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.
sick; lethargic; throwing up; woke up and had some phlegm and couldn't get it up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FK52A) at the age of 5 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Febrile seizure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu vaccine. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; LETHARGY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "lethargic"; VOMITING (non-serious) with onset 10Nov2021, outcome "not recovered", described as "throwing up"; PRODUCTIVE COUGH (non-serious) with onset 10Nov2021, outcome "unknown", described as "woke up and had some phlegm and couldn't get it up". Therapeutic measures were not taken as a result of illness, lethargy, vomiting, productive cough. Additional Information: Caregiver was Calling on the behalf of her son (male, 5 and half years old) who got a pediatric Pfizer Covid19 vaccine, has been feeling very lethargic, throwing up, initially he was sick on Wednesday was fine yesterday and sick again this morning. Reporter states she is calling regarding the Pediatric Covid shot, clarified that she is referring to the Pfizer pediatric Covid shot. She states that her 5-and-a-half-year-old son got his shot Monday. On Wednesday, he had one episode where he threw up, then he was fine. Today, he woke up at pone point and threw up and was quite a bit lethargic. He has no fever. He woke up about 6:00am and he tried to eat breakfast, which did not go over very well. He is still sleeping and has been waking up and then he threw up and fell back asleep. He threw up twice Wednesday morning and they kept him home from school. Then, by lunch time, he looked like a new kid, and he went to school Thursday. It started back up this morning. He looks worse now. She thought on Wednesday, it was just the flu. He woke up and had some phlegm and couldn't get it up. He only had a little episode in the morning, and they thought it was congestion. Treatment was no, they were going to give him some Guaifenesin, but he looked fine Wednesday and they didn't worry. They haven't given him anything. The Vaccination Facility Type was Pharmacy/Drug Store No follow-up attempts are possible. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FK52A | LA |
| RECVDATE: | 03-15-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Febrile seizure |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101572418 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-14-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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