Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 J&J; Dose Number: 2 Pfizer / BioNTech; Dose Number: 3 Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 3 (booster), single (Lot number: GJ3277) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Lot number: FF2587) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 1808979) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2021, outcome "unknown", described as "Dose Number: 1 J&J; Dose Number: 2 Pfizer / BioNTech; Dose Number: 3 Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results on 20Mar2023. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot GJ3277 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 GJ3277, bulk and fill lots, GJ2421, and GJ2427. 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. No corrective or preventative actions were identified because it was determined that the controls in place were sufficient at preventing and removing defects that could cause a complaint of this nature. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. 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.  Follow-up (20Mar2023): This is a follow-up report from Product Quality Complaint Group providing investigation results.