Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052864 | IM |
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
adult dose of Spikevax was given to a pediatric patient; adult dose of Spikevax was given to a pediatric patient; undigested food in his stools; This spontaneous case was reported by an other health care professional and describes the occurrence of ABNORMAL FAECES (undigested food in his stools), WRONG PRODUCT ADMINISTERED (adult dose of Spikevax was given to a pediatric patient) and OVERDOSE (adult dose of Spikevax was given to a pediatric patient) in an 18-month-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052864) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052864) for COVID-19 prophylaxis and non-company co-suspect products included Influenza vaccine for an unknown indication, Hepatitis a vaccine for an unknown indication and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for an unknown indication. No Medical History information was reported. On 18-Dec-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter, dose of Influenza vaccine (unknown route) 1 dosage form, dose of Hepatitis a vaccine (unknown route) 1 dosage form and dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In December 2025, the patient experienced ABNORMAL FAECES (undigested food in his stools). On 18-Dec-2025, the patient experienced WRONG PRODUCT ADMINISTERED (adult dose of Spikevax was given to a pediatric patient) and OVERDOSE (adult dose of Spikevax was given to a pediatric patient). At the time of the report, ABNORMAL FAECES (undigested food in his stools), WRONG PRODUCT ADMINISTERED (adult dose of Spikevax was given to a pediatric patient) and OVERDOSE (adult dose of Spikevax was given to a pediatric patient) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medications were not reported. HCP stated that the parents were going to see a GI as they were concerned for undigested food in his stools. HCP reported that an adult dose of Spikevax was given to a pediatric patient on 18-Dec-2025. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.