Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Gait disturbance, Headache
Clinical narrative: Sometimes when patient wakes up in AM vision becomes blurred; Sometimes when patient wakes up in the morning his walking becomes wobbly; Headache pain goes from my head to my neck; Headache pain on my ears; My injection site arm became red and had a circle the size of a 50 cent piece; Constant headache/headache pain on my temple temple, ears, and forehead.; Joint pain, joint pain becomes worse at night; Fever; Chils; Pain in his left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred) and GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMOXICILLIN, TRAMADOL, DEXAMETHASONE and LEVOFLOXACIN for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Pain in his left injection site arm). On an unknown date, the patient experienced VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred) (seriousness criterion medically significant), GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly) (seriousness criterion medically significant), NECK PAIN (Headache pain goes from my head to my neck), EAR PAIN (Headache pain on my ears), VACCINATION SITE ERYTHEMA (My injection site arm became red and had a circle the size of a 50 cent piece), HEADACHE (Constant headache/headache pain on my temple temple, ears, and forehead.), ARTHRALGIA (Joint pain, joint pain becomes worse at night), PYREXIA (Fever) and CHILLS (Chils). At the time of the report, VISION BLURRED (Sometimes when patient wakes up in AM vision becomes blurred), GAIT DISTURBANCE (Sometimes when patient wakes up in the morning his walking becomes wobbly), NECK PAIN (Headache pain goes from my head to my neck), EAR PAIN (Headache pain on my ears), VACCINATION SITE ERYTHEMA (My injection site arm became red and had a circle the size of a 50 cent piece), HEADACHE (Constant headache/headache pain on my temple temple, ears, and forehead.), ARTHRALGIA (Joint pain, joint pain becomes worse at night), PYREXIA (Fever), CHILLS (Chils) and VACCINATION SITE PAIN (Pain in his left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on antibiotics and steroids.  Patient had  injection site arm which  became red and had a circle the size of a 50 cent piece.    Sometimes when the patient wakes up in the morning his vision was blurred and his walking becomes wobbly.  It was reported that the headache pain goes from head to neck. Patient felt the headache pain on temple, ears, and forehead.  Company Comment : This case concerns a 67-year-old, male patient with previous relevant medical history of use of concomitant medication amlodipine, acetylsalicylic acid and tramadol, who experienced the expected events of vision blurred and gait disturbance. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was positive only for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. The only events medically significant are vision blurred and gait disturbance because the patient sought medical attention for only these events, the rest of the events were downgrade to non-serious due to no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.   This case was linked to MOD-2021-321124 (Patient Link).; Sender's Comments: This case concerns a 67-year-old, male patient with previous relevant medical history of use of concomitant medication amlodipine, acetylsalicylic acid and tramadol, who experienced the expected events of vision blurred and gait disturbance. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was positive only for vaccination site pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. The only events medically significant are vision blurred and gait disturbance because the patient sought medical attention for only these events, the rest of the events were downgrade to non-serious due to no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.