Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | — | IM |
Ill; Achy; low grade temp; it was just slightly sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was just slightly sore in the arm), ILLNESS (Ill), PAIN (Achy) and PYREXIA (low grade temp) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot on 12-Sep-2025. Past adverse reactions to the above products included No adverse effect with Flu shot. Concomitant products included Paracetamol (Tylenol) and Ibuprofen for an unknown indication. On 03-Oct-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 03-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced PAIN IN EXTREMITY (it was just slightly sore in the arm). On 04-Oct-2025, the patient experienced PAIN (Achy) and PYREXIA (low grade temp). On 06-Oct-2025, the patient experienced ILLNESS (Ill). On 04-Oct-2025, PAIN IN EXTREMITY (it was just slightly sore in the arm) had resolved. At the time of the report, ILLNESS (Ill), PAIN (Achy) and PYREXIA (low grade temp) outcome was unknown. The patient didn't feel any side effects right after getting the vaccine and was surprised by that. Later, at night of vaccination had slightly sore in the arm and next day patient was fine. On 06-Oct-2025 she got ill. Patient also had low grade temperature and was achy. She was unsure about when she could safely take Ibuprofen or Tylenol again. She also felt she wasn't given enough information about the vaccine type and dose. Despite this, she gave positive feedback and appreciated the lower dose. Treatment medication was not reported. This case was linked to MOD-2025-789983, MOD-2025-789984 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live non-significant follow-up received: Reference numbers added On 06-Oct-2025: Live significant follow-up received includes new events like Illness, Ache, Low grade fever and concomitant medications Tylenol and ibuprofen were added. On 06-Oct-2025: Live non-significant follow-up received. Reference numbers were added. On 07-Oct-2025: Live non-significant follow-up received. Reference numbers added
Tylenol; Ibuprofen