Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Stomach cramping, and aching.; Diarrhea starting after bowels were emptied; Full body Violent shaking; Very cold esp hands and feet.; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 30Sep2025 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 7; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Diarrhea starting after bowels were emptied"; TREMOR (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Full body Violent shaking"; ABDOMINAL PAIN UPPER (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Stomach cramping, and aching."; PERIPHERAL COLDNESS (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Very cold esp hands and feet.". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, tremor, peripheral coldness. Additional information: Patient did not receive other vaccines on the same date as the vaccine(s) for which they are reporting. Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient taking any other medications within 2 weeks of the event starting: Yes. Patient has no known allergy.
Medical History/Concurrent Conditions: High cholesterol; Osteoporosis; Scoliosis