Received Jul 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
Bedridden for three days, feeling weak and unable to get up without assistance; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Bedridden for three days, feeling weak and unable to get up without assistance) in a 79-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: RSV vaccine and Flu. Past adverse reactions to the above products included No adverse effect with Flu and RSV vaccine. Concurrent medical conditions included Leukemia and Immunocompromised. Concomitant products included Pemivibart (Pemgarda) for Prevention. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 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 ASTHENIA (Bedridden for three days, feeling weak and unable to get up without assistance). In 2025, ASTHENIA (Bedridden for three days, feeling weak and unable to get up without assistance) had resolved. The patient did not receive any other vaccines in the four weeks prior. Every time the patient received Moderna vaccine, the patient experienced a reaction- not life-threatening or alarming, but it resulted in about four days in bed after which the patient was fine. For instance, in October 2025, the patient was essentially bedridden for three days, feeling weak and unable to get up without assistance. After three or four days, the patient recovered, and the patient's doctor was not concerned about it. The usual response was that it was a good sign, indicating the vaccine was working. However, due to the patient's underlying medical condition, the patient's doctor recommended Pemgarda, a preventive measure that was not a vaccine. It was an infusion administered every three months, in addition to continuing with the vaccine. Historically, the patient had not received the Tdap vaccine. It was only with the COVID vaccine that the patient experienced this reaction. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2022-669829 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2026: Follow-up received non-significant information: Narrative was updated and reference numbers were added.
Immunocompromised; Leukemia
Pemgarda