Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 13Feb2021 as dose 2, single (Lot number: EL9266), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient received no other medication in 2 weeks and had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: another positive test; (31May2022) Positive, notes: initial positive test; (11Jun2022) Positive, notes: 11 days after initial positive test, tested positive again. Therapeutic measures were taken as a result of vaccination failure, Covid-19. As reported, patient thought she got Paxlovid rebound. She got Covid, took Paxlovid, got better in 4 days, did not test herself again until 11 days after her initial positive test, and she tested positive again. That night she got symptoms. The next day she had congestion and sneezing, the day after that a dull headache (and another positive test). Product Quality Group provided investigational results on 14Jun2022 for BNT162B2. Lot #30135BA: Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*: The complaint for a Lack of effect of the Pfizer-BioNTech Covid-19 vaccine lot 30135BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer (name-withheld). The final scope was determined to be lot 30135BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required. Lot #EL9263: Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 vaccine injectable lot EL9263 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 EL9263, fill lot EL9254, and the formulated drug product lot EL9245. 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 #EL9266: Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*: The complaint for lack of effect of the Pfizer-BioNTech covid-19 vaccine lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. 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.