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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
979
Local Anesthetics: Adverse Effects01:12

Local Anesthetics: Adverse Effects

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While local anesthetics are generally safe and well-tolerated, they can occasionally cause adverse effects that vary in severity. Local anesthetics can induce toxicity at two distinct levels. They can either produce local effects through direct contact with the neural elements or be absorbed into the bloodstream from the injection site, leading to systemic effects.
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
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Allergic Drug Reactions01:27

Allergic Drug Reactions

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Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing...
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Allergic Reactions02:06

Allergic Reactions

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Overview
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Endocrine Signaling01:45

Endocrine Signaling

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Endocrine cells produce hormones to communicate with remote target cells found in other organs. The hormone reaches these distant areas using the circulatory system. This exposes the whole organism to the hormone but only those cells expressing hormone receptors or target cells are affected. Thus, endocrine signaling induces slow responses from its target cells but these effects also last longer.
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Vaccinations01:51

Vaccinations

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Related Experiment Video

Updated: Sep 6, 2025

Dynamic Monitoring of Seroconversion using a Multianalyte Immunobead Assay for Covid-19
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Signaling COVID-19 Vaccine Adverse Events.

Rave Harpaz1, William DuMouchel2, Robbert Van Manen2

  • 1Oracle Health Sciences, Burlington, MA, USA. rave.harpaz@oracle.com.

Drug Safety
|June 23, 2022
PubMed
Summary

Masking, a statistical issue, can hide COVID-19 vaccine risks. Advanced methods can help detect these signals, improving vaccine safety surveillance.

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Area of Science:

  • Pharmacovigilance and drug safety
  • Biostatistics and epidemiological methods
  • Vaccine safety surveillance

Background:

  • Statistical signal detection is vital for identifying pharmaceutical product risks.
  • The COVID-19 pandemic created unique challenges for vaccine surveillance.
  • Common signal detection methods are susceptible to the masking effect, potentially obscuring vaccine risks.

Purpose of the Study:

  • Investigate the masking effect in COVID-19 vaccine safety signal detection.
  • Assess the impact, extent, and root causes of masking.
  • Evaluate the performance of different statistical methodologies.

Main Methods:

  • Utilized data from the Vaccine Adverse Event Reporting System (VAERS).
  • Applied three common statistical signal detection methodologies.
  • Employed an advanced regression-based methodology for comparison.

Main Results:

  • Masking can lead to undetected or delayed adverse event signals for COVID-19 vaccines.
  • Advanced methodologies show potential in mitigating the masking effect.
  • Masking is more prevalent in COVID-19 vaccine signaling and its characteristics evolve with data.

Conclusions:

  • Masking is a significant issue in vaccine safety surveillance, particularly during the COVID-19 pandemic.
  • The problem of masking is addressable with appropriate methodologies.
  • Careful consideration of masking is crucial for emergency use authorization products.