Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 06Aug2021 as dose 3 (booster), single (Lot number: EW0168) at the age of 62 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 29Apr2022 as dose 4 (booster), single (Lot number: 057MZHA), in left leg for Covid-19 immunisation. The patient's relevant medical history included: "Addison's" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Feb2015; HYDROCORTISONE, start date: 01Feb2015; FLUDROCORTISONE, start date: 01Feb2015; LIPITOR, start date: 01Feb2015. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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 vaccination failure, Covid-19. Patient had received Other medications in two weeks and patient had received as a treatment of Covid-19 of Paxlovid from 17May2022 to 21May2022. This is a notification generated from the gQTS 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. AE Ref No. (CC): PR ID (CR): 7228311. Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot- (CR): EL3246, AE Ref No. (CC): PR ID (CR): 7228313, Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot- (CR): EL9265, AE Ref No. (CC): PR ID (CR): 7228314 Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Lot- (CR): EW0168. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3246, EL9265 and EW0168 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 and product type. The final scope included the reported finished goods lot EL3246, fill lot EL3229, and the formulated drug product lot EL3222. The final scope included the reported finished goods lot EL9265, fill lot EL9256, and the formulated drug product lot EL9247. The final scope included the reported finished goods lot EW0168, fill lot EP8699, and the formulated drug product lot EP8601. 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. PR ID of Previously Completed Investigation: PR Link (Previously Investigated CR): PR ID of Previously Completed Investigation: PR Link (Previously Investigated CR): PR ID of Previously Completed Investigation: PR Link (Previously Investigated CR): Unknown. No follow-up attempts are possible. No further information is expected.