Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | — | OT |
arthritis (flare up in right hip); high blood pressure; Initial information received on 12-Dec-2025 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp (non healthcare professional). This case involves a patient with unknown age and gender who had high blood pressure and flare up in right hip after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok] and Covid-19 Vaccine Mrna Omicron (Mrna 1283) [Mnexspike 2024-2025 Formula]. The patient's past medical history included Road traffic accident on 17-Mar-2024 and Stent placement. The patient's past vaccination(s) included Spikevax and has always used Moderna from the very beginning. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Cardiovascular disorder in 2017 and Arthritis. On an unknown date in Oct-2025, the patient received 1DF(dosage form) of suspect Influenza Quadrivalent Recombinant Vaccine via unknown route in unknown administration site or product used for unknown indication and 1DF(dosage form) of suspect Covid-19 Vaccine Mrna Omicron (Mrna 1283) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for COVID-19 Prophylaxis (lot number, formulation, expiry date and strength not reported) On an unknown date in Oct-2025, the patient developed high blood pressure (hypertension) (latency approximately few days) following the administration of Influenza Quadrivalent Recombinant Vaccine and Covid-19 Vaccine Mrna Omicron (Mrna 1283). On an unknown date in Nov-2025, the patient developed flare up in right hip (arthritis) (latency approximately a month) following the administration of Influenza Quadrivalent Recombinant Vaccine and (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine and Covid-19 Vaccine Mrna Omicron (Mrna 1283). Relevant laboratory test results included: Blood pressure measurement - In 2025: 174/110 mmHg then 150/100 mmHg then 130/80 mmHg Ultrasound scan - On 02-Dec-2025: [Arteries and heart were checked for the patient and there was thickness of the patient arteries] Final diagnosis was (life-threatening) high blood pressure. Reportedly, 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 Action taken was not applicable. The patient was treated with Telmisartan (Telmisartan) and Ezetimibe (Zetia) for Blood pressure increased. At time of reporting, the outcome was Unknown for the event (arthritis) and was Not Recovered / Not Resolved (high blood pressure). Seriousness criteria: The event was assessed as medically significant and life-threatening (hypertension).; Sender's Comments: Sanofi company comment dated 16-DEC-2025: This case involves a patient with unknown age and gender who had high blood pressure and flare up in right hip after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok] and Covid-19 Vaccine Mrna Omicron (Mrna 1283) [Mnexspike 2024-2025 Formula]. The temporal relationship supports a possible association; however, the patient's pre-existing cardiovascular condition and arthritis provide alternative explanations for both events. The abrupt onset following a medication-free period complicates assessment. Critical information gaps include patient demographics, precise vaccination dates, lot numbers, complete concomitant medication history, baseline blood pressure measurements, arthritis severity assessment, and dechallenge information. Given the significant confounding factors and limited data, a definitive causal relationship cannot be assessed.
Arthritis; Cardiovascular disease, unspecified
Medical History/Concurrent Conditions: Stent placement; Vehicular accident
Test Date: 2025; Test Name: blood pressure measurement; Test Date: 2025; Test Name: blood pressure measurement; Test Date: 2025; Test Name: blood pressure measurement; Test Date: 20251202; Test Name: Ultrasound scan; Result Unstructured Data: Arteries and heart were checked for the patient and there was thickness of the patient arteries