Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Took the COVID test has COVID; Took the COVID test has COVID; He has a seizure; Likely a syncopal event; Shoulder in soreness; Felt lightheaded had to sit in chair; This is a spontaneous report from a contactable physician (patient himself), received from the FDA. The regulatory authority report number is 910202. A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine; batch/lot EH9899, expiration date: 31Mar2021) on 18Dec2020 on the right arm, at a single dose, for COVID-19 immunization. Concomitant medication was none. The pediatrician was working in the hospital and was exposed to an office contact who had COVID. The patient had a shoulder in soreness. He was at work on Wednesday and felt lightheaded and had to sit in chair. He had a workup to a CODE team putting oxygen on him. He had a seizure. The patient took the COVID test and had COVID. He was admitted to the hospital for 2 days. It was likely a syncopal event. The onset dates of the events and the hospitalization dates were not reported. The patient was not recovered from the events "took the COVID test and had COVID, seizure, and likely a syncopal event," while the outcome of the events "shoulder in soreness and felt lightheaded" was unknown. The events "took the COVID test and had COVID, seizure, and likely a syncopal event" were reported as serious due to hospitalization, and the other events were reported as non-serious.  On 01Mar2021, investigation results from the Product Quality Complaints group was received for the described complaint of "Took the COVID test has COVID" for PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE with lot #: EH9899, batch expiry date: 31Mar2021. Reasonably Suggest Device Malfunction was reported as "No." Severity of Harm was not applicable. No CAPA was previously identified. A full investigation was not required. Root Cause/CAPA: This was not process related; Final Confirmation Status was "Not Confirmed," Vendor Related: No. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EH9899 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 the reported finished goods lot EH9899, fill lot EH9783, and the bulk formulated drug product lot EH9782. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. No reserve sample evaluation was required; this was not a confirmed reserve defect. No lot-specific trend was identified. No expedite trend was identified and no other trend was identified. Complaint sample evaluation: (Parent) Sample Status was not available; site sample status was not received.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Mar2021): New information received from the Product Quality Complaints Group includes investigational results regarding the previous complaint.  No follow-up attempts are possible. No further information is expected.