Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 7+ | — | IM |
dry heaves/Every 20 to 30 min, probably had at least 15 episodes of the dry heaves; diarrhea with diarrhea becoming clear water/ strong, fast fecal explosion of feces (not clear water); weak; tired; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves/Every 20 to 30 min, probably had at least 15 episodes of the dry heaves), DIARRHOEA (diarrhea with diarrhea becoming clear water/ strong, fast fecal explosion of feces (not clear water)), ASTHENIA (weak) and FATIGUE (tired) in an 82-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Fall (Really bad fall last November which also lead to dry heaves) in November 2025 and Dry heaves in November 2025. Previously administered products included for COVID-19 prophylaxis: Spikevax LP.8.1 PFS (Dose 10) in October 2025 and Spikevax NOS (9 previous Covid vaccines). Past adverse reactions to the above products included No adverse effect with Spikevax LP.8.1 PFS and Spikevax NOS. On 17-Apr-2026 at 10:00 PM, the patient received eleventh dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 18-Apr-2026, the patient experienced ASTHENIA (weak) and FATIGUE (tired). On 18-Apr-2026 at 1:00 AM, the patient experienced RETCHING (dry heaves/Every 20 to 30 min, probably had at least 15 episodes of the dry heaves) and DIARRHOEA (diarrhea with diarrhea becoming clear water/ strong, fast fecal explosion of feces (not clear water)). On 19-Apr-2026, ASTHENIA (weak) and FATIGUE (tired) had resolved. On 19-Apr-2026 at 8:30 AM, RETCHING (dry heaves/Every 20 to 30 min, probably had at least 15 episodes of the dry heaves) and DIARRHOEA (diarrhea with diarrhea becoming clear water/ strong, fast fecal explosion of feces (not clear water)) had resolved. No concomitant medications were reported. The patient had 10 previous Moderna COVID-19 vaccines with absolutely no reactions. The patient had one last October, and, like all the previous vaccines going back to the beginning of the pandemic, experienced nothing, not even hardly a sore arm. At 1:00 AM on saturday that night while patient was sleeping, she began severe dry heaves and light diarrhea and that continued for 7.5 hours. Every 20 to 30 minutes, she probably had at least 15 episodes of the dry heaves and diarrhea with diarrhea becoming clear water. At 8:30 in the morning, she had this severe dry heaves again and a strong, fast fecal explosion. All day saturday, she was very weak, tired. She ate a soft bland food, slept several times all day, and she felt very. She was felt fine yesterday i.e. by Sunday. She completely resolved as of yesterday that was on 19-APR-2026. It just seemed to happen 7.5 hours overnight on saturday night and saturday morning too mean early Saturday morning 1 a.m. to 8:30 a.m. On Sunday, the patient was fine. The patient did not experience any additional symptoms/events. No treatment medications were reported. Reporter did not allow further contact
Medical History/Concurrent Conditions: Dry heaves; Fall (Really bad fall last November which also lead to dry heaves)