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.
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.
Chief Complaint Neurologic problem (Complaint of) Arrival Date/Time: 01/21/2022 13:05:00 History of Present Illness 5 yo M with hx of autism (non-verbal) presenting with unresponsive episode. Pt was in usual state of health last night when he received his 2nd COVID-19 vaccine. He awoke today with fatigue and malaise that seemed to improve so pt went to school where he was sent home for malaise and fever (temp unknown). After arriving home, father went to change his pull up and while laying down pt was unresponsive and drooling and did not appear to be breathing. His eyes were open and rolled backwards. He appeared limp. No rhythmic jerking but family did say he seemed shaky earlier today. He turned blue during the episode so family called EMS and when police showed up, cyanosis resolved and pt had rapid, shallow breathing. He was sleepy afterwards but slowly improving. POC glucose 185 en route. PIV placed. No meds or interventions performed. Tachy en route 140-150's. He was given tylenol earlier today. PMHx: Autism (non-verbal) Home meds: None. NKDA FMHx: NO hx of seizure or febrile seizure. Social Hx: Lives with family. Attends school. Review of Systems General: +fever, +decerased appetite today Neuro: no headache or focal weakness. Skin: no rashes, bruising. HEENT: no vision changes, nasal congestion, sore throat. Cardiac: no chest pain. Respiratory: no cough, difficulty breathing, shortness of breath. GI: no recent nausea, vomiting, diarrhea. GU: no dysuria, hematuria. MSK: no joint pain or swelling. 10 ROS reviewed and otherwise negative Physical Exam Vitals & Measurements T HR RR BP Sp02 First Set 37.4 DegC (01/21/22 13:15:25) 140 bpm (01/21/22 13:25:13) 28 br/min (01/21/22 13:25:13) 121/63 mmHg (01/21/22 13:25:13) 100 % (01/21/22 13:25:13) VS as above. GEN: sleepy, non-verbal, intermittently follows commands. No acute distress. HEENT: PERRL, clear conjunctiva, oropharynx clear, moist mucous membranes. NECK: supple, full neck ROM. No LAD. CV: RRR, no murmurs. RESP: CTAB. ABD: soft, nontender, non-distended. EXT: warm, well perfused. NEURO: Moves all extremities equally. He is unable to cooperate with strength exam but full strength in lower extremities noted when touching his feet. Normal gait but slow. Normal balance. No tremors. Medical Decision Making 5 yo M with autism (non-verbal) presenting with unresponsive episode with cyanosis in the setting of malaise and fever post-COVID vaccine last night. DDx: febrile seizure, epileptic seizure, syncope, arrhythmia, myocarditis (post-vaccine), acute COVID-19 infection. Plan: chemistry, troponin, EKG, ibuprofen, COVID PCR, observe Reexamination/Reevaluation 15:45 - Pt is still sleeping. Feels warm to touch. HR downtrending. Labs significant for mild hyponatremia (Na 134), neg trop, neg rapid COVID/FLU/RSV PCRs. EKG normal. Will continue to observe to re-assess after waking. 16:57 - Pt is awake, alert and at baseline. Eating a banana. Care instructions and return precautions given to family. Family will follow-up with his primary Neurologist. Given this was a simple febrile seizure, he does not require Neuro consultation in ED or urgent EEG/imaging. Final Diagnosis 1. Febrile seizure Additional information for Item 19: Problem List/Past Medical History Ongoing Autism Global developmental delay Low muscle tone Relative macrocephaly Historical No qualifying data Procedure/Surgical History No Procedure History Family/Social History Basic Social History Living Arrangement Parent(s)/Guardian. Legal Guardian: Parent. Lives With: Mother, Father, Sister. Language Spoken at Home. Medications Prescribed This Visit Prescription No prescriptions for this encounter Allergies No known allergies Most Recent Results Current Encounter Lab Results - Current Encounter Sodium: 134 mmol/L Low (01/21/22 14:32:00) Potassium: 4.38 mmol/L (01/21/22 14:32:00) Chloride: 102 mmol/L (01/21/22 14:32:00) CO2: 20 mmol/L Low (01/21/22 14:32:00) Anion Gap: 12 mmol/L (01/21/22 14:32:00) Glucose Level: 99 mg/dL (01/21/22 14:32:00) BUN: 11 mg/dL (01/21/22 14:32:00) Creatinine: 0.35 mg/dL (01/21/22 14:32:00) Calcium: 9.4 mg/dL (01/21/22 14:32:00) Phosphorus: 4 mg/dL (01/21/22 14:32:00) Magnesium: 2 mg/dL (01/21/22 14:32:00) Troponin T: <0.01 (01/21/22 14:32:00) SARS-CoV-2 POCT: BINEG (01/21/22 14:32:00) Influenza A POCT: BINEG (01/21/22 14:32:00) Influenza B POCT: BINEG (01/21/22 14:32:00) RSV POCT: BINEG (01/21/22 14:32:00) Diagnostic Results EKG: sinus tachycardia, normal intervals, normal axis. rsR' in V1 which is likely normal variant. No pre-excitation, WPW, Brugada, or prolonged QTc.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FL8094 | IM |
| RECVDATE: | 01-29-2022 | RPT_DATE: |
| CAGE_YR: | 5 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Problem List/Past Medical History Ongoing Autism Global developmental delay Low muscle tone Relative macrocephaly Historical No qualifying data |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Fiber gummies, omega-3 supplements |
| CUR_ILL: | |
| HISTORY: | History of non-verbal autism, relative macrocephaly |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 01-29-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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