Pfizer

Vaccine was given at 3pm. At 4:30pm patient had a tight chest so he used his inhaler. At 8:30pm he went into anaphylaxis---red from head to toe, swollen hands and feet, could not move fingers or toes, lips blue and swollen. He was transported to the ER.

pt received Pfizer covid 19 vaccine with mom in the room. Less than 5 minutes later, step dad reported that patient passed out and hit his head on the side. Pt was bleeding from the left forehead. A technician called 911. I wiped blood from the injury and applied a gauze and instant ice pack. pt was breathing and fully responsive. pt denied any other pain or discomfort other than the injury on the forehead and injection site pain in the arm.

He got a superficial blood clot in left arm ?He's got the shot May 21 and I noticed he had two hard knots on left arm and there was probably about a half inch between them and as hard as a rock on that following Monday may 24,2021 , he said it was sore some more when you touched it we was told to keep an ion it make sure it didn't get any worse, turn red, swell, feel hot to the touch, and then to put a warm compresses on it ??

Patient presented to emergency room on 6/7/21 with chest pain, chills and fatigue. His troponin was noted to be elevated concerning for myocarditis. He was hemodynamically stable. He was admitted to Pediatric ICU for close monitoring and remained stable on admission. Initial echo was concerning for low normal function, however cardiac MRI showed normal function. His troponins trended down with ibuprofen therapy for anti-inflammation and he was discharged to home on 6/9/21.

12 y.o. male patient with history of developmental delay, seizure disorder who presented to the emergency department today with acute encephalopathy, unresponsive with bradycardia, V-tach requiring defibrillation, and acute respiratory failure requiring intubation. The family had been traveling and vacationing with extended family members and recently returned Saturday night. No sick contacts during the trip and he recently received his second COVID-19 vaccine on June 5th. On Sunday, June 20th, he had cold symptoms with stuffy nose, sneezing and minimal oral intake. Mother gave him 10ml of a multi-symptom OTC cold medication that evening. Unsure what is in the medication or if it contains Benadryl. This morning, he had an 11am swim lesion and then came back and slept on the couch. Still minimal oral intake and was resting all day long but awake most of the time. This evening at 5:43pm per mother, he received another 10ml of the multi-symptom cold medication. He was given his Vimpat and Valproic Acid medications around 7:30pm. Around 8:20/8:25pm, he was asleep and had an emesis and was not responding In the ED, he was unresponsive and poor respiratory effort with episodes of apnea and was incontient of stool during the exam. He was brought to the resuscitation room, PIV placed x2. Placed on oxygen initially. Ativan given once for possible seizure. Epinephrine given for bradycardia. Noted V-tach on rhythm. Second Epi given, started Epinephrine infusion and Shock given 2J/kg. Cardiology at bedside. Rocuronium and Etomidate given for intubation. He was intubated on the second attempt with 6.0c ETT.

yelled out loudly when he received the vaccine but was fine immediately after. He was sitting for about 5 minutes before his mother said that he was feeling dizzy. The doctor was going to grab an ice pop for him when he fainted. was there as he was sliding off of the chair and had him in her arms. He then began to have a tonic-clonic seizure that lasted approximately 1 minute. The mother called 911. He woke up and asked what happened. The ambulance arrived and suggested that he go the hospital. The mother was on the phone with his father and he said he did not think an ER visit was necessary. The ambulance left and after waiting another 30 minutes, mom took home.

full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021. No follow-up attempts are possible. No further information is expected.

Pt presented to the ER 7/11/21 with joint pain in bilateral arms, left hip, and posterior knees, and 1 episode of SOB for over a week. 3 weeks prior he reported having a fever and headache but that resolved. Pt at this time was Diagnosed with Rhabdomyolysis

Patient was in his usual state of health until 3 weeks after the covid vaccine, when he played basketball for 3 hours on 6/22. He had been inactive prior to 6/22 and it was hot day. He developed leg pain that evening and was diagnosed with rhabdomyolysis with a CK of 21,980. Patient was hospitalized for IV fluids and since then his CK has been down trending and his leg pain has now resolved.

Patient received the vaccine and was completely fine immediately following. We walked around the store, conversed, and 10-12 minutes after injection he had syncope and generalized tonic clonic seizure for minutes. We were transported 911 to Hospital ED where he had normal labs, normal brain MRI, and consultation with Peds Neuro. He was post-ictal for 30+ minutes to follow the incident. He has secondary trauma to his R temporal and occipital bones and likely a mild concussion resulting from the fall.

Post vaccination patient lost consciousness, had involuntary muscle movements. mother was worried same reaction patient had during anaphylactic reaction to tree nut allergy and insisted to use the epipen patient had on hands and rph administered epipen and contacted paramedics

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Weakness-Severe, Additional Details: pt was mostly unresposive and turning white and motionless; throat closing up; no other choice but to give the epi-jr shot; after administering the shot the patient started to feel better but we decided to still call 911 to be on the safe side

Upper substernal chest pain with exertion and deep inspiration and when lying down. Began approximately 36 hours after the 2nd dose of the Pfizer COVID 19 vaccine. No fever, shortness of breath, palpitations, cough, sick contacts. Pain is described as dull and does not radiate. No medications were given by mother for the pain. Patient came to ED with mother 4 days after the onset of the chest pain since the severity of the pain had not changed.

13 year old previously healthy male presenting on 6/13/2021 with petechiae and ecchymosis. Found to have thrombocytopenia (platelet count 2). Diagnosed with ITP. Currently admitted and receiving IVIG. No adverse sequelae of ITP thus far.

Patient was admitted from PCP for extreme tachycardia and tachypnea and developed multi organ involvement with tachycardia (HR to 140-150s), slight elevation in BNP (H of 490), Troponin (H of 0.244), mild proteinuria (50-70 proteins), respiratory distress with tachypnea (RR 50s) and hypoxia requiring escalation in O2 supplementation. Also with daily fevers until starting steroids. Laboratory findings concerning for slight hypertriglyceridemia, normal Ferritin, worsening thrombocytopenia, lymphopenia, hyponatremia, and hypoalbuminemia. CT with bibasilar atelectasis vs. consolidation, but no evidence of PE. Extensive ID and rheumatological evaluation performed and unremarkable so far. Received 2 days of Doxycycline. Was started on pulse dose steroids and began to show improvement in all markers.

Patient is a 13 yo male, otherwise healthy, who received his second covid vaccine on Saturday. He did well until Tuesday morning when he started to have emesis and "chest pressure". He was brought to the ER where work up included a troponin level that was elevated at 20.43. Due to concern for myocarditis, he was transferred and admitted to the hospital for further work up and management. -Echo results note that the cardiac function and coronaries are normal. Very trace pericardial effusion -EKG at Good Patient consistent with pericarditis -Repeat troponin 15 Discharged 6/17

Date of Admission: 6/19/2021 Date of Death: 6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field, found to be in the context of large cerebellar hemorrhage secondary to brain lesion (AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine drips to maintain perfusion and was administered bicarbonate x2. Head CTA was obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no contrast enhanced blood flow in the brain. Brain death exams were completed at 09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of brain death. Official cause of death was brainstem herniation from intracranial hemorrhage. Mechanical ventilation was continued to allow family time to grieve and perform last rites. Time of cardiac death after mechanical ventilation withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart rate. His sodium was 141 upon presentation but reached a maximum of 160 due to central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to improve hypernatremia, which was monitored Q1h until normonatremic. He additionally required vasopressin drip to be started due to central DI, which was increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission, he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine and norepinephrine were discontinued. Two doses of adenosine were administered (6 mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4 seconds after the second dose however returned to ~180. EKG arrived which showed sinus tachycardia so no further medications or cardiac interventions were done. Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was administered. Norepinephrine and epinephrine were restarted and escalated due to low blood pressures in the early afternoon.to allow family time with patient. Both titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had no primary pulmonary disease during this admission. Neuro: #Intraparenchymal hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and hypertonic saline 23% x1 were administered to decrease intracranial pressures. Keppra 2g was administered for seizure prophylaxis. No sedation was needed during patient's hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp 36.5 °C (97.7 °F) | Resp (!) 15 | Ht 1.65 m (5' 4.96") | Wt 46.5 kg (102 lb 8.2 oz) | SpO2 99% | BMI 17.08 kg/m² Estimated body mass index is 17.08 kg/m² as calculated from the following: Height as of this encounter: 1.65 m (5' 4.96"). Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug Allergies

Pt has developed severe myocarditis and heart failure requiring ECMO. Reported by parents to have gotten the pfizer COVID vaccine ~2 weeks prior. Card not available at the time of this filling but will ask them to get it if possible, given critical illness. We are looking into other etiologies of myocarditis as well. Has only received 1 dose of the vaccine and 2 weeks following seems to be a bit out of the range of usual but no other reported illness

Developed dizziness and fever the morning following vaccination followed by chest pain around 48 hours after vaccination. Presented to outside urgent care where pt noted to have elevated troponin >10, prompting transfer to ED. and admission for myocarditis. Symptoms improved over next several days and chest pain was well controlled with ibuprofen and tylenol.

Dose #1 recieved May 27th, 2021. Dose #2 recieved June 17th, 2021. 6/26/21 2:00pm Grand Mal seizure (Full body convulsions, foaming at the mouth, eyes twitching and rolled back/up. Postictal immediately following seizure activity for roughly 10-15 minutes) on June 26th, 2021, with no history of seizures or any other comorbidities. Resulted in an ER visit on 6/26/21. MRI and EEG ordered for testing. Lab worked ordered on 7/8/21. Rescue medication ordered in the event that he has another seizure. Outcomes: EEG showing absence seizure activity however that remains undetermined at this time due to the fact that the patient never displayed any physical evidence of an absence seizure during the test as he remained alert, responsive followed directions and was able to recall information, during the part of the test that displayed absence seizure activity. MRI: No acute infarct, intracranial hemorrhage or mass effect. Referral to pediatric neurologist.

Throat felt tight, hx of allergy to shellfish-has epi-pen at home. This feels similar to his prior anaphylaxis. Pt. and mom agreed to epi and EMS transport. R. thigh epi administered and care was turned over to onsite EMS. Blood sugar was 210. Pt. has type 1 diabetes and uses insulin pump.

Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.

Fever, Chest pain, presented to the ER and now admitted to the cardiac stepdown unit with myocarditis

Received 2nd COVID-19 vaccine on 6/14 and developed headache and myalgia that evening. On 6/15, continued to have these symptoms then developed abdominal pain and vomited once. Symptoms persisted on 6/16; then developed chest pain at 11:00PM and reported that pain seemed worse when inhaling and was sharp, shooting pain. Presented to ED at 12:00 AM on 6/17 and subsequently transferred to Pediatric ICU due to elevated troponin and d-dimer. Initial EKG showed tachycardia. Cardiologist consulted. He had an echocardiogram on 6/17 AM that showed mildly depressed LV systolic function with EF ~58%. Troponin was elevated from 2.9 to 16.9. Due to echo and elevation in troponin patient received 100 gm IVIG (max dose based on IBW). Has required one dose of 15 mg ketorolac IV and 650 mg acetaminophen PO x1 for chest pain. At 1:00 PM on 6/17, troponin increased to 54.6 and aspirin 81 mg started. Chest x-ray showed borderline cardiomegaly. On 6/18 repeat echocardiogram with normalized LVEF and considered a normal echocardiogram per cardiologist.

Patient was given vaccine with no initial side effects and was asked to wait for 15 minutes before leaving facility. During that wait time patient started to develop blurred vision, and the pharmacist was alerted that the patient fell on the way to the bathroom. Patient was then guided into the immunization room when he briefly lost consciousness. While patient was seated, pharmacist assessed for anaphylaxis reaction and contacted emergency services. Blood pressure was taken and noted to be elevated, other symptoms included blurred vision and sweating. Patient denied itching, swelling, or trouble breathing. Patient did not receive epi-pen and was assessed by emergency services. Patient recovered shortly after emergency services arrived, no further services were needed

14yo M initially presented to the ED with headache, fever, myalgia, abdominal pain, NBNB emesis, unsteady gait and soft/garbled speech, 6 days after returning from a recent trip to Mexico and 4 days after receiving 2nd dose of Covid-19 vaccine. In the ED patient had multiple tonic clonic seizures, total episode lasting about 5 minutes requiring ativan and keppra. Pt was admitted to PICU for management, found to have continued seizures on EEG resolved with fosphenytoin

The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg. The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000. He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000. He was diagnosed with immune thrombocytopenic purpura. No treatment was given, observation only. Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19. He was ANA negative. His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.

Approximately 22 hours after receiving Pfizer vaccine #1, he became febrile to 100 degrees fahrenheit, and desaturated down to mid 80% on RA requiring O2 via NC at 2l. Was taken and admitted with impending respiratory failure.

AFTER VACCINE WAS GIVEN ABOUT 5-10 MINUTES LATER, PATIENT WAS EXPERIENCING DIFFICULTY SWALLOWING , NUMBNESS IN MOUTH. TOLD PATIENT TO LAY DOWN, GAVE EPIPEN 0.3MG AND CALLED 911. STAYED WITH PATIENT UNTIL EMT'S ARRIVED. AFTER PATIENT WAS HELPED BY EMT, HE WAS ABLE TO WALK OUT OF THE RX. SPOKE WITH PARENT AT 330PM ON 5/25/21 WHO STATED THAT THEY TOOK HIM TO URGENT CARE WHERE HE WAS STARTED ON ZYRTEC AND GIVEN AN RX FOR AN EPIPEN. PATIENT WILL FOLLOW UP WITH ALLERGIST, AND I RECOMMENDED IF HE IS TO GET A 2ND DOSE, THAT HE HAS IT IN AN MD OFFICE. LEFT A MESSAGE WITH PATIENT'S PEDIATRICIAN ABOUT WHAT HAPPENED.

Mostly nonverbal pt developed temp 100-102 evening following vaccine through following day, and on day 3 had significant chest pain warranting 911 call and ED visit. Labs were significant for leukocytosis (WBC 19.8) and CXR w R hilar pneumonia. Troponin level was normal. He has improved on ABX.

Unprovoked first-time seizure. Teen was sitting outside a restaurant waiting while watching phone, listening to music 15 days after first Pfizer COVID vaccine (no issues at time of vaccination). Parents witnessed his neck and eyes roll up and left before having a two short generalized tonic-clonic seizures. Taken to nearest ED by paramedics.

15 year old male with a passed medical history significant for Marfan syndrome, aortic root dilation, and ADHS transferred to our facility for further evaluation and management of chest pain with elevated troponin. Father reports patient recieved the first dose of the COVID-19 Pfizer vaccine on 5/21/2021. On 5/22 patient developed a mild headache as per father that self resolved with rest. On 5/23 as per patient he was feeling back to baseline with some mild body aches. On the night of 5/23 patient felt some mild chest pain prior to going to bed that had self resolved. This morning patient refused to eat breakfast, and complained of stomach pain. Patient took Tylenol, however began to complain of severe chest pain and asked father to take him to the hospital. Patient was taken to his Doctor where his labs were significant for a WBC of 6.6, creatinine of 0.62, normal LFTs, troponin of 7.26, CPK of 312, D-dimer less than 0.19. EKG at Doctor was significant for normal sinus rhythm with an ST elevation, and chest x-ray was negative for cardiopulmonary disease. Patient had an episode of emesis at Doctor. A troponin was repeated prior to transferring to our facility and it had increased to 11.8. Father/patient denies chills, fever, diarrhea, sore throat, nasal congestion, and cough. ID consulted for further recommendations on management of myocarditis in the setting of recent Pfizer COVID-19 vaccination. Troponin repeated upon arrival to our facility, and has improved with no interventions. Interval History 5/27/21 No acute events overnight. Denies chest pain, SOB, cough, or palpitations. Cardiac MRI yesterday describing inflammation related to possible myocarditis, along with stable findings of MVP and aortic root dilation. Troponin this morning dowtrending to 0.28. No fever. He received a Mg Sulfate bolus yesterday due to low Mag on BMP

6/7 - patient received 2nd dose of Pfizer vaccine. 6/8 - patient developed tactile fevers (for 2-3 days), diarrhea (4-5 days of non-bloody diarrhea) 6/9 - developed chest pain and tightness and mild cough 6/12 - few episodes of NBNB emesis, cough with blood tinged sputum 6/13 - presented to urgent care, referred to hospital and admitted to floor. Patient found to have tachycardia and hypertension. CXR with pleural effusion, renal US with medical renal disease. Worsening renal function and concern for hyper coagulable state with worsening D-Dimer and possible pulmonary embolus but unable to obtain contrast images due to renal failure. 6/15 - transferred to ICU for heparin drip for worsening D-dimer. Nephrology, rheumatology and infectious disease consulted. Continued chest pain, cough with hemoptysis. Remains afebrile and otherwise hemodynamically stable. Started on ceftriaxone empirically. Concern for MIS-C, vaccine related adverse event vs autoimmune vasculitis.

broke out into hives; throat began to swell; breathing became difficult; anaphylaxis; patient age: 15; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 03Jun2021 14:30 (at 15-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included low growth hormone production, and known allergies: many foods. Concomitant medications included somatropin (NORDITROPIN); anastrozole (ANASTRAZOLE DENK); olopatadine; levocetirizine dihydrochloride (XYZAL); diclofenac sodium, heparin sodium (ALLE). 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. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), via an unspecified route of administration, administered in left arm on 13May2021 17:30 (at 15-year-old) as 1st dose, single dose for COVID-19 immunization. On 03Jun2021 at 17:30, the patient experienced 3-4 hours after dose, broke out into hives. He took benadryl. Throat began to swell and breathing became difficult. He used epi-pen to stop anaphylaxis. The seriousness criteria of the events was reported as life threatening. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events hives, throat began to swell, breathing became difficult, anaphylaxis was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Diagnosis: Acute myopericarditis. Presentation: Pt had typical post-vaccine side effects on 6/7/21 including fever and malaise. Also had intermittent mild substernal chest pain starting 6/7/21. Malaise and fever resolved by 6/8/21 but intermittent chest pain continued to occur. Vomited x1 on 6/9/21 in early morning hours, which was followed by severe constant substernal chest pain, pain worse when lying down. Presented to medical care on 6/9/21, seen first via phone visit, then pediatric office visit, then sent to ED and admitted to hospital. Treatment: Naproxen 250 mg PO BID starting on 6/9/21, continues on this treatment as of 6/17/21. Outcome: Symptoms resolved on 6/9/21 after naproxen started, discharged home on 6/10/21. Doing well in outpatient without any complications.

15 yo male with myocarditis following 2nd dose of pfizer COVID-19 vaccine. He reports that he received the Pfizer COVID-19 vaccine on 6/16/21. In the 1-2 days following the vaccine he experienced fatigue, body aches, and fever to Tmax 101F. Family treated this with anti-pyretics. On 6/18 he started having a pain in his left chest. He was again febrile at that time. On the day of admission his chest pain was worse and he was experiencing pain all over his body. He was noted to be tachycardic in the ED. His initial labs showed a modestly elevated BNP to 593 with a markedly elevated troponin to 1233. CRP was mildly elevated at 3.8. Electrolytes were unremarkable as were LFTs. CBC w/ diff showed an absolute lymphopenia with ALC of 1000 but was otherwise unremarkable. D-Dimer was normal. He was admitted initially to hospital medicine and then was transferred to the ICU due to concern for risk of developing a cardiac arrhythmia. An echocardiogram done showed trace mitral regurgitation but was otherwise normal with normal LV function. CXR was fairly unremarkable. Coags are normal. Repeat electrolytes showed a slight bump in his creatinine. LFTs largely unchaged and procalcitonin of 0.16. He does have a past medical history of PCR proven COVID-19 disease in December 2020.

He received his 2nd dose of COVID vaccine (Pfizer) on 6/19. He developed a fever on 6/20 which lasted for a day. He then felt better on 6/21. Then, on 6/22 at 1am, he woke from sleep due to chest pain. It was sharp and did not radiate anywhere, and not reproducible. He took 400 mg ibuprofen which improved his pain somewhat. Denies any other fever, rhinorrhea, cough, SOB, difficulty breathing, n/v/d, dysuria or difficulty with urination. Admitted 6/22 due to elevated troponin and abnormal EKG. Troponin leak and MRI with findings consistent with myocarditis. Had NSVT x 4 beats on 6/22. He was treated with 5 days of Motrin 600 mg ATC.

Anaphylactic reaction requiring medical attention.; This is a Spontaneous case report received from Pfizer Sponsored Program, from a contactable consumer (parent). A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 09Jun2021 at 19:30 as dose 2, single for covid-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2, administered in left arm for COVID-19 immunization received on 19May2021 at 19:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination includes dentist twilight sedation. On 11Jun2021 at 12:00, the patient experienced anaphylactic reaction requiring medical attention (medically significant). Pregnazone shots, steroids shots were received as treatment for adverse event. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 13Jun2021. Therapeutic measures were taken as a result of anaphylactic reaction requiring medical attention. The adverse events resulted in Emergency room/department or urgent care. Device Date: 14Jun2021. The patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was reported as not resolved. Information on the lot/batch number has been requested.

Pt is a 15 y.o. with a history of chest pain here today for evaluation. He is an ex 29 weeker with no long term consequences of prematurity. Pt has been in his usual state of health until he developed intermittent chest pain x a few weeks. Pt had a URI for which he wasn't sure if it was allergies or a cold in April 2021. He did receive Pfizer Covid-19 vaccine (First dose 5/16/21 and 2nd dose 6/6/21). Pt came to cardiology for echo for chest pain on 6/22/21. Echo showed pericardial effusion. Pt feel that he had chest pain before the vaccine, but Mom feels like it may have no started until after the first vaccine. Pt is quite active in basketball without issues. The pain lasts for a few minutes and is on his left side radiating down. He did notice that the pain worsened in certain positions, especially while lying down. There is no history of syncope, dyspnea, cyanosis, or heart palpitations. On 6/29, Pt was still having intermittent chest pain.

7/4/2021: 15 year old male with autism and ADHD that presents to PICU from another hospital status post cardiac arrest times two. Mom states that patient has been having coughing for the past 2 weeks. Went to PMD on 6/25 who noticed wheezing on his exam. Ordered a CXR for 6/29. The next day, told mother of the results which showed pneumonia, "fluid in lungs." Started on albuterol q4, cefdinir, and OTC cough medicine with no improvement of symptoms. Began having decreased appetite, urine output. Had a couple episodes of post tussive emesis with blood tinged secretions. Abdominal pain started the day before admission. Patient continued having increased coughing and shortness of breath. On day of admission, patient was walking up the stairs to take a shower. He then fell and hit his head on the wall. Denies LOC at that time. Stated that he could not breath. Patient brought to ER. Patient went into cardiac arrest at 1840 until 1910. CPR was done, given epinephrine, and intubated. Then went into cardiac rest again. Placed on Vent, TV 450, PEEP 6, Rate 15, Peak pressure high 30s. Given ceftriaxone, vancomycin, toradol, 40mg lasix, 4mg zofran and 2L NS bolus. CBC, CMP, blood gas, troponin, pro BNP, RVP/COVID ordered. Started on versed (6.5), epinephrine (20) and norepinephrine (10) drips. Was then flown by helicopter to our PICU. Of note, patient had second dose of Pfizer vaccine on 6/19. Mom believes symptoms started just before his vaccine dose.

15 yo M with no PMH p/w 1 day of chest pain and elevated troponin and lateral ST segment elevations. On Wednesday 6/30 he had his second dose of Pfizer COVID vaccine. There after he had headache, tactile fever, fatigue and myalgias which resolved by Friday 7/2. On Friday at midnight, he awoke with 7/10 sharp substernal chest pain, non radiating. No recent trauma to the chest. He took Tylenol at home which did not relieve the pain. No recent URI sx over the last month. The last time he remembers having URI sx was 1.5 years ago. He does endorse "one or two sneezes" over the past month, which he attributes to allergies. Today 7/3, he presented to urgent care center where he got an EKG, which was concerning for ST elevations. He was given ASA which did not relieve the pain. He was sent to hospital for further work up where he had a Troponin to 1.59, CRP to 36, AST to 79, ALT to 64, Alkphos to 74, BNP to 119, ESR to 10, and WBC to 13.4. EKG showed ST elevation in I, II, precordial leads V4 V5 V6. CXR wnl. He was given IV toradol at hospital, which alleviated his CP. He was transferred to ED for further evaluation. On arrival to the ED on 7/3, he was HDS afebrile, with BP 111/69, HR of 80, and satting 100% on RA. His CP had resolved to a level of 0/10. Additional labs were obtained including repeat CBC (with WBC 10K, Hgb of 14), normal ESR of 20, normal D-dimer of less than 0.27, BMP wnl, elevated LFTs with AST 103, ALT of 61, elevated LDH to 293, normal GGT and alk phos, normal BNP to 28, elevated CRP to 3, and an extremely elevated troponin of 3.15. NP swab for COID, Influenza A/B, and RSV were negative. CXR wnl but did note findings consistent with degenerative disc disease at one level in the mid-distal thoracic spine. Hospital Course: Patient was admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. He was then treated with IVIG 2g/kg and started on methylprednisolone IV x 8 doses. His chest discomfort improved by day 2 of admission. An echocardiogram was performed which did not show any cardiac dysfunction. His troponin downtrended while on IV steroids, therefore he was transitioned over to PO steroids which he tolerated well. On day of discharge, his troponin levels were continuing to trend down, and EKG was WNL. Cardiac MRI was performed and showed late gadolinium enhancement in the left ventricle. He had occasional NSVTs/PVCs; he was started on Bisoprolol 2.5mg daily to prevent arrhythmias after discharge. He was discharged home with a Holter monitor to be worn for 4 days. Viral myocarditis studies were sent and all negative. By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake. 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. Patient will follow up in cardiology clinic next week with a repeat MRI 3-6 months. Of note, CXR from 7/3 with incidental findings suspicious for degenerative disc disease at one level in the mid-distal thoracic spine. This should be followed by his primary care physician as an out patient. Reasons for new, changed, and discontinued medications: - Bisoprolol 2.5mg daily (for prevention of NSVT) - Prednisone 30mg BID (myocarditis) - Famotidine 20mg daily (while on steroids) Reasons for new, changed, and discontinued equipment: NA Relevant Diagnostic Images/Studies: Cardiac MRI (7/7): ? Normal biventricular size and systolic function. ? No regional wall motion abnormalities. ? Suggestion of increased T2 signal intensity/edema. ? Positive myocardial late gadolinium enhancement without functional correlate. ? No significant valvular dysfunction. ? No coronary artery aneurysms. ? Small pericardial effusion. Echocardiogram (7/3): ? Normal valvular function. ? Normal left ventricular size and systolic function. ? Normal diastolic function indices. ? Reduced longitudinal strain with normal circumferential strain. ? Normal appearing proximal coronary arteries. ? Qualitatively normal right ventricular systolic function. ? No pericardial effusion present. ? A comprehensive anatomic survey was not performed at this time. Tests Pending Enterovirus PCR QuaL, Stool Miscellaneous Test Arup These tests will be followed after Discharge Vitals and Discharge Physical T: 36.5 °C HR: 64 (Monitored) RR: 20 BP: 131/59 SpO2: 98% HT: 168 cm WT: 76.4 kg BMI: 27.1 Discharge Physical Exam General: NAD, lying in bed, sleepy, but conversational HEENT: atraumatic, normocephalic, no icterus, no conjunctivitis; extraocular muscles intact; moist mucous membranes CV: RRR, S1/S2, no murmurs, gallops or rubs noted; dp pulses 2+; capillary refill <2 seconds. Resp: unlabored respirations; symmetric chest expansion; clear breath sounds bilaterally Abd: soft, nontender, nondistended; bowel sounds normal Ext: no clubbing, cyanosis, or edema; normal upper and lower extremities Neuro: no atrophy, normal tone; moves all extremities equally; no focal deficits Skin: no rash or erythema Diagnosis List 1. Myocarditis, 07/04/2021 2. COVID-19 mRNA vaccine adverse reaction, 07/04/2021

Patient presented 3 weeks after the vaccine with worsening dyspnea on exertion, orthopnea, cough that began 2 days after vaccine administration. Two days prior to presentation to Harbor ER on 7/1/2021 he had nausea and vomiting with a fever 101F on day of presentation. He was found to be in congestive heart failure with severely diminished biventricular function. While inpatient he had worsening respiratory status requiring CPAP and O2 though he improved with initiation of diuresis. His inflammatory markers were not elevated and he had negative troponins. cMRI revealed an LVEF 13% with no signs of active myocarditis. Viral studies were negative and there was no evidence of bacterial infection. Prior to this, he was in his USOH with no limitations. He was seen in cardiology clinic 5/2021 and was stable at that time. He required initiation of diuretics and oral heart failure management and was discharged with close follow-up.

covid_test_name_post_vaccination=PCR covid_test_result=Positive; Condition worsen; pericardial effusion; develop GI; Heavier Insomia; dierrea; vomiting; fever; Headache; Hypotensive; Dehydrated; Developed into MISC; Patient said he had 4 vaccines; PCR resulted as positive on 17Jun2021 Nasal Swab; This is a spontaneous report received from a contactable other-HCP (father) reported for old son (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173 F) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing known allergy in mosquito bite (sketter syndrome) an allergic reaction to mosquito bites, as his son has grown up it has become less and less relevant. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Dose:01 Lot number: EW0171 Anatomical Location: Arm left) on 17May2021 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations dates of birth or immunizations are not available. It was reported that my son traveled on 16May2021. Covid test prior traveling negative. On Jun2021, 4 days after vaccination develop GI, heavier insomia, dierrea, vomiting, fever, hypotensive, dehydraeted. On 11Jun2021 experienced pericardial effusion. On an unknown date Jun2021, developed into MISC and was intubated. The patient was hospitalized from 14 Jun 2021 to 6 Jul 2021. Treatment was received. On 15Jun2021, admission at (withheld), (Hidratation IV and IVIGs). On 16Jun2021 condition worsen and Intubated in (withheld). On 17Jun2021, transfer to (withheld) (7 days at PICU, another 7 at pediatrics). On Jun2021, developed a strong insomnia and headache. Events resulted in emergency room/department or urgent care. Treatment received for the adverse event was MISC protocol IVIGsAnakinra, esteroids and others. On an unknown date, Patient said he had 4 vaccines. His son spent 7 days in the ICU and 7 days in the pediatric unit was discharged from the hospital yesterday. Reported that other researchers studying MIS-C in children have seen how the epithelium cells in the intestine become loose, then the protein goes through the blood stream and can start a cytokine storm and asked if we have studies regarding how much S protein is being produced by different age groups; can it be checked how much S protein is going into the bloodstream to see adverse effects of the vaccine and stated he needs more data to see if his son was possibly infected with Covid during his vaccination period or what he previously infected and absolutely asymptomatic. Most MIS-C occurs 4-6 weeks after having Covid. States that for his son to travel he had to have antigen testing, which was negative. His son did well until 3-4 days after the second shot. States at that time his son became ill with vomiting, diarrhea, headache, and insomnia. She took her son to the hospital and they found him to be hypotensive and dehydrated. They started intravenous fluids and their protocols; the hospital did not have all the required medications for their son and recommended he be transferred to (withheld) Hospital. He was very tired and they decided to put him on ventilation for the ambulance drive. States that when they arrived in (withheld), his son was placed in ICU where he was on the ventilator for 5 days, the recuperating for 2 more days. His son was then moved throughout the hospital system until his discharge yesterday. His son's insomnia may have started before he left for the (withheld). States that it was worsened after the vaccine, his son mentioned after his hospitalization that he was actually given 4 shots the day he got his vaccines, assumed it to be some kind of delirium from his son being in the ICU for so long, stated he told his son that was not possible that he got 4 vaccines at once because of the paperwork you have to fill out to get the vaccine, the lady at the vaccination site told him to sit down and then gave shothim four shots. The patient underwent lab tests and procedures which included IgG and IgM resulted as positive on 15Jun2021, PCR resulted as negative on 15Jun2021 Nasal Swab, PCR resulted as positive on 17Jun2021 Nasal Swab. The clinical outcome of the event developed MIS-C and was intubated, vomiting, dierrea, headache, insomnia, hypotensive, dehydrated on an unknown date 2021 was resolved and the event pericardial effusion, develop GI, fever was resolving, the event condition worsen, Vaccination failure, patient said he had 4 vaccines and PCR resulted as positive on 17Jun2021 Nasal Swab was unknown; Sender's Comments: Based on the limited information currently available, the causal association between the event Insomnia, Diarrhea, vomiting, fever, Drug ineffective, COVID-19, Headache, overdose and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Multisystem inflammatory syndrome in children, Pericardial effusion, Gastrointestinal inflammation, Condition worsened, Hypotensive, Dehydration and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

PATIENT RECEIVED VACCINE AND WAS ASKED TO SIT DOWN FOR OBSERVATION PERIOD, PATIENT WAS NOTICED TO BE QUIET, LOST CONSCIOUSNESS, EYES ROLLED BACK AND STARTED WITH TONIC-CLONIS SEIZURES THAT LASTED ABOUT 1-1 1/2 MINUTES. PATIENT THEN REGAINED CONSCIOUSNESS, OPENED EYES, AND ASKED WHAT HAPPENED.

Chest pain and palpitations, fatigue immediately post vaccine and chest pain starting 43 hours later. Admitted at 48 hours with troponin 20,000 and decreased biventricular function on echo (RVEF 37%) consistent with myocarditis. Symptomatic improvement post IVIG treatment. Hospital stay 4 days without arrhythmia or other events. Treated with IVIG alone.

7/22/2021 Child collapsed on soccer field while playing soccer at a local camp. CPR was initiated immediately. EMS arrived and found patient in vtac. Shock x 5. ACLS, intubation attempted. Transported to Medical Center. Patient had covid in April 2021. Dx in May 2021 hypertrophic cardiomyopathy. Started on lopressor 25mg BID. Patient had reported to parents that he had not recently taken his medications. Patient had his second covid vaccine on Sunday 7/18/2021.

Received 1st dose of Pfizer Covid Vaccine and started becoming increasingly manic within about an hour. Complained of stomach discomfort. Became increasingly anxious and manic and was only able to sleep for two hours (received at 4pm, slept from 12am to 2am). Awake and manic the day following. Complained of stomach pain. Eating normally with no other symptoms. Started complaining of being cold and chills. Applied rotating heated blankets until he feel asleep about 10pm. Woke up at 2am. Manic and anxious. Stomach started swelling more and becoming rigid. Gave him Miralax. No change in swelling. Increased stomach pain. Gave him a suppository. Immediate small bowel movement. After two more hours and no change in swelling, gave a second suppository. Immediate small bowel movement. Stomach becoming distended and complaining of increased pain. Took him to the ER. Pain amplified on the way. Admitted to PICU after EKG in ER. Quickly declined and went into respiratory failure. Right lung had no air exchange and left lung collapsed. Myocarditis, pleural effusion, kidney damage and new onset Type I diabetes. Unexplained pneumonia. No growth from fluid in lung.

I was called at bedside because pt had a grand mal sz which lasted for a few seconds. Pt woke up alert and oriented right away. No posttictal episode. Pt stated that he felt pain and started to feel dizzy. Pt was pale, cool to touch, diaphoretic. No injuries noted. Pt was leaning against mother. C/O weakness. Assisted to gurney by 2 person assist. Tol well. Pt felt better being placed on supine. Color slowly coming back. Per mother, pt has a history of syncopal episode. Pt had a finger fracture before, got reinjured. Pt blanked out and passed out. Pt was brought to the ED then and was cleared. 1138 92/41 (58) 51 99% RA 16; 1140 89/39 (54) 50 99% RA 16; 1143 95/46 (62) 54 100% RA 18; 1153 92/55 (65) 55 100%RA 16; Pt is now placed on semi fowlers position. Pt is tolerating positioning well. Tolerating crackers and fluids. Mother at bedside, assisting patient. Doctor on call, Dr. made aware of pt's situation and current condition. Per MD, to observe patient for 30 mins and to let him know pt's condition then. Per MD, to introduce PO intake as tolerated. @1208 Pt ate 3 packets of crackers and on the second box juice. Made mother aware that doctor on call was notified and discussed plan of care. Mother and patient verbalized understanding. Instructed mother to make appointment with pediatrician for follow up. Instructed pt and mother that pt should rest, increase PO intake today. Pt and mother verbalized understanding. @1205 98/53 (71) 56 100%RA 16 Pt sat up in a high fowlers position. Tolerating well. Denies dizziness, nausea. Pt ambulated. Tol well. No problems. Made Dr. aware. Pt is cleared to go home with PMD follow up and ED precaution instructions. Pt and mother aware. Mother is confident of taking pt home.

Patient received his 1st COVID (Pfizer) vaccine and he bled more than usual. Patient reported feeling faint and nauseous. While monitoring patient, he threw up a few minutes later. He felt better shortly after. We kept in the pharmacy area for observation for 30 minutes to ensure that he was ok before he left. Patient was feeling fine when he finally left.