Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | my9548 | RA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | 407264 | RA |
Increased bowel movements; Nausea; Vomiting; Chills; Aches; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Oct2025 as dose 5 (booster), single (Lot number: my9548), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Oct2025 as dose 4 (booster), single (Lot number: 407264), in right arm. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ABATACEPT. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE (BOOSTER)), for Immunisation. The following information was reported: PAIN (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering", described as "Increased bowel movements"; NAUSEA (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering"; VOMITING (non-serious) with onset 17Oct2025 at 23:00, outcome "recovering". Therapeutic measures were not taken as a result of frequent bowel movements, nausea, vomiting, chills, pain. Additional information: The patient was taking other medications within 2 weeks of the event. No follow-up attempts are possible.
Medical History/Concurrent Conditions: Rheumatoid arthritis
ABATACEPT