Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | — | — |
Felt like going to pass out; Shivering; Patient did have a fever, like 101; This spontaneous case was reported by a physician and describes the occurrence of PRESYNCOPE (Felt like going to pass out) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for an unknown indication. No Medical History information was reported. On 27-Jan-2026, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form and dose of Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRESYNCOPE (Felt like going to pass out) (seriousness criterion medically significant), CHILLS (Shivering) and PYREXIA (Patient did have a fever, like 101). At the time of the report, PRESYNCOPE (Felt like going to pass out), CHILLS (Shivering) and PYREXIA (Patient did have a fever, like 101) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2026, Body temperature: 101. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported that the patient had received a combination of the COVID vaccine (Moderna) and a MenB shot. The reporter believed the administration occurred on 27 Jan 2026. The patient had a reaction and felt like they were going to pass out and were shivering. The patient went to the emergency room but was sent home and was fine after a couple of days. The reporter did not know whether this reaction was due to the COVID shot or Trumenba. The patient had a fever of around 101 and experienced shivering for approximately three hours. No treatment medications provided by the reporter.; Reporter's Comments: Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) was assessed as confounding factor for reported events. The benefit-risk relationship of the product is not affected by this report.
Test Date: 2026; Test Name: Body temperature; Result Unstructured Data: 101