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.
Intussusception; This is a spontaneous report from the regulatory authority. The regulatory authority number is v20100768. A contactable physician reported that a 2-month-old male infant received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe, lot number; DC9617, expiration date: 31Aug2022), via an unspecified routed of administration on 21Jan2021 12:10 at single dose for immunization, first doses of rotavirus vaccine live oral 1v (ROTARIX, GSK, lot number; RT014), hib vaccine conjugate (tetanus vaccine toxoid) (ACTHIB, Sanofi, lot number; R1F61), and hepatitis b vaccine rhbsag (yeast) (BIMMUGEN, Biologics, lot number; Y118L), all via unspecified route of administration on 21Jan2021 12:10, at 1, single for immunisation. Birth weight was 4150 g. Body temperature before vaccinations was 36.5 degrees centigrade. The infant was the 2nd child of his family. He had an elder sister. The family member had no symptom. The infant had no relevant medical history. On 24Jan2020, the infant presented with intussusception at 08:30 am. The clinical course was as follows: Bloody stool and vomiting developed at 08:30 on 24Jan2021. The infant visited the pediatric department of the reporter's hospital at 10:30. Dance sign was observed. Abdominal ultrasound showed target sign. Gastrografin barium enema examination revealed the advanced part in the ascending colon, and barium running through the ileocecum was confirmed, and then, the treatment was completed. Invagination of intestine was diagnosed and the infant was hospitalized. On 25Jan2021, no recurrence of symptoms was observed, and the infant was discharged from the hospital. The event was recovering as of 25Jan2021. The reporting physician classified the event, intussusception, as serious (hospitalization) and assessed it as related to vaccinations. There was no other factor contributing to the event. Reporter's comment: Invagination of intestine developed 3 days after the vaccinations and an adverse reaction caused by rotavirus vaccine live oral 1v was diagnosed.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
HIB (ACTHIB) | 1 | HIBV | SANOFI PASTEUR | R1F61 | Unknown | Unknown |
HEP B (NO BRAND NAME) | 1 | HEP | Unknown | Y118L | Unknown | Unknown |
PNEUMO (PREVNAR13) | 1 | PNC13 | PFIZER\WYETH | DC9617 | Unknown | Unknown |
ROTAVIRUS (ROTARIX) | 1 | RV1 | GLAXOSMITHKLINE BIOLOGICALS | RT014 | Unknown | Unknown |
RECVDATE: | 02-04-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | 1 |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Test Date: 20210121; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210124; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:target sign; Test Name: Birth weight; Test Result: 4150 g; Test Date: 20210124; Test Name: Gastrografin barium enema examination; Result Unstructured Data: Test Result:Assessment; Comments: revealed the advanced part in the ascending colon |
V_ADMINBY: | OTH |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | JPPFIZER INC2021077692 |
FORM_VERS: | |
TODAYS_DATE: | 02-03-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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