Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian disorder, Pruritus, Sjogren's syndrome, Swollen tongue, Ultrasound scan
Clinical narrative: inflammation in my eyes, very dry; vision was affected; body itches; affect my menstrual periods and hormonally; complex variances on my left ovary; cyst in cervix; diagnosed Sjogren's syndrome; my tongue swells up; trouble swallowing; felt tired maybe due to the Benadryl; This spontaneous case was reported by a pharmacist and describes the occurrence of SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Information regarding medical history was not reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LANSOPRAZOLE (PREVACID), LINACLOTIDE (LINZESS) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWOLLEN TONGUE (my tongue swells up) and DYSPHAGIA (trouble swallowing). In February 2021, the patient experienced FATIGUE (felt tired maybe due to the Benadryl). In March 2021, the patient experienced SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome) (seriousness criterion medically significant), EYE INFLAMMATION (inflammation in my eyes, very dry), VISUAL IMPAIRMENT (vision was affected), PRURITUS (body itches), MENSTRUAL DISORDER (affect my menstrual periods and hormonally), OVARIAN DISORDER (complex variances on my left ovary) and CERVICAL CYST (cyst in cervix). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 11-Feb-2021 to 12-Feb-2021 for Swollen tongue and Swallowing difficult, at a dose of 2 doses and stayed on Benadryl for 24 hrs. On 12-Feb-2021, SWOLLEN TONGUE (my tongue swells up) and DYSPHAGIA (trouble swallowing) had resolved. At the time of the report, SJOGREN'S SYNDROME (diagnosed Sjogren's syndrome), EYE INFLAMMATION (inflammation in my eyes, very dry), VISUAL IMPAIRMENT (vision was affected), PRURITUS (body itches), MENSTRUAL DISORDER (affect my menstrual periods and hormonally), OVARIAN DISORDER (complex variances on my left ovary), CERVICAL CYST (cyst in cervix) and FATIGUE (felt tired maybe due to the Benadryl) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) complex variances on my left ovary, cyst in cervix.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was reported as rest and exercise for the fatigue and tiredness, but the patient can't do what she was doing before. It has affected her ability to do things.  This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Sjogren's syndrome and non-serious events of Swollen tongue, Dysphagia , Visual impairment, Menstrual disorder, Ovarian disorder  and Cervical cyst. The events occurred approximately 1 days after the first  dose of Spikevax. The rechallenge is unknown since there's no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Sjogren's syndrome and non-serious events of Swollen tongue, Dysphagia , Visual impairment, Menstrual disorder, Ovarian disorder  and Cervical cyst. The events occurred approximately 1 days after the first  dose of Spikevax. The rechallenge is unknown since there's no information about the second dose. The benefit-risk relationship of Spikevax is not affected by this report.