Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia, COVID-19, Electroencephalogram, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 010M20A) and on 03Mar2021 as dose 2, single (Lot number: 036A21A) for covid-19 immunisation. The patient's relevant medical history included: "caller is a smoker" (unspecified if ongoing), notes: caller is a smoker, Are there predisposing factors? Smoker. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): , Vaccine Name: Flu vaccine, thinks it was Flucelvax or something like that., Manufacturer: Unknown, Lot Number: Unknown). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Mar2022, outcome "unknown" and all described as "tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Electroencephalogram: (15Mar2022) Unknown results, notes: Got an MRI and EEG on 15Mar2022; Magnetic resonance imaging: (15Mar2022) Unknown results, notes: Got an MRI and EEG on 15Mar2022; SARS-CoV-2 test: (unspecified date) Negative, notes: caller tested negative for Covid periodically until 27Mar2022; (27Mar2022) Positive, notes: On 27Mar2022 caller tested positive for Covid.  Conclusion: The complaint for a Lack of effect of the Pfizer Biontech COVID-19 Vaccine lot 32030BD 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 (Site withheld). The final scope was determined to be lot 32030BD. 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.  No follow-up attempts are possible. No further information is expected.