Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Extra dose administered, Headache, Pain in extremity, Poor quality sleep
Clinical narrative: Couldn't see/couldn't see from both eyes; Was sleeping on and off; Slight headache; She got the shot, even though she is not immunocompromised; The arm hurt a little bit after 3rd shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS (Couldn't see/couldn't see from both eyes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ) and DILTIAZEM for an unknown indication.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PAIN IN EXTREMITY (The arm hurt a little bit after 3rd shot) and EXTRA DOSE ADMINISTERED (She got the shot, even though she is not immunocompromised). On 01-Sep-2021, the patient experienced POOR QUALITY SLEEP (Was sleeping on and off) and HEADACHE (Slight headache). On 02-Sep-2021, the patient experienced BLINDNESS (Couldn't see/couldn't see from both eyes) (seriousness criterion medically significant). The patient was treated with PREDNISOLONE ACETATE ongoing since an unknown date at a dose of 1 % every six hours; OFLOXACIN at a dose of .3 % twice a day; BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) at a dose of 1 dosage form and Surgery (Laser surgery) for Blindness. On 31-Aug-2021, EXTRA DOSE ADMINISTERED (She got the shot, even though she is not immunocompromised) had resolved. At the time of the report, BLINDNESS (Couldn't see/couldn't see from both eyes), POOR QUALITY SLEEP (Was sleeping on and off), PAIN IN EXTREMITY (The arm hurt a little bit after 3rd shot) and HEADACHE (Slight headache) outcome was unknown.            The patient went to the eye doctor for cataract surgery before the shot, patient had the cataract surgery in both the eyes. The patient needed to have the contacts that were put in removed in one eye and reattached, because it had formed a "z" in patient's eye. Patient's husband was immunocompromised and was going to pharmacy to get his 3rd shot, and pharmacy offered it to the patient  as well, so got it, even though patient was not immunocompromised. On Thursday 2Sep2021 patient went to the eye doctor and  had to treat with a laser surgery, patient  had to have a 2 holes poked into the eye by laser to release the pressure since the canal had closed, to create an opening so the gel could pass through and release all this pressure. The pressure was the cause that patient  couldn't see. The eye doctor mentioned that  patient  might have been permanently blind. On the same day patient had her surgery on right eye. Company comment- This case concerns a 75-year-old, female patient with previous relevant medical history of cataract and cataract surgery, who experienced the unexpected event of blindness. The event occurred 3 days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-320953, MOD-2021-320954 (Patient Link).; Sender's Comments: This case concerns a 75-year-old, female patient with previous relevant medical history of cataract and cataract surgery, who experienced the unexpected event of blindness. The event occurred 3 days after the third dose of mRNA-1273. The rechallenge was unknown since no information about the first or second dose were disclosed. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.