Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Infusion site pain, Infusion site reaction, Injection site pain, Injection site reaction, Oedema
Clinical narrative: Ascites; dealing with site pain; site is okay but painful; Site went bad; shortness of breath; feeling a little more short of breath compared to normal; Fluid retention; weight is up (oedema); loose stool [Diarrhea]; Extra food has put an extra 5 pounds on her; Bilateral lower extremity edema +1; Heartburn; Increased shortness of breath with exertion; Chest heaviness; Sinus congestion; weight is up.; Fatigue; Tiredness; This serious case was reported by a consumer via other manufacturer and described the occurrence of ascites in a 60-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included riociguat (Adempas) for product used for unknown indication.   Concurrent medical conditions included pulmonary arterial hypertension. Concomitant products included treprostinil sodium, pantoprazole sodium sesquihydrate (Pantoprazole) and macitentan (Opsumit).   On 06-NOV-2023, the patient received Shingles vaccine. On an unknown date, the patient started Adempas 2 mg three times a day (6 mg daily). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ascites (Verbatim: Ascites) (serious criteria GSK medically significant), injection site pain (Verbatim: dealing with site pain), infusion site pain (Verbatim: site is okay but painful), infusion site reaction (Verbatim: Site went bad), shortness of breath (Verbatim: shortness of breath), allergy to vaccine (Verbatim: feeling a little more short of breath compared to normal), fluid retention (Verbatim: Fluid retention), edema (Verbatim: weight is up (oedema)), diarrhea (Verbatim: loose stool [Diarrhea]), weight increased (Verbatim: Extra food has put an extra 5 pounds on her), edema of lower extremities (Verbatim: Bilateral lower extremity edema +1), heartburn (Verbatim: Heartburn), exertional dyspnea (Verbatim: Increased shortness of breath with exertion), chest heaviness (Verbatim: Chest heaviness), sinus congestion (Verbatim: Sinus congestion), weight gain (Verbatim: weight is up.) and fatigue (Verbatim: Fatigue; Tiredness). The action taken with Adempas was unknown. The outcome of the ascites, infusion site reaction, shortness of breath, allergy to vaccine, fluid retention, edema, edema of lower extremities, exertional dyspnea, chest heaviness, sinus congestion and fatigue were unknown and the outcome of the injection site pain, infusion site pain, diarrhea, weight increased, heartburn and weight gain were not reported.   It was unknown if the reporter considered the ascites, injection site pain, infusion site pain, infusion site reaction, shortness of breath, allergy to vaccine, fluid retention, edema, diarrhea, weight increased, heartburn and weight gain to be related to Shingles vaccine. The reporter considered the edema of lower extremities, exertional dyspnea, chest heaviness, sinus congestion and fatigue to be possibly related to Shingles vaccine.     It was unknown if the company considered the ascites, injection site pain, infusion site pain, infusion site reaction, shortness of breath, allergy to vaccine, fluid retention, edema, diarrhea, weight increased, heartburn and weight gain to be related to Shingles vaccine. The company considered the edema of lower extremities, exertional dyspnea, chest heaviness, sinus congestion and fatigue to be possibly related to Shingles vaccine.   Additional Information: RA receipt date: 25-NOV-2023 On 6th November 2023, the patient received the shingles vaccine and was feeling a little more short of breath compared to normal (allergy to vaccine and dyspnoea).  The patient asked if that could cause someone to feel short of breath, it was clarified that everyone responds differently to vaccine.  The patient stated that they received the shingles vaccine, dealing with site pain, and titrating on Remodulin so their body has a lot going on. unknown if physician was aware. Further it was reported that the site went bad (infusion site reaction) while she was on a cruise, she developed shortness of breath and fluid retention (fluid retention), noticed ascites (ascites, medically significant).  She finally changed the site, the fluid retention went down a little but has increased again, weight was up (oedema) with Adempas she complains of diarrhea on/off (diarrhoea previously reported) and heartburn (dyspepsia previously reported).  She currently complained of the following side effects from her medications, bilateral lower extremity edema +1 (oedema peripheral), increased shortness of breath with exertion (dyspnoea exertional), chest heaviness (chest discomfort), fatigue (fatigue), tiredness, sinus congestion (sinus congestion). At the time of reporting, the outcome of ascites, dyspnoea, allergy to vaccine, infusion site reaction, oedema peripheral, dyspnoea exertional, chest discomfort, fatigue, sinus congestion, fluid retention and oedema was unknown whereas the outcome of fluid retention was considered to not resolved. It was unknown if the reporter considered the ascites, injection site pain, infusion site pain, infusion site reaction, shortness of breath, allergy to vaccine, fluid retention, edema, diarrhea, weight increased, heartburn and weight gain to be related to Adempas. The company has assessed the serious event of ascites likely due to complications associated with underlying chronic and progressive disease of PAH. The reporter considered the edema of lower extremities, exertional dyspnea, chest heaviness, sinus congestion and fatigue to be possibly related to Adempas.