Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR test was positive; PCR test was positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Lot number: 013A21A), in left arm, on 25Mar2021 as dose 2, single (Lot number: 032M20A), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Macrobid" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "inflammation of the lungs due to radiation" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing); "currently on steroids for the inflammation" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 28Jul2021; EXEMESTANE, start date: 03May2021; SULFAMETHOXAZOLE+TRIMETHOPRIM, start date: 01Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "PCR test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive; (09Jun2022) Positive; (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was updated as yes. As part of the 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 Q1215 and/or Q1252. Refer to the below table for details:  ID : 7276876; Product- Description (CR): COMPOUND BNT162 COVID- 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 ADULT 10X 2.25ML; Lot-#  FM9992. Conclusion of Previously Completed Investigation. The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The  process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. ID of Previously Completed Inv: 7142808;  Link  7142605.  No follow-up attempts are possible. No further information is expected.