Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chest X-ray, Eructation, Feeling abnormal
Clinical narrative: Bronchitis; Felt funny when laying down; Had to burp; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Bronchitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 93990A, 013A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt funny when laying down) and ERUCTATION (Had to burp). The patient was treated with PREDNISONE (oral) at a dose of 3 tablets by mouth for 3 days; ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency; AZITHROMYCIN at a dose of Day 1: 2 tablets and AZITHROMYCIN at a dose of Days 2- 5: 1 tablets( 250 mg). At the time of the report, BRONCHITIS (Bronchitis), COVID-19 (COVID-19), FEELING ABNORMAL (Felt funny when laying down) and ERUCTATION (Had to burp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: Positive. On an unknown date, Chest X-ray: Clear.         Concomitant medications were not reported.  Patient's Covid symptoms started on 01 Oct 2022. Patient was prescribed with Albuterol, but felt funny when laying down, had to burp and stopped the medication. Patient went to Emergency room. Patient was given 1 dose of prednisone at the hospital and discharged with other medications.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization) event of Bronchitis, in the context of the four doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 3 doses of mRNA-1273 vaccine given at a recommended vaccine dosing schedule, approximately 3 months and 2 weeks prior to the fourth mRNA-1273 vaccination. It was reported that the patient had symptoms of COVID-19 and was tested positive for SARS-CoV-2 after 4 days. Patient went to the emergency room and underwent chest x-ray with unremarkable result. Patient was diagnosed with bronchitis and was given with one dose of prednisone at the hospital and was discharged with other medications. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 70-year-old female patient with no medical history reported, who experienced the unexpected serious (hospitalization) event of Bronchitis, in the context of the four doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 3 doses of mRNA-1273 vaccine given at a recommended vaccine dosing schedule, approximately 3 months and 2 weeks prior to the fourth mRNA-1273 vaccination. It was reported that the patient had symptoms of COVID-19 and was tested positive for SARS-CoV-2 after 4 days. Patient went to the emergency room and underwent chest x-ray with unremarkable result. Patient was diagnosed with bronchitis and was given with one dose of prednisone at the hospital and was discharged with other medications. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.