Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Hypokinesia, Magnetic resonance imaging
Clinical narrative: Brain swelling due to vaccine; headache which is making her teeth and bones hurt; headache which is making her teeth and bones hurt; arm has been hurting and difficult to move; Shaking; Eyes were not tracking or working together. The right eye would move to the center; Jumbled eyesight/ Vision blurred and perspective is wrong; Eyesight very sensitive to light and sound; Pressure; really really bad headache/Extreme head pain; sometime has chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN OEDEMA (Brain swelling due to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (FLUXOTINE) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Brain swelling due to vaccine) (seriousness criterion medically significant), TOOTHACHE (headache which is making her teeth and bones hurt), BONE PAIN (headache which is making her teeth and bones hurt), HYPOKINESIA (arm has been hurting and difficult to move), TREMOR (Shaking), BINOCULAR EYE MOVEMENT DISORDER (Eyes were not tracking or working together. The right eye would move to the center), VISION BLURRED (Jumbled eyesight/ Vision blurred and perspective is wrong), PHOTOPHOBIA (Eyesight very sensitive to light and sound), HEAD DISCOMFORT (Pressure), HEADACHE (really really bad headache/Extreme head pain), CHILLS (sometime has chills) and FATIGUE (Fatigue). At the time of the report, BRAIN OEDEMA (Brain swelling due to vaccine), TOOTHACHE (headache which is making her teeth and bones hurt), BONE PAIN (headache which is making her teeth and bones hurt), HYPOKINESIA (arm has been hurting and difficult to move), TREMOR (Shaking), BINOCULAR EYE MOVEMENT DISORDER (Eyes were not tracking or working together. The right eye would move to the center), VISION BLURRED (Jumbled eyesight/ Vision blurred and perspective is wrong), PHOTOPHOBIA (Eyesight very sensitive to light and sound), HEAD DISCOMFORT (Pressure), HEADACHE (really really bad headache/Extreme head pain), CHILLS (sometime has chills) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. In 2021, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive.         Patient reported that even pain medicines that she took for treatment did not help her. Reporter did not allow further contact.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: New event added from TCR form On 19-May-2021: Case upgraded to serious; 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.