Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected 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 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 17:30 (Lot number: FF2593) at the age of 25 years as dose 3 (booster), single, administered in arm left, administration date 27Apr2021 17:15 (Lot number: EW0172) as dose 2, single and administered in arm left, administration date 06Apr2021 17:15 (Lot number: ER8737) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing); "Low pneumococcal titers" (unspecified if ongoing); "Prothrombin G20210A mutation" (unspecified if ongoing), notes: Blood Clotting; "Prothrombin G20210A mutation (blood clotting)" (unspecified if ongoing); "Hormonal acne" (unspecified if ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE], start date: Aug2017; XYZAL ALLERGY 24HR, start date: 18Aug2021; ASTEPRO, start date: 18Aug2021; MELATONIN, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Feb2022 19:00, outcome "recovered" (03Mar2022), described as "Drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 25Feb2022 19:00, outcome "recovered" (03Mar2022), described as "Suspected Covid-19". The patient underwent the following laboratory tests and procedures: covid-19: positive. Therapeutic measures taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 25Feb2022 to 02Mar2022.  Additional information: Patient experienced the known side effect of altered sense of taste upon the first time taking the pill. She experienced nausea every morning that she was on the medication. She also experienced muscle cramps (not muscle pain), which could've been a combination of dehydration as well. Patient received other medication in 2 weeks. Product quality group providing investigation results report included: 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 Q1215 and/or Q1252. Refer to the below table for details: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. 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. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2593 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 FF2593, fill lot FF5584, and formulated drug product lot FA9147. A complaint sample was not returned. 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. The complaint for lack of effect of the PFIZER- BIONTECH COVID-19 VACCINE INJECTABLE lot EW0172 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0172, fill lot EP8724, and the bulk formulated drug product lot EP8605. 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.