Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller mentioned his wife received the 3 doses Pfizer-BioNTech COVID-19 Vaccine, but tested positive; Caller mentioned his wife received the 3 doses Pfizer-BioNTech COVID-19 Vaccine, but tested positive; Caller mentioned his wife received the 3 doses Pfizer-BioNTech COVID-19 Vaccine, but tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558).  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Jul2021 04:00 (Lot number: FA6780) at the age of 39 years as dose 3 (booster), single, administered in arm, administration date 20Mar2021 (Lot number: EP7534) as dose 2, single and administered in arm, administration date 02Mar2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Multiple sclerosis" (ongoing), notes: Diagnosed: 7-8 years ago; "Psoriatic arthritis" (ongoing), notes: Diagnosed: 7-8 years ago; "Psoriasis" (ongoing), notes: Diagnosed: 7-8 years ago; "ADHD" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS taken for multiple sclerosis (ongoing); VYVANSE taken for attention deficit hyperactivity disorder (ongoing). Prior Vaccinations (within 4 weeks) was reported as none. The following information was reported: IMMUNISATION (medically significant) with onset 23Jul2021, outcome "unknown", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "unknown" and all described as "Caller mentioned his wife received the 3 doses Pfizer-BioNTech COVID-19 Vaccine, but tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. Caller mentioned his wife received the 3 doses Pfizer-BioNTech COVID-19 Vaccine, but tested positive. Caller asked about Pfizer's COVID-19 pill that was given the EUA today, was there any lag time of drug to the stores. He also clarified his wife has already gotten three doses. She got three doses already because she was immunocrompoised, she got the third one back in Jul2021. She was due for a booster within the next week. He stated there was no real safety issue or anything with it, it's just the timing did not work out in time for her to get the booster. Adverse events did not result in Emergency room or physician office visit. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): Lot-# FA6780The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6205 was investigated. The investigation included a review of manufacturing and packaging. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FA6780 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 FA6780, fill lot ET8450, and the formulated drug product lot EP8632. 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): Lot-# EP7534. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): Lot-# EN6203. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6203 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 EN6203, fill lot EN5336, and the formulated drug product lot EN5324. 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.