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.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from the Regulatory Authority. The reporter is the patient. Regulatory number: FR-RA-TS20221121 (RA). A 51-year-old female patient received BNT162b2 (COMIRNATY), on 18Oct2021 as dose 1, single (Batch/Lot number: Unknown) intramuscular for covid-19 immunization. The patient relevant medical history included: "COVID-19", start date: 22Jan2022 (not ongoing), "early menopause" (unspecified if ongoing), notes: 6 years ago, "Taste loss" (ongoing), notes: I only recovered 20% of taste and smell; "smell loss" (ongoing), notes: I only recovered 20% of taste and smell, "I am often exhausted and out of breath following my Covid infection on 21Jan", start date: 21Jan2021 (ongoing), "I am often exhausted and out of breath following my Covid infection on 21Jan", start date: 21Jan2021 (ongoing), "cysts during menstruation" (not ongoing), notes: of spontaneous improvement, no more cyst for about 20 years, "Migraine" (unspecified if ongoing), notes: Periods after 6 years of menopause, migraines, rapid heartbeat for no reason, "Rapid heartbeat" (unspecified if ongoing). Concomitant medication(s) included: INEXIUM [ESOMEPRAZOLE MAGNESIUM]. The following information was reported: BREAST PAIN (non-serious) with onset 05Nov2021, outcome "recovered" (20Nov2021), MIGRAINE (non-serious) with onset 05Nov2021, outcome "recovering", described as "Migraine headache", PALPITATIONS (non-serious) with onset 05Nov2021, outcome "recovering", POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 05Nov2021, outcome "recovered" (20Nov2021), described as "Postmenopausal bleeding (Her period lasted 2 weeks)", UTERINE CYST (non-serious) with onset Nov2021, outcome "unknown", DRUG INEFFECTIVE (medically significant) with onset 22Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 22Jan2022, outcome "recovered", MENTAL DISORDER (non-serious), outcome "unknown", described as "Psychologically difficult to live with because I had trouble accepting this early menopause 6 years ago. Their return broke me down psychologically", BREAST SWELLING (non-serious), outcome "unknown", described as "After having swollen and sore breasts". The events "postmenopausal bleeding (her period lasted 2 weeks)", "breast pain", "palpitations", "migraine headache", "psychologically difficult to live with because i had trouble accepting this early menopause 6 years ago. their return broke me down psychologically", "after having swollen and sore breasts" and "uterine cyst" required physician office visit. The patient underwent the following laboratory tests and procedures: routine consultation: (21Aug2021) There was nothing, Mammogram: (unspecified date) normal, notes: performed at time of effects, SARS-CoV-2 test: (22Jan2021) Positive, Specialist consultation: (Nov2021) uterine cyst. Clinical information: The patient reported, I only recovered 20% of taste and smell. I am often exhausted and out of breath following my Covid infection on 21Jan" Synthesis produced by the CRPV from additional information obtained from the patient. Postmenopausal patient for 6 years. Has in the past presented with cysts during menstruation, of spontaneous improvement; no more cyst for about 20 years. Psychologically difficult to live with because I had trouble accepting this early menopause 6 years ago. Their return broke me down psychologically. Cyst that appeared as a result of these rules. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | OT | Unknown |
| RECVDATE: | 06-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210821; Test Name: routine consultation; Result Unstructured Data: Test Result: There was nothing; Test Name: Mammogram; Result Unstructured Data: Test Result: normal; Comments: performed at time of effects; Test Date: 20210122; Test Name: SARS-CoV-2 test; Test Result: Positive; Test Date: 202111; Test Name: Gynecological consultation; Result Unstructured Data: Test Result: uterine cyst. |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | INEXIUM [ESOMEPRAZOLE MAGNESIUM] |
| CUR_ILL: | Breathing difficult; Exhaustion; Smell loss (I only recovered 20% of taste and smell); Taste loss (I only recovered 20% of taste and smell.) |
| HISTORY: | Medical History/Concurrent Conditions: COVID-19; Early menopause (6 years ago); Heartbeats increased; Migraine (Periods after 6 years of menopause, migraines, rapid heartbeat for no reason); Uterine cyst (of spontaneous improvement; no more cyst for about 20 years.) |
| PRIOR_VAX: | |
| SPLTTYPE: | FRPFIZER INC202200844369 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 06-23-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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