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.
Muscle cramps, spastic signs of paralysis on the hands after the first vaccination, and then again the same after the second vaccination; Inappropriate schedule of vaccine administered; Muscle cramps, spastic signs of paralysis on the hands after the first vaccination, and then again the same after the second vaccination; Muscle cramps, spastic signs of paralysis on the hands after the first vaccination, and then again the same after the second vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2022272204 (RA). Other Case identifier(s): DE-CADRPEI-2022272204 (RA Webportal), DE-PEI-202200071965 (RA). A 57-year-old male patient received BNT162b2 (COMIRNATY), on 16Jun2021 as dose 2, 0.3 ml single (Lot number: FD9234) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "pollen allergy" (unspecified if ongoing); "Drug Allergy" (unspecified if ongoing), notes: Novalgin; "Heart attack", start date: 2019 (unspecified if ongoing), notes: Heart attack 2019; "Crohn's disease" (unspecified if ongoing); "Bechterew's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1, Strength: 0.3 mL, Batch/lot number: EX8679), administration date: 05May2021, for Covid-19 immunization, reaction(s): "Paralysis", "Myalgia", "Muscle cramps". The following information was reported: PARALYSIS (medically significant), MYALGIA (non-serious), MUSCLE SPASMS (non-serious), outcome "recovered" (16Jul2021) and all described as "Muscle cramps, spastic signs of paralysis on the hands after the first vaccination, and then again the same after the second vaccination"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". Result of Assessment for event Paralysis and Muscle cramps are: D. Unclassifiable, Result of Assessment for event Myalgia are: B. Indeterminate. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200871453 Same patient/drug, different dose/events.;
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FD9234 | Unknown | Unknown |
| RECVDATE: | 06-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Bechterew's disease; Crohn's disease; Drug allergy (Novalgin); Heart attack (Heart attack 2019); Pollen allergy |
| PRIOR_VAX: | |
| SPLTTYPE: | DEPFIZER INC202200846482 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 06-23-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.