Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; 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 77-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 09Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack 2000", start date: 2000 (unspecified if ongoing); "Aortic valve replacement 2017", start date: 2017 (unspecified if ongoing); "Minor Factor VII deficiency" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Aug2017; METOPROLOL TARTRATE, start date: Jun2019; BIOTIN, start date: Jun2018; D3, start date: Oct2000; ASPIRIN [ACETYLSALICYLIC ACID], start date: Aug2000; FOLIC ACID, start date: May1995; ELIQUIS, start date: Aug2017; CLONAZEPAM, start date: Jun2010; LISINOPRIL, start date: May2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: I believe that I am experiencing a Rebound Effect. I tested positive for Covid on 31May2022 and began Paxlovid; (05Jun2022) Weak Positive, notes: for the first five days the only side effect that I noticed was diarrhea. At the end of Paxlovid my rapid test was a weak positive.(06Jun2022): Strong Positive, (07Jun2022), (08Jun2022), (09Jun2022), (10Jun2022), (11Jun2022),(12Jun2022), (13Jun2022): Positive, notes: The next day I was strong positive; (07Jun2022) Positive, notes: The next day I was strong positive and have remained a strong positive through today (13Jun2022); Therapeutic measures were taken as a result of vaccination failure, covid-19.  Conclusion (Investigation results): 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 business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Product-Description (CR): Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1, Lot (CR): ER8731. 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 FK9895. 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. (name-withheld) 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. Product-Description (CR): Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1, Lot (CR): FF8839. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot FF8839 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148. 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.  Clinical course: Report about covid treatment was Yes. If vaccine received and Other medication in 2weeks reported as Yes. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 31May2022, Treatment stop date: 04Jun2022, Lot number:, Indication: Treatment of COVID-19. Reported adverse event: I believe that I am experiencing a rebound Effect. I tested positive for Covid on 31May2022 and began Paxlovid. for the first five days the only side effect that I noticed was diarrhea. At the end of Paxlovid my rapid test was a weak positive. The next day I was strong positive and have remained a strong positive through today (13May2022) I have had symptoms throughout these days. Sinus congestion, headache (first couple of days), caugh, sneezing and just not feeling "right". I wouldn't think that I should be positive for 13 days. Known allergies reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.