Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Hypotonic Hypo-responsiveness reaction/Unresponsive; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) in a 5-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) (seriousness criterion medically significant). At the time of the report, HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. The reporter had incident where the patient getting concomitant flu and Covid vaccines was going unresponsive (Hypotonic Hypo-responsiveness reaction). They were looking into lots of medication. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790768 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2025: Live follow-up received and non-significant information includes reporter contact details updated.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790768:Master case (Same reporter for different patient)