Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; 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 56-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 28Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive, notes: I experienced a "rebound" case of Covid after taking Paxlovid; (04May2022) Positive, notes: My doctor prescribed Paxlovid on the day I tested positive (04May), and I completed the regimen after five days (08May); (09May2022) Negative, notes: tested negative on 09May and 10May and was feeling much better, with only lingering symptoms; (10May2022) Negative, notes: tested negative on 09May and 10May and was feeling much better, with only lingering symptoms; (17May2022) Positive, notes: On 17May, I woke up with worsening symptoms and tested positive on both a rapid antigen and a PCR test; (17May2022) Positive, notes: On 17May, I woke up with worsening symptoms and tested positive on both a rapid antigen and a PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient experienced a "rebound" case of Covid after taking Paxlovid. My doctor prescribed Paxlovid on the day he tested positive (04May), and completed the regimen after five days (08May). The patient know seven other people who have taken Paxlovid as a Covid treatment. So far, six have experienced a "rebound" case of Covid within 10 days of finishing their Paxlovid regimen. Adverse event start date: 17May2022, Adverse event start time: 07:00 AM. 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 agency. Refer to the below table for details:  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER8730 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 and product type. The final scope included the reported finished goods lot ER8730; fill lot EP8682, and the formulated drug product lot EP8569. 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 Pfizer-biontech covid-19 vaccine lot EW0153 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 EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. 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.  Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the Pfizer-biontech 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. 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.  When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.