Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oral herpes, Pyrexia
Clinical narrative: Severe fever; Fatigue; Headache; Cold sores; This literature-study case was reported in a literature article and describes the occurrence of PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Safety of COVID-19 vaccination in immune-deficient patients receiving supplemental immunoglobulin therapies. Immunol. 2021;41(7):1527-30.    Concurrent medical conditions included Common variable immunodeficiency. Concomitant products included IMMUNOGLOBULINS NOS for Common variable immunodeficiency.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Severe fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ORAL HERPES (Cold sores) (seriousness criterion medically significant). At the time of the report, PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) to be possibly related.    No treatment was provided. An associated condition Enteropathy was mentioned.  Deidentified patient information was provided for 37 patients from 24 RA members from primarily academic medical centers. For the final analysis, 25 patients had complete survey information regarding reaction to an initial dose and 22 had complete information for both the first and second doses.  Patient characteristics demonstrated that 68.0% (17/25) of patients were female, 96.0% (24/25) were White and 20.0% (5/25) were identified as Hispanic or Latino. The most common diagnosis was common variable immunodeficiency (CVID) in 72.0% (18/25 patients), and 1 patient each was reported with secondary hypogammaglobulinemia due to use of rituximab, X-linked agammaglobulinemia (XLA), severe combined immune deficiency (SCID) due to adenosine deaminase deficiency following gene therapy, Hyper-IgE syndrome, ataxia telangiectasia with hypogammaglobulinemia, CD25 deficiency (compound heterozygote), and combined immunodeficiency (CID) with hypogammaglobulinemia.  Injection site pain and fatigue were the most frequently reported symptoms after both doses.  COVID-19 vaccines appear safe and well tolerated in patients with immunodeficiency who are receiving supplemental immunoglobulin therapy.  This case concerns a 29-year-old female patient, with reported medical history of common variable immunodeficiency, who experienced the unexpected events of pyrexia, fatigue, headache and oral herpes. The events occurred following an unspecified date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not unknown as second dose details was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed as as medically significant.  However, there was no information in the source docum   This case was linked to MOD-2021-342156, MOD-2021-342334, MOD-2021-342335, MOD-2021-342336, MOD-2021-342337, MOD-2021-342338, MOD-2021-342339, MOD-2021-342340, MOD-2021-342341, MOD-2021-342342, MOD-2021-342343, MOD-2021-342344, MOD-2021-342345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up received by safety 07-OCT-2021 included an Email with FTA received from Regulatory Authority team and does not contain any new information.; Sender's Comments: This case concerns a 29-year-old female patient, with reported medical history of common variable immunodeficiency, who experienced the unexpected events of pyrexia, fatigue, headache and oral herpes. The events occurred following an unspecified date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not unknown as second dose details was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed as as medically significant.  However, there was no information in the source document supporting that criteria.