Received Jul 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Had taken Moderna vaccine previously at 2.5/doctor sent the shot at 5 the patient had to take it 2 weeks after; Felt awful; Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt awful), NAUSEA (Nauseated), HEADACHE (Headache) and INCORRECT DOSE ADMINISTERED (Had taken Moderna vaccine previously at 2.5/doctor sent the shot at 5 the patient had to take it 2 weeks after) in a female patient of an unknown age 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. The patient's past medical history included Haemorrhoid operation (going through haemorrhoid surgery 3 weeks ago) in June 2026. On 11-Jul-2026, 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. On 11-Jul-2026, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced INCORRECT DOSE ADMINISTERED (Had taken Moderna vaccine previously at 2.5/doctor sent the shot at 5 the patient had to take it 2 weeks after). In July 2026, the patient experienced FEELING ABNORMAL (Felt awful), NAUSEA (Nauseated) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Felt awful), NAUSEA (Nauseated), HEADACHE (Headache) and INCORRECT DOSE ADMINISTERED (Had taken Moderna vaccine previously at 2.5/doctor sent the shot at 5 the patient had to take it 2 weeks after) outcome was unknown. No concomitant medications were reported. It was reported that the patient's doctor sent the shot at 5, the patient had to take it 2 weeks after. The reporter did not confirm what the patient meant by 2.5 and 5 and what the understanding was. Later, the reporter mentioned dosage by sharing the patient's pharmacist recommendation to go back to 2.5 the lowest dose. The reporter was very unclear as it seemed the patient was taking the vaccine as regular medication. Additionally, it was reported that the vaccine was administered to the patient by her husband. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2026-798590 (Patient Link). Reporter did not allow further contact
Medical History/Concurrent Conditions: Haemorrhoid operation (going through haemorrhoid surgery 3 weeks ago)