Vaccine Adverse Event Reporting System VAERS Data 2024
Keywords
Vaccine Adverse Event Reporting System VAERS Data
VAERS Data
VAERS Data 2024
Vaccination Reporting System 2014
FDA Vaccine Reports
CDC Vaccine Reports
Vaccine Side Effects
Vaccine Adverse Event Reporting System 2024
The Vaccine Adverse Event Reporting System (VAERS) 2014 was created by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to receive reports about adverse events that may be associated with vaccines. No prescription drug or biological product, such as a vaccine, is completely free from side effects.
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Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors. About 85-90% of vaccine adverse event reports concern relatively minor events, such as fevers or redness and swelling at the injection site. The remaining reports (less than 15%) describe serious events, such as hospitalizations, life-threatening illnesses, or deaths. The reports of serious events are of greatest concern and receive the most careful scrutiny by VAERS staff. VAERS researchers apply procedures and methods of analysis to help them closely monitor the safety of vaccines. When a concern arises, action is taken. The hope is that this brief explanation of the factors associated with vaccines and adverse events will assist users in understanding the data they are viewing.
Vaccines protect many people from dangerous illnesses, but vaccines, like drugs, can cause side effects, a small percentage of which may be serious. VAERS is used to continually monitor reports to determine whether any vaccine or vaccine lot has a higher than expected rate of events.
About this Dataset
Data Info
Date Created
2014
Last Modified
2024-09-27
Version
2024-09-27
Update Frequency
Annual
Temporal Coverage
2024
Spatial Coverage
United States
Source
John Snow Labs; Department of Health and Human Services;
Source License URL
Source License Requirements
N/A
Source Citation
N/A
Keywords
Vaccine Adverse Event Reporting System VAERS Data, VAERS Data, VAERS Data 2024, Vaccination Reporting System 2014, FDA Vaccine Reports, CDC Vaccine Reports, Vaccine Side Effects
Other Titles
VAERS Identification 2024, Vaccine Adverse Events 2024, Vaccine Adverse Event Reporting System VAERS Data 2024
Data Fields
Name
Description
Type
Constraints
VAERS_Identification_Number
Unique Vaccine Adverse Event Reporting System Identification Number
integer
level : Nominal
Received_Date
Date report was received
date
-
State_Abbreviation
State Abbreviation
string
-
Age_Of_Patient_In_Years
Age of patient in years calculated by (vax_datebirthdate)
number
level : Ratio
Age_Of_Patient_In_Months
Age of patient in months calculated by (vax_datebirthdate).The values for this variable range from 0 to <1
number
level : Ratio
Sex
Gender
string
-
Date_Form_Completed
Date Form Completed
date
-
Reported_Symptom
Detail description for Reported symptom
string
-
Is_Died
Died ('Y' = true)
boolean
-
Date_Of_Death
Date of Death
date
-
Is_Life_Threatening_Illness
Life-Threatening Illness ('Y' - true)
boolean
-
Is_Emergency_Room_Or_Doctor_Visit
Emergency Room or Doctor Visit ('Y' - true)
boolean
-
Is_Hospitalized
Hospitalized ('Y' - true)
boolean
-
Number_Of_Days_Hospitalized
Number of days Hospitalized
integer
level : Number
Is_Prolonged_Hospitalization
Prolonged Hospitalization ('Y' - true)
boolean
-
Is_Disability
Disability ('Y' - true)
boolean
-
Is_Recovered
Recovered ('Y' - true, 'N' - false)
boolean
-
Vaccination_Date
Vaccination Date
date
-
Adverse_Event_Onset_Date
Adverse Event Onset Date
date
-
Number_Of_Days
Number of days (Onset date - Vax. Date)
integer
level : Nominal
Diagnostic_Laboratory_Data
Diagnostic laboratory data
string
-
Vaccines_Administered
Vaccines Administered at (PUB=Public,PVT=Private,OTH=Other, MIL=Military)
string
-
Vaccines_Purchased
Vaccines purchased with (PUB=Public,PVT=Private, OTH=Other, MIL=Military) funds
string
-
Other_Medications
Other Medications
string
-
Current_Illnesses
Current Illnesses
string
-
Pre_Existing_Physician_Diagnosed_Allergies
Pre-existing physician diagnosed allergies, birth defects, medical conditions
string
-
Prior_Vaccination_Event_Information
Prior Vaccination Event information
string
-
Manufacturer_Number
Manufacturer Number
string
-
Data Preview
VAERS Identification Number
Received Date
State Abbreviation
Age Of Patient In Years
Age Of Patient In Months
Sex
Date Form Completed
Reported Symptom
Is Died
Date Of Death
Is Life Threatening Illness
Is Emergency Room Or Doctor Visit
Is Hospitalized
Number Of Days Hospitalized
Is Prolonged Hospitalization
Is Disability
Is Recovered
Vaccination Date
Adverse Event Onset Date
Number Of Days
Diagnostic Laboratory Data
Vaccines Administered
Vaccines Purchased
Other Medications
Current Illnesses
Pre Existing Physician Diagnosed Allergies
Prior Vaccination Event Information
Manufacturer Number
2728969
2024-01-01
AK
14.0
M
fluzone qiv hd administered to a minor patient with no reported adverse event; patient was supposed to receive the Flumist Nasal Spray but she grabbed the FLUZONE QIV HD and inadvertently gave it to intranasally with no reported adverse event; patient was supposed to receive the Flumist Nasal Spray but she grabbed the FLUZONE QIV HD and inadvertently gave it to intranasally with no reported adverse event; Initial information received from Regulatory Authority on 18-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient to whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] was administered who was supposed to receive the Influenza Vaccine Live Reassort 3v (Flumist) nasal Spary but she grabbed the Fluzone QIV HD and inadvertently gave it to intranasally with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the minor patient received (dose 1) of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine, (lot 370679: formulation, strength and expiry date; unknown) via nasal route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (unknown latency). On an unknown date the was supposed to receive the flumist nasal spray but she grabbed the fluzone qiv hd and inadvertently gave it to intranasally with no reported adverse event (wrong product administered) (incorrect route of product administration) (unknown latency). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
UNK
USSA2023SA396019
2728982
2024-01-01
NJ
U
administering vaccines subcutaneously to patients; Reason for deletion: No GSK suspect
UNK
USGSKUS2023AMR179885
2728984
2024-01-01
U
extreme joint pain; Unable to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: extreme joint pain) and unable to walk (Verbatim: Unable to walk). The outcome of the joint pain and unable to walk were not reported. It was unknown if the reporter considered the joint pain and unable to walk to be related to Arexvy. It was unknown if the company considered the joint pain and unable to walk to be related to Arexvy. Additional Information: GSK Receipt Date: 26-DEC-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient reported that got extreme joint pain of almost unable to walk The reported that all symptoms except injection site pain. The patient reported that he/she scared badly.
UNK
USGSKUS2023AMR180978
2728992
2024-01-01
MO
F
was due to have 2nd when everything shut down for pandemic; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: was due to have 2nd when everything shut down for pandemic). The outcome of the social problem was unknown. Additional Information: GSK receipt date: 27-DEC-2023 The patient was due to have 2nd dose of Shingrix when everything shut down for pandemic (pandemic shutdown caused her to miss 2nd vaccine). The patient asked if she could still get 2nd shot or she should start series over? There was no information about having the 2nd shot years later There was no information regarding this gap. The patient stated that length of a gap was surprised by this because she could not be the only one affected that way. The patient stated that one pharmacist told her 2nd shot was not worthwhile, primary physician did not know what to advise. The patient asked, what is GlaxoSmithKline (GSK) advising to people with years since 1st vaccine? The patient thought that GSK needs to address this issue As the CDC had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients do not need to restart the vaccine series. The patient stated that, more than 6 months was very different than almost 4 years. The patient look forward to hearing more from the safety department.
UNK
USGSKUS2023AMR181463
2728993
2024-01-01
U
Injection site hot; Hypersentivity reaction; Chills/Shivering; cold and hot; temperature was 100.5; redness expanded and completely circled the entire am/Injection site redness; all around arm and very itchy/ itchy in the size for the golf ball; area of hardness was probably like the size of an orange or avocado; was a good sized lump/the lump in arm about the size of a golf ball now; Hives; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site warmth in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (expiry date 30-NOV-2024) for prophylaxis. Concurrent medical conditions included autoimmune disorder (Autoimmune disorder diagnosed in August 7 years ago) and immunosuppression. Concomitant products included azathioprine (Imuran). On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced injection site warmth (Verbatim: Injection site hot), hypersensitivity reaction (Verbatim: Hypersentivity reaction), chills (Verbatim: Chills/Shivering), feeling hot and cold (Verbatim: cold and hot), fever (Verbatim: temperature was 100.5) and erythema of extremities (Verbatim: redness expanded and completely circled the entire am/Injection site redness). In DEC-2023, the patient experienced hives (Verbatim: Hives), itchy upper limbs (Verbatim: all around arm and very itchy/ itchy in the size for the golf ball), induration (Verbatim: area of hardness was probably like the size of an orange or avocado) and swelling arm (Verbatim: was a good sized lump/the lump in arm about the size of a golf ball now). The outcome of the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities and induration were not reported and the outcome of the itchy upper limbs and swelling arm were not resolved. It was unknown if the reporter considered the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities, itchy upper limbs, induration and swelling arm to be related to Arexvy. It was unknown if the company considered the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities, itchy upper limbs, induration and swelling arm to be related to Arexvy. Additional Information: GSK receipt date: 20-DEC-2023 The patient self-reported this case. The patient was doing the math in head and this agent may be able to do the math faster. The reporter got the Prevnar 20 shot so and it was the first time had the pneumonia shot and also got the Arexvy RSV shot the same time in the same arm; had never had very little in the way of any kind of reaction to any kind of vaccine and thought did had a somewhat severe reaction for these and did not know which one it could be. The patient was also on Imuran as was immunosuppressed and was surprised had any reaction at all because immune system was suppressed. The patient did went on and do clinical research for 25 years so and was familiar with the process and was less concerned about the reaction and looked up both drugs for what happened and was already aware and the pharmacist mentioned these were one and done and never had to get a pneumonia vaccine again but if that was to change in the future was more concerned if was allergic to one ingredient and there was no way of knowing what ingredients might be sensitive to. The patient showed to the pharmacist his/her arm and they said definitely had a hypersensitive reaction for one of the vaccines and that if had the vaccine again it would be way worse and was trying to figure out what could possibly be sensitive to for one of these ingredients that might be more likely causing the adverse events. Reporter details were declined email. The health care professional (HCP) information, declined to provide information and stated did not see a physician and did call them and told them how was treating and they said fine and to keep doing that. The patient got the Prevnar 20 and the reaction started that evening, the reaction was in right arm. The patient did not get up to take temperature and woke up that night with chills, shivering and cold and hot and when finally, did get up in the morning took temperature and at that time was not shivering any longer and temperature was 100.5 and was making the assumption that temperature was higher than that to had the chills or any of that by the time took temperature. It had started out just as redness probably like a 2 inch by 2 inch area where the injection had gone in and it was hot. On Monday went back to the pharmacy by Monday and had hives and the area of redness expanded and completely circled the entire am and was about 2 hand widths for 6 to 8 inches wide all around arm and very itchy and red and the area of hardness was probably like the size of an orange or avocado and was a good sized lump and went to the pharmacist. The concern was not having this reaction but if needed the shot again what was going to happen and still had the lump in arm about the size of a golf ball now and itchy. The Arexvy vaccine and stated the manufacturer of that was GSK and it was given in the same arm and same location and did not think it was the Pfizer vaccine that bothered. The pharmacy gave the vaccine. The caller was asked for the dosage and dosage units and stated the app on phone lists the quantity of 0.5 but did not know what that was and did not had any other information on phone for the lot number. The reporter did not consent to follow up.
False
2023-12-01
2023-12-01
0.0
Test Name: Body temperature; Result Unstructured Data: (Test Result:100.5,Unit:unknown,Normal Low:,Normal High:)
UNK
Imuran
Autoimmune disorder (Autoimmune disorder diagnosed in August 7 years ago); Immunosuppression
USGSKUS2023AMR181703
2728994
2024-01-01
FL
M
muscle at the injection site is sore; He cannot lift anything more than 5 pounds.; Arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis. On an unknown date, the patient received Arexvy (right arm), Influenza vaccine (left arm) and Pfizer BioNTech COVID-19 vaccine (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site muscle pain (Verbatim: muscle at the injection site is sore), activities of daily living impaired (Verbatim: He cannot lift anything more than 5 pounds.) and pain in arm (Verbatim: Arm soreness). The outcome of the injection site muscle pain and activities of daily living impaired were not reported and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site muscle pain, activities of daily living impaired and pain in arm to be related to Arexvy. It was unknown if the company considered the injection site muscle pain, activities of daily living impaired and pain in arm to be related to Arexvy. Additional Information: GSK receipt date: 22-DEC-2023 Reporter was the patient. The patient was received a dose of AREXVY 4 months ago on his right arm and received a COVID-19 vaccine (Pfizer) and Flu vaccine (unknown manufacturer) on his left arm in the same visit. The patient states that the muscle at the injection site was sore. The patient cannot lift anything more than 5 pounds. The patient was an X ray done on his rotator cuff to see if it was the cause for soreness. The patient did not disclose results of exam. The reporter consented to follow up.
Test Date: 2023; Test Name: Xray of rotator cuff; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:)
PHM
USGSKUS2023179248
2728995
2024-01-01
CA
11.0
M
completed 5-series of Infanrix and was back for Boostrix booster; Infanrix was administered to a 11 y/o instead of Boostrix; Infanrix was administered to a 11 y/o; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. Previously administered products included Infanrix (received 1st dose on an unknown date), Infanrix (received 2nd dose on an unknown date), Infanrix (received 3rd dose on an unknown date), Infanrix (received 4th dose on an unknown date) and Infanrix (received 5th dose on an unknown date). On 18-DEC-2023, the patient received the 6th dose of Infanrix. On 18-DEC-2023, an unknown time after receiving Infanrix, the patient experienced extra dose administered (Verbatim: completed 5-series of Infanrix and was back for Boostrix booster), wrong vaccine administered (Verbatim: Infanrix was administered to a 11 y/o instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infanrix was administered to a 11 y/o). The outcome of the extra dose administered, wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-DEC-2023 The licensed practical nurse reported that the Infanrix vaccine was administered to a 11-year-old child instead of Boostrix, which led to wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration. The patient had completed 5 series of Infanrix vaccine and was back for Boostrix booster. The reporter wanted to know could the Infanrix count as a completed series for the Boostrix. The reporter consented the follow up.up.
2023-12-18
2023-12-18
0.0
UNK
USGSKUS2023179249
2728996
2024-01-01
PA
75.0
F
patient received 3rd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 23G34, expiry date 27-JUN-2024) for prophylaxis. Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT) and INFLUENZA VACCINE (INFLUENZA). On 26-DEC-2023, the patient received the 3rd dose of FluLaval Quadrivalent 2023-2024 season. On 26-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season and not applicable after receiving FLULAVAL QUADRIVALENT, the patient experienced extra dose administered (Verbatim: patient received 3rd dose). The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-DEC-2023 The reporter inquired about FluLaval and what information was available about the administration of extra doses of FluLaval, which led to extra dose administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up granted.
2023-12-26
2023-12-26
0.0
UNK
FLULAVAL QUADRIVALENT; INFLUENZA
USGSKUS2023180154
2728997
2024-01-01
U
The highest temperature reported in temperature excursion was 50°F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the unspecified number of patients received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patients experienced incorrect storage of drug (Verbatim: The highest temperature reported in temperature excursion was 50°F). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date:26-DEC-2023 The Nurse was called on 26th December 2023, to report on 8th September 2023 Boostrix vaccine was involved in a temperature excursion and was administered to an unknown number of patients. The reporter did not consent to follow up.
UNK
USGSKUS2023180157
2728998
2024-01-01
VA
70.0
F
Patient had 2nd dose of arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2X7NA, expiry date 23-MAR-2025) and (batch number PK74B, expiry date 22-FEB-2025) for prophylaxis. Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY). On 26-DEC-2023, the patient received the 2nd dose of Arexvy. On 26-DEC-2023, an unknown time after receiving Arexvy and an unknown time after receiving AREXVY, the patient experienced extra dose administered (Verbatim: Patient had 2nd dose of arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 27-DEC-2023 Pharmacist requested guidance on how to proceed or what to expect with a patient who was administered Arexvy vaccine on 2nd December 2023 and a 2nd dose on 26th December 2023, which led to extra dose administered. The patient had not reported any side effects at the time of the call. The reporter consented to follow up.
Demos
