Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Vaccination site pain
Clinical narrative: Immunodeficiency/IMMUNE SYSTEM LOW; Vaccination site pain/SITE OF VACCINE WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency/IMMUNE SYSTEM LOW) in an adult female 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) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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) Citrate Free. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunodeficiency/IMMUNE SYSTEM LOW) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Vaccination site pain/SITE OF VACCINE WAS SORE). At the time of the report, IMMUNODEFICIENCY (Immunodeficiency/IMMUNE SYSTEM LOW) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain/SITE OF VACCINE WAS SORE) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. It was reported that humira was not working. The reporter causality for the events of vaccination site pain, immunodeficiency was Not reported for cosuspect humira. The reporter causality for the event of lack of drug effect was  assessed as reasonable possibility for cosuspect humira. 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 is a spontaneous case, reported by a consumer, concerning an adult female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) event of Immunodeficiency, reported as low immune system, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days which falls within the recommended vaccine dosing schedule. The patient also experienced vaccination site pain. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab, which is an immunosuppressant, could be a confounding factor for the event Immunodeficiency. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow-up received includes new event(immunodeficiency) was added.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) event of Immunodeficiency, reported as low immune system, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days which falls within the recommended vaccine dosing schedule. The patient also experienced vaccination site pain. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab, which is an immunosuppressant, could be a confounding factor for the event Immunodeficiency. The benefit-risk relationship of mRNA-1273 is not affected by this report.