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 the vaccine on Monday, November 8th. She was not anxious to get the vaccine, she was excited and proud to get it. She didn't have lunch before the vaccine, but did have cereal for breakfast. Immediately after getting the vaccine (while still sitting in the chair), Patient held her head and said "my head mommy, my head hurts so much" and then they had her stand up and she opened her eyes wide and said "I can't see mommy, everything is white" and I asked the person who gave the vaccine to help. She laid patient on the ground and put her feet up. She was clammy, very pale, and still. She shivered a little as if she was cold. She laid there with tears, but awake for about 20 minutes. They brought a wheelchair and moved her to a cot. We gave her some crackers and they asked us to leave about 10 minutes later. She was very tired following the event and for the rest of the day, but she was awake and talking and walking. On Tuesday and Wednesday, she complained of a "bad headache" and said her ears and her head were hot. On Thursday she was a little pale, but didn't complain of anything. On Friday in school they sent her to the school nurse becasue she was pale and clammy and said her head hurt really bad. On Saturday (11/13) evening, she started throwing up. She threw up and had water-diarrhea all day on Sunday. She coudn't sit up or move on her own. I took her to a Pediatric Urgent Care on Monday (11/15), and they sent us to the Hospital Emergency Room (details below). They tested her for everything they could think of, and the only abnormal result was a positive Strep test. Today is Thursday (11/18) and she has been at home since we left the ER on Monday, but only very slowly feeling better. She hasn't eaten much since Saturday (11/13), though she is drinking fine. She has thrown up 1-2 times each day and still feels very weak and tired. She's slept most of the day, every day. This morning is the first time she's willingly eaten a little bit. She's definitely not been herself over the past 5 days. I'm honestly terrified to get her the second dose of the vaccine. I realize the illness could be completely unrelated to the vaccine, but I'd like to get an opinion on whether or not to get her the second dose on time, or wait a while.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FK5127 | SYR | LA |
| RECVDATE: | 11-18-2021 | RPT_DATE: |
| CAGE_YR: | 8 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | The pediatric Urgent Care tested her for COVID, flu, and urinary tract infection. All were negative. They suspected that she may have appendicitis because of the severity of her vomiting, diarrhea, and stomach pain when we were in the office and sent us to the Emergency Room. I took her directly to the ER, where they did blood tests, a strep test, an ultrasound, and gave her IV fluids. The only abnormal finding was a positive strep test and a lot of gas in her stomach. They sent her home with Amoxicillin and she has taken it 2x a day since. |
| V_ADMINBY: | PUB |
| OTHER_MEDS: | She was not taking any medications. |
| CUR_ILL: | She was not sick at the time of vaccination and had not been sick any time in the recent past. |
| HISTORY: | No chronic or long-standing health conditions or concerns |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 11-18-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | No known allergies to medications, foods, or environmental |
| V_FUNDBY: |
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