Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ1614) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Recurrence / rebound of Covid 19 infection; (09May2022) Negative, notes: I was asymptomatic and antigen test negative; (17May2022) Positive, notes: 7 days after completing the 5 days course I was symptomatic and antigen positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received anti-viral therapy Paxlovid for COVID 19 Treatment (Treatment start date: 06May2022, Treatment stop date: 11May2022). Recurrence / rebound of Covid 19 infection. 3 days after completing the 5 days course of Paxlovid he was asymptomatic and antigen test negative. 7 days after completing the 5 days course he was symptomatic and antigen positive again. He did not receive any other medication in 2weeks. Investigation results: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in database. Lot (CR): FJ1614: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer- Biotech COVID-19 vaccine injectable lot FJ1614 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1614, fill lot FH8033, and the bulk formulated drug product lot FJ8496. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Regulatory Authority and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Covid 19 cannot be completely excluded.