Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test
Clinical narrative: My son died within days after the second dose of the vaccine / autopsy remarks No known cause was found; Safety information originally reported under manufacturer case 202200358143 has been nullified and re-entered under this new manufacturer report number 202400232574  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EN5318, Expiration Date: 31May2021) at the age of 21 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, intramuscular, administered in the left arm (right deltoid), (batch/lot number: EL3249)), administration date: 28Jan2021, when the patient was 21-year-old, for COVID-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 25Feb2021, outcome "fatal", described as "My son died within days after the second dose of the vaccine / autopsy remarks No known cause was found". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The patient date of death was 25Feb2021. The autopsy revealed "no known cause was found" (death). Clinical information: Autopsy information: Yes, If yes, provide autopsy results: As indicated on your cover letter, family states no known cause of death. Mr. (Name) was not a patient of (name provided). His vaccines were administered by (name provided) as he was part of our nursing program. No further medical information is known.  Investigation results: The complaint for an adverse event requested by Safety with the use of the Pfizer-BioNTech Covid-19 Vaccine lot EN5318 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to include the reported finished goods lot EN5318, fill lot EN5317, and the bulk formulated drug product lot EN5316. A complaint sample or photographs were not received. There were no deviations that may have caused a complaint of this nature. No other related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up (23Mar2022): This is a follow-up spontaneous report from product quality group providing investigation results. Updated information included: Investigation results.  Follow-up (31Mar2022): Follow-up attempts completed. No further information expected.  Follow-up (13Apr2022): New information received from a contactable Nurse in response to HCP letter sent which included: New reporter added in reporter slider: 03, historical vaccine (dose 1 age at vaccination, lot number, anatomical location reported as right deltoid), suspect dosage regimen details (route of administration, anatomical Location), vaccine facility information (vaccination facility name added, vaccine administered at facility populated as no), seriousness criteria (Medically Significant) checked since the event is always serious event and narrative updated accordingly.  Follow-up attempts are completed. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202200358143 and 202400232574 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232574.; Autopsy-determined Cause(s) of Death: No known cause was found