adverse events Archives - Medical Design Sourcing

Top 12 reported events for Moderna and Pfizer omicron-targeting COVID-19 boosters

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

With updated COVID-19 boosters set to launch in the near future and COVID-related hospitalizations on the rise again, scrutiny is on the rise of emerging variants and the benefit-safety profile of COVID-19 vaccines.

We performed a retrospective analysis of data from the Vaccine Adverse Event Reporting System (VAERS), focusing on the period covering the launch of the bivalent COVID-19 boosters in 2022 to August 25, 2023. The data captures 15,592 reported events for the Moderna vaccine and 21,553 for the vaccine from Pfizer and BioNTech.

COVID-19 reports: Correlation does not equal causation

Both Moderna and Pfizer vaccine boosters have associated reports of …

Benefits of adding a case collection system upstream of AE intake

[Image courtesy of NEC Corp. of America via Flickr]

While numerous types of technology have a rightful place in life sciences to cut down on errors, decrease costs and boost efficiency, the adverse event intake and collection process remains primarily manual. It’s common for organizations to use software to support adverse event intake, but end-user intervention is often necessary to collect, input and share data.

This practice poses a problem because pharmacovigilance is a team sport. Patients, patient support programs, local representatives of a life science organization, healthcare providers and pharmacovigilance physicians are all needed to contribute to and review an adverse event report before it gets sent to a government regulatory agency. It is critical to gather and understand these insights before reporting is underway.

Beyond this workflow challenge, organizations often face a problem of scalab…

Automating audio records processing to manage surges in patient data

Photo by Tima Miroshnichenko from Pexels

The volume of audio files that potentially contain valuable data on adverse events (AEs) has exploded, outpacing the pace pharmacovigilance (PV) operations originally anticipated in the COVID era. Healthcare company call centers, which in some instances saw up to 75% of adverse drug reaction (ADR) notifications reported through this channel, are challenged to handle this drastic increase in source data that requires tedious review for potential safety events or risks contained in audio interactions and transcriptions. As the increase in source volumes surpasses normal hiring capabilities, pharmaceutical companies face a growing challenge to ensure compliance with AE reporting regulations.

The need for a technology solution

Anyone contacting a healthcare provider (HCP), healthcare regulator or a medical commercial call center could disclose potential adverse events (PA…

COVID-19 vaccine adverse events: Separating the signal from the noise

Image by Spencer Davis from Pixabay

In the U.S., more than 125 million people have been fully vaccinated against COVID-19. While most vaccine recipients tend to have relatively minor and fleeting adverse events from the shots, many people continue to worry about side effects.

According to a recent survey from the physician social network Sermo found that 72% of physicians reported that their patients continue to be concerned about vaccine side effects. Almost 30% of physicians surveyed have encountered patients who have skipped their second dose over adverse event concerns.

Scientific rigor and solid epidemiology are needed to improve our understanding of vaccine safety, according to Dr. Jan Bonhoeffer, a Switzerland-based expert on infectious diseases and vaccine safety who is the founder of the non-profit foundation Heart Based Medicine.

“We need to formulate the right questions to provide th…

39-year old Utah woman dies after getting second dose of COVID-19 vaccine

Image courtesy of Nataliya Vaitkevich via Pexels.

Researchers have not found causal links between COVID-19 vaccination and deaths, but a handful of post-vaccine deaths are making headlines.

One such case is the death of Kassidi Kurrill, a 39-year-old resident of Ogden, Utah, who recently passed away four days after receiving the second dose of Moderna COVID-19 vaccine.

Before her death, Kurrill complained that her heart was racing and was later rushed to the emergency room. Doctors reported that “her liver was not functioning,” according to her father, Alfred Hawley, in an interview with Salt Lake City–based KUTV.

Get the full story from our sister site, Drug Delivery & Development.

What are the most common COVID-19 vaccine side effects?

[Photo by Daniel Schludi on Unsplash]

Now that it has been nearly four months since the FDA authorized the first COVID-19 vaccine, a decent amount of safety information is available about the Pfizer-BioNTech vaccine.

CDC recently released a summary of adverse event data related to the Pfizer-BioNTech vaccine based on more than 5,000 entries to the Vaccine Adverse Event Reporting System collected from Dec. 14, 2020, to Jan. 13.

The summary also included data related to more than 1,000 recipients of the first dose of Moderna COVID-19 vaccine.

The entries make up only a minuscule fraction of the more than 90 million doses of COVID-19 vaccine that Americans have received to date.

A total of 93.7% of the reports related to the first dose of Pfizer-BioNTech vaccine were nonserious, although that figure dropped to 78.6% when it came to the second dose. For the Moderna vaccine, 81.2% of the event…

6 questions about facial swelling and COVID-19 vaccines answered

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients.

But the risk of problems is minuscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery (ABCS).

In the following interview, Dr. Hah puts the risk into perspective, explains why Botox recipients are unlikely to experience vaccine-induced facial swelling, and provides advice for drug developers and the CDC.

Get the full story from our sister site, Drug Discover & Development.

Facial swelling and COVID-19 vaccines: 4 facts

Image from Nataliya Vaitkevich via Pexels

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines.

To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.

1. Facial fillers ≠ Botox

Delayed inflammation is possible for patients who receive either hyaluronic acid or non-hyaluronic acid fillers. The former option, comprising brands such as Juvéderm from AbbVie subsidiary Allergan (NYSE:ABBV) and Restylane from Galderma Laboratories, is the most common.

Facial fillers, however, are distinct from Boto…