Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | OT |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
patient experienced BACK PAIN (lower backache); INSOMNIA (couldn'tsleep); HEADACHE (terrible headaches); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790767 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single intramuscular for covid-19 prophylaxis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "patient experienced BACK PAIN (lower backache)"; INSOMNIA (non-serious), outcome "unknown", described as "INSOMNIA (couldn'tsleep)"; HEADACHE (non-serious), outcome "unknown", described as "HEADACHE (terrible headaches)". Additional information: It was reported that the patient had a bad reaction to all the Covid vaccines that has gotten before (that includes the Moderna and the Pfizer Covid vaccines) with terrible headaches, lower backache was so bad for the patient and the patient unable to sleep. So, the patient always dreaded going to get a Covid vaccine. The patient never had any reaction to any vaccine except the Covid vaccines. No treatment medications were reported. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.