Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, HLA marker study, Iris adhesions, Treponema test
Clinical narrative: newposterior synechiae in the left eye; mild irritation in the left eye; This literature-non-study case was reported in a literature article and describes the occurrence of IRIS ADHESIONS (newposterior synechiae in the left eye) and EYE IRRITATION (mild irritation in the left eye) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Anterior uveitis (3 weeks after Hepatitis B vaccination) and Synechiae posterior (Patient developed posterior synechiae in her right eye only following the previous vaccination). Previously administered products included for Product used for unknown indication: Hepatitis B vaccination. Past adverse reactions to the above products included No adverse event with Hepatitis B vaccination.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IRIS ADHESIONS (newposterior synechiae in the left eye) (seriousness criterion medically significant) and EYE IRRITATION (mild irritation in the left eye) (seriousness criterion medically significant). At the time of the report, IRIS ADHESIONS (newposterior synechiae in the left eye) and EYE IRRITATION (mild irritation in the left eye) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA marker study: negative (Negative) human leukocyte antigen B27 (HLA-B27)was Negative. On an unknown date, Treponema test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IRIS ADHESIONS (newposterior synechiae in the left eye) and EYE IRRITATION (mild irritation in the left eye) to be related.    Patient noted mild irritation in the left eye just after her vaccine but was not noted to have any ocular inflammation at that visit. At her 3-week examination, she was asymptomatic and had no keratic precipitates or anterior chamber cell or flare but was found to have new posterior synechiae in the left eye. Secondary to these findings, the second vaccine dose was not obtained.  No concomitant and treatment medications were reported.  Company Comment.  This literature case concerns a 58 year old, female patient, with a relevant medical history of bilateral anterior uveitis 3 weeks after Hepatitis vaccination, and posterior synechiae of the right eye only following previous vaccination, who experienced the unexpected, serious (medically significant) event of eye irritation on the day of vaccination and unexpected, serious (medically significant) event of iris adhesions approximately 3 weeks after receiving a first dose of mRNA-1273.  Due to her history of uveitis following previous vaccination, she received eye examinations by an ophthalmologist just after Covid-19 vaccine and weekly to evaluate for any ocular changes.  She noted mild irritation of her left eye just after vaccination though no ocular inflammation was noted.  3 weeks later, she was asymptomatic but was found to have a new posterior synechiae (iris adhesions) in the left eye.  Laboratory testing included rapid plasma reagin and human leukocyte antigen B27 which were negative.  Secondary to these findings, the second dose of vaccine was not obtained.  The outcome of the events is unknown.  The medical history remains a confounder.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-516590.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up received by safety 18-Mar-2022 has Email with Agency received from team and contains significant information. Reporter information, Literature information, Lab data, event added, suspect dose details were updated.; Sender's Comments: This literature case concerns a 58 year old, female patient, with a relevant medical history of bilateral anterior uveitis 3 weeks after Hepatitis vaccination, and posterior synechiae of the right eye only following previous vaccination, who experienced the unexpected, serious (medically significant) event of eye irritation on the day of vaccination and unexpected, serious (medically significant) event of iris adhesions approximately 3 weeks after receiving a first dose of mRNA-1273.  Due to her history of uveitis following previous vaccination, she received eye examinations by an ophthalmologist just after Covid-19 vaccine and weekly to evaluate for any ocular changes.  She noted mild irritation of her left eye just after vaccination though no ocular inflammation was noted.  3 weeks later, she was asymptomatic but was found to have a new posterior synechiae (iris adhesions) in the left eye.  Laboratory testing included rapid plasma reagin and human leukocyte antigen B27 which were negative.  Secondary to these findings, the second dose of vaccine was not obtained.  The outcome of the events is unknown.  The medical history remains a confounder.  The benefit risk relationship of mRNA-1273 is not affected by this report.