Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Stomach upset; Nausea; Low grade fever; Exhaustion; Dizziness; Feeling weak and unable to get up without assistance; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak and unable to get up without assistance), ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever) and FATIGUE (Exhaustion) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: RSV vaccine and Flu vaccine. Past adverse reactions to the above products included No adverse effect with Flu vaccine and RSV vaccine. Concurrent medical conditions included Leukemia and Immunocompromised. Concomitant products included Pemivibart (Pemgarda) for Prevention. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced ASTHENIA (Feeling weak and unable to get up without assistance). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever), FATIGUE (Exhaustion) and DIZZINESS (Dizziness). In October 2025, ASTHENIA (Feeling weak and unable to get up without assistance) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), NAUSEA (Nausea), PYREXIA (Low grade fever), FATIGUE (Exhaustion) and DIZZINESS (Dizziness) had resolved. Due to patient's underlying medical conditions, 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, patient had not received the Tdap vaccine. It was reported that patient had always received the Moderna vaccine. Being an older person, patient got a booster last year. Every time patient had received the vaccine, experienced a reaction which is not life-threatening or alarming, but it resulted in about four days in bed with nausea and other symptoms, after which patient was fine. Patient had compromised immune system and the doctor strongly advised that patient should continue with the vaccinations. This has been the case for the past four or five years. Each time patient had received the Moderna vaccine, had a reaction, which the doctor doesn't considered an adverse effect, but it might be categorized as such for record-keeping purposes. It was reported that typically, the first few times, patient experienced a low-grade fever, exhaustion, dizziness, and stomach upset. For instance, last month, patient was essentially bedridden for three days, feeling weak and unable to get up without assistance. After three or four days, patient recovered, and the doctor was not concerned about it. The usual response was that it was a good sign, indicating the vaccine was working. Treatment medication was not reported. It was unknown if the patient experienced any additional symptoms/events.
Immunocompromised; Leukemia
Pemgarda