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.
Hypotension; Hypotonia; Anaphylaxis grade II; Stridor inspiratory; This is a spontaneous report received from a contactable physician via Regulatory Authority, the regulatory authority. Regulatory authority report number CH-SM-2021-22333. A 14-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE6029) via intramuscular route, on 18Aug2021 15:45 (at the age of 14-years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. There was no information on possible pathologies, allergies or pharmacotherapy. The patient's concomitant medications were not reported. On 18Aug2021 at 16:15, the patient experienced anaphylaxis grade II, stridor inspiratory. On 19Aug2021 at 11:30, patient had hypotonia and hypotension. On the same day, the patient was hospitalized for all the events. Her clinical summary stated that patient received her first dose of Comirnaty at 3:45 pm on 18Aug2021. About half an hour later, she developed inspiratory stridor (still present at the vaccination center), and was treated with steroids, bilaxten epipen, and due to lack of improvement with tavegyl and adrenaline inhalation. In the emergency room improvement of symptoms. The next day, around 11.30 AM, she developed symptoms again with inspiratory stridor and hypotonia, which necessitated the use of epipen, tavegyl, solu medrol and adrenaline inhalers. The patient improved. Hospitalisation required for more than 48 hours. The physician reported that the patient's mother developed similar symptoms after administration of Moderna COVID-19 vaccine (inspiratory and expiratory stridor) and is known to have asthma; however, the mother also received the second vaccination and did not need Epipen. Therapeutic measures were taken as a result of events which included treatment with steroids, bilaxten, epipen, tavegyl, solu medrol and adrenaline inhalers. The outcome of the events was recovering. Reporter's comments: Grade II anaphylactic reaction in a young patient, occurring 30 minutes after administration of Comirnaty. Requires hospitalisation> 48 hours. The patient's mother experienced similar symptoms (aspiratory and expiratory stridor) after the Moderna vaccination. She is known to have asthma. Nevertheless, she had a second vaccination. She didn't need the epipen. Sender's comments: Grade II anaphylactic reaction in young patient, occurring 30 minutes after administration of Comirnaty. We consider the case serious. The Comirnaty monograph reports anaphylactic reactions as one of the known side effects. Given the very close temporal correlation and the absence of any known causal factors, we consider likely the correlation between Comirnaty and the anaphylactic reaction manifested in the patient with inspiratory stridor and hypotonia. A causal relationship between Comirnaty and anaphylactic reaction, stridor and hypotension was assessed as being probable/likely.This case was reported as serious Hospitalized. No follow-up attempts are required. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FE6029 | OT |
| RECVDATE: | 10-25-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Asthma |
| PRIOR_VAX: | |
| SPLTTYPE: | CHPFIZER INC202101383384 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-25-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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