Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9269), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer resulting in mastectomy 7 years ago" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Breast cancer resulting in mastectomy 7 years ago" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; ATORVASTATIN; METOPROLOL. Patient had no known allergies and was also reported to be taking unspecified vitamins. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID from 03Dec2022 to 08Dec2022.  Product Quality Group provided investigational results on 14Dec2022 for BNT162B2: The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EL9269 , fill lot EL9260, the bulk formulated drug product lot EL9251. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause were identified as the complaint was not confirmed.  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. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FE3590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3590, fill lot FA9134, and the bulk formulated drug product lot FE5064. 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 were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201373781 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373767 Same Reporter/Patient, Different AE/Vaccine Dose;