Pfizer

0930 red, puffy, tingling hands 0945 cough 0948 benadryl 50 mg administered by medic. pt hx of anaphylaxic reactions to nuts. mom stated she did not have pt's epi pen with her. pt stated these same symptoms happen with anaphylaxis prior. mom/pt wanted transport via ambulance vs POV for peace of mind in case any symptoms worsened. to ED.

8 days of intermittent fevers 101-106 (ongoing), rigors, chills and fatigue. Started 24 hours after COVID vaccine. This is ongoing, day 8 and fever still 101+ without ibuprofen. Seen twice at PCP's office listed above (seen by Dr. and Dr. this week but Dr. is normal pediatrician. Labs abnormal as below. No other URI, bladder, GI or infectious symptoms other than fever, rigors and fatigue. Negative COVID test 3 days into symptoms and no exposures.

Urticaria of trunk and extremities developed ~48 hours after vaccination. Relatively mild with only intermittent pruritis. Pain and swelling of feet. Still present as of visit on 4/12/21. No other symptoms.

Recipient experienced brief loss of consciousness (few seconds per report) / vasovagal syncope from a standing position. He fell and hit his right frontal bone of skull upon fainting. Patient awoke after a few moments per report and was AAOx4 within moments of this reporting clinician's arrival to scene. Vital signs stable. Patient's frontal bone with minor red abrasion / erythema and scant swelling. He did not complain of changes in vision/ nausea / emesis. Neurological and Musculoskeletal exam intact without issues.

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.

Fever, chills, headache and swallen axillary lymphnodes. Pain and redness in left axillary area limited left arm and shoulder range of motion. Tylenol and warm compress was used to provide comfort. Today a call is going out to the Dr. to provide any further instruction as today is day 3 and there is still quite a bit of axillary discomfort.

Presented with chest pain, found to have diffuse ST elevation, elevated troponin/CRP/pro-BNP and echo concerning for low normal left ventricular systolic function. Ultimately diagnosed with myopericarditis.

Pt had syncopal episode approximately 2 minutes post 1st dose of Pzifer vaccine. He landed on the left side of his body and hit his head on the ground. He was immediately alert and oriented and knew that he had a syncopal episode. Pt and Mom state he has a history of vasovagal episodes, latest episode after getting an allergy shot. BP 117/46, HR 59 immediately after syncopal episode (12:17), and 111/76, HR 78 when EMS arrived (12:26). Pt had swelling on the left side of his forehead but denied pain or headache. Mom declined EMS transport. Pt sat in chair for remaining 15 minutes of observation.

Covid vaccine site: Per chart pt received covid vaccine at 1413 accompanied by his Grandma. About a minute later, pt had a syncopal episode while walking to observation area. Per grandma, pt hit L-side of face on plastic chair. Medical staff responded to incident, RN and Dr, pt supine on ground - awake and alert. Dr examined pt. VSS taken: BP: 130/60 HR: 74 O2sat: 99% RA. 1420: With permission from Dr, pt stood up to sit on the wheelchair. Pt wheeled to observation/triage area. Intervention: Ice and gauze dressing. Pt is awake and alert, mild swelling to L side of-face, under eye - small break in skin noted, bleeding controlled. Pt had some juice, water and crackers, no difficulty swallowing. Pain 2/10, tolerable. Cold compression on and helping. Grandma remains with pt - per grandma, pt has history of passing out with blood draws. 1440: Pt remains awake and alert, NAD, no new or worsening complaints. Grandma remains at bedside. 1505: Orthostatic BP done per Dr. Results given to MD. No new orders. 1510: Dr OK'd pt to go home with grandma. Grandma and pt stated they are comfortable to go home. Instructed pt and grandma to monitor for symptoms and to call PCP or 24 hour advice line for new or worsening symptoms. Call 911 or go to emergency if has emergent symptoms. Grandma and pt verbalized understanding and agreed. Pt and grandma exited triage area, ambulatory with steady gait and in no apparent distress. Grandma will drive pt home.

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.

Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date. Information on batch/lot number was requested.

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.

Received dose #1 on 4/8/21 and dose #2 on 4/30/21. On 5/1 evening developed chest pain and tightness. He told his family about the chest pain the following day, on 5/2, which prompted his Mom to take him to an ED. In ED on 5/2 and found to have ST elevation, elevated troponins and elevated inflammatory markers. ECHO with mildly decreased systolic function. Picture consistent with perimyocarditis. Admitted to Hospital 5/3 AM. Currently clinically stable but admitted for close monitoring.

The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient reported an episode of palpitations, chest pain, and left arm pain that was relieved after 1 hour. On 5/3/21 at 0230 the patient reported a second episode of palpitations, chest pain, and left arm pain that was not relieved, pt presented to the Clinic, to ED at 0340 on 5/3/21, the patient had an EKG and lab work done. Troponin I lab level was 4.52, which is over 100 times the normal limit. Pediatric cardiology was consulted and the patient was sent to Hospital via life flight.

16 year old male who got first Pfizer Covid vaccine 4/30, then by the next morning experienced non-bilious emesis for a few hours, as well as fever, chills, body aches, and HA. The body aches and HA continued through today when he began experiencing chest pain while lying down. Chest pain improved on sitting up, standing, sitting forward. No shortness of breath.

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.

Patient received his 2nd Pfizer COVID vaccine on Tuesday 4/27/2021; he had low grade fever (100.3 deg F) on Wed 4/28/2021. On Thursday 4/29/2021, he developed "heartburn", and on Friday 4/30/2021 he developed chest pain that radiated to his jaw and left arm. He presented to Hospital on late 4/30/2021 or early 5/1/2021 for evaluation; initial labs showed a CRP of 1.23, POC troponin of 6.56 ng/mL (03:18 on 5/1) and lab level of 17.6 ng/mL (03:05 on 5/1) that increased to 24 ng/mL later in the morning on 5/1. COVID-19 PCR was negative. He was transferred to another Hospital mid-day on 5/1/2021 due to concerns for myocarditis/myopericarditis. He was started on NSAIDs. His troponin level improved, had decreased to 9.69 ng/mL on 5/2/2021; at that point as his chest pain had improved and labs were improving, parents requested that he be discharged from the hospital. He had 2 echocardiograms at PCH which reportedly showed normal biventricular systolic function. He had an echo at the hospital on 5/2/2021 which showed normal biventricular systolic function, no pericardial effusion, and normal valves. As an outpatient, he had repeat troponin-I levels: 2.49 ng/mL on 5/3; 0.31 ng/mL on 5/5; the troponin level was reportedly normal on 5/10/2021 per his primary cardiologist

Acute narcolepsy. Suspected Guillain-Barre Syndrome. Could be related to concurrent-onset campylobacter infection.

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.

The patient developed severe chest pain on the 4th day after the vaccine, he presented to the local emergency room and had the abnormal tests as described below. His symptoms improved rapidly but due to active myocarditis was given recommendations for limited activity to reduce risk of fatal arrhythmia

Started with sore arm and headache, progressed to high fever (101). Next day had sores on mouth, which spread all over lips and started sore throat. Fever did not go away without medication. Medication would alleviate it but it continued for 6 days, reaching 102.4. Pediatrician tested for strep and for COVID, both were negative. Sore throat persisted after fevers subsided. Had to finally be prescribed magic mouthwash. Doctor said sores on lips were herpes so prescribed viral medications. My son never has a sore throat and has never had a herpes sore until after the shot.

patient developed dizziness about 5 hours after vaccine and began sweating profusely. initial blood pressure was quite low in the 77/46 however subsequent reading was 108/76 and patient exhibited no other signs of anaphylaxis. paramedics were called in case reaction became more severe but patient recovered and was back to baseline within 15 minutes or so. no intervention given.

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.

Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

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 sudden onset of chest pain and shortness of breath worse with supine position. Patient went to the ER and ECG was done which was consistent with Acute Pericarditis. Patient was treated with Ibuprofen 600mg PO TID with resolution of his chest pain and SOB. patient was discharge home from the ER with cardiology follow-up 2 days later. Patient continues to have no chest pain or SOB and continues on Ibuprofen 600mg PO TID at this time. Repeat labs are pending.

Patient developed chest pain starting 3 PM on 5/17. Presented to a local ED for this on 5/18 and was found to have elevated troponin level. Transferred to a hospital with pediatric floor and was seen by a pediatric cardiologist. Echocardiogram notable for evidence of pericarditis but normal cardiac function. Given concern for development of arrhytmia, transferred to a hospital PICU. Chest pain was mild to moderate, stabbing, and was somewhat relieved by antinflammatory therapy. He never had fever, chills, vomiting, diarrhea or rash. He had no ill contacts. He had no history of prior COVID nor did his family

Chest pain, fever, headache and fatigue starting morning after vaccination. Progression of chest pain prompting evaluation in the emergency room where he was found to have a Troponin of 23,000 (nl less then 50). D'Dimer mildly elevated. ST changes on EKG. CTA negative. LFT mildly elevated. Sent to hospital where admitted to cardiology service pm 5/19 and given a diagnosis of myocarditis. Still under care at this time of report.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium, Additional Details: Pt is a 16 yo male who came in for second dose pfizer vaccine on 05/18/21. His mother reported that the pt experienced redness and swelling of the left eye at 2am on 05/19/21. At 3am, the patient mother gave her son benadryl and ibuprofen. I called the patient at 11am on 05/19/21 to check up and he is currently sleeping with some swelling and redness present. He has made a doctor appointment later today.

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

Suspect pericarditis, elevated CRP, very very slight pericardial effusion, classic story, few EKG findings

large mass 2in x 2in in L axillae on the side his injection was given. no pain or redness, just fullness

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.

Vaccine administered at outside facility. Pt. is a 16 yo male with no significant PMH admitted on 4/26 with myocarditis, elevated troponin, and abnormal EKG. Pt. states that he was feeling his usual self until the day that he received his 2nd dose of the COVID vaccine on 4/24. On 4/24, he started to have a headache and subjective fevers. On 4/26, he reports having substernal chest pain at rest, non-radiating, associated with shortness of breath. Patient took tylenol with minimal relief. Patient denies cough, congestion, abdominal pain, nausea, vomiting, diarrhea, rash. No sick contacts. Since admission, troponin has been rising (up to 16), BNP normal, CRP to 87, ESR normal, CBC and electrolytes unremarkable. Clinical course and findings consistent with myocarditis. ID consulted for infectious workup and management. In my prelim recs upon admission, I recommended a dose of IVIG and holding off on steroids and antibiotics.

Patient developed chest pain and difficulty breathing when lying down; symptoms started at 7pm on 5/21/2021. Seen in the emergency room at Hospital for chest pain, found to have elevated troponin level of 11.6 ng/mL (normal <0.05). CT chest negative for pulmonary embolism. Patient transferred to Medical Center. Initial high sensitivity Troponin-T level 1224 ng/L (normal <15), BNP 805 pg/mL (nl <300). EKG with diffuse ST segment changes. Echocardiogram (5/23 AM) with normal systolic and diastolic function, LVEF 58%; no pericardial effusion, no pathologic valve regurgitation. Patient admitted to telemetry monitoring bed (no arrhythmias noted during hospitalization). Patient treated initially with Ibuprofen 400 mg PO q6 hours and famotidine 20 mg PO q12 hours for presumed myopericarditis. Workup sent for viral causes of myocarditis: Respiratory viral panel negative. Infectious Myocarditis workup sent: CMV, Cocksakievirus A and B antibody, CMV IgG/IgM, Echovirus antibody, Infectious Mononucleosis Screen, Lyme C6 AB IgG/IgM, Mycoplasma IgG/IgM, Parvo IgG/IgM, Varicella IgG/IgM. Follow-up echocardiogram on 5/23 (PM) and 5/24 (AM) demonstrated no change in LV systolic or diastolic function. Cardiac enzymes, including high-sensitivity troponin T, CK and CKMB, were trended. Cardiac MRI was performed - preliminary results show evidence of myocarditis Lab Trends (earliest to most recent, as of 1 pm on 5/25/2021): High sensitivity Troponin T: 1224, 732, 664, 1058, 1332, 1141 CKMB: 65.6, 41.6, 19.3, 11.4, 6.3, 3.2 Pro-NT-BNP: 803,493, 392, 293 CRP: 58.2, 32.8, 28.6, 14.9. At the time of sumission of this report, the patient remains in the hospital. Further results will be communicated to VAERS.

5/15/2021 1120: EW0182 1st dose QMC -BVC Pt c/o itching to throat, chest tightness immediately. Mother gave benadryl at 1207. Epi pen at 1235. Pt taken to ED by mother. Pt rec'd prednisone, famotidine after observation and dx of anaphylaxis to Pfizer Covid 19 vaccine.

patient presented w/ acute onset Chest pain, tachycardia Found to have cardiomegaly on xray elevated BNP, elevated CRP and Echo with severe decreased Left Ventricle Function

Patient is a 16 y.o. previously healthy male transferred from different Hospital for chest pain and elevated troponin. He had received his 2nd dose Covid vaccine (Pfizer) on Saturday 5/22, then had a fever to 103 on Sunday and then 101 on Monday measured by laser thermometer to forehead, associated with chills. Mother gave him Advil for fever. States he was awakened from sleep on Tuesday 5/25 at ~4am by a sharp chest pain. He describes a non-radiating, aching pain with some sense of pressure in the LUSB that initially lasted 2 hours. Once he arrived to Hospital it went away completely, but then returned several times after lasting about 30-60min each. Denies pleuritic pain, positional pain, dyspnea, or exertional pain. Tried Ibuprofen which he feels helped, but then the pain returned 30min later. Also endorsed headache and fatigue. At Hospital he had elevated troponin concerning for mild myocarditis. EKG had diffuse ST elevation suggestive of possible pericarditis.

Previously healthy 16 year old male presenting to hospital as a transfer for chest pain and elevated Troponin levels concerning for myocarditis. Patient has otherwise been healthy. Two days ago he received his second dose of COVID vaccination. He initially felt fine, but later that day had some body aches. The next day he felt feverish off and on and had dull left upper sternal border chest pain intermittently. Today, he reports sharp 7/10 mid sternal chest pain, lightheadedness, sweating, chills, and intermittent non-productive cough. He presented to original hospital for evaluation. The patient admits to tactile warmth since Sunday with no documented temperatures. He recently received his second dose of Pfizer just before onset of these symptoms. He reports difficulty sleeping since Sunday, but no shortness of breath, rashes, syncope, nausea, or vomiting. He has not had any other recent illness, fevers, or known COVID-19 exposures. He denies any history of prior cardiac disease and there is no known family history of cardiac disease, arrhythmias, or sudden death in the child or adolescent period. He denies illicit or recreational drug use. In the ED, he was well appearing with pain now 1 out of 10. POC troponin was 16.8 ng/mL. He had labs pertinent for ESR 10, CRP 3.0, BNP 24. RP2 PCR was negative. UDS was negative except for opiates (s/p morphine). IV was placed and patient was started on IV fluids. EKG was obtained and showed questionable left atrial enlargement per ED read. Cardiology was consulted and performed Echocardiogram in the ED at bedside and was within normal limits. Cardiology resident team contacted for admission. Past Medical History: No major medical diagnoses Past Surgical History: Orchiopexy, T&A Family History: No cardiac family history Social History: Lives at home with mother. Has two healthy siblings not living at home Immunizations: Up to date Medications: None Allergies: NKDA Etiology of likely myocarditis remains unclear at this time. In his age group, this would most likely represent a viral myocarditis. He would likely benefit from cardiac MRI during this admission for further evaluation of myocarditis. His EKG findings with his age group are unlikely to be secondary to myocardial infarct. No arrhythmias or heart block noted on EKG at time of admission or telemetry in ED. There is no family history of autoimmune disease or cardiac disease to suggest an autoimmune component or genetic etiology.

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.

Acute somnolence; Flaccid Areflexia in legs; Suspected Guillain-Barre Syndrome; Possible linkage to simultaneous campylobacter infection; This is a spontaneous report from a contactable consumer (patent). A 16-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left (at the age of 16 years old) on 01May2021 at 10:00 (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included campylobacter infection from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. The facility in which the most recent COVID-19 vaccine was administered was a Public Health Clinic/Administration facility. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Acute somnolence, Flaccid areflexia in legs, Suspected Guillain-Barre Syndrome, Possible linkage to simultaneous campylobacter infection on 03May2021 at 0000. The events required an emergency room visit. The patient was hospitalized for acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection from 2021 to an unknown date for 5 days. The patient underwent lab tests and procedures which included polymerase chain reaction (post vaccination) results: negative on 09May2021 (Nasal Swab). Therapeutic measures were taken as a result of acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection. Treatment included IV immunoglobulin. The clinical outcome of the events was not recovered. Additional information was requested.

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.

myocaritis - chest pain with elevated troponin reequiring hospital admission. symptoms started 3 days after vaccination which was his second dose of the Pfizer vaccine. First dose was on 5/1/21.

Pt developed chest pain appx 24-36 hours after receiving the 2nd Covid-19 vaccination. Three days after receiving the 2nd vaccination, he went to the emergency room to be evaluated for chest pain. He was admitted to the hospital on 5/29/21 because of elevated troponin levels. He was given a dose of Ketorlac for pain. He was observed x 2 days and then discharged to home on 5/31/21

16 year old c/o mid-sternal chest pain x 2 days which worsens on inspiration. Pt had Pfizer vaccine #1 on 4/25. About 10 days later pt developed cough and around that same time his mother tested positive for Covid-19. On 5/8 the patient tested positive for Covid-19 and his 2nd vaccine dose was postponed. His symptoms resolved after appx 1 week. He then received his 2nd Pfizer Covid-19 vaccine on 5/26. The next day 5/27 (2 days PTA), pt c/o of mild chest pain. On 5/28 (1 day PTA) he was able to run a mile during PE but ran slower than usual and had some mild chest discomfort during the run. This morning pt felt worsening chest pain and parents brought him to ED. Since his recovery from presumed Covic-19 infection earlier in the month, the patient has not had any SOB/cough/fever/chills/rash. No pain radiating to extremities. No lethargy. Pt continues to have a normal appetite w/ normal u/o and normal BMs.

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

In the evening on 5/29 pt experienced chest pain in the center-left chest, was advised at urgent care where he was found to have elevated troponin levels with normal vitals, exam, EKG, and chest X-ray. He was admitted to the hospital where he continued to have intermittent chest pain and had increase in troponin levels during his admission. He was then transferred to a different hospital where he continues to have elevated troponins and is being worked up for possible myopericarditis.

Patient had received 1st dose approximately on 03/24/2021, 2nd dose on 04/14/2021. Pt was noted with swollen lymph nodes at the clavicle where he was seen 04/13/2021 for a virtual appointment for further eval.

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

June 4: Vaccine received June 6 (AM): felt arm pain and mild chest pain not affected by breathing or moving. Continues on and off, but was relieved by ibuprofen. June 7: 1PM- chest pain became persistent, not relieved by ibuprofen. Describes as "squeezing" with palpitations. Accompanied by feeling clammy, weak, pale, subjective fever. Brought to ED and transferred to ICU 6/7 at 18:44 for labs and imaging consistent with myopericarditis. Started treatment on scheduled Ibuprofen (600 mg q8 hours). Chest pain improving, but serial troponin continued to rise. 6/9: NSAID changed to Toradol for continued chest pain with colchicine

myocarditis; elevated troponin/troponin has been rising (up to 16); substernal chest pain at rest; shortness of breath; CRP to 87; abnormal EKG; headache; fevers; This is a follow up-spontaneous report from a contactable HCP (Nurse). A 16-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 16 years old. The patient medical history was not reported. NKA (No known allergies). Historical vaccine included first dose of BNT162B2 for covid-19 immunization. Concomitant medication included tretinoin (RETIN-A) 0.025 % cream taken for an unspecified indication, start and stop date were not reported. The patient experienced myocarditis, elevated troponin/troponin has been rising (up to 16), headache, fevers, substernal chest pain at rest, shortness of breath, crp to 87, abnormal EKG, all on 26Apr2021 with outcome of recovered on Apr2021. Reported as Patient with no significant PMH admitted on 4/26 with myocarditis, elevated troponin, and abnormal EKG. He states that he was feeling his usual self until the day that he received his 2nd dose of the COVID vaccine on 4/24. On 4/24, he started to have a headache and subjective fevers. On 4/26, he reported having substernal chest pain at rest, non-radiating, associated with shortness of breath. Patient took tylenol with minimal relief. Patient denies cough, congestion, abdominal pain, nausea, vomiting, diarrhea, rash. No sick contacts. Since admission, troponin has been rising (up to 16), BNP normal, CRP to 87, ESR normal, CBC and electrolytes unremarkable. Clinical course and findings consistent with myocarditis. ID consulted for infectious workup and management. In my prelim recs upon admission, I recommended a dose of IVIG and holding off on steroids and antibiotics.The patient underwent lab tests which included electrolytes: unremarkable on 26Apr2021, BNP: normal on 26Apr2021, c-reactive protein: to 87 on 26Apr2021, electrocardiogram: abnormal on 26Apr2021, CBC: unremarkable on 26Apr2021, ESR: normal on 26Apr2021, sars-cov-2 antibody test: positive on 29Apr2021 (Blood test), Symptomatic COVID-19 (Standard NAA): negative on 26Apr2021 (Nasal Swab), troponin: has been rising (up to 16) on 26Apr2021, troponin: elevated on 26Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for events for 4 days. Treatment received for events. Patient had no covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Information about batch/Lot number has been requested.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 use. 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 AE. 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.

RECEIVED THE 2ND DOSE OF COVID VACCINE ON 06/09/2021, AND BY 06/10/2021 MY SON HAD DEVELOPED A SWOLLEN LYMPHNODE IN HIS ARMPIT THE SIZE OF A GOLF BALL IN AN OVAL SHAPE.

chest pain that began 24 hours after vaccination, continued and worsened over 24 hours hours, sought treatment at ED approximately 48 hours after vaccination. At ED given IV fluids and toradol with notable improvement in pain,

Presented to urgent care on 5/28 with complaints of sore throat, Headache, body aches and fever for 103, slight cough, denies chest pain or SOB. Had a neg rapid strep. Diagnosed with viral illness 5/30 presented to the ED with chest pain, cough, wheezing and SOB. Also had diarrhea and low abdominal pain. Was hypotensive and bradycardia. Received 2 bolus of Lactated Ringers . EKG with ST segment elevation. Concern for MISC. Transferred to hospital. 5/30 at the hospital he had another bolus of fluid, continued bradycardia admitted to the ICU for potential for hypotension during IVIG for suspected MISC, worsening ST elevation on EKG. TTE unremarkable. Started on IVIG, anakinra, lovenox and solumedrol. Monitored on telemetry. EKGs consistent with myopericarditis. discharged home on prednisone on 6/4 with a long taper, has follow up with rheumatology and cardiology. Stool enterovirus positive culture positive. He had previously been diagnosed with COVID-19 in November 2020

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.

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.

The day following the second Pfizer shot the patient developed a fever to 101.5 that improved with Tylenol and did not recur. On that same day he felt tingling in the hands and feet and reported a floating sensation. This too resolved with resolution of fever. On the third day after the shot he developed chest pain, difficulty taking a deep breath. He woke up the following morning with nausea which resolved but the chest pain and a feeling that it was hard to take a deep breath worsened. The pain was significant enough that he went to the ER. In the ER, he was found to have an ECG consistent with acute pericarditis and his troponin was elevated (2.75, upper limits of normal 0.03). He was started on IV Toradol and admitted to the hospital. His troponin kept climbing so he was also given IVIG (80 gm). The following morning his Troponin started coming down and he no longer was reporting any symptoms.

Received second covid vaccine and one month later, developed chest pain, shortness of breath and was admitted to hospital for concern of myocarditis.

16yo previously healthy male presenting with chest pain. He received second dose of Pfizer Covid vaccine on Wednesday at 3p. That evening, he developed fevers, chills and had trouble sleeping. On Thursday, he began feeling heart palpitations and again slept. Overnight, he developed midline chest pain, and decided to present to the emergency room. His EKG showed elevated ST segments. Labs were remarkable for elevated troponin, leukocytosis, and elevated CRP; echo showed normal function but subtle hypokinesis of the apex. He was given morphine, Tylenol, Ketorolac, 1L NS, and possibly aspirin before being transferred to the ED. In our ED, he had a reassuring exam, was no longer reporting chest pain. He had labs drawn which showed a white count to 15.3, normal H/H, Plt 152, ESR 12, CRP 10, and Trop T 1.14. Aside from the above symptoms, he has been in his usual well state without viral symptoms, nausea, vomiting, diarrhea, rash, joint pain, or other symptoms. He has no past medical or surgical history. Immunizations are up to date. His social history is benign. Patient was admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. An echocardiogram was performed which showed mild LV systolic dysfunction. He was then treated with IVIG 2g/kg and started on methylprednisolone IV q12h. He remained asymptomatic with no chest pain throughout his admission. He was transitioned over to PO steroids on 6/13 which he tolerated well. On day of discharge, his troponin levels were trending down. Cardiac MRI showed an area of late gadolinium enhancement in the LV, with no abnormal function. By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake including tolerance of PO steroid. Prescriptions sent to preferred pharmacy. Follow up with cardiology to be arranged. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan. Reasons for new, changed, and discontinued medications: - Prednisone - Famotidine Patient was admitted for management of myocarditis thought to be due to his SARS-CoV2 vaccination. He received IVIG and steroids. He had multiple EKGs, echocardiogram, and a cardiac MRI. He showed improvement during his hospitalization. He will be followed closely by Cardiology who will advise return to exercise and repeat imaging needs. **Please note that we do not have access to the vaccination records (lot, etc)**

Patient was hospitalized on 6/11/2021 after presenting to the ER with a history of chest pain x 48 hours. Labs showed an elevated troponin and an EKG was consistent with pericarditis/ myopericarditis. On further questioning patient had received the second dose of his COVID-19 Pfizer vaccine 2 days prior to the onset of chest pain. In the ER he was given a dose of ketorolac which relieved his chest pain. An echo as done which showed normal left ventricular systolic function and no pericardial effusion. He was admitted for further monitoring of his heart rhythm and to trend his troponin. He remained in the hospital for ~ 48 hours and was discharged on 6/13. His troponin was at its peak at his initial presentation and was 7,077. It initially decreased in the first 3 hours, but had small increases in the first 24 hours of admission. However, it had decreased to a low of 1575 at the time of discharge. His CRP initially was 4.4 (normal < 1 mg/dL) and decreased to 1.5 at discharge. ESR was mildly elevated at 23 and decreased to 18 at discharge. Chest pain had completely resolved within 12 hours of admission. He was maintained on ibuprofen 600 mg three times daily.

Developed intermittent sharp chest pain 1-2 days after receiving the vaccine, worse when supine (c/w pericarditis); no fever or other symptoms. Seen by his pediatrician & an EKG showed diffuse ST segment elevation; TnI was markedly elevated at 13,259ng/L (nl up to 57). Was admitted to the PICU & begun on IV ketorolac. By the time of admission he had no more chest pain. Received two doses of IV ketorolac, then transitioned to po ibuprofen q.8h.

Abdominal pain, fever, diarrhea, malaise starting on 6/12 => diagnosed with complex appendicitis on 6/18 with intra-abdominal abscess

Patient developed chest pain and shortness of breath a day after vaccine Admitted to the hospital, troponin were elevated, Echo showed mildly reduced EF treated with colchicine and NSAIDs

The day of vaccination general malaise and low grade fever which resolved with Motrin. Four days after woke up with chest pain. Presented to ER where he was found to have elavated troponin 1.01. EKG showed Normal sinus rhythm, with ST elevation.

My son had a swollen lymph node in his left clavicle area. It was very painful and lasted for 5 days. Our doctor ran blood tests and a chest x Ray to rule out other possible causes. It was determined to be a side effect from his second shot.

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.

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.

Day after vaccine: headache, nausea, low grade fever, "pinching feeling in chest", decreased appetite. Felt better for a few days, then 4 days after vaccine, low grade fever returned, pt developed rash/swelling on 75% of body, itching, little nausea, elevated diastolic blood pressure when measured at urgent care. pt was given steroids for swelling/rash.

Myocarditis with onset 7/12, worse on 7/13 and admitted to hospital to Cardiology service. Had non-sustained ventricular tachycardia and was transferred to the cardiac ICU on 7/14 morning and placed on a lidocaine drip. He had no further arrhythmia, and lidocaine was stopped and transferred out of CICU on 7/15.

Lymphadenopathy (adenopathy) under the left armpit. Off & on, more painful during the beginning of the side effect (days 3-7 after vaccination). Onsets at random at this point, latest being 10 weeks 2 days after vaccination on July 15th. Unsure if it will continue. Other side effects I had during /after dose 2 from May 4th- (about) May 11 were reported.

Extreme Irritability/Aggitation, increased impulsivity, Trouble controlling emotional outbursts, lump under armpit where vaccine was given for 3 days

Anaphylactic Reaction. Throat began closing up, difficulty breathing, dizzy, disoriented. Received several treatments of Epinephrine, Streroids, Benadryl, and Ativan. Put on Oxygen. He is now on Benadryl every 6 hours for the next 3 days and been told to carry around an Epi-pen in case he has more adverse reactions. Follow-up with his primary care is scheduled for tomorrow 3/19/21.

Approximately 15 minutes after vaccination, recipient developed tightness in throat. Taken into ambulance by EMTs. Seen by doctor at 20 minutes post vaccine. Patient developed stridor and shortness of breath. Treated for anaphylaxis- IM epinephrine x2, IV dexamethasone, 250 mL normal saline bolus. Transported to emergency department by EMS.

one day of fever found to have elevated inflammatory markers, LV dysfunction (now resolved), elevated troponin and ST elevation in EKG concerning for myopericarditis. Admitted to hospital. No documented fever in hospital, no rash, no GI symptoms, no other criteria met for MIS-C. Unclear etiology of myopericaraditis.

multi-phase anaphylaxis/several anaphylactic reactions; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 17Mar2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to sticking plaster (adhesive) and diabetes type 1. Family history included allergies to some antibiotics in the mother. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced multi-phase anaphylaxis/several anaphylactic reactions in Mar2021, which caused hospitalization and was reported as an important medical event and life-threatening. The clinical course was reported as follows: The patient had multi-phase anaphylaxis following his first dose of vaccination. He went to three different hospitals and was in the pediatric intensive care unit (PICU) at the time of reporting. The patient was heavily sedated, intubated, and on a ventilator for 3 days. The clinical outcome of multi-phase anaphylaxis/several anaphylactic reactions was unknown. Follow-up attempts are completed. No further information expected.

severe reaction to the vaccine had a anaphylactic shock had 2 more the next day; This is a spontaneous report received from a contactable consumer. A 17-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history includes diabetic (reported as Takes diabetic med humaran). It was reported that the patient experienced severe reaction to the vaccine had an anaphylactic shock had 2 more the next day. It was added that very sedated fighting it so he dont die. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Had facial swelling/warmth/redness within 15 months of getting the vaccine. Then had hives on and off over the next 4-5 days.

Patient fell back in chair, the chair fell and patient hit his head on the floor, slight swelling noted on right forehead. BP 93/41. HR 58. He was transferred to the ED via gurney. Lost consciousness for 1 minute. Recovered and was discharged home.

Fatigue set in about 6 hours after vaccine administration, followed by nausea, headache and fever about 9 hours after. Vomiting, chills, headache continued all through night. Fever never reached higher than 100.3 degrees F. Headache continued all the next day, as well as loss of appetite. Used Advil to treat headache. 48 hours later, a swollen lymph gland above left collarbone was discovered. Doctor suggested a warm compress.

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.

Two days following vaccine, patient experienced N/V and right lymphadenopathy (on same side as injection) which continued for two additional days. On Day 5, patient experienced neck and facial swelling, rash, itchy mouth, throat tightening, and difficulty breathing following lunch (chicken with cashews, no prior food nor medication allergies nor prior symptoms with any tree nuts nor peanuts nor soy). Symptoms improved with 50 mg diphenhydramine, but swelling continued, administered corticosteroids at urgent care facility and continued Medrol dose pack. Food allergy testing scheduled for mid-May.

Body aches, chills, sweating within 12 hours of shot, lasting for about 36 hours. 72 hours post injection a full body rash appeared, with hands especially affected (red & itchy), and swollen sore lymph nodes in armpits

Patient received vaccine, was observed for 15 minutes, and left. Patient came back a few minutes later with red swollen fingers. Patient brought to observation room and given 25mg of benedryl. Redness improved by 1843, and was cleared to leave by RN.

Systemic rash with hives and itching, chest pain and shortness of breath, neck and facial edema, edema to extremities, nausea and vomiting Benadryl 50mg PO every 4-6 hours for 4 days and then PRN for itching/rash. Medrol Dose pack as directed, Daily Pepcid PO, Zofran PO PRN

Within days of 2nd vaccine: Pain at the site, fever, chills, soreness, exhaustion, mental fatigue, swollen lymph nodes. Within weeks of vaccination: depressive symptoms including lack of motivation .

Patient with initial low grade fever which resolved but then developed 3 days after shot developed acute myopericarditis with elevated troponins requiring intensive care unit and therapy.

FEVER, CHILLS, FATIGUE, HEADACHE, ARM PAIN, CONGESTION, SWOLLEN & PAINFUL LYMPH NODE UNDER RIGHT ARM. THESE SYMPTOMS LASTED FOR SEVERAL DAYS AND WHILE NO LONGER SEVERE, CONTINUES TO BE FATIGUE AND HAVE PAIN WITH SWOLLEN LYMPH NODE.

The day after the vaccination started hives. But it was slow so thought could be food allergic reaction. Over a period of 2 weeks it developed never went off. Noticing the hives getting worse and the epsode starting day after vaccination suspected it the cause and so went to primary care physician. She diagnosed the hives related to medical side effects and only medical related item he had within the last 1 year was this vaccine. She put him on Methylprednisolone for 6 days along with Cetirizine HCL 10mg. The hives appeared to be suppressed for the first 3 days where the dose was higher, however, when the dosage was getting lower after day 3 it came back with high intensity. Lips, fingers, tongue...swollen and with fever running at upto 101.6. Again went to the doctor, she put him on Prednisone with 40 mg for 3 days, 20 mg for 3 days, 10mg for 3 days and 10mg alternate days. It literally took more than 1 and half month still not recovered. Hives are still on and also severe cold with mucus and cough started since (05/09/21). Fever show up on and off even now. We're referred to allergy specialists. She asked to not take 2nd dose. Increased dosage of Antihistamines, asked to continue Prednisone 10mg for 6 more day daily 10mg and if cold and cough does go in the next 2 days may put on antibiotics.

Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet and to the extensor surfaces of the extremities, and a geographic tongue.

17-year old M with history of recurrent ear infections requiring PE tube placement who was in his usual state of health until 5/5 when he noticed a new itchy hive-like rash. He was short of breath 5/6, and developed fevers that night along with vomiting. He was seen 5/6 with negative COVID19 PCR and documented fever to 104. Fevers continued, and he was admitted the evening of 5/10 with concern for myocarditis. See below for hospital course. Additional information for Item 18: ...Screening labs were notable for mild lymphopenia, hyperbilirubinemia, hepatitis, and elevated inflammatory markers. Given prior COVID infection, rash, and systemic inflammation, additional studies including troponin, D-dimer, BNP, and EKG were obtained. EKG was reassuringly normal, however the D-dimer (2.48), troponin (1.27), and BNP (469) were elevated. Other work-up included chest x-ray which was unremarkable, and right upper quadrant ultrasound with incidental cavernous hemangioma of the liver. He was started on milrinone (5/11-5/12) after initial TTE was concerning for severely diminished LV function. Follow-up TTE 12 hours later was normal (on milrinone), and remained so after milrinone was discontinued 5/12. Follow-up TTE after discontinuation remained normal. Cardiac MRI was completed 5/14, although read remains pending. He received IVIG on 5/11, and was started on methylpred 50 mg IV BID, Anakinra 100 mg SQ BID 5/14, and transitioned to prednisone 30 mg PO BID with clinical improvement, down-trending troponin and systemic inflammatory labs. Subsequent CBCs have been notable for rising leukocytosis (5/16 WBC 56.3) and thrombocytosis (5/16 plts 690) and 4+ spherocytes (with no known personal or prior history of spherocytosis). He will likely be discharged 5/17. Infectious evaluation was unrevealing including cultures and viral studies. COVID spike and nucleocapsid antibodies were sent, but remain pending. Pt. initial COVID-19 infection was diagnosed October 2020, with positive saliva PCR testing. He was symptomatic for 3-5 days. He received his second dose of the Pfizer COVID19 vaccine 4/27 in his left arm; denies any significant reactions (arm swelling, injection site redness, lymphadenopathy, myalgias, fatigue, or fever). He has had passing contact with school classmates who have recently been diagnosed with COVID19.

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.

5/14/21 - day 1 after vaccine dose #2 - had fevers, body aches, chills, fatigue. 5/15/21 - day 2 after vaccine dose #2 - began to have chest pain that started out at 5/10 and then became constant and persistent sharp, 10/10 chest pain that was worse with lying back and improved with sitting up and leaning forward. Pt went to Urgent Care, had ECG done and demonstrated ST wave changes where he was brought to ED and ECG confirmed ST/T wave changes and Troponin T was elevated to 1.62 - thus with these findings and the chest pain that was consistent with pericarditis - diagnosis of myopericarditis was made.

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.

About 18 hours after the vaccine was given, the patient developed chest pain. The chest pain progress over about 24 hours to 9/10. He presented to the ER where he was found to have elevated troponin (up to 15) and ST changes on EKG. Echo was normal x2. He was treated for myopericarditis with NSAIDs and colchicine. He quickly improved. No clear etiology of his myopericarditis was identified, raising suspicion that it may have been an adverse reaction to the vaccine.

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.

COVID-19, mRNA, LNP-S, PF (PFIZER-BIONTECH) 5/19/2021 (17 Y) , 4/28/2021 (17 Y) Severe chest pain, Requiring hospitalization for pain management and MI/Myocarditis therapy.

17-year-old male with no medical history, no allergies and no surgeries presented to the ER on 5/22 at 11 PM with concern for chest pain. The patient received his 2nd COVID-19 Pfizer vaccine on Thursday, 05/20/2021 in his left arm. The patient developed a temperature of a 102.5° with aches, chill, and pain overnight. The symptoms subsequently dissipated. Around noon on 5/22 he began to experience an achiness and pressure beneath the sternum and it has been constant since. The pain does not radiate into the back. No associated ripping or tearing sensation. No shortness of breath or difficulty breathing. In ED, EKG showed normal intervals, no ST changes and no STEMI. The patient underwent a CT angio of the chest and abdomen and did not show any dissection of the aorta. The left and right proximal coronaries are visible, however their path could not be seen on the studies performed. No pneumomediastinum both pneumothorax was observed. He had an elevated troponin of 3.1 and it increased to 7.3 prior to transfer to the ICU. VS were stable with HR 80 - 90 and normal BP. Repeat ECG was normal but his troponin increased x 2 with maximum of 16. His CRP was mildly elevated and BPN upper limits of normal. Echo was normal. Cardiologist consulted and pt diagnosed with myocarditis. As of 5/24/21, patient remains hospitalized as troponin was 13.1 at 9:00 am.

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.

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 2nd Pfizer COVID vaccine on 5/21/21. He had fever and headache for about 24-36 hours, which he had also had after the first dose of the vaccine. On 5/23, he woke up with constant substernal chest pain, which worsened with exertion and deep inspiration. The pain increased throughout the day. In the ED, he was found to have elevated troponin ,CK-MB, elevated CPK, and elevated liver enzymes. EKG was concerning for ST elevation initially. Bedside echocardiogram showed low-normal function, normal coronaries, trace effusion, and no evidence of RV strain. Troponin and NT pro BNP were increased upon admission to our facility. Repeat ECHO showed borderline global hypokinesis of the LV with an LVEF of 51%. He received IVIG on 5/24/21 and also was started on ketorolac on 5/24/21. Troponin and CK were trending downwards at the time of this submission.

Headache, stuffy nose, body aches , swollen glands under his throat, pain when swallowing, hard to swallow. No difficulty breathing, no wheezing, no cough, no rashes. Mother gave Benadryl. Mother reports symptoms started the day the vaccine was given. Resolved within 3 days.

Patient's mother states her son experienced hives on his right side of his forearm. She states the hives were huge in size also that he also had diarrhea 24 hours after his vaccine. He was taken to the ER to get checked out. At the ER they told her that maybe a bee sting him or it was because of the vaccine. His right hand and forearm were swollen. The hives lasted a few hours then it went away. He was given Benadryl for 5 days straight at the ER which helped to decrease his symptoms. His mother states he is no longer having the hives or diarrhea.

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.

Critical thrombocythemia, causing anemia due to nose bleeding, GI bleeding and metrorrhagia. Elevated WBC. Acute kidney failure. Pancreatitis. Admitted with Dx of Tumor lysis syndrome required blood and platelets transfusion

Patient began with substernal chest pain 8 out of 10. Patient was taken to emergency room. At the outside hospital patient was given Motrin with improvement of pain. Patient's troponin at outside was 34.5. CK-MB was 41.6. CK was 523. CBC was unremarkable. Sed rate was 15. CRP 1.46. Patient had chest x-ray that showed no acute process. EKG at outside hospital shows sinus rhythm with occasional PVC. Mild diffuse settle ST elevation and no PR depression. Upon arrival to the floor patient had no significant pain. On telemetry patient was found to have an episode of nonsustained ventricular tachycardia. Patient denies recent cough, congestion or fevers. Patient does have 2 parents and a dog at home. Of note patient got first dose of pfizer Sars-Covid-19 vaccine on April 14. Second dose of Pfizer vaccine was given on May 14. Initial troponin i-STAT presentation was 11.03. Patient also experiencing nausea and vomiting on 5/20.

Pt with headache frontal swelling on the face, chills, next day after receiving the vaccine pt seen at ER, received IV fluid and tylenol, Toradol, Decadron and sent home in Motrin. Pt still has headaches and frontal swelling.

swollen lymph node under the left armpit; the lymph node used to hurt a lot but now it is just really big; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733) on 02Apr2021 at Noon (age the age of 17-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0170), on 26Apr2021, both doses via an unspecified route of administration, administered in left arm as single dose for COVID-19 immunization. Patient medical history included no other illness except that he usually gets fever after vaccines, no vaccine in particular, just after most vaccines, he gets a fever. There was no history of any previous immunization with Pfizer Vaccine and no additional vaccines administered on same date of vaccination. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 (next day after first dose), when woke up, patient experienced swollen lymph node under the left armpit (the same arm he got vaccine), and lymph node used to hurt a lot but now it was just really big. It was still there a month later when he was getting his second dose. The patient mother stated that they wanted to see the doctor to see how bad her son symptoms were and because of pain but the doctor told them to call Pfizer and stated that family doctor does not want to see them because there is nothing that they can do. The events not required any visit to emergency room or physician office. No relevant tests were done. There was no investigation assessment. Reporter stated that he was wondering if this is still normal to be there. The patient did not receive any treatment for the events. The outcome of the event swollen lymph node under the left armpit was not resolved, while outcome of the event lymph node used to hurt a lot but now it was just really big was unknown. Information on Lot/Batch number was available. Additional information has been requested.

lymphadenopathy under the arm of the vaccine (left) and to the right of the sternum. chills for 7 days. Fatigue for 7 days

On Monday, May 31, 2021 at 1:20am pt. woke up with intense chest pain and labored breathing. He was able to fall back to sleep and woke up two hours later (3am) with the pain escalating. He did fall back to sleep again and once again woke up at 9am only to learn the pain was even worse and was barely able to breathe. He called me, his mother, and I raced him home and straight to our local Emergency Room. The ER originally thought it was a collapsed lung. After the x-ray came back negative for a pneumothorax, they continued testing. The very last test they did showed extremely elevated Troponin numbers at 1.05 and C-reactive Protein (CRP) numbers at 5.42. We were transferred by EMS/ambulance to the hospital 40 minutes away and checked into the Pediatric Intensive Care Unit (PICU). Pt was admitted in the afternoon of May 31st and was released on June 3rd at 1:30pm. June 1st his Troponin was 0.26 and CRP was 6.10. June 2nd Troponin was .45 and CRP was 3.54. The day he was released from the PICU (June 3rd ), his Troponin was .45, and the CRP was down to 1.83. Pt received daily EKGs, 24-hour heart monitoring, constant blood pressure tests, as well as blood oxygen levels. Once released from the hospital, Pt will be on light duty for at least a week, if not more. First follow-up Cardiologist appointment was June 8th at 10:30am. Echocardiogram, EKG, and blood work was ?normal.? Pt was put on a 72 hour heart monitor on June 8th and will be removed June 11th. Will start weaning off Ibuprofen and acid reducer, Pantoprazole, the next three weeks. Will continue to take Colchicine for three months, as well as light movement and exercise, nothing strenuous (swimming, running, etc.). Follow-up with cardiologist in one month (beginning of July).

swollen forehead; Caller states the patient's swollen forehead is very very painful; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 17-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0186) via an unspecified route of administration on 23May2021 (at the age of 17 years) as 1st single dose for COVID-19 immunisation. The patient had no medical history, family history and concomitant medications. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received the first dose of the vaccine on 23May2021 and he had a bad reaction, he had a swollen forehead. The swollen forehead was very very painful and patient had been back and forth to the ER. On 24May2021 patient went to the ER and was given dexamethasone, Toradol, Benadryl, Tylenol and after that IV hydration, and he was in a lot of pain, did a CT scan and it was clear. The events did start to get better but now it was still swollen and very painful. Patient went back to the ER on 29May2021 in the evening, gave him Benadryl, Tylenol and Reglan, and did blood work. The case was assessed as serious (medically significant). The events resulted in patient to visit emergency room. The patient underwent lab tests and procedures which included computerized tomogram which was clear on 24May2021 and blood test: unknown result on 29May2021. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Swollen Glands/Swollen lymph nodes in groin; Throat pain; Dehydration; Oral lesions; Oral ulcers; Fissured lips; Lethargy; Body aches; This is a spontaneous report received from a contactable physician. A 17-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6200) via intramuscular route of administration on 19Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation. The patient's medical history included type 1 diabetes mellitus, ADHD, known allergies: cats and horses, acne and depression. The patient underwent lab tests and procedures which included blood immunoglobulin g: negative, blood immunoglobulin m: negative, herpes simplex test: negative. Acyclovir (stopped when HSV 1 and 2 IgG and IgM were neg), sars-cov-2 test: negative on 24Feb2021. The patient's concomitant medications included insulin lispro (HUMALOG) and isotretinoin (ACCUTANE). On 22Feb2021, the patient developed severe swollen glands in his submand region, throat pain, swollen lymph nodes in groin, dehydration, oral lesions, oral ulcers and severely fissured lips, lethargy and body aches. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for all the events. Hydration, discontinued Accutane, gave Acyclovir (stopped when HSV 1 and 2 IgG and IgM were neg). The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Patient developed significant swelling in his legs and feet approx three weeks after the second shot which was treated at home with water pills and tylenol. the swelling has lasted about five days.

History of prior COVID19 infection in March 2021, mild symptoms. Vaccine #1 on 5/14/21, Vaccine #2 on 6/11/21. Acute onset chest pain/pressure on 6/13/21 in the early morning. Chest pain slowly improved throughout the day. Treated with NSAIDs and colchicine due to concern for myopericarditis.

the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0170, (Reporter stated that they could be 0's or O's, she did not know) Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 14:00 (at the age of 17 years old) as first dose, single for COVID-19 immunisation. The patient has no medical history and no family medical history relevant to adverse effect. No prior vaccinations was received within 4 weeks. The patient's concomitant medications were not reported. On 13May2021 at 23:00, the patient experienced that on the side where the patient received the injection, which was his left side, the area right by his arm pit, right by the front of his body was swollen and hurt like crazy. The events did not require visit to Emergency Room or Physician Office. Outcome of all events was unknown. The reporter was asking if this is normal and if she should be concerned. No follow-up attempts are needed. No further information is expected.

Got the vaccine on 6/13. Developed fatigue, sore throat, runny nose within 24 hours on 6/14. Was stable, but on 6/17 developed high fevers up to 101-102, erythematous rash on his neck, bilateral conjunctivitis and runny nose. Presented to the ED under my care on 6/18 due to ongoing fever, dehydration and neck pain. Currently undergoing full evaluation: COVID19 PCR positive. ESR, CRP, procal elevated. ALT/AST elevated High sensitivity troponin elevated. BNP normal. CBC with neutrophilic predominance, platelets clumped - repeating. RVP pending. Evaluating for MIS, COVID reinfection, post-vaccine reaction, different viral illness, post-covid reaction + development of a cellulitis.

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.

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.

Swollen lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (reporting himself). This 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 17Apr2021 at 09:30 (age at the time of vaccination was 17 years) as a single dose for COVID-19 immunization. The patient had no known medical history. The patient previously took penicillin, ibuprofen, amoxicillin and experienced drug allergy. The patient's concomitant medication included calcium, colecalciferol (CALCIUM +D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were 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 vaccination with in 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 27Mar2021 at 09:00 as a single dose for COVID-19 immunization. On 17Apr2021, the patient experienced swollen lymph nodes in left arm pit. The patient received 1 aleve pill (naproxen) as treatment for the event. The outcome of the event was resolving.

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.

Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axillary lymph node inflammation, general discomfort and pain. Lasted approximately 2-3 days.

Having seasonal allergies and it made them exponentially worse; Having seasonal allergies and it made them exponentially worse; Swollen tonsils; Pin inside ears; Swollen lymph nodes in my neck; This is a spontaneous report 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: UNKNOWN) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies which was ongoing. Concomitant medications were 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. On 31Mar2021 at 19:00, after vaccination the patient's seasonal allergies became exponentially worse. The patient also experienced swollen lymph nodes in neck, swollen tonsils and pin inside ears. The events resulted in doctor/other healthcare professional office/clinic visit. The patient's doctor believed that the events were related to vaccine administration. The patient received treatment with steroid and other unspecified pain relief pills. The clinical outcome of the events vaccine made seasonal allergies exponentially worse, swollen lymph nodes in neck, swollen tonsils in neck and pin inside ears was not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.

**Please note - we do not have access to the immunization registry and cannot provide lot numbers or exact dates** Admission Date/Time: 07/18/2021 18:23:00 Discharge Date/Time: 07/21/2021 12:53:15 Chief Complaint COVID vaccine myocarditis Patient Narrative ILLNESS SEVERITY: The patient is returning to baseline, requires assessment. PATIENT SUMMARY: Reason for Hospitalization: Chest pain Admission HPI: a 17 year old young man with a remote history of asthma (last used inhaler 5-6 years ago) who is presenting with 1 day chest pain in the setting of recent Pfizer Covid vaccination. He received his second Pfizer vaccine dose 3 days ago. The following day, he experienced low grade fever to 100.4 and mild headache. He felt fine yesterday, but this morning he woke up with dyspnea and feeling like he "couldn't get air in all the way". He denied feeling chest pressure but endorsed mid sternal chest pain without radiation. The pain was not exacerbated by exercise and was not positional. He presented to an urgent care facility this morning, where they did an EKG that showed ST segment elevations diffusely. He was then transferred to Hospital. he was overall well appearing with slight tachypnea but otherwise normal vital signs. He initially was not endorsing chest pain. They drew a troponin that was elevated to 1515 ng/L with an upper limit of normal 54 (likely 1.5 on our scale). BNP, electrolytes, CBC were all within normal limits. Initial EKG did not have any ST segment elevation. They did a chest XR which did not show any signs of pulmonary edema or cardiomegaly. He later developed chest pain so an EKG was repeated which showed recurrence of the ST elevations diffusely; most prominently in V1-2. Repeat troponin was 2000. He was given a single dose of aspirin 81mg and transferred for further care. In the ED, he was well appearing and no longer endorsing chest pain. He was monitored on continuous telemetry with no abnormalities. His troponin here was 0.27 ng/mL, CRP was elevated to 2.6, he had a mild transaminitis of 41/37 and mildly elevated LDH to 236. Covid antibodies were positive. CBC, ferritin, d-dimer, ESR were all within normal limits, rapid Covid/flu/RSV negative. Repeat EKG was similar to the second EKG with very minimal ST-segment elevations. He denies any URI symptoms, rashes, N/V/D, and joint pain. He's had good PO intake until today. He is an athlete (currently playing baseball) and has never experienced chest pain with exercise. Surgical hx: T&A Family history: Negative for any cardiac pathology or autoimmune disease Allergies: rash with penicillin Social: here with grandma who is legal guardian Hospital Course: admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. The morning after his admission, his troponin was uptrending slightly to 0.37 and echocardiogram showed mildly depressed systolic function and longitudinal strain, so the decision was made to treat. Cardiac MRI performed prior to treatment showed good systolic function but mild LV late gadolinium enhancement and corresponding hypokinesis. He received one time IVIG 2g/kg and IV methylprednisolone 30mg BID for 2 doses. His chest pain came and went throughout his admission and was treated with ibuprofen and Tylenol as needed. He was transitioned over to PO steroids on 7/20 which he tolerated well. On day of discharge, his troponin levels were trending down. Pt was scheduled for outpatient follow up including ECHO at that time. By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake. Chest pain was fully resolved. Prescriptions sent to preferred pharmacy. Follow up with cardiology in place. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan. Reasons for new, changed, and discontinued medications: Prednisone for myocarditis to complete 5 day steroid course (last dose morning of 7/24) Famotidine (GI protection while taking prednisone) Reasons for new, changed, and discontinued equipment: NA Relevant Diagnostic Images/Studies: Echocardiogram 7/19: ? Technically difficult examination due to suboptimal echocardiographic windows. Unable to evaluate the atrial septum, systemic and pulmonary veins, pulmonary arteries, and aortic arch. Coronary artery dilation is not excluded. ? Normal valvular function. ? Normal left ventricular size and low-normal systolic function. Reduced longitudinal strain. ? Qualitatively normal right ventricular systolic function. ? No pericardial effusion. Cardiac MRI 7/19: ? Normal left ventricular size and global systolic function. ? Basal inferoseptal, inferior, and inferolateral left ventricular late gadolinium enhancement with corresponding mild hypokinesis. ? Normal right ventricular size and global systolic function. No right ventricular late gadolinium enhancement or regional wall motion abnormalities. ? No significant valvular dysfunction. ? No coronary artery aneurysms. ? No pericardial effusion. Admission EKG 7/18: ST segment changes, non-specific. Discharge EKG: minimal ST segment changes, improved from admission. Tests Pending Adenovirus PCR QuaNT, Stool Adenovirus PCR QuaNT, Urine CMV Antibody IgG CMV Antibody IgM EBV Antibody IgG EBV Antibody IgM EBV Antibody to EA-D, IgG EBV Antibody to NA, IgG Enterovirus PCR QuaL, Stool HSV I/II Combined Antibody IgG Lyme Antibody, Total Mayo Misc Test Miscellaneous Lab Test Miscellaneous Test Arup Miscellaneous Test Arup Miscellaneous Test Arup Parvovirus B-19 IgG Parvovirus B-19 IgM Parvovirus DNA PCR QuaNT, Blood Respiratory Virus PCR Panel - sendout Viral Culture, Non Respiratory These tests will be followed by the Primary Service at Discharge after Discharge Vitals and Discharge Physical T: 37.1 °C HR: 64 (Monitored) RR: 20 BP: 120/58 SpO2: 96% HT: 167 cm WT: 94.9 kg BMI: 34 Discharge Physical Exam Gen: Well-appearing, well-developed teenager sitting up in bed. Appropriately interactive./ HEENT: Normocephalic, atraumatic. Moist mucous membranes. EOMI, no conjunctivitis. Resp: Clear to auscultation bilaterally, no increased work of breathing. No wheezes CV: Normal rate, RR with no murmurs, rubs, or gallops. Capillary refill <2 sec. Distal pulses 2+. Abd: Soft, non-distended, non-tender. Normal bowel sounds Ext: Normal range of motion of all extremities, no peripheral edema Skin: Pink, warm, no bruising Neuro: Alert, responsive, developmentally appropriate, normal tone Diagnosis List 1. Chest pain, 07/18/2021 2. Shortness of breath, 07/18/2021 3. Myocarditis, 07/18/2021 Procedure History No Procedure History Social History Smoking Status No Smoking Status Documented Allergies penicillin Laboratory Results Returned 48 Hours Prior to Discharge Labs Last 48 Hours Event Name Event Result Date/Time WBC 7.88 K cells/uL 07/20/21 Hemoglobin 12.6 g/dL 07/20/21 Hematocrit 36.6 % Low 07/20/21 Platelet 298 K cells/uL 07/20/21 MPV 9.1 fL Low 07/20/21 RBC 4.17 M cells/uL Low 07/20/21 MCV 87.8 fL 07/20/21 MCH 30.2 pg 07/20/21 MCHC 34.4 g/dL 07/20/21 Red Cell Distribution Width CV 11.9 % 07/20/21 Nucleated Red Blood Cell % 0 /100 WBC 07/20/21 Nucleated Red Blood Cell Count 0 K cells/uL 07/20/21 Absolute Neutrophil Count 6.38 K cells/uL High 07/20/21 Absolute Lymphocyte Count 0.97 K cells/uL Low 07/20/21 Absolute Eosinophil Count 0.02 K cells/uL Low 07/20/21 Absolute Basophil Count 0.01 K cells/uL Low 07/20/21 Absolute Monocyte Count 0.45 K cells/uL 07/20/21 Absolute Immature Granulocyte Count 0.05 K cells/uL High 07/20/21 Neutrophil/Band 81 % High 07/20/21 Immature Granulocytes 0.6 % High 07/20/21 Lymphocyte 12.3 % Low 07/20/21 Monocyte 5.7 % Low 07/20/21 Eosinophil 0.3 % Low 07/20/21 Basophil 0.1 % Low 07/20/21 Sodium 137 mmol/L 07/19/21 Potassium 5.14 mmol/L High 07/19/21 Chloride 102 mmol/L 07/19/21 CO2 21 mmol/L Low 07/19/21 Anion Gap 14 mmol/L 07/19/21 Glucose Level 133 mg/dL 07/19/21 BUN 11 mg/dL 07/19/21 Creatinine 0.61 mg/dL 07/19/21 Calcium 9.3 mg/dL 07/19/21 Phosphorus 4.5 mg/dL 07/19/21 Magnesium 1.9 mg/dL 07/19/21 Troponin T 0.21 ng/mL Critical 07/21/21 Troponin T 0.22 ng/mL Critical 07/20/21 Troponin T 0.22 ng/mL Critical 07/20/21 C-Reactive Protein 0.77 mg/dL High 07/20/21 Mycoplasma pneumoniae, IgG 1.87 High 07/19/21 Mycoplasma pneumoniae, IgM 0.47 07/19/21 Microbiology Results (Last 30 Days) Micro Results: Updates since 06/21/2021 00:00. Collection date displayed. Cytomegalovirus PCR, blood, QuaNT: (Blood) 07/19/2021. Final Report: No CMV detected by PCR. This test does not detect latent CMV infections. A reference range for this test has not been established. Results should be interpreted in the context of other clinical and laboratory information. This test should not be used to diagnose latent or previous CMV infection. People with latent or previous CMV may not have detectable CMV DNA by this test. The variability of this test should be considered when interpreting results. Changes of approximately three fold in the quantity of CMV DNA detected may be due to variation in the test rather than actual changes in the level of CMV DNA in the sample. Note: This test was developed and its performance characteristics determined by the Hospital. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Epstein-Barr Virus PCR, QuaNT: (Blood) 07/19/2021. Final Report: No EBV detected by PCR. This test does not detect latent EBV infections. A reference range for this test has not been established. Results should be interpreted in the context of other clinical and laboratory information. This test should not be used to diagnose latent or previous EBV infection. People with latent or previous EBV infection may not have detectable EBV DNA by this test. The variability of this test should be considered when interpreting results. Changes of approximately three fold in the quantity of EBV DNA detected may be due to variation in the test rather than actual changes in the level of EBV DNA in the sample. Note: This test was developed and its performance characteristics determined by the Hospital. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Health Care Proxy: Under 18 years old MOLST: Under 18 years old Follow-Up and Patient Instructions Patient Instructions He was admitted for management of myocarditis thought to be due to his SARS-CoV2 vaccination. Myocarditis is inflammation of the heart muscle that can happen with many different types of infections and virusesHe received IVIG and steroids. He had multiple EKGs, echocardiograms, and a cardiac MRI which showed mild changes but overall good heart function. His chest pain and heart studies improved throughout his stay and he was safe for discharge home. He should refrain from strenuous exercise for the next couple of months and you should discuss when it is safe to return to exercise with your outpatient cardiologist. Medications: --- Prednisone 30mg twice per day for _ days (last day _) --- Famotidine 20mg twice per day for _ days (last day _) It is important to minimize activity that raises his heart rate for the next 3 months. This will be discussed in more detail at cardiology appointment. Until then, no strenuous exercise. Attending Attestation CARDIOLOGY INPATIENT ATTENDING DISCHARGE NOTE: I reviewed the history and hospital course, examined the patient on rounds, reviewed the testing, discussed the findings with the Cardiology Team, and participated directly in formulation of the assessment and plan for discharge. I have reviewed and agree with the documentation above with the following additions/revisions:17yo admitted with COVID vaccine associated myocarditis, with repolarization abnormalities on ECG, elevated troponin, and chest pain within days after receiving his 2nd dose. He remained hemodynamically stable with preserved ventricular systolic function. Echo did show abnormal strain, and MRI showed LGE with focal hypokinesis. Due to increasing troponin level, he was treated with IVIG and steroids with improvement in troponins. No significant arrhythmia. Plan for follow-up next week with MISC/vaccine myocarditis group, and to complete a 5-day course of steroids. Restricted from sports and intense activity for likely at least 3 months.

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.

PT was in observation period and came up to the consultation window asking if a numb arm was a normal side effect of the vaccines. At further inspection I noticed that he was having a rash . I had a sit for a few more minutes then his mom came up and we noticed that his arm started to swell. We gave him 2 capsules Benadryl 25mg and instructed him to go to urgent care. Called for a follow up later in the evening and found that urgent care send him to the ER. The rash was spread all over and well as the swelling. He swelled all the way to his toes. He also tuned white and became very lightheaded at the ER. They gave him IV Benadryl and dexamethasone and was sent home. It has been recommended by the ER doctors to not get the 2nd dose.

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.

Patient presented to the emergency department early March 28, 2021 after experiencing 5-7 hours of chest pain. The chest started when the patient went to bed the evening of March 27, where he began having substernal non-radiating chest pain with inspiration. The pain was relieved by sitting upright and by taking some acetaminophen. He received his 2nd dose of the Pfizer COVID-19 vaccine on March 25 (first dose was March 5). He was initially treated with ketorolac 15mg IV and given 1 liter of lactated ringer's solution via IV. His chest pain resolved after this. He was eventually given colchicine 0.6mg twice daily and ibuprofen 600mg 3 times daily due to concern for myopericarditis. He was ultimately found to have no evidence of pericarditis after undergoing a cardiac MRI, thus colchicine and ibuprofen were discontinued. Due to findings of mildly reduced ejection fraction on imaging, he was started on metoprolol XL 25mg once daily at discharge.

My son received his first vaccine dose in his left arm on Friday April 9 at 8:45 am. By Sunday when he woke up, he noticed a walnut sized lump on his left clavicle. It felt unusual and moved on the bone every time he turned his head or moved his arm. There was no redness or fever and it felt hard. It was still there on Monday morning (April 12) so we called his primary care doctor which is where he received the vaccine. The doctor felt it could be a cyst or swollen lymph node and is sending him to a general surgeon next week for further evaluation. The doctor was uncertain if the lump was directly related to the vaccination. Other than acne, patient has no other preexisting conditions. He did have COVID19 in November with only mild symptoms (positive test on 11-23-20; no fever or cough, just felt tired for a couple days).

Recurrence of pancreatitis requiring hospitalization, with abdominal pain, lipase to 6740, D-dimer to 4516, without flare of primary symptoms of MCTD (no arthritis, myositis, dyspnea, worsening of Raynauds, photosensitive or vasculitic rashes). Still hospitalized on d4 after admission, anticipate d/c in next 24-48 hours

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.

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.

Sickle cell disease patient with a history of Covid infection in Dec 2020, received first dose of Pfizer vaccine in April 2021 followed by second dose on May 7th2021. He was admitted to the hospital on May 11th 2021 for a vaso-occlusive pain crisis. He then developed fevers, increased inflammatory markers, coagulopathy and significant tachycardia- echocardiogram, was done which showed coronary artery aneurysms raising concern for Mis-C. Retrospectively, his previous echocardiogram few years ago also showed coronary dilation although now it was slightly worse. patient was given IVIG and steroids as treatment for Mis-C following which fevers resolved and his inflammatory markers improved. He is being followed with serial echocardiograms which shows stable echo findings. He remains in the hospital still for treatment of his pain crisis.

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.

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.

right hand swelled up around the size(twice the size of his normal hand would be); Scrotum was swollen; Bottom lips swelled; Normal flu like symptoms; He was sore; Didn't feel well; This is a spontaneous report from a contactable nurse (patient's mother). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscularly, administered in left arm at the age of 18-year-old on 24May2021(around 1 PM) (Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscularly, administered in left arm at the age of 18-year-old on 03May2021(around 1 PM) (Lot Number: ER8737) as single dose for covid-19 immunization. The patient hadn't taken any vaccine 4 weeks prior to the COVID 19 Vaccine. There was no family history relevant to the adverse event. Nurse stated her son had the normal flu like symptoms afterwards when he was sore and didn't feel well in May2021. A day later(in May2021) his bottom lips swelled just his bottom lips there was no oropharyngeal response on the side of the lips. He took Benadryl and about 8 to 12 hours later it went down. On Thursday(27May2021), his right hand swelled up around the size, she meant twice the size of his normal hand would be, that also lasted around 12 hours or so. Today(in May2021) he called her from work and his scrotum was swollen. And she was trying to find out if this was a normal, she was a nurse working in an emergency department and this was not a normal response in anyone else that she had heard of who had gotten the vaccine but she wanted to call to see if this was something maybe somebody else has experienced, or one of the doctor, one of the doctor that she work with prescribed a Medrol dose pack for him just in case. The outcome of the event 'bottom lips swelled was recovering, of the event right hand swelled up around the size(twice the size of his normal hand would be) was recovered in May2021, of the other events was unknown.

Allergy to red meat became prevalent again. Since becoming allergic to red meat in the summer of 2020, I had gained a tolerance to red meat to the point where I could consume as much as I wanted. This lasted between August 2020 and the date listed in this report. On that date I consumed red meat and had an allergic reaction to it. The reaction was a swelling of the fingers, hives on the arms and knees and wrist. As I didn?t have any reactions to red meat in the previous 10 months I didn?t make the connection that I was allergic to red meat again. The following Monday I consumed more red meat. That night I was very drowsy and went to bed at 1900. At around 0100 Tuesday morning I woke up with a terrible stomach ache and could feel my hands itching. I tried to go back to sleep. At around 0430 I woke up again with completely swollen hands to the point where I couldn?t bend any joint in them, hives on my wrists, knees, elbows, neck, forehead, back, and back of thighs. I went to the hospital for a severe allergic reaction. This is the exact same allergic reaction that I would have when I consumed red meat in June 2020 at the height of my allergy, but I had never had a reaction like it since then. Now I am sensitive to red meat again and I can?t think of any reason except that I received the vaccine. I have not consumed red meat since.

Blood Clot/DVT Pain and swelling in lower extremity following left elbow reconstruction with contralateral gracilis autograft.

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 and back itch incredibly; Does feel hot; now swelling of his face or throat; now swelling of his face or throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's father). An 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, batch/lot number: EN0187 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:30 (at the time of vaccination 18-years-old), as a single dose for COVID-19 immunization. The patient's medical history include sunburn and reported that he did have a sunburn 3 days ago. No concomitant medications were not reported. The caller provided other relevant medical history including but not limited to these conditions; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have any other vaccination prior to COVID vaccine (within 4 weeks). No family Medical History Relevant to adverse events. On 25Jun2021, the patient experienced chest and back itch incredibly, does feel hot, and now swelling of his face or throat. It was reported that, today (25Jun2021) the caller 18-year-old son had the Covid-19 vaccination. He had the vaccine about 2 hours ago. Everything was fine up until about 30 minutes ago. He claims his chest and back itch incredibly. He had no other symptoms and no rash. He does feel hot. He had no difficulty breathing and now swelling of his face or throat. The caller wife was a nurse. She did not feel like it was an emergency at that point but being a nurse, she wanted him to check and see if they have any Benadryl. No relevant tests. Patient did not visit to emergency room, physician office and not hospitalized. The outcome for all the events was not resolved. Additional Information has been requested.

Myopericarditis. Relatively asymptomatic admitted 6/15/21 with Left sided pleuritic chest pain 48 hrs. after 2nd Pfizer COVID vaccination.

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.

Patient presented to ED with fever, vomiting. Found to have elevated troponins with myocarditis. ECHO was normal, treated with indomethacin and colchicine and will follow up with Cardiology in a couple of weeks.

Anaphylaxis. Turned gray, diaphoretic, blurred vision, difficulty hearing. Blood pressure quickly dropped to 66/31. Perfusion was 5 seconds. Received EpiPen (0.3mg Epinephrine) x1. BP better but slow to return to baseline. To Emergency Room for 4 hours observation. While in ED, received IV Benadryl and IV Zofran. Condition improved by the end of 4 hour observation so discharged with an EpiPen.

4/4 headache, chills, temp 102.8, sore arm, hard swollen lymph node in right axilla. Symptoms persisted into 4/5 with addition of nausea. 4/6 tightness in chest, short of breath. Went to ER and was found to have elevated troponin level peaking at 9.6. Transferred to hospital, direct admit to CCU for suspected non STEMI. Hospital stay through 4/9 and diagnosed with myocarditis.

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.

patient developed anaphylactic symptoms, hypotensive, dizziness, facial paleness. Epi-pen and 1 liter NS administered. Patient brought to ED, medicated with diphenhydramine and ondansetron. sent home from ED after approx 4 hours.

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.

lump under his armpit; Fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EW0157), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 10:30 as single dose for covid-19 immunisation; ibuprofen (IBUPROFEN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication.History: She says he took ibuprofen and that they all started to have fever and chills.He took ibuprofen. She things the dose was 300mg or 400mg and he took a total of 3 doses .Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): no. The patient medical history, concomitant medications were not reported. On 21Apr2021 The patient experienced fever, chills, and on 23APr2021 lump under his armpit. The outcome of events was recovered ,On 23Apr2021 and lump under his armpit (axillary mass) was not recovered. Follow-up (23Apr2021): No follow-up attempts are needed. No further information is expected.

A male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient had formed swollen nodes, a swollen kind of region above my left collar bone, patient can't really press into it, it was slightly sore when I press into it. Caller reported his experience after first dose. He recently had first dose on 16Apr2021 and since then well 3 days later he had formed swollen nodes, a swollen kind of region above his left collar bone? He can't really press into it was slightly sore when he pressed into it. Second dose was scheduled for 07May2021. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

lump under his armpit on same arm that he got the shot in; lump under his armpit on same arm that he got the shot in; swollen lymph nodes (lymphadenopathy); Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0157), via an unspecified route of administration, on 21Apr2021 at 10:30, administered in Arm Right as single dose for covid-19 immunisation. Patient's first dose of bnt163b2 (BNT162B2, Batch/lot number: ER8733) was administered on 31Mar2021 at 10:30 in left arm. The patient's concomitant medications were not reported. On 21Apr2021 the patient experienced fever (08:00), chills (thinks around 21:00 or 22:00). She says on 21Apr2021, the same day as his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. She does not know the NDC number, lot number, or expiration date of the ibuprofen he took. On 23Apr2021 lump under his armpit on same arm that he got the shot in. On 23Apr2021 swollen lymph nodes. Prior Vaccinations within 4 weeks were none. The patient was not sick at the time of either vaccination. There was no family history. The outcome for events fever and chills were recovered on 22Apr2021 but for event lump under his armpit on same arm that he got the shot in was unknown. No follow-up attempts are needed. No further information is expected.

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.

Patient presented to ED with progressive shortness of breath with exertion. Patient has a history of vaping nicotine for 2 years with increasing respiratory symptoms, shortness of breath for several months. Patient received first dose of Pfizer on 5/7/21 symptoms of shortness of breath predated vaccine but due to ongoing symptoms presented to ED 5/14/21 where he was found to have myocarditis. Patient was hospitalized for 2 days treated with colchicine with improvement in symptoms. Patient readmitted 5/21/21 with recurrent myopericarditis with newly reduced ejection fraction from 60% to 40-45%. Remains in the hospital at this time

Desquamating rash of hands, feet, groin/legs after covid vaccine. Patient received his first COVID-19 vaccine dose on 5/2/2021. Patient initially had sore throat that started 5/4/2021 followed by rash 5/6/2021. He had TAV with on 5/8/2021 and reported headache, sore throat, swollen glands, tactile temps, chills, nausea, vomiting, loss of appetite. Prescribed amoxicillin for 10 days. TAV on 5/13/2021 complaining of diffuse itchy rash all over body, started on face, but now everywhere including groin. Video appointment on 5/17/2021; sore throat better after antibiotics, rash continues to itch. Advised to stop antibiotics and pending in person clinic visit. Seen in clinic on 5/18/2021; antihistamine and hydrocortisone ointment has not helped the rash. Rash by this time less erythematous than when started and skin starting to dry/peel. Rash on bilateral palms, axilla/neck, groin. Telederm appointment probable atypical viral exanthem and recommended moisturizers, low potency topical steroids. Came to the ER on 5/20/2021 for continued skin peeling. Discussed with dermatology and prescribed prednisone 40mg daily for 7 days. Returned to the ER on 5/21/2021 for continued progression of the rash, started on clobetasol ointment, a higher dose steroid than what he was previously on. Presented 5/23/2021 of burning, itching, flaking off of rash and uncontrolled pain. States it hurts to sit due to the rash behind his thighs and buttocks.

Patient developed chest pain, shortness of breath and fatigue. Chest pain was worse with laying down. Went to Urgent Care and EKG revealed abnormal changes and was sent to ER for evaluation. Found to have minimally elevated troponin, WBC, Sed Rate, CRP and D-dimer. CXR and CT scan were normal with only small L axillary lymph node identified. Diagnosed with pericarditis and discharged home with Ketorolac for 5 days. Symptoms resolved.

Felt fatigued with arm soreness. Two days later developed left supraclavicular lymph node swelling. Pt describes swelling as size of "ping pong ball" with tenderness. No axillary nodal swelling or tenderness. Progressive decrease in size of lymph node. Pt evaluated by clinician on 05/20/21. Non-tender palpable node measuring 2 cm X 1 cm. No axillary or cervical nodes noted. Recheck one week later, 05/27/21 - non-tender palpable node measuring 1 cm X 1 cm. CDC consultation sought 05/20 and 05/27.

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

Systemic: swelling of fingers/hand-Medium, Additional Details: as detailed by technician who was present-- patient reported fingers swelling during observation period. pharmacist on duty directed them to remain in observation area. after a few minutes, patient reported that swelling had improved, stated that at the end of observation period they wished to leave. pharmacist advised them if any further adverse reaction occurs (swelling, tightness in throat) to go to emergency room. patient then left observation area.

Acute myocarditis. Presented with palpitations. He had wide complex tachycardia (diagnosed as fasicular ventricular tachycardia). Required cardioversion. Started on metoprolol. Hospitalized two days. Send home with LifeVest.

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

19-year-old male no past medical history brought in by father with complaint of shortness of breath, chest discomfort, palpitations, tachycardia x2 days. Symptoms began 1 day after vaccination. EKG revealed diffuse ST elevations, machine read as *ACUTE MI*. Patient was given 325 mg ASA, placed on O2, and transferred to ER via 911. Patient was hospitalized overnight for observation. Troponins were elevated at 13. Patient had full cardiology work-up and cath lab that did not reveal any arthrosclerosis or underlying heart disease. Diagnosed with myocarditis, discharged on metoprolol and aspirin. Has pending follow-up with cardiology, currently still with mild symptoms.

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.

Original side effects were chills, fever, headache, and cough. Current side effects are swelling of armpit region and stiffness of joints.

Ball under armpit; Ball under armpit; This is a spontaneous report from a contactable consumer or other non-HCP (patient's girlfriend). A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in Arm Left on 15Mar2021 09:30 (age at the time of vaccination 19-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. No prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced Ball under armpit. Patient did not received treatment for adverse event. Caller wanted to see if it was swollen lymph nodes. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Swollen Lymph Nodes; This is a spontaneous report from a contactable consumer. A20-year-male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/lot number: EL1284 ) via an unspecified route of administration, on 07Jan2021 14:00 at a single dose, for COVID-19 immunization. Facility type vaccine: Military Base. Anatomical Location: Arm Left. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No patient's medical history reporter and concomitant medication included creatine monohydrate (CREATINE MONOHYDRATE). The patient experienced swollen lymph nodes on 07Jan2021 19:00 with outcome of not recovered. he action taken was not applicable. No treatment was received.

Very sore and swollen lymph node in right armpit, general body aches, exhaustion without ability to fall asleep (restlessness during day and at night)

20 yo healthy male with onset of severe urticarial reaction, swelling of face, hands and feet, fever on 4/11, hospitalized 4/16/2021, resembles serum sickness.

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.

patient reports left arm swelling, tingling and numbness. Patient educated that is normal to have some swelling and numbness in the vaccinated arm. patient instructed if new or worsening symptoms occurred, after 2 minutes patient stated that she felt less anxtous knowing that symptoms were expected

presented to the ER with complaints of abdominal pain. Found to have a ruptured appendix with intra-abdominal abscess, UTI, acute hypoxic respiratory failure related to bilateral aspiration pneumonia, and sepsis. Principal Problem: Perforated appendix POA: Unknown Active Problems: Sepsis (CMS/HCC) (HCC) POA: Yes

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.

Acute onset chest pain began 4/11/2021, he took NSAIDS and tried to sleep. The following day, 4/12/21 the chest pain was still present. He was admitted to hospital and diagnosed with acute myo-pericarditis. He was treated with Colchicine with improvement in his symptoms.

Noticed a bump below my collarbone 12 hours after injection. Now believe that it is a swollen lymph node based on what other people have reported and pictures of lymph nodes online.

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.

Patient rec'd Pfizer COVID vaccine dose 1 on 2/26/21; dose 2 on 3/18/21. He began to have substernal chest pain on 3/20/21, took Tums with partial relief. He had additional episodes of chest pain over the next 2 days and came to the ED on 3/22/21. EKG was abnormal and troponin was elevated, so he was admitted with a diagnosis of myopericarditis .

20 yr. old male, received his 2nd dose of Pfizer Covid vaccine on Friday, 5/7/21. He experienced the normal chills Friday night, followed by fatigue and chills on Saturday, 5/8/21. At 1:30am Sunday night, he experienced chest pain with no relief. Patient was seen at an urgent care and emergency room. EKG was abnormal and showed a right bundle branch block, CRP levels elevated 10.37 - normal range 0-10. He was evaluated by cardiologist and is continuing to be monitored.

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.

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.

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.

Left supraclavicular lymph node swelling was noticed on 12/29 after I received the first dose of the vaccine. It continue to persists even today and fluctuates in size and temperature throughout the day with the lymph node being largest in the morning. NP has prescribed doxycycline and prednisone to see if the swelling will reduce.

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.

Vaccinee noted mild soreness at injection site on day of vaccine. Next day vaccinee noted fever to 101.5 and tender axillary adenopathy, fatigue and malaise. Two days after injection noted headaches with come and go

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

Arm soreness, Chills throughout the day on 03/13, Swollen and painful Lymph Node near left armpit 03/14. Shot was administered to Left arm.

Swollen lymph nodes on the left side of my face near my periauricular pit in my ear. This pit has been leaking fluid since 7:00 AM yesterday, on April 2. There is a mild, numbing pain in the region, and I've taken Ibuprofin to deal with that pain. I don't know how long this will last, but according to the handout I got, swollen lymph nodes are normal and I had no other adverse side effects other than feeling a bit drowsy this morning, though me staying up until 3:00 AM playing video games could be a confounding effect.

On 4/22 I felt two lymph nodes behind my left clavicle. Today is 4/26 and the lymph nodes felt larger so I saw the NP at the Drs Office and she gave me an order for an ultrasound of my neck if my lymph nodes don't go down in 10 days or if they get larger. The order states it is due to the assessment finding lymphadenopathy of left cervical region.

My hands began to swell, turned red, itched, and felt a burning sensation, and it hurt but then it went away. I don?t know what happened.

Swollen lymph nodes [Onset: 3 Day(s); Frequency: Constant; Duration: 3 Day(s); Free text: Pt reports a swollen lymph node on his left side of his neck, and he states it was after he had his 2nd dose of Pfizer vaccine on 4/27/21, and on 4/28/21 he noticed the swollen lymph node.; Intensity: Now-9]

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)

Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday. Patient says that he was in his USOH until yesterday when he started having substernal chest pain which was getting worse with inspiration but also with specific movements. He does have pain even at rest sometimes but he thinks that it's exacerbating by breathing. Had some nausea/vomiting as well. Denies other symptoms. Not really sob or leg swelling. In the ER, his Trop I was 10.7 and his WBC was 12.2. His EKG was NSR with short PR and STE I, II, III, AVF, V4-V6 Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday with some pleuritic characteristics. He was found to have a very elevated trop I to 10.7, leukocytosis to 12.2 and STE in I, II, III, AVF, V4-V6. His POCUS in the ER was without significant pericardial effusion and probably normal EF. Differential at this point includes pericarditis vs myopericarditis (there are some myocarditis cases reported in Israel post Pfizer vaccination, predominantly in young male patients) vs less likely ACS. Will need admission and further work up and treatment -Admission to Cardiology -NPO in case team tomorrow decides to proceed to LHC -Full echo and cardiac MRI tomorrow -Telemetry monitoring -Repeat EKG q4h overnight -send CRP, ESR -trend Trop to peak -would not start heparin gtt at this point -Please start tonight ASA 650 TID + Colchicine 0.6 mg BID 21-year-old man admitted with signs and symptoms of acute myo-pericarditis or in the setting of recent COVID-19 vaccination. He apparently had the findings are vaccine 2 days ago and developed pleuritic chest pain. His ECG shows pathognomonic changes for pericarditis in the is a small troponin elevation. He has no past medical history or exertional symptoms to suggest CAD. Bedside echocardiogram showed preserved left ventricular systolic function. He was admitted and placed on aspirin and colchicine. A cardiac MRI today showed evidence of myopericarditis. He had 3 beats of nonsustained VT on tele.

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.

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.

Armpit lymph nodes swelled up for about a week and a half. Along with the usual nausea and sluggishness of the the vaccine.

Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later. He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%. On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO. Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.

Moderate to severe headache, minor but continuous nausea, minor swelling of lips/face, odd tingling sensation (primarily of the head/face), Resolved after administration of 24 hour dose of naproxen sodium, and Tylenol PM (acetaminophen + diphenhydramine). Patient still combated lethargy until 6:00-7:00 PM, though it could have been a side effect of the dose of diphenhydramine. Felt fine after.

2nd Dose: - Pain in the injection arm roughly ~9 hours after. - Pain escalated from a 1-2 to a 4-5 throughout the night. - Pain on left arm, near first injection site returned. Unsure if correlation or just early signs of body fatigue/soreness starting. - Minor swelling on right arm & was warm to touch. Applied ice pack and went to sleep. - Pain escalated to a 5-6 the following morning (6/16) at ~8-10am. - Full body fatigue started around 10-11am on 6/16. (No mental fog present, fatigue incl. soreness & general pain) - Throughout the day, chills are present intermittently. - Throughout the day, nausea is present intermittently. - At time of writing (9:05pm 6/16) pain is at a 3-4 on right arm, pain throughout body is a 2-3 depending on location. OTC pain medication such as Tylenol has limited effect. 1st Dose: (not sure if you want this but I will add it anyway) Received 5/13/2021 @ 1:40pm @ Clinic (same location as above; lot # above as well) - Pain in the injection arm roughly ~3-4 hours after. - Pain remained a low level 2-3 on a general pain index throughout the day. - Following morning, at ~8am (5/14) pain was a 3-4. Responded to OTC Tylenol immediately. - Arm was tender for 3-4 days, until it resolved.

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

He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He could barely breathe; he felt like his heart it was something involved with his heart, he couldn't even take the normal breath; He had a swelling around the calves; This is a spontaneous report from a contactable consumer. The consumer (patient's mother) reported for her son. A 21-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 in arm as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccines were administered. The reporter stated that her husband got the first dose (lot number: ER8732) on 03Apr2021 at 11:30 and all of a sudden, his ears started ringing, but in one ear it was like unbearable siren going on and it calm down. He received the second dose on 24Apr2021 at 11:30 (lot number: EW0170; expiry date 31Aug2021) and the events came back with full force again but were gone. She was sure that the events were because of the vaccine. Her husband went for an MRI because he got something going on with his brain and went to a neurologist but later it was gone. She reported that her girlfriend's husband lost hearing in one ear after he got the vaccine. She also reported that her son received the vaccine on 12May2021 and had lot of side effects which were very normal for 21 years old, but the third day he woke up and said he could barely breathe, he felt like something was involved with his heart and he couldn't even take the normal breath. She reported that they almost took him to the hospital, and he started to calm down by the end of the day, the events were gone but he had swelling around calves. The outcome of the events was recovered in 2021. Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021694827 Same reporter, different drug/patient/ AE

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

Swollen lymph node armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 10:45 (at the age of 21-year-old) as single dose for COVID-19 immunisation. The medical history included covid-19 and no known allergies. The concomitant medications were not reported. Prior to vaccination, the patient was 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 unspecified date in 2021, the patient experienced swollen lymph node armpit. The patient underwent lab tests and procedures, which included nasal swab test on 23Mar2021 and the result was negative. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lymphadenopathy axillary was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

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

Patient was sitting in the chair and then fell onto the floor head first causing him to bump his head and also hit his nose. He appeared to have a bump on his forehead and his was bleeding.

Swollen lymph node under left arm.; Fever; Headache; Body ache; 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: UNKNOWN) via an unspecified route of administration in the arm left on 26Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included tetanus vaccine (TETANUS) started from 21Apr2021 for an unknown indication and isotretinoin (ACCUTANE) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 (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 not been tested for COVID-19. The patient received any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced swollen lymph node under left arm. After lymph node swelling went down delayed reaction with headache, fever, body aches, 6 days after vaccination. The clinical outcomes of headache, fever, body aches were not recovered while that of swollen lymph node was recovered on an unknown date in May2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

I started feeling achy around 9:00 pm and felt like I was going to get more ill. I took some Tylenol in hopes it would help but it got worse throughout the night. During the night, I couldn?t hardly sleep due to feeling really hot and achy. I felt like I had a fever but did not have a thermometer to check it. When I woke up this morning, I noticed I had a knot on my clavicle which I believe it to be a swollen supraclavicular lymph node. I was unable to go to my internship today due to feeling ill but I am feeling better now after sleep and medication.

Lymphadenopathy near left side of clavicle, near injection site; This is a Spontaneous report from a contactable Consumer (patient). A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left arm on 09Jan2021 at 13:00 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced lymphadenopathy near left side of clavicle, near injection site on 10Jan2021 at 13:00. The patient did not receive treatment for the event. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered. Information about Lot/batch number has been requested.

The day after shot I noticed pain on my right side chest. That pain lasted till January 3- I felt my chest and noticed there was a swollen bump. I went to the ER where they did an X-ray. They didn't see anything and dismissed me with swollen Lymph nodes. My Lymph node is still swollen till today.

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.

Extreme sensitivity to cold contact on skin. Routine icing after physical therapy (only 8-10 minutes) resulted in severe pain at site of icing along with swelling and redness that has persisted for 4 days. It has evolved now into itchy boils.

Swelling in both hands, more in the left hand as it was vaccination arm. Tingling through body. Multiple Hives (about 5) formed on my arms and upper body. Took 50mg benadryl to manage. Was already on Zyrtec at the time in case of reaction. Slight congestion and sinus irritation but no feeling of anaphylaxis or much in the throat. Symtoms stopped worsening and were gone by the next day.

The patient was given the vaccine at 1200 noon on 3/9/21 The patient reports left side facial swelling and upper lip swelling. The patient was prescribed benadryl 25 mg 1 tab po q 6 hours The patient was instructed on using a cool pack The patient was instructed on 911 precautions for worsening swelling of face, lips tongue or throat or shortness of breath or trouble breathing

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 --

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

Per EMS, patient with history of T2 diabetes reporting nausea and blurred vision post second vaccine. He stated he had "swelling" of his hand (vaccine arm) and "felt funny" with the first vaccine but he did not declare that on his screening form today. BP 190/110, HR 95,blood glucose 292, RR 15 PSO2 99%. He did not take his blood sugar this AM, did not take metformin, and did not eat today. He was oriented to time and place, responses were one to two syllable words. Transport at patient's request.

On 3/24/21 received vaccine and then on 3/31 began breaking out in hives on face/hands front and back and in between fingers/hives on arms/elbows/legs/knees/feet too and bottom hives also around eyes.Pain really bad in hands and feet. Swelling around eyes/face/hands/some fingers in the joint area. Itching was all over except back and tummy. Priority Care seen by said serum sickness but had never seen from vaccine recommended to follow up with family Dr . I contacted Dr 's office was told no need to see him as Priority care diagnosed and prescribed predisone 10 mg. I still wanted some answers call back next day and we went in 4/12/21 was told need to get with Infectious disease dr at major hospital spoke with his nurse on 4/12/21 and she said I would get call back about a referral appt. I did get call back from Family Dr and they said they spoke with Dr and he said no need to see him it's very common and he can get the 2nd shot. Never saw him or anything. So we are finishing up predisone script on Saturday 4/17/21 and he is also taking benadryl and the hives disappear but come right back and sometimes worse. Please help

Young healthy patient presented with chest pain starting 3 days after vaccine. Profoundly abnormal EKG and marked troponin elevation. Workup consistent with acute myocarditis of unclear etiology.

Unusual dreams/nightmares ? at least 2 nights Swollen armpit lymph node ? 2 days Fatigue ? 2 days ?Brain fog? ? 2 days

develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; develop red, swollen fingers that were tender to the touch, and were "cold at first but now they're pretty hot" to the touch and "they were a little bit itchy, as well; inflammation; swelling; allergic reaction; This is a spontaneous report received from a contactable male consumer (patient). This 22-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the on 05Apr2021 at 12:45 as a single dose for COVID-19 immunisation. The patients familial history included a reaction to unknown vaccine to patients mother. The patients medical history included allergy to gantrisin, sulfa drug and penicillin. Concomitant medications were not reported. No other vaccine in four weeks. On Tuesday 06Apr2021 at around 15:00, the patient developed red, swollen fingers that were tender to touch and were cold at first but later were pretty hot to touch and were a little bit itchy. It was unknown if the redness has gone down but on 07Apr2021, it started blistering is still red and itchy. The events resulted in a visit to the ER and they believe he is having an allergic reaction to the vaccine and was seen by his primary care physician. The patient went to the Emergency Room on 06Apr2021. The patient was prescribed treatment as Benadryl and Prednisone. The outcome of the events was unknown. The patient wants to know if he will be contacted, or where he can find more information about the symptoms he experienced, when that information would be available. No follow-up attempts are needed. No further information is expected.

Numbness/loss of sensation in toes began around 4/16/2021: Sensation reduced from the toes up to the hip bilaterally (R<L). Strength 5/5 bilaterally. 2+ reflexes in lower extremities. 2-3 beats of clonus bilateral ankle jerk. Mottling on feet, interior ankles, kneecaps. Decreased cap refill in feet, knees, and interior ankles. Feet extremely cold. Presented to urgent care 4/26/2021. While there, noticed purplish discoloration over knees and feet as well as diminished sensation up to both hips as well as over the right arm and right side of face. Subsequently transferred to emergency department from urgent care for further evaluation. Neurology consulted after examination was notable for brisk lower extremity reflexes and bilateral ankle clonus. CRP mildly elevated at 12.5.

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

Seven days after received Dose 1 of Pfizer Covid-19 vaccine, right arm was swollen and uncomfortable, the next day was purple. He want to urgent care center who thought he had "Covid arm" and was put on prednisone. Arm worsened, so he went to ER in middle of night on 5/4/21. He was given shot of Lovenox and sent home to return in am for ultrasound. Ultrasound next morning showed right subclavian vein DVT. He was put on Eliquis and told to follow up with hematologist. He is working on getting appointment with a hematologist before flying home, where he will do further work up with hematologist there.

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.

Similar to the reaction to his first dose, patient experienced extreme fatigue and increased seizure frequency, and more generalized seizures that worsened, and then resolved by day 26. Rescue medication (ativan) was used at home on 5 occasions. On April 7, 2021, (day 14) Pt had an in-person with neurologist to follow up on the seizures that occurred after the first dose. Later that day, Pt went into status epilepticus and had to go to the emergency room, which resulted in his being admitted to the neuroscience ICU for observation. He was discharged to home on April 8. Symptoms improved gradually and resolved by April 19 (day 26). Video foolow-up visit with neuro on 4/22.

Patient experienced extreme fatigue and increase seizure frequency, and a new type of generalized seizures. This began 2 days after the injection, worsened, and then resolved by day 16. Rescue medication (ativan) was used at home on 3 occasions. Patient had a video visit with neurologist, who ordered tests thatr returned mostly nirmal votes (elevated whites consistent with immune response to vaccination). Prior to this, patient had been mostly seizure-free since October 2020.

Leg and feet swelling 4-5 days after the vaccine injection; After the medical check discovered abnormal heart size and systolic heart failure that never happened before. The patient was sent to the hospital and stay for 5 days for cardio check-ups and monitoring. Now is discharged from the hospital on the pill.

The day after receiving the vaccine, the lymph nodes in my left arm (armpit, clavicle, left pectoral, etc) became swollen and painful. This has continued today. This also happened during the first round of vaccination, although much less severe in pain and scope; prior, it was just my armpit that became swollen and painful.

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

Patient is a 22 y.o. male with PMH of obesity who presented to ED on 5/22 with c/o chest pain 3 days after receiving his second dose of Pfizer COVID-19 vaccine. Trop elevated to 12.7 and ECG with diffuse ST segment elevation consistent with pericarditis. He had an episode of NSVT. Trop peak 29. Patient was started on ASA + colchicine and metoprolol. TTE revealed LVEF 49% with multiple segmental abnormalities. Due to concern for worsening arrhythmia and possible need for myocardial biopsy patient was transferred to BMMC on 5/23. Cardiology was consulted and cardiac MRI was performed. No further arrhythmias noted on telemetry monitoring. Cardiac MRI revealed LVEF 57% RVEF 53%, no vasodilator induced perfusion defect, delayed enhancement MRI is abnormal, epicardial enhancement of distal anterior and anterolateral walls with small pericardial effusion, consistent with perimyocarditis. Patient chest pain resolved and he denied other associated symptoms.Ttroponin level down to 5, VSS. Medically stable for discharge with no strenuous activities until inflammatory biomarkers normalize and close f/u with cardiology in 1 week. New medications: - ASA 650mg TID for 7 days followed by ASA 325mg daily - Colchicine 0.6mg BID for at least 3 months - Metoprolol succinate 25mg daily Follow up with cardiology clinic in 1 week with CRP, ESR, and troponin

The side effects didn't all occur simultaneously. Friday evening I noticed severe arm soreness. Later Friday night (about 10 hours after getting the vaccine) I developed gradual onset chills, body aches, and fatigue. Saturday I woke up with a severe headache, body aches, fatigue, and fever. The headache became severe by mid-day, with fatigue also worsening throughout the day. Sunday was more of the same, though I believe the fever started inching down and the headache lessened. What developed Sunday afternoon/evening took me off guard though. I noticed a sudden drop in heart rate, a feeling of pressure and discomfort in the chest, nausea, and shortness of breath with exertion (consistently - not just once). (I'm a long-distance runner, so this is unusual for me.) At first I debated going to the emergency room, but since I'm so young and in otherwise good condition I thought nothing of it. I had similar symptoms the following day, but I avoided exerting myself until all of my symptoms from the vaccine had ended. I felt groggy and fatigued for several additional days, but by Saturday (8 days after getting the first dose of Pfizer) everything had resolved. I also developed swollen lymph nodes, which returned to normal size within about 3 weeks (before swelling again after the second vaccine). The second dose of the vaccine caused a more sudden and intense reaction, though I never developed chest pain/slow heart rate with it. Instead I developed sudden onset severe chills, fatigue, and body aches about 9 hours after getting the shot. A fast heart rate, shortness of breath, and sudden onset fever (temperature jumped nearly five degrees in about 90 minutes) quickly followed. My fever stabilized around 102.2 around 3 a.m. that morning, and slowly crept down throughout the afternoon/evening. Overall, with dizziness, body aches, extreme fatigue, etc., this was the sickest I've been since I had a severe case of the Flu in high school. The fatigue, shortness of breath, and fast heart rate continued for about a week - getting slightly better each day.

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.

A few minutes after immunization, patient stood up from chair and fainted after he fell to the ground on knees; then hitting left cheek on the ground. He quickly regained conscious in 3 seconds and was oriented to person, place and date. He was able to move all extremities and neck well and 5/5 strength; no misalignments, asymmetry or defects. Left cheek was slightly swollen and slightly tender. Breath sounds clear and abdomen soft and non-tender. He remained lying on the ground for 15 minutes BP 100/70 HR 120. An ice pack placed on his cheek. After sitting in the chair for 15 minutes and drinking approximately 12 oz of water, he stood for 2 minutes and was without dizziness BP 100/80. Patient declined going to the ER at this time; discussed warning signs and when to go to the ER and when to f/u. Patient walked out of the clinic in a stable condition with father.

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.

Itchy red hives, sometimes all over body, mainly been arms and legs and during the evening. Recently, swelling has occurred near mouth. Pressure on body parts can result in large swelling (arm pushed on edge of table while using a electronic device). Been taking Benadryl to relieve symptoms.

Pt received COVID vaccine in left arm and sent to observation room for 15 mins. After 5 minutes patient stated he felt tingling in both hands with noted swelling in his palms. Pt was flush and stated he felt warm. Dr. evaluated patient and order Benadryl 25mg PO. Vital signs 124/70, P 72, R 20, SPO2 98%. After Benadryl administration Pt escorted to the emergency room by staff for further follow up. Pt was given 25mg of Benadryl PO c/o of tingling and swelling in hands with flushing of the face without signs of SOB.

swollen lymph node left supraclavicular approx. 30 hours post injection, mildly tender, on same side as vaccination

Slight swelling and moderate pain from the axillary lymph nodes started: Friday morning, swelling disappeared Sunday morning; pain still persists

Pfizer-BioNTech COVID-19 Vaccine EUA The day after the injection, in the afternoon (so about 36 hours after the injection of the second dose), I started to develop slight chills and fatigue, but no fever. This was accompanied by a mass that developed under my right armpit, about 4-5 cm in diameter and bulging out to the point that I felt it touching my upper arm before I even saw it in a mirror. It was not red, and it was malleable with a small, hard nodule in the center. I used an ice compression and some ibuprofen over a few days, and it has receded about 95% of the way, almost back to normal.

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.

rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy. There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.

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

23 year old male with a history of 31 allergic reactions, Mast cell activation syndrome, Addisons disease, and POTS, developed anaphylactic reaction after receiving first Pfizer COVID-19 vaccine. Patient took 50 mg benadryl 30 minutes before arriving at vaccine clinic in anticipation of possible reaction per physician's recommendation. Per pt he asked multiple physicians regarding receiving the covid vaccine and was given the permission to proceed. Also took 20mg hydrocortisone in the morning, then 10mg this afternoon for Addison's disease. 1603 - Pt received 1st dose of Pzifer covid-19 vaccine and during the first 5 minutes of observation complained of feeling itchy and wheezing, light headed, nauseous. 1608 - 0.3mg epi given at - self administered right thigh. 1613 - 90 mg of hydrocortisone (solu-cortef), patient's own medication, given by RN through pt's PICC line RUE; line was flushed with NS before and after and cleaned with alcohol swab. 1615 - Self-administered 4 mg Zofran (patient's own medication) at 1615 into the RUE PICC; cleaned with alcohol swab. 1615- Second 0.3mg of epi given- self administered left thigh. 1617 - Fire department arrived. 1621- pt complains of itchiness still but wheezing is reduced. BP 118/83 at 4:25 PM, normal O2 sat and pulse, normal respiratory rate. 1626 - patient placed in gurney, escorted out by Fire Dept en route to Hospital Physician assistant and five other RN were with the patient and his mother.

After receiving the "Pfizer-BioNTech COVID-19 Vaccine EUA" I woke up the next day with swelling in the lymph nodes on the back of my neck, as well as swelling in the face, the appearance of facial hives and a severe headache. The swelling persisted for 5 days after the injection and the hives on my face and scalp have persisted beyond five days. On day 4 I experience uncontrollable facial spasms originating from a swollen lymph node.

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

Metallic taste and swollen lymph node around the neck area below the jaw line (submandibular area maybe).

Approximately 7-10 days or so after receiving the first dose of the pfizer Covid vaccine I started to develop this red, nodule-like, painful "rash" on both of my forearms. Not only the left arm where the vaccine was administered. This did not go away after a couple of days, and I was instructed by a physician to being taking Benadryl. This appeared to alleviate the symptoms (no visible red nodules anymore) 4-5 days prior to my second dose, so I stopped the medication and presumed it was done. Then, within 4-5 hours of receiving my second Pfizer covid vaccine, I broke out into the same red, painful, nodule-like "rash" along both of my forearms. This time was worse than the previous reaction. I was instructed to take Allegra at the time by a physician, which I did for approximately 4 weeks. This seemed to get rid of the symptoms I was experiencing, and I could not visualize the nodules on my forearms anymore. However, after approximately 2 weeks, I noticed a painful and swollen vein in my right forearm, opposite arm to the one I received the vaccine in. I did not think much of it at the time, since I had no other associated symptoms. Then, over the next couple of weeks, it appeared to become more swollen and painful. Also, I saw another swollen vein near my knee. On April 6, I had labs drawn and CBC, CMP, TSH, and ESR came back normal, but the CRP was elevated. Thus, I was instructed to begin aspirin 325mg, which I took for 4 days beginning April 8th and ending April 12th. On April 13th, an official ultrasound confirmed a DVT in my right popliteal vein, a superficial thrombus in my proximal great saphenous vein, and a superficial thrombus in my right forearm where the pain originated from weeks prior. The initial presumption at this time is that the clots are vaccine-related, but could be linked to an underlying blood disorder that was triggered by the vaccine. Blood hyper coagulation labs have not yet come back. I was initiated on Eliquis starting April 12th for the DVT.

Patient reports symptoms starting about 30 minutes after 2nd dose of vaccine. Started with headache, then progressed to severe chills, and fever. On 4/11 patient had severe weakness and was unable to walk or sit, altered mental status, high fever 104, nausea, diffuse, red bumpy rash on face, neck, torso. Orbital and facial swelling. Mother took to urgent care and patient was transported to ER and was admitted.

Swollen lymph node on right side of upper neck, parallel to ear. began 3 days following first shot and lasted for two days. Slight sharper pain in left side of chest occurring a few times throughout the day. Began the day after first shot. Feels like a muscle spasm. Twitching of eye lid on left side beginning 3 days from this date. It is not constant, but comes and goes.

24 hrs after vaccine had malaise, mild ST, then felt better. Then 48 hrs after vaccine, worsening ST, fever, chills, body aches, lymphadenopathy

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

First day: severe chills (extreme body shaking), and body temperature alternating between overheating and moderate/severe chills every several hours. Body fatigue, temperature varying from low 99 F up to 101.3 F. These symptoms subsided after about 2 days. Also developing during this time was an asthma attack, characterized by wheezing, coughing, and difficulty breathing. Patient has had life-long history of asthma, moderate, well-maintained with albuterol inhaler (life-long) and Qvar redihaler (beginning in early-mid 2020). However, after the common symptoms subsided, the asthma attack prolonged for over a week (2nd injection on 22 Apr 2021, and present as of reporting (03 May 2021). Albuterol inhaler would ease the wheezing, but no effect on mitigating the coughing / difficulty breathing. Qvar redihaler had no effect. Asthma attack would alternate in waves (approximately every hour up to 4-6 hour cycles), of breathing mostly clearly (some difficulty persisting), and severe attacks when extremely difficult to breathe.

Patient returned to office this c/o itching noted to scattered areas of his body. Patient noted with scattered red, slightly raised areas to back of thighs, behind bilateral knees, one area to right forearm (inner), noted to left antecubital area as well. Patient also noted with some patchy areas of redness to abdominals folds and below navel area. Patient alert and oriented. Denies shortness of breath. Talking to staff without difficulty. Benadryl 25mg administered in doctor's office.

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.

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

Fever, body aches starting 1 day after vaccination. Progressed by day 3 after vaccination to chest pain and vomiting. Patient presented to ER and diagnosed with perimyocarditis; transferred to tertiary hospital. Required hospitalization with troponin level of >6000. Patient required cardiac catheterization but no stenting. Required ibuprofen, colchicine, steroids.

Stiff joints, fatigued, rash on lower arms, swollen hands (itchy due to swollen ness) - 06/05/2021 7:00am to 8:00pm Rash continue to inner thighs and swollen feet (itchy due to swollen ness) - 06/06/2021 1:00am to present (around 5:45pm)

Headache, chills and chest tightness. Beginning 8 hours after injection of second dose in series. Patient presented to emergency department two days later with persistent chest tightness and abnormal breathing sensation. ECG consistent with acute pericarditis.

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)

Swelling of face, redness, excess sweating and overheating, allergy-type reaction, skin blotches compared to snake skin, eczema like reaction with no history of skin disorders. Painful to the touch

Patient started developing throat swelling, shortness of breath, and paresthesia of the left upper extremity and neck approximately 10-15 minutes after receiving the first dose of the Pfizer Covid Vaccine. Visual examination detected slight facial and periorbital swelling but no posterior oropharyngeal edema. Patient was slightly hypertensive (150/93) and tachycardic (105 bpm) upon arrival in the ED. Patient had no rash or urticaria. Diphenhydramine 50 mg, famotidine 20 mg, and lactated ringers administered IV. Patient was observed for several hours in the ED, and discharged in stable condition.

Suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration; This is a spontaneous report from a contactable nurse (patient himself). A 24-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), intramuscular in the left arm on 21Dec2020 18:45 at single dose, and then second dose (lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient experienced suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration on 24Dec2020 09:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.

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

severe weakness to point of not being able to walk, nausea, chest pain, dizziness immediately after vaccine given; rapid response team was called and then taken to ED; had shortness of breath and chest tightness, severe weakness, severe body aches. Fever up to 100.7 about 19 hours post vaccine; at 28 hours post vaccine continues to have severe weakness, chest tightness with SOB at times, slight cough with wheezing, diarrhea X3

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.

A quarter sized knot in the left axilla with erythema spreading toward the left hand and also swelling and pus exuding from the left middle finger of the left hand.

Itchy and puffy spots of swelling in various spots on whole body, lasted from 24-48 hours after vaccination before subsiding.

10 Minutes following the vaccine I experience G.I (Gastro intestinal) issues, upset stomach. The following day my neck felt as if there was a lump in it, probably from swollen lymph nodes. As days pass I had several sinus attacks, Acid reflux, and being weak in general. Which I dont regularly have. I am still experiencing a lump like feeling in my throat.

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.

This 24 yo male reports receipt of his first Pfizer Covid vaccine lot #EN6199 to his Left deltoid. He advised within <15 minutes following the vaccine he sensed the left side of his neck was swelling. He notified Immunization staff who brought him to the ER via w/c. He stated the ERMD did not perceive/palpate any swelling or nodules, and treated him with IV Benadryl with resolution of s/s. He did not require any other doses of benadryl. He received his 2nd Pfizer covid vaccine on 3/30/2021 lot#ER8734 to right deltoid. He stated within 15 min again, he had the sensation of throat stiffness (as if muscles really tight/tensed) and this made it difficult to breath and caused his chest to hurt. He was taken to the ER again and given Benadryl again with resolution of symptoms. He was released later without any reoccurrence of symptoms. He states he went to work on 3/31 where he began to feel bad/achy-feverish. Today he had a fever (not taken), total body aches but mostly to his left hand. He reports feeling fatigue and unable to do normal AM routine of working out. He could only stretch today. He denies any trauma, recent illness, difficulty breathing, swallowing, eating, ha, n/v/d, or other symptoms.

04/03/2021 Itchiness on belly, arms, face, armpits Rashes Swellings like mosquito-bites wherever scratched, on right upper arms, and on hands at night when sleeping Tiredness which could be relieved by toileting Pain in hands from blood flow when clutching and moving 04/04/2021 Pain in upper arm, including left upper arm where dose 1 of Pfizer vaccine was given

Extremely swollen lymph node right axillae approximately 30 hours post injection. (Size of a grapefruit). Painful to touch. Treating with warm compresses, Tylenol/ Ibuprofen as needed. Highest temperature within 24 hours of receiving the vaccine 101.3....temp has returned to normal.

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.

After the vaccine my left nostril started to be In pain the next day my whole left face started to swel up and is currently still in pain.

Left pinky toe itchy and swollen/inflamed, sometimes hurts. It's been only a week so far, just started applying Cortizone.

Experienced pressure in right ear, similar to tinnitus where there was ringing in my ears. Lymph nodes were also firing off

Concern for Vaccine induced Myocarditis. Fever 101, headache, started 12 hours after vaccine dose #2. 48 hours after vaccine, severe substernal chest pain with left arm radiation, fatigue required emergency visit to ER to rule out Myocarditis. Patient is currently being watched for myocarditis development in this young male.

Several days after vaccine patient developed itching of ankle. A day or so later developed swelling, itching and redness in several areas of his body. On 5/9 he came to PF with swelling of upper lip and left hand. He had been having chest tightness the day before.

Headache starting Saturday night following injection, lymph node swollen. Temperature at 38.1 at 1:45 on 5.9 Sunday. Temperature was 38.4 at 7:30 in the morning, with high heart rate of 110-120 bpm resulting in intermittent chest discomfort. Highest temperature was at 39.5 at 20:00 Sunday. Temperature fluctuates from 38.1 to 38.5 on Monday from 06:50 to 13:00, with HR at 105 bpm.

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.

Pt complained of dizziness, racing heart rate, face swelling/numbness and throat tightness. Zyrtec 10mg given. MD recommended epinephrine injection. Patient refused. EMT called to bedside for EKG. MD recommends transfer via ambulance to ER. Patient declined after thorough education of importance of going to ER. Patient declined and signed to leave Against Medical Advise.

05/28/21 around 22:30 waves of convulsions including uncontrolled shacking of the hands and upper body followed by chills and high body temperature. This lasted for until about 03:00 05/29/21. 05/29/21 consisted of mainly being in a bedridden state of fatigue, sleeping, loss of appetite, swollen and inflamed lymph glands particularly under the armpit of the injection site arm, soreness and pain in the injection site arm, headache, aches and pains throughout the entire body, and the inability to walk or stand for long periods of time. 05/30/21 lymph glands are still inflamed and swollen (particularly as stated above under the armpit of the arm that got the injection), head stills persists, along with some fatigue, and loss of appetite.

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.

Lump above the left collarbone. Seems to be swollen/tender to touch. On the same side as the injection. The lump seems to move around when being pressed.

Days following dose 2, I began having fluid retention and elevated blood pressure. Over time, it has worsened. I am now having dizzy spells that can last 10 minutes to 6 hours up to twice a day, confusion/brain fog and heart flutters/elevated heart rate usually accompanied with fatigue. My previous doctor treated me by increasing the metoprolol and adding hydrochlorothiazide for fluid retention. I saw a new healthcare provider who is sending me to a cardiologist, neurologist, lipidologist and endocrinologist to figure out what is going on. I can not function in daily life. I cannot stand when dizzy and cannot drive. Symptoms appear to be worsening. In the meantime, he prescribed Ubrelvy to rule out migraines. None of this appeared until after dose 2 of Pfizer.

Patient had fever and body aches 1 day after receiving vaccine. Patient had pain, swelling and bruising near and around the injection site 2 days after injection, along with swelling and pain on chest near breast area. Patient is currently taking Tylenol and will begin using ice packs or cold compress as well.

Pt received both doses of the Pfizer COVID-19 vaccine, on 3/31/21 and 4/20/21. He then presented to the ER on 6/29/2021 for an unrelated reason (DKA) and was tested per protocol for COVID-19 prior to admission. This test on 6/29/2021 was positive. Pt reports having a mild cold about a week ago, with a mild cough on presentation to the ER. EMR also indicates that he had COVID 12/2020 (fatigue, loss of taste, cough).

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.

Two days after My second Dose of the Pfizer Covid-19 Vaccine I began to show signs of impaired cognitive ability, difficulty standing, and irregular gait while walking. Four days after My second dose of the Covid vaccine I lost all ability to stand and had no sense of feeling in my legs or feet I also had very severe cognitive issues. I was told I have guillian Barre Syndrom.

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

Swollen lymph nodes; Immune system has been compromised; This is a spontaneous report from a contactable other hcp. A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jun2021 at 15:45 (at the age of 24-years-old) as dose 1, single for covid-19 immunisation. Medical history included autism spectrum disorder. There were no concomitant medications. Family medical history relevant to ae was none. History of all previous immunization with the Pfizer vaccine considered as suspect was provided as ‘no.' No additional Vaccines Administered on same date of the Pfizer Suspect. The patient experienced swollen lymph nodes on 29Jun2021, and immune system has been compromised on Jun2021. The patient underwent lab tests and procedures on 29Jun2021 which included blood test: unknown, tuberculin test: unknown. This case was reported by a nurse for her son. It was reported that the patient. On 29Jun2021 received and MMR vaccine to fulfill college requirements. He was told at this appointment that he had swollen lymph nodes and was advised to wait for 2 weeks after his originally scheduled (14Jul2021) second Pfizer Covid vaccine dose. This would place his second Pfizer Covid vaccine dose at a 5 week interval, and not a 3 week interval. The caller wanted to know what are the implications of receiving an MMR vaccine in between the Pfizer Covid vaccine doses. Caller wanted to know how the effectiveness of the vaccine would be if her son waited an additional 2 weeks to get the second dose of the vaccine and if there are recommendations for treatment of his side effect (swollen lymphnodes) in the interim. Upon follow-up on 29Jun2021, new information were provided. Reporter specified herself as a Registered Nurse. It was confirmed that the report was not related to any study or programme. NDC number of Pfizer Covid 19 vaccine was unknown. Caller did not have the vaccine card and did not have in-formation about lot number to provide. Investigation Assessment was not provided. With the swollen lymph nodes, the immune system was compromised, and she assumes it was the effect of the DNA. The reporter thought that it was very specific to have in that window between the two dose of the vaccine, otherwise, the second shot may not be going to be effective. The patient was told to wait 2 weeks later than originally scheduled for the second shot. She has no idea what the implications this vaccinations has during this time. It was said that said that the lymph nodes were all enlarged because the immune system was compromised. After vaccination, patient went to the doctor today, instead of getting an MMR titer, he got the MMR vaccination. After that, they told him his lymph nodes were all enlarged and told him to get the second Pfizer shot later. The MMR shot was given between the 2 doses of the Covid vaccine. The patient went to an urgent care in withheld for his physical for college. They are now telling him to come back Thursday because they didn't do blood work. He is in the doctors office now. They noticed today during his evaluation and Swollen lymph nodes have stayed the same. The doctor told him to wait. Why did they give him the MMR? It doesn't sit well with her. The Pfizer expert told him to wait 2 weeks outside the window. Some people don't practice within their scope. The reporter can't believe they gave him the MMR, he has a developmental disability. It just shows that he has a compromised immune system. She thinks it is in response to the Pfizer. The reporter informed that it is good that the body is responding in some way. It is the body building immunity, she would think. Is supposed to go back 14Jul2021 for the second one. The doctor said to call Pfizer to see if it is acceptable to push it back 2 weeks. Causality as reported was related and reports it is the bodys response to developing immunity. The patient was given a TB test. Does not know why they didn't do a titer. MMR vaccine name/NDC, LOT, EXP unknown as reporter did not have that information right now. Outcome of the event swollen lymph nodes was not recovered and outcome of the immune system has been compromised was unknown. Information on the lot/batch number has been requested.

severe headache, 104.1 fever, high heart rate (160) treatment: IV, ketorolac discharged from ER after 4 hours

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.

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.

pt had immediate chills and rigors after the shot Started with hives the day after. These have been progressive Face started to swell , went to ER twice Started on benedryl, pepcid and prednisone

faint; Dizziness; tachycardia; BP sys: 160; HR 120+,; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00 at single dose in left arm for COVID-19 immunization. The patient previously took diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on an unspecified date for immunization and had had reaction to this vaccine with swelling of arm and surrounding lymph nodes. The patient had no other medical history was reported. The patient's concomitant medications were none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced dizziness, tachycardia, BP sys (systolic blood pressure): 160, HR 120+, and faint on 22Jan2021 10:30 and events result in Emergency room/department or urgent care. The outcome of the events was recovering.

On day of vaccination, he developed tactile fever, chills, headaches, body aches, and mild nausea without emesis. The next day, he took ibuprofen with mild relief of his symptoms. On day of presentation, the patient was riding an armored vehicle and developed headache and chest discomfort. On admission, treated with colchicine and Motrin.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient reported a shell fish allergy that produces similar reactions. Patient has not taken Benadryl before and dose not own an Epi-pen.

Patient reports that 5 hours after injection he began to have some mild swelling on right side of face and lip- no treatment needed and symptoms resolved spontaneously

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.

The patient reported that they were experiencing tightness in their arm and believed it swelled initially. They left the pharmacy area and went to get Tylenol that was recommended by the pharmacist. They then began to get lightheaded and had syncope, attempted to get back up and the cashier asked to if they wanted to sit, but fell again. It was not clear initially to the employee who was helping them they had received the vaccine. 911 was called and the employee helping them let the pharmacist know they had just gotten their vaccine. The immunizing pharmacist went to check on the patient. EMTs were already helping the patient and had taken his blood pressure which was normal the lightheadedness had stopped and both sitting and standing blood pressure was the same. He had an elevated heart rate per the patient but didn't know any of the numbers the EMTs had taken. His father was driving him. He was not experiencing any symptoms and the injection site had no swelling and was otherwise unremarkable.

8 hours later burning feeling all over body, rash across the forehead, 2 weeks later swollen gland/infection on left side of ear and face

Vomiting Fever Pneumonia due to COVID-19 virus Sepsis Acute respiratory insufficiency -Continue supplemental oxygen as needed to maintain spO2 over 90% -Patient completed remdesivir as well as a convalescent plasma. -Patient will complete 5 more days of oral dexamethasone. oral Decadron.

The adverse event I am reporting is swelling face. The start was the lip and nose area and now it is all the way to the eye area (right half of my face). Did some reading and some said it could be due to facial fillers. I never had facial fillers before. Other side effects that came are the same as many have reported. Fever and chills day after taking. Fever lasted for two days. Chills are still happening at night.

Currently suffering from symptoms indicative of brain damage, namely new anxiety, mood changes, some occasional headaches, mild brain fog, and insomnia (have not slept for more than 4-5 hours injection date. Also have messed up sense of temperature, as well as occasional aches. Also had soreness in jabbed arm as well as inflammation in said arm.

Received second dose of vaccine 5/13/21. Reportedly noticed bilateral lower extremity swelling Saturday 5/15/21, and mild to moderate chest pressure 5/17/21. Noticed swelling of the extremities worsening 5/22/21. Came to the emergency room for evaluation 5/24/21.

Swelling in the left armpit that spread to the left upper arm and the left rib cage. Feels like there is a baseball in my left armpit. It is painless most of the time, just uncomfortable. I did wake up in the middle of the night once due to pain associated with the swelling. The swelling started more than 24 hours after my second dose. It is still swollen four full days after my second dose.

My lymph node above my left shoulder blade was swollen.; 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: EL3247), administered in left arm, on 27Jan2021 at 09:30 AM (at the age of 25-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included known allergies: pollen. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. No other vaccine received in four weeks and no other medications in two weeks. The patient reported that his lymph node above the left shoulder blade was swollen on 30Jan2021 at 08:30 AM. He went to receive an ultrasound in 2021 to confirm. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received due to the event. The patient then received the second dose of BNT162b2 (lot number: EL3247) on 17Feb2021 at 08:30 AM, administered in left arm for COVID-19 immunisation. The patient was recovering from the event.

Pt is a 25M with PMH of GERD, ADHD, obesity who presented to the ED on 5/11 for chest pain. That morning he had noticed increased substernal chest pressure associated with palpitations, nausea, diaphoresis, and left arm tingling. He notes that early last year he was very sick and though he had COVID but confirmatory testing was not available at that time. After recovering from the illness he noted that he had occasionally episodes of chest pressure and palpitations. However yesterday was the worst his symptoms have ever been. He did receive his 2nd COVID vaccine this past Saturday and experienced fatigue, nausea, weakness. In the ED patient has HD stable, afebrile, saturating well on RA. Labs were notable for troponin of 5.2 which trend down to 3.1. ESR WNL, CRP elevated 2.4. EKG showed normal sinus rhythm with signs suggestive of possible pericarditis. CXR negative. CTA showed no pulmonary embolism, enlarged and prominent left axillary lymph nodes, nonspecific, cholelithiasis. Patient admitted for NSTEMI. Enlarged axillary lymph nodes likely reactive in the setting of recent COVID vaccine. Cardiology consulted. Patient underwent cardiac cath which was unremarkable. Cardiology recommends short course NSAIDs for possible pericarditis, however EKG changes unimpressive per cardiology. Discharged home on ibuprofen 400 mg TID for 5 days. Advise follow up with PCP within 1 week.

Patient developed sudden onset of fevers and malaise on 5/7/21 (26 days after his 2nd Pfizer COVID vaccine). His symptoms progressed to involve shortness of breath which prompted his admission to our Hospital on 5/12/21. He rapidly deteriorated requiring intubation and ultimately placement on ECMO and temporary internal heart pump (Impella device) placement. He was thought to have myocarditis due to elevated troponins at the time of admission and cardiac MRI showing wide spread myocardial inflammation suggestive of myocarditis. He was treated with high dose steroids and supportive care due to the concern for cytokine storm and eventually started to show signs of improvement. He was eventually taken off ECMO, internal heart pump and ventilatory support and went home after 20 days in the hospital. However, follow up cardiac MRI revealed ongoing myocarditis, but his ejection fraction had improved.

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.

throat fell really tight. They told him was throat was closing up.; Anaphylaxis/anaphylactic shock/severe allergic reaction; Swelling of the throat/throat was swelling; Trouble breathing; Itchy throat; Said that his throat felt really thirsty.; He is very upset./He is pretty devastated.; His throat started to do it again.; They said maybe it was something he ate or maybe sinuses; This is spontaneous report from contactable consumer (patient) and contactable consumer (patient's mother). A 25-year-old male patient received the first dose for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EWO187) at single dose for COVID-19 immunization on 19May2021 at 12:00 or 13:00. Relevant history included Diabetes, obesity, endocrine abnormalities, genetic/chromosomal abnormalities, respiratory illness, compromised immune status and Allergies. The patient had Allergies to non-steroidal anti-inflammatory drugs that can induce anaphylactic shock, severe reaction, swelling of face and throat. Relevant concomitant drug was unknown. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect If applicable. No Vaccines were Administered prior vaccinations (within 4 weeks). Family Medical History was none. About 3-5 minutes after being administered the Vaccine, the patient immediately developed anaphylactic shock. He was transported via ambulance to the Emergency Room on 19May2021 where he verified he was admitted to the hospital Emergency room for about 5-6 hours and discharged from the hospital the same day, 19May2021. He was told not to get any additional doses. He was still having swelling of the throat and went back to the ER today and was given a steroid prednisone 40mg a day for 5 days. He was advised to take benadryl also. He said he didn't get any IVs or anything. He had a past medical history of anaphylactic reaction to NSAIDS. He has been advised not to get the second dose. The patient stated the anaphylactic shock occurred with trouble breathing, throat was swelling and itchy throat. He did go into ER, they told him to just keep drinking fluids, that there was nothing else they could really do. When he was seen in the emergency room they gave him Benadryl and a steroid: Prednisone for now which he is on for the next couple of days. He was told that after 2 days or something, that after getting injected that he wouldn't have any symptoms-but he is still having those pretty severe symptoms of anaphylactic shock. Initial onset of anaphylactic shock was about 3-5 minutes after Pfizer Covid Vaccine shot was administered. Within 10-15 minutes he had swelling of tongue and throat and difficulty breathing. They called an ambulance, the ambulance took him to the Hospital emergency room where he was admitted and discharged that same date on 19May2021 after about 5-6 hours; he reported discharge time was around 16:40. They told him to come back if he had any issues that occurred over next couple of days or worsening or causing problems; to call back the nurses line. He was on a lot of Benadryl, a lot of antihistamines. When he gets off the antihistamines almost all the allergic reactions of the anaphylactic shock reoccur. This morning, 21May2021, he didn't take any Bendaryl before bed, and this morning when he woke up he was alright. After being at work like 30 minutes he felt the itchiness; scratchy throat; swelling of tongue; a little swelling of the throat; difficulty breathing. He took Benadryl and called the hotline who told him to call the Emergency room, he called the emergency room and went there. He talked to them this morning because he went to work and had issues breathing. He called and they told him to come in asap, so he went in to the emergency room; they gave him Benadryl and told him there was nothing else they could do other than him taking the steroid: Prednisone. The patient was in the hospital 3 days and will be day 4 tomorrow. He was trying to figure out how long this will last. They told him to talk to his doctor. They basically told him they were not responsible. The patient's mother reported that her son received the shot Wed 19May2021. Does not know if the Walgreen's reported this. He left there in an ambulance within 10 minutes of getting the shot. They took him to the emergency room and he got mixed information. He went back again today. They blew him off and told him maybe it was something he ate. She assumed that an allergic reaction would be about 24 hours but this is day 3. She is scared he may be taking too much Benadryl. He said he felt like he needed something to drink. Said that his throat felt really thirsty. He went back inside since his throat fell really tight. They told him was throat was closing up. They saw that his throat was swollen and they called the paramedics. Within 15 minutes they came and brought him to the emergency room. Nobody had given him Epi. They were going to give it to him an Epi pen but he wanted to wait for the paramedics. He was freaking out. The paramedics showed up and they were unable to give him Epi, stating he didn't have hives. He only received Benadryl. They he had to have to give him extra Benadryl because whatever they gave him in the IV because the first didn't work and his throat was still closing up. It made him feel like a drug addict asking for Benadryl. She was not sure if they gave him Benadryl in the ambulance, knows that it was given in the emergency room. The Benadryl may have been started in the ambulance but she is not sure. They did give him oxygen in the ambulance. Clarified he was in the ER over 4 hours, but was not admitted to the hospital. They gave him steroids but forgot to send him home with steroids. He had to call to find out about getting them and they told him they forgot to send the prescription in. He was late starting the next dose of steroids. He went back to the ER today, day 3. He didn't feel too bad today and went to work. After exerting a little energy and moving around, his throat started to do it again. He didn't have Benadryl on him. He left work because he thought it was going to close up again the day he got the shot. Once he calmed down, he took Benadryl. He called the hospital to ask if this was normal. He was told that it is not normal and was told that if he still felt bad, to come to the hospital. They said maybe it was something he ate or maybe sinuses. He spoke to one of the doctors. They had never shown him how to use an ePi pen. He does not know how long this will last. He gets scared. Treatment: Has only been taking Benadryl. He started the steroids yesterday and today. They had given him Benadryl today in the ER and he is home now. The patient visited to the Emergency room twice, first time by ambulance, confirmed he was not admitted. He was pretty devastated. The outcome of events was unknown.

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.

swelling in left leg and left arm (side of body where vaccine administered) . patient states having difficulty walking due to swelling in his leg

Patient stated the day that he received vaccine his body was sore. Patient stated that on 6/2121 his foot was swollen up to the point that he could not walk on it. whole left leg under knee is in pain.

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.

Developed profuse bloody diarrhea and lower abdominal pain beginning ten days after vaccination on 4/17. Went to see Dr who performed lab work and stool tests that all came back negative (4/19). Was treated with Zithromax but had no resolution to his symptoms. No family history or prior history of IBD. It seems the onset of disease is clearly temporaly related to the timing of his Pfizer vaccine.

Follow up report: This time that it happened: I had on Saturday morning - urinating pain followed by blood in my urine. That persisted for the next two days. I went to an Urgent Care - this time. They did Urinalysis - confirmed blood in my urine; also leukocytes were high - they gave me course of antibiotics and it resolved that same day but I continued the seven day course of antibiotics - Bactrim. I thought it might be kidney stones but I never saw anything come out and it seemed to resolve pretty quickly. Yet it almost seemed resolved before I really started taking the antibiotics. They also gave me an ultrasound of my kidneys at the Urgent Care.

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.

Cold sores, Severe Pain upper arm, High Fever, Cough, Sneezing, Runny nose, Malaise, Mucus congestion, Feeling of impeding Doom

after his 2nd dose of the vaccine the lump got even larger; after his 2nd dose of the vaccine the lump got even larger; states that after the 2nd dose, he had a second lump; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 25-year-old male son (Patient). A 25-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 19Apr2021 15:30 (at the age of 25-years-old) as dose 2, single for COVID-19 immunisation. Reason for no lot number: of Pfizer COVID Vaccine: Other: Caller states Reporter has no lot numbers, expiry dates or NDC numbers to provide as her son is not there and he has his patient card for the Pfizer COVID vaccine. Medical history included gene mutation (they have a weird gene mutation called SCN5A). The patient concomitant medications were not reported. The patient has not had any vaccines since Dec2020 when his mother made him get a flu shot and has had no others prior to that for a year. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration, administered in Arm left on 29Mar2021 11:45 as dose 1, single for COVID-19 immunisation and experienced lump on neck. No Investigation Assessment reported. The reporter stated she was calling about the Pfizer COVID vaccine and was calling regarding her 25-year-old son and he got the two different Pfizer COVID vaccine doses. Reporter stated after his second dose of the vaccine the lump on his neck got even larger and was probably the size of a large grape and has also gotten firmer. Reporter further stated that after the 2nd dose, patient had a second lump, and it was probably the size of like between a raisin or a small green olive. Reporter stated the second lump happened the same day as the 2nd dose of the Pfizer COVID Vaccine on 19Apr2021. Reporter wanted to know if that was normal or if it was something they need to be concerned about and at what point do they see the HCP. Reporter stated the patient has not yet had any treatment for the reported events. Adverse events did not require a visit to ER or MD office. Reporter seriousness for the events was reported as unspecified. The outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Extremely swollen feet; Extremely swollen hands; 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: EW0736) via an unspecified route of administration in the right arm on 03May2021 at 09:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Patient medical history was reported as none. Patient did not take any medications in the past. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 12Apr2021 at 09:30 as a single dose for COVID-19 immunisation. 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 was not tested for COVID-19. On 04May2021 at 04:00, on the day 2 of the second dose, the patient experienced extremely swollen feet and hands. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely swollen feet and hands were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.