Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Frequent bowel movements
Clinical narrative: bloating; stomach pains; gas; loose and frequent bowel movements; loose and frequent bowel movements; loss of appetite; FATIGUE; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; PRAVASTATIN SODIUM; BISOPROLOL/HYDROCHLOROTHIAZID; FOSAMAX, start date: 06Jul2024. Past drug history included: Penicillin, reaction(s): "Allergy"; Epinephrine, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9264, Expiry date: May2021), administration date: 09Feb2021, for COVID-19 immunization, reaction(s): "Unexpected therapeutic effect"; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Bivalant, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 11Sep2024, outcome "recovering"; ABDOMINAL DISTENSION (non-serious) with onset 11Sep2024, outcome "recovered" (Sep2024), described as "bloating"; FLATULENCE (non-serious) with onset 11Sep2024, outcome "recovered" (Sep2024), described as "gas"; FREQUENT BOWEL MOVEMENTS (non-serious), DIARRHOEA (non-serious) all with onset 11Sep2024, outcome "recovering" and all described as "loose and frequent bowel movements"; DECREASED APPETITE (non-serious) with onset 11Sep2024, outcome "recovering", described as "loss of appetite"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Sep2024, outcome "recovered" (Sep2024), described as "stomach pains". Therapeutic measures were not taken as a result of abdominal distension, abdominal pain upper, flatulence, frequent bowel movements, diarrhoea, decreased appetite, fatigue.  Additional information: Facility where vaccine was administered was at pharmacy or drug Store. Patient did not receive any other vaccines on the same date as the Comirnaty (2024-2025 Formula) vaccine. Patient did not receive any other vaccines within 4 weeks prior to the Comirnaty (2024-2025 Formula) vaccine. Patient was taking other medications within 2 weeks of the event starting. Patient had pfizer covid shot on monday 09Sep2024 and on wednesday 11Sep2024 developed gastro symptoms (bloating, stomach pains, gas, loose and frequent bowel movements, loss of appetite and fatigue). Patient had this significantly for 5 days and it was 9 days since the shot and the pain and bloating and gas were gone but patient still had little appetite, (which was very unusual for her) and the loose frequent bowel movements were 75 % better, but that may be because she was not eating much at the time of reporting. This was patient 6th covid shot since 2021 (2 initial and 3 boosters (including the bivalent) prior to this) and she never had any side effects from previous ones at all. She was in very good health.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.