"Notes" "VAERS ID" "VAERS ID Code" Adverse Event Description Lab Data Current Illness Adverse Events After Prior Vaccinations Medications At Time Of Vaccination History/Allergies "1199455-1" "1199455-1" "Patient reported difficulty breathing and chest pain; suffered cardiac arrest and death" "No lab data for this event." "NA" "No prior vaccinations for this event." "fluoxetine, fesoterodine, ortho-tricyclen, oxybutynin" "spina bifida, spinal meningocele, VP shunt, scoliosis, neurogenic bladder, constipation,bananas, cephalexin, kiwi, mango, pineapple, latex" "1225942-1" "1225942-1" "Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21." "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "Reported to be on Drospirenone-Ethinyl Estradiol 3-0.02 MG per tab" "," "1242573-1" "1242573-1" "Heart failure" "No lab data for this event." "No" "No prior vaccinations for this event." "Vaccinated with Pfizer/Biontech, died 04/20/2021, 2 days after vaccination" "No,Nothing" "1382906-1" "1382906-1" "Unexplained death within 48 hours" "No lab data for this event." "none noted" "No prior vaccinations for this event." "None known" "Acne, no other conditions noted,None noted" "1386841-1" "1386841-1" "Prodrome of headache and gastric upset over 2 days following second dose. Then felt fine. Found the following day dead in bed. Autopsy pending" "Autopsy pending" "Headache, upset stomach" "No prior vaccinations for this event." "Adderall" "ADHD,NKDA" "1406840-1" "1406840-1" "Flu like symptoms for 2 days then was found deceased" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1420630-1" "1420630-1" "~4 weeks after the 2nd dose of Pfizer, patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died." "No lab data for this event." "disseminated mycobacterium chelonae infection" "No prior vaccinations for this event." "Artane, azithromycin, calcium carbonate, dicyclomine, doxycycline, escitalopram, flovent, gabapentin, lansoprazole, melatonin, ondansetron, tedizolid," "ataxia telangiectasia; EBV-associated lymphoma,none" "1431289-1" "1431289-1" ""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/m¦ Estimated body mass index is 17.08 kg/m¦ 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"" "see above. Was covid positive on admission 6/19. Family gave a history of previous covid infection earlier this year." "none" "No prior vaccinations for this event." "none" "none,none" "1463061-1" "1463061-1" "Died three days after vaccine; 13 year old boy dies three days after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died three days after vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was unknown. Company comment: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1466009-1" "1466009-1" "My son died, while taking his math class on Zoom. We are waiting for the autopsy because the doctors did not find anything. He was a healthy boy, he had a good academic index, he wanted to be a civil engineer. He was the best thing in my life." "He had no previous symptoms. I was with him one hour before and my assistant saw him 20 minutes prior and he did not show any irregularities." "None" "No prior vaccinations for this event." "None" "None,None" "1475434-1" "1475434-1" "The patient died 6 days after receiving dose #2" "No lab data for this event." "unknown" "No prior vaccinations for this event." "unknown" "enlarged heart,unknown" "1505250-1" "1505250-1" "patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death." "CBC, CMP normal except slightly elevated glucose COVID PCR negative" "none" "No prior vaccinations for this event." "one dose of dramamine given in the evening prior to arrival." "none, remote history of asthma,none" "1655100-1" "1655100-1" "dead from second dose of Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program by a non-contactable consumer. This report reported same event for two patients. This is the first dose of two reports. A 13-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 13-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) for covid-19 immunisation. A 13 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101091793 same report/drug/AE, different patients; Reported Cause(s) of Death: dead from second dose of Pfizer Covid 19 vaccine" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1668800-1" "1668800-1" "Death/passed away; This is a spontaneous report from a contactable consumer or other non HCP (parent, father of patient). A 15-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 09Aug2021 at 09:00 AM (at the age of 15-year-old; lot number: FF2154) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The father reported that the patient (the son) received the dose 1 of the Pfizer vaccine on 09Aug2021 at 9AM on left arm. Unfortunately, patient passed away (death) on Friday 13Aug2021 at 04:30 without any history of illness. The event resulted in Emergency room/department or urgent care. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. Device date was 29Aug2021. No treatment received. Outcome of the event was fatal. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death/passed away" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1688720-1" "1688720-1" "had a reaction and is hospitalized in serious condition / the patient had died; This is a spontaneous report from a contactable consumer received through COVAES portal (firstly by logistic colleague). A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at the vaccination: 17-years-old) as DOSE 1, SINGLE for covid-19 immunisation. At the time of vaccination, pregnancy was reported as unknown. Medical history included raynaud's phenomenon from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Other vaccine in four weeks was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. The reporter reported an adverse event that occurred in the school where she worked, a student took the 1st dose of the pfizer vaccine and she had a reaction and was hospitalized in serious condition in the hospital. The reporter informed that the patient had died on an unspecified date for an unspecified reason. Treatment AE was reported as unknown. It was unknown if any autopsy was performed.; Reported Cause(s) of Death: had a reaction and is hospitalized in serious condition / the patient had died" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "Medical History/Concurrent Conditions: Raynaud's syndrome," "1689212-1" "1689212-1" "SARS COV2 POSITIVE ON 7/20; EXPIRED 8/29/2021" "No lab data for this event." "STAGE IV TESTICULAR EMBRYONAL RHABDOMYOSARCOMA W/ LUNG & BONE METASTASES" "No prior vaccinations for this event." "CETIRIZINE, ERGOCALCIFEROL," "SEE ABOVE,VANCOMYCIN, TEMSIROLIMUS" "1732657-1" "1732657-1" "death; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 88130], license party for BNT162B2 (COMIRNATY). A 16-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at 16-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that parents stated on 16 years old female patient who received a vaccination in the morning and was found dead in her bed in the afternoon. No further details and no cause of death could be obtained by reporting physician. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information on the circumstances of the patient's death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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.; Reported Cause(s) of Death: death" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1757635-1" "1757635-1" "fatigue then death" "No lab data for this event." "unknown" "No prior vaccinations for this event." "unknown" "none,unknown" "1757964-1" "1757964-1" "Death; Bilateral myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and MYOCARDITIS (Bilateral myocarditis) in a 17-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and MYOCARDITIS (Bilateral myocarditis) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDITIS (Bilateral myocarditis) outcome was unknown. Concomitant product was not provided. Treatment medication was not reported. Patient died at 17 was reported. Company Comment: This case concerns a 17-year-old male patient with no reported medical history, who experienced the unexpected, serious event of death and expected and AESI event of myocarditis. Time to onset from vaccination was not reported. Date of death was not reported and autopsy report is not available. The rechallenge was not applicable, since vaccination dose number were not specified. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected. This case was linked to MOD-2021-332861 (Patient Link).; Sender's Comments: This case concerns a 17-year-old male patient with no reported medical history, who experienced the unexpected, serious event of death and expected and AESI event of myocarditis. Time to onset from vaccination was not reported. Date of death was not reported and autopsy report is not available. The rechallenge was not applicable, since vaccination dose number were not specified. The benefit-risk relationship is not affected by this report. Further information is expected.; Reported Cause(s) of Death: Unknown cause of death" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "1784945-1" "1784945-1" "Blood in airway, Death" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "Trisomy 18, Scoliosis, Closed Ventricular Septal Defect, Ectopic Kidney, Gastrostomy Tube dependent, GERD, and Obstructive Sleep Apnea," "1800410-1" "1800410-1" "Found dead in the bedroom; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Found dead in the bedroom) in a 17-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 2021 The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. Treatment information was unknown. Patient was found dead in the bedroom, few days after 2nd dose of Moderna vaccine. Company comment: This case involves a 17-year-old male subject with unknown medical history who experienced the serious unlisted adverse event of death a few das after receiving his second dose of mRNA-1273. The patient was found dead in his bedroom. No further information is currently available on the reason of his death or events that may have resulted in death. The reporter declined further information on his name or address. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case involves a 17-year-old male subject with unknown medical history who experienced the serious unlisted adverse event of death a few das after receiving his second dose of mRNA-1273. The patient was found dead in his bedroom. No further information is currently available on the reason of his death or events that may have resulted in death. The reporter declined further information on his name or address. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death" "No lab data for this event." "No current illness for this event." "No prior vaccinations for this event." "No other medications for this event." "," "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Age: 6-17 years" "Symptoms: DEATH" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: VAERS ID" "Show Totals: False" "Show Zero Values: False" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Nov 3, 2021 8:27:26 PM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Nov 3, 2021 8:27:26 PM" "---" Messages: "1. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "2. These results are for 21 total events." "3. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "4. Click on a VAERS ID to see a report containing detailed information for the event." "---" Footnotes: "1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse" "event (possible side effect)." "---" Caveats: "1.

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine" "manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports" "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain" "information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they" "are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports" "should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope" "and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to" "post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events," "also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as" "the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have" "the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine." "

Key considerations and limitations of VAERS data:

" "2." "3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more than 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "4. Data contains VAERS reports processed as of 10/22/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or" "reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting." "5. About COVID19 vaccines: "