Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 at 12:00 as dose 1, single (Lot number: EK5730, Expiration Date: 31Mar2021), in left arm, on 10Jan2021 at 10:00 as dose 2, single (Lot number: EK9231, Expiration Date: 30Apr2021), in left arm, on 25Sep2021 at 17:00 as dose 3 (booster), single (Lot number: 301308A, Expiration Date: 28Feb2022), in left arm and on 19Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FK9894, Expiration Date: 30Sep2022) at the age of 61 years, in left arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NIACINAMIDE, start date: Jan2020, stop date: May2022. Past drug history included: Trimethoprim, reaction(s): "Known allergies: Trimethoprim"; Sulfamethoxazole, reaction(s): "Known allergies: Sulfamethoxazole". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with onset 22May2022 at 18:00, outcome "not recovered" and all described as "COVID-19 Infection after immunization". It was reported that COVID rebound after Paxlovid treatment. Treated 13May2022-17May2022, felt well until 21May, then developed recurrent symptoms on 22May. Did home antigen test on 25May, which was positive. Product quality group investigation results included: Lot# (CR): EK5730, EK9231 - The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lots EK5730, EK9231 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 EK5730, fill lot EK3313, and the formulated drug product lot EK3312. The final scope included the reported finished goods lot EK9231, fill lot EK9229, and the formulated drug product lot EK9226. 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. Lot# (CR): 30130BA - The complaint for a Lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot 30130BA 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 withheld). The final scope was determined to be lot 30130BA. No quality issues were identified during the investigation. There is no impact on product quality. An RA was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of 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 any lot being released to the market. No further investigation required. Lot# (CR): FK9894 -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 FK9894. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA 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. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown result, notes: COVID rebound after Paxlovid treatment; (25May2022) Positive, notes: home antigen test. Therapeutic measures were taken as a result of Covid-19.