Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got Covid despite having 3 doses Moderna Covid-19 vaccine/dyspnoea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid despite having 3 doses Moderna Covid-19 vaccine/dyspnoea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006M20A and 007M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Flu vaccine sometime in Jan2022 or Feb 2022). Past adverse reactions to the above products included No adverse reaction with Flu vaccine. Concurrent medical conditions included COPD (COPD for 10 years now). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for COPD.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (got Covid despite having 3 doses Moderna Covid-19 vaccine/dyspnoea). The patient was treated with FLUVOXAMINE at a dose of 1 dosage form twice a day and DEXAMETHASONE (oral) at a dose of 6 milligram once a day. At the time of the report, COVID-19 (got Covid despite having 3 doses Moderna Covid-19 vaccine/dyspnoea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient got COVID even after the 3rd vaccination. Patient was taken to the hospital on 17-APR-2022 where series of tests were carried out.  It was also reported that a doctor from the health department checked up on patient on 19-APR-2022 and was told to continue quarantining for 3 more days and advised to observe the symptoms. It was stated that 3rd dose was not recorded on the card and he already had an appointment for 2nd booster dose. No allergies were reported. Company Comment:This spontaneous case concerns an 81-year-old male patient with underlying medical history of Chronic obstructive pulmonary disease who experienced the unexpected, non-serious AESI of COVID-19, which occurred approximately 5 months and 12 days after receiving a third dose of mRNA1273 vaccine. Patient had trouble breathing and series of tests confirmed to have Covid 19.  Patient was treated with Fluvoxamine and Dexamethasone and advised quarantine. The patient's advanced age and underlying medical history of COPD can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-543564.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Non-significant follow up received.; Sender's Comments: This spontaneous case concerns an 81-year-old male patient with underlying medical history of Chronic obstructive pulmonary disease who experienced the unexpected, non-serious AESI of COVID-19, which occurred approximately 5 months and 12 days after receiving a third dose of mRNA1273 vaccine. Patient had trouble breathing and series of tests confirmed to have Covid 19.  Patient was treated with Fluvoxamine and Dexamethasone and advised quarantine. The patient's advanced age and underlying medical history of COPD can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.