Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Photophobia, Pyrexia, Seasonal allergy
Clinical narrative: Itchy eyes; Coughing; he must have allergies/ seasonal allergy; Diagnosed with GERD; She was sick; She had migraine; was sensitive to light; Dehydrated; Blood-red eye all week long / like had pink eye; Shivering (chills); Fever and temperature of 104 F/ burning up (pyrexia); Exhausted; Prescribed 15 breaths, four times a day (QID); This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itchy eyes), COUGH (Coughing), SEASONAL ALLERGY (he must have allergies/ seasonal allergy), GASTROOESOPHAGEAL REFLUX DISEASE (Diagnosed with GERD) and ILLNESS (She was sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    The patient's past medical history included Bunion operation (a left bunion removal) in December 2021. Concurrent medical conditions included Pulmonary arterial hypertension, Alopecia areata, Mixed connective tissue disease, Osteoporosis, Raynaud's phenomenon, Scleroderma, Hypothyroidism (underactive thyroid) and Anxiety. Concomitant products included ALBUTEROL SULFATE, SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), OMEPRAZOLE, GABAPENTIN, CLONAZEPAM (KLONOPIN), PAROXETINE HYDROCHLORIDE, LEVOTHYROXINE SODIUM, DILTIAZEM HCL, LISINOPRIL, FENOFIBRATE, ATORVASTATIN CALCIUM, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOF), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), NAPROXEN and ZOLEDRONIC ACID (RECLAST) from 20-Feb-2019 to an unknown date for an unknown indication.   On 28-Jun-2018, the patient started TREPROSTINIL SODIUM (TYVASO) (Inhalation use) 90 microgram four times per day. On 30-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2018,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Prescribed 15 breaths, four times a day (QID)). On 01-May-2022, the patient experienced ILLNESS (She was sick), MIGRAINE (She had migraine), PHOTOPHOBIA (was sensitive to light), DEHYDRATION (Dehydrated), OCULAR HYPERAEMIA (Blood-red eye all week long / like had pink eye), CHILLS (Shivering (chills)), PYREXIA (Fever and temperature of 104 F/ burning up (pyrexia)) and FATIGUE (Exhausted). In June 2022, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Diagnosed with GERD). On an unknown date, the patient experienced EYE PRURITUS (Itchy eyes), COUGH (Coughing) and SEASONAL ALLERGY (he must have allergies/ seasonal allergy). The patient was treated with CODEINE PHOSPHATE, GUAIFENESIN (VIRTUSSIN AC) for Coughing, at an unspecified dose and frequency. On 09-May-2022, ILLNESS (She was sick), MIGRAINE (She had migraine), PHOTOPHOBIA (was sensitive to light), DEHYDRATION (Dehydrated), OCULAR HYPERAEMIA (Blood-red eye all week long / like had pink eye), CHILLS (Shivering (chills)), PYREXIA (Fever and temperature of 104 F/ burning up (pyrexia)) and FATIGUE (Exhausted) had resolved. At the time of the report, EYE PRURITUS (Itchy eyes), COUGH (Coughing), SEASONAL ALLERGY (he must have allergies/ seasonal allergy), GASTROOESOPHAGEAL REFLUX DISEASE (Diagnosed with GERD) and OFF LABEL USE (Prescribed 15 breaths, four times a day (QID)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2022, Body temperature: 104 104 F.         The patient started clinical trial from beginning of 2018 to Sep 2020.Patient took 15 breaths which was more than anyone had ever took which meant the patient had off-label dosing. On Dec 2021, the patient had a left bunion removal at outpatient surgery and was continuing using Orthofix Physiostim until further notice and had a hard boot for walking. Patient found a pair of shoes that patient was able to wear to this last convention. 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.   This case was linked to MOD-2022-594485 (Patient Link).