Received Jul 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (MRESVIA) | MODERNA | UNK | — | IM |
Pneumonia/ Fevers to begin; possible Endocarditis; Some digestive noted; Fever; Blood clot/R leg red and swollen/ leg pink and swollen off and on/Blood clot; Hi dose IV antibiotics for a bacteria/ Bacteria testing; Dose of 05 milliliter was administered; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia/ Fevers to begin), ENDOCARDITIS (possible Endocarditis) and THROMBOSIS (Blood clot/R leg red and swollen/ leg pink and swollen off and on/Blood clot) in a 56-year-old male patient who received mRNA-1345 (mRESVIA PFS) for Respiratory syncytial virus immunization. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for Respiratory syncytial virus immunization. The patient's past medical history included Headache (headaches not migraine). Previously administered products included for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included Penicillin allergy with Penicillin. Concurrent medical conditions included Mitral valve prolapse (MVP since a Teen) and Penicillin allergy. In 2024, the patient received dose of mRNA-1345 (mRESVIA PFS) (Intramuscular use) 5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced OVERDOSE (Dose of 05 milliliter was administered). In September 2024, the patient experienced PNEUMONIA (Pneumonia/ Fevers to begin) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Blood clot/R leg red and swollen/ leg pink and swollen off and on/Blood clot) (seriousness criterion medically significant), BACTERIAL INFECTION (Hi dose IV antibiotics for a bacteria/ Bacteria testing) and PYREXIA (Fever). On an unknown date, the patient experienced ENDOCARDITIS (possible Endocarditis) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (Some digestive noted). The patient was hospitalized from sometime in September 2024 to sometime in 2024 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia/ Fevers to begin) and PYREXIA (Fever) had not resolved and ENDOCARDITIS (possible Endocarditis), THROMBOSIS (Blood clot/R leg red and swollen/ leg pink and swollen off and on/Blood clot), BACTERIAL INFECTION (Hi dose IV antibiotics for a bacteria/ Bacteria testing), GASTROINTESTINAL DISORDER (Some digestive noted) and OVERDOSE (Dose of 05 milliliter was administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2024, Chest X-ray: pneumonia. In September 2024, X-ray: saw the old blood clot. On an unknown date, White blood cell count: On June 30, they did lab and his WBC was okay then. The patient did not have any additional medical history, concomitant disease or risk factor. No concomitant medication was reported. The patient had fever and went to clinic, where a chest X-ray showed pneumonia. The patient was hospitalized for 2 weeks on high potency anti biotics and blood thinners. The patient left and was put on Eliquis and daily high dose IV antibiotics for a bacteria. The patient was concerned over heart valve. The patient was on Eliquis for 3 months and finished it. The patient did not continue thinking that it might be okay even though leg was pink and swollen off and on. The patient did not take any more medications due to lack of insurance. The patient's fevers stopped. The patient had bacteria testing and all the medications IV at time and a month after discharge. The patient believed one was Vancomycin due to penicillin allergy. For blood clot, the patient took other things noted online. The patient had fevers again past spring and in current week. The patient was suggested to visit different hospital because of concerns regarding recurrent fevers and the possibility of endocarditis involving his heart valve. The physician ordered several X-rays also Echo on his legs. The old blood clot was found in X-rays. The patient felt it had not moved and considered it as okay. He was given Eliquis on discharge for 30-days. Prior to vaccinations, he had hiked daily in the mountain area where he lived. However, he had been unable to do it since the September 2024 incidents. He was no longer working and did not have insurance to pay for either of the hospitals. Post 30 June, several other blood samples were drawn. He was told on discharge that some of the tests needed to be sent out for further testing to try to figure out the cause of continued fevers, what was the cause or concern on his heart valve since as per first hospital it was possible endocarditis. This case was linked to MOD-2024-770010 (Patient Link).; Reporter's Comments: Pneumonia, Bacterial infection and Endocarditis were assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Mitral valve prolapse (MVP since a Teen); Penicillin allergy
Medical History/Concurrent Conditions: Headache (headaches not migraine)
Test Date: 202409; Test Name: CXR; Result Unstructured Data: pneumonia; Test Name: WBC; Result Unstructured Data: On June 30, they did lab and his WBC was okay then; Test Date: 202409; Test Name: xrays; Result Unstructured Data: saw the old blood clot