Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Lacrimation increased, Ocular hyperaemia, Paraesthesia, Product dose omission issue
Clinical narrative: Problem with balance; she feels like she is falling, she notices when laying down or getting up/balance seems to have good and bad days; Patient did not received the second dose; Eyes continue to be blurry; Red/itchy eyes; Eye itching / Red/itchy eyes; Prickling/Tingling sensation; Flushing; my eyes continued to hurt; eyes continued to hurt and consisted burning and red; I had dry eyes.; buzz in middle of head on most days; when I lay down I have a feeling of constant falling; Vision was off; slight hearing loss but was unable to hear some of the sounds because of ringing; Vertigo/Vertigo started about this same time and would come and go; Tinnitus in both ears, the righ ear is the worst and it never stops; the left is worst at night, it comes and goes/ringing in my right ear; eyes were watering, then swollen shut; eyes were watering, then swollen shut; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision was off), HYPOACUSIS (slight hearing loss but was unable to hear some of the sounds because of ringing) and TINNITUS (Tinnitus in both ears, the righ ear is the worst and it never stops; the left is worst at night, it comes and goes/ringing in my right ear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Antinuclear antibody increased, Allergy to insect sting (Bull Gnat Bite) and Bee sting hypersensitivity (Bee Stings) since 01-Jun-1990. Concomitant products included LORATADINE (CLARITIN [LORATADINE]), LACTOBACILLUS NOS (CULTURELLE), COLECALCIFEROL (VITAMIN D3) from 01-Jun-2019 to an unknown date and LANSOPRAZOLE from 10-Jan-2021 to an unknown date for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LACRIMATION INCREASED (eyes were watering, then swollen shut) and EYE SWELLING (eyes were watering, then swollen shut). On 15-Mar-2021, the patient experienced TINNITUS (Tinnitus in both ears, the righ ear is the worst and it never stops; the left is worst at night, it comes and goes/ringing in my right ear) (seriousness criterion medically significant). In April 2021, the patient experienced VERTIGO (Vertigo/Vertigo started about this same time and would come and go). On an unknown date, the patient experienced BLINDNESS (Vision was off) (seriousness criterion medically significant), HYPOACUSIS (slight hearing loss but was unable to hear some of the sounds because of ringing) (seriousness criterion medically significant), BALANCE DISORDER (Problem with balance; she feels like she is falling, she notices when laying down or getting up/balance seems to have good and bad days), PRODUCT DOSE OMISSION ISSUE (Patient did not received the second dose), VISION BLURRED (Eyes continue to be blurry), OCULAR HYPERAEMIA (Red/itchy eyes), EYE PRURITUS (Eye itching / Red/itchy eyes), PARAESTHESIA (Prickling/Tingling sensation), FLUSHING (Flushing), EYE PAIN (my eyes continued to hurt), EYE IRRITATION (eyes continued to hurt and consisted burning and red), DRY EYE (I had dry eyes.), HEAD DISCOMFORT (buzz in middle of head on most days) and FEELING ABNORMAL (when I lay down I have a feeling of constant falling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 07-Mar-2021 to 15-Mar-2021 for Watering eyes and Eyes swollen, at a dose of UNK, qd and LORATADINE (CLARITINE) (oral) ongoing from 04-Jan-2021 at a dose of UNK, qd. At the time of the report, BLINDNESS (Vision was off), HYPOACUSIS (slight hearing loss but was unable to hear some of the sounds because of ringing), TINNITUS (Tinnitus in both ears, the righ ear is the worst and it never stops; the left is worst at night, it comes and goes/ringing in my right ear), LACRIMATION INCREASED (eyes were watering, then swollen shut), EYE SWELLING (eyes were watering, then swollen shut), VERTIGO (Vertigo/Vertigo started about this same time and would come and go), BALANCE DISORDER (Problem with balance; she feels like she is falling, she notices when laying down or getting up/balance seems to have good and bad days), VISION BLURRED (Eyes continue to be blurry), OCULAR HYPERAEMIA (Red/itchy eyes), EYE PRURITUS (Eye itching / Red/itchy eyes), PARAESTHESIA (Prickling/Tingling sensation), FLUSHING (Flushing), EYE PAIN (my eyes continued to hurt), EYE IRRITATION (eyes continued to hurt and consisted burning and red), DRY EYE (I had dry eyes.), HEAD DISCOMFORT (buzz in middle of head on most days) and FEELING ABNORMAL (when I lay down I have a feeling of constant falling) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not received the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient called the walk in clinic on 06MAR2021; they were concerned she could have pink eye.  Laboratory data included a "normal" urine test. Additional concomitant product use included Vitamin D and an unspecified probiotic.  Patient went to her Primary Care Physician on 24-MAR-2021 and she also went to an ENT on 07-APR-2021 for tinnitus.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Tinnitus and Hypoacusia were upgraded to serious event sbased on info avail and medical judgment (as per SD the duration of tinnitus is at least 5 months).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received on 23-Aug-2021.  Patient medical history added, Patient allergy added, Laboratory data added, Concomitant product added, Treatment information added, New serious event (Blindness) added and other new event added.  Case upgraded to serious.  Narrative updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Tinnitus and Hypoacusia were upgraded to serious event sbased on info avail and medical judgment (as per SD the duration of tinnitus is at least 5 months).