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.
I'm having pain in the balls of my eyes; I'm having burning in the balls of my eyes; I'm losing my hearing; The rash was also under my breasts; The rash was on my ear cartilage, too. It was red, swollen; The rash was on my ear cartilage, too. It was red, swollen; Blisters on both sides of my tongue. It was worse on left side; The outside of my vaginal area had inflammation & was burning; The outside of my vaginal area had inflammation & was burning; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The rash was on my ear cartilage, too. It was red, swollen), EAR SWELLING (The rash was on my ear cartilage, too. It was red, swollen), TONGUE BLISTERING (Blisters on both sides of my tongue. It was worse on left side), VULVOVAGINAL INFLAMMATION (The outside of my vaginal area had inflammation & was burning) and VULVOVAGINAL BURNING SENSATION (The outside of my vaginal area had inflammation & was burning) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eyes, Penicillin allergy, Drug allergy (Sulfa Allergy), Drug allergy (Codeine allergy), Latex allergy, Allergy to antibiotic (Tetracycline allergy) and Allergy to NSAIDs (Celecoxib allergy). On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ERYTHEMA (The rash was on my ear cartilage, too. It was red, swollen), EAR SWELLING (The rash was on my ear cartilage, too. It was red, swollen), TONGUE BLISTERING (Blisters on both sides of my tongue. It was worse on left side), VULVOVAGINAL INFLAMMATION (The outside of my vaginal area had inflammation & was burning), VULVOVAGINAL BURNING SENSATION (The outside of my vaginal area had inflammation & was burning) and RASH (The rash was also under my breasts). On 12-Nov-2021, the patient experienced EYE PAIN (I'm having pain in the balls of my eyes), EYE IRRITATION (I'm having burning in the balls of my eyes) and HYPOACUSIS (I'm losing my hearing). The patient was treated with NYSTATIN (topical) for Vaginal inflammation and Vaginal burning sensation, at an unspecified dose and frequency and PREDNISONE (ophthalmic) for Dry eyes, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (The rash was on my ear cartilage, too. It was red, swollen), EAR SWELLING (The rash was on my ear cartilage, too. It was red, swollen) and RASH (The rash was also under my breasts) had not resolved and TONGUE BLISTERING (Blisters on both sides of my tongue. It was worse on left side), VULVOVAGINAL INFLAMMATION (The outside of my vaginal area had inflammation & was burning), VULVOVAGINAL BURNING SENSATION (The outside of my vaginal area had inflammation & was burning), EYE PAIN (I'm having pain in the balls of my eyes), EYE IRRITATION (I'm having burning in the balls of my eyes) and HYPOACUSIS (I'm losing my hearing) outcome was unknown. No Concomitant medication were reported. On 16July2021 & 12April2021 Patient saw her gynecologist. She got Nystatin topical powder. It helps. Nothing else works. On 18Nov2021 Patient has an appointment with her Ophthalmologist.It was reported that patient lost her hearing, she doesn't know when it started happening and she is going to have a hearing test. This case was linked to MOD-2021-385946 (Patient Link).
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 030L21A | OT | LA |
| RECVDATE: | 11-19-2021 | RPT_DATE: |
| CAGE_YR: | 82 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | Allergy to antibiotic (Tetracycline allergy); Allergy to NSAIDs (Celecoxib allergy); Drug allergy (Sulfa Allergy); Drug allergy (Codeine allergy); Dry eyes; Latex allergy; Penicillin allergy. |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | USMODERNATX, INC.MOD20213 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-19-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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