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.
Lymphedema; Fever; night sweats; chills; throwing up; on going infections; red leg; swollen foot; swollen foot; Fluid leaking from leg; fingers tingly; fingers numbness; Neurological I cannot close my hands sometimes/cannot make a fist at times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Other Case identifier(s): GB-MHRA-WEBCOVID-202310161130278480-YKLFP (RA), GB-MHRA-ADR 28254958 (RA). A 44-year-old female patient received bnt162b2 (COMIRNATY), on 21May2021 as dose 1, single (Lot number: EW0193) for covid-19 immunisation. The patient's relevant medical history included: "respiratory illnesses" (unspecified if ongoing), notes: that I needed antibiotics for, Patient has not had symptoms associated with COVID-19. Date of last menstrual period: 16Oct2023. The patient's concomitant medications were not reported. The following information was reported: LYMPHOEDEMA (hospitalization, disability, medically significant), outcome "not recovered", described as "Lymphedema"; PYREXIA (hospitalization, disability, medically significant), outcome "unknown", described as "Fever"; NIGHT SWEATS (hospitalization, disability, medically significant), outcome "unknown"; CHILLS (hospitalization, disability, medically significant), outcome "unknown"; VOMITING (hospitalization, disability, medically significant), outcome "unknown", described as "throwing up"; INFECTION (hospitalization, disability, medically significant), outcome "not recovered", described as "on going infections"; ERYTHEMA (hospitalization, disability, medically significant), outcome "unknown", described as "red leg"; PERIPHERAL SWELLING (hospitalization, disability, medically significant), SKIN DISCOLOURATION (hospitalization, disability, medically significant), outcome "unknown" and all described as "swollen foot"; FLUID RETENTION (hospitalization, disability, medically significant), outcome "unknown", described as "Fluid leaking from leg"; PARAESTHESIA (hospitalization, disability, medically significant), outcome "unknown", described as "fingers tingly"; HYPOAESTHESIA (hospitalization, disability, medically significant), outcome "unknown", described as "fingers numbness"; CARPAL TUNNEL SYNDROME (hospitalization, disability, medically significant), outcome "unknown", described as "Neurological I cannot close my hands sometimes/cannot make a fist at times". The events "lymphedema", "fever", "night sweats", "chills", "throwing up", "on going infections", "red leg", "swollen foot", "fluid leaking from leg", "fingers tingly", "fingers numbness" and "neurological i cannot close my hands sometimes/cannot make a fist at times" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2023) Positive. Therapeutic measures were taken as a result of infection, erythema, peripheral swelling, skin discolouration, fluid retention. Clinical course reported as follows: Fever, night sweats, chills, throwing up. On going infections, red leg swollen foot, fluid leaking from leg, had leg cut into and drained, skin turns black, penicillin 4 times a day. Multiple hospital visits. Neurological I cannot close my hands sometimes, fingers numbness, and tingly, cannot make a fist at times. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected. Follow-up (20Oct2023): Follow-up attempts are completed. No further information is expected. Follow-up (08Nov2023): Follow-up attempts are completed. No further information is expected. Follow-up (10Nov2023): This is a follow-up report received from the Regulatory Agency (RA). Updated information included: Country of primary reporter updated.
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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)) | 1 | COVID19 | PFIZER\BIONTECH | EW0193 |
| RECVDATE: | 11-17-2023 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | Y |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20230614; Test Name: COVID-19 virus test; Test Result: Positive |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Respiratory disorder (that I needed antibiotics for, Patient has not had symptoms associated with COVID-19); Comments: Had a few respiratory illnesses that I needed antibiotics for. Patient has not had symptoms associated with COVID-19 |
| PRIOR_VAX: | |
| SPLTTYPE: | CAPFIZER INC202300369870 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-16-2023 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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