Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 31Mar2022 as dose 2, single (Lot number: EP7533), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: tetanus vaccine, reaction(s): "Known allergies: Tetanus vaccine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Paxlovid from 27Sep2022 to 01Oct2022 as treatment of COVID-19. Investigation results from the product quality group was received on 06Oct2022 and as follows: 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 INJECTABLE lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6199 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 EN6199, fill lot EN5331, and the formulated drug product lot EN5320. 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.