Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
having a headache since the day after she received the vaccine/Headache is ongoing/constant; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant) in a 62-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer; for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included Headache with Pfizer and Spikevax NOS. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 18-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant). The patient was treated with Paracetamol (Tylenol) in September 2025 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant) had not resolved. No concomitant medication was reported. The patient had a variety of Moderna and Pfizer in the past and had a headache that's just not stopping. She had been having a headache since the day after she received the vaccine. She was pretty laid out, thought she had a migraine, took migraine medicine, and it didn't work like it always works, though it was probably a reaction to the vaccine. Headache was ongoing/constant, and patient was taking Tylenol and NSAIDs. It was almost as if the patient ever had the flu, where the head felt heavy, and it hurt. Headache was also described as unrelenting. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789597, US-MODERNATX, INC.-MOD-2025-789603 (E2B Linked Report). This case was linked to MOD-2025-789596 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789597:Husband's case US-MODERNATX, INC.-MOD-2025-789603:Husband case