Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EJ1685), on 14Jan2021 as dose 2, single (Lot number: EL1283) and on 23Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 45 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Sjogren's disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: Jan2020. Past drug history included: Nystatin, reaction(s): "Know allergies: Nystatin",  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Symptoms recurred 24May22 with positive antigen and PCR test; (19May2022) Negative, notes: Negative antigen test 19May22; (14May2022) Positive, notes: Positive test 14May22; (24May2022) Positive, notes: Symptoms recurred 24May22 with positive antigen and PCR test. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Antiviral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 14May2022, treatment stop date: 18May2022, indication: Treatment of COVID-19. Relapse of COVID symptoms following Paxlovid. Symptom onset 13May2022 - mild symptoms congestion, runny nose, slight cough, fatigue, diarrhea, no fever. Positive test 14May2022 - treated with Paxlovid 14May2022 - 18May2022. Took all doses as prescribed. Symptoms resolved by 17May2022. Negative antigen test 19May2022. Symptoms recurred 24May2022 with positive antigen and PCR test. Symptoms are still mild, congestion, cough, no fever. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FD0809 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 FD0809, fill lot EY0564, and the formulated drug product lot FE3194. 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): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL1283 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 EL1283, fill lot EL1281, and the formulated drug product lot EL1279. 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): 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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events