Sex: F
Vaccine: COVID19, FLUA3
Symptoms: Arthralgia, Blood pressure measurement, Blood pressure systolic increased, Feeling abnormal, Myocarditis
Clinical narrative: Due to some complaints about the chest, she was concerned about myocarditis; Her blood pressure is usually around 130s but it went up to 168-175 systolic after injection; can taste the vaccine; feeling this pulsating feeling in chest and it is running down the body to legs and there was pain in hip and leg; feeling this pulsating feeling in chest and it is running down the body to legs and there was pain in hip and leg; feeling this pulsating feeling in chest and it is running down the body to legs and there was pain in hip and leg; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 26Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Oct2023, outcome "unknown", described as "Due to some complaints about the chest, she was concerned about myocarditis"; BLOOD PRESSURE SYSTOLIC INCREASED (medically significant) with onset Oct2023, outcome "unknown", described as "Her blood pressure is usually around 130s but it went up to 168-175 systolic after injection"; TASTE DISORDER (non-serious) with onset Oct2023, outcome "unknown", described as "can taste the vaccine"; FEELING ABNORMAL (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2023, outcome "unknown" and all described as "feeling this pulsating feeling in chest and it is running down the body to legs and there was pain in hip and leg". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (Oct2023) around 130s; (Oct2023) 168-175 systolic, notes: after injection; (Oct2023) 140s, notes: about 2-3 hours later, her blood pressure was in the 140s systolic. Clinical course: Pharmacist stated that patient was not sure if the side effects were related to the COVID-19 vaccine or flu vaccine. Due to some complaints about the chest, she was concerned about myocarditis. Patient received both Fluad and Comirnaty 2023-2024 Formula in the same arm. After vaccination, the patient stated she could taste the vaccine. She felt pulsating feeling in her chest and it was running down the body to her legs and there was pain in hip and leg. The pharmacist continued to monitor the patient after the vaccinations and stated that the patient was still talking so no epipen was administered. The patient also developed elevated blood pressure after vaccination. Her blood pressure was usually around 130s but it went up to 168-175 systolic after injection. Upon follow-up with the patient about 2-3 hours later, her blood pressure was in the 140s systolic.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Myocarditis , Blood pressure systolic increased  cannot be 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