Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral vasoconstriction, Eye pain, Headache, Magnetic resonance imaging, X-ray
Clinical narrative: Constent headache and pain behind the right eye.; The MRI showed narrowing of the arteries in the brain; Constent headache and pain behind the right eye.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL VASOCONSTRICTION (The MRI showed narrowing of the arteries in the brain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Limbic encephalitis from June 2005 to 2014. Concurrent medical conditions included Drug allergy (Sulfa drugs). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Allergy, LORATADINE for Allergy NOS, ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL / NORETHINDRONE ACETATE) for Bone density decreased, MIRABEGRON (MYRBETRIQ) for Incontinence.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Constent headache and pain behind the right eye.). On 12-May-2021, the patient experienced CEREBRAL VASOCONSTRICTION (The MRI showed narrowing of the arteries in the brain) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE PAIN (Constent headache and pain behind the right eye.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBRAL VASOCONSTRICTION (The MRI showed narrowing of the arteries in the brain), EYE PAIN (Constent headache and pain behind the right eye.) and HEADACHE (Constent headache and pain behind the right eye.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, X-ray: negative (Negative) Negative. On 12-May-2021, Magnetic resonance imaging: abnormal (abnormal) The MRI showed narrowing of the arteries in the brain.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EYE PAIN (Constent headache and pain behind the right eye.) and HEADACHE (Constent headache and pain behind the right eye.) to be probably related. No further causality assessment was provided for CEREBRAL VASOCONSTRICTION (The MRI showed narrowing of the arteries in the brain).    It was stated that the patient visited specialist on April 26th to check eyes. They said there was no glacoma or macular degeration. On September 27, the patient visited ophthalmologist and doctor scheduled a cat scan, the patient will have on October 8th.  Company Comment: This case concerns a 77-year-old, female patient with previous relevant medical history of limbic encephalitis, who experienced the unexpected event cerebral vasoconstriction. The event occurred 2 month and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The medical history of limbic encephalitis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-281096 (Patient Link).; Sender's Comments: This case concerns a 77-year-old, female patient with previous relevant medical history of limbic encephalitis, who experienced the unexpected event cerebral vasoconstriction. The event occurred 2 month and 20 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The medical history of limbic encephalitis remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.