Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | — | OT |
not able to walk; Trouble breathing; Had problems remembering things; This spontaneous report was received from a Consumer and refers to a 79-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Pulmonary arterial hypertension, Allergy to Latex, Allergy to penicillin) and Interstitial lung disease. Concomitant therapies included mirabegron (MYRBETRIQ), venlafaxine hydrochloride, empagliflozin (JARDIANCE), insulin glargine (BASAGLAR KWIKPEN), cinacalcet hydrochloride, allopurinol, aspirin, losartan potassium, trospium chloride, albuterol sulfate, levothyroxine sodium, calcitriol, venlafaxine hydrochloride (EFFEXOR), citalopram hydrobromide, oxygen, omeprazole, polycarbophil calcium (FIBER), hydrozyxine hydrochloride, amlodipine besylate, furosemide and bimatoprost (LUMIGAN). On 29-Jan-2024, the patient started therapy with Treprostinil (TYVASO DPI) Inhalation powder 16 ug, administered four times a day (qid) by Respiratory (inhalation) route (lot # and expiration date were not reported), as treatment for Secondary pulmonary arterial hypertension and interstitial pulmonary disease, unspecified (Pulmonary arterial hypertension). On 17-Jul-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) (lot #, expiration date, strength, dose number, route of administration, anatomical location not provided) as immunization. On 18-Jul-2025, the patient experienced to be not able to walk and had Trouble breathing; therefore, she was hospitalized due to these events. She also had problems remembering things, and it was stated that she had been downhill since the shot. The patient was hospitalized for about a week and on an unspecified date in July 2025, she was discharged. At the reporting time, the patient was recovering from the problems remembering things and not being able to walk (also reported as she was now doing better), and the outcome of Trouble breathing was unknown. The action taken with Treprostinil (TYVASO DPI) regarding the events was unknown. The reporter all the events to be possibly related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX). Causality assessment between the events and Treprostinil (TYVASO DPI) was not reported.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : withheld , Index date : 2025-09-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : UNT-2025-027733 , Central date : 2025-09-21 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Interstitial lung disease; Latex allergy; Penicillin allergy; Pulmonary arterial hypertension
Myrbetriq; Venlafaxine HCL; Jardiance; Basaglar kwikpen; Cinacalcet HCL; Allopurinol; Aspirin; Losartan potassium; Trospium chloride; Albuterol sulfate hfa; Levothyroxine sodium; Calcitriol; Effexor; Citalopram hbr; Oxygen; Omeprazole; Fibe