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.
My left armpit was also sore; The lesion is scabbing over with very little drainage; My arm was very painful; Had a raised, red welt surrounding the vaccination site lesion; Spontaneous report was received on 12NOV2021. A healthcare professional reported that "had a raised, red welt surrounding the vaccination site lesion" (PT: Urticaria), "my arm was very painful" (PT: Pain in extremity), "my left armpit was also sore" (PT: Axillary pain), and "the lesion is scabbing over with very little drainage" (PT: Injection site scab) following the administration of ACAM2000 (Smallpox (Vaccinia) Vaccine, Live). On 26OCT2021, the patient received first dose of ACAM2000. On 05NOV2021, 10 days post-vaccination, had a raised, red welt surrounding the vaccination site lesion which got to maximum size of 4 inches long by 3 inches wide. It was reported that the patient's arm was very painful and left armpit was also sore. By 07NOV2021, the red welt went down and barely noticeable. Now, as of 12NOV2021, 17 days post-vaccination, the welt was completely gone with no pain in the arm. The lesion was scabbing over with very little drainage. The patient had recovered from the reported events "had a raised, red welt surrounding the vaccination site lesion" and "arm was very painful" whereas the outcome of the event "the lesion is scabbing over with very little drainage" was resolving and the outcome of the event "left armpit was also sore" was unknown. Company comment: A consumer received ACAM2000 and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000. Significant follow up information received from the healthcare professional on 24NOV2021. The follow up information included description of the needle and site of administration of ACAM2000, medical history and concomitant medications of the patient, treatment, and outcome of the events. It was updated that the patient was a female. It was reported that she was administered with ACAM2000 via a 15 times bifurcated needle on her upper arm. She was prescribed by her physician to take Tylenol, Claritin and Ibuprofen as a treatment medication for the events and her physician stated that the reaction might be due to the bandage. The outcome of the events was updated as she had not recovered from the events "had a raised, red welt surrounding the vaccination site lesion", "my left armpit was also sore" and "my arm was very painful". The patient's medical history included anxiety and depression. It was reported that she had a migraine treatment and currently she is off from the treatment. Concomitant medications included bupropion (bupropion hydrochloride), Wellbutrin (bupropion hydrochloride; 300 mg), Cymbalta (duloxetine hydrochloride; 60 mg a day) and other over the counter (OTC) women multivitamins (ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride) included Vitamin D (colecalciferol), Vitamin B12 (cyanocobalamin), and probiotics (bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus). Company comment: A consumer received ACAM2000 on her upper arm and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000.; Sender's Comments: A consumer received ACAM2000 on her upper arm and after about 10 days developed a raised, red welt surrounding the vaccination site lesion (urticaria), reported that arm was very painful (pain in extremity), left armpit was also sore (axillary pain), and the lesion is scabbing over with very little drainage (injection site scab). Considering the case information and the expected response to vaccination, the causality of urticaria, pain in extremity, axillary pain, and injection site scab is assessed as possible with ACAM2000.
Open in Wayback Machine
(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 |
|---|---|---|---|---|---|---|
| SMALLPOX (ACAM2000) | 1 | SMALL | SANOFI PASTEUR | OT | Unknown |
| RECVDATE: | 12-08-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | Bupropion Hcl; Wellbutrin; Cymbalta; Multivitamins; Vitamin D; Vitamin b12; Probiotics |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Anxiety; Depression; Migraine (It was reported that she had migraine treatment and currently she is off from the treatment.) |
| PRIOR_VAX: | |
| SPLTTYPE: | USEMERGENT BIOSOLUTIONS21 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 12-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.