Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test
Clinical narrative: positive for a COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: FK5618) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot, administration date: Oct2021, for immunisation. The following information was reported: COVID-19 (non-serious) with onset 04Jan2022, outcome "recovered", described as "positive for a COVID infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Caller is the patient's mother, she is reporting that her 8 year old son received the first dose of the Pfizer's COVID-19 vaccine on 28Dec, on 04Jan the patient started to develop COVID symptoms and he started to cough on 06Jan, and on 06Jan he tested positive for a COVID infection with both the rapid test and the PCR. He was scheduled to receive the second dose of the vaccine today but was informed that the vaccination provider (pharmacist) that she should contact Pfizer as they advised that the patient should wait 6 weeks before receiving the second dose of the vaccine. Caller is not sure if the patient received the vaccine or the adult vaccine. No other vaccines were administered 4 weeks prior to Covid 19 shot. Reporter stated, "He weighs about 103 pounds. I guess he's like 4 feet (Unclear hence not captured in tab). I am not sure for the height." For treatment for adverse events, reporter stated, "No, he's taken the over the counter medication. Tylenol, yes just Tylenol." Patient had no more symptoms and events were not persistent. Reporter stated if it was okay for him to get the second dosage now. Investigational results were received for Lot number FK5618. Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality regulatory, validation and stability. (name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.