Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group and medical information team, Program ID: Unknown. The reporter is the patient. An 86-year-old female patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EN6201, Expiration Date: 30Jun2021), on 07Mar2021 as dose 2, single (Lot number: EN6206, Expiration Date: 30Jun2021) and on 17Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 85 years for COVID-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medications included: CARVEDILOL; LISINOPRIL. Vaccination history included: Flu shot (had Guillain-Barre from Flu shot, they gave her 8 plasma exchanges), administration date: 2016, when the patient was 80 years old, for Immunization, reaction(s): "Guillain-Barre". Patient did not have prior vaccinations within four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had COVID; a very mild COVID, positive just one time after the first booster". The patient underwent the following laboratory tests and procedures: Covid-19 test: Positive, notes: just one time after the first booster. Clinical course: Patient got the Pfizer COVID Vaccine the primary series and 2 booster shots. She had Covid; a very mild Covid, positive just one time after the first booster, she did lose her taste and smell, have not gotten back her taste and smell back after the Covid. The patient received the fourth dose on 26Apr2022 (Lot number was FK9893). Product Quality Group provided investigational results on 12Sep2022 for BNT162b2: Conclusion of Previously Completed Investigation: 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 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 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 EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. 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 or CAPA were identified as the complaint was not confirmed.