Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 2 (booster), single (Lot number: FH8028), in left arm and on 09Jun2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 20Mar2021 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cleocin, reaction(s): "known allergies: Cleocin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after negative rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2weeks. Patient received Anti viral product  Paxlovid on 29Nov2022 to 03Dec2022 for the Treatment of COVID-19. Reoccurrence of symptoms 3 days after symptoms ended and after negative rapid test. No medical history.  Conclusion of Previously Completed Investigation of Lot FH8028: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FH8028 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FH8028, fill lot FH4341 and the formulated drug product lot FH4347. 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 of Lot 33025BD: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, and an analysis of 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 33025BD. No quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notification were held because 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 as incoming quality component testing and 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.