Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 5 | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
I have so much energy; little bit of soreness at the injection site for the flu; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy) and INJECTION SITE PAIN (little bit of soreness at the injection site for the flu) in a 66-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. The patient's past medical history included Dengue fever (she believed it was related to a prior dengue fever infection in 2014.) in 2014. Previously administered products included for Drug use for unknown indication: HYDROXYCHLOROQUINE (She had previously tried infusions and hydroxychloroquine but had not found an effective treatment.), ORENCIA (Patient had also tried Orencia, which knocked her down for 4 days.), SIMPONI (Patient had tried Simponi for 4 months, which did not improve her condition.), SIMPONI (made her feel worse.), ORENCIA (was nauseated throughout.), ORENCIA (Her arm and back would not stop hurting.), ORENCIA and ORENCIA (She could not eat during that time.). Past adverse reactions to the above products included Back pain with ORENCIA; Bedridden with ORENCIA; Condition aggravated with SIMPONI; Drug ineffective with HYDROXYCHLOROQUINE and SIMPONI; Nausea with ORENCIA; Pain in arm with ORENCIA; and Unable to eat with ORENCIA. Concurrent medical conditions included Arthritis (It was reported that the patient had been struggling with inflammation and swelling in her feet since last July and that her physicians were unsure whether it was rheumatoid or psoriatic arthritis.). On 08-Nov-2025, the patient received fifth 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. In November 2025, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site for the flu). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have so much energy) and INJECTION SITE PAIN (little bit of soreness at the injection site for the flu) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received 4 Moderna COVID-19 vaccines and experienced a significant increase in energy each time. She mentioned that she had ongoing inflammation and that her healthcare providers were still uncertain about how to treat her condition. The patient wanted to know how often she could receive a COVID-19 vaccine and whether it could be used off-label for arthritis. The reporter indicated that patient had consulted two rheumatologists without resolution. She had previously tried infusions and hydroxychloroquine but had not found an effective treatment. She expressed that it would be ideal if the vaccine could resolve her symptoms and prevent further suffering. According to the patient, after receiving the Moderna COVID-19 vaccine, her inflammation decreased and her energy level improved the following day. She also noted that she had received a flu vaccine at the same time as the COVID-19 vaccine and experienced only mild soreness at the flu injection site, which did not limit her activity. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to MOD-2025-791554 (Patient Link).
Arthritis (It was reported that the patient had been struggling with inflammation and swelling in her feet since last July and that her physicians were unsure whether it was rheumatoid or psoriatic arthritis)
Medical History/Concurrent Conditions: Dengue fever (she believed it was related to a prior dengue fever infection in 2014.)