Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Confusional state, Drug ineffective
Clinical narrative: his wife and himself had Covid mid Aug2022 after getting 3 dosesof the Moderna Covid-19 vaccine and one dose of Pfizer; his wife and himself had Covid mid Aug2022 after getting 3 dosesof the Moderna Covid-19 vaccine and one dose of Pfizer; Interchange of vaccine products; he ran a temperature of 102.5; confused; This is a spontaneous report received from non-contactable reporter(s) (Physician) from product quality group. The reporter is the patient. Other Case identifier(s): MOD22-022731 (MODERNA), 147943 (MODERNA), 147942 (MODERNA).  A male patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Lot number: 011M20A), on 05Mar2021 as dose 2, single (Lot number: 002A21A) and on 08Nov2021 as dose 3 (booster), single (Lot number: 065F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17May2022, outcome "unknown"; CONFUSIONAL STATE (non-serious) with onset 2022, outcome "unknown", described as "confused"; BODY TEMPERATURE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "he ran a temperature of 102.5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "his wife and himself had Covid mid Aug2022 after getting 3 dosesof the Moderna Covid-19 vaccine and one dose of Pfizer". The events "his wife and himself had covid mid aug2022 after getting 3 dosesof the moderna covid-19 vaccine and one dose of pfizer", "he ran a temperature of 102.5" and "confused" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (2022) 102.5; SARS-CoV-2 test: (Aug2022) Positive. Clinical course: A retired Physician reports that his wife and himself had Covid mid Aug2022 after getting 3 doses of the Moderna Covid-19 Vaccine and one dose of Pfizer. He had to seek an out patient consult when he had the covid as he ran a temperature of 102.5 and he was confused.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer-biontech covid-19 vaccine lot FJ9943 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. 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 the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.