Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Migraine, Ocular hyperaemia, Off label use
Clinical narrative: Prescribed 15 breaths, four times a day (QID); Itchy eyes; Coughing; Must have allergies; GERD; Migraine; Sensitive to light; Dehydrated; Exhausted; Fever and was sick for a few days, temperature of 104, burning up; Shivering; Blood-red eye all week long [like I had pink eye]; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2022-013451 (company).  A 60-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years and on 30Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), since 28Jun2018 (ongoing) (Batch/Lot number: unknown) at 90 ug 4x/day (90 ug, 4x/day (90 µg, qid, inhalation)), nasal for pulmonary arterial hypertension. The patient's relevant medical history included: "Procedure Bunion operation", start date: Dec2021, stop date: Dec2021; "pulmonary arterial hypertension" (ongoing); "Mixed connective tissue disease" (unspecified if ongoing); "Osteoporosis" (ongoing); "Raynaud's phenomenon" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "Hypothyroidism" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] (ongoing); PROAIR [SALBUTAMOL SULFATE] (ongoing); OMEPRAZOLE (ongoing); GABAPENTIN (ongoing); KLONOPIN (ongoing); PAROXETINE (ongoing); LEVOTHYROXINE SODIUM (ongoing); DILTIAZEM (ongoing); LISINOPRIL (ongoing); FENOFIBRATE (ongoing); ATORVASTATIN CALCIUM (ongoing); MYCOPHENOLATE MOF (ongoing); BENADRYL (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] (ongoing); XYZAL (ongoing); NAPROXEN (ongoing); RECLAST, start date: 20Feb2019 (ongoing). The following information was reported: OCULAR HYPERAEMIA (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Blood-red eye all week long [like I had pink eye]"; DEHYDRATION (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Dehydrated"; FATIGUE (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Exhausted"; PYREXIA (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Fever and was sick for a few days, temperature of 104, burning up"; MIGRAINE (non-serious) with onset 01May2022, outcome "recovered" (09May2022); PHOTOPHOBIA (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Sensitive to light"; CHILLS (non-serious) with onset 01May2022, outcome "recovered" (09May2022), described as "Shivering"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Jun2022, outcome "unknown", described as "GERD"; OFF LABEL USE (non-serious), outcome "unknown", described as "Prescribed 15 breaths, four times a day (QID)"; EYE PRURITUS (non-serious), outcome "unknown", described as "Itchy eyes"; COUGH (non-serious), outcome "unknown", described as "Coughing"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Must have allergies". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for treprostinil sodium was unknown.  Additional information: The patient started in Tyvaso clinical trial from beginning of 2018 to Sep2020 (clinical trial name information unknown) and she took 15 breaths which was more than anyone she had ever talked to. On Dec2021, the patient had a left bunion removal at outpatient surgery and was continuing using Orthofix Physiostim until further notice and she had a hard boot for walking. She found a pair of shoes that she was able to wear to this last convention. She woke up miserable with itchy eyes and coughing and thought she must have allergies. She was on Virtussin (codeine phosphate, guaifenesin) for coughing. On 30Apr2022, after her first COVID booster, she was fine that day but the next day she was sick. On 01May2022 (Sunday), 3 years, 10 months and 4 days after initiating Tyvaso, she had a migraine, was sensitive to light, dehydrated and exhausted. She had a temperature of 104 F, burning up and shivering. She also had a blood-red eye all week long (like she had pink eye). This lasted until Monday, 09May2022 and then she was better. On 20May2021, she had second COVID vaccine shot and had fever and was sick for a few days. Action taken with Tyvaso was dose not changed due to the events of eye pruritis, cough, seasonal allergy, migraine, photophobia, dehydration, fatigue, pyrexia, chills, ocular hyperaemia , and gastroesophageal reflux disease. At the time of the reporting, the outcome of eye pruritis, cough, seasonal allergy, and gastroesophageal reflux disease was unknown, and the outcome of migraine, photophobia, dehydration, fatigue, pyrexia, chills, and ocular hyperaemia was resolved on 09May2022. The reporter did not provide the causality for the events of eye pruritis, cough, seasonal allergy, migraine, photophobia, dehydration, fatigue, pyrexia, chills, ocular hyperaemia and gastroesophageal reflux disease with Tyvaso. The reporter's causality for the events of migraine, photophobia, dehydration, fatigue, pyrexia, chills, and ocular hyperaemia with COVID-19 Vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.