Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on May 13; tested positive on May 13; 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EN6204), in left arm, on 03May2021 as dose 2, single (Lot number: ER8730), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies (seasonal, dust, mold)" (unspecified if ongoing); "Sinus Issue" (unspecified if ongoing); "asthma", start date: 2012 (unspecified if ongoing), notes: don't have an inhaler or receive any treatment. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ADVIL 12 HOUR, start date: 13May2022, stop date: 16May2022; TYLENOL, start date: 14May2022, stop date: 15May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "tested positive on May 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient first tested positive on 13May2022 and started taking PAXLOVID the same day. Adverse event start date also reported as: 24May2022. As of 03Jun2022, investigation results were received from product quality group. Lot number (CR): 30155BA. Conclusion of Previously Completed Investigation: The complaint for a lack of effect in a vial of PFIZER BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Pfizer (site name). The final scope was determined to be lot 30155BA. No quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notifications were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER8730 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lo and product type. The final scope included the reported finished goods lot ER8730, fill lot EP8682, and the formulated drug product lot EP8569. 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 EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200767692 Same reporter/patient, different drug/events