Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053669 | IM |
| TTOX | TETANUS TOXOID (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
experienced being extremely cold; slight lower back pain; hot and in a sweat; hot and in a sweat; my body has felt fatigued and slightly achy; fell asleep around 6 pm after feeling fatigued; fatigued; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat) and PAIN (my body has felt fatigued and slightly achy) in a 29-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3053669) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3053669) for COVID-19 prophylaxis and non-company product included Tetanus vaccine toxoid (Tetanus vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: flu shot on 06-Oct-2025. Past adverse reactions to the above products included No adverse effect with flu shot. Concurrent medical conditions included Narcolepsy (Type 2 Narcolepsy) and Asthma. On 20-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter and dose of Tetanus vaccine toxoid (Tetanus vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 20-Oct-2025, the patient experienced FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat), PAIN (my body has felt fatigued and slightly achy), SOMNOLENCE (fell asleep around 6 pm after feeling fatigued), FATIGUE (fatigued) and HEADACHE (a slight headache). At the time of the report, FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat), FATIGUE (fatigued) and HEADACHE (a slight headache) was resolving and PAIN (my body has felt fatigued and slightly achy) and SOMNOLENCE (fell asleep around 6 pm after feeling fatigued) outcome was unknown. The patient did not have any additional medical history, concomitant disease or risk factor. No concomitant medications were reported. The patient received the vaccination at work on 20-Oct-2025 at approximately 1:45 P.M. Later on, that same evening, she experienced being extremely cold, fell asleep around 6 P.M after feeling fatigued, and then woke up at 10:45 P.M feeling hot and in a sweat. Since then, her body had felt fatigued and slightly achy. She experienced slight lower back pain and a slight headache as well. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment information was provided.
Asthma; Narcolepsy (Type 2 Narcolepsy)