Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Heart rate, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Mild case of Covid with coughing, sore throat and headache; Mild case of Covid with coughing, sore throat and headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Lot number: FF2590) as dose 3 (booster), single, administration date 11Feb2021 (Lot number: EL8982) as dose 2, single and administration date 21Jan2021 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: taking blood pressure medicine. Concomitant medication(s) included: ALLOPURINOL. Clinical Course: The patient experienced coughing, sore throat and headache and tested positive for COVID-19 on 15Jan2022. On Monday (17Jan2022), he was feeling better. At that time he started the treatment with nirmatrelvir, ritonavir (PAXLOVID). He only had a mild case of COVID-19 and by the time he got the treatment it was 2 days later so he was not feeling as bad as he had been. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovered" (Jan2022) and all described as "Mild case of Covid with coughing, sore throat and headache". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 144/76; heart rate: (unspecified date) 75; oxygen saturation: (unspecified date) 99%; sars-cov-2 test: (15Jan2022) positive. Therapeutic measures taken as a result of vaccination failure, covid-19 included Paxlovid.   Product Quality Group provided investigational results on 19Jan2022 for bnt162b2:  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected vaccination failure.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.