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.
muscle weakness of limbs; Loss of consciousness; ADHD; Consciousness disturbed; Blepharospasm; eyelids myoclonus-like convulsions; Convulsion/Seizure; Eyeball upturn; felt down; HR was 120 times/min; This is a spontaneous report from a contactable Other Health Professional received from the regulatory authority. Regulatory authority report number is v21128909. A 15-year and 11-month-old female received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021) via an unspecified route of administration on 25Sep2021 at 13:52 at age of 15 years old as a single dose for COVID-19 immunization.Body temperature before vaccination was 36.9 degrees centigrade. Patient's history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included trichotillomania, intestinal obstruction and stature short. Concomitant drugs was not reported. On 25Sep2021 at 13:52 (the day of vaccination), the patient received the first dose of bnt162b2. On 25Sep2021 at 14:07 (15 minutes after the vaccination), the patient experienced consciousness disturbed, Blepharospasm, Eyeball upturn, Convulsion. On 25Sep2021 (the day of vaccination), the patient was admitted to the hospital. On 25Sep2021 (the day of the vaccination), the outcome of the event was not recovered. Clinical course of the events was reported as follows: After vaccination, while the patient was under 15 minutes observation, the patient felt down when standing up, then consciousness disturbed appeared and persisted for 5 minutes. Then eyeball upturn, eyelids myoclonus-liked Convulsion appeared. Blood pressure was 130/60, HR was 120 times/min, RR was 16 times/min, SPO2 was 98%. After that the symptoms were improved. On 25Sep2021 around 15:40 (1 hour 48 minutes after the vaccination), Loss of consciousness appeared again. Because of symptoms of Blepharospasm and muscle weakness of limbs, CERCINE was given by intravenous injection, and then Blepharospasm disappeared. ALEVIATIN was administered. The patient was hospitalized for under observation. On 25Sep2021 at 21:35 (7 hours 43 minutes after the vaccination), there was Seizure. The patient was treated with Diazepam and the symptom tended to improve. On 25Sep2021 at 22:10 (8 hours 17 minutes after the vaccination), Seizure for the third time, Dormicum was used by intravenous injection, and the symptom disappeared. On 25Sep2021 at 22:20 (8 hours 27 minutes after the vaccination), Seizure for the fourth time, increased dose of Dormicum was used by intravenous injection. The patient was transferred to another privacy hospital because it was difficult for our hospital to handle. The reporting Other Health Professional classified the event serious (hospitalization, can lead to disability) and assessed that the event was related to bnt162b2. The other possible cause of the events was ADHD. The reporting Other Health Professional commented as follows: The patient was under observation, and the treatment plan is under discussion. The reason and others will be reported again.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FF9944 |
| RECVDATE: | 10-14-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210925; Test Name: blood pressure; Result Unstructured Data: Test Result:130/60; Comments: after the vaccination; Test Date: 20210925; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before the vaccination; Test Date: 20210925; Test Name: HR; Result Unstructured Data: Test Result:120; Comments: unit: times/min after the vaccination; Test Date: 20210925; Test Name: SOP2; Test Result: 98 %; Comments: after the vaccination; Test Date: 20210925; Test Name: RR; Result Unstructured Data: Test Result:16; Comments: unit: times/min after the vaccination |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Intestinal obstruction; Short stature; Trichotillomania |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101292000 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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