Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on Monday, 30May2022; Tested positive for COVID-19 on Monday, 30May2022; 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL3247), on 12Mar2021 as dose 2, single (Lot number: EN6203) and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "breast cancer survivor" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN. Past drug history included: Percocet, reaction(s): "Known Allergies: Percocet". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on Monday, 30May2022". The event "tested positive for covid-19 on monday, 30may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Covid test name post vaccination: unknown. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. Other medications in two weeks was Tamoxifen daily. No covid prior vaccination. Covid tested post vaccination. 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 PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation: The complaint for Lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. 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 Pfizer-Biontech Covid-19 Vaccine lot EN6203 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. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. 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/preventati ve 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: The complaint for Lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. 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/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.