Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Migraine/Severe headache/Nausea; Sick; body and joint aches; chills; body and joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Severe headache/Nausea), ILLNESS (Sick), PAIN (body and joint aches), CHILLS (chills) and ARTHRALGIA (body and joint aches) in an 82-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Migraine (Migraines from steroids.), Trigeminal neuralgia (Atypical Trigeminal Neuralgia) and Tendonitis (rotator cuff tendonitis.). On 15-Dec-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 16-Dec-2025, the patient experienced MIGRAINE (Migraine/Severe headache/Nausea), ILLNESS (Sick), PAIN (body and joint aches), CHILLS (chills) and ARTHRALGIA (body and joint aches). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency and Sumatriptan succinate (Sumatriptan) at a dose of 25 milligram. At the time of the report, MIGRAINE (Migraine/Severe headache/Nausea), PAIN (body and joint aches), CHILLS (chills) and ARTHRALGIA (body and joint aches) was resolving and ILLNESS (Sick) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had received a Moderna COVID and flu shot on Monday and that, on Tuesday, she had become very sick, which she noted had never happened to her before. She stated that she had experienced terrible headaches, nausea, severe chills, and, on the following day, a migraine, which she mentioned she normally did not experience unless steroids were present in a product. It was further reported that she had already filed an online report but was specifically calling to find out whether those injections contained steroids. She expressed that she had thought she was overreacting because she had never had side effects before and had always specified Moderna for her vaccinations. She emphasized her surprise at having these side effects and mentioned that she had been sick enough to call her doctor and beg for help, which she noted was something she never did. She stated that the doctor had advised her to go to the ER. Finally, it was reported that she had recalled receiving a pain injection on 06-Oct. The patient did not experience any additional symptoms or events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There were no lab data or results available. This case was linked to US-MODERNATX, INC.-MOD-2025-792750 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2025: Live follow-up received contains significant information includes added medical history, updated vaccine administration date of suspect influenza, new event sickness added, reference ID added and updated narrative.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-792750:a medical doctor case
Migraine (Migraines from steroids.); Trigeminal neuralgia (Atypical Trigeminal Neuralgia)
Medical History/Concurrent Conditions: Tendonitis (rotator cuff tendonitis.)