Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "general anxiety disorder with panic attacks" (unspecified if ongoing), notes: general anxiety disorder with panic attacks; "general anxiety disorder with panic attacks" (unspecified if ongoing), notes: general anxiety disorder with panic attacks; "depression" (unspecified if ongoing); "Adhesives (not latex)" (unspecified if ongoing); "Known allergies: bananas" (unspecified if ongoing); "Known allergies: olives" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: melons" (unspecified if ongoing); "Known allergies: peaches" (unspecified if ongoing). Concomitant medication(s) included: XYZAL; MONTELUKAST; DYMISTA; PROZAC; MUCINEX; IBUPROFEN. Past drug history included: Polysporin, reaction(s): "known allergies: Polysporin"; Neosporin, reaction(s): "known allergies: Neosporin". 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course included: This was a daily 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 Q1215 and/or Q1252. Refer to the below table for details: PR ID (CR). Product-Description (CR): compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 Lot (CR): GJ2524. 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 GJ2524. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. (withheld) concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM 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.