Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunodeficiency, Injection site pain, Pain
Clinical narrative: stinging with injections; achy with second dose of covid-19 vaccine; reactions from covid-19 vaccine/had chills; lowered immune system; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (lowered immune system) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced PAIN (achy with second dose of covid-19 vaccine) and CHILLS (reactions from covid-19 vaccine/had chills). In 2021, the patient experienced IMMUNODEFICIENCY (lowered immune system) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE PAIN (stinging with injections). In 2021, PAIN (achy with second dose of covid-19 vaccine), CHILLS (reactions from covid-19 vaccine/had chills) and INJECTION SITE PAIN (stinging with injections) had resolved. At the time of the report, IMMUNODEFICIENCY (lowered immune system) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of lowered immune system was not provided. The reporter causality for the events of reactions from covid-19 vaccine and had chills and achy with second dose of covid-19 vaccine onset in March 2021, stinging with injections and reactions from covid-19 vaccine/had chills and achy with second dose of covid-19 vaccine onset in March 2021 with Humira(adalimumab) was a reasonable possibility.   No treatment medications were reported.  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 male patient aged 75 years with reported concurrent condition of crohn's disease on Humira, experienced unexpected serious (medically significant) event of  Immunodeficiency on unknown dates (in 2021) after second dose of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment  was available in the report.  Outcome of the event was unknown at the time of report. Patient had received first doses of same vaccine at an interval of 1 month.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 75 years with reported concurrent condition of crohn's disease on Humira, experienced unexpected serious (medically significant) event of  Immunodeficiency on unknown dates (in 2021) after second dose of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment  was available in the report.  Outcome of the event was unknown at the time of report. Patient had received first doses of same vaccine at an interval of 1 month.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.