Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
headache; nauseous/ feels like throwing up; arm is swollen; arm is tender; feeling kind of hot; very tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued) and HEADACHE (headache) in a 41-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. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Syndrome lupus. On 27-Oct-2025 at 5:00 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued) and NAUSEA (nauseous/ feels like throwing up). On 27-Oct-2025, the patient experienced HEADACHE (headache). The patient was treated with Paracetamol (Tylenol) in October 2025 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued), HEADACHE (headache) and NAUSEA (nauseous/ feels like throwing up) had not resolved. Patient did not receive any vaccines within the past 4 weeks. No concomitant medication was reported. The patient received Spikevax on 27-Oct-2025 and was very tired and fatigued right till the day of reporting and was experiencing a headache for two days. She was nauseous too. Her arm was swollen and tender and mostly had a headache. She was having a headache during the call and felt kind of hot. On 29-Oct-2025, her headache was bad and felt like throwing up. She used Tylenol and it did not help. It was unknown if the patient experienced any additional symptoms/events.
Syndrome lupus