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:
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Cardiac arrest; Septic shock; Hypovolemic shock; Hypovolemic shock; Hypoxic encephalopathy; Acute kidney injury; Metabolic acidosis; This case was received via Agency Regulatory Authority (Reference number: PH-PHFDA-300120200) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority prospective pregnancy case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (Cardiac arrest), SEPTIC SHOCK (Septic shock), the first episode of HYPOVOLAEMIC SHOCK (Hypovolemic shock), the second episode of HYPOVOLAEMIC SHOCK (Hypovolemic shock), HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (Hypoxic encephalopathy), ACUTE KIDNEY INJURY (Acute kidney injury) and METABOLIC ACIDOSIS (Metabolic acidosis) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 083F21B) for COVID-19 vaccination. No Medical History information was reported. On 05-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 an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), SEPTIC SHOCK (Septic shock) (seriousness criteria death and medically significant), the first episode of HYPOVOLAEMIC SHOCK (Hypovolemic shock) (seriousness criteria death and medically significant), the second episode of HYPOVOLAEMIC SHOCK (Hypovolemic shock) (seriousness criteria death and medically significant), HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (Hypoxic encephalopathy) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria death and medically significant) and METABOLIC ACIDOSIS (Metabolic acidosis) (seriousness criterion death). The reported cause of death was Cardiac arrest, Septic shock, Hypovolaemic shock, Hypoxic-ischaemic encephalopathy, Acute kidney injury and Metabolic acidosis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided G2P1 patient , pregnancy uterine 34 weeks AOG by LMP, Cephalic in labor was provided Company Comment : This is a regulatory case concerning a 31 year-old, female patient with no relevant medical history, who experienced the Fatal unexpected, according Agency, AESI of Hypoxic-ischaemic encephalopathy and Acute kidney injury; and the Fatal unexpected, according Agency, events of Cardiac arrest, Septic shock, Hypovolaemic shock (reported twice) and Metabolic acidosis. Additionally, the patient was 34 weeks pregnant and in cephalic labour, no dates and fetal outcome were provided, probably a case of maternal exposure during pregnancy. The events occurred on an unknown date after the mRNA-1273 vaccine, dose number not provided. The patient died on an unknown date, it is unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a 31 year-old, female patient with no relevant medical history, who experienced the Fatal unexpected, according Agency, AESI of Hypoxic-ischaemic encephalopathy and Acute kidney injury; and the Fatal unexpected, according Agency, events of Cardiac arrest, Septic shock, Hypovolaemic shock (reported twice) and Metabolic acidosis. Additionally, the patient was 34 weeks pregnant and in cephalic labour, no dates and fetal outcome were provided, probably a case of maternal exposure during pregnancy. The events occurred on an unknown date after the mRNA-1273 vaccine, dose number not provided. The patient died on an unknown date, it is unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Cardiac arrest; Septic shock; Hypovolaemic shock; Hypoxic-ischaemic encephalopathy; Acute kidney injury; Metabolic acidosis
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 | 083F21B | OT |
| RECVDATE: | 12-08-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| 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.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 12-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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