Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Diplopia, Headache, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Venous Sinus Thrombosis; Headache continued; She had an event where she lost consciousness; double vision; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She had an event where she lost consciousness), VENOUS THROMBOSIS (Venous Sinus Thrombosis) and HEADACHE (Headache continued) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 610M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myelodysplasia (she has Myelodysplasia, Osteopenia), Osteopenia (she has Myelodysplasia, Osteopenia) and Breast cancer (had breast cancer 17 years ago but has not had any problems since then). Previously administered products included for an unreported indication: XARELTO and ADVIL [IBUPROFEN]. Concomitant products included EPOETIN ALFA (PROCRIT), CITALOPRAM HYDROBROMIDE (CITALOPRAM [CITALOPRAM HYDROBROMIDE]), LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) and APIXABAN (ELIQUIS) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (She had an event where she lost consciousness) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced VENOUS THROMBOSIS (Venous Sinus Thrombosis) (seriousness criteria hospitalization prolonged and medically significant), HEADACHE (Headache continued) (seriousness criterion hospitalization prolonged) and DIPLOPIA (double vision). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LOSS OF CONSCIOUSNESS (She had an event where she lost consciousness), VENOUS THROMBOSIS (Venous Sinus Thrombosis) and DIPLOPIA (double vision) outcome was unknown and HEADACHE (Headache continued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Angiogram: abnormal (abnormal) blood clot. On 23-Jul-2021, Magnetic resonance imaging: abnormal (abnormal) blood clot.         Patient was received blood thinner for 2 months.  She stated that she had neurological problems with double vision, and headaches since she received the Moderna vaccine.  The hematologist put on Lovenox for a week and then started on Eliquis. Lot number reported is 025A21A.  Company comment: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidities, additional information required.   This case was linked to MOD-2021-281091 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Live Follow up received on 09-Aug-2021, it contains significant information. Medical history was added. Lab tests was added. Concomitant medication were added. Events updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidities, additional information required