Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Exposure during pregnancy, Headache, Magnetic resonance imaging head, Nervous system disorder
Clinical narrative: THROMBOCYTOPENIA; DECREASED/ALTERED CONSCIOUSNESS; NEUROLOGIC DEFICIT; CURRENT/RECENT PREGNANCY; HEADACHE; VOMITING; This solicited report received from a health care professional via literature concerned a multiple female patients of unspecified age. The patients were enrolled in a non-company sponsored study. Aim: Cases of cerebral venous thrombosis (CVT) associated with vaccine induced thrombotic thrombocytopenia (VITT) were reported following administration of the adenoviral vector COVID-19 vaccines, resulting in a pause in Ad.26.COV2.S vaccine administration. This study aimed to quantify and characterize an anticipated increase in brain venograms performed in response to this pause. Brain venogram cases were retrospectively identified during the 3-week period following the vaccine pause and during the same calendar period in 2019. For venograms performed in 2021, we compared COVID vaccinated to unvaccinated patients. The patients height, and weight were not reported. The patient's pre-existing medical conditions included: Para and gravida are Unknown. It was not reported whether the patient had been pregnant before. The patients received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Study method: To determine the difference in brain venogram utilization following the pause compared to historical cohorts, the total number of venograms performed from April 14-APR-2019 to 05-MAY-2019 (pre-pandemic) and 2020 (pandemic) were compared to the same 3-week period in 2021. The 2021 cohort was divided into vaccinated versus unvaccinated patients for comparative analyses. Cases were identified in a retrospective cross-sectional manner based on the inclusion criteria of age 18 and older who had a computed tomography brain venogram (CTV) or magnetic resonance brain venogram (MRV) performed/ Patients less than 18 years of age and any patient with health records not accessible via our electronic medical record (EMR) were excluded from the study. Patients excluded who had a repeat venogram performed to assess progression or resolution of a previously diagnosed CVT. Individual cases were identified by querying the radiology report database. Data abstracted from our EMR included patient demographics, CVT symptoms, CVT risk factors, comorbidities, radiologic evaluation, and additional non imaging diagnostic workup. Vaccination status was verified. Data analyzed with standard statistical methods. Descriptive statistics are reported as means with corresponding standard deviations for continuous variables and percentages for categorical variables. Univariate analysis was performed to compare the vaccinated versus unvaccinated cohorts. Categorical variables were evaluated using Pearson's chi-squared and Fisher's exact test where appropriate. Continuous and ordinal variables were evaluated using Wilcoxon 2-sample tests. Statistical significance was set at p = 0.05, and all reported p values are two-tailed. On an unspecified date, the patients experienced thrombocytopenia, decreased/altered consciousness, neurologic deficit, current/recent pregnancy, headache, and vomiting (dose series 1). The date of the patients last menstrual period and expected delivery date were not reported. Laboratory data (dates unspecified) included: CT venograph not provided, MRI brain not provided, and Platelet count less-than (<) 150 × 10 9/L. Results: There was a 262% increase (dramatic increase) in the number of venograms performed when comparing the same 3-week period from 2021 (n = 94) following the vaccine (Ad.26.COV2.S COVID-19) pause to 2019 (n = 26). In contrast, there were 117,335 radiologic studies performed during the 3-week period in 2021, versus 98,406 in 2019, representing only a 19% increase in all radiologic studies performed. Additional relative changes of venograms and all radiologic studies performed in 2019, 2020, and 2021. For patients undergoing venography in 2021, 56% (n = 53/94) of venograms were performed in the ED, 32% (n = 30/94) were performed as an inpatient, and 12% (n = 11/94) were ordered as outpatient studies. 57% (n = 54) of patients had a history of COVID-19 vaccination, with the majority being Ad.26.COV2.S vaccinations. A comparison of COVID-19 vaccinated versus unvaccinated patients undergoing venography in 3-week study period is provided performed. Significantly more vaccinated versus unvaccinated patients had a headache (94% versus 70%, p = 0.001), but otherwise lacked compelling presentations for CVT, such as decreased/altered consciousness (7% vs 23%, p = 0.036), neurologic deficit (headache) (28% vs 48%, p = 0.049), and current/recent pregnancy (2% vs 28%, p = 0.0003). No COVID-19 vaccinated patients were diagnosed with a CVT, versus 5% (n = 2) in the unvaccinated group. Of COVID-19 vaccinated patients undergoing venography, 83% (n = 45) had a platelet count performed, of whom only 1 had thrombocytopenia, defined as less-than (<) 150 × 10 9/L. Additionally, only 5.6% (n = 3) of patients had a D-dimer performed, with no values markedly elevated and consistent with vaccine induced thrombotic thrombocytopenia (> 4 times upper limit of normal). This study suggests that the observed increase in venogram utilization occurred in a population at low risk for CVT. Therefore, in patients recently vaccinated with an adenoviral vector COVID-19 vaccine, in the absence of thrombocytopenia and D-dimer elevation, especially without other compelling CVT risk factors or symptom it may be prudent to reconsider pursuing venography. Clinicians should carefully consider if brain venogram performance is indicated in COVID-19 vaccinated patients lacking thrombocytopenia and D-dimer elevation, especially without other compelling CVT risk factors or symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neurologic deficit, current/recent pregnancy, decreased/altered consciousness, headache, thrombocytopenia and vomiting was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and thrombocytopenia, decreased/altered consciousness, neurologic deficit, current/recent pregnancy, headache, and vomiting was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Altered state of consciousness, Thrombocytopenia. 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.