Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 63-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 18:00 as dose 3 (booster), single (Lot number: FF2590), in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Known allergies: Bupropion"; Amoxicillin (mild), reaction(s): "Known allergies: Amoxicillin (mild)". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive, notes: Positive antigen test; (22May2022) Negative, notes: negative antigen test; (26May2022) Positive, notes: Mild symptoms recurred 24May, positive antigen test. Therapeutic measures were taken as a result of Covid-19. Treatment start date was 16May2022, treatment stop date: 21May2022, Indication was treatment of COVID-19. Other medication in 2 weeks was yes. Initial symptoms 14May. Positive antigen test 15May. Paxlovid 16May-21May. Asymptomatic with negative antigen test 22May. Mild symptoms recurred 24May, positive antigen test 26May. Other medication in 2 weeks product was IC Amphetamine Salts ER 30 Mg Cap, Other medication in 2 weeks brand as Actavis/Teva, Other medication in 2 weeks start date: Apr2022, Other medication in 2 weeks stop date: May2022, Other medication in 2 weeks lot number was unknown. Initial symptoms 14May. Positive antigen test 15May. Paxlovid 16May-21May. Asymptomatic with negative antigen test 22May. Mild symptoms recurred 24May, positive antigen test 26May. Clinical Course: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 Vaccine Injectable lot FF2590 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 FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. 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. Follow-up (31May2022): This is a spontaneous follow-up report from product quality group providing investigation results. This report included that: Updated information included: Product details (Batch and lot tested and found within specifications checked) and investigation results updated. No follow-up attempts are possible. No further information is expected.