Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: oropharyngeal pain; chest soreness; coughing; gagging; Gastrointestinal upset; oedema; shortness of breath; fatigue; joints hurt; nausea; headaches; pneumonia; Occasional shortness of breath at rest; Occasional palpitations; Weight increased, weight was up approximately 10 pounds; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and DYSPNOEA AT REST (Occasional shortness of breath at rest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TREPROSTINIL DIOLAMIN for Secondary pulmonary arterial hypertension, TREPROSTINIL DIOLAMIN (ORENITRAM) for Secondary pulmonary arterial hypertension and RIOCIGUAT (ADEMPAS) for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS).   On 21-May-2020, the patient started TREPROSTINIL DIOLAMIN (Oral) 4 mg every eight hours. On 21-May-2020, TREPROSTINIL DIOLAMIN (Oral) dosage was changed to 1 mg. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) at an unspecified dose On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose. and RIOCIGUAT (ADEMPAS) (unknown route) 1.5 mg. On 08-Feb-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). In February 2021, the patient experienced DYSPNOEA AT REST (Occasional shortness of breath at rest) (seriousness criterion medically significant), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness) and PALPITATIONS (Occasional palpitations). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), COUGH (coughing), RETCHING (gagging), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), OEDEMA (oedema), DYSPNOEA (shortness of breath), FATIGUE (fatigue), ARTHRALGIA (joints hurt), NAUSEA (nausea) and HEADACHE (headaches). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA AT REST (Occasional shortness of breath at rest), WEIGHT INCREASED (Weight increased, weight was up approximately 10 pounds), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Gastrointestinal upset ), DYSPNOEA (shortness of breath) and HEADACHE (headaches) was resolving, OROPHARYNGEAL PAIN (oropharyngeal pain), CHEST PAIN (chest soreness), RETCHING (gagging), PALPITATIONS (Occasional palpitations), FATIGUE (fatigue), ARTHRALGIA (joints hurt) and NAUSEA (nausea) outcome was unknown and COUGH (coughing) and OEDEMA (oedema) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: 170 lb (High) Weight gain of 7 pounds. In March 2021, Weight: 164 lb High. In 2021, Weight: up approximately 10 lbs High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prescribed levofloxacin antibiotic for 7 days for pneumonia. The patient did not need to use oxygen as often.   Reporter did not allow further contact; Sender's Comments: This case concerns a 44-year-old female with serious unexpected events of pneumonia and dyspnea at rest, and nonserious unexpected dyspnea, chest pain, cough, oropharyngeal pain, retching, abdominal discomfort, palpitations, dizziness, edema, weight increased and expected fatigue, headache, nausea, arthralgia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.