Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Asthma; COVID-19; COVID-19 VIRUS TEST: Positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (COVID-19 VIRUS TEST: Positive) and ASTHMA (Asthma) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In August 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (COVID-19 VIRUS TEST: Positive). On an unknown date, the patient experienced ASTHMA (Asthma). At the time of the report, COVID-19 (COVID-19) and ASTHMA (Asthma) was resolving and DRUG INEFFECTIVE (COVID-19 VIRUS TEST: Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported by reporter. Formulation for HUMIRA was reported as Solution for injection in pre-filled pen. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns a 33-year-old female patient on concomitant Adalimumab (Humira) for Crohn's disease,  with no relevant medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 approximately 3 months after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. No treatment was reported. Outcome of the event COVID-19 was resolving at the time of report. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Adalimumab is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 33-year-old female patient on concomitant Adalimumab (Humira) for Crohn's disease,  with no relevant medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 approximately 3 months after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. No treatment was reported. Outcome of the event COVID-19 was resolving at the time of report. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Adalimumab is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.