Sex: U
Vaccine: COVID19
Symptoms: Pericarditis, Pulmonary embolism, Thrombosis with thrombocytopenia syndrome
Clinical narrative: IMMUNE THROMBOCYTOPENIA; ANAPHYLAXIS; THROMBOSIS WITH THROMBOCYTOPENIA; ACUTE MYOCARDIAL INFARCTION; DISSEMINATED INTRAVASCULAR COAGULATION; NON-HEMORRHAGIC STROKE; HEMORRHAGIC STROKE; ENCEPHALOMYELITIS; ENCEPHALITIS; NARCOLEPSY; APPENDICITIS; TRANSVERSE MYELITIS; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; MYOCARDITIS; PERICARDITIS; GUILLAIN-BARRE SYNDROME; BELLS PALSY; This solicited report received from a health care professional from literature. The purpose of this study was to summarize the results for 17 outcomes based on biweekly and monthly descriptive monitoring and sequential testing of claims data submitted to large commercial insurance organizations. This extensive study enables signals to be rapidly identified for public health purposes, which can provide preliminary scientific evidence about vaccine safety to clinicians, regulators, and public health officials and prompt further in-depth investigation on this topic. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Among individuals aged 12 to 64 years, a total of 9,604,918 doses were observed in 5,070,372 recipients in the database, 14,146,413 doses were observed in 7,445,051 recipients in the database, and 8,003,958 doses were observed in 4,326,594 recipients in the database. In the database, there were 299,886 Ad26.COV2.S doses; in database, there were 507,120 Ad26.COV2.S doses; in the database, there were 240,595 Ad26.COV2.S doses. Timing of Ad26.COV2.S vaccine administration was similar across age groups and databases with peaks in mid-MAR and mid-APR-2021. Results presented for data through 22-JAN-2022, data through 7-JAN-2022, data through 31-DEC-2021. On an unspecified date, the patient's experienced acute myocardial infarction, disseminated intravascular coagulation, non-hemorrhagic stroke, hemorrhagic stroke, encephalomyelitis, encephalitis, narcolepsy, appendicitis, transverse myelitis, deep vein thrombosis, pulmonary embolism, immune thrombocytopenia, myocarditis, pericarditis, guillain-barre syndrome, bells palsy, anaphylaxis, and thrombosis with thrombocytopenia. Safety signals were not detected following vaccination with Ad26.COV.2.S in study. While analysis found a relatively large rate ratio associated with GBS following Ad26.COV2.S, the test did not meet the statistical threshold for a signal and reflected substantial uncertainty with very few observed events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myocardial infarction, deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, non-hemorrhagic stroke, hemorrhagic stroke, immune thrombocytopenia, myocarditis, pericarditis, guillain-barre syndrome, bells palsy, encephalomyelitis, encephalitis, anaphylaxis, transverse myelitis, narcolepsy, appendicitis and thrombosis with thrombocytopenia was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenia, anaphylaxis, transverse myelitis, deep vein thrombosis, pulmonary embolism, myocarditis, pericarditis, guillain-barre syndrome, bells palsy, and thrombosis with thrombocytopenia was related, and between covid-19 vaccine ad26.cov2.s, and acute myocardial infarction, disseminated intravascular coagulation, non-hemorrhagic stroke, hemorrhagic stroke, encephalomyelitis, encephalitis, narcolepsy, and appendicitis was not related.  The authors emphasized that near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method was intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method's utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231129711- immune thrombocytopenia, anaphylaxis, thrombosis with thrombocytopenia, transverse myelitis, deep vein thrombosis, pulmonary embolism, myocarditis, pericarditis,  guillain-barre syndrome, bells palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. 20231129711- acute myocardial infarction, disseminated intravascular coagulation, non-hemorrhagic stroke, hemorrhagic stroke, encephalomyelitis, encephalitis, narcolepsy, appendicitis.The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.