Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Flushing, Head discomfort, Tremor
Clinical narrative: not aware of his surroundings/felt as if he was in a dream; fine trembling; flushed; felt almost normal but felt as if he had a hat on; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: pacemaker/defibrillator/micro clip; "pacemaker/defibrillator/micro clip" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 03Apr2023; TAMULOSIN, start date: Jan2018; METOPROLOL, start date: Mar2024; JARDIANCE, start date: Mar2024; ENTRESTO, start date: Jan2023; FUROSEMIDE, start date: Mar2024; SPIRONOLACTON, start date: Jan2021; APIXABAN, start date: Aug2023. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization; Pfizer (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization; Typhoid (for travel abroad several years ago); Yellow fever (for travel abroad several years ago). Patient did not receive any other vaccines on the same date or within 4 weeks prior to the suspect vaccine. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 13Sep2024, outcome "recovered" (13Sep2024), described as "felt almost normal but felt as if he had a hat on"; TREMOR (non-serious) with onset 13Sep2024, outcome "recovered" (13Sep2024), described as "fine trembling"; FLUSHING (non-serious) with onset 13Sep2024, outcome "recovered" (13Sep2024), described as "flushed"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 13Sep2024, outcome "recovered" (13Sep2024), described as "not aware of his surroundings/felt as if he was in a dream". The clinical course was reported as follows: Within 5-10 minutes of Covid vaccination patient experienced a 10-15 second reaction where he developed fine trembling, his eyes closed and his head fell forward. Patient's wife and the pharmacist said he was also quite flushed. Patient was not aware of his surroundings. Patient felt as if he was in a dream. Patient was later able to move unaided.  After about 30 minutes patient felt almost normal but felt as if he had a hat on. Two hours later and after resting he felt OK. Patient had never had a reaction to any vaccination or medication. Patient had all "normal" vaccinations including Yellow Fever, typhoid etc. for travel abroad several years ago. He also had all recommended Covid vaccines both Moderna and Pfizer and never had any reaction including no sore arms or dizziness. The pharmacist said he had seen this type of reaction in very small children but never in an adult. Therapeutic measures were not taken as a result of depressed level of consciousness, tremor, flushing, head discomfort.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.