Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
weakness of the limbs; chills; headache; broken ankle; COVID, in her nose, residual cough; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness of the limbs), ANKLE FRACTURE (broken ankle), CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID, in her nose, residual cough) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product RSV VACCINE for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. In September 2022, the patient experienced COVID-19 (COVID, in her nose, residual cough). In 2025, the patient experienced ANKLE FRACTURE (broken ankle). On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness of the limbs), CHILLS (chills) and HEADACHE (headache). In 2022, COVID-19 (COVID, in her nose, residual cough) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness of the limbs), CHILLS (chills) and HEADACHE (headache) had resolved and ANKLE FRACTURE (broken ankle) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that the patient got Moderna COVID-19 shots twice a year since 2021. She received 3 in the first year (in January and February, and then again halfway through the year), and 2 a year afterwards and she was now on shot number 11. It was reported that after each shot, the patient had a day in bed where she would have chills, headache and weakness of the limbs and things like that and it would subside after 24 hours. The patient had a broken ankle this year and was laid up and did not get her COVID vaccine when she wanted to get it, and the patient also got the flu shot 2 weeks before her COVID vaccine. The patient received the mNEXSPIKE on 09-OCT-2025 and has had absolutely no reaction. She used to get the COVID vaccine and the RSV vaccine together. She got the RSV vaccine twice in consecutive years, 2 years ago. On Sep-2022, the patient came down with COVID halfway through a cruise where everybody was vaccinated on the cruise and 98% of the passengers were vaccinated. The patient had just liked a bad cold that started at night, and it was overwhelming, in her nose and everything but by the end of the day it was just a residual cough. The patient had to stay isolated for the rest of the cruise, but she did not really have any terrible symptoms, and the patient was fine within the 5 days. No treatment medications provided by the reporter. This case was linked to MOD-2025-791542 (Patient Link).