Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT / LA |
flu-like symptoms; feeling icky; sore arm; bad headaches; period was horribly heavy; period was "horribly heavy" and arrived about 2 weeks earlier than normal after receiving the dose of NUVAXOVID; Initial information received on 10-Nov-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 39 years old female patient who had flu-like symptoms, feeling icky, sore arm, bad headaches and period was "horribly heavy" and arrived about 2 weeks earlier than normal after receiving the dose of NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past vaccination(s) included MRNA COVID vaccine (her periods were heavier for a while). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Crohn's disease. On 02-Nov-2025, the patient received unknown dose of suspect NVX-COV2373 (original) adjuvanted vaccine, Injection (strength, lot number and expiry date not reported) via intramuscular route in the left deltoid for COVID vaccine (COVID-19 immunization). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 02-Nov-2025 on same day the patient developed flu-like symptoms (influenza like illness), feeling icky (feeling abnormal) , sore arm (pain in extremity) and bad headaches (headache). On unknown date in Nov-2025 the patient reported period was horribly heavy and arrived about 2 weeks earlier than normal after receiving the dose of nuvaxovid (heavy menstrual bleeding) (menstruation irregular) (unknown latency). Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on 06-Nov-2025 for the event (flu-like symptoms, feeling icky, bad headaches and sore arm) and was Unknown for the event (heavy menstrual bleeding, menstruation irregular) .
Crohn's disease