Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6208), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 69 years, in left arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 29Apr2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 21:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown result, notes: I was recovering from COVID19; Negative; Negative; Positive, notes: I retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19  Clinical course: I was recovering from COVID19 and had two negative tests then a few days later started having symptoms again (mostly congestion). I retested and was positive. The patient received Other medication in 2weeks that is Losartan for Heart Medication.  Antiviral details:  Product=COVID 19 Treatment Brand=Paxlovid Treatment start date=13May2022 Treatment stop date=17May2022 Lot number=GA3595 Indication=Treatment of COVID-19  This is a follow-up report from product quality group providing investigation results. This report included that: Lot# (CR): EN6208 Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. 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.  Lot# (CR): EN6200 Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 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. .