Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID after second dose of the Pfizer COVID vaccine; got COVID after second dose of the Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP, patient's wife) and additional information from Pfizer product quality group.  A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: ER8729) as dose 2, single and administration date 24Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19(medically significant) all with onset Aug2021, outcome "recovered" (2021) and all described as "got COVID after second dose of the Pfizer COVID vaccine". The patient got the second dose of the Pfizer COVID vaccine 21Apr2021. In Aug2021, their son went to school. His son got COVID, and brought it home. The patient got COVID. The patient didn't have to go to the hospital. It lasted three days, and then he was okay.  The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8733 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8733 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8733 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8733, fill lot EP8685, and the bulk formulated drug product EP8572. 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot ER8729 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8729, fill lot EP8681, and the formulated drug product lot EP8568. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101864592 same patient/drug, different dose/event