Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 09:45 as dose 1, single (Lot number: EL8982), in left arm, on 27Feb2021 at 09:30 as dose 2, single (Lot number: EN6202), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "T1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; LEVOTHYROXINE; LIOTHYRONINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 20:30, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (unspecified date) negative; (unspecified date) negative; (24May2022) positive, notes: tested positive on 24May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid from 12May2022 to 16May2022.  On 01Jun2022, investigation results for lot numbers EL8982, EN6202, 30155BA and FK9893 were reported as follows: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6202 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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 a lack of effect in a vial of PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing 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. 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 NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs 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. The complaint for "PFIZERBIONTECH 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 FK9893. 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 concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.