Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Eye haemorrhage, Fatigue, Headache
Clinical narrative: I got blood clot, it was in a different arm the left arm/Since then I had blood clot; blood sugar 510; Bleeding behind the eye due to the sugar blood; Headache; Feeling very fatigued; Not able to function; Feeling tire; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (I got blood clot, it was in a different arm the left arm/Since then I had blood clot), BLOOD GLUCOSE INCREASED (blood sugar 510) and EYE HAEMORRHAGE (Bleeding behind the eye due to the sugar blood) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METFORMIN and INSULIN GLARGINE (LANTUS) for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced FATIGUE (Feeling tire). On 10-Aug-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar 510) (seriousness criterion hospitalization), VACCINATION COMPLICATION (Not able to function) and FATIGUE (Feeling very fatigued). On 26-Aug-2021, the patient experienced THROMBOSIS (I got blood clot, it was in a different arm the left arm/Since then I had blood clot) (seriousness criteria hospitalization and medically significant), EYE HAEMORRHAGE (Bleeding behind the eye due to the sugar blood) (seriousness criterion medically significant) and HEADACHE (Headache). The patient was hospitalized for 3 days until 13-Aug-2021 due to BLOOD GLUCOSE INCREASED. The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Headache, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (I got blood clot, it was in a different arm the left arm/Since then I had blood clot), BLOOD GLUCOSE INCREASED (blood sugar 510), VACCINATION COMPLICATION (Not able to function), HEADACHE (Headache), FATIGUE (Feeling tire) and FATIGUE (Feeling very fatigued) outcome was unknown and EYE HAEMORRHAGE (Bleeding behind the eye due to the sugar blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Blood glucose: 510 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was hospitalized for 3 days, until 13Aug2021.  In addition, the caller said I got blood clot, it was in a different arm, the left arm, blood clot on August 26th and since then I had blood clot.   Also, in the hospital they put her on insulin and pills (put me on insulin and put me on pills for my sugar, and on pills on the blood clot).   The patient take regular meds for blood sugar: Metformin and Lantus and for the blood clot she take Eliquis. Then, for the headache I take what they gave me, pain medicine (Fioricet)  Furthermore, the patient also said: bleeding behind the eye due to the sugar blood and headache. Bleeding still happened and will see the doctor this week.  Company Comment : This case concerns a 61 year-old female patient with no reported medical history, who experienced he unexpected serious events of blood sugar 510, blood clot left arm, and bleeding behind the eye. The event of Blood glucose increased occurred 19 days after the first dose of mRNA-1273 vaccine, the event s of Thrombosis and Eye haemorrhage occurred approximately one month after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 61 year-old female patient with no reported medical history, who experienced the unexpected serious events of blood sugar 510, blood clot left arm, and bleeding behind the eye. The event of Blood glucose increased occurred 19 days after the first dose of mRNA-1273 vaccine, the event s of Thrombosis and Eye haemorrhage occurred approximately one month after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.