Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Eating disorder, Feeding disorder
Clinical narrative: Mild case of pneumonia; slight fever; Not eating well, unable to eat; nausea; Feels weak; upset stomach; vomiting; Extreme diarrhea; Initial information received on 25-Nov-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient (50.8 kg) who experienced mild case of pneumonia, slight fever, not eating well, unable to eat, nausea, feels weak, upset stomach, vomiting and extreme diarrhea while receiving vaccines OFEV, TYVASO and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension. Notes: #1 Ongoing, Current Condition, Pulmonary arterial hypertension  Concomitant medications included SILDENAFIL CITRATE (SILDENAFIL CITRATE); and MACITENTAN (OPSUMIT).  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect TYVASO not produced by Sanofi Pasteur lot 2102215 via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect OFEV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  In 2022 the patient developed a serious mild case of pneumonia (pneumonia),  slight fever (pyrexia), not eating well, unable to eat (feeding disorder),  nausea,  feels weak (asthenia)  upset stomach (abdominal discomfort), vomiting and  extreme diarrhea (diarrhoea) (unknown latency)  following the administration of INFLUENZA VACCINE, (unknown latency) following the administration of TYVASO and (unknown latency) following the administration of OFEV. This event was assessed as medically significant.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Mild case of pneumonia, slight fever, Not eating well, unable to eat, nausea, Feels weak, upset stomach, vomiting, Extreme diarrhea).  At time of reporting, the outcome was Unknown for the event mild case of pneumonia, was Unknown for the event slight fever, was Unknown for the event not eating well, unable to eat, was Unknown for the event nausea, was Unknown for the event feels weak, was Unknown for the event upset stomach, was Unknown for the event vomiting and was Unknown for the event extreme diarrhea.; Sender's Comments: Sanofi company comment dated 30-Nov-2022: This case involves a 67 years old female patient (50.8 kg) who experienced mild case of pneumonia, slight fever, not eating well, unable to eat, nausea, feels weak, upset stomach, vomiting and extreme diarrhea while receiving vaccines OFEV, TYVASO and INFLUENZA VACCINE. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.