Sex: F
Vaccine: UNK
Symptoms: Anxiety, Condition aggravated, Drug interaction, Electrocardiogram abnormal, Hepatic enzyme increased
Clinical narrative: Electrocardiogram abnormal; Heart attack; Elevated liver enzymes; Anxiety; Hepatomegaly/ENLARGED LIVER; Drug interaction; Psoriasis flare-up; FACILITATED COLLECT  This is a solicited report received by Pfizer from Agency (manufacturer control number 21K-163-3906067-00). A contactable consumer (patient) who reported for herself stated that a 46-year-old female patient received first dose of BNT162B2 (Batch/Lot number was not reported), intramuscular in 2021 as 1st dose, single for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to 28Apr2021, at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced electrocardiogram abnormal, anxiety, heart attack, hepatomegaly/enlarged liver, drug interaction, psoriasis flare-up, elevated liver enzymes all in 2021, the events were serious per hospitalization. Solicited report by a consumer of a 46 years old female with events of irregular electrocardiograph, anxiety and mild heart ttack and non-serious enlarged liver, drug interaction, outbreak of psoriasis and increased liver enzymes with adalimumab (HUMIRA). There was no reported medical history. On unknown dates, the patient experienced enlarged liver, drug interaction and outbreak of psoriasis. In 2021, the patient experienced irregular electrocardiograph, anxiety, mild heart attack and increased liver enzymes. COVID-19 VACCINE was also considered suspect. The patient had heart related issues. In 2021, she was in hospital for mild heart attack, irregular electrocardiograph and anxiety. She also had enlarged liver. She experienced increased outbreaks of psoriasis before mensuration. On 28Apr2021, she took last dosage of Humira and her first COVID-19 Vaccine of Pfizer had contributed to her increased liver enzymes issue and sudden cardiac issues. The patient agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient received first dose of COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was not available. The patient underwent lab tests and procedures which included electrocardiogram: abnormal in 2021, hepatic enzyme: increased in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of events for anxiety and elevated liver enzymes were unknown, for hepatomegaly/enlarged liver and drug interaction were not resolved, for other events was resolving.  The reporter's causality for the events of irregular electrocardiograph, mild heart attack, enlarged liver, drug interaction and outbreak of psoriasis with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the events of anxiety and increased liver enzymes was not provided.  The reporter's causality for the events of electrocardiogram abnormal, heart attack and elevated liver enzymes with bnt162b2 was probable, for other events was not reported.  AbbVie's opinion is that the events of irregular electrocardiograph, anxiety, mild heart attack, enlarged liver, drug interaction, outbreak of psoriasis and increased liver enzymes are not assessable.  The reporter's assessment of the causal relationship for the events of Anxiety, Hepatomegaly, Drug interaction, Psoriasis flare-up with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.