Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | — |
swelling; redness; she had a little bit of flu; pain at the injection site at the right arm; muscle aches; developed fever on one occasion which had reached to 100'F which lasted for 24 hours; then felt tired and fatigued for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm) and MYALGIA (muscle aches) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Concurrent medical conditions included Multiple sclerosis, Hypothyroidism (hypothyroidism(underactive)) and Chronic insomnia. Concomitant products included Clonazepam, Zolpidem tartrate (Ambien) and Suvorexant (Belsomra) for Chronic insomnia, Levothyroxine for Hypothyroidism, Aciclovir (Acyclovir) for an unknown indication. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In September 2024, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In March 2025, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm), MYALGIA (muscle aches), PYREXIA (developed fever on one occasion which had reached to 100'F which lasted for 24 hours) and FATIGUE (then felt tired and fatigued for 2 days). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm), MYALGIA (muscle aches), PYREXIA (developed fever on one occasion which had reached to 100'F which lasted for 24 hours) and FATIGUE (then felt tired and fatigued for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100degree F and 97degree F. Patient was taking supplements. Patient had swelling and redness, pain at the injection site at the right arm. Also had muscle aches which started first then developed fever on one occasion which had reached to 100degree F which lasted for 24 hours, which was quite high for the patient as she usually had 97degree F. It took a day before the fever started. There was no vomiting, no diarrhea, but she felt a little bit of flu and then felt tired and fatigued for 2 days. No treatment medication was reported.
Chronic insomnia; Hypothyroidism (hypothyroidism(underactive)); Multiple sclerosis
Levothyroxine; Acyclovir; Clonazepam; Ambien; Belsomra
Test Name: Body temperature; Result Unstructured Data: 100degree F; Test Name: Body temperature; Result Unstructured Data: 97degree F