Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She got a COVID infection despite being fully vaccinated; She got a COVID infection despite being fully vaccinated; This is a spontaneous report from a contactable other HCP. This other HCP (Patient's Mother) reported for her daughter. A 21-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EP7533) via unspecified of administration on Apr2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EP7534) via unspecified of administration on unspecified date in 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, it was reported that reporter's daughter (21 years old, female) had been fully vaccinated since Apr. she had breakthrough Covid-19 infection in Aug and was just now bouncing back and was asking about ongoing studies for breakthrough covid infections and was asking whether or not the boosters are helpful. This event was considered as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021. The outcome of events was reported as recovering.  Product-Description (CR) : COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-#(CR) : EP7534- Conclusion of Previously Completed Investigation (FCI/SI/OffCI) : The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.  COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot-#(CR) : EP7533- Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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  Product-Description (CR) : COMPOUND BNT162COVID-19 VACCINE SUSPENSION FOR INTRAMUSCU LAR 2ML MULTIPLE DOSE VIAL X 1 Lot-#(CR) : EP7534- Conclusion of Previously Completed Investigation (FCI/SI/OffCI) :The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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  Product-Description (CR) : COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1Lot-#(CR) : EP7533- Conclusion of Previously Completed Investigation (FCI/SI/OffCI) :The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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: As there is limited information in the case provided, the causal association between the events drug ineffective, Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.