Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Pneumonia, Post-tussive vomiting, SARS-CoV-2 test
Clinical narrative: Bad case of Pneumonia; Acute bronchitis; lost her voice from coughing so much; Voice is very hoarse; Diarrhea because of the antibiotics; lost her voice; Sometimes coughs so hard she vomits; experienced fatigue (immediately after vaccine); This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Bad case of Pneumonia) in a 43-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.     The patient's past medical history included Ex-smoker (It was reported that the patient quit smoking and had a patch.). Concurrent medical conditions included COPD and Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Bad case of Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)). At the time of the report, PNEUMONIA (Bad case of Pneumonia), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Chest X-ray: Results unknown. In May 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PNEUMONIA (Bad case of Pneumonia), BRONCHITIS (Acute bronchitis), COUGH (lost her voice from coughing so much), DYSPHONIA (Voice is very hoarse), DIARRHOEA (Diarrhea because of the antibiotics), APHONIA (lost her voice), POST-TUSSIVE VOMITING (Sometimes coughs so hard she vomits) and FATIGUE (experienced fatigue (immediately after vaccine)) to be possibly related.    Concomitant medications included several unspecified cardiac meds.  On an unspecified date, two to three days after the vaccine shot, it was reported that the patient went to the urgent care and was diagnosed with acute bronchitis. Treatment medications provided included Solumedrol (methylprednisolone). 4-5 days later, the patient went to the emergency room and had a chest x-ray- no results provided. The patient was diagnosed with pneumonia. Treatment medications provided included two types of intravenous antibiotics and a prescription for two oral antibiotics and an albuterol inhaler.  This report was received from the patient's niece.  Company Comment:  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   This case was linked to MOD21-088666 (E2B Linked Report).; 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 MOD21-088666:Invalid Case