Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 30Jan2021 as dose 2, single (Lot number: E09264), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 44 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16May2022, outcome "recovering", COVID-19 (medically significant) with onset 16May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative, notes: I had a negative antigen test on 22May2022; (16May2022) positive, notes: My initial positive test occurred on 16May2022; (02Jun2022) positive, notes: tested positive for a second time on 02Jun2022. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: The patient had initial Covid positive test occurred on 16May2022 and the Paxlovid course was started from the same day to 20May2022. He had a negative antigen test on 22May2022 following the completion of the Paxlovid course. But he experienced a rebound of Covid symptoms beginning on 28May2022 and tested positive for a second time on 02Jun2022. Investigation result: 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 PQS. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI) for Lot-# (CR): EK9231: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EK9231 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EK9231, fill lot EK9229, and the formulated drug product lot EK9226. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion of Previously Completed Investigation (FCI/SI/OffCI) for Lot-# (CR): FF2593: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FF2593 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2593, fill lot FF5584, and formulated drug product lot FA9147. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.