Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Hypotension, Loss of consciousness, Nausea
Clinical narrative: Got an allergic reaction; passed out; Not terrible nausea; Difficulty in breathing; trouble in breathing on and off; Blood pressure was very low; Tingling in my hand; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). Vaccination history included: Covid-19 vaccine (had been taking all the series of COVID Vaccine been so far, Manufacturer unknown, ), for Immunization. The following information was reported: HYPOTENSION (hospitalization) with onset 15Oct2023, outcome "unknown", described as "Blood pressure was very low"; DYSPNOEA (hospitalization) with onset 15Oct2023, outcome "unknown", described as "Difficulty in breathing; trouble in breathing on and off"; HYPERSENSITIVITY (hospitalization) with onset 15Oct2023, outcome "unknown", described as "Got an allergic reaction"; NAUSEA (hospitalization) with onset 15Oct2023, outcome "unknown", described as "Not terrible nausea"; PARAESTHESIA (non-serious) with onset 15Oct2023, outcome "unknown", described as "Tingling in my hand"; VOMITING (non-serious) with onset 15Oct2023, outcome "unknown"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 15Oct2023, outcome "unknown", described as "passed out". The patient was hospitalized for hypersensitivity, loss of consciousness, nausea, dyspnoea, hypotension (start date: 15Oct2023, discharge date: 16Oct2023, hospitalization duration: 2 day(s)). Clinical course was as follow: Like after she had the injections, she started having reactions right after it. It was like 11:13 the morning on 15Oct2023 that she had the appointment for the vaccination and she guessed the 15 minutes later day they had to call the ambulance. The reason of hospitalization was because they were concerned that she would continue to pass out, she had the nausea that would go away and difficulty in breathing and her blood pressure was very low. The patient was treated in the ambulance and the Hospital for it. Not herself but she was administered the treatment at the Hospital, so she ended up, she passed out in the Pharmacy for a minute or so and then she started having a not terrible nausea and she vomiting, so the medication that they gave she had a little bit of trouble in breathing on and off and she had like tingling in her hand the, so they did medication that was given to her were for the, mostly for the nausea to keep it, try to keep the nausea under controlled. So, one medication they gave her, she had it from the Hospital paperwork was Zofran for nausea. It was Ondansetron, She was given Zofran and then Compazine. The Ondansetron she thought it was same as Zofran, for Compazine was also said 'chlorpromazine' which she thought was the regular name instead of the brand name.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.