Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: COVID-19 Vaccine: COVID-19 positive; COVID-19 Vaccine: COVID-19 positive; 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 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), 0.3 ml single (Lot number: 6149694) at the age of 74 years for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6200), on 11Mar2021 as dose 2, single (Lot number: EN6204), on 19Sep2021 as dose 3 (booster), 0.3 ml single (Lot number: FF2589) and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunization. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol, Diagnosed 20 years; "Low thyroid" (unspecified if ongoing), notes: Low thyroid Guessing was diagnosed 8 years. It was a big deal; "arthritis" (unspecified if ongoing), notes: She was taking meloxicam for arthritis. Concomitant medication(s) included: ADVIL [IBUPROFEN]; MELOXICAM PFIZER taken for arthritis; PROBIOTICS; CALCIUM; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Dec2022, outcome "unknown" and all described as "COVID-19 Vaccine: COVID-19 positive". The patient underwent the following laboratory tests and procedures: LAMP Covid-19 test: (unspecified date) Confirm  the rapid test., notes: then got LAMP COVID-19 test results in another day to confirm the rapid test; SARS-CoV-2 test: (12Dec2022) Positive, notes: Was positive on rapid COVID-19 test on 12Dec2022. Was given prescription for Paxlovid; Weight: (unspecified date) 115 lbs; Weight decreased: (unspecified date) 110 lbs, notes: Was 115lbs, now 110lbs. she stepped on a scale and noticed she lost 5 pounds in 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Investigation result was received on 20Dec2022 from product quality group. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. 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 PFIZERBIONTECH 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 PFIZERBIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. A complaint sample was not returned. 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 PFIZERBIONTECH COVID-19 VACCINE lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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.