Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild case of COVID; mild case of COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982), on 18Feb2021 as dose 2, single (Lot number: EN6201), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 25May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Probably back when caller was about 45 years old or 40 years old, so 30 years ago.; "COPD" (unspecified if ongoing), notes: Comments COPD From: Probably about 25 years ago; "left knee replaced", start date: 2018 (unspecified if ongoing), notes: Had a left knee replaced but that was 4 years ago in 2018. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "mild case of COVID". The event "mild case of covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: and at 3 weeks just out of curiosity tested again and still positive but by then feeling 100 percent fine, called doctor and told doctor, doctor said don't worry about that, doctor said never retests after first testing for Covid; (unspecified date) Negative, notes: tested for Covid but was negative; (Jul2022) Positive, notes: Tested positive going into it,.  Clinical information: Patient had a mild case of COVID in July of the past year. Had 4 shots prior to having Covid. Start date of adverse event: Started having Covid either 20Jul2022 or 21Jul2022. Stop date of adverse event: Tested positive going into it, isolated for 10 days, and at 3 weeks just out of curiosity tested again and still positive but by then feeling 100 percent fine, called doctor and told doctor, doctor said don't worry about that, doctor said never retests after first testing for Covid. Back in Dec2022 caller came down with a lovely cold, has COPD and asthma, went to walk-in clinic for medicine and help, tested for Covid but was negative. Dose amount and route: Thinks intramuscular, remembers seeing a long needle not a short one. Was given in upper arm, unknown dose amount, sometimes use the tuberculin syringe and sometimes use the 3cc syringe, not that caller had a 3cc syringe, syringe was not full. Indication: Because Covid was around, and vaccine had come out and caller was one to have vaccines, but caller was not getting anymore. Description of Product Complaint: Description of complaint: PC was not on suspect product, PC was on the Pfizer COVID-19 mRNA: Received all vaccine shots, had mild case of Covid. Had 4 shots prior to having Covid which were all the Pfizer COVID-19 mRNA. Product strength and count size dispensed: Not provided. Additional lot numbers: EL8982, EN6201, FF2590, and FX9894 or maybe FK9894 providing from vaccination card which was handwritten. This was a notification generated from the gQTS system. Conclusion of Previously Completed Investigation included: Lot-# (CR): EL8982: 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 was 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. Lot-# (CR): EN6201: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6201 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 EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was 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): FF2590: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine Injectable lot FF2590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical released 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 FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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. 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 was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect was 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 or CAPA were identified as the complaint was not confirmed. Sender's Comments: Linked Report(s): PFIZER INC-202300036682 same patient, different dose, different event;