Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coronary artery bypass, International normalised ratio
Clinical narrative: Quadruple vessel bypass graft; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20K-163-3286601-00 (AbbVie).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 27Dec2019 (Batch/Lot number: unknown) to 03Mar2020, subcutaneous for psoriasis; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non Smoker" (unspecified if ongoing); "No alcohol use" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CORONARY ARTERY BYPASS (hospitalization, medically significant), outcome "recovered", described as "Quadruple vessel bypass graft". The patient was hospitalized for coronary artery bypass (start date: 27Dec2019, discharge date: 03Feb2020, hospitalization duration: 38 day(s)). The patient underwent the following laboratory tests and procedures: International normalised ratio: Unknown results. The action taken for adalimumab was unknown.  Clinical course: Other relevant history: Non-smoker and no alcohol use. Drug: Humira; Daily dose: 1 in 2 week. On an unknown date, the patient experienced quadruple bypass. In 2019, the patient experienced intensive care unit. On unknown dates, quadruple bypass and intensive care unit resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) and Janssen Covid-19 Vaccine (Covid-19 vaccine NRVV AD26 (JNJ 78436735) were also considered suspect. It was reported that patient had quadruple bypass and her medicines were discontinued. She was hospitalized from 27Dec2019 and 03Feb2020 and was in intensive care unit for eleven months. She was hospitalized and was in intensive care unit for three times. The patient took no concomitant medication. Her intensive care unit medicines were discontinue and she was back on her medicines. It was unknown if patient was enrolled in a covid-19 Vaccine trial. Events abate after stopping drug.   The reporter's causality for the events of Quadruple bypass and Intensive care unit with Humira (Adalimumab) was no reasonable possibility. Abbvies option is that there is no reasonable possibility that the events of Quadruple bypass and Intensive care unit are related to Humira (Adalimumab).  Causality for Humira: Event Quadruple vessel bypass graft causality as per reporter (drug/vaccine) was not related. Event intensive care (intensive care) causality as per reporter (drug/vaccine) was not related.  Causality for Pfizer Bio-N-Tech covid 19 vaccine: Event quadruple vessel bypass graft and intensive care (causality as per reporter (drug/vaccine) was possible.   Causality for Janssen covid-19 vaccine: Event quadruple vessel bypass graft and intensive care (causality as per reporter (drug/vaccine) was possible.  The reporter considered "quadruple vessel bypass graft" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the event coronary artery bypass graft cannot be totally excluded. 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.