Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chalazion, Eye infection bacterial, Inappropriate schedule of product administration
Clinical narrative: similar to chalazion but is behaving differently; the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes; delayed receiving the second dose due to a planned vacation; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Bone disorder NOS.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed receiving the second dose due to a planned vacation). On 30-Sep-2021, the patient experienced EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) (seriousness criterion medically significant). On an unknown date, the patient experienced CHALAZION (similar to chalazion but is behaving differently). The patient was treated with DOXYCYCLINE MONOHYDRATE on 23-Sep-2021 for Eye infection, at a dose of 100 mg twice a day and ERYTHROMYCIN for Eye infection, at an unspecified dose and frequency. On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed receiving the second dose due to a planned vacation) had resolved. At the time of the report, EYE INFECTION BACTERIAL (the infection is over in the right eye, but it never clears up 100% and infection keeps jumping back and forth between eyes) had not resolved and CHALAZION (similar to chalazion but is behaving differently) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information also included one other different ophthalmic ointment.  Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Bacterial eye infection after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The onset of the event occurred after the first dose without resolution and reoccurred after the second dose of Spikevax. The rechallenge is not applicable, since the vaccination schedule has been completed.  The benefit-risk relationship of Spikevax vaccine is not affected by this report.   This case was linked to MOD-2021-338356 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Bacterial eye infection after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, inappropriate schedule of vaccine administered was captured. The onset of the event occurred after the first dose without resolution and reoccurred after the second dose of Spikevax. The rechallenge is not applicable, since the vaccination schedule has been completed.  The benefit-risk relationship of Spikevax vaccine is not affected by this report.