Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
lower backache; couldn't sleep; terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches). At the time of the report, BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that the patient had a bad reaction to all the Covid vaccines that he 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. This case was linked to MOD-2025-790814 (Patient Link).