Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood iron, Hysterectomy, Inappropriate schedule of product administration
Clinical narrative: Hysterectomy; The patient experienced Low energy level; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of HYSTERECTOMY (Hysterectomy) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Hidradenitis suppurativa.    The patient's past medical history included Iron low on 01-Jan-2019 and Injection site pain on 01-Jan-2019. Concurrent medical conditions included Psoriatic arthritis and Hidradenitis suppurativa.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jul-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 01-Jul-2022, the patient experienced ASTHENIA (The patient experienced Low energy level) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced HYSTERECTOMY (Hysterectomy) (seriousness criterion medically significant). On 02-Jul-2022, ASTHENIA (The patient experienced Low energy level) had resolved. At the time of the report, HYSTERECTOMY (Hysterectomy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2019, Blood iron: Low.         Patient had no known allergies.   It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant product use was not provided by the reporter.  The reporter's causality for the events HYSTERECTOMY and LOW IRON was not provided for HUMIRA. The reporter's causality for the event LOW ENERGY LEVEL with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events BURNING AND PAIN AT INJECTION SITE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 32-year-old, female patient with current condition of psoriatic arthritis treated with Humira (ADALIMUMAB), who experienced the unexpected serious (medically significant) event of hysterectomy. Onset date of event was not reported, timeframe between the event and the administration of a dose of mRNA-1273 vaccine could not be assessed. Patient received two doses of mRNA-1273 vaccine 6 months apart. Inappropriate schedule of vaccine administered is noted in this case. Patient experienced asthenia for one day, after the second dose.  No further information was disclosed. Patient´s concomitant medication of adalimumab is a confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 32-year-old, female patient with current condition of psoriatic arthritis treated with Humira (ADALIMUMAB), who experienced the unexpected serious (medically significant) event of hysterectomy. Onset date of event was not reported, timeframe between the event and the administration of a dose of mRNA-1273 vaccine could not be assessed. Patient received two doses of mRNA-1273 vaccine 6 months apart. Inappropriate schedule of vaccine administered is noted in this case. Patient experienced asthenia for one day, after the second dose.  No further information was disclosed. Patient´s concomitant medication of adalimumab is a confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.