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.
Patient got scared and did not get his second dose; tried to urinate and could not; passed a clot with some drops of blood; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (tried to urinate and could not) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) in a 73-year-old male patient who received mRNA-1273 (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tumor (Malignancy in the tubular tumor in Penis) and Bladder operation (in past 3 months). Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, LISINOPRIL, AMLODIPINE and ESCITALOPRAM for an unknown indication, PRAVASTATIN SODIUM (PRAVASTATIN NA). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced URINARY RETENTION (tried to urinate and could not) (seriousness criterion medically significant) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) (seriousness criterion medically significant). On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose). At the time of the report, URINARY RETENTION (tried to urinate and could not), HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) and PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown. Treatment medication was not reported. Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 024M20A | OT |
| RECVDATE: | 04-21-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | METFORMIN; LISINOPRIL; AMLODIPINE; ESCITALOPRAM; PRAVASTATIN NA |
| CUR_ILL: | Diabetes; Hypertension |
| HISTORY: | Medical History/Concurrent Conditions: Bladder operation (in past 3 months); Tumor (Malignancy in the tubular tumor in Penis) |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20210 |
| FORM_VERS: | |
| TODAYS_DATE: | 04-20-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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