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.
Cardiac arrest; abdominal pain; HEMATEMESIS/ vomited blood; DIFFICULTY OF BREATHING; spO2 of 45%; Cardiac rate of 197 bpm; Fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300138966 (RA). An 8 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 18Feb2022 (Lot number: FR8392) at the age of 8 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (death) with onset 04Mar2022 10:00, outcome "fatal", described as "Fever"; HEADACHE (death) with onset 04Mar2022 10:00, outcome "fatal", described as "Headache"; ABDOMINAL PAIN (death) with onset 06Mar2022 17:00, outcome "fatal", described as "abdominal pain"; HAEMATEMESIS (death) with onset 06Mar2022, outcome "fatal", described as "HEMATEMESIS/ vomited blood"; DYSPNOEA (death) with onset 06Mar2022, outcome "fatal", described as "DIFFICULTY OF BREATHING"; OXYGEN SATURATION DECREASED (medically significant) with onset 06Mar2022, outcome "unknown", described as "spO2 of 45%"; HEART RATE INCREASED (medically significant) with onset 06Mar2022, outcome "unknown", described as "Cardiac rate of 197 bpm"; CARDIAC ARREST (medically significant), outcome "unknown", described as "Cardiac arrest". On 04Mar2022, patient had fever and headache (with check-up at Private Clinic). On 06Mar2022, patient had abdominal pain, vomited blood and complained of difficulty of breathing (Oxygen given); with check-up, upon assessment the patient with Cardiac Rate of 197bpm; spO2 of 45%. The patient again vomited blood; ROD advised intubation but emergency kits were unavailable; patient transferred to other hospital - ECG done twice; patient was also intubated; IV fluids were also given. The patient suffered from Cardiac Arrest and was revived and emergency drugs were given intravenously. The patient underwent the following laboratory tests and procedures: electrocardiogram: (06Mar2022) unknown results, notes: twice; heart rate: (06Mar2022) 197 bpm; oxygen saturation: (06Mar2022) 45 %. Therapeutic measures were taken as a result of pyrexia, headache, abdominal pain, haematemesis, dyspnoea, oxygen saturation decreased, heart rate increased, cardiac arrest. The patient date of death was unknown. The reported cause of death was abdominal pain, pyrexia, headache, haematemesis, dyspnoea. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: abdominal pain; Fever; Headache; Hematemesis; DIFFICULTY OF BREATHING
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 0 | COVID19 | PFIZER\BIONTECH | FR8392 | OT |
| RECVDATE: | 03-23-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20220306; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Comments: twice; Test Date: 20220306; Test Name: heart rate; Result Unstructured Data: Test Result:197 bpm; Test Date: 20220306; Test Name: oxygen saturation; Test Result: 45 % |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | PHPFIZER INC202200427392 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-22-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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