Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: Hives on both arms, rash on flu shot arm going from shoulder cap down to elbow; This is a spontaneous report received from an Other HCP. Other Case identifier(s): UNT-2024-031176 (RA).  A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; treprostinil sodium (TYVASO DPI), first regimen since 13Sep2022) at 16 ug 4x/day (16 ug, 4x/day (inhalation)) and second regimen) at unk (inhalation), all resp inhalation for pulmonary arterial hypertension; influenza vaccine (FLU VACCINE VII), on 19Sep2024 as dose number unknown, single) for influenza. The patient's relevant medical history included: "sensitive skin" (ongoing); "Dermatitis contact" (ongoing), notes: Two-piece adhesive barriers; "Drug hypersensitivity" (ongoing), notes: dilaudid, morphine sulfate IR, chlorhexidine gluconate, lidocaine, ciprofloxacin hcl, erythromycin. Concomitant medication(s) included: VALACYCLOVIR HCL; OXYBUTYNIN CHLORIDE ER; CLARITINE; FIORICET; PEPCID [FAMOTIDINE]; VITAMIN D3; MAGNESIUM; ASPIRIN EC; GABAPENTIN; TADALAFIL; TYLENOL; ESTRADIOL; PREDNISONE; OXYGEN; SPIRONOLACTONE; SODIUM CHLORIDE; AMBRISENTAN; TORSEMIDE. The patient also took other concomitant therapy. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives on both arms, rash on flu shot arm going from shoulder cap down to elbow". The action taken for treprostinil sodium was unknown.  Additional information: This case is a spontaneous report received on 27Sep2024, from a consumer via specialty pharmacy. This 70-year-old, 185 lb, female patient began therapy with Tyvaso DPI (treprostinil inhalation powder) delivered by dry powder inhaler, on 13 Sep 2022 for primary pulmonary arterial hypertension. The patient was supplied with Tyvaso DPI 16 ?g and the current dose was reported as 16 ?g, four times a day (QID) via inhalation (IH) route. The patient had history of sensitive skin. On 19Sep2024, the patient received flu vaccine in one arm and a COVID vaccine in other arm and on an unreported date in Sep 2024, couple days], she realized she was getting hives on both arms, rash on flu shot arm was going from shoulder cap down to elbow (urticaria). Flu shot arm was worse than other. She had taken Benadryl and it had helped. Co-suspect medications included Flu vaccine VII (influenza vaccine) and Pfizer BioNTech COVID-19 vaccine (tozinameran).Concomitant medications included valacyclovir, oxybutynin chloride ER, Claritin (loratadine), Fioricet (butalbital, caffeine, paracetamol), Pepcid (famotidine), vitamin d3, K-tab (potassium chloride), magnesium, low dose aspirin EC, gabapentin, tadalafil, Tylenol (paracetamol), estradiol, prednisone, oxygen, spironolactone, sodium chloride, ambrisentan, and torsemide. Relevant medical history included primary pulmonary arterial hypertension. Action taken with Tyvaso DPI was not reported for the event of urticaria. At the time of reporting, the outcome of urticaria was unknown. The reporter did not provide the causality for the event of urticaria with Tyvaso DPI. The reporter's causality for the events of urticaria with Flu vaccine VII and Pfizer BioNTech COVID-19 vaccine was considered to be possibly related.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.