Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Heart rate, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. A 58-year-old female patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years, on 04Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 30145BA), on 02Apr2021 as dose 2, single (Lot number: EP87534, Expiration Date: 31Jul2021), on 12Mar2021 as dose 1, single (Lot number: EN6202, Expiration Date: 30Jun2021) and (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: History of heart rate goes through the roof when sick. Racing heart beat. She's had this for a few years at least, a long time. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022 at 08:00, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 2 and a half weeks after her second booster"; DISEASE RECURRENCE (non-serious) with onset 21May2022, outcome "unknown", described as "Rebound symptoms of Covid-19". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) 104; SARS-CoV-2 test: (12May2022) negative, notes: Tested negative on Thursday night; (14May2022) Positive, notes: 14May2022 initially tested positive for COVID-19; (21May2022) Positive, notes: COVID-19 test was 21May2022 was roaring red indicating positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. When she tested positive for COVID-19 virus initially, she had nausea, diarrhea, headache, sore throat, fever, cough, and was exhausted. Just felt awful, but not too sick. She didn't feel debilitated, had the cough. States it wasn't that terrible. Because of her tachycardia, her heart rate skyrockets when she's sick and they wanted her to be safe. Her heart rate was 105 and it is usually in the 60s. Had a little fever and oxygen went down to 93. 14May2022 initially tested positive for COVID-19. Felt horrible the day before. Thursday, felt a little rough, but just a little cough. Was breathing in a lot of smoke fumes from a car. Tested negative on Thursday night. Friday felt lousy, it was her stomach, thought it was something she ate. Had a stomach ache. Saturday morning really felt rough and tested positive for COVID-19. States her COVID-19 test faded while taking Paxlovid and then came roaring back when she took a COVID-19 that Saturday. It was immediately bright red. When she stopped Paxlovid, the line on the COVID-19 test was very, very faint, at one point thought she couldn't see it. The day after, might have been at one point, the line on the COVID-19 test didn't show at all. Already a day after Paxlovid and took a COVID-19 test and it was very faint. The next day it was roaring red COVID-19 test was 21May2022 was roaring red indicating positive. No prior Vaccinations (within 4 weeks). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No relevant test were performed. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6202 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9894. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH 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): The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 30145BA 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. The final scope was determined to be lot 30145BA. No quality issues were identified during the investigation. There is no impact on product quality. An RA was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The compliant condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing, bulk release testing and certificate of analysis indicates all product testing was determined to be acceptable at time of release. 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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.