Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Hypothyroidism; General heart problems; Cholesterol problems; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Hypothyroidism) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPOTHYROIDISM (Hypothyroidism) (seriousness criterion medically significant), CARDIAC DISORDER (General heart problems) and BLOOD CHOLESTEROL ABNORMAL (Cholesterol problems). At the time of the report, HYPOTHYROIDISM (Hypothyroidism), CARDIAC DISORDER (General heart problems) and BLOOD CHOLESTEROL ABNORMAL (Cholesterol problems) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Abnormal, Cholesterol problems. On an unknown date, Blood pressure measurement: Abnormal, Control BP (blood Pressure). The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had all the Moderna Covid vaccines available. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Name: Blood cholesterol; Result Unstructured Data: Abnormal, Cholesterol problems; Test Name: Blood pressure; Result Unstructured Data: Abnormal, Control BP (blood Pressure)