Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID disease after first booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID disease after first booster) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced COVID-19 (COVID disease after first booster). At the time of the report, COVID-19 (COVID disease after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) Home test was positive.         No treatment medication were provided. It was reported that patient received 5 doses of Moderna COVID-19 vaccine  ( 3 primary doses and 2 booster doses). Patient does not have his vaccination card on him and does not remember the dates and lot numbers, but he states that all shots were Moderna COVID-19 brand. After the first 4 shots, patient did not have side effects. Patient has asthma and uses Advair. Company comment-This spontaneous case concerns a 86-year old, male patient with relevant medical history of Immunocompromised and Asthma reported, who experienced the unexpected non-serious ADR event of COVID-19 (SARS-COV2 test positive) which occurred unspecified days after receiving first booster dose (Dose number 4) of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment received were reported. Patient had received 5 doses of Moderna COVID-19 vaccine (3 primary doses and 2 booster doses) on unknown dates. Outcome of the event was unknown at the time of report. Elderly age of the patient and relevant medical history remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-539762 (Patient Link).; Sender's Comments: This spontaneous case concerns a 86-year old, male patient with relevant medical history of Immunocompromised and Asthma reported, who experienced the unexpected non-serious ADR event of COVID-19 (SARS-COV2 test positive) which occurred unspecified days after receiving first booster dose (Dose number 4) of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment received were reported. Patient had received 5 doses of Moderna COVID-19 vaccine (3 primary doses and 2 booster doses) on unknown dates. Outcome of the event was unknown at the time of report. Elderly age of the patient and relevant medical history remains as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.