Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | 1 | 6315MF001C | OT / LA |
Chest pain began within one hour of vaccine administration and continued. Patient presented to the emergency department the following day. Concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion.; Chest pain began within one hour of vaccine administration and continued. Patient presented to the emergency department the following day. Concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion.; Chest pain began within one hour of vaccine administration and continued. Patient presented to the emergency department the following day. Concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion.; Initial information received on 22-Jan-2026 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional). This case involves a 32 year old female patient who had chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion., chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion. and chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion after receiving NVX-COV2373 (ORIGINAL) ADJUVANTED VACCINE [NOVAVAX COVID-19 VACCINE, ADJUVANTED]. The patient's past medical history included Post-acute COVID-19 syndrome. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to CLAVULANIC ACID. Concomitant medications included Midodrine hydrochloride (Midodrine). On 07-Nov-2025, the patient received an unknown dose (dose 1) of suspect NVX-COV2373 (ORIGINAL) ADJUVANTED VACCINE lot 6315MF001C (strength and expiry date-unknown) via intramuscular route in the left arm for Prophylactic vaccination (Immunisation). On 13-NOV-2025 the patient developed chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion. (pericardial effusion), (chest pain) and (pericarditis) (latency-6 days). Relevant laboratory test results included: Echocardiogram - On 13-Nov-2025: [11/8 EKG consistent with pericarditis and 11/13 echo consistent with pericarditis and pericardial effusion] Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the events Seriousness Criteria- The events of (pericardial effusion and pericarditis were assessed as medically significant and all the events were leading to disability.; Sender's Comments: Sanofi company comment dated 29-Jan-2026: This case involves a 32 year old female patient who had chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion., chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion. and chest pain began within one hour of vaccine administration and continued. patient presented to the emergency department the following day. concern for pericarditis was confirmed with echocardiogram on 11/13 with trace pericardial effusion after receiving NVX-COV2373 (ORIGINAL) ADJUVANTED VACCINE [NOVAVAX COVID-19 VACCINE, ADJUVANTED]. Further information regarding family history, cardiac history if any , tolerance excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Medical History/Concurrent Conditions: Long COVID; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: CLAVULANIC ACID, Continue: true
Midodrine
Test Date: 20251113; Test Name: Echocardiogram; Result Unstructured Data: 11/8 EKG consistent with pericarditis and 11/13 echo consistent with pericarditis and pericardial effusion