Received Apr 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
sleepiness/sleepy; a little bit of soreness (in the arm); fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness/sleepy), PAIN IN EXTREMITY (a little bit of soreness (in the arm)) and FATIGUE (fatigue) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included High cholesterol. Concurrent medical conditions included Diabetes and Gout (taking medicine for it, under control). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepiness/sleepy), PAIN IN EXTREMITY (a little bit of soreness (in the arm)) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (sleepiness/sleepy), PAIN IN EXTREMITY (a little bit of soreness (in the arm)) and FATIGUE (fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. No concomitant medications were reported. It was reported that the patient had vaccine few years back. The patient had only received Moderna COVID-19 vaccines since they were available. The reporter was not familiar with the product names Spikevax or mNEXSPIKE. He never had a bad reaction except maybe sleepiness once. One time he had a little bit of a reaction but did not have severe reactions. It was reported that it was never severe and it was only once, and he had been getting the vaccine for years. It was reported that he had last received Moderna COVID-19 vaccine in October 2025 or November 2025. He and his wife got their vaccines at the same time together, he did not have a reaction from the last vaccine. He was just sleepy from it. It was reported that usually on the boosters, he had a 24-hour period of fatigue and a little bit of soreness, but it had gone away in one day. It was only once; most of the time he did not have any reaction. It was reported that he could not say when it was but just remembered that for one of the Moderna shots, he was sleepy. It was reported that the reaction was so long ago. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2026-795253 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795253:Same reporter different patient (Wife's case)
Diabetes; Gout (taking medicine for it, under control)
Medical History/Concurrent Conditions: High cholesterol
Test Name: Cholesterol; Result Unstructured Data: High