Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
she has breathing and swallowing issues; she has breathing and swallowing issues; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (she has breathing and swallowing issues), DYSPHAGIA (she has breathing and swallowing issues) and INJECTION SITE REACTION (COVID arm) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Swallowing difficult (swallowing issues). Previously administered products included for Drug use for unknown indication: Epipen. Past adverse reactions to the above products included Allergy with Epipen. Concurrent medical conditions included Diabetes, Rheumatoid arthritis (diagnosed before having her first COVID-19 shot), Asthma, Drug allergy (a lot of allergies and with EpiPen), Immunocompromised and Breathing difficult (slight breathing issues). Concomitant products included Methotrexate for an unknown indication. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (she has breathing and swallowing issues), DYSPHAGIA (she has breathing and swallowing issues) and INJECTION SITE REACTION (COVID arm). At the time of the report, DYSPNOEA (she has breathing and swallowing issues), DYSPHAGIA (she has breathing and swallowing issues) and INJECTION SITE REACTION (COVID arm) had resolved with sequelae. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. The patient had received every single dose of the Moderna COVID-19 vaccine since its initial circulation back in 2020. It was quired to ask about mNEXSPIKE for the 2025-2026 season, specifically if the patient would be best suited to receive the said vaccine. The patient had received every single dose of the Moderna COVID-19 vaccine since its initial circulation back in 2020. It was reported that the patient has breathing and swallowing issues and she had these with her first two COVID shots with Moderna between 2020 - 2022 as well as a COVID arm. The patient had the RSV vaccine which was, probably in August or September in 2025.The patient also had a flu shot recently which was the Fluzone high dose and she got itching all over but no rash, and it took 3 days it to go away. The patient was consulted with an allergist, and the patient was advised to take antihistamine for 3 days. The patent was unable to remember when she had the Fluzone but it was mentioned around 3-4 months ago. The patient had second booster for 2024 or 2025, and it was reported that the second booster was received around September. This case was linked to US-MODERNATX, INC.-MOD-2025-791601 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2025: Live non-significant follow up received in which new reference number was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791601:Husband case
Asthma; Breathing difficult (slight breathing issues); Diabetes; Drug allergy (a lot of allergies and with EpiPen); Immunocompromised; Rheumatoid arthritis (diagnosed before having her first COVID-19 shot)
Medical History/Concurrent Conditions: Swallowing difficult (swallowing issues)
Methotrexate