Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Migraine
Clinical narrative: spikes in blood pressure and heart rate; spikes in blood pressure and heart rate; migraine; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4337186.  A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 16Dec2019 (ongoing) (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (Dose 1), for COVID-19 immunisation; Pfizer biontech covid-19 vaccine (Dose 2), for COVID-19 immunisation; Pfizer biontech covid-19 vaccine (Dose 3), for COVID-19 immunisation. The following information was reported: MIGRAINE (hospitalization) with onset 06Jan2023, outcome "recovering"; BLOOD PRESSURE INCREASED (hospitalization), HEART RATE INCREASED (hospitalization) all with onset 06Jan2023, outcome "recovering" and all described as "spikes in blood pressure and heart rate". The patient had adverse reaction with covid 19 vaccine booster. She had spikes in blood pressure and heart rate accompanied by migraine after booster number 4 bivalent. She had beta blockers continued to spike. As of 08Mar2023, on six days of steroids and no longer having blood pressure spikes. She had spent two and a half days in hospital. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: spiked; Heart rate: increased. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of blood pressure increased, heart rate increased, migraine.  Causalities: The reporter's causality for the event(s) of covid 19 booster reaction/spikes in blood pressure and heart rate/migraine onset 06Jan2023 with Adalimumab Solution for Injection was Not Provided The reporter's causality for the event(s) of covid 19 booster reaction/spikes in blood pressure and heart rate/migraine onset 06Jan2023 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided agency opinion was that the causality for the event(s) of covid 19 booster reaction/spikes in blood pressure and heart rate/migraine onset 06Jan2023 with Adalimumab Solution for Injection was No Reasonable Possibility agency opinion was that the causality for the event(s) of covid 19 booster reaction/spikes in blood pressure and heart rate/migraine onset 06Jan2023 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency Alternative Etiology for covid 19 booster reaction/spikes in blood pressure and heart rate/migraine with Adalimumab Solution for Injection: Most likely related to Covid-19 vaccine booster patient had taken. Assessment Results: Humira for all events: Non-Health Care Professional, Global Introspection, Not Reported and Market Authorization Holder, Global Introspection, No Reasonable Possibility. Pfizer BioNTech covid-19 vaccine for all events: Non-Health Care Professional, Global Introspection, Not Reported.   The reporter's assessment of the causal relationship of "spikes in blood pressure and heart rate" and "migraine" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event "spikes in blood pressure and heart rate" and "migraine" cannot be excluded based on temporal association and available information. 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.