Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Immunodeficiency, Inappropriate schedule of product administration
Clinical narrative: IMMUNE SYSTEM HAD BEEN BROUGHT DOWN; Fatigue; Headache; 1st dose 26-JAN-2021 and Second dose 04-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (IMMUNE SYSTEM HAD BEEN BROUGHT DOWN) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Tobacco user ((Stopped 1998)) in 1998 and Tuberculosis. Concurrent medical conditions included Abstains from alcohol, Drug allergy, Dizziness, Rheumatoid arthritis and Arthritis. Concomitant products included MELOXICAM for Arthritis, MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) for Dizziness, LEFLUNOMIDE and FOLIC ACID for Rheumatoid arthritis, PREDNISONE, DILTIAZEM, CITALOPRAM, LISINOPRIL, TOPIRAMATE, PREGABALIN, ONDANSETRON, BENZONATATE, MONTELUKAST and PRAVASTATIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 26-JAN-2021 and Second dose 04-MAR-2021). On an unknown date, the patient experienced IMMUNODEFICIENCY (IMMUNE SYSTEM HAD BEEN BROUGHT DOWN) (seriousness criterion medically significant), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, IMMUNODEFICIENCY (IMMUNE SYSTEM HAD BEEN BROUGHT DOWN) had not resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 26-JAN-2021 and Second dose 04-MAR-2021) outcome was unknown and FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 99.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of IMMUNE SYSTEM HAD BEEN BROUGHT DOWN BY HUMIRA, HEADACHE AND FATIGUE DUE TO VACCINE unknown onset and HEADACHE AND FATIGUE DUE TO VACCINE unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The patient was treated with PAXLOVID and this is related only to the events surrounding the 3rd dose and not necessarily to the 2nd dose, since this case is limited only to the events surrounding the 2nd dose.  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 70-year-old female patient, with body mass index of 42.295, with relevant medical history of tuberculosis, who experienced the unexpected serious (medically significant) event of Immunodeficiency on an unknown date in the context of receiving a dose of mRNA-1273 vaccine along with other non-serious events. Onset latency could not be determined as onset date of event was not provided. The outcome of event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine given 37 days apart which is not in accordance with the recommended vaccine interval. The patient's high body mass index and tuberculosis which impair immunity could be considered as risk factors, and Adalimumab (Humira) for rheumatoid arthritis as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-644616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2022: Follow-up received include : Patient details (Height, weight), Medical history updated, Lab test (Body temperature) added, Event (Inappropriate schedule of product administered) added.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with body mass index of 42.295, with relevant medical history of tuberculosis, who experienced the unexpected serious (medically significant) event of Immunodeficiency on an unknown date in the context of receiving a dose of mRNA-1273 vaccine along with other non-serious events. Onset latency could not be determined as onset date of event was not provided. The outcome of event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine given 37 days apart which is not in accordance with the recommended vaccine interval. The patient's high body mass index and tuberculosis which impair immunity could be considered as risk factors, and Adalimumab (Humira) for rheumatoid arthritis as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.