Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | — | — |
flare up in right hip; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) in an elderly male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine rHA 3v (baculovirus) (Flublok) for an unknown indication. The patient's past medical history included Vehicular accident (The patient was on bicycle back and hit by a car.) on 17-Mar-2024 and Stent placement (4 stents in heart). Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (always used Moderna from the very beginning). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Heart disease, unspecified (since 2017) since 2017 and Arthritis. In October 2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine rHA 3v (baculovirus) (Flublok) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced HYPERTENSION (high blood pressure) (seriousness criteria medically significant and life threatening). In November 2025, the patient experienced ARTHRITIS (flare up in right hip). The patient was treated with Telmisartan in 2025 at an unspecified dose and frequency and Ezetimibe (Zetia) at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure) had not resolved and ARTHRITIS (flare up in right hip) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Blood pressure measurement: 174/110, 150/100 and 130/80. On 02-Dec-2025, Ultrasound scan: Arteries and heart were checked for the patient and there was thickness of the patient arteries. No concomitant medications provided by the reporter. The patient received vaccination of mNEXSPIKE vaccination, but the patient was uncertain about the exact date of administration. It was reported that before vaccination the patient had been off all the prescriptions for 3 months. But after the vaccination the patient immediately started to have blood pressure problems and the symptom have not been able to get back to normal. The patient had treatment medication of telmisartan and Zetia. But the patient was unable to get the blood pressure back to normal. It was reported that within a day of the shot the patient symptom of blood pressure problem was started. The patient had a cardiologist visit on 10-Dec-2025. The patient had a sonogram upon the cardiologist visit but the result was unavailable. The sonogram was done to diagnosis the cause of blockage and the patient would see primary care physician the next day or two. It was reported that the patient started to notice that the increased blood pressure. The patient was now less than a month ago went to emergency with a blood pressure 174/110. On 03-Nov-2025 and 05-Nov-2025, the patient had hospital visits and doctor visited for flare up in right hip after doing exercise. It was reported that the patient had the first-time flare-up that happened to the patient right hip after quite a bit of exercise and walking 2 miles a day. The patient had cardiologist visit on 10-Nov-2025 and Physician off follow -up visit on 11-Nov-2025. The patient had a cardiologist visit on 02-Dec-2025 and had a follow-up appointment on 10-Dec-2025. It was reported that the patient at morning blood pressure used to 150/100 and then the blood pressure went down into 130/80. Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2025: Live significant follow-up received in which vaccination administration dates for suspect and co suspect product was updated and reference numbers were added.; Reporter's Comments: Underlying heart disease could be a risk factor for the event. The benefit-risk relationship of product is not affected by this report.
Arthritis; Heart disease, unspecified (since 2017)
Medical History/Concurrent Conditions: Stent placement (4 stents in heart); Vehicular accident (The patient was on bicycle back and hit by a car.)
Test Date: 2025; Test Name: blood pressure; Result Unstructured Data: 174/110; Test Date: 2025; Test Name: blood pressure; Result Unstructured Data: 150/100; Test Date: 2025; Test Name: blood pressure; Result Unstructured Data: 130/80; Test Date: 20251202; Test Name: ultrasound; Result Unstructured Data: Arteries and heart were checked for the patient and there was thickness of the patient arteries