Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK9231), in left arm and on 04Feb2021 as dose 2, single (Lot number: EL9261) at the age of 77 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: Esomeprazole; Potassium; Furosemide; Clopidogrel; Vitamin D3; Singulair. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: If vaccine received was reported as, yes. Other medications were received in 2 weeks. Anti-viral details were provided as, COVID-19 Treatment with Paxlovid. Treatment start date was 30Jan2022 and treatment stop date was 02Feb2022. Adverse event Blood clot in brain caused loss of half of sight. On 04Feb2022, event resulted in [Disability or permanent damage]. AE treatment Started one half low dose aspirin a day. Known allergies were reported as, yes. 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]. 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 in PQS Unknown. Refer to the below table for details was, PR ID (CR): Unknown. Product-Description (CR), Compound BNT 162 Covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1. Lot-#(CR): EK9231 Conclusion of Previously Completed Investigation (FCI/SI/OffCI) was, the complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EK9231 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 EK9231, fill lot EK9229, and the formulated drug product lot EK9226. 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): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EL9261 was investigated. The investigation included reviewing manufacturing and packaging batch records, release test results, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EL9261, fill lot EL9252, and the bulk formulated drug product EL9243. 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. PR ID of Previously Completed Inv. was, Unknown. PR Link (Previously Investigated CR) was Unknown. PR ID (CR) was, Unknown. Compound BNT 162 Covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1 (Lot-#(CR) EL9261). PR ID of Previously Completed Inv. was, Unknown and PR Link (Previously Investigated CR) was, Unknown. No follow-up attempts are possible. No further information is expected.