Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL8982), in left arm and on 25Mar2021 as dose 2, single (Lot number: EN6208) at the age of 64 years, in left arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose number 3 (booster), single (Lot number: 034F21A), in left arm and on 05May2022 at 15:00 as dose number 4 (booster), single (Lot number: 05ZM21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Iritis" (unspecified if ongoing); "Milk Protein allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive with rapid test; positive, notes: very strong positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid form 29Jun2022 to 04Jul2022 as treatment of COVID-19. 2 and 3 days after completing paxlovid course, patient still tested positive with rapid test, though extremely weakly. Day 4 after completion, symtoms returned and were even worse and had a very strong positive rapid test. Now at day 3+ of relaspse and still have fever and other symptoms.  This is a notification generated from the system. 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 RA. 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): EL8982: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizerbiontech 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. Product-Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1, Lot-# (CR): EN6208: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine lot EN6208 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 EN6208, fill lot EN5338, and the formulated drug product lot EN5329. 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.