Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Ocular discomfort, Platelet count, Thrombocytopenia, Visual impairment
Clinical narrative: Thrombocytopenia/platelets still low; Bruises all over her body/bruises; Eyes weird; Troubled vision; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia/platelets still low) and CONTUSION (Bruises all over her body/bruises) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia/platelets still low) (seriousness criteria hospitalization and medically significant), CONTUSION (Bruises all over her body/bruises) (seriousness criterion hospitalization), OCULAR DISCOMFORT (Eyes weird) and VISUAL IMPAIRMENT (Troubled vision). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia/platelets still low) and CONTUSION (Bruises all over her body/bruises) had not resolved and OCULAR DISCOMFORT (Eyes weird) and VISUAL IMPAIRMENT (Troubled vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: low (Low) Still Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOCYTOPENIA (Thrombocytopenia/platelets still low) and CONTUSION (Bruises all over her body/bruises) to be possibly related. No further causality assessments were provided for OCULAR DISCOMFORT (Eyes weird) and VISUAL IMPAIRMENT (Troubled vision).    No concomitant medications were reported.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 44-year-old, female patient with no medical history reported, who experienced the unexpected, serious AESI of thrombocytopenia and the unexpected, serious event of contusion and other associated unexpected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. About less than 3 weeks after vaccination, the patient experienced thrombocytopenia. She had bruises all over the body and was hospitalized a number of times. Laboratory test results were not provided but the report mentioned that the platelets were still low. The patient got a little bit better but the bruises recurred. She sought consult with a health care provider who suggested that perhaps the events were related to the vaccine. It was also reported that the vaccine made the patient's eyes 'weird' and she had 'troubled vision'. Treatment information was not provided. The events thrombocytopenia and contusion had not resolved at the time of the report. The outcomes of the other unexpected, non-serious events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with no medical history reported, who experienced the unexpected, serious AESI of thrombocytopenia and the unexpected, serious event of contusion and other associated unexpected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. About less than 3 weeks after vaccination, the patient experienced thrombocytopenia. She had bruises all over the body and was hospitalized a number of times. Laboratory test results were not provided but the report mentioned that the platelets were still low. The patient got a little bit better but the bruises recurred. She sought consult with a health care provider who suggested that perhaps the events were related to the vaccine. It was also reported that the vaccine made the patient's eyes 'weird' and she had 'troubled vision'. Treatment information was not provided. The events thrombocytopenia and contusion had not resolved at the time of the report. The outcomes of the other unexpected, non-serious events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.