Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Papilloedema, Paraesthesia, Peripheral swelling, Rash, Urinary tract infection
Clinical narrative: Had high blood pressure; Had permanent vision loss; Diagnosed with edema of the optic nerve in the right eye; She says that she can see from the right eye, but it looks like there's a gray cellophane over her eye. The vision is not right and is fragmented, blurry, and gray.; UTIs which was diagnosed during a visit to the ER; She also experienced rashes on her left leg and thigh; Pain in knee joints; Bad headache in the back of the head; Pain in neck; Night sweats; Numbness; Tingling shooting down her arms, legs. She was feeling this in all her extremities including her toes and fingers/Burning; Developed carpal tunnel in right hand and eventually went into the left hand as well.; Toes became very swollen; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (Had permanent vision loss) and PAPILLOEDEMA (Diagnosed with edema of the optic nerve in the right eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 010A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost her sense of taste and had a terrible sore throat. She also felt funny electric shocks in her body.). Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 15-Nov-2021, the patient experienced NECK PAIN (Pain in neck), ARTHRALGIA (Pain in knee joints) and HEADACHE (Bad headache in the back of the head). In November 2021, the patient experienced CARPAL TUNNEL SYNDROME (Developed carpal tunnel in right hand and eventually went into the left hand as well.), PERIPHERAL SWELLING (Toes became very swollen), NIGHT SWEATS (Night sweats), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling shooting down her arms, legs. She was feeling this in all her extremities including her toes and fingers/Burning). In December 2021, the patient experienced RASH (She also experienced rashes on her left leg and thigh). In January 2022, the patient experienced VISION BLURRED (She says that she can see from the right eye, but it looks like there's a gray cellophane over her eye. The vision is not right and is fragmented, blurry, and gray.) and URINARY TRACT INFECTION (UTIs which was diagnosed during a visit to the ER). On 17-Jan-2022, the patient experienced BLINDNESS (Had permanent vision loss) (seriousness criterion medically significant) and PAPILLOEDEMA (Diagnosed with edema of the optic nerve in the right eye) (seriousness criterion medically significant). In March 2022, the patient experienced HYPERTENSION (Had high blood pressure). The patient was treated with PREDNISONE at an unspecified dose and frequency and Wound care for Carpal tunnel syndrome. In March 2022, URINARY TRACT INFECTION (UTIs which was diagnosed during a visit to the ER) had resolved. At the time of the report, BLINDNESS (Had permanent vision loss), PAPILLOEDEMA (Diagnosed with edema of the optic nerve in the right eye), VISION BLURRED (She says that she can see from the right eye, but it looks like there's a gray cellophane over her eye. The vision is not right and is fragmented, blurry, and gray.), CARPAL TUNNEL SYNDROME (Developed carpal tunnel in right hand and eventually went into the left hand as well.), HYPERTENSION (Had high blood pressure), PERIPHERAL SWELLING (Toes became very swollen), NECK PAIN (Pain in neck), NIGHT SWEATS (Night sweats), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling shooting down her arms, legs. She was feeling this in all her extremities including her toes and fingers/Burning), RASH (She also experienced rashes on her left leg and thigh), ARTHRALGIA (Pain in knee joints) and HEADACHE (Bad headache in the back of the head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Blood pressure measurement: High. On an unknown date, Blood test: Negative for lyme's disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information available   Company comment: This spontaneous case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) events Blindness and Papilloedema. The events occurred 73 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 8 months prior, the interval between the two doses is 28 days. It has been reported that the patient experienced pain on her knee and neck, headache and started to develop carpal tunnel on both her hands approximately 10 days after administration of the booster dose. She also experienced burning sensation and numbness on both her upper and lower extremities and night sweats. 73 days after booster dose, she woke up with blindness of her right eye, sought consult and edema of the right optic nerve was visualized, her left eye was normal, she is currently being treated for her loss of vision. The patient also reported of having recurrent UTI for 3 months and was put on antibiotics. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per Important Medical Event List.   This case was linked to MOD-2022-660509, MOD-2022-660535 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) events Blindness and Papilloedema. The events occurred 73 days after administration of third dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 8 months prior, the interval between the two doses is 28 days. It has been reported that the patient experienced pain on her knee and neck, headache and started to develop carpal tunnel on both her hands approximately 10 days after administration of the booster dose. She also experienced burning sensation and numbness on both her upper and lower extremities and night sweats. 73 days after booster dose, she woke up with blindness of her right eye, sought consult and edema of the right optic nerve was visualized, her left eye was normal, she is currently being treated for her loss of vision. The patient also reported of having recurrent UTI for 3 months and was put on antibiotics. The events have not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per Important Medical Event List.