Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She contracted Covid-19; She contracted Covid-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Lot number: EW0176), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0185), in left arm and on 06Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 15 years, in left arm, all intramuscular for covid-19 immunisation. Facility type was Pharmacy or Drug Store. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine was received in four weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "recovering" and all described as "She contracted Covid-19". The event "she contracted covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Negative; (05Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. No covid prior to vaccination.  Additional information: Conclusion of previously completed investigation for Lot# FL3198, EW0176 and EW0185 received from Product Quality Group included: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot FL3198 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 FL3198, fill lot FJ8804, and the formulated drug product lot FL3162. A complaint sample was not returned. 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. The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine Injectable lot EW0176 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 EW0176, fill lot EP8727, and the bulk formulated drug product lot EP8608. 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. The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the formulated drug product lot EP8616. 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.  No follow up attempts are needed. No Further information is expected.