Regulatory agencies in many countries collect reports of adverse events that occur after a person receives a covid-19 vaccine. This data collection is crucial for identifying adverse events that may not have emerged during clinical studies. But in the UK, at least, patients and doctors are reporting a wide variety of these events, many of which are clearly unrelated to a recent covid-19 vaccination.
More countries in the European Union suspended their rollout of the AstraZeneca vaccine Tuesday, citing concerns about a possible higher risk of blood clotting in people using it. At the same time, the EU’s own health regulators said on Tuesday that there does not appear to be a clear link between coagulation and the vaccine and that its benefits still outweigh its potential downsides. Meanwhile, other countries, such as the UK, continue to affirm its security.
At the heart of this ongoing controversy largely comes down to voluntary adverse event reports from patients and physicians in these different countries. This system is absolutely essential to catch potential red flags from a newly released drug or vaccine. But it’s also an imperfect one, and any conclusions based on these reports should be carefully weighed – just ask the people who might think their case of genital herpes is vaccine-related.
Here is a collection of the most baffling claims reported in the UK about the AstraZeneca vaccine:
- Genital herpes (four reports)
- Appendicitis (two reports)
- Diet failure (one report)
- Breast augmentation (one report)
- Moan or scream (three reports each)
- Hairy tongue (two reports)
- Clavicle fracture (two reports)
- Arthropod bite, although unclear whether it is spider or tick (two reports)
- Chapped lips (two reports)
- Flatulence (89 reports)
- Electric shock (two messages)
- Bad breath (five reports)
- Ejaculation failure (one failure)
These allegations come from the UK’s Yellow Card Scheme, a system that tracks adverse event reports from the public and doctors (the UK was the first country to authorize the AstraZeneca vaccine last December). Last week, UK health regulators released the latest and very long report on the vaccine based on data collected with this system. These spontaneous reports, as they are sometimes called, were made between January 4 and February 28, 2021. On the UK website specifically set up Before submitting these reports, it calls on people to “report suspected side effects of drugs and vaccines” involved in Covid-19 treatment.
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As Gizmodo has covered previously, however, “adverse events” and “side effects” are not the same. One side effect is each health problem or condition that occurs after receiving treatment, even if the problem is not really related to it. Sometimes a headache after taking a cold medicine is just a headache that would have occurred anyway. This is why placebo-controlled studies are so important in medicine, as they can help clarify the real benefits and possible side effects of a treatment rather than taking nothing at all.
Once a drug is released to the public, you cannot control every person who uses it the way you can in a clinical trial. That’s why most countries, including the US, rely on reporting systems that encourage patients (or their doctors) to describe possible side effects they may have experienced after taking treatment. Importantly, although these systems sometimes ask people to report “side effects” they think they may have experienced, they still only collect adverse event data.
If you scroll through the UK report, you will see symptoms that were often noticed during the vaccine studies, such as headache, tiredness and pain at the injection site. But as a Twitter user CTWarriorMonkey noted, you will also see many symptoms that are unlikely to be related at all.
Not all of these crazy-sounding reports are from people who honestly believe they got a tick or spider bite because of their vaccination shot. Some reports may be jokes. In other cases, doctors may have felt compelled to file a report just because the event occurred after vaccination, even if they don’t believe it is really caused by the vaccine. In fact, some side effects, such as death, are strongly encouraged (or legally required) are reported by physicians, regardless of how plausible their relationship to treatment is.
That’s because, despite all its warts, this system is still one of the fastest ways to gather as much real-world data on a new drug or vaccine as possible. Scientists sometimes miss side effects in clinical trials, often because they are so rare that they only occur in a very large population or because some groups may be particularly vulnerable to a complication but have not been studied in the study (a long-term problem in pregnant people) .
When evaluating the safety of a new treatment, health authorities should separate the less plausible reports and key in the reports that could be a real sign of trouble. Only then can they try to find out if there is actually an additional danger. They often do this by looking at the percentage of suspected problems among the treated population and comparing it with the baseline figure among the general public.
The EU’s health regulators, the European Medicines Agency, are expected to submit the formal findings of their investigation into the AstraZeneca vaccine later this week. But Tuesday at a press conference, EMA chief Emer Cooke repeated the agency’s view that there is “no indication” of an increased risk of blood clotting associated with the vaccine, based on the coagulation rate studied so far between vaccinated and unvaccinated people. The UK is also stand by the vaccine, just like the World Health OrganisationAccording to AstraZeneca, there have been a total of 37 reports of blood clotting since last Friday identified among 17 million people in the EU and the UK who have received the vaccine.
In Germany, regulators said they were forced to suspend vaccination after receiving reports of a very rare form of blood clotting, not just blood clotting alone. There have been several reports in multiple countries traced to people who have received doses from the same batch, which makes the risk of contamination likely.
These are reasonable things to keep studying. But much of Europe is at risk from a renewed wave of the pandemic, and the lagging vaccine rollout is only exacerbated by these suspensions. By trying to avoid the potential hidden risks of this vaccine, which probably does not include appendicitis, many of these countries are now increasing the well-known risks of a resurgent pandemic.