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.
Congenital anomaly; At the time of my injection I was 5 weeks pregnant.; This is a spontaneous report. This consumer reported for both the mother and baby case. This is the baby case. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 10Sep2021 13:45 (Batch/Lot Number: FD7206) as DOSE 1, SINGLE for covid-19 immunisation. The mother at 32-years-old received the vaccine on 10Sep2021 in the Arm Right. The last menstrual period 06Aug2021 pregnancy due date is on 13May2022. The mother also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of pregnancy complications, bleeding, spotting, and no history of miscarriage. 4 healthy, successful pregnancies. The patient medical history was not reported. Concomitant medication included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Congenital anomaly/birth defect (reported as Congenital anomaly/birth defect: YES). The mother reported that: "At the time of my injection I was 5 weeks pregnant. I miscarried 13 days later (also reported as 23Sep2021 12:00). I have no history of pregnancy complications, bleeding, spotting, and no history of miscarriage. I have had 4 healthy, successful pregnancies. I have no reason to believe this pregnancy would have been any different if not for receiving this vaccine which doesn't have adequate testing on pregnant women" The patient died on 23Sep2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : CA-PFIZER INC-202101281587 Maternal case; Reported Cause(s) of Death: congenital anomaly
Open in Wayback Machine
(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 | FD7206 | OT |
| RECVDATE: | 10-13-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 09-23-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | MULTIVITAMIN FOR WOMEN |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | CAPFIZER INC202101359925 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-13-2021 |
| BIRTH_DEFECT: | Y |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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