activity on ship, back sleeper, no alcohol, no trauma,. nsp: skin intact, no erythema. Mild edema to upper arm around triceps. Mild purple discoloration to dorsum of hand. Palp: TTP about triceps. TTP anterior shoulder. TTP biceps. Able to palpate triceps tendon and biceps tendon. NTTP throughout the rest of hand and forearm. Hand is cooler relative to contralateral side. NTTP cervical spine. ROM: Full passive ROM of the shoulder and elbow with pain. No micromotion pain with any joint in the upper extremity. Painless cervical spine ROM. Motor: 3/5 strength to OP/FPL/2nd FDP, EIP/EPL, 1st and 2nd DIO. 3/5 deltoid, biceps, triceps, wrist extensors, wrist flexors. Sens: Decreased sensation throughout entirety of forearm and hand distal to the elbow. Above the elbow, sensation is intact. Vasc: 2+ radial pulse, symmetric to contralateral side. BCR <3 sec. Hand is cooler than contralateral side. Lab: CRP <5, ESR 4, CK 31,924, PT 14, INR 1.1, D-dimer 0.46, AST 610, ALT 186, Cr 0.94, WBC 6.3 Imaging: Radiographs of the chest, shoulder, elbow, wrist, and hand demonstrate no fracture. The shoulder is well located. CTA starting at the heart demonstrate no vascular abnormalities. Assessment: unlikely that he has compartment syndrome or a cervical spine pathology. His exam does not localize to one specific innervation or muscle group. His paresthesias and diffuse 3/5 weakness on exam may be related to parsonage turner syndrome (post viral neuritis) versus edema. While he does have a cool hand and mild/moderate edema on exam, his CTA is normal and his exam is very reassuring that this is not compartment syndrome. He likely has rhabdomyolysis based on upper arm swelling in the setting of CK of 31924. Discharge 2/22/2021: He received a total of 3 liters of IV fluids and was encouraged to drink large amounts of water. Repeat CK levels showed to be down trending as were his AST and ALT enzymes. Plain radiographs of his left arm and shoulder were unremarkable as was CT angiography of his chest. Electrolytes and renal lab work was within normal limits throughout the hospitalization.On the day of discharge, he was tolerating a PO diet, ambulating without difficulty, and hemodynamically stable. LUE w/ minimal swelling, no erythema. TTP over L triceps belly, No TTP over the distal LUE. Somewhat decreased sensation to light touch over distal LUE. 2+ radial pulses b/l. LUE ROM somewhat limited 2/2 pain, but intact. ---- to f/u with HCP in 2 weeks, sooner if worse (medical officer) CK 2/22/21 was down to 14653

Soreness and disabled triceps muscle (two days), no treatment, gradually became usable again; fever with migraine and sore throat (second day), treated with ibuprofen, normal on third day

He has got a 100 fever; He got up this morning with a high fever; Very bad headache in his head and in the front of the head, it hurts a lot; The face, the top and the front is hurting a lot going through the eyes; sleeping a lot; bodyaches; This is a spontaneous report from a consumer (patient's father). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient's medical history included low potassium. Concomitant medication included potassium. On an unknown date, patient had got a 100 fever and very bad headache in his head and in the front of the head, it hurts a lot. And the face, the top and the front is hurting a lot going through the eyes. He has got fever and what I did is I gave him Tylenol treatment, patient also experiencing minor side effects such as sleeping a lot due to bodyaches from the second dose. The outcome of the event He has got a 100 fever; He got up this morning with a high fever was not recovered and unknown for the other events.

Got woken up by intense leg pain around 6:00am the day following vaccination. I took 1000mg methocarbamol, 400mg ibuprofen (split between 2 pills each containing 500mg methocarbamol and 200mg ibuprofen), and 1000mg acetaminophen before a hot bath which relieved pain enough to get back to sleep around 7am. I woke up again around 11am with similar extreme pain, took another set of 1000mg methocarbamol, 400mg ibuprofen , and 1000mg acetaminophen along with 5mg of hydrocodone left over from recent dental work. Pain subsided until approximately 4:00pm when legs started to hurt again before getting to severe levels around 5pm (and so did the back of my neck which was the first neck pain experienced) so I took another set of 1000mg methocarbamol, 400mg ibuprofen , and 1000mg acetaminophen along with 5mg of hydrocodone (which has helped ease discomfort again). Leg pain is not sharp but very persistent and painful and is located behind both knees. Neck pain was sharp and located directly at the back. I have had no arm pain or injection site swelling or pain, just leg pain and neck. I did not experience any side-effects after my first dose, not even injection site pain.

Roughly 12 hours after dose, began feeling chills. (roughly 11 pm on day of second dose). By 2 am, Saturday, symptoms had reached their worse. For the next 12 hours, had hot and cold flashes, along with strong headaches. Nausea when standing or moving quickly. Likely fever. Nighttime acetaminophen taken at about 6 am. By 2 pm the next day, able to stand. Nausea gone, and hot and cold flashes not as bad (but still present). Appetite was poor. Regular acetaminophen taken at around 2 pm. By end of Saturday (10 pm), headache and chill/heat, but to a lesser degree. Nighttime acetaminophen taken at 10pm or so. Next day, Sunday, most symptoms were gone, except for join pains. Neck in particular was sore when head was tilted at all. Monday, all symptoms gone. Maybe some minor soreness.

Patient presented to medical for concerns of right sided radiating neck/shoulder pain. Patient noticed a lump on his neck just before deciding to seek medical evaluation. The pain initially started 3 days after his first Covid vaccine and was followed by night sweats and SOB which spontaneously subsided after one night. The neck/shoulder pain is still present. Noticed a single swollen cervical lymph node that was very tender to palpation. No other concerns found or surrounding LND.

Muscle pain, Arm numbness, Lymph nodes under armpits swollen and tender, malaise, dizziness, drowsiness

About 6 hours post injection, with only a small amount of muscle soreness in the injected arm, I was suddenly very very dizzy. I ran from my living room to my bedroom and got under the sheets, I was very very cold. My whole body was twitching violently, and I had extreme muscle pain. Joints popped like knuckles cracking that I wouldn't normally be able to pop. This lasted for about 10 minutes very violently and then calmed down over another 10, and I just felt very very feverish. I felt numb all over but I was shivering a little. Moving was very hard and my whole back was very sore, with the injection arm in a little extra pain. Fell asleep until about 7:30 am, woke up still a little feverish. I have had waves of extreme dizziness and muscle aches continuing even to today a couple days later. I am also experiencing a rather persistent headache in the very center of my head, making it hard to think. I lose track of my thoughts and it feels like I can't focus, this seems to be improving gradually over time. treatment only included extra fluid intake and over the counter pain killers

Patient fainted about 5 to 10 minute after receiving dose of COVID-19 vaccine. He was very rigid and not responsive to commands. This went on for a few minutes, patient was placed on the ground where he gained consciousness and responsive to commands. Upon coming to patient did say this had happened in the past but he was sorry he failed to mention it.

Pt reports left arm weakness and numbness, chest pain/tightness, and overall does not feel well. does not take any medications

Stuffy nose, fever, chills, sore throat, fatigue, sore muscles beginning 8 hours after receiving 2nd dose of Pfizer COVID-19. Lasted for 24 hours.

-Severe Body soreness lasting one week -Extreme fatigue and muscle weakness lasting three weeks -Frequent muscle twitching lasting four and a half weeks (ongoing)

IMMEDIATELY AFTER INJECTION PATIENT BECAME DIZZY, EYES STARTED ROLLING BACK AND FORTH, PATIENT'S BODY BECAME HOT, PATIENT'S BODY BECAME TENSE AND STIFF, AND PATIENT VOMITTED. 911 WAS IMMEDIATELY CALLED AND PATIENT WAS TAKEN BY PARAMEDICS.

So on the same day, starting at 11PM, my body started to ache and my bones started hurting a lot. I then became feverish and felt cold. As I tried to sleep, I had difficulty sleeping. The next day, I awoke with a splitting headache and my body aching worse than before including my neck which was impossible for me to look around. Still felt a little cold. Head was hurting a lot. Slept better the second night. Awoke on Sunday with mainly head hurting and body aching a little less.

Regular shoulder & arm soreness for the arm of injection at night of vaccination (had the same symptom for the first shot, was no big deal). Shoulder upper body (muscle) soreness started around the second day, and I felt easily tired because of it. The real shoulder pain (both shoulders) came on 5/3 early morning, and I was not able to sleep because of it.

Shortly after receiving his 2nd dose, he developed the expected fever, chills, and myalgias. However, he also developed substernal chest pain that was persistent.

Received first dose of Pfizer on 3/1. Felt tired for few days and was fine. Started having neck and back pain and then extreme heart burn, pain down left arm, trouble breathing etc. Admitted into hospital on 3/20/21 with Triponin Level at 1.8 and Blood Platelets level at 20,000. Fever and resting heart rate of 135 BPM. Extreme heart burn and pain down left arm. Triponin level rose to 4.5. Platelet levels did not increase. After multiple blood tests to make sure they were correct Cardiologist and Hematoligist diagnosed as Myopericarditis and ITP blood disorder. Spent 4 days in hospital on heavy Decadron dose for ITP and levels improved. Myopericarditis being treated with Colchicine and Metoprolol. Was discharged from hospital on 3/24 and monitored at home. ITP levels still fluctuating and Myocarditis and Pericarditis are still being treated. No previous history of any heart or blood problems and no family history. 23 year old healthy male with no previous health conditions.

Swollen lymph node underneath left armpit. Shot was received on left arm. The area was swollen slightly larger than a golf ball for a little over a week and caused discomfort. The area was tender but there was no physical mass in the swollen area. Was uncomfortable to work with and was treated with ibuprofen and a warm compress.

Chills and fever felt approximately 12 hours after the second dose. Muscle soreness all over the body, fatigue, and mild throbbing headaches when standing up quickly we?re felt upon waking up the following morning and lasted through the entire day. Side effects slowly waned after eating dinner, approximately 30 hours after the second dose. No painkillers/pain relievers were used.

Sensitive skin, everything that touched me hurt. Clothes, air, water, etc. 9:00am Aching bones, 5pm, knees, arms, shoulders. Everything felt like i was a 90 year old man. I?m 23.

Sore joints; his butt is still a little sore from falling; dizziness/ light headed; fainting; pain in upper abdomen area; Sweating; Nausea; falling; This is spontaneous report from a contactable consumer (patient). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Apr2021 at 1 pm (around 12:20ish as reported) (Lot Number: FN6206) (at 23-year-old) at single dose in arm right for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations within 4 weeks, no family medical history relevant to AEs. The patient stated he is a pretty healthy guy. All day after getting the vaccine he was fine. He got the shot at like 1 came home took a nap, ate some dinner, and was playing XBOX with the boys when this happened. At around 10:30 pm on 29Apr2021 he went to rub, his stomach just above his belly button and it hurt. He said that he read on line that that area is called the pancreas or liver, it has a lot of names for that area when looking online. He stated it's the left upper abdomen area he felt pain when he pressed on it. It radiated really fast across his abdomen while he was on the phone with mother. The more he pressed the more the pain got sharper, and it radiated right across the abdomen, mainly above belly button not too much in lower abdomen, not much in upper abdomen. It was very sensitive. He didn't have to press hard to trigger the pain. It was almost like the area was inflamed. It happened really fast and that it was his upper stomach not so much the lower part of his abdomen. He felt dizziness and nauseous and like a silly boy he tried to run to the bathroom. He stated that he fell and fainted. His butt was still a little sore from falling. He said when he woke up, he was sweating like he had been out side all day. He did not recall sweating any time he fainted in the past. The side effects were gone after about ten minutes. He was really light headed and had the crazy sharp pain in abdomen for about ten minutes and then it was gone. He had never had that kind of pain. He was laying on the floor for a couple minutes. He went to get his phone, and then sat back down and was sweating. He still had pain at that time but it only lasted about 10 minutes at most. He was still a little bit sore in some joints which was not unexpected. He confirmed that he had a little bit of sweating, and he fainted a little bit. Since the episode he hasn't felt any symptoms like that before, he has not had any pain like gastritis but he has had some random gastrointestinal things before. It's also reported nausea on 29Apr2021. No required to emergency room and physician office. He was on the verge of going to the ER while the pain was there. He was going to go until it stopped and to get checked out. No relevant test. The outcome of the events sore joints, dizziness and butt sore was unknown; for other events was resolved on 29Apr2021. No follow-up attempts are needed. No further information is expected.

As per patient, he got the second dose of Pfizer COVID vaccine on the 05/13/2021, and the following day, 05/14/2021, he had fever with chills and muscle aches; however, those subsided. Then, on following day, 05/15/2021, he woke up with chest pain/pressure like and burning pain throughout the day, and then the patient's pain became more severe; however, it became less around the night, at 11 p.m. and then he went to sleep, and he woke in the morning with the pain, around 3:30 am. The pain was 6-7/10, pressure-like, burning sensation, no radiation, associated with mild nausea.

Pt. developed arm site pain, fever chills and muscle aches day after 2nd dose, 05/14/2021 symptoms resolved by night time. He awoke on 5/15/2021 with waxing and waning chest pain/ burning and chest pressure, seemed too improve but by 5 AM on 5/16/21 was more intense and he presented to E.D. where EKG showed diffuse ST elevations and PR interval depressions. Troponin was elevated at 0.494, increased in next hour to 0.569 and patient was admitted. TTecho showed normal E.F. of 60-65%, nl valves and trace pericardial effusion. CXR was negative for pulmonary infiltrates, (no Hx of Covid Dx) P.E. showed no conjunctivitis, no rashes, all else also WNL

Was doing fine for about 20 minutes while in observation. Then fell out of his chair, was confused, body went stiff, and didn't feel well.

onset of right knee pain on 5/24, followed by left knee pain on 5/26. DVT of left lower extremity diagnosed 5/27

Headache; Nausea; Malaise; Chills; Fever; Fatigue; Myalgia; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (at the age of 23-year-old) (Lot Number: 204A21A) as single dose (unknown if first or second dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myalgia on 10Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 15 hours), malaise on 11Apr2021 with outcome of recovering, chills on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 2 hours), fever on 11Apr2021 with outcome of recovering and fatigue on 11Apr2021 with outcome of not recovered. The events were considered as non-serious. The patient underwent lab tests and procedures which included body temperature: fever, temperature not measured on an unspecified date. No follow-up attempts are needed. No further information is expected.

headache; nausea; tiredness; muscle pain; feeling unwell; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9264) via an unspecified route of administration in the left arm on 09Feb2021 at 01:45 PM as FIRST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had no allergies to medications, food, or other products. 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 has not tested for COVID-19. On 10Feb2021 at 09:15 AM, the patient experienced feeling unwell with headache, nausea, tiredness, and muscle pain. The patient did not receive any treatment. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

3 days of pain at injection side, on the left shoulder. It hurts when lifting left arm. I also had left knee pain after 5-7 hours of receiving shot. Luckily, I had no fatigue, no headache or fever.

My first dose of the pfizer vaccine was relatively asymptomatic. Received at local hospital. Sore arm that lasted a few hours, nothing too concerning. This adverse event describes my second dose however, received Jan 23, 2020, approximately 3 weeks after the first. Again, this was received at local hospital. The next day, I felt the expected side effects of terrible chills, whole-body myalgia, and a slight fever. Again, I was not too worried as this was expected. I could not sleep that night, but otherwise, I felt significantly better in the morning. Unfortunately, on Jan 25, 2 days after the second dose, I began to feel a strange tingling sensation in my forearms, and a pain in my lower back. This paresthesia felt as if the insides of my arms were vibrating, and rather than a "pins and needles" sensation, I felt electric shocks through my forearms and extremely discomforting tingles. I could not bend forward without terrible shocks through my arms, and my back pain can only be described as aching. I immediately scheduled an appointment with my doctor for Monday afternoon, That entire Sunday, it felt as if the tingling sensation, rated at 7/10 discomfort, grew to 10/10. I physically was wincing and turning, unable to find any position where my arms were not experiencing electric vibrations. My back pain, which was tender to touch, and if I pressed hard enough on it or laid on my back, caused the same electric sensation not just in the forearms but the entirety of my upper torso and my arm. Taking deep breaths was painful, as it elicited the same discomforting paresthesia. At the time, I was one of the first groups taking the pfizer shots, and it was still unclear if taking NSAIDs was a good idea to alleviate pains and the suppress the immune response. I agonized that entire Sunday and through Monday morning, the shocking expanding from just the forearms to the shoulders around the deltoid, and the back pain soon covered my entire upper torso. For whatever reason, waist-down I was completely fine. Even bending forward only elicited the pain upwards, nothing ever went down my legs. I had slight neck stiffness, a throbbing headache, intense back aches, bilateral upper extremity paresthesia, and pain on deep inspiration at the height of my pain on Monday morning. By this point, the pain had kept me awake for almost 30 hours. When I finally could see my doctor via telehealth appointment, he prescribed me 800 mg ibuprofen to be taken every 6-8 hours I believe. After taking the ibuprofen, the pain lessened significantly, going from 10/10 to 2/10. I was finally able to go to sleep sitting up straight on a sofa chair. The paresthesia was gone, the pain on deep inspiration was gone, but the tenderness and dull ache in the lower back seemed to stay even on the ibuprofen. I noticed that if I laid down on my back to try and sleep, even with the medicine in full effect, the electric shooting and paresthesia would immediately return. If I quickly removed pressure from that area, it went away. The ibuprofen's effect lasted only about 5 hours. I would take another as it slowly crawled back up to 4/10 pain or if the paresthesia was returning. Over the course of an entire week, I constantly needed to be on ibuprofen. By Friday, so almost 6 days after the shot, the paresthesia and back pain could be completely suppressed by the ibuprofen and I was able to lay on my back with no problems. Without medicine, I was sitting at a dull 3-10 back pain, but the paresthesia was gone. The back pain finally vanished on Sunday, 8 days after the shot, and I no longer needed ibuprofen. No fevers, chills, nausea, vomiting, diarrhea, radiation of electrical pain down the leg, vision change, or loss of bowel/urinary control throughout the course of these symptoms. My experience reported to my primary care doctor, via our health messages. I did not return any contact to hospital or my vaccination site.

Sudden migraine leading to fatigue and all-over muscle soreness which became excruciating and combined with rapid felt temperature fluctuations despite no fever being recorded. Symptoms seemed to die out in a few hours, then came back full force through that night, keeping me awake and in agony for several hours

He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He couldnt sleep because of the pain; Also reports stomach discomfort; Experienced fatigue; Feeling under the weather and restless; Restlessness; This is a spontaneous report from a contactable consumer (patient's mother).Follow-up (06Jun2021) and Follow up (07Jun2021) received from previously reported consumer were processed together along with initial information. A 23-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187; Expiration Date: 31Aug2021), via an unspecified route of administration on 03Jun2021 (at an age of 23-year-old during vaccination) as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included multiple allergic reactions (including drug allergies) after having his wisdom teeth out and had chest muscle pain. The patient's concomitant medications were not reported. The reporter stated that, the patient was not related to any study or programme. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on unspecified date as a 1st dose, single dose for COVID-19 immunisation. On 03Jun2021, the reporter stated that the patient experienced fatigue, feeling under the weather and restlessness. On Sunday early morning, the patient developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid, he could not sleep because of the pain and stomach discomfort. The reporter stated that as of last evening that it was kind of the same. No investigational assessment was reported. The reported wanted to know if her son chest muscles pain was normal or not. The reporter worried if her son needed medical care right away. The reporter concerned about lot number whether there was any issue involved with lot number. The reported stated that, the pharmacist did not follow proper procedure while with the administration of the vaccine however she was unable to identify a specific concern. The reporter was informed to provide information about side effects and to refer to doctor about side effects if there continue. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Around 3:30 am on 4/17/21 typical vaccine side effects started: muscle aches, fatigue, temp. Symptoms continued through day time 4/17. Highest temp 102, took tylenol every 4 hours to help with fever and aches. At 9:30 pm began with continuous strong chest pain/shortness of breath. Nothing made it feel better. 9:45 PM Called after hour line of primary physician, who recommended going to ER. Left for ER at 10 PM. Chest pain had eased somewhat on the way to ER. Was seen at ER. Received EKG, lab work, CT scan, IV fluids and toradol. Chest pain was mild in ER and felt better by discharge around 3:30 AM. Felt normal by 4/19/21 and returned to work. Have seen a few reports in news about myocarditis/pericarditis in males which seem to fit patients experience, so wanted to report the incident.

A few days after my first dose my left arm went completely numb and there is a shooting pain all the way down to my fingertips and up my neck. The pain is so bad it makes me nauseous. This has been going on for a few weeks now and I havent been told anything that will help me get better

recent COVID vaccination on 06/12, who presents for arm pain. He had received his vaccination on 06/12 in the left arm, and states that the next day he noticed a lump in his axillary region, and significant pain. acetaminophen (TYLENOL) tablet 975 mg (975 mg Oral Given 6/16/21 2052) ibuprofen (MOTRIN) tablet 800 mg (800 mg Oral Given 6/16/21 2053)

Severe lower back pain, elevated blood pressure and elevated liver enzymes. CT scan and lab work was done, with follow up with primary physician. Monitoring blood pressure daily and repeat lab work. New symptom 6.22.21 - tightness and soreness in left chest area

Headache; fever (101.2); arthralgia; fatigue; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534) via an unspecified route of administration on 23Mar2021 in the left arm (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and migraine. The patient had known allergies with avocado and strawberries. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number en6205) via an unspecified route of administration on 02Mar2021 in the left arm (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced headache, fever (101.2), arthralgia and fatigue. The patient lab test included body temperature which was measured on 24Mar2021 and the result was 101.2 (unspecified units). The patient received acetaminophen as treatment medication for the events headache, fever (101.2), arthralgia and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of headache, fever, arthralgia and fatigue was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

immunisation. Prior to the vaccination, the patient was 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 28Mar2021, after 12 hours of vaccination at 23:00, the patient experienced shortness of breath, brief fever, chills, muscle soreness, head fog and exhaustion. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were provided for the reported events. The clinical outcome of the events shortness of breath, brief fever, chills, muscle soreness, head fog and exhaustion were resolved with lasting effects at the time of reporting. No follow-up attempts are needed. No further information is expected.

He said he felt light headed at first then like he was going to throw up. Then he started to black out and did blackout eyes went to the back of his head lips turned blue. Then when he came to throat started hurting lungs were tight started sweating. Then his back started hurting and had the cold chills. This was terrifying!!

Patient experienced pain from the elbow to shoulder the evening of vaccination (7/22), expanding to include the hand and wrist the following day (7/23). The 2nd day after vaccination (7/24), patient stated pain worsening to the point that it limited use of his arm. the 3rd day after vaccination (7/25), patient reported to the emergency room for follow-up, No X-ray or MRI was performed. Patient was prescribed a steroid and Norco for treatment, and advised to keep arm in a sling and treat with heat or cold as appropriate, based on symptoms and relief given.

Site: Pain at Injection Site-Severe, Additional Details: Pain starting at injection site, expanding to include arm from elbow to sholder evening of 7/22, on 7/23 expanding to include hand and wrist, becoming more severe on 7/24. Patient visited emergency room on 7/25.

24 hrs after vaccination patient developed nausea, vomiting and fatigue. After 1 week went to ER dx with Aki, Since in followup after ER. Diclofenac stopped d/t aki. Had significant weight gain and was admitted over the weekend. Further testing at the hospital with biopsy of kidney revealed minimal change nephropathy

Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 02/28/2021 Pfizer, lot# EN6202; 2nd dose: 03/23/2021, Pfizer, lot# ER8727. Diagnosed COVID positive: 07/19/2021. Symptoms started:07/20/2021. Exposure: Community exposure. Symptoms: Fever; fatigue; muscle ache; loss of smell/taste.

Injection Site Pain - 20:30 on 11/11 Fevers, chills, myalgias (specifically lower back), headache, nausea, vomiting

Fever; Muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 30Dec2020 (08:45) at a single dose on the left arm, with route of administration and therapy date unspecified, for COVID-19 immunization at a public health clinic. Medical history included COVID-19 prior to vaccination. There were no concomitant medications. On 30Dec2020 (20:00), the patient had fever and muscle aches. The patient had not been tested for COVID-19 post-vaccination, and did not receive any treatment for the reported adverse events. The outcome of the events, fever and muscle aches, was recovered on 31Dec2020.

Pt. states that he started having body/muscle aches, chills, fever of 100 degrees Fahrenheit, headache, nausea at 2100 pm on 1/11/21. Pt. states that symptoms are resolving, body aches on and off, and headache is worse. Denies taking ibuprofen or tylenol.

Migraine; fever; muscle soreness; chills; issues staying asleep; shortness of breath; This is a spontaneous report from a contactable Other HCP (patient). This 24-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),LOT# EL0140 at right arm on 06Jan2021 02:15 PM at SINGLE DOSE for COVID-19 immunization. The patient received his first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 02:30 pm at right arm Lot # EK5730 .Medical history included : Ilioinguinal neuralgia and Migraine without status migrainosus, not intractable.Patient had past drug allergy to Valacyclovir and Nsaids.No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received concomitant medications within 2 weeks of vaccination.On 07Jan2021 at 08:00 AM, upon second dosage of vaccine, the patient experienced Migraine, fever, muscle soreness, shortness of breath, chills and issues staying asleep. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. No treatment received for the events.The outcome of the events was recovering.

Swollen lymph node in armpit for4 days, 99.8 temp for one day, chills, fatigue, headache, injection site pain and swelling, lymphadenopathy, malaise, new or worsened joint pain

Cold chills/sweats in the middle of the night, headache in the morning, muscle aches (not just in the arm of injection), and congestion

Chills(moderate), HA(mild), muscle aches (severe), lightheadedness (moderate), fatigue (moderate) Resulted in leaving work at hospital early

Patient complained of pain in left shoulder radiating to left chest 4/10 and nausea immediately following injection. Response Team called. Chest pain at the side 5/10. Taken to the ED via wheelchair at 1700. No rash, no swelling of lips/tongue or throat.

Woke up approximately 14 hours after receiving dose #2 with body fatigue. My large joints (e.g., hips, knees, elbows, shoulders) started to develops aches/discomfort. A hot shower helped relieve the initial discomfort, and I took 1g of APAP ~45 minutes after waking up. I then reported to work, which is an ambulatory care clinic that is working a drive-up clinic. As such, I had to work outside in ~20F weather. I had 4 layers on my upper body and 2 layers on lower body with wool socks. The cold did not bother me for the first two hours as I was able to return to a warm area between patients; however, as work became busy, I spent more time outside. The aches/discomfort in my joints progressively worsened as well as the general bodily fatigue. I took another 500mg of APAP, but it did not help much more. Eventually, the cold and body fatigue made breathing uncomfortable, and my breathing became slightly labored. Returning to the warm environment helped the symptoms not get worse, but focusing on tasks became slightly difficult. I returned home at approximately 1630, took another 1g of APAP, and proceeded to sleep from ~1730 until 0530 the next morning. I woke up feeling much better.

Mild fever, moderate pain, fatigue, joint pains. Moderate-severe swollen lymph nodes, headache, and chills.

unable to bear weight on legs/could not walk or bear weight; shortness of breath; fever; nausea/nauseous; pain in left shoulder radiating to left chest 4/10; Chest pain at the side 5/10; tried to get up to walk but was very shaky and could not get up to walk/unable to walk/could not walk or bear weight; dizzy/light headed; almost instantly was sharp stinging in injection site; tried to get up to walk but was very shaky and could not get up to walk; WBC 14000, no unit of measurement, normal was 11000; This is a spontaneous report received from a contactable pharmacist and consumer (patient). A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302 and expiry date: May2021), via intramuscular route on deltoid left on 25Jan2021 15:57 at 0.3 ml single for COVID-19 immunization at hospital. Patient did not receive other vaccine in four weeks and in last two weeks. Patient's medical history, family medical history and concomitant medications were reported as none. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number; EL1284; expiry date: Apr2021) via intramuscular route on left deltoid on 04Jan2021 at 10:45 AM for COVID-19 immunization; Hep B Adult Energix-BPFS (HEPATITIS B VACCINE, lot number; 2793Z) on left deltoid on 12Jan2021. Patient received 3 previous doses of HEPATITIS B VACCINE. It was reported that, the patient complained of pain in left shoulder radiating to left chest 4/10 and nausea immediately following injection, Chest pain at the side 5/10 (on 25Jan2021 at 14;00, after second dose of COVID vaccine). Taken to the ED (emergency department) via wheelchair at 1700. No rash, no swelling of lips/tongue or throat. No treatment was given for the events nausea and pain in left shoulder. No COVID was presented prior vaccination and post vaccination. Patient stated almost instantly was sharp stinging in injection site, he felt nauseous, dizzy, light headed, and had chest pains, he tried to get up to walk but was very shaky and could not get up to walk on25Jan2021 at 14:00. Stated that he was wheeled to the emergency room, he was admitted to the emergency room for almost 8 hours. Clarified he was not admitted to the hospital that he did leave that night. He was able to stumble out of the emergency room to go home. Clarified he got the vaccine on 25Jan2021 (his second dose). Stated he woke up next morning on 26Jan2021, unable to bear weight on legs, chest pain, and shortness of breath, fever. HCP prescribed Arnuity for the chest pain. WBC 14000, no unit of measurement, normal was 11000. Patient was unable to walk, nausea, dizzy, lightheaded and having some chest pain and patient was not hospitalized, spent 8 hours in Emergency Room. Outcome of the event fever was recovered on 27Jan2021; nausea, dizziness, was recovered on 31Jan2021; Unable to walk, lower extremities weakness of, shortness of breath was recovering; the event chest pain was not recovered; and for remaining events it was unknown.

Minutes after receiving my vaccine my left arm began to go numb with a full head headache following soon after. I was then moved to the observation area where my chest got tight, I had difficulty breathing and my temperature fluctuated which made me shake. When hives began to show on my face, neck and ears the on-site medical staff gave me a shot of epinephrine and Benadryl and put me on oxygen, during this time an ambulance was called by the staff. When I got to the hospital my heart rate and blood pressure was high, I was given oral steroids to help my anaphylaxis. For days after being released from the hospital I continued to have deep muscle pain and weakness in my left arm as well as a very strong headache

headache, arm feels too heavy, legs feels heavy, neck hurts, face hurts, eyes on fire, back hurts, and hands hurts

The vaccine was received through hospital at Community Health. Pt states that after he got his first Pfizer COVID shot 2 weeks ago he began having excessive fatigue, it got better after a week but pt states still "extremely tired". Pt states that he also had a rash develop the day after the vaccine and it was on his chest and back initially but has spread all over his body. The rash is not pruritic but is very tender to touch. Pt states increase amount of migraines, almost daily. Aleve helps the HAs. He had migraines years ago but they had virtually resolved. He also reports intermittent joint pain in the last few days and some central chest discomfort with deep breaths. He has a hx of chronic IBS like bowel issues after experiencing an infection abroad that took 4 rounds of antibiotics to treat. Treatment: 5 day course of Prednisone 20 mg BID. Tylenol 100 mg TID for aches and HAs. Follow up with PCP.

Itching at site 5-12 hours post injection, severe muscle pain at sight 8-16 enough to wake from sleep in any pressure was applied, 12 hours post injection sever migrain, chills borderline hypothermic, immediate hot flashes as though I was in boiling water, sneezing. All subsided by 24 hours post injection beside migrain which became vary minor and at 24 hours full body soreness and fatigue equivalent to an extreme full body workout set in.

After previously feeling no side effects, at 3am the day following the vaccine I awoke with chills, dizziness, fatigue, whole body arthralgias that I can only describe as feeling like my bedsheets felt like broken glass. Around 6am I measured my axillary temperature to be 100.9 F and took 650 Tylenol once which broke the fever. I was unable to go in to work that day. Now, two days after the vaccine, my other symptoms have resolved aside from a painful, and visibly noticable, lymph adenopathy in my left arm pit the same side as the vaccine.

Excessive ear wax production; acne; immense pain at injection site and in shoulder of that arm; nausea; excessive hunger; feeling/acting inebriated

Nausea and Headaches occurred about 5 hours after the injection, since then they have come and gone periodically, usually lasting about 30 minutes, then going away for a few hours. I have been experiencing tightness in my chest and dyspnea upon exertion since about noon, Tuesday, March 23. NSAIDs have helped relieve some discomfort. Last night, I woke up with racing heart palpitations and tingling in my extremities. Today, I have experienced a sore neck and cramps in my legs, tingling in my extremities, and chest tightness with tachycardia. I have spent the week studying for an exam on Friday, so I plan on going to urgent care afterward.

Severe joint pain, swelling around joints, specifically complete swelling of both ankles. Difficulty bending knees. Pain putting weight on either leg

PATIENT PRESENTED TO CLINIC FOR DOSE 2 OF COVID-19 AT 0920 (PFIZER LOT NUMBER ER8734 EXP 07/2021). AFTER RECEIVING COVID VACCINE DOSE 2, PATIENT COMPLAINT OF "STIFFNESS" ON RIGHT NECK AND "DIFFICULTY TAKING DEEP BREATHS". PATIENT DENIES OTHER S/S. PATIENT TRANSPORTED TO ED BY WHEELCHAIR FOR FURTHER EVALUATION.

On Friday, April 4, 2021 client (DOB 5/3/1996) received his first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 12:56pm. Per EMT report: at 1:06pm, client fell out of chair, landed on his left knee and regained consciousness immediately. Upon assessment, client stated his left knee pain was a 3 out of 10 scale. At 1:07pm, client was sat in the zero-gravity chair in supine position and given a bottle of water. Client stated he "felt pressure in ears-mainly right ear." EMT & 2nd EMT coached client to breathe normally. At 1:09pm vitals were taken: BP: 120/70, HR: 52, RR: 10, O2 sat: 95%, skin: pale, moist, cool, eyes: PERRLA, LOC: A&O x4. Lead RN was notified and advised vitals be taken every 5 minutes for an additional 30 minutes. At 1:13pm vitals were retaken: BP: 120/70, HR: 69, RR: 12, O2 sat: 94%, eyes: PERRLA, skin, pale, moist, cool, LOC: A&O x4. On assessment, client stated he has no history of fainting, no allergies, and not taking any medication. Client stated he had a small amount of food and water intake and was not currently experiencing nausea. At 1:20pm, client stated the pressure in his ear subsided and was experiencing no headache, light-headedness or dizziness. At 1:25pm vitals were retaken: BP: 120/70, HR: 69, O2: 98%, skin: warm, pink, dry, LOC: A&Ox4. At 1:35pm, vitals: BP: 120/78, HR: 72, RR: 12, O2: 96%. Client was lowered to sitting position in gravity chair. No changes in vital signs were assessed by EMTs. At 1:40pm one final set of vitals were taken: BP: 120/76, HR: 66, RR: 13, O2 sat: 97%, eyes: PERRLA, A&O x4, skin: pink, warm & dry. At 2:15pm, client was able to safely stand up. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up. Client left vaccination site at approximately 2:15pm with a steady gait. A family member was able to pick him up and drive him home.

Pfizer-BioNTech COVID-19 Vaccine EUA Full-body muscle tightness, Extreme Full-body pain, delirium, violent shaking, fever of 105 F, Extreme shortness of breath, vision impairment. All adverse effects lasted for approximately four hours Ambulance would have been called but inability to move/speak prevented call for help

Sitting in general observation area, began screaming and holding his head with clenched arms and hands. 1000 became rigid, suspect seizure, EMT reports syncopal episode. Assisted per EMT to w/c and taken to private observation area. BP 84/52 HR 54 O2 96% on room air. Color pale. EMT remains present. Offered patient water. Patient oriented x 3, Educated on taking next vaccine while lying down. Sister states patient has history of passing out while donating blood. Patient has needle phobia 1011 patient eating cookies and drinking water without difficulty. PB 105/79 HR 80 O2 98%. Denies dizziness, lightheadedness, Denies headache. 1015. STood at w/c - no dizziness. Patient states he feels well enough to leave, gait steady, ambulated to POV

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium

The first few days it was extreme muscle pain in my shoulder and arm. My arm was swollen for about 3 days, I couldn?t move my arm for almost a whole week. My muscles were very weak in the arm and hurt to put pressure on it and couldn?t lift my arm. It has gotten better but it has now been 3 weeks and I am still experiencing some muscle pain and weakness in my left shoulder. The shit was administered in my left arm directly below my shoulder bone. I still can?t move my arm to shoulder height or higher with feeling pain and weakness in the muscle.

I experienced chills, which intensified in the evening into full body shudders before finally calming. Alongside this, I felt extremely sore, especially in the joints and feet, like they had or were being pressed or squeezed. This made it hard to move around or get out of bed. I also experienced a headache, and likely a fever. I had similar symptoms after my first shot, but while those symptoms were still noticeable and took me out of work, I had a much stronger reaction this time around. I have been experiencing a sore neck and shoulders due to tension even until today.

I feel arm snoring, high temperature, dryness and fever. I feel tired and very cold and my bones hurts. This began after 3 hours of my shot and continue until the moment of reporting.

Immediate Effects: 10 Minutes - Heat Flash, Feeling of Fainting, Gasp for Air (Lasted 20 seconds) Post-Immediate Effects: 45 Minutes - Extreme Difficulty Breathing while driving; Symptoms of Panic Attack Set in (Never Had a Panic Attack Prior - Arms, Legs and Lower Jaw was tingling and numb; Could not speak; Difficulty in Dialing 911 from rapid finger movement.) Received Medical Attention from EMT and chose to go home when severe symptoms subsided after 20 minutes. Long Term Effects: Day 2 to Present: Difficulty breathing, confusion, unable to do any physical task (walking up stairs) without being dizzy, disoriented and gasping for air, pain near arteries in neck, knee and heart - with each pulse. On 4/12/2021 - Urgent Care Visit - Long Term Symptoms Present. PulseOx read 96; Tested Negative for COVID-19. Nurse Practitioner recommended ER if condition worsened. On 4/17/2021 - ER Visit - Severe Long Term Symptoms Present. Blood Panel Done; Chest X-Ray, EKG, Brain MRI. ER Doctor recommended seeing neurologist, immunologist and cardiologist.

Pt. reports left arm pain/heaviness after receiving 2nd dose of vaccine. Pt. was given 2nd dose in the right arm. Pt. described the feeling in his left arm as aches and mild heaviness. He reports pain in his left arm after the first dose that went away after a few hours. He denied chest pain and chest tightness, swelling, itching, and syncope. Pt. appeared stable after vaccine. He improved after further observation. Pt. given directions to go to ER if symptoms worsen.

acute sharp pain in lower rib cage , HR elevated to 150's while walking then went back down to 110 after 5-10 minutes , HR is now 92 ... and coolness in L arm for 10-15min He states he used marijuana an hour prior to the onset of these sx. Called his mother and was advised to call the COVID hotline and report RN recommended that he self monitor and to discontinue the marijuana for a few days to make sure that didnt exacerbate or cause the reactions. He was agreeable

Woke up in the middle of the night, 12 hours after the shot, with uncontrollable chills, nausea, headache, and fever. Had to stay awake from 3am-5am because on the verge of vomiting, but never did. Kept sipping water and took 2 ibuprofen. The symptoms dulled slightly after 5am but had a 100 degree fever all day, along with full body muscle soreness and couldn't leave the couch more than a few times because of moderate nausea, headache, and soreness.

He states he had the first Pfizer COVID-19 vaccine in the series on 4/13/2021. He states that two days later on 4/15/2021 he felt like his feet were heavy. He continues to experience that sensation in his feet, and even feeling like his feet are asleep at nighttime and when he first gets up in the morning. The asleep feeling in the feet gets better when he gets up and moves around but the heavy sensation in the legs does not get better. He states that his mobility is affected though that his legs feel heavy and he is not as easily mobile as he used to be. He feels his balance is off. Patient later reported that he did have and episode of syncope about 5 minutes after he got the vaccine but otherwise was doing okay until 4/15/2021. He presented to the ED with these symptoms on 5/3/2021 at approximately 7:14pm and was admitted to the hospital for evaluation. Patient states that he normally exercises regularly and has been having a great deal of difficulty especially with squatting and now has difficulty walking up stairs, feels very weak and his legs feel heavy. He reports that the numbness and tingling sensation of his feet when sleeping is new and he has never had it in the past. Symptoms get worse with exertion and prolonged activity. Neurologist was consulted and several tests were ordered. Neurology consult noted that patient had a prior COVID 19 infection in November 2020. Per neurologist notes: His symptoms first started about two days after he received Pfizer COVID vaccine on April 13, 2021. He recalled feeling his feet heaviness and it was hard to pick them up. He also had some calf pain. He also had difficulty with doing his stretches and yoga positioning. A week ago, he began to have difficulty with picking up a ball or anything from the ground. He also developed pins and needles at the fingertips at the same time he developed tingling sensation of his feet. He also has lower back pain. He tested positive for SARS-COV-2 antigen on November 12, 2020. He recalled having symptoms lasting for a few days consisting of diaphoresis, cough, and flu-like symptoms. Per neurologist, symptoms seem to resemble acute inflammatory demyelinating polyneuropathy (AIDP). Patient was treated with IVIG for 5 days.

Patient states he was in his normal state of health prior to the vaccine and then started to notice left foot numbness and tingling along with left hand weakness/tingling approximately 5 minutes after his vaccine administration in the left arm. Patient denies any similar reaction with the first dose of the vaccine. Pt denies any anxiety about the vaccine or previous reactions to other vaccines. He states the left hand weakness seemed to have resolved over about 2 minutes but the strange feeling in his foot persisted. The original numbness seems to be better, but he has a persistent icy-hot feeling confined to the left foot. Pt denies any trauma to the limb. He is able to ambulate normally. No concerns for TIA/stroke, reassuring neurvascular exam. Patient was evaluated for an additional 30 minutes in the medical department aboard the ship with no resolution of foot symptoms. Pt given return precautions and advised to proceed to ER with any progressive symptoms.

Tingling sensation in hand of vaccinated arm for approximately 30 minutes after vaccination, ongoing upper arm pain of varied severity throughout the day and between multiple days, mixture of achy pain, sharp pain, and feeling of tightness, occasional muscle twitching; treatment of gabapentin for potential nerve irritation ongoing

Pain in the muscle. Later in the day, pain and slight swelling developed in the lymph node under left arm pit. Took 200mg Ibuprofen. The pain generally resided the next day.

Patient fainted, was out for approximately 5 minutes, complained of sore neck. Patient refused ambulance

24-year-old male with no prior medical problems presents for evaluation of chest pain. Patient complains of midsternal chest pain that started approximately an hour ago. He states that it woke him up from sleep. Pain is sharp without any radiation or other associated symptoms including diaphoresis presyncopal symptoms or palpitations. He denies any significant air hunger or shortness of breath. He otherwise had been feeling better after what he tall was post COVID vaccine symptoms. Patient received a 2nd dose of pfizer vaccine 3 days ago. He states that within 24 hours he had symptoms of myalgia fever and feeling unwell. That has been resolving patient has been feeling better until the chest pain today. Patient otherwise denies any other medical problems in. He denies any history of drug use including any recent cocaine or other drug abuse. Elevated cardiac enzymes and chest discomfort are likely secondary to myocarditis and secondary to vaccination/ inflammatory reaction. Although there is low likelihood of obstructive coronary artery disease as well. I recommended cardiac catheterization for clarification. He does not want to have the procedure done, understands the risk of undiagnosed coronary artery disease and risk of MI. He would like to be discharged home. I reviewed the images of echocardiogram and it seems that he has a small area of hypokinesis in infero basal segment. Recommended to take aspirin and be seen in Cardiology office in 2 weeks. Advised to abstain from exercise and significant physical activity till that time and return to the hospital if any symptoms. Subjective: I saw patient in consultation for evaluation of chest pain and elevated cardiac enzymes. Patient is a 24-year-old healthy male who had COVID-19 vaccination with his second Pfizer shot 4/14/21. He developed fever, chills, nausea and vomiting 1 day after vaccination. He did not have any reaction to the 1st dose. He presented to the hospital with substernal chest discomfort which woke him up from sleep, radiated to throat and had a throbbing feeling. This lasted for 1 to 2 hours and subsided completely in the hospital. He smokes 5 cigarettes a day, is physically very active and exercises regularly. He is not on any medication at home.

Sore arm (like the first shot?s side effects), but most notably, muscles aching in entire body, noticeable increase in body temperature (felt like a fever, temp was 99.5)

MYOCARDITIS. I experienced extreme chest pain, tightness, shortness of breath, painful heart beats, I could feel each beat. I hunched over in my bed groom grabbing my abdomen and fell onto my bed and almost passed out from whack I?d assume is lack of oxygen. I could barely breathe for about five minutes and felt relatively severe pain particularly in the right side of my chest. I could feel every muscle, tendon, and artery inflamed, enlarged, and hurting. My chest felt like it filled up with a balloon. Heart rate went up too. I have NEVER EVER felt ANYTHING like this in my LIFE. Not even close. It was a brand new sensation to me first time I?ve ever felt anything like this at all, and very intense and frustrating. Keeping in mind I am in perfect health. I am a body builder with a perfect physique. I work at a high end restaurant and have an extremely good diet. I have a normal sleep and sexual routine, I don?t use any medications whatsoever even Tylenol or ibuprofen. I have no pre existing conditions. I have no history of heart or cardio problems. My family has a history of low blood pressure. I have next to no stress or anxiety in my life. I am 24 years old I work out and run miles, five to six days a week. I don?t use nicotine, tobacco, and I haven?t had a drink of alcohol in ten years (14yrs old). I smoke marijuana on a daily basis. After about ten minutes the incident went down and I was able to breathe a little better but still had pain and tightness in my chest. I have had shortness of breath ever since. This is being written the day after the event about 26 hours later. I ran a mile last night and went to the gym it seemed to help both my breathing and the pain and tightness but it has not fully gone away. I feel my heart straining somehow as I am typing this. One thing to note is I did not want to get vaccinated but was pressured to do so, and before getting it I was very nervous and honestly upset. The woman administering it was not helpful at all and actually mocked my unsureness and was very rude and unprofessional. She didn?t answer any technical questions I had. During my interaction with her between my nerves and her behavior I?m absolutely certain my heart rate was elevated at the time of getting the shot. I have only had one shot. The episode of myocarditis occurred two weeks after my first shot. Two days after my scheduled second shot, which I missed because of work and was going to reschedule before this occurred. I am not going to be getting the second shot. Will be following up with my primary care doctor as soon as possible. Haven?t had time.

Fever for 2 days post vaccine, diffuse headache and mild pharyngitis, chronic back pain, discharged AMA to go see his other oncologist about chemo as that helped improve his back pain last month

Since my second shot of the vaccine, I have been experiencing chest pain. My chest feels tight and hurts a little bit. Any psychical exertion causes the tightness and pain to increase a lot, like i'm being stabbed by a knife. If I go on a walk, it gets really bad and I start to feel it in my throat and back. It subsides if I lay down or sit still for a while. It seems to be caused by movement and exertion. Also, my left toe is now partially numb. It is not fully numb, but feels like pins and needles when I touch it. This has been happening since I got the second shot I think.

Woke up with chest pains when breathing, overall tightness with sharp pain in the right pectoral as well as neck pain. Waited a week and then went to an urgent care for symptoms and they sent me to ED. After evaluation I was admitted for more testing and started on treatment. Discharged on 6/10 taking ibuprofen and colchicine with outpatient follow-up on 6/17/2021.

Feel like I'm experiencing myocarditis, it felt like a sore muscle in my chest, and gradually went from one pulse of pain to a mild constant pain, about a 2 on a scale of 1-10

Muscle pain; Chills; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- EN6207) via an unspecified route of administration in an unknown anatomical site on 18Mar2021 (at an age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient experienced muscle pain, chills and tiredness. No treatment was received for the event. The clinical outcome of muscle pain, chills and tiredness were not recovered. This follow-up (17Jun2021) report is being submitted to amend previously reported information: patient's initial added in first name field in patient tab, final sentence should be No follow-up attempts are possible. No further information is expected. since reporter is non-contactable. No follow-up attempts possible. No further information expected.

TC to Client and spoke with patient. Patient received COVID 19 vaccine on 6/30/2021, at 1400. Around 11:00 pm, on 6/30/2021 symptoms started, feeling warm, chills, sweats, headache, body aches, joint pain, brain fog, dizziness, lightheaded, slight coughing episodes, swollen lymph nodes. Per patient, had one time episode of vomiting, having abdomen pain and mild diarrhea. Per patient, some symptoms have subsided, no follow up for medial treatment and has not taken any medications. No underlying medical condition, but is a former smoker, as of two weeks now. PHN recommend that Client follow up with PCP and to call 911 for medical emergency. Patient verbalized understanding information provided by PHN.

On 7/4 starting at 9 am until noon, he had substernal chest pain,with radiation to his left upper arm and 4th & 5th fingers. On a scale of 1 -10, it was a 6-7 at its worst. Though the pain stopped, he continued to have nausea, decreased appetite, but did not vomit. On 7/5 the pain started again and this time was associated with clammy hands and transient shoulder pain. he states he had Pfizer vaccine, 1st dose on July 2, 2021.

Approximately 12 days after the shot, May 12, 2021, I began feeling numbness(pins and needles) in my feet. My feet felt swollen and it was hard to stand or walk. I dismissed it and went on with my day. For the next 11 days my symptoms progressively got worse. On May 16, 2021 my friends and I traveled. By the end of the trip my legs became very weak, hard to walk and trying to stand up was becoming almost impossible. Returning from travel, May 23, 2021, I had a constant numbness in my legs and hands. I decided to go to my parents, because I live alone, just incase I didn't get better. On May 29, had 2 falls. Admitted to hospital on June 2, diagnosed with GBS and treated with 5 rounds of Plasmaqherisos. discharged June 14 to outpatient physical therapy

Slight dizziness; Fatigue; nausea; Body ache; Sore shoulder; Stiff shoulder; getting hot then cold with no fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 24-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 arm right on 01Apr2021 at 14:15(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included Advil, Amphet/Dextr, Buspirone, Vitamin D3 (MANUFACTURER UNKNOWN FOR ALL) from unknown date for unknown indication. Medical history was not reported. 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 02Apr2021 at 07:45 the patient experienced Slight dizziness. On 02Apr2021 at 07:45 the patient experienced Fatigue. On 02Apr2021 at 07:45 the patient experienced nausea. On 02Apr2021 at 07:45 the patient experienced Body ache. On 02Apr2021 at 07:45 the patient experienced Stiff shoulder. On 02Apr2021 at 07:45 the patient experienced Sore shoulder. On 02Apr2021 at 07:45 the patient experienced getting hot then cold with no fever. On 02Apr2021 at 07:45 the patient experienced Headache. The clinical outcome of the event slight dizziness, fatigue, nausea, body ache, stiff shoulder, sore shoulder, getting hot then cold with no and headache was not recovered. No follow-up attempts are needed. No further information is expected.

Patient experienced diffuse muscle weakness in all 4 extremities, beginning 2 days after the 2nd dose of the Pfizer COVID-19 Vaccine. It progressed equally in upper and lower extremities. 4 days after vaccination, he was unable to walk and couldn't stand from a seated position. Presented to the ER and had a 5 day hospital stay. His upper extremities graded 4/5 strength, his lower extremities graded 3/5. Initially throught to be Guillan-Barre Syndrome, he received 5 doses of IV IG over 3 days. Reflexes preserved throughout his stay. He was treated by physical therapy and occupational therapy throughout his hopsital stay. He improved dramatically over the last two days of his stay and was discharged home with home PT.

Nausea, diarrhea, chills, body aches, shortness of breath, fatigue, muscle aches, headache, sore throat

Sharp throbbing pain in the left arm pit. Dull nerve pain shooting down left arm from shoulder to wrist. Pain started the morning after vaccination. Swollen and tender shoulder noted with limited mobility and range of motion. Had no other health condition or disability prior to this.

Right shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), via an unspecified route of administration in the left deltoid on 22Dec2020 at a single dose as preventative and to protect the people around him. The patient had no relevant medical history and no concomitant medications. The patient stated that ever since he got the vaccine, he has had shoulder pain (onset date was on 24Dec2020). He was unsure if it was joint or muscular. When he raises it to a certain level, there was intense pain. This was only his right shoulder, he got the vaccine on his left side. The pain had stayed the same. It goes away every so often and then it comes back, that was with him helping it. He had used heat, taking Advil, and sometimes icing it. It had stayed the same and it has not gone away and it has not improved. The patient thinks his dose was 3mL, if he can recall. He stated that he did have one question. He was about to resume classes at his college and they were requesting that he took a tetanus shot and get a TB skin test. He was trying to figure out if that was okay. He remembers reading something that he should not get another vaccine at this time. If that was true, the patient was inquiring what was the time span. Outcome of the event was not recovered/not resolved.

Rapid onset of headache, muscle aches, joint pain, and fever the evening after getting the shot. Injection arm soreness, general weakness. Minor cough, and possible throat swelling. Swollen lymph nodes. Treated fever with cool washcloth to the head all night . Fever reached a maximum of 103 °F at midnight. Around 5:30am took ibuprofen. All symptoms subsided by late morning around 9:30am, except for slight headache.

On December 16th, I received my 1st dose of the COVID-19 Pfizer vaccine at 11:49am. I was off of work for the remainder of the day and driving to an appointment at a different town. Between towns, during the drive fatigue settled in and I started to get drowsy. I switched seats and fell asleep for some time in the vehicle. I had fatigue for about 3-4 weeks following the 1st dose. On December 23rd, my symptoms started to get worse. Headaches increased, muscle pain/aches, chills, fatigue and this was the first day I had a temp of 100.4. I took some Tylenol and it made it bearable for me to continue to work throughout the day. From 12/20-26/2020, I kept feeling like I had a cold or the flu. Through the Holiday, I remained in bed and didn't have energy to do anything. I still had all the symptoms and decided on December 28th to call into work and get seen for a Telehealth. Some lab work were done and test results came back. I'm still working with my provider on figuring out what's going on with me.

Headache, Myalgia, Diarrhea, NauseaVomiting, chills, sweats Narrative: 1/9 employee woke up with a headache, chills and nausea. He threw up and felt better. Then he had sweats and diarrhea. He threw up 4 times throughout the day until about 3:00 in the afternoon. He called in sick for work. He also had minor aches and pains. He felt better on Sunday though he still had headache, body aches, sweats, and diarrhea. All symptoms resolved as of 1/11. He took tylenol and Nyquil which helped.

Nausea; vomiting; Fever with chills; Myalgias; Upper respiratory tract congestion; Injection site pain; patient received the second dose of BNT162B2 on 05Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via intramuscular on 05Jan2021 13:00 in left arm at single dose for covid-19 immunization. Medical history included none. Allergies to medications, food, or other products was no. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 10:00 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered was in hospital. The patient experienced nausea, vomiting, fever with chills, myalgias, upper respiratory tract congestion and injection site pain, all on 06Jan2021 03:00 with outcome of not recovered. Treatment of paracetamol (TYLENOL) was received for the events. All events were reported as non-serious.

1/16/21 - 3:40 PM - Metallic taste in mouth 1/16/21 - 3:45 PM - Chills 1/16/21 - 3:50 PM - Neck / Back soreness 1/16/21 - 3:55 PM - Lightheadedness 1/16/21 - 6:45 PM Difficulty Breathing / Lung Pain, tiredness 1/17/21 - Arm / Body pain, difficulty sleeping, tiredness 1/18/21 - Arm / Body pain, difficulty sleeping, tiredness 1/19/21 - Full body aches, arm pain, lightheadedness, dizziness, tiredness

Focal pain at injection site; chills/tremors; elevated body temperature; body aches; mechanical allodynia; neck/join pain and stiffness; substernal chest pain radiating to abdomen and right side of neck and jaw. All symptoms began to present approximate twelve hours after vaccine administration. As of 36 hours post-vaccination, symptoms have diminished, but not completely resolved.

25yo M with no sig PMHx or FMHx for ACS presents with 4 days of viral symptoms: f/s/c/myalgia/fatigue/HA that progressed to include CP for last 3 days. Classic positional CP, dull pressure, worse lying flat, better leaning forward, feels every heart contraction. Work up consistent with Acute Pericarditis and treated outpatient with Ibuprofen and Colchicine. symptoms worsened and he was evaluated and admitted overnight hospital for observation due to elevated troponin and STE on EKG. Pt stable and discharged next day.

I received the 2nd dose of my Pfizer COVID-19 vaccine on 01/25/2021 at ~7:30am, at around 2:00pm I noticed I had generalized fatigue, a general sense of feeling cold, and the muscles in the back of my neck were sore, which was causing a tension-like headache. The fatigue gradually increased throughout the day. I attempted to go to bed around 11:00pm and I was so cold my entire body was shivering to a point where my whole body was shaking. I also began noticing muscle cramps throughout my body as well, primarily located in my calves. Eventually fell asleep around 2:00am (symptoms were preventing me from falling asleep), when waking up noticed the symptoms had resolved.

Muscle tightness; soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 14Jan2021 13:15 at single dose for Covid-19 immunization. The patient's medical history included Penicillin allergy (reported "known allergies: Penicillin". Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (20:00), the patient experienced muscle tightness and soreness at the injection site up to 24 hours post injection. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

The night following 2nd vaccine, I experienced fever, chills, headache , injection site muscle soreness and overall myalgia.

Shortness of breath at rest, chest tightness, coughing with deep breathing: approx. 48 hours after the vaccination Otherwise, normal flu-like symptoms between 12 to 24 hours: - pounding headache - night sweats - feverish - muscle aches - fatigue

Received dose 2 of COVID vaccine. Within 12 hours of receiving the vaccine, started to have intensifying symptoms all of a sudden: low grad fever of 100.0, cold chills, cold intolerance, a migraine, joint pain, muscle pain, injection site pain, increased hart rate and a heaviness in the chest that made it slightly more difficult to breathe. At 24 hour mark, only injection site pain and headache persisted. Reported injection site swelling 36 hour after vaccination.

I, the patient am reporting this after speaking with my neurologist today, after receiving the first dose of the covid vaccine I starting experiencing excruciating migraines, migraines that felt like when I was NOT treated for my chronic migraines. Prior to the vaccine I had been stable on topiramate and was only experiencing about 1-2 migraines a month and was fine with sumatriptan. However, after the first dose of the vaccine I experienced muscle pain across my arms/shoulder/shoulder blades/neck that attributed to my head hurting. This pain has not subsided since the second dose but has decreased in its severity. Basically, the pain is still there, but it is not as excruciating. I am able to still go about my day, and I no longer have the arm/shoulder pain, but the migraines have not gone away. After speaking to my neurologist, he feels that the vaccine most likely triggered the muscle pain as that is a very common reaction which spiked the migraines to resurface, which is why I wanted to report this AE, especially because it has caused my prophylactic treatment (topiramate) and acute treatment (sumatriptan) to BOTH fail and I am needing to have my medications readjusted in order to deal with these migraines that have not subsided over the 3 weeks since the first vaccine. My neurologist feels that these migraines MAY subside, but he cannot rule out that they may never and I may need new/stronger therapy for them.

Patient came in for 2nd vaccination and stated that his neck started hurting a couple of hours after the shot. And at time of 2nd vaccination, his neck was still hurting and he could barely turn his head. Pain is easing up but still sore.

Acute shoulder pain at site of shot, has spread underneath into armpit. Fever and acute tiredness for 12+ hrs the day after, low fever and tiredness second day after.

10:40AM Apprehension. Patient stated that arm felt weak right after shot, and he's a little anxious about the vaccine. Vitals signs: 10:45am 121/78 75 13 O2 98%; 11:00am 122/80 70 13 O2 100%; Disposition: After 20 minutes he felt ok going home.

Soreness under left armpit on the second day of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9244), via an unspecified route of administration, in the left arm on 15Feb2021 at 17:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included haemophilia, congenital emphysema, pneumothorax, and allergy to adhesives on foot, all from an unknown date and unknown if ongoing. 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's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 at12:00, the patient experienced soreness under left armpit on the second day of the vaccination. It got better, and then got worse on the 7th day following the vaccination. The patient did not receive any treatment for the event. The clinical outcome of soreness under left armpit on the second day of the vaccination was not recovered.

Around 6 pm the same day of first pfizer vaccine (3/18/21), i woke up from a nap and my back hurt so bad that i couldn't leave the bed without falling out. My parents came and helped me out and gave me painkillers but really nothing helped. Next day, it started down my right arm (the arm NOT injected with the shot) and it started to hurt in my muscles everywhere and hasn't stopped to this day (3/25/21). Numbness and pins and needles feeling have occurred in my pinky and ring finger of right arm. Pain has now started in my knees as well after a few days from the shot. No pain killers work and I'm unable to write or type properly, or even work at my job frankly. I can't hold an object without it falling out of my hand, and when i am able to hold something, after about 2 seconds pain fills my arm. Nothing helps the pain. I saw my primary care physician on 3/25/21 and the PA said there wasn't anything to do for the intense pain i was having except take tylenol arthritis, melatonin (to help me sleep through the pain), exercise (even though it may cause me even worse pain), and a stress ball for my arm. I don't know what else to do with this pain and this was only the first round of shots.

I had chest pains that felt like tightness of my chest. Friends and family said it sounded like a heart attack (despite being only 25 years old). It hurt to sit up or maneuver my chest/rib cage in any manner, for example, a sit up caused extreme pain. The pain was consistent throughout the day. After it began to dissipate, it was only reproducible when my chest/rib cage was moved or had pressure put onto it. Went to the doctor, diagnosed me with costochondritis. Received an anti-inflammatory shot. Reduced the pain. From initial pain to full recovery was about 3 days (if memory serves correctly, VSafe should have the correct dates as I responded accurately there). A slight discomfort in my chest did occur after my second shot, but nowhere near the same amount of discomfort.

Adverse event started the morning of 3/10/21 around 08:00 am. Symptoms included headache, fatigue, brain fog, memory issues, feeling feverish, and itching on torso, arms, and legs . Symptoms seemed to improve over the next week or two before worsening again on 3/27/21 around 10:00 am. On the day of 3/27 /21 I experienced headaches, fatigue, brain fog, memory issues, muscle aches, diarrhea, and vision problems. Currently on 3/30/21 symptoms have improved but I am still experiencing dull headaches and brain fog, as well as itching on torso, arms and legs and some vision problems. I have not seen a provider for these issues but have an appointment scheduled for 3/31/21. Treatment includes ibuprofen as needed.

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms included severe fever, headache, nausea, lack of appetite, chills, fatigue, joint paint beginning approximately 12 hours after administering of dose and continuing for about 18 hours after onset of symptoms. Treatment involved two acetaminophen every 12 hours after onset of symptoms for about 36 hours, a total of 3000mg of acetaminophen.

Reported fever, chills, chest pain, sweating, body aches, fatigue, and confusion 4/2/21-4/3/21. Symptoms resolve by 4/4/21. Right rib/flank pain started 4/6/21, rated 2/10, increased in frequency today 4/7/21.

At 1455 client had a vasovagal syncopal reaction following 1st dose of Pfizer vaccine. Client stated he had a history of syncope and anxiety with injections and blood draws. No injuries were sustained and client regained consciousness with sternal rub and verbal prompts. Client was unconscious for less than 20 seconds. Vital signs were obtained and were within normal limits. Client denied shortness of breath, headache, nausea, vomiting, diarrhea, dizziness or blurry vision. Client's pupils were PERRLA. Client complained of feeling stiffness and cramping in hands and arms. Paramedic was able to flex hands and arms without resistance, capillary refill was less than 2 seconds. Client offered 911 evaluation and declined three times. Client left via wheelchair and released to care of significant other following a 60 minute observation time and stated resolution of symptoms.

Sore left shoulder immediately, Sore left leg hours later Unable to sleep soundly, began to become feverish over night Difficulty moving in the morning, severe aches all over body Specifically my thighs incredibly achy, felt like bones were hot, by the late morning, Took a hot bath to relax, reduce pain, worked, but became very faint Took Tylenol and Ibuprofen, ate lunch, rested, slowly felt better by evening, slept, and was perfectly fine the next morning 48 hours later

Swollen armpit lymphnodes around 11am, followed by body chills and muscle aches. Fatigue happened around 3. After Tylenol chills went away after 7 hours but my armpits still hurt 24 hours later.

Patient suffered from an LOC with contractions. Vital signs were taken. BP 82/47, HR 44, O2 sat 100% on room air, glucose 89. Patient taken by ambulance to ER for evaluation.

Had flu like symptoms for 24 hours about 12 hours after I received my 2nd shot. I had a fever, the chills, muscle soreness through out my body. This lasted for about 24 hours as I feel fine now.

Nurse at clinic incorrectly diluted a Pfizer vaccine vial with 0.8 ml of sodium chloride instead of 1.8 ml of sodium chloride and administered 0.3 ml to the patient. The patient experienced 104 degree fever with vomiting, dizziness and extreme muscle joint pain. We explained to him that we noticed the dose he was given had been diluted improperly and he had received a slightly higher than normal dose. I apologized for the incident and he said ?it?s ok?, and that now he knew why he was so sick. He was very pleasant and appreciative of us trying to contact him over the weekend. He was encouraged to contact us with any questions or if any new symptoms arise. We also offered to have one of our providers contact him to discuss further, but he declined.

Tingling chills, muscle ache, headache, bouts of nausea, completely weak and feeling like falling over, drowsiness

with small amounts of blood in vomit; Pain in right arm; back and head ache; back and head ache; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (lot number and expiration date: unknown) at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies with Nyquil. The patient had no other vaccine in four weeks, had no COVID prior to vaccination and was not tested post vaccination. The patient experienced pain in right arm, back and head ache, nausea and vomiting, with small amounts of blood in the vomit on 11Apr2021 at 02:00. No treatment was administered for the events. The events were resolving at the time of the report. Information about lot/batch has been requested.

On Wednesday April 14th I got my second vaccination shot. The following day I had a 103 F fever, body aches, chills, migraine, sore muscles, couldn't walk, excessive thirst. Those effects lasted all day and I felt better on Friday. Saturday night chest pain started along with sore arm getting worse. I took ibuprofen and melatonin to sleep. Woke up Sunday morning and pain came back and gradually got worse until I went into the ER around 9 am. They gave me Morphine to put the chest pain at bay. Then transferred me by ambulance to a different hospital with a cariology department. They treated me as if it was Myocarditis and also got an x-ray of my chest. The next morning I had an MRI and that is what confirmed it to be Myocarditis. I was then discharged with lots of medications to keep the inflammation down.

Symptoms: arm pain, fever, headache, chills, thirst, tiredness, joint pain. Length of most severe symptoms: 48h. Strong arm pain in the first evening after the vaccination (April 28) which caused poor sleep. Fever and chills start that night, along with excessive thirst. Arm pain alleviates first on the 29th, but fever lasts for the entire day, around 37.8C. Tiredness and light joint pain are also present. In the morning of April 30th, 48h after the vaccination, most symptoms are gone and only a light arm pain remains.

Headache, Joint Pain, Eye Muscle Pain, Skin Sensitivity, Injection Site Pain. The joint pain and injection site pain lasted roughly two days after the vaccination. All other symptoms still ongoing as of two and a half days after vaccination but with less intensity than the first two days.

Chills, headache, nausea, fatigue, light soreness through body, joint pain in hands it was worse in arm shot was administered

25-year-old male with a history of exercise-induced asthma who presents with headache, myalgias, nausea, vomiting as well as sudden onset chest pain with diarrhea in the setting of recent Covid-19 vaccination. He was found to have diffuse ST elevations and PR depressions on EKG with downtrending troponins from 0.15 ng/mL and admitted for myopericarditis.

Headache, fever (100 degrees plus), chills, tiredness, joint aches, flashes of pain in very specific parts of my body (not near the injection site), sore arm to the point it hurt to raise above shoulder level.

Fever, chills, headache, vertigo, nausea, fatigue, heart palpitations, muscle & joint pain. All symptoms except headache, vertigo, and fatigue have resolved as of 05/06/2021.

9 hours after the shot I started to feel really groggy and sore with my left arm hurting. 12 hours in I started to feel like I had a fever so i checked it and it was 102 degree F, I was also unable to pick my left arm up due to the pain and my whole body hurt a lot. 13 hours in at about 10 pm that night I started full-body shaking violently and needed help from my parents into my room because I could not walk because my legs were wobbling so much. I felt lightheaded and the shaking continued for about 20 minutes. During this time I checked my temp again and it was 105 degrees F. Once the shaking stopped the fever and intense pain continued until 2 am when it dropped down to 102 degrees F and I was able to fall asleep. The next morning I woke at 8am with a temp of 100 degree F with the same all-over-body pain that lasted all day but the fever dropped until that night. That night it came back at 100 degrees F. This cycle lasted from when I got my shot on the 1st until 4th when the fever stopped. The pain has subsided around the 6th. But I am currently still having pain in my left shoulder where I got my shot today on the 8th.

Dull Pain in Left Shoulder along with pain in left and right kneecaps, more intense pain in right knee. Pain in the knees also ran along the course of both legs. Pain lasted roughly 3 days.

Injection site pain: intense pain/soreness for day after injection, moderate soreness for 3 days Tiredness, severe headache, fever, chills, muscle pain, nausea from 10 hours after injection until ~48 hours after Mild headache for next 5 days

Fever 15 through 28 hours after second dose of vaccine. Fatigue 0-4 days after second dose of vaccine. Achey body (everywhere) 0-4 days after second dose of vaccine. Dull aches and soreness in my groin area, and also in my knee joints and feet, 0 days to 26 days (present day, i.e. I'm still experiencing these issues) after second dose of vaccine.

Minor muscle soreness in arm and neck. Left facial paralysis and minor pins and needle sensation in neck area. Starting 4:30pm 05/26/21.

Sore arm; Felt light headed; left side of my face becoming numb; restricted breathing threw my nose; pain forming in the left side of my neck; left cheek on my face began to swell; top left part of my throat began to swell; tingling feeling on the left side of my face.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 16Mar2021 at 03:15 PM as a single dose for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications included ZYRTEC D for unknown indication from an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 03:30 PM the patient experienced pain in arm, light headed (waited the recommended 15 minutes and left), numbness in face, breathing difficulty, neck pain (immediately went back to the facility that administrated the shot, was put under observation), cheek swelling, throat swelling and tingling. Treatment received for the events included diphenhydramine and Tylenol. The clinical outcome of the events pain in arm, light headed, numbness in face, breathing difficulty, neck pain, cheek swelling, throat swelling and tingling was resolving. No follow-up attempts are possible. No further information is expected.

chills occasionally; Fatigue; Has had more frequent headaches; While going to the bathroom, felt like the whole world was spinning; pain and aching in his groin; aches/ Has had a few more random aches and pains in the body; Fever; the joints in feet and knees are more sore than ever; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 02May2021 09:30 as (age at vaccination 25) single for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. The patient's historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0158) via an unspecified route of administration, administered in Arm Left on 11Apr2021 11:00 (age at vaccination 25) as single for COVID-19 immunisation. Patient was not received any other vaccine on same date of vaccination. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 02May2021, the patient had fever, aches/ Has had a few more random aches and pains in the body, pain and aching in his groin, the joints in feet and knees are more sore than ever. On 03May2021, the patient While going to the bathroom, felt like the whole world was spinning. On 04May2021, the patient has had more frequent headaches. On an unspecified date, the patient had chills occasionally and fatigue. The caller stated that the fever started during the night. The caller received the second dose Pfizer Covid Vaccine at 09:30 on Sunday, 02May2021 and had a fever may be 15 hours after the caller would say. The caller stated this fever lasted 2 days, then clarifies it lasted a day and a half. The caller states he recovered completely. The caller states aches began right when the caller was going to bed, 12 hours after receiving second dose Pfizer Covid Vaccine. The caller had aches and fatigue. The caller stated he was super achy across entire body. The caller states this lasted the first two days after the Pfizer Covid Vaccine. Now the caller has achiness in goin area. The joints in feet and knees were more sore than ever, Now the caller has slight achiness in knee. The caller clarifies the aches felt better after three days. The achiness in groin is persisting. The joints in feet and knees were more sore than ever and were persisting. The aches across body everywhere went away. The caller stated he did not have chills, more fatigue and achy. Maybe the caller had chills occasionally, mostly not much of an issue. When asked when the callers pain began, the caller stated he doesn't know if he meant pain. The caller thought he meant aching and pain was the same thing. When using the word fatigue the patient was describing his issues still going on. The caller's localized fatigue with his feet and knees, nothing systemic. The caller stated Pain in groin began right when all the other aching in caller's body happened, so 12 hours after receiving the second dose Pfizer Covid Vaccine on 02May2021. The caller's body started aching and hasn't totally gone away since. The caller stated the pain in the groin is persisting. The caller stated the pain in the groin is better some days and worse some days. The joints in feet and knees were more sore than ever: The caller thought this has been ongoing since 12 hours after receiving the second dose Pfizer Covid Vaccine. For a week and a half there the caller didn't really use feet and knees very much. The caller started to run again. The caller stated this started probably 12 hours after receiving second dose Pfizer Covid Vaccine, but not entirely sure. The caller guessed he has had more frequent headaches and a few more random aches and pains in the body. Has had a few more random aches and pains in the body: The caller stated that the random aches and pains in the body were sporadic and come and go since receiving the second dose Pfizer Covid Vaccine. The caller doesn't think he was just noticing them, doesn't think it was just the caller hallucinating them. Has had more frequent headaches, the caller usually doesn't get headaches. The caller stated these began the second day after receiving the Pfizer Covid Vaccine on 04May2021. Has had a few more random aches and pains in the body: The caller stated that the aches and pains come and go and they began the same day the caller received the second dose Pfizer Covid Vaccine, 12 hours after on 02May2021. Has had more frequent headaches: The caller states the headaches come and go and it was hard to tell if they were ongoing, the caller thought but it was hard to tell. The caller states the headaches were not super frequent, more frequent than the caller had before. The caller does not think the headaches were lessening in frequency. Has had a few more random aches and pains in the body and the caller stated these were ongoing. The caller will have a pain in his back or somewhere the caller usually wouldn't feel pain. The caller stated the random aches and pains were persisting. After the second dose, the caller woke up in middle of night and had to go to bathroom. While going to the bathroom, the caller felt like suddenly the whole world was spinning. The caller tried to shake himself awake, shake himself out of it. For probably like two minutes, multiple minutes, the caller couldn't get out of this haze. The next thing the caller knew he was in his room bent over the garbage can. The caller did not throw up, but the caller felt like he was going to black out. If this had gotten worse, the caller would have gone to the hospital or done something. The caller stated it kind of went away after that. The caller stated this began on 03May2021, 18 hours after the caller received the second dose Pfizer Covid vaccine on 02May2021. The caller stated this went away. The episode lasted for about half an hour. The caller thought he recovered completely, but again isn't sure, still having issues and doesn't know. In Sep2020, the caller got an antibody test and it was negative. The caller doesn't think he had Covid, at least not until Oct2020 and was sure he did not have Covid from Oct2020 to Apr2021. The caller was pretty certain he has never had Covid, ever. The caller queried if there was anyone who has experienced something similar with the aching in their groin, The caller has read something about how women could experience menstrual issues, but stated he was not female. The outcome of the events fever was recovered on 04May2021; while going to the bathroom, felt like the whole world was spinning was recovered on 03May2021; the joints in feet and knees are more sore than ever, pain and aching in his groin, aches/Has had a few more random aches and pains in the body were not recovered; has had more frequent headaches, chills occasionally and fatigue was unknown.

Woke up in the middle of the night with sharp chest pain. Went to the ER and was diagnosed with costochondritis. I recovered within a few days just medicating with advil and tylenol. I am reporting this incident because I have seen reports from the CDC about cases of myocondritis occuring after vaccination, and symptoms very similar to what I experienced. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html

Extreme chest pain, pain started coming up to neck like it was going to come out of mouth, and then settled in middle of chest and upper abdomen, I sat down to try to see if it would go away and it didn't so I laid down and it did. Dizziness/light headedness started a bit later and now I have discomfort in right leg below knee.

getting good sleep, but he's absolutely exhausted all day; feeling absolutely terrible; under his left armpit, there's a bump and it's super sore; his whole armpit and chest area has been sore out of no where for a few days; his whole armpit and chest area has been sore out of no where for a few days; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 07Jun2021 (at the age of 25-years-old) as, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The details about patient history and other products were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported) on an unspecified date as single dose for COVID-19 Immunization and experienced the left arm was so sore after the first one but the soreness went away after a few days. On unspecified date, patient was getting good sleep, but he is absolutely exhausted all day. Patient stated that under his left armpit, there was a bump and its super sore and his whole armpit and chest area has been sore out of nowhere and its been for a few days. It was reported that the patient got his second dose of the Pfizer vaccine this Monday, it's now Thursday morning and he is honestly just feeling absolutely terrible and he just wants to make sure this was normal. Patient stated that he has other symptoms he is getting concerned about at this point, it's been a few days since he started having them. Patient stated that he honestly feels terrible, he cannot physically do anything. Patient stated that he was actually going to a doctor's appointment in 15 minutes and stated he will call back at a later time, he just wanted to know if what he was feeling was normal or if he needs to seek further medical advice and confirms it was the Pfizer Covid vaccine that he was speaking of and received. The outcome of the events was reported as unknown Information about lot/batch number has been requested.

Patient started to loose weight after the first dose It became more pronounced after the second dose

Fever Chills Aches/Joint Pain Headache Tiredness/Lack of Energy Nausea Diarrhea Injection Site Pain Arm Pain

This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955) administered in the left arm on 18Mar2021 at 10:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, high blood pressure and hypothyroidism. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included enalapril (MANUFACTURE UNKNOWN), levothyroxine (MANUFACTURE UNKNOWN), albuterol (MANUFACTURE UNKNOWN). The patient was allergic to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 18Mar2021 at 0100 hours, the patient experienced generalised muscle aches and headache. The patient reported muscle pain throughout entire body, including lower back, arms, and legs and very very mild headache which was noticeable only if paid attention. The patient did not receive any treatment for the events. The clinical outcome for generalised muscle aches and headache was not resolved. Information about lot/batch number cannot be obtained. No further information is expected.

Pain and lymph node swelling in right side neck; pain in armpit; General body soreness; discomfort; Soreness in right arm; lymph node swelling in right side neck and armpit; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727,) via an unspecified route of administration in the right arm on 22Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to codeine. The concomitant medications were not reported. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. 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. On 22Mar2021, the patient experienced soreness in right arm, pain and lymph node swelling in right side neck and armpit, general body soreness, discomfort, headache, and fatigue. The patient did not receive any treatment for reported events. The clinical outcome of pain in arm, swollen lymph nodes, lymph node pain, armpit pain, general body pain, discomfort, headache and fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Sx onset 6/29/2021 with fever, chills, sore throat, headache & muscle aches. Tested positive for COVID-19 on 6/30/2021.

Sx onset 6/29/2021 (fever, chills, sore throat, muscle aches, and headache). Tested positive for COVID-19 via PCR on 6/30/2021.

Severe headache, the day following the administration of the second dose.; Fever, the day following the administration of the second dose.; Joint pain, the day following the administration of the second dose.; Body aches, the day following the administration of the second dose.; Radical change in my temperament/ Intense rage, the following week.; Irritable; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in right arm in Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the day following the second dose, the patient had experienced severe headache, fever, join pain and body aches. The following week, the patient had experienced anger/rage and irritability. The patient had noticed a radical change in his temperament. The patient was then very irritable, and prone to fits of intense rage. The patient never had anger issues in the past, or and any other psychiatric issues. The patient was hoping this as temporary issue, but right then, it was quite debilitating. The patient did not receive any treatment for the events. The clinical outcome of all the events headache, fever, join pain body aches, anger/rage and irritability was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pt called health system call ceneter on 5/18/2021 and verified pt with 2 identifiers. Pt stated pt got 1st covid vaccine Pfizer @9:25am 5/14/2021 at Pharmacy and pt got chest pain(mild chest pain), mild SOB, abdominal cramping(last 2 days), fatigue since next day from vaccination. Noted pt has hx of seizure 2 years ago and taking medication for seizure. Pt also said upper back pain and pt had mild fever next day from vaccination. Noted no known allergies. Instructed pt to call 911 or go to ED d/t pt shows 3 emergency s/sx of covid vaccine side effects. Pt is educated covid vaccine side effects.

25yr old patient with no significant PMH presented to urgent care on 7/4 for left side chest pain x 4-5 days. Just prior, patient had upper back pain (thought to be muscle related) which resolved and then chest tightness/pain started. Patient denied sweats, nausea, lightheadedness, dizziness, palpitations, or shortness of breath. Patient did endorse sharp stabbing pain under left breastbone while taking a deep breath which improved slightly. Patient endorsed pain improved if "laying completely flat and stretching out upper body so heart is not touching his chest wall". Patient had been taking ibuprofen 200mg daily x several days and Tums. Patient developed upper respiratory infection with cough and congestion 2-3 we Patient developed upper respiratory infection with cough and congestion 2-3 weeks ago, symptoms resolved. Self swab Covid test on 6/15 was negative. Patient endorsed receiving Pfizer vaccine (second dose 5/28/21). Unknown LOT number, sight of administration or details and date of first Pfizer vaccine administration. On 7/4, ECG noted ST elevation with multiple leads with concern for acute pericarditis. Provider noted "likely viral, related to recent URI which may have been COVID". VS normal, and chest x-ray normal. D-dimer negative (<100), cardiac panel/troponin normal (Troponin < 0.05). Patient prescribed ibuprofen 600mg TID and colchicine 0.6mg daily x 14 days (# 551151809). Cardiology referral pending EKG formal read. Patient returned to urgent care on 7/7 for follow up with resolution of symptoms. EKG still noted ST elevation in multiple leads but had improved from prior. Repeat labs deferred (as patient self pay). Patient placed on 3 week taper for ibuprofen and instructed to continue colchicine until completed (2 weeks). Provider noted while standard 3 month colchicine course typical for acute pericarditis, normal labs and mild symptoms supported discontinuing med early.

Weakness of muscles; body aches; lethargy; headache; shivers; joint pain; muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3247) via an unspecified route of administration in left arm on 23Mar2021 at 09:30 (at the age of 25-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin since unknown date. The patient not had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate (FLONASE) started from unknown date for unknown indication. Since the vaccination, the patient had not tested for COVID-19. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on an unknown date (also reported as 23Mar2021 at 09:00) as single dose for COVID-19 immunisation. On 23Mar2021 at 22:30, the patient experienced weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers. The peak of these symptoms took place 14 hours after he got the shot. It persisted for 24 hours. 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 received treatment for the events. The clinical outcome of the events weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers were resolved on 24Mar2021. No follow-up attempts are needed. No further information is expected.

Severe shoulder joint pain. Injection site located over left shoulder joint instead of over muscle. Pain began two hours after injection, with dull pain while motionless and sharp pain with movement of the shoulder joint or while bearing weight. Pain subsided over several days, but slight pain and arm weakness has persisted for 6 weeks with occasional flares after excessive usage or stretching. Treatment has consisted of cold compresses, ibuprofen, and acetaminophen. Symptoms have not yet resolved.

Pain in my shoulder; Numbness in my arm; feel like tingling sensation moving to my arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose (Lot Number: EW0217) administered in arm left (left shoulder as reported) on 05Jun2021 as dose1, single and second dose (Lot Number: EW0191) administered in right arm (right shoulder as reported) on 26Jun2021 at 11:00 A.M, as dose 2 single both via an unspecified route of administration for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No prior vaccinations (Within 4 weeks). Patient stated, "I have like pain in my shoulder and numbness in my arm in Jun2021" Patient further stated, "So I basically taken the Pfizer vaccine Saturday afternoon and I really started feeling it Sunday morning but I didn't pay any attention to it because I felt the pain as when I got my first shot in my left arm so I didn't take any medication, but when I woke up in the morning I was like oh you know my arm, I can't feel it, it was really numb and it really feel like a tingling sensation moving to my arm in Jun2021. I just need a second opinion, because I called my doctor they told me to go to ER. I am kind of having same reaction in my right arm that I did have in my left arm it felt numb like if I like slept on it wrong or something and blood was trying to circulate through it. I got feel like any pain but it was really numb, I was just trying to figure is this like any side effect or I should go to ER like emergency room." No treatment received for events. The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested

blood in urine, neck stiffness, headache in back of head, stabbing headache, temporal pressure, visual disturbances,

Within two weeks of getting my second dosage of the Pfizer Covid vaccine, I developed panuveitis; My ophthalmologist diagnosed me with TINU, Tubulointerstitial Nephritis and Uveitis Syndrome; I experienced pain, sensitivity to light, and ankle sores; I experienced pain, sensitivity to light, and ankle sores; This is a spontaneous report from a contactable physician (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in arm left on 20Jan2021 (at the age of 25-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none, No family history of autoimmune disease or significant medical history of disease. The patient had no known allergies. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration in left arm on 20Jan2021 at 05:00 PM (at the age of 25-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, 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, has the patient been tested for COVID-19 was reported as no. On an unspecified date in 2021, within two weeks of getting his second dosage of the Pfizer Covid vaccine, the patient developed panuveitis. Stated that, his ophthalmologist diagnosed him with TINU, Tubulointerstitial Nephritis and Uveitis Syndrome. On an unspecified date in 2021, the patient experienced pain, sensitivity to light and ankle sores and had to go to urgent care clinic to get steroid eye drops to reduce inflammation in his eye. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The reporter seriousness and seriousness criteria was non serious. Treatment medication included prednisone eye drops. Device date was on 01Jul2021. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal relation between the BNT162b2 and the onset of Tubulointerstitial Nephritis and Uveitis, the association cannot be ruled out. 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.

Neck hurts; Back of neck a little puffy; still hurts a little in the back; Neck has been pretty stiff/ couldn't just turn his neck; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration in left deltoid on 03May2021 at 15:00 (lot number: EW0173) at single dose for COVID-19 immunization. The relevant medical history included autism from 07Dec1997 and ongoing (diagnosed with autism when he was 2 years and 3 months old/ able to get the patient into early intervention), bipolar disorder from 2016 and ongoing, anxiety from 2016 and ongoing, allergies from unspecified date and ongoing (has always struggled with allergies), psoriasis from Apr2020 and ongoing (the patient came to the doctor after nothing was working for what they thought was eczema. The patient went to a specialist and was just recently having flare ups and they took a biopsy to see if it was something else, but the result was leaning heavily to psoriasis. The patient sometimes needs Kenalog or steroid injections to suppress if there is a flare-up, but it's better), mood stabilizer from unspecified date, broke his foot from unspecified date (playing basketball in the Special Olympics and went 2 weeks without saying anything). Concomitant medications included valproate semisodium (DEPAKOTE) from 2016 and ongoing for bipolar disorder; asenapine maleate (SAPHRIS) from 2016 and ongoing for mood stabilizer; hydroxyzine from 2016 and ongoing for anxiety; loratadine from 2016 and ongoing for allergy; ixekizumab (TALTZ) from Apr2020 and ongoing for psoriasis. The patient previously received flu vaccine on an unspecified date (patient had a flu vaccine but that was back in flu season) and the first dose of BNT162B2 (Lot Number: ER8737; Anatomical Location: Left Deltoid) on 31Mar2021 at the age of 25 years old for COVID-19 immunization. The consumer reported that her adult autistic son, the patient, had the Covid-19 vaccine. Caller reported that the patient went for his checkup last week and the caller mentioned that the patient's neck had been pretty stiff since receiving the second dose of the Covid-19 vaccine. Caller reported that the patient's doctor said that she should call the line for Pfizer and report it. Caller reported that when the patient turns his neck, he says that it still hurt a little in the back. Neck had been pretty stiff: Caller reported that the patient couldn't just turn his neck, he turned the whole body. Caller reported that she noticed that the patient was turning his whole body and she asked him why he was not turning his neck. Caller reported that the patient responded that he thought he was just turning his neck. Caller reported that it wasn't immediately after the second dose that the patient developed the stiff neck. Caller reported that some weeks went by and she started to notice it. Caller reported that she couldn't think of any other thin that could have caused the patient's stiff neck. Caller reported that she asked the patient if he had curled up funny. Caller stated that she didn't even think to call and report the patient's stiff neck until his physician recommended that she call. Caller reported that originally, it seemed like the back of the patient's neck was a little puffy but it isn't any more. Caller reported that the patient was seen at the hospital. Caller reported that the physician there prescribed the patient's meds. Caller reported that he did see another doctor there about once a year for a physical, but he primarily saw them for med checks every 3 months. She didn't think about reporting the patient's stiff neck and that's the only issue. Caller reported that the patient has never had issues with other medications. Caller reported that the pain was just in the patient's neck area and he was doing fine otherwise. Caller reported that the patient had a very high tolerance for pain. Caller reported that the patient typically didn't complain, but he did complain about his neck. Neck had been pretty stiff: Caller reported that she noticed that the patient's neck seemed stiff about 2 weeks after the second dose of the Covid-19 vaccine. Caller reported that she didn't think that that the Covid-19 vaccine could have caused the patient's stiff neck. Caller reported that she was asking the patient why he was moving so stiff, then she thought 3 weeks ago maybe it's connected to the Covid-19 vaccine. Caller reported that the patient's stiff neck was about the same. Caller reported that the patient was still turning stiffly but stated that he was trying to turn his neck. Caller reported that she didn't think that the patients neck hurt as much. Caller reported that the patient stated that his neck hurt just a little, but he had a high pain threshold. The patient underwent lab test included biopsy on his wrist: didn't even flinch on an unspecified date in 2021 (biopsy on his wrist few weeks ago and didn't even flinch); Biopsy: leaning heavily to psoriasis on an unspecified date; blood work: fine (to watch his liver and all that for the Depakote, and he's been fine) on an unspecified date. The outcome of the event back of neck a little puffy was recovered on an unspecified date in 2021, while other events were not recovered. Follow-up attempts are completed. No further information is expected.

5 minutes after vaccine was received, the patient's eyes rolled back and he fell off his chair. his body stiffened up and he seized. We called the ambulance and they arrived shortly after. Water was given and back support was provided until the EMT and the patient's mother arrived.

severe headache; nausea; chills; body aches; body aches/joint pain; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWo150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 03Apr2021, side effects took place approximately 12 hours after injection at 03:00, the patient experienced severe headache, nausea, chills, body aches/joint pain and dizziness. The events 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 severe headache, nausea, chills, body aches/joint pain and dizziness and included treatment with acetaminophen, 1000mg every 12 hours for 36 hours. The clinical outcome of the events headache, nausea, chills, body aches/joint pain and dizziness was recovered on an unknown date of Apr2021. No follow-up attempts are needed. No further information is expected.

Patient had what appeared to be a seizure within 5 minutes of receiving vaccination. Per sister-in-law: he has a history of "fainting" with shots, but to me, it did not appear as a "fainting" episode since he became rigid and his eyes rolled back while he remained seated. 9-1-1 emergency services was called and patient was taken to the local E.R.

This is a spontaneous report from a contactable pharmacist. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 16Apr2021(at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus and asthma. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via intramuscular route of administration on 26Mar2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced bad fatigue, migraine headache, muscle pain, joint pain, body aches and upset stomach. 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 event fatigue, migraine headache, muscle, joint pain, body aches and upset stomach was recovered on any unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Bad fatigue; migraine headache; muscle and joint pain; muscle and joint pain; body aches; upset stomach; fever; chills; This is a spontaneous report from a contactable pharmacist. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 16Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 26Mar2021 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. It was unknown if the patient received 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 16Apr2021, the patient experienced bad fatigue, migraine headache, muscle and joint pain, body aches, upset stomach, fever and chills. The clinical outcome of the events bad fatigue, migraine headache, muscle and joint pain, body aches, upset stomach, fever and chills was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.