Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Injection site pain, Insomnia, Myalgia, Nausea
Clinical narrative: hyperdynamic precordium; Fever 101°F; dizziness; chills without rigors; diaphoresis; bilateral retroorbital headache; tachycardia HR 106 (normal: 52); widened pulse pressure without hypotension; feeling of impending doom; insomnia; nausea; myalgias; pain at injection site; This is a spontaneous report received from a Physician.  A 65-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 at 09:30 as dose 1, single (Lot number: Lm2215) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "Fever 101°F"; HEADACHE (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "bilateral retroorbital headache"; CHILLS (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "chills without rigors"; HYPERHIDROSIS (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "diaphoresis"; DIZZINESS (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024); ANXIETY (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "feeling of impending doom"; HYPERDYNAMIC LEFT VENTRICLE (medically significant) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "hyperdynamic precordium"; INSOMNIA (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024); MYALGIA (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "myalgias"; NAUSEA (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024); VACCINATION SITE PAIN (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "pain at injection site"; TACHYCARDIA (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "tachycardia HR 106 (normal: 52)"; PULSE PRESSURE ABNORMAL (non-serious) with onset 06Nov2024 at 20:00, outcome "recovered" (07Nov2024), described as "widened pulse pressure without hypotension". The patient underwent the following laboratory tests and procedures: Body temperature: (06Nov2024) 101 Fahrenheit; Heart rate: (06Nov2024) 106, notes: normal: 52. Therapeutic measures were not taken as a result of hyperdynamic left ventricle, pyrexia, dizziness, chills, hyperhidrosis, headache, tachycardia, pulse pressure abnormal, anxiety, insomnia, nausea, myalgia, vaccination site pain.; Sender's Comments: It appears unlikely that the suspect product BNT162b2 omicron (kp.2) contributed to the reported serious event of hyperdynamic precordium, which likely represent an intercurrent medical condition. Conversely, a reasonable possibility that all other non-serious events are related to BNT162b2 omicron (kp.2) administration cannot be excluded. Case will be reassessed should additional information become 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 Regulatory Authorities, Ethics Committees and Investigators as appropriate.