Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chest X-ray, Computerised tomogram, Confusional state, Feeling abnormal
Clinical narrative: Urinary tract infection; Multiple clots in my lungs/multiple blood clots in her right lung; Could not remember which day of the week it was; A little bit confused; Not 100% me; Asking the same questions; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), THROMBOSIS (Multiple clots in my lungs/multiple blood clots in her right lung), MEMORY IMPAIRMENT (Could not remember which day of the week it was), CONFUSIONAL STATE (A little bit confused), FEELING ABNORMAL (Not 100% me) and ABNORMAL BEHAVIOUR (Asking the same questions) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Family history included Stroke.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), THROMBOSIS (Multiple clots in my lungs/multiple blood clots in her right lung) (seriousness criteria hospitalization and medically significant), MEMORY IMPAIRMENT (Could not remember which day of the week it was) (seriousness criterion hospitalization), CONFUSIONAL STATE (A little bit confused) (seriousness criterion hospitalization), FEELING ABNORMAL (Not 100% me) (seriousness criterion hospitalization) and ABNORMAL BEHAVIOUR (Asking the same questions) (seriousness criterion hospitalization). The patient was hospitalized on 19-Aug-2021 due to ABNORMAL BEHAVIOUR, CONFUSIONAL STATE, FEELING ABNORMAL, MEMORY IMPAIRMENT, THROMBOSIS and URINARY TRACT INFECTION. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency. On 19-Aug-2021, MEMORY IMPAIRMENT (Could not remember which day of the week it was), CONFUSIONAL STATE (A little bit confused), FEELING ABNORMAL (Not 100% me) and ABNORMAL BEHAVIOUR (Asking the same questions) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and THROMBOSIS (Multiple clots in my lungs/multiple blood clots in her right lung) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) Found multiple blood clots in her right lung. On an unknown date, Computerised tomogram: abnormal (abnormal) Found multiple blood clots in her right lung. On an unknown date, Fibrin D dimer: abnormal (abnormal) Found multiple blood clots..         Laboratory information included patient had urinary tract infection and CT scan of head with unknown result.  No relevant concomitant medications were reported.  Company Comment : This case concerns a 74-year-old female patient with relevant family history of stroke, who experienced the unexpected events of Urinary Tract Infection, Thrombosis, Confusional State, Memory Impairment, Feeling Abnormal and Abnormal Behavior. The events occurred approximately 5 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The family history of Stroke remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient with relevant family history of stroke, who experienced the unexpected events of Urinary Tract Infection, Thrombosis, Confusional State, Memory Impairment, Feeling Abnormal and Abnormal Behavior. The events occurred approximately 5 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the second dose was disclosed. The family history of Stroke remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.