Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiac failure, Cardiomyopathy, Echocardiogram
Clinical narrative: Cardiomyopathy; Heart failure; This is a spontaneous report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163--3936808-00). A contactable consumer (patient) reported that a 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6202), intramuscular on 26Feb2021 (at age of 71 years old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from Dec2019 to 22May2021, at 40 mg for Chron's disease. Relevant medical history included: No known allergies, Tobacco use/A Pack of Cigarettes a day (from 1970 to 1995), Abstains from alcohol, ongoing Chron's disease. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL926Y) on 05Feb2021 (at 71 years old) as single dose for COVID-19 immunisation. Spontaneous report from the consumer of a 71-year-old male with events of Cardiomyopathy and heart failure with HUMIRA 40MG/0.4ML (ADALIMUMAB). In May2021, the patient experienced Cardiomyopathy (Medically Significant and Life-threatening), Heart Failure (Other medically important condition). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient was told that he had a type of heart failure called cardiomyopathy. Health care provider instructed him to stop taking HUMIRA and his last injection was two weeks before, on 22May2021. He had a shot of COVID-19 vaccine before at least one symptom happened, therefore COVID-19 vaccine was considered as co-suspect product. The patient did not have the use of any concomitant medications for Crohn's disease. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. On 05Feb2021, the patient received first dose of COVID-19 Vaccine manufactured by PFIZER, lot number EL926Y. On 26Feb2021, he received second dose of COVID-19 Vaccine manufactured by PFIZER, lot number EN6202. Relevant Laboratory & Other Diagnostic Tests: May2021 cardiac magnetic resonance imaging: Confirmed cardiomyopathy. May2021 Echocardiogram: Confirmed cardiomyopathy. The action taken in response to the events for adalimumab was permanently withdrawn on 22May2021. Cardiomyopathy-Not recovered/not resolved Heart failure-Not recovered/not resolved. Product-Reaction level: Seq.No.: 1 Drug: Humira (Solution for injection in pre-filled pen) (ADALIMUMAB): Causality: 1) Cardiomyopathy (Cardiomyopathy) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not assessable Dechallenge was No. 2) Heart Failure (Cardiac Failure) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Not assessable Dechallenge was No. Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (Injection) (TOZINAMERAN): Causality: 1) Cardiomyopathy (Cardiomyopathy) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not reported Dechallenge was N/A. 2) Heart Failure (Cardiac Failure) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): Not reported Dechallenge was N/A. Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB). The reporter's causality for the event(s) of CARDIOMYOPATHY and HEART FAILURE was not provided.