Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
uncomfortable; fever; shivering; pain; Absolutely no energy and no strength; I've been very sick since I got that vaccine yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), DISCOMFORT (uncomfortable) and PYREXIA (fever) in a 73-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 Systemic anaphylaxis (5 times since twenties). Previously administered products included for COVID-19 prophylaxis: SPIKEVAX [ELASOMERAN] (Patient had two Moderna's) and SPIKEVAX [ELASOMERAN] (Patient had two Moderna's); for Product used for unknown indication: COMIRNATY (Patient had two Pfizer's), COMIRNATY (Patient then got a Pfizer alternating) and COMIRNATY (Patient had two Pfizer's). Past adverse reactions to the above products included No adverse effect with COMIRNATY, COMIRNATY, COMIRNATY, SPIKEVAX [ELASOMERAN] and SPIKEVAX [ELASOMERAN]. Concurrent medical conditions included Asthma and Allergy. Concomitant products included Influenza vaccine from 11-Sep-2025 to 11-Sep-2025 for an unknown indication. On 05-Nov-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. On 05-Nov-2025, the patient experienced PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), PYREXIA (fever) and CHILLS (shivering). On 06-Nov-2025, the patient experienced DISCOMFORT (uncomfortable). At the time of the report, PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), PYREXIA (fever) and CHILLS (shivering) had not resolved and DISCOMFORT (uncomfortable) outcome was unknown. The patient could not get COVID, as the patient had Moderna before. The patient had two Pfizer's, then had two Moderna's, then got a Pfizer alternating, and this time the patient was supposed to get the mNEXSPIKE. The patient was very sick since she got that vaccine the day before reporting. The patient had so many allergies and everything. The patient was so sick last night, all night shivering, pain, uncomfortable on the day of reporting. Patient had no energy and strength. The patient still had a fever, but it was not quite as bad. The patient was at very high risk of serious complications from COVID because patient was asthmatic, old, and had gone through systemic anaphylaxis reactions maybe 5 times since the patient was in her twenties. The patient was very upset and confused due to receiving Spikevax 2025-2026 instead of mNEXSPIKE 2025-2026. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No causality provided.
Allergy; Asthma
Medical History/Concurrent Conditions: Systemic anaphylaxis (5 times since twenties)
Influenza vaccine