Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Culture stool, Decreased appetite, Diarrhoea, Fatigue, Heart rate
Clinical narrative: Increased heart rate; Within 24 hours I began vomiting then diarrhea; Within 24 hours I began vomiting then diarrhea; Pain at the injection site; Fatigue; Feeling unwell; Decreased appetite; Other Vaccine on Same date product: Flu shot; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 11:30 as dose number unknown (bivalent; booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; JARDIANCE; RISPERDAL; METFORMIN. Past drug history included: Can't take bactrim (causes nausea),, reaction(s): "Known allergies: Can't take Bactrim (causes nausea)", notes: Known allergies: Can't take Bactrim (causes nausea). Vaccination history included: Covid-19 vaccine (primary immunization series complete: unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "Other Vaccine on Same date product: Flu shot"; DECREASED APPETITE (non-serious) with onset 14Sep2022 at 04:00, outcome "recovering"; FATIGUE (non-serious) with onset 14Sep2022 at 04:00, outcome "recovering"; MALAISE (non-serious) with onset 14Sep2022 at 04:00, outcome "recovering", described as "Feeling unwell"; HEART RATE INCREASED (non-serious) with onset 14Sep2022 at 04:00, outcome "recovering", described as "Increased heart rate"; VACCINATION SITE PAIN (non-serious) with onset 14Sep2022 at 04:00, outcome "recovering", described as "Pain at the injection site"; VOMITING (non-serious), DIARRHOEA (non-serious) all with onset 14Sep2022 at 04:00, outcome "recovering" and all described as "Within 24 hours I began vomiting then diarrhea"; NAUSEA (non-serious) with onset Sep2022, outcome "recovering". The events "increased heart rate", "within 24 hours i began vomiting then diarrhea", "pain at the injection site", "fatigue", "feeling unwell", "decreased appetite" and "nausea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, vomiting, diarrhoea, vaccination site pain, fatigue, malaise, decreased appetite, nausea.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. Treatment received for the adverse events Includes Zofran. Within 24 hours patient began vomiting then diarrhoea. Pain at the injection site, fatigue, feeling unwell, decreased appetite, increased heart rate. Called PCP unable to get an appointment due to schedule, so after day 6 went to walk in clinic and they did lab work and stool cultures. Prescribed Zofran that help with with nausea & vomiting. All lab came back ok indicating it must have been the vaccine. (Due to previous COVID vaccines & booster with no reaction, patient  thought taking the booster and flu shot together would not be an issue) Pharmacy confirmed it would be fine. Patient will never take the Bivalent again.  Follow-up attempts are completed. No further information is expected.