Regulators in many countries collect reports of adverse events that occur after a person gets a covid-19 vaccine. This data collection is crucial to identify side effects that may not have occurred during clinical trials. But in the UK, patients and doctors report at least a wide range of these events, many of which obviously have nothing to do with a recent covid-19 vaccination.
More countries in the European Union suspended their launch of the AstraZeneca vaccine on Tuesday, citing the possibility of a higher risk of blood clotting in people taking it. At the same time, the EU’s own health regulators said on Tuesday that there appears to be no clear link between coagulation and the vaccine and that its benefits still outweigh possible harm. Meanwhile, other countries such as the UK continue to reaffirm their security.
The crux of this ongoing controversy largely amounts to voluntarily submitted reports of adverse events by patients and physicians in these various countries. This system is absolutely essential for catching potential red flags of a newly released drug or vaccine. But it is also imperfect, and any conclusions based on these reports need to be carefully weighed. Just ask the people who think their case of genital herpes is linked to the vaccine.
Here is a collection of the most harsh claims reported on the AstraZeneca vaccine in the UK:
- Genital herpes (four reports)
- Appendicitis (two reports)
- Diet failure (one report)
- Breast augmentation (a report)
- Whining or screaming (three reports each)
- Hairy tongue (two reports)
- Clavicle fracture (two reports)
- Arthropod bite, though unclear whether spider or tick (two reports)
- Chopped lips (two reports)
- Flatulence (89 reports)
- Electric shock (two reports)
- Bad breath (five reports)
- Ejaculation failure (one failure)
These claims stem from the UK’s yellow card scheme, a system that keeps track of reports of adverse events from the public and doctors (the UK was the first country to approve the vaccine against AstraZeneca last December). Last week, UK health regulators released the latest and very comprehensive report on the vaccine based on data collected from this system. These spontaneous reports, as they are also sometimes called, were made between January 4 and February 28, 2021. On the UK website specifically designed to submit these reports, people are asked to “report suspected side effects to medications and vaccines” involved in covid-19 treatment.
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As Gizmodo has cover previously, however, “side effects” and “side effects” are not the same. An adverse event is any health problem or condition that appears after treatment, even if the problem is not really related to it. Sometimes a headache after taking a cold is just a headache that would have happened regardless. This is why placebo-controlled trials are so important in medicine, because they can help make the real benefits and possible side effects of a treatment clearer than taking nothing.
However, once a drug is released to the public, you cannot monitor every person taking it in a clinical trial. Therefore, most countries, including the US, rely on reporting systems that encourage patients (or their doctors) to discuss possible side effects they might experience after treatment. Importantly, although these systems will sometimes require people to report “side effects” that they feel they are experiencing, it is still just a collection of adverse events.
If you browse the UK report, you will see symptoms commonly observed in the vaccine trials, such as headache, fatigue and pain at the injection site. But as a Twitter user CTWarriorMonkey pointed out, you will also see many symptoms that are probably not related at all.
Not all of these bad-sounding reports are from people who believe they got a tick or a spider bite because of their vaccination. Some reports can be jokes. In other cases, doctors would have felt compelled to submit a report just because the event happened after vaccination, even if they did not believe it was really caused by the vaccine. Some adverse events, such as death, are in fact strongly encouraged (or legally binding) by being reported by doctors, no matter how plausible they are related to a treatment.
This is because this system is still, with all its warts, one of the fastest ways to gather as much real data as possible about a new drug or vaccine. Scientists sometimes miss side effects in clinical trials, often because they are so rare that they will only appear in a very large population or because some groups are uniquely vulnerable to complications but have not been studied in the study (a long-term problem with pregnant people).
When evaluating the safety of a new treatment, health regulators should separate the less plausible reports from each other and enter information that could be a true signal of problems. Only then can they try to find out if there is a real danger. They often do this by looking at the rate of the alleged problems among the treated population and comparing it with the base figure in the general public.
EU health regulators, the European Medicines Agency, are expected to submit the formal findings of their investigation into the AstraZeneca vaccine later this week. But on Tuesday at a press conference, Emer Cooke, head of the EMA repeat the agency’s position that there is “no indication” of an increased risk of blood clotting associated with the vaccine, based on the rate of clotting between vaccines and non-vaccines studied so far. The United Kingdom is also stand by the vaccine, as well as the World Health Organization. According to AstraZeneca, there have been 37 total reports of blood clots since last Friday identified among 17 million people in the EU and the UK who received the vaccine.
In Germany, regulators said they were forced to discontinue the vaccination after experiencing a particularly rare form of blood clotting, not just blood clotting alone. Several reports in several countries have been found to people who received doses from the same group, which probably caused the possibility of contamination.
These are reasonable issues to keep studying. But much of Europe is in danger from a renewed spate of pandemics, and the backlog of vaccination of the area is only getting worse as a result of these suspensions. To try to avoid the potential hidden risks of this vaccine, which probably does not include appendicitis, many of these countries are now increasing the very known risks of a resurgent pandemic.