Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Immunosuppressed due to the reason of taking Methotrexate and Humira; COVID/did not do very well; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Methotrexate sodium (Methotrexate) for an unknown indication and Adalimumab (Humira) for an unknown indication. Concurrent medical conditions included Autoimmune disorder NOS (rare autoimmune disease related to uveitis (also known as bird shot)) and Uveitis (rare autoimmune disease related to uveitis (also known as bird shot)). In December 2020, the patient started Methotrexate sodium (Methotrexate) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and Adalimumab (Humira) (unknown route) at an unspecified dose. In June 2023, the patient experienced COVID-19 (COVID/did not do very well). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) had not resolved and COVID-19 (COVID/did not do very well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: titer was not very high the first time she got the vaccine. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient was immunosuppressed due to the reason of taking Methotrexate and Humira. She had always taken the Moderna vaccine and had not missed any COVID vaccines. She took time off her medications to get the vaccine; she stopped the meds 2 weeks prior and 2 weeks after taking the medication again. She started Methotrexate at the end of December 2020 and could not remember if she had done Humira yet. Her doctor at the time recommended that she get her first dose of COVID and "see what happens". Her titer was not very high the first time she got the vaccine, but that they decided on the next one. She had COVID in June 2023 and did not do very well, so she did not want it again. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up received included reference numbers were added.; Reporter's Comments: Patients immunosuppresion is secondary to Methotrexate and Humira. Hence, this event is assessed as not related to Moderna COVID-19 vaccine. The benefit-risk relationship of product is not affected by this report.
Autoimmune disorder NOS (rare autoimmune disease related to uveitis (also known as bird shot)); Uveitis (rare autoimmune disease related to uveitis (also known as bird shot))
Humira; Methotrexate
Test Name: Virus antibody test; Result Unstructured Data: titer was not very high the first time she got the vaccine