Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Foreign body sensation in eyes, Hypersensitivity, Lacrimation increased
Clinical narrative: eyes became swollen/ mildly swollen eyelids; eyes became painful/ red irritated eyes; tearing in eyes; felt like a grittiness in the eyes; runny nose; sensitivity to light in both eyes; felt like they had a foreign object in eyes; Sore left arm; Swelling at injection site; Hypersensitivity reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes became swollen/ mildly swollen eyelids), EYE PAIN (eyes became painful/ red irritated eyes), LACRIMATION INCREASED (tearing in eyes), FOREIGN BODY SENSATION IN EYES (felt like a grittiness in the eyes) and RHINORRHOEA (runny nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction since an unknown date, Hives since an unknown date, Hay fever since an unknown date and Stroke (October 2020). Previously administered products included for an unreported indication: flu vaccine (Received on 1970s, and had reactions like Rash & swelling at injection site /severe flu-like symptoms x 2wks (cough,fever,tearing andsore throat)). Concurrent medical conditions included Asthma, Drug allergy (NSAID , and had reactions like GI Bleeding, Diverticulitis, GERD's), Drug allergy (Morphine and Codeine and had reactions like  Itching, Rash, Hypersensitivity-altered mental status, easily agitated With both medications), Drug allergy (RTimolol Drops/ Atenolol PO and had reactions like rash, Itching, Cough with both medications), Neptazane and Harvoni (Neptazane and Harvoni  and had reactions like Rash,Itching with both medications), Non-Hodgkin's lymphoma since 16-Aug-2013, Hypertension (1995), Diabetes (1970s), Diabetic peripheral neuropathy (1970s), Glaucoma, Cataracts (1995) and Connective tissue disorder (2018). Concomitant products included GABAPENTIN for Diabetic peripheral neuropathy, METOPROLOL TARTRATE for Heart rate irregular, AMLODIPINE and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE) for Hypertension, LATANOPROST, DORZOLAMIDE HCL, BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE TEVA), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), BISACODYL, ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (Vitamin B12) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced EYE SWELLING (eyes became swollen/ mildly swollen eyelids), EYE PAIN (eyes became painful/ red irritated eyes), LACRIMATION INCREASED (tearing in eyes), FOREIGN BODY SENSATION IN EYES (felt like a grittiness in the eyes), RHINORRHOEA (runny nose), PHOTOPHOBIA (sensitivity to light in both eyes), OCULAR DISCOMFORT (felt like they had a foreign object in eyes), PAIN IN EXTREMITY (Sore left arm) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with EPINEPHRINE at a dose of 1 dosage form and PREDNISOLONE ACETATE (ophthalmic) on 22-Apr-2021 at a dose of 1 drop four times per day. On 25-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, EYE SWELLING (eyes became swollen/ mildly swollen eyelids), EYE PAIN (eyes became painful/ red irritated eyes), LACRIMATION INCREASED (tearing in eyes), FOREIGN BODY SENSATION IN EYES (felt like a grittiness in the eyes), RHINORRHOEA (runny nose), PHOTOPHOBIA (sensitivity to light in both eyes), OCULAR DISCOMFORT (felt like they had a foreign object in eyes), PAIN IN EXTREMITY (Sore left arm) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Pantoprazole DR 40 MG qd for GERD  Treatment medication included Lotemax Ophthalmic Gel 0.5% BID-QID started on 19-May-2021 and ended on 20-May-2021   This case was linked to MOD-2021-194807, MOD-2021-194807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received on 01-Jun-2021: Updated the Patient demographics, medical history, Allergies, concomitant medications, treatment medication, event details and outcome.