This is a report of my personal experience participating in a coronavirus vaccin trial. All statements can be verified upon request. Actors and organisations can be identified if necessary, but this discussion is primarily meant to inform policymakers and improve medical trials.
In Belgium, corona policies are notoriously poorly executed. It was the first country after Italy to suffer from the initial European wave, and had the world's highest death toll for a long time. The main reason for this probably is the high urbanization, meaning the whole country should rather be compared to large cities in other countries, like London or New York. Another reason is the high average age of the population, the high prevalence of comorbidities, unhealthy lifestyles, and one good thing: the fact that coronavirus deaths were fairly well registered. Nevertheless, the risks of coronavirus were very real, certainly when living in the capital, where mitigation measures are laughable.
I therefore decided not to wait my turn for a coronavirus vaccine that might never come, or only after summer, and applied for a testing vaccin. It was an mRNA vaccine, which was expected to be as good as other mRNA vaccines that had proven to be successful, and the trial was in phase 3, meaning safety was already investigated.
On 13 march, the first injection was administered in the left-hand delta muscle. I had expected fever for two days, and indeed suffered from this. In addition, I felt tingling in the fingers, notably the pinkies of both hands, which was also among the possible side effects. During the first night, with 38.5 fever and sweating a lot, my heart was also hurting. Finally, I had a large brown spot where the blood sample had been taken, and I felt extremely tired for one week. Over time, the tingling faded but did not disappear.
On 12 april, the second jab was given in the right-hand delta muscle. I had asked for this in order to avoid confusing shoulder pain and heart pain, and prevent panicking about it. There was no heart ache this time, and less sweating, but I suffered again from the tingling in the pinkies, now dominantly (but not uniquely) on the right-hand side. In addition, after an afternoon-nap, I sent a text message in bed, after which my entire head started tingling. This was before the onset of fever, but I had taken 500mg of paracetamol as the trial doctor had recommended. As this was very frightening, I alerted the trial director and asked whether I should go to the hospital. He suspected a nerve may have been physically damaged from the injection, but did not believe hospitalisation was needed unless symptoms reoccured. To avoid surprises, I went to the hospital anyway and tested my temperature (low) and blood pressure (very high) on the spot. In general, I felt good, but as the blood pressure on my device reached 18/9, I went in and asked the first line nurse to do checks on both arms. At the time, rare side effects from blood clots were much discussed, and I knew that imbalances between both arms could signal issues. Both arms showed 15/9, which was obviously high for someone who usually has normal blood pressure, but not alarming. I went to my girlfriend and spent the night there. Again, the fever reached 38.5°C and by the morning had dropped to 38°C without pain killers.
The trial required us to signal side effects only from the fourth day onwards. COVID-19 symptoms had to be signalled using a diary application, which would give us alerts. Now there are a number of issues with this tool and procedure:
- Initial side effects were not registered (not the focus of the study).
- Consecutive side effects could only be registered after consulting a doctor or taking medicines.
- The COVID-19 symptom list included about 12 symptoms, in order to decide whether or not you should see a doctor and get a PCR test, which is fair, but it also included a free form. If you fill in this free form, you could not submit the form.
- After entering the wrong password a couple of times, I was unable to get back into the application, until today. Looking at the reviews in the Google app Store, many others experienced problems with the app and gave it a very low average rating of 2 stars (out of 5).
As I did not go to hospital and did not suffer much from the tingling, I could not register this. I mentioned it on the free form and asked to be heard by the doctors from the experiment, but this was not followed up - probably because of the bug in the software. After while, I twice received an email saying I had not filled in the diary, after which I told them I did and mentioned the absence of COVID-19 symptoms and the continued high blood pressure, increased heart beat, and tingling of the pinkies and occasionally my left foot - none of which I had experienced before the vaccination. During the planned doctor visits and phone calls, I repeated these complaints. A quick manual test of neurologic functioning turned out favourable, but I was recommended to visit my GP, who prescribed vitamin D and vitamin B for general fitness and nerve health. I also got a recommendation to see a neurologist.
Symptoms seemed to gradually improve, and when contacted by the director of the trial, I mentioned the positive evolution. He told me to stop using vitamin B and filed the side effects as not severe, as there had not been a hospitalisation, which is fair. I sent him the blood reports taken at the GP visit and he unblinded me, confirming I had the test vaccin and recommending me not to take a commercial vaccin. Yet early July, after three to four months, the tingling in the right-hand side still occasionally returned, and paresthesia of the hands and left foot during sleep was still occasionally experienced. Moreover, the test vaccin was not approved due to low efficacy and I was urged to take a commercial vaccin, if not I could not travel in summer without PCR testing. Meanwhile I noticed from the scientific debates that the dosage of the mRNA vaccines was probably unnecessarily high for some (e.g. younger) groups of the population, but there was not much transparency around this question (e.g. no reply to questions from the BMJ). I therefore decided to see the neurologist after all.
Neurological examination and brain wave assessment turned out favourable. However, as I had experienced bilateral sensory issues of both ulnaris nerves, the neurologist suspects problems at the c7-c8 cervical disc which is wiring the upper limbs. This of course matches with the tingling of the head (once) and left foot (regularly), meaning it is not simply a cubital tunnel syndrome, which would be one-sided and unrelated to vaccination, except for hypothetical explanations such as oedema, vasculitis, or neuritis. The disc issue could be related to early and very moderate arthrosis, or to a mineral imbalance, accentuated by vaccination, according to the neurologist, but this was also speculation. Also, and most importantly, as I have a computer job, relieving pressure on the forearm is recommended. Holidays and two weeks of rest should make the symptoms disappear. Pure magnesium could help for muscle relaxation and restoring the mineral balance, and vitamin B (B-fact Forte complex, including B1) use should be continued. In short: vaccination triggered some sensitivity of the neural plexus, but symptoms continued most likely because of RSI issues.
The question remains whether additional vaccines would aggravate symptoms and what the precise cause of the relatively chronic albeit mild neurological condition had been. Not being an expert, some form of inflammation or immune reaction (arthritis rather than arthrosis) seems plausible and has been documented in the literature. General allergies may be a contributing factor. It is a shame that the trial organisers after unblinding me did not reveal the two blood reports taken during the experiment, as this would tell me antibodies before vaccination and levels created through vaccination, to inform my decision to take a commercially approved vaccine, which would make sense if levels were low even if there is no evidence available yet for a dose-response reaction, however strange this may be. The trial organisers communicated that around 200 persons from the test group had quit the experiment to take a commercial vaccine, and did not report a different safety profile compared to the test group of the commercial vaccine. No tables or statistical tests were shown. Coming from a team that runs a poorly designed and executed experiment, which also is very selective in its communication on the final effectiveness of the vaccin (no information on the effectiveness by variants or linear effects by age), and not conditional on side effects experienced during the trial vaccination, which are rare but did affect me (e.g. allegedly only 17% developed fever), as a researcher I do not find this information of any worth and certainly not justifying entering into a voluntary experiment on mixing vaccins - even less so in light of the fact that the trial team leaves you sorting things out for yourself.
This brings me to my final point: although the outcome of the experiment for me is disappointing, having a failed vaccin, no corona passport, and still suffering from mild side effects and some more uncertainty, there are two issues health policy should watch over:
- First, the quality of the trial design needs more thorough methodological assessment before and during the trial. In this case, there is a clear censoring of potentially important information. The Oxford and Johnson and Johnson vaccines have been appealed after commercial approval to investigate serious side effects. In this case, the trial team literally replied to me side effects are not the focus of the phase 3 - which is correct - and would therefore not be looked into - which is creating a bias.
- Secondly, participants in a medical experiments should feel safe and reassured that maximum efforts are undertaken to follow up on complaints and side effects. This is of importance to medical science in general and a matter of deontology. Besides my interest to be vaccinated, I was also interested in experiencing the testing procedure. The lack of professionalism encountered is discouraging.
Self-evidently, errors are part of the game. Good policy cannot take away mistakes and misfortunes. The trial team had probably expected no side effects and good effectiveness, and must have been taken aback by the outcome. This is not the point of my criticism. Taking part in a trial means accepting it can fail. The issue here is about the effort that has been done to watch over the health of the participants, in my case when evaluating the need and safety of a second vaccine. In this respect, the trial team has let participants down, and policy should look into the competences and motivations of both the vaccine producer and the trial teams to ensure errors are sanctioned.
