Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), in left arm and on 21Apr2021 as dose 2, single (Lot number: EW0167) at the age of 40 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (COVID-19 VACCINE MODERNA), on 02Dec2021 as dose 3 (booster), single (Lot number: 076C21A), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies Sulfa antibiotics. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID-19/Rebounding of COVID symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of Covid-19; (25May2022) Positive, notes: 25May2022 rapid tested positive; (27May2022) Positive, notes: 25May2022 rapid tested positive. Today, 27May2022 still congested and rapid tested positive again this morning. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient was on treatment with drug Paxlovid for COVID 19, Treatment start date was 13May2022 and stop date was 17May2022. Rebounding of COVID symptoms. Tuesday 17May2022 was last day of Paxlovid. Tuesday 24May2022 started feeling congested. 25May2022 rapid tested positive. Today, 27May2022 still congested and rapid tested positive again this morning. Known allergies included sulfa antibiotics. Product quality complaint summary: Batch and lot tested and found within specifications in Product tab per verbatim [All release testing performed prior to the release of the reported batch was within specifications]. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done'  business process according to in PQS Unknown. Refer to the below table for details: Product-Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot-#(CR) was EW0167 and ER8733. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0167 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 EW0167, fill lot EP8698, and the formulated drug product lot EP8595. 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.