Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test, Therapeutic product effect decreased
Clinical narrative: therapeutic product effect decreased; Diagnosed with COVID-19; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) and THERAPEUTIC PRODUCT EFFECT DECREASED (therapeutic product effect decreased) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third 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) at an unspecified dose. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 14-Jan-2022, the patient experienced COVID-19 (Diagnosed with COVID-19). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (therapeutic product effect decreased). At the time of the report, COVID-19 (Diagnosed with COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) and THERAPEUTIC PRODUCT EFFECT DECREASED (therapeutic product effect decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication provided. No treatment information mentioned.  Prior, on unknown dates patient experienced diarrhea if anxious or nervous and chest tightness. Somewhere in 2021, patient experienced sore arm with COVID vaccines. On 14JAN2022, patient was diagnosed with COVID-19.  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 is a spontaneous case reported by a consumer, concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 with a positive SARS-CoV-2 test, approximately 2 months and 24 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received the 2 primary doses of mRNA1273 vaccine at an interval of 20 days, with the 2 dose taken about 6 months prior to the 3 dose. Inappropriate schedule of product administration and therapeutic product effect decreased were noted. On an unknown date the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Chron's Disease. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia, inappropriate schedule of product administration and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-623590 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 35-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 with a positive SARS-CoV-2 test, approximately 2 months and 24 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received the 2 primary doses of mRNA1273 vaccine at an interval of 20 days, with the 2 dose taken about 6 months prior to the 3 dose. Inappropriate schedule of product administration and therapeutic product effect decreased were noted. On an unknown date the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Chron's Disease. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia, inappropriate schedule of product administration and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.