Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL0142), in right arm, on 26Jan2021 as dose 2, single (Lot number: EL8982), in right arm and on 03Jan2022 as dose 3 (booster), single (Lot number: FH8030) at the age of 32 years, in right arm for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No Other medication in 2weeks. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. It was reported About 5-6 days after completing full dose of Paxlovid I started feeling COVID symptoms again. They were different from the symptoms I had when first diagnosed with COVID the week earlier. Very disappointing and upsetting that I felt so much better and then a week later felt even worse.- Lot EN6198 Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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: FH8030 Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FH8030 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 FH8030, fill lot FH4343, and the formulated drug product lot FA9187. 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. Lot: EL0142 Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 'For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID (see File attachment in this investigation record). Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.