Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EL9267), on 08Mar2021 as dose 2, single (Lot number: EN6205), on 29Aug2021 as dose 3 (booster), single (Lot number: FC3183) and on 30Jan2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 50 years for covid-19 immunization. The patient's relevant medical history included: "SIgMD" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "CIU" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing) and no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Jun2022, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID symptoms in addition to a positive test after previously taking a full course of Paxlovid; Negative, notes: experiencing all my symptoms resolve, and testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 22May2022 and stopped on 27May2022. Clinical course was reported as, I have experienced a recurrence of COVID symptoms (start date 01Jun2022) in addition to a positive test after previously taking a full course of Paxlovid, experiencing all my symptoms resolve, and testing negative. Treatment received for symptoms was unknown and patient was recovering from symptoms.  Information from Product quality group, provided from division includes conclusion of previously completed Investigation for lot number EL9267: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL9267 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 EL9267, fill lot EL9258, and the formulated drug product lot EL9249. 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. For lot number EN6205: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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. For lot number FC3183: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release 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 FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. 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.  No follow-up attempts are possible. No further information is expected.