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.
diarrhoea; Hypothyroidism; Hepatic function disorder; Pyrexia; This is a spontaneous report initial received from a contactable pharmacist via regulatory authority and Follow-up received on 09Oct2021 from a contactable physician from the regulatory authority. Regulatory authority report number is v21129085. A 12-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly administered in left arm on 29Sep2021 at 16:30 (Batch/Lot Number: FG0978; Expiration Date: 30Nov2021) at age of 12-year-old as single dose for covid-19 immunisation. There were no points to be considered on 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). Prior to vaccination, the patient was not diagnosed with COVID-19. Body temperature before vaccination was 36.7 degrees Centigrade. The patient's concomitant medications were not reported. On 30Sep2021 at 16:30 (one day after the vaccination), the patient experienced hypothyroidism and pyrexia and hepatic function disorder. The course of the event was as follows: On 30Sep2021 from about 16:30, the patient experienced pyrexia of 38~40 degrees centigrade. From 04Oct2021, the patient experienced diarrhoea. On 06Oct2021, blood test showed hepatic function disorder and the patient was admitted to reporter's hospital. On 06Oct2021, Blood test showed AST increased to 299, ALT increased to 261, gamma-GTP increased to 186. On 07Oct2021, Blood test showed high value of ASL 318, ALT 322, gamma-GTP 280. Abdominal echo showed Scattered abdominal lymph nodes. On 08Oct2021, pyrexia tended to abated. The cause reason was still under scrutiny. Patient received treatment including Liver protectant, drip infusion, antipyrectic. Since the vaccination, the patient has been tested for COVID-19 (Antigen quantitative test) negative. On 08Oct2021 (8 days after the vaccination), the outcome of the events was not recovered. The reporting physician classified the event as serious (caused hospitalization from 06Oct2021 and still in hospitalization as of 08Oct2021) and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was that viral infection or immunization disease.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the event hypothyroidism cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FG0978 | OT | LA |
| RECVDATE: | 10-22-2021 | 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: 20211006; Test Name: blood test; Result Unstructured Data: Test Result:hepatic funcion disorder; Test Date: 20210929; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210930; Test Name: body temperature; Result Unstructured Data: Test Result:38~40 Centigrade; Test Date: 20211006; Test Name: Antigen quantitative test; Test Result: Negative ; Test Date: 20211007; Test Name: abdominal echo; Result Unstructured Data: Test Result:Scattered abdominal lymph nodes; Test Date: 20211006; Test Name: ALT; Result Unstructured Data: Test Result:261; Comments: increased; Test Date: 20211007; Test Name: ALT; Result Unstructured Data: Test Result:322; Comments: high value; Test Date: 20211006; Test Name: AST; Result Unstructured Data: Test Result:299; Comments: increased; Test Date: 20211007; Test Name: AST; Result Unstructured Data: Test Result:318; Comments: high value; Test Date: 20211006; Test Name: gamma-GTP; Result Unstructured Data: Test Result:186; Comments: increased; Test Date: 20211007; Test Name: gamma-GTP; Result Unstructured Data: Test Result:280; Comments: high value |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101334078 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-21-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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