Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Intense soreness that increased at night; Insomnia; Palpitations; Ribs were catching; hurts to move arm (worse than normal); Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching) and PAIN IN EXTREMITY (hurts to move arm (worse than normal)) in a 29-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: Hepatitis b. Past adverse reactions to the above products included No adverse effect with Hepatitis b. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Oct-2025, the patient experienced PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching), PAIN IN EXTREMITY (hurts to move arm (worse than normal)) and HEADACHE (Pounding headache). At the time of the report, PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching), PAIN IN EXTREMITY (hurts to move arm (worse than normal)) and HEADACHE (Pounding headache) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient had intense soreness that increased at night, insomnia, pounding headache, palpitations, the ribs were catching, and it was hurting to move arm (worse than normal). It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. Treatment information was not reported.