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.
Chills; Aches; Drowsiness; Dizziness; Nausea; Extreme pain starting from left arm up the left side of neck; Extreme pain starting from left arm up the left side of neck; Pain shooting down spine; Pain jabs in right side sinus cavities; Pain jabs in right side of frontal lobe; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: JDAMH) via an unspecified route of administration in the left arm on 15Sep2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medicines (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448,) via an unspecified route of administration in the left arm on 25Aug2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 03:30, the patient experienced chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and the patient also developed itchy, red, hot spot where vaccine was injected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and itchy, red, hot spot where vaccine was injected was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
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(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 |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | JDAMH | LA |
| RECVDATE: | 09-23-2021 | 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: | PVT |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Sulfonamide allergy (Known allergies: Sulfa). |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101227756 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-22-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.