Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052733 | IM |
How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR; positive for COVID; headache; increasing deep cough/heavy cough/definitely bronchial cough; general malaise; real sore arm; sick; extreme fatigue; This spontaneous case was reported by a physician and describes the occurrence of COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick) and FATIGUE (extreme fatigue) in an 81-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052733) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. In 2025, the patient experienced COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick) and FATIGUE (extreme fatigue). On 05-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HEADACHE (headache). On 06-Oct-2025, the patient experienced COVID-19 (positive for COVID). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR). The patient was treated with Ibuprofen on 05-Oct-2025 at a dose of every 4 to 6 hours and Paracetamol (Tylenol) on 05-Oct-2025 at a dose of every 4 to 6 hours. At the time of the report, COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick), FATIGUE (extreme fatigue), HEADACHE (headache) and COVID-19 (positive for COVID) had not resolved and PRODUCT LABEL ISSUE (How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2025, Body temperature: 96.8 F. On 06-Oct-2025, SARS-CoV-2 test: Positive. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient got sick two days after getting the vaccine and was COVID-19 positive on an expired test with a really strong positive test and a blank control. The patient was really fatigued and had cough, general malaise, but an increasingly deep cough, it was a heavy cough, bronchial, definitely bronchial cough, headache and extreme fatigue. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live non-significant information received included: Reference numbers were added.
Test Date: 20251006; Test Name: Body temperature; Result Unstructured Data: 96.8 F; Test Date: 20251006; Test Name: COVID-19 test; Test Result: Positive