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.
Patient received first injection of Pfizer's COVID-19 vaccine on March 27, 2021. Approximately a week or so after the injection, the patient stated that she had headaches, back aches, and occasional cough. On April 17, 2021, patient received second dose of the Pfizer COVID-19 vaccine (ER8735). Within a couple of days of the injection, patient complained that the back pain was worse. By Wednesday, April 21, 2021, patient indicated that back pain was "excruciating" and cough had increased. She contacted her Primary Care Provider's office to set up an appointment. An appointment was scheduled for Friday, April 23, 2021. In the interim, the back pain continued, the coughing increased and she developed chest pain. During the Dr. Visit on April 23, 2021, the Physician ordered a Chest X-ray which showed "bibasilar pleural effusions with associated atelectasis". The patient was advised to take Aleve for the pain and was also prescribed a muscle relaxant (Flexeril). (Please Note: Patient has never had any lung problems. Previous Xrays and CT indicated clear lungs). The Physician also ordered a CT Scan of the Chest. The CT Scan of the Chest was completed on May 12, 2021. Chest CT Findings: multiple areas of lympadenopathy in chest and lungs; Possible pulmonary metastases. Mild upper abdominal lymphadenopathy was also present. Most recently (week of 05/09/2021), patient developed pain in left calf. Ultrasound negative. Additional Note: Patient is post left mastectomy for breast cancer (Sept. 2020)- with negative margins and negative lymph nodes. Patient had remained healthy up until the onset of the headaches, back pain and chest pain, as described above. As stated, these symptoms appear to have started after the first dose of Pfizer COVID-19 vaccine.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | ER8734 | IM | RA |
| RECVDATE: | 05-19-2021 | RPT_DATE: |
| CAGE_YR: | 49 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | 2 View Chest Xray (04/23/21): Bibasilar pleural effusions; CT Chest (05/12/21): Extensive intrathoracic lymphadenopathy, possible pulmonary metastases; Lab tests unchanged. |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | One-A-Day Multivitamin |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 05-19-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | None Known |
| V_FUNDBY: |
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