Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Anaphylactic reaction, Asthenia, Bronchospasm, Cough
Clinical narrative: Short of breath; Weak; Anaphylaxis diagnosis; Acute respiratory distress; Bronchospasm; Cough, worsening cough, coughing hard; Gagging like you're going to vomit; Arm a little sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress), BRONCHOSPASM (Bronchospasm), COUGH (Cough, worsening cough, coughing hard), RETCHING (Gagging like you're going to vomit), DYSPNOEA (Short of breath), ASTHENIA (Weak) and ANAPHYLACTIC REACTION (Anaphylaxis diagnosis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included CARBIDOPA MONOHYDRATE, LEVODOPA (CARBIDOPA + LEVODOPA), ALPRAZOLAM (XANAX), LOSARTAN, METHOCARBAMOL, PRAVASTATIN, SERTRALINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALLOPURINOL (ELAVIL [ALLOPURINOL]), GABAPENTIN, ALBUTEROL [SALBUTAMOL], IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB), PREDNISONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DEXAMETHASONE and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for an unknown indication.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress) (seriousness criteria hospitalization and medically significant), BRONCHOSPASM (Bronchospasm) (seriousness criterion hospitalization), COUGH (Cough, worsening cough, coughing hard) (seriousness criterion hospitalization), RETCHING (Gagging like you're going to vomit) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (Anaphylaxis diagnosis) (seriousness criteria hospitalization and medically significant). On 10-Jun-2021, the patient experienced DYSPNOEA (Short of breath) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (Arm a little sore). On 09-Jun-2021, ACUTE RESPIRATORY DISTRESS SYNDROME (Acute respiratory distress), BRONCHOSPASM (Bronchospasm), COUGH (Cough, worsening cough, coughing hard), RETCHING (Gagging like you're going to vomit) and ANAPHYLACTIC REACTION (Anaphylaxis diagnosis) had resolved. At the time of the report, DYSPNOEA (Short of breath), ASTHENIA (Weak) and PAIN IN EXTREMITY (Arm a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications: Cold Medicine ,Apple Cider Vinegar Capsules,Breathing treatment,Cough Medicine.  Treatment included Prednisone 20MG 1 tablet daily for 5 days, cough medicine, a nebulizer, Benadryl, and Dexamethasone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.