Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146670 | IM |
It looks like the vial expired 5/15/25; general malaise; she could not keep fluids down; a little bit of sore arm; chills; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills) and VOMITING (vomiting) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146670) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 8146670) for COVID-19 prophylaxis No Medical History information was reported. On 20-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills), VOMITING (vomiting) and HEADACHE (headache). On 20-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (It looks like the vial expired 5/15/25). At the time of the report, MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills), VOMITING (vomiting) and HEADACHE (headache) was resolving and EXPIRED PRODUCT ADMINISTERED (It looks like the vial expired 5/15/25) outcome was unknown. No concomitant medications were reported. The patient had experienced general malaise, a slight sore arm, and chills, but was unsure about having a fever as she had not taken her temperature. She also stated that the worst part had been the headache and vomiting, and she was unable to keep fluids down. As hours passed, she had thought she could, however she was not able to. The reporter stated that she had been much better on 22-Oct-2025 and had been able to eat and drink, and food had stayed down. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790515 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2025: Live significant follow-up information received contains patient information updated, suspect dose details added, additional events added (General malaise, Fluid loss, Pain in arm, Chills, Vomiting, Headache), narrative updated, and additional references added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790515:same patient different product