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.
erythema multiforme/Erythema multiforme on palmar and planta; skin eruption on the palmar; Chest pain/Worsen pain precordial was consider for sitting and bend forward position; headache; pyrexia; the result of CRP was 1.35 mg/dL. It was considered as slight increase; urine test showed urine ketone was 2+, positive.; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128373. A 15-year-old (also reported as 15-year and 2-month-old) female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration, at age 15 years, on 17Sep2021 (the day of vaccination) (Batch/Lot Number: FF5357; Expiration Date: 30Nov2021) as DOSE 2, SINGLE for COVID-19 immunisation. Relevant medical history was none. 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). The patient's concomitant medications were not reported. From 17Sep2021 (the day of vaccination), the patient experienced pyrexia. The course of the event was as follows: From the evening of vaccination on 17Sep2021, pyrexia developed. From the morning of next day on 18Sep2021, chest pain and headache developed. Worsen pain precordialin 18Sep2021 was consider for sitting and bend forward position. On 19Sep2021 (also reported as two days later), during daytime, skin eruption on the palmar appeared, so the patient visited the nearby doctor and was introduced to the reporting hospital. The condition improved by lying position. Erythema multiforme on palmar and planta developed on 20Sep2021. On 22Sep2021 (also reported as: 5 days after the vaccination), the patient was admitted to the hospital. After hospitalized, the patient received treatment with drip. On the next day, the pyrexia was subsided, and the chest symptoms disappeared. Erythema disappeared gradually. On an unspecified date in 2021, a blood test showed a CRP value of 1.35 mg/DL, which meant a slight increase. Other abnormal blood tests including troponin were not observed. A urine test showed urine ketone was 2+, positive. No abnormality of electrocardiogram or echocardiography. On 22Sep2021, the outcome of the events was recovered. The reporting physician classified the event as serious (caused Hospitalized from 22Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Reporter's Comment: The reporting physician commented as follows: A 15-year-old health by nature girl experienced pyrexia, chest pain, and erythema multiforme after receiving the second dose of COVID-19 vaccine. There were no other findings of suspected preceding infection. The symptoms disappeared quickly on day 4 of the onset. So it was strongly suspected that there were adverse reactions after receiving vaccination. ; Reporter's Comments: The reporting physician commented as follows: A 15-year-old health by nature girl experienced pyrexia, chest pain, and erythema multiforme after receiving the second dose of COVID-19 vaccine. There were no other findings of suspected preceding infection. The symptoms disappeared quickly on day 4 of the onset. So it was strongly suspected that there were adverse reactions after receiving vaccination.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FF5357 |
| RECVDATE: | 10-08-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 2021; Test Name: CRP; Test Result: 1.35 mg/dl; Comments: slight increase; Test Date: 2021; Test Name: echocardiography; Result Unstructured Data: Test Result:No abnormality; Test Date: 2021; Test Name: electrocardiogram; Result Unstructured Data: Test Result:No abnormality; Test Date: 2021; Test Name: troponin; Result Unstructured Data: Test Result:no abnormality; Test Date: 2021; Test Name: urine ketone; Result Unstructured Data: Test Result:2+ |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101261695 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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