Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: Ej1865), on 08Jan2021 as dose 2, single (Lot number: El1283), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "reflux" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pcn, reaction(s): "known allergies: Pcn". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  product quality group providing investigation results as:  Lot-#: EL1283 Conclusion of Previously Completed Investigation: 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. Lot-# : FF2587 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer /Biontech covid-19 vaccine lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. 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.  Clinical information: Other medication in 2weeks reported as Singulair and Ventolin. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 25May2022, Lot number: GA3558, Indication-Treatment of COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.