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.
Left underarm swelled with mild sensitivity; Left underarm swelled with mild sensitivity; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8757) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Bee sting" (unspecified if ongoing), notes: known allergies: Bee sting. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 22Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (non-serious), SENSITISATION (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Left underarm swelled with mild sensitivity"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Pain and stiffness from front of left shoulder to bicep". Therapeutic measures were not taken as a result of peripheral swelling, sensitisation, arthralgia, musculoskeletal stiffness, myalgia, musculoskeletal stiffness. Additional information: The patient did not covid prior to vaccination and covid was not tested post vaccination. The patient did not take other vaccine in four weeks and other medication in two weeks. No follow-up attempts are needed. No further information is expected.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | FJ8757 | LA |
RECVDATE: | 12-31-2021 | 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: Insect sting allergy (known allergies: Bee sting) |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101844779 |
FORM_VERS: | |
TODAYS_DATE: | 12-27-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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