Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunodeficiency, Inappropriate schedule of product administration, Mouth ulceration, Oral mucosal blistering
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in a 67-year-old 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) injection for Rheumatoid arthritis. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 16-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain). On 16-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had on 2nd dose 14-Apr-2021 and booster on 16-Aug-2021). On 11-Dec-2021, the patient experienced MOUTH ULCERATION (Mouth ulcer). On 27-Dec-2021, the patient experienced ORAL MUCOSAL BLISTERING (Oral mucosa blister). On 16-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had on 2nd dose 14-Apr-2021 and booster on 16-Aug-2021) outcome was unknown. At the time of the report, IMMUNODEFICIENCY (Immunodeficiency), MOUTH ULCERATION (Mouth ulcer), ORAL MUCOSAL BLISTERING (Oral mucosa blister), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Concomitant drugs not reported. Patient had non-serious events tired, mouth ulcer on the roof of mouth, injection site pain/pain In arm after receiving Moderna Covid vaccines, weaker immune system, and blisters in mouth with HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of tired and injection site pain/pain in arm after receiving Moderna Covid vaccines with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of mouth ulcer on the roof of mouth, weaker immune system and blisters in mouth was not provided. Treatment drugs not 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 67-years-old female patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of Immunodeficiency among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. It was reported that patient had non-serious events mouth ulcer on the roof of mouth, injection site pain/pain ,In arm after receiving Moderna Covid vaccines, weaker immune system, and blisters in mouth with HUMIRA (ADALIMUMAB).The Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event Immunodeficiency. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Significant Live follow up appended: Event Information updated. Sender's Comments: This spontaneous case concerns a 67-years-old female patient with medical history of Rheumatoid Arthritis that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of Immunodeficiency among other non-serious events. The event occurred on an unknown date in context to first dose of mRNA-1273 vaccine. It was reported that patient had non-serious events mouth ulcer on the roof of mouth, injection site pain/pain ,In arm after receiving Moderna Covid vaccines, weaker immune system, and blisters in mouth with HUMIRA (ADALIMUMAB). The Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Rheumatoid Arthritis treated with HUMIRA remains a confounder to the event Immunodeficiency. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.