Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; Vaccine response impaired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Vaccine response impaired) and COVID-19 (COVID-19) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION FAILURE (Vaccine response impaired). In October 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINATION FAILURE (Vaccine response impaired) outcome was unknown and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medications were reported. In October 2021, the patient experienced covid vaccine did not work that way since patient still got covid. On 25 Dec 2021, the patient experienced issue with humira pen/the needle punctured skin on leg but most of the liquid spilled out. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  Company comment  This is a spontaneous case reported by a consumer, concerning a 61-year-old male patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 5 months after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Vaccination Failure was also reported as an event. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 28 days. In the same month of receiving the 2 dose of Moderna vaccine, the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for ulcerative colitis.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was not resolved. Ongoing Covid 19 pandemia 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.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 61-year-old male patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 5 months after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Vaccination Failure was also reported as an event. The primary 2 doses of m RNA1273 vaccine was given at an interval of about 28 days. In the same month of receiving the 2 dose of Moderna vaccine, the patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for ulcerative colitis.  Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was not resolved. Ongoing Covid 19 pandemia 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.