Regulators in many countries are collecting reports of adverse events that occur after a person gets a covid-19 vaccine. This data collection is crucial to being able to identify side effects that may not have shown up during clinical trials. But in the UK at least, patients and doctors are reporting a wide range of these events, many of which quite obviously have nothing to do with a recent covid-19 vaccination.
More countries in the European Union suspended their rollout of the AstraZeneca vaccine Tuesday, citing concerns of a possibly higher risk of blood clotting in people who take it. At the same time, the EU’s own health regulators said on Tuesday that there appears to be no clear link between clotting and the vaccine and that its benefits still outweigh any potential harms. Meanwhile, other countries such as the UK continue to affirm its safety.
The crux of this ongoing controversy largely comes down to voluntarily submitted adverse event reports from patients and doctors in these various countries. This system is absolutely vital for catching potential red flags of a newly released drug or vaccine. But it’s also an imperfect one, and any conclusions based on these reports have to be weighed carefully — just ask the people who might think their case of genital herpes is tied to the vaccine.
Here’s a collection of the most head-scratching claims reported in the United Kingdom about the AstraZeneca vaccine:
Genital herpes (four reports)
Appendicitis (two reports)
Diet failure (one report)
Breast enlargement (one report)
Moaning or screaming (three reports each)
Furry tongue (two reports)
Clavicle fracture (two reports)
Arthropod bite, though unclear if spider or tick (two reports)
Chapped lips (two reports)
Flatulence (89 reports)
Electric shock (two reports)
Bad breath (five reports)
Ejaculation failure (one failure)
These claims come from the UK’s Yellow Card Scheme, a system that keeps track of adverse event reports from the public and doctors (the UK was the first country to authorise the AstraZeneca vaccine last December). Last week, UK health regulators released the latest and very lengthy report on the vaccine that’s based on data collected from this system. These spontaneous reports, as they’re also sometimes called, were made between January 4 and February 28 2021. On the UK’s website set up specifically for submitting these reports, it calls for people to “report suspected side effects to medicines and vaccines” involved in covid-19 treatment.
As Gizmodo has covered before, though, “adverse events” and “side effects” are not the same thing. An adverse event is any health problem or condition that appears after taking a treatment, even if the problem isn’t actually connected to it. Sometimes, a headache after taking a cold medication is just a headache that would have happened regardless. This is why placebo-controlled trials are so important in medicine, because they can help clarify the real benefits and possible side effects of a treatment versus not taking anything at all.
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Once a drug is released to the public, though, you can’t monitor every person who takes it the way you can in a clinical trial. That’s why most countries, including the U.S., rely on reporting systems in which patients (or their doctors) are encouraged to detail possible side effects they might have experienced after taking a treatment. Importantly, while these systems will sometimes prompt people to report “side effects” they feel they experienced, it’s still just collecting adverse event data.
If you scroll through the UK report, you’ll see symptoms that were commonly noticed in the vaccine trials, such as headache, fatigue, and injection site pain. But as Twitter user CTWarriorMonkey pointed out, you’ll also see lots of symptoms that probably aren’t connected at all.
Not all of these sillier-sounding reports are from people who genuinely believe they got a tick or spider bite because of their vaccine shot. Some reports might be pranks. In other cases, doctors might have felt compelled to submit a report just because the event did happen after vaccination, even if they don’t believe it’s really caused by the vaccine. Some adverse events, such as death, are in fact strongly encouraged (or legally mandated) to be reported by doctors, no matter how plausible their connection to a treatment.
That’s because this system is still, for all its warts, one of the fastest ways to collect as much real-world data on a new drug or vaccine as possible. Scientists do sometimes miss side effects in clinical trials, often because they’re so rare that they’ll only show up in a very large population or because some groups might be uniquely vulnerable to a complication but weren’t studied in the trial (a long-running problem with pregnant people).
When evaluating the safety of a new treatment, health regulators have to separate out the less plausible reports and key in on ones that could be a real signal of trouble. Only then can they try to figure out if there’s an actual added danger. They often do this by looking at the rate of any suspected problems among the treated population and comparing it to the baseline rate in the general public.
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The EU’s health regulators, the European Medicines Agency, are expected to submit the formal findings of their investigation on the AstraZeneca vaccine later this week. But on Tuesday at a press conference, EMA chief Emer Cooke reiterated the agency’s stance that there is “no indication” of an increased risk of blood clotting linked to the vaccine, based on rates of clotting between vaccinated and unvaccinated people studied so far. The UK is also standing by the vaccine, as is the World Health Organisation. According to AstraZeneca, as of last Friday, there have been 37 total reports of blood clotting identified among 17 million people in the EU and UK who received the vaccine.
In Germany, regulators said they were compelled to suspend vaccination after getting reports of an especially rare form of blood clotting, not just blood clotting alone. Several reports in multiple countries have been traced to people who received doses from the same batch, which plausibly raised the possibility of contamination.
These are reasonable issues to keep studying. But much of Europe is in danger from a renewed wave of the pandemic, and the area’s lagging vaccine rollout is only getting worse due to these suspensions. In trying to avoid the possible hidden risks of this vaccine, which probably don’t include appendicitis, many of these countries are now increasing the very well-known risks of a resurgent pandemic.