Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chest X-ray, Drug ineffective, Oxygen saturation
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of BRONCHITIS (Bronchitis), COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The patient's past medical history included Flu (She used the inhalers in the past when she had the flu). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect). On an unknown date, the patient experienced BRONCHITIS (Bronchitis). The patient was treated with CEFTRIAXONE SODIUM (ROCEPHIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at a dose of for 7 days; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Adverse event, at an unspecified dose and frequency; CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE - CODEINE [CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. On 24-Dec-2021, COVID-19 (COVID-19 infection/ result was positive) had resolved. At the time of the report, BRONCHITIS (Bronchitis) had resolved and DRUG INEFFECTIVE (Lack of Drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Chest X-ray: bronchitis (abnormal) bronchitis. On an unknown date, Oxygen saturation: normal (normal) Oxygen saturation level was fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. It was reported it has been about 2 weeks since the recovery. Company comment: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.