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.
pain in the left buttocks and exertional pain in the left lower limb; pain in the left buttocks and exertional pain in the left lower limb; blood flow infection; Osteomyelitis of the left ilium/osteomyelitis due to immunoreaction could not be ruled out; left sacroiliac arthritis; pyrexia; This is a spontaneous report from a contactable physician (Physician of the hospital to which the patient was admitted because of the adverse events) received from the regulatory authority. Regulatory authority report number is v21129753. A 12-year and 8-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via intramuscular route at the deltoid of the left upper arm on 10Sep2021 16:00 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's mother received 2 doses of the novel coronavirus vaccine without any problem. The patient's father needed to be reexamined on thorough medical examination for heart dock in 2020. The result showed no problematic finding. However, he refrained from receiving the novel coronavirus vaccine for just in case. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 10Sep2021 at an unspecified time (the day of the vaccination), the patient experienced osteomyelitis of the left ilium, left sacroiliac arthritis. On 10Sep2021, the same day in the evening, the patient experienced pyrexia. On 13Sep2021, the patient experienced pain in the left buttocks and exertional pain in the left lower limb. On 15Sep2021, the patient was referred to this hospital by the vaccination venue hospital for the purpose of detailed examinations. Since the patient retained the general health condition, the clinical course of the events was continuously followed up only with antipyretics. On 17Sep2021, the patient revisited the hospital. Since the symptoms did not improve, the patient was admitted to the hospital for the purpose of detailed examination and treatment. Based on a pelvis MRI taken on the same day, the above diseases (osteomyelitis of the left ilium, left sacroiliac arthritis) were considered. An antibiotic (cefazolin 6g/day) therapy was intravenously initiated. On 18Sep2021, the pyrexia tended to subside. From 19Sep2021, antipyretic effect persisted. On 01Oct2021, cefazolin was switched to CEFACLOR for internal use 750 mg/day. Antibiotics were planned to be administered for 4 to 6 weeks in total. The pain in the lower limb was reduced in severity but still persisted as of 08Oct2021. The reporting physician classified the event as serious (risk of disability and caused hospitalization from 17Sep2021) and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was: there was a possibility that the event was incidentally complicated. The causative bacteria could not be identified from blood cultures (two sets). The reporting physician commented as follows: The possibility that the causative bacteria might get in through the vaccination site causing blood flow infection as well as osteomyelitis due to immunoreaction could not be ruled out. Body temperature before vaccination was 36.5 degrees Centigrade. The patient 's birth weight was 3,200 g. As of 08Oct2021 (21 days after the vaccination), the outcome of the events was not recovered.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FD0349 | OT | LA |
| RECVDATE: | 10-22-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: blood cultures; Result Unstructured Data: Test Result:causative bacteria could not be identified; Test Date: 20210910; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210917; Test Name: pelvis MRI; Result Unstructured Data: Test Result:osteomyelitis of the left ilium, left sacroiliac a; Comments: osteomyelitis of the left ilium, left sacroiliac arthritis were considered; Test Name: birth weight; Result Unstructured Data: Test Result:3, 200 g |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101345565 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-21-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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