Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dehydration, Electrocardiogram, Eye haemorrhage, Migraine
Clinical narrative: slight headache that progressively got worse to the point of a migraine; severely dehydrated; fever; migraine so severe that blood was coming out of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (migraine so severe that blood was coming out of her eyes), MIGRAINE (slight headache that progressively got worse to the point of a migraine) and DEHYDRATION (severely dehydrated) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced EYE HAEMORRHAGE (migraine so severe that blood was coming out of her eyes) (seriousness criterion medically significant), MIGRAINE (slight headache that progressively got worse to the point of a migraine) (seriousness criterion hospitalization), DEHYDRATION (severely dehydrated) (seriousness criterion hospitalization) and PYREXIA (fever). On 05-Jun-2021, MIGRAINE (slight headache that progressively got worse to the point of a migraine) was resolving. At the time of the report, EYE HAEMORRHAGE (migraine so severe that blood was coming out of her eyes), DEHYDRATION (severely dehydrated) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found that she was severely dehydrated. On an unknown date, Electrocardiogram: abnormal (abnormal) found that she was severely dehydrated. On an unknown date, X-ray: abnormal (abnormal) found that she was severely dehydrated.         Concomitant product use was not provided by the reporter.   Patient was placed on IV for dehydration and a shot for migraine which made migraine worse and that it was so severe that blood was coming out of her eyes. Patients blood type was A positive.  Company comment: This case concerns a 38-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of eye haemorrhage, dehydration, and migraine, among another non-serious event. The events occurred 8 days after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-330419, MOD-2021-330845 (Patient Link).; Sender's Comments: This case concerns a 38-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of eye haemorrhage, dehydration, and migraine, among another non-serious event. The events occurred 8 days after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.