Sex: F
Vaccine: RSV
Symptoms: Pain, Paranasal sinus discomfort, Paranasal sinus inflammation, Perfume sensitivity, Sinusitis
Clinical narrative: Oxygen dropped into the 80's, patient's oxygen has been back into the 90s; Strong smells such as perfume, christmas trees and cleaning solvent make her sinuses get inflamed; Strong smells such as perfume, christmas trees and cleaning solvent make her sinuses get inflamed; Sinus infection; Intestinal distress; She was sick to her stomach; Ached all over the following day; Diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2023-026044.   A 78-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for respiratory syncytial virus immunisation; for respiratory syncytial virus immunisation; treprostinil sodium (TYVASO), since 08Sep2022 (Lot number: 000393P, Expiration Date: 31May2025) at 32 ug 4x/day (32 ug, 4x/day (32 ug, qid, inhalation)) for pulmonary arterial hypertension; tetracycline hydrochloride (TETRACYCLINE HYDROCHLORIDE), (Batch/Lot number: unknown) for sinusitis; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "primary pulmonary arterial hypertension" (unspecified if ongoing). Concomitant medication(s) included: NASACORT; KETOTIFEN; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; ADEMPAS; SIMVASTATIN; TRELEGY; LEVOTHYROXINE; LASIX [FUROSEMIDE]; SERTRALINE; OXYGEN; SYSTANE; IPRATROPIUM; LEVALBUTEROL HCL; GABAPENTIN; BLINK [POLYVINYL ALCOHOL]; ERYTHROMYCIN; BACTRIM; MODERNA COVID-19 VACCINE; VOLTAREN [DICLOFENAC SODIUM]; CETRIZINE; QVAR; VITAMIN D3; VITAMIN C [ASCORBIC ACID]. The following information was reported: PAIN (non-serious) with onset 2023, outcome "recovering", described as "Ached all over the following day"; DIARRHOEA (non-serious) with onset 2023, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 2023, outcome "recovering", described as "Intestinal distress"; OXYGEN SATURATION DECREASED (medically significant) with onset 2023, outcome "recovering", described as "Oxygen dropped into the 80's, patient's oxygen has been back into the 90s"; NAUSEA (non-serious) with onset 2023, outcome "recovering", described as "She was sick to her stomach"; SINUSITIS (non-serious) with onset 2023, outcome "unknown", described as "Sinus infection"; PARANASAL SINUS DISCOMFORT (non-serious), PARANASAL SINUS INFLAMMATION (non-serious) all with onset 2023, outcome "unknown" and all described as "Strong smells such as perfume, christmas trees and cleaning solvent make her sinuses get inflamed". The patient underwent the following laboratory tests and procedures: Oxygen saturation: (2023) dropped into the 80s; (2023) back into the 90s. The action taken for treprostinil sodium and tetracycline hydrochloride was unknown. Therapeutic measures were taken as a result of sinusitis, abdominal discomfort.   Clinical course: This case is a solicited report received on 08Sep2023, from a consumer from a patient support program via (withheld) specialty pharmacy. This female patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by Tyvaso dry powder inhaler, on 08Sep2022 for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 32 ug, and the current dose was reported as 32 ug, four times a day (QID) via inhalation (IH) route. The patient stated that strong smells such as perfume, christmas trees and cleaning solvent made her sinuses get inflamed and irritated (paranasal sinus discomfort and paranasal sinus inflammation). She was particularly sensitive since the onset of her pulmonary arterial hypertension (PAH). She recently had a sinus infection (sinusitis) and was prescribed tetracycline, which caused her intestinal distress (abdominal discomfort). She took a probiotic (unspecified) and it helped with the intestinal issues. Co-suspect medication included tetracycline. The reporter did not provide causality for the events of paranasal sinus discomfort, paranasal sinus inflammation, sinusitis and abdominal discomfort with Tyvaso DPI. The reporter's causality for the event of abdominal discomfort with tetracycline was considered to be possibly related. Follow-up information was received as a solicited report on 22Sep2023, from the consumer from a patient support program via (withheld) specialty pharmacy. Additional co-suspect medications included RSV vaccine and Influenza vaccine. On an unreported date in 2023, the patient recently had the respiratory syncytial virus [RSV] vaccine and flu shots and she was sick to her stomach (nausea), ached all over the following day (pain), plus diarrhea (diarrhoea), and her oxygen dropped into the 80's, her oxygen had been back into the 90s (oxygen saturation decreased) and she had felt better this week. The reporter did not provide causality for the events of nausea, pain, diarrhoea and oxygen saturation decreased with Tyvaso DPI. The reporter's causality for the events of nausea, pain, diarrhoea and oxygen saturation decreased with RSV vaccine and Influenza vaccine was considered to be possibly related.  The reporter considered "oxygen dropped into the 80's, patient's oxygen has been back into the 90s", "she was sick to her stomach", "ached all over the following day" and "diarrhea" related to rsv vaccine prot.subunit pref 2v. The reporter's assessment of the causal relationship of "strong smells such as perfume, christmas trees and cleaning solvent make her sinuses get inflamed", "sinus infection" and "intestinal distress" with the suspect product(s) rsv vaccine prot.subunit pref 2v was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is not a reasonable possibility that the reported events sinusitis, decrease in oxygen saturation, and strong smell was related to the suspect product event most likely due to patient underlying contributory factors. All the other events are possibly related based on the known safety profile