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.
HYPOVOLEMIC SHOCK; POSTPARTUM HEMORRHAGE; UTERINE ATONY; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Oct-2022 and was forwarded to Moderna on 07-Oct-2022. This regulatory authority retrospective pregnancy case was reported by an other health care professional and describes the occurrence of HYPOVOLAEMIC SHOCK (HYPOVOLEMIC SHOCK), POSTPARTUM HAEMORRHAGE (POSTPARTUM HEMORRHAGE) and UTERINE ATONY (UTERINE ATONY) in a 30-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 010G21B) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Sep-2022 at 6:30 AM, the patient experienced HYPOVOLAEMIC SHOCK (HYPOVOLEMIC SHOCK) (seriousness criteria death and medically significant), POSTPARTUM HAEMORRHAGE (POSTPARTUM HEMORRHAGE) (seriousness criterion death) and UTERINE ATONY (UTERINE ATONY) (seriousness criteria death and medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient died on 12-Sep-2022. The reported cause of death was Hypovolemic shock, Postpartum hemorrhage and Uterine atony. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment medications were not reported. Worldwide unique case identification number was reported as PH-PHFDA-300157100. Company comment: This regulatory case concerns a 30-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) and fatal outcome of Hypovolaemic shock and Uterine atony and unexpected, fatal outcome of Postpartum haemorrhage. The events occurred 293 days after administration of an unknown dose of mRNA-1273. The reported cause of death were Hypovolemic shock, Postpartum hemorrhage and Uterine atony. It is unknown if post-mortem autopsy was done. Details of concomitant medications, medical history, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per Regulatory Authority's report.; Sender's Comments: This regulatory case concerns a 30-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) and fatal outcome of Hypovolaemic shock and Uterine atony and unexpected, fatal outcome of Postpartum haemorrhage. The events occurred 293 days after administration of an unknown dose of mRNA-1273. The reported cause of death were Hypovolemic shock, Postpartum hemorrhage and Uterine atony. It is unknown if post-mortem autopsy was done. Details of concomitant medications, medical history, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per Regulatory Authority's report.; Reported Cause(s) of Death: HYPOVOLEMIC SHOCK; POSTPARTUM HEMORRHAGE; UTERINE ATONY
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 (MODERNA)) | 0 | COVID19 | MODERNA | 010G21B | OT |
| RECVDATE: | 10-12-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 09-12-2022 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | PHMODERNATX, INC.MOD20226 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-11-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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