Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
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Thrombosis with thrombocytopenia; Thrombosis with thrombocytopenia; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP098758) on 27-Sep-2021 and was forwarded to Moderna on 01-Oct-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21127721). The patient was born a premature baby and had mild intellectual disability, but no other abnormalities were noted including abnormal blood clotting. On 07-Sep-2021, the patient received the 1st dose of this vaccine. On 16-Sep-2021, the patient experienced vomiting. On 17-Sep-2021, the patient experienced headache. On 20-Sep-2021, the patient received detailed examinations, and simple CT and MRI (MRV) showed occlusion of the right transverse venous sinus, venous infarction in the right temporal occipital lobe, and hemorrhagic infarction. Venous infarction and haemorrhage due to venous sinus thrombosis were diagnosed. On 21-Sep-2021, the patient was hospitalized. Neurological symptoms were suspected to be left homonymous hemianopsia, and the patient was scheduled for detailed examinations by an ophthalmologist. Contrast-enhanced CT for systemic screening revealed suspected thrombus in the right transverse venous sinus and multiple thrombi in the lung. When the patient visited a hospital, blood collection showed Plt of 130,000/mcL and D-dimer of 18.5 mcg/mL. No other causes of clotting abnormality or history of heparin use were found in the various blood samples. Thrombosis with thrombocytopenia (TTS) was suspected, and it was confirmed that there was no increase in hemorrhage, and administration of argatroban hydrate was started. Headache tended to improve. Antiplatelet factor 4 antibody (latex agglutination) showed positive. On 26-Sep-2021, the symptoms were resolving. The measurement of antiplatelet factor 4 antibody with ELISA was planned to be requested to a university institution. The situation applied to all commonly stated criteria for TTS today. The outcome of thrombosis with thrombocytopenia was reported as resolving. (Blood test) (Date of test: 21-Sep-2021) Blood count: No aggregation findings in smear. (Echography) (Date of test: 21-Sep-2021) Imaging site: Heart Findings of thrombosis and embolism: None No abnormality in the echography. (CT scan) (Date of test: 21-Sep-2021) No imaging Imaging site: Head Findings: Hemorrhagic infarction (MRI examination) (Date of test: 21-Sep-2021) No imaging, Imaging site: Head Findings of thrombosis and embolism: Suspected Findings: Sigmoid venous sinus occlusion in the right transverse sinus (Chest X-ray examination) (Date of test: 21-Sep-2021) Findings of thrombosis and embolism: None (Blood test) (Date of test: 22-Sep-2021) Anti-HIT antibody (test method: latex agglutination): Positive 1.6 U/mL (CT scan) (Date of test: 24-Sep-2021) With imaging Imaging site: Head to lower extremities Findings: Right transverse sinus thrombus and pulmonary artery thrombosis (SARS-CoV-2 test) (Date of test: 24-Sep-2021) Nucleic acid amplification: Negative Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: Approximately 2 weeks after the vaccination, venous infarction due to venous sinus thrombosis, haemorrhage, and multiple thrombi in the pulmonary artery developed. Plt: 130,000/mcL, and D-dimer: 18.5 mcg/mL. Latex agglutination was made and tested positive for antiplatelet factor 4 antibody.; Sender's Comments: This case concerns a 15-year-old female patient with no relevant medical history, who experienced serious AESI, unlisted event of Thrombocytopenia and thrombosis. The events occurred approximately 10 days after 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the dose detail was not provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 3005293 | OT |
| RECVDATE: | 10-06-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | Y |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210921; Test Name: Blood test; Result Unstructured Data: No aggregation findings in smear.; Test Date: 20210922; Test Name: Blood test; Test Result: Positive ; Result Unstructured Data: Anti-HIT antibody (test method: latex agglutination): Positive 1.6 U/mL; Test Date: 20210921; Test Name: Chest X-ray examination; Result Unstructured Data: Findings of thrombosis and embolism: None; Test Date: 20210920; Test Name: CT Scan; Result Unstructured Data: showed occlusion of the right transverse venous sinus, venous infarction in the right temporal occipital lobe, and hemorrhagic infarction; Test Date: 20210921; Test Name: CT Scan; Result Unstructured Data: No imaging Imaging site: Head Findings: Hemorrhagic infarction; Test Date: 20210924; Test Name: CT Scan; Result Unstructured Data: With imaging Imaging site: Head to lower extremities Findings: Right transverse sinus thrombus and pulmonary artery thrombosis; Test Date: 20210921; Test Name: D-dimer; Result Unstructured Data: 18.5 mcg/mL; Test Date: 20210920; Test Name: MRI; Result Unstructured Data: showed occlusion of the right transverse venous sinus, venous infarction in the right temporal occipital lobe, and hemorrhagic infarction; Test Date: 20210921; Test Name: MRI; Result Unstructured Data: No imaging, Imaging site: Head Findings of thrombosis and embolism: Suspected Findings: Sigmoid venous sinus occlusion in the right transverse sinus; Test Date: 20210921; Test Name: Plt; Result Unstructured Data: 130,000/mcL; Test Date: 20210924; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210921; Test Name: Echography; Result Unstructured Data: Imaging site: Heart Findings of thrombosis and embolism: None No abnormality in the echography. |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPMODERNATX, INC.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-05-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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