Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Does not have the energy for that; Every time tries to lay down head just spins; As sick as she is feeling; sick to stomach; Nauseous, wants to throw up; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach) and NAUSEA (Nauseous, wants to throw up) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (has had Covid 5 times, sick to her stomach for nine months when had actual COVID, nauseous every day). Previously administered products included for Drug use for unknown indication: prednisone; for COVID-19 prophylaxis: Moderna covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine and prednisone. In November 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In November 2025, the patient experienced ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach), NAUSEA (Nauseous, wants to throw up) and DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Does not have the energy for that), VERTIGO (Every time tries to lay down head just spins), MALAISE (As sick as she is feeling), GASTROINTESTINAL DISORDER (sick to stomach), NAUSEA (Nauseous, wants to throw up) and DIZZINESS (Dizzy) had not resolved. No concomitant medications provided by the reporter. It was reported that the patient received Moderna COVID vaccine earlier this week. Post vaccination the patient felt sick to her stomach, the patient was dizzy, every time she tried to lay down her head just spins, and she wanted to throw up. The patient had those symptoms for 4 days now, it was not going away by itself. she experienced similar symptom when she was sick with COVID for the second time. In the past she had covid five times. It was reported that the patient had Moderna vaccines in the past and present symptom did not happen to the patient. No treatment medications provided by the reporter.
Medical History/Concurrent Conditions: COVID-19 (has had Covid 5 times, sick to her stomach for nine months when had actual COVID, nauseous every day)