Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna bivalent booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), on 11May2022 at 14:11 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years intramuscular, in arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Apr2021 at 12:40 as dose 1, single (Lot number: EP7534), in arm, on 22Apr2021 at 15:42 as dose 2, single (Lot number: ER8737), in arm and on 30Aug2021 at 10:22 as dose 3 (booster), single (Lot number: FE3592), in arm, all intramuscular for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 27Sep2022 as dose 5 (booster), single (Lot number: AS716413) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "recovered", described as "Moderna bivalent booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Aug2023 at 14:00, outcome "recovered" (19Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2023) Positive, notes: 2 noon; (19Aug2023) Negative; (21Aug2023) Negative; (26Aug2023) Positive, notes: am; (27Aug2023) Positive; (28Aug2023) Positive; (29Aug2023) Positive; (30Aug2023) Positive; (31Aug2023) Positive; (01Sep2023) Positive; (02Sep2023) Positive; (03Sep2023) Positive; (04Sep2023) Positive; (05Sep2023) Positive; (06Sep2023) Positive; (07Sep2023) Positive; (08Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Aug2023 to 19Aug2023.  Based on Investigational Results of Lot number # FE3592, EP7534, ER8737: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EP7534, ER8737, FE3592, FJ4991 were 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. The final scope was determined to be the reported finished goods lot FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. The final scope was determined to be the reported finished goods lot FJ4991, fill lot FJ4988, and the bulk formulated drug product lot FJ4985. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.  Based on Investigational Results of Lot number # FJ4991: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FJ4991 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ4991, fill lot FJ4988, and the bulk formulated drug product lot FJ4985. A complaint sample was not returned. The following potential quality issue was identified during the investigation: all test points of TFF permeate stream flow meters failed during their annual calibration. A manufacturing investigation under PR 7130626 is investigating the reported complaint. Any quality issues identified, root cause or corrective/preventative actions assigned, and the final quality of the batch will be documented in the manufacturing investigation PR 7130626.   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 (21Oct2023): Follow-up attempts are completed. No further information is expected.  Follow-up (19Oct2023): This is a spontaneous follow-up report received from a contactable consumer. This consumer (Patient) reported in response to Non-HCP letter sent that included:  Updated information: Reporter & patient name updated. Patient height & weight added. Lab test added. Suspect recoded & new suspect added. New event added as Moderna bivalent booster. Drug ineffective & COVID-19 events onset/stop date added and outcome updated.  Follow-up (23Oct2023): This is a follow-up report from product quality group providing investigation results. Updated information included: Investigation results reported for lot number FE3592, FJ4991, EP7534, ER8737.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300285847 same patient, different drug/event;