Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19/Covid symptoms were severe; Treatment of COVID-19/Covid symptoms were severe; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: GJ3274) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EP7533), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 33030BD), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactemia", start date: 2011 (ongoing); "Thallasemia trait" (ongoing), notes: from Birth. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "recovered" (15Oct2023) and all described as "Treatment of COVID-19/Covid symptoms were severe". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive; (03Oct2023) Positive; (05Oct2023) Positive; (15Oct2023) Negative; (18Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 20Dec2023 for bnt162b2: Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the PfizerBiontech Covid-19 Vaccine lot 33030BD was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk and is manufactured, labeled and packaged by Pfizer (withheld). The final scope was determined to be lot 33030BD. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.  The complaint for lack of effect of the PfizerBiontech Covid-19 Vaccine Injectable lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PfizerBiontech Covid-19 Vaccine lot GJ3274 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ3274, bulk and fill lots GJ2419, and GJ2425. 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.  Clinical information: Patient stated as of her Covid illness onset of 01Oct2023 patient had all available vaccines. The most resent covid vaccine become available around the time she got covid, so patient had not had the opportunity to receive that one. This was her first known covid infection. Prior Vaccinations reported as none. Her covid symptoms lasted for many weeks and as of today 04Dec2023 it has been 2 days since she actually started to get her energy back and had better breathing. Specific relevant tests for thromboembolic events with thrombocytopenia were none. Patient received Paxlovid treatment from 04Oct2023, to 09Oct2023 for the treatment of COVID-19. Batch/Lot number for dose 3 on Vax card state this FD7218/ Online record states this lot # 33030BD.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (11Dec2023): This is a spontaneous follow up report received from a contactable consumer. This consumer (patient) reported in response to non-HCP letter sent. Updated information included: Reporter information updated, Patient height and weight added, medical history ongoing updated, Lab data added, Suspect dosing (regimen) added, and event onset date updated.  Follow-up (20Dec2023): This is a follow-up report from product quality group providing investigation results. Updated information included: QC result and QC result date added for Lot 33030BD, EP7533, lot GJ3274 and Lot EWD153 is invalid per agency and Invalid lot removed from Dose 2  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Follow-up (13Feb2024): Follow-up attempts are completed.