Sex: U
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Ehlers-Danlos syndrome, Fatigue, Mast cell activation syndrome, Myocarditis
Clinical narrative: MAST CELL ACTIVATION SYNDROME; MYOCARDITIS; POTS (POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME); EHLER-DANLOS SYNDROME; DYSAUTONOMIA; URINARY TRACT INFECTIONS; FATIGUE; This solicited report received from a consumer via NON-COMPANY STUDY: No Description Available, concerned multiple patients (19637 approximately). This patient was also referenced in literature.  The patient's weight, height, and medical history were not reported. The objective of the authors was to evaluated the relation between COVID-19 vaccination and new Postural orthostatic tachycardia syndrome (POTS) related diagnoses by assessing the odds of diagnosis in the baseline 90?days before first vaccine exposure versus the subsequent 90?days after vaccine exposure in a sequence symmetry analysis. For the post-vaccination analysis, they studied 284,592 patients. The types of vaccinations received included: 62 percent Pfizer-BioNTech (BNT162b2); 31 percent Moderna (mRNA-1273); 6.9 percent Johnson & Johnson/Janssen (Ad26.COV2.S); and less than 0.1 percent other vaccines, including AstraZeneca (ChAdOx1-S), Novavax (NVX-CoV2373) and Sinovac (CoronaVac). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported 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. On an unspecified date, the patient experienced pots (postural orthostatic tachycardia syndrome) and it was clinically diagnosed on the basis of orthostatic dizziness, pre-syncope, palpitations, and a table tilt test or 10.0-minute standing test demonstrating elevated heart rate when changing from a supine position to a standing position. In primary cohort study the relation of COVID-19 vaccination with POTS diagnoses, the primary exposure was first COVID-19 vaccination. Of all patients who had at least one COVID-19 vaccination dose documented (n?=?289,662), authors excluded those with SARS-CoV-2 infection before and within 90?days after the first vaccination dose (n?=?5,070). We identified new diagnoses occurring within 90?days of exposure, associated with an outpatient encounter and defined by codes or grouping. They considered three groups of diagnoses: POTS-associated diagnoses, myocarditis and CPC diagnoses. Given the lack of a single code for POTS, we garnered expert opinion from clinical specialists to define a POTS-associated group of diagnoses that includes dysautonomia, other specified cardiac dysrhythmias (the primary ICD code, herein referred to as POTS), mast cell activation syndrome, urinary tract infection (UTI) and related disorders, EDS and fatigue. The Patients with POTS-associated diagnoses (n?=?1,924) after vaccination had similar demographics and vaccine types compared to the overall population. The CPC diagnoses were prospectively selected from codes frequently documented in primary care 35, excluding diagnoses with strong biological plausibility for being directly related to COVID-19 (for example, upper respiratory infection, cough and fever). To assess the validity of our approach to identifying possible POTS diagnoses, we conducted clinical adjudication of 50 sequentially encountered patients identified has having both the codes. From this adjudication process, we observed that 40 (80 percent) were either formally confirmed POTS through comprehensive diagnostic testing or with signs and symptoms consistent with guidelines definitions of POTS but still awaiting full diagnostic testing for confirmation. We used limited but available codes in attempts to identify POTS diagnoses with optimal sensitivity and specificity while recognizing that misclassification can result from both variable coding patterns and the prior absence of a unique code for POTS. Notwithstanding the acceptable results of having clinically adjudicated a subset of our identified cases, we recognize that our analyses of data are intrinsically subject to non-differential misclassification that generally tends to bias results toward the null. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pots (postural orthostatic tachycardia syndrome), myocarditis, ehler-danlos syndrome, fatigue, dysautonomia, urinary tract infections and mast cell activation syndrome was not reported. Their results identify a possible association between COVID-19 vaccination and incidence of POTS. Notwithstanding the probable low incidence of POTS after COVID-19 vaccination, particularly when compared to SARS-Cov-2 post-infection odds, which were five times higher, our results suggest that further studies are needed to investigate the incidence and etiology of POTS occurring after COVID-19 vaccination The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and mast cell activation syndrome, pots (postural orthostatic tachycardia syndrome), ehler-danlos syndrome, dysautonomia, and urinary tract infections was not related, and between Myocarditis, covid-19 vaccine ad26.cov2.s, and fatigue was related.  This report was serious (Other Medically Important Condition). This case is a duplicate of 20221258839 and 20221258725.  It was determined that Manufacturer Case Number (20221258839 and 20221258725) was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number (20221250463); Sender's Comments: V0- 20221250463-Mast cell activation syndrome. 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.  V0- 20221250463- Myocarditis. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. 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 related.