Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Developed bronchitis; Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.; Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.), COVID-19 (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.) and BRONCHITIS (Developed bronchitis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.) and COVID-19 (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.). On an unknown date, the patient experienced BRONCHITIS (Developed bronchitis). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for Adverse event, at an unspecified dose and frequency; LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency and REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.), COVID-19 (Had COVID-19 breakthrough infection diagnosed a month ago exact date unknown.) and BRONCHITIS (Developed bronchitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested Negative three times, negative (Negative) Negative and negative (Negative) Negative.         No relevant concomitant medications were reported. Treatment medication included monoclonal antibodies.  Company comment This case concerns a 77-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected AESI event of COVID-19 and unexpected non-serious events of Vaccine breakthrough infection and bronchitis. The events occurred on an unknown date after the second dose of mRNA-1273 and, at the time of the report, are recovered. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.   This case was linked to MOD-2021-404985 (Patient Link).; Sender's Comments: This case concerns a 77-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected AESI event of COVID-19 and unexpected non-serious events of Vaccine breakthrough infection and bronchitis. The events occurred on an unknown date after the second dose of mRNA-1273 and, at the time of the report, are recovered. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.