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.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
Date of Admission: 6/19/2021 Date of Death: 6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field, found to be in the context of large cerebellar hemorrhage secondary to brain lesion (AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine drips to maintain perfusion and was administered bicarbonate x2. Head CTA was obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no contrast enhanced blood flow in the brain. Brain death exams were completed at 09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of brain death. Official cause of death was brainstem herniation from intracranial hemorrhage. Mechanical ventilation was continued to allow family time to grieve and perform last rites. Time of cardiac death after mechanical ventilation withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart rate. His sodium was 141 upon presentation but reached a maximum of 160 due to central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to improve hypernatremia, which was monitored Q1h until normonatremic. He additionally required vasopressin drip to be started due to central DI, which was increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission, he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine and norepinephrine were discontinued. Two doses of adenosine were administered (6 mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4 seconds after the second dose however returned to ~180. EKG arrived which showed sinus tachycardia so no further medications or cardiac interventions were done. Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was administered. Norepinephrine and epinephrine were restarted and escalated due to low blood pressures in the early afternoon.to allow family time with patient. Both titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had no primary pulmonary disease during this admission. Neuro: #Intraparenchymal hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and hypertonic saline 23% x1 were administered to decrease intracranial pressures. Keppra 2g was administered for seizure prophylaxis. No sedation was needed during patient's hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp 36.5 C (97.7 F) | Resp (!) 15 | Ht 1.65 m (5' 4.96") | Wt 46.5 kg (102 lb 8.2 oz) | SpO2 99% | BMI 17.08 kg/m Estimated body mass index is 17.08 kg/m as calculated from the following: Height as of this encounter: 1.65 m (5' 4.96"). Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug Allergies
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|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EW0191||IM||Unknown|
|LAB_DATA:||see above. Was covid positive on admission 6/19. Family gave a history of previous covid infection earlier this year.|
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