Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection bacterial, Eye irritation, Eye swelling, Eyelid irritation, Feeling abnormal
Clinical narrative: first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast; left arm was sorer than normal after the injection; left eye bacterial eye infection/ infection moved into her right eye; left eye started swelling/swelled from the top of the eye to the bottom eyelid; left eye started burning; left eyelid started swelling; left eyelid started burning; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history 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. In 2021, the patient experienced EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) (seriousness criterion medically significant), EYE SWELLING (left eye started swelling/swelled from the top of the eye to the bottom eyelid), EYE IRRITATION (left eye started burning), SWELLING OF EYELID (left eyelid started swelling) and EYELID IRRITATION (left eyelid started burning). On 16-Jun-2021, the patient experienced FEELING ABNORMAL (first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast) and VACCINATION SITE PAIN (left arm was sorer than normal after the injection). The patient was treated with SULFACETAMIDE (ophthalmic) for Eye infection, at an unspecified dose and frequency; PREDNISOLONE (ophthalmic) for Eye infection, at a dose of 0.23 %; DOXYCYCLINE MONOHYDRATE on 23-Sep-2021 for Eye infection, at a dose of 100 milligram; ERYTHROMYCIN (ophthalmic) for Eye infection, at an unspecified dose and frequency and Surgery (Eyelid incision) for Feeling abnormal. At the time of the report, EYE INFECTION BACTERIAL (left eye bacterial eye infection/ infection moved into her right eye) was resolving and EYE SWELLING (left eye started swelling/swelled from the top of the eye to the bottom eyelid), EYE IRRITATION (left eye started burning), EYELID IRRITATION (left eyelid started burning), FEELING ABNORMAL (first injection "popped" like a trigger mechanism type/weird shot/it almost made her jump after the injection/jolted her/dose went in real fast) and VACCINATION SITE PAIN (left arm was sorer than normal after the injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a very bad reaction to the Moderna vaccine. Two to three weeks after the first injection, she started had bacterial eye infections. First, her left eye and eyelid started swelling and burning and was prescribed an ophthalmic ointment. The eye specialist needed to cut her eyelid to alleviate the swelling. She stated just as her left eye started to improve, the infection moved into her right eye.  Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event of Eye infection bacterial after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred approximately 2 to 3 weeks after the first dose of Spikevax. The rechallenge is not applicable, as the events were reported as ongoing prior to dose 2. The benefit-risk relationship of Spikevax vaccine is not affected by this report.   This case was linked to MOD-2021-338392 (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 Eye infection bacterial after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the event occurred approximately 2 to 3 weeks after the first dose of Spikevax. The rechallenge is not applicable, as the events were reported as ongoing prior to dose 2. The benefit-risk relationship of Spikevax vaccine is not affected by this report.