Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Pruritus, Skin irritation
Clinical narrative: Autoimmune disease; My scalp feels like it has acid poured on it and it itches something fierce; My scalp feels like it has acid poured on it; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disease) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 01M20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to sulfa drugs), Drug allergy (Allergic to lisinopril), Drug allergy (Allergic to albuteral), Chronic kidney disease, Alopecia, Potassium supplementation, Urinary urgency and Water retention. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from 28-Mar-2021 to an unknown date for Alopecia, MULTIVITAMINS [VITAMINS NOS] for Hypovitaminosis, KCL for Potassium supplementation, SOLIFENACIN for Urinary urgency, FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) for Water retention, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LOSARTAN POTASSIUM (LOSARTIN), DULOXETINE, METOPROLOL, SERTRALINE, CLONAZEPAM (KLONOPIN), ATORVASTATIN CALCIUM (LIPITOR) and PRIMIDONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease) (seriousness criterion medically significant), PRURITUS (My scalp feels like it has acid poured on it and it itches something fierce) and SKIN IRRITATION (My scalp feels like it has acid poured on it). The patient was treated with CLOBETASOL at a dose of 1 dosage form at bedtime and DOXYCYCLINE at a dose of 1 dosage form twice a day. At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disease), PRURITUS (My scalp feels like it has acid poured on it and it itches something fierce) and SKIN IRRITATION (My scalp feels like it has acid poured on it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had been going to the dermatologist once a month since october 2021 to get steroid injections in her scalp. It was reported that doctor changed his treatment medication from Doxycycline to Plaquenil.  Company comment: This spontaneous case concerns a 71-year-old, female patient with medical history of alopecia, who experienced the unexpected, serious (due to medically significant) event of Autoimmune disorder and other non-serious events, which occurred on an unknown date. The patient received 3 doses of mRNA-1273 vaccine. It was reported that The medical history of alopecia remains a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-511741 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with medical history of alopecia, who experienced the unexpected, serious (due to medically significant) event of Autoimmune disorder and other non-serious events, which occurred on an unknown date. The patient received 3 doses of mRNA-1273 vaccine. It was reported that The medical history of alopecia remains a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.