Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose; was diagnosed with diabetes; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (was diagnosed with diabetes) in a 44-year-old 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 (Flu) for an unknown indication. Concurrent medical conditions included Undifferentiated connective tissue disease (autoimmune condition - undifferentiated connective tissue disease) and Obesity. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In July 2024, the patient experienced DIABETES MELLITUS (was diagnosed with diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced UNDERDOSE (this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose). At the time of the report, DIABETES MELLITUS (was diagnosed with diabetes) had not resolved and UNDERDOSE (this is a lower dose than the standard, number one, so that got me a little worried. Also, it seems like it's a tailored dose) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that the patient had received mNEXSPIKE and unspecified Flu vaccine on 30-Sep-2025. The patient's first COVID vaccine was the first one that Moderna ever created. The patient was used to get standard Spikevax every 6 months and only received Moderna vaccine as a COVID vaccine. The patient never had any issues, and it was always super well tolerated. The patient was diagnosed with diabetes last July. It was stated, Initially, patient was doing it yearly because patient wasn't going anywhere. When patient moved to every 6 months and patient felt a little bit better about going into public spaces. It was stated that this was a lower dose than the standard, number one, so that patient got a little worried. Also, it seemed like it's a tailored dose. It was unknown if the patient experienced any additional symptoms or events. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up received: Reference ids added On 06-Oct-2025: Live non-significant follow-up received: Reference ids added; Reporter's Comments: Co-suspect product Influenza vaccine, Concurrent medical conditions autoimmune disease and Obesity are confounders for the event. The benefit-risk relationship of product is not affected by this report.
Obesity; Undifferentiated connective tissue disease (autoimmune condition - undifferentiated connective tissue disease)