Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye inflammation, Peripheral swelling, Product dose omission issue, Ulcerative keratitis
Clinical narrative: week before her second shot developed in her right eye a cornea ulcer; Said her doctor mentioned he has seen patients that had eye problems similar to hers -another flare up in her eyes; both hands were swollen; both times she had inflammation in left eye; She did not get the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ULCERATIVE KERATITIS (week before her second shot developed in her right eye a cornea ulcer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included RA since an unknown date. Concomitant products included ETANERCEPT (ENBREL), ADALIMUMAB (HUMIRA), METHOTREXATE, FOLIC ACID, DOXYCYCLINE, FISH OIL and CALCIUM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ULCERATIVE KERATITIS (week before her second shot developed in her right eye a cornea ulcer) (seriousness criterion medically significant), EYE DISORDER (Said her doctor mentioned he has seen patients that had eye problems similar to hers -another flare up in her eyes), PERIPHERAL SWELLING (both hands were swollen), EYE INFLAMMATION (both times she had inflammation in left eye) and PRODUCT DOSE OMISSION ISSUE (She did not get the second vaccine.). At the time of the report, ULCERATIVE KERATITIS (week before her second shot developed in her right eye a cornea ulcer), EYE DISORDER (Said her doctor mentioned he has seen patients that had eye problems similar to hers -another flare up in her eyes), PERIPHERAL SWELLING (both hands were swollen), EYE INFLAMMATION (both times she had inflammation in left eye) and PRODUCT DOSE OMISSION ISSUE (She did not get the second vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not reported.  Company comment: This case refers to a female patient of unknown age with unrelated medical history but concomitantly taking Embrel, Adalimumab, Methrotrexate and Doxycycline who experienced the unexpected event of Ulcerative Keratitis on an unspecified date after the first dose of Spikevax. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Significant follow-up received appended with Medical history, concomitant medication, new events and patient initials.; Sender's Comments: This case refers to a female patient of unknown age with unrelated medical history but concomitantly taking Embrel, Adalimumab, Methrotrexate and Doxycycline who experienced the unexpected event of Ulcerative Keratitis on an unspecified date after the first dose of Spikevax. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.