Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
swollen lips; asthenia; local pain aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 06-Sep-2025, the patient experienced LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue). At the time of the report, LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.