Introduction

The scientific community rapidly responded to the COVID-19 pandemic by developing novel SARS-CoV-2 vaccines (table 1). As of early June 2021, an estimated 2 billion doses have been administered worldwide.1 Neurological adverse events following immunisation (AEFI), such as cerebral venous sinus thrombosis and demyelinating episodes, have been reported. In some countries, these have led to the temporary halting of both vaccine trials and roll-out programmes. In the absence of clear evidence of causal associations between the vaccine and adverse events, or the rarity of the AEFIs themselves, programmes have thus far been restarted, although sometimes with modifications to recommendations.2

Transient influenza-like symptoms such as headache, myalgia and fatigue have been reported in up to 5% of SARS-CoV-2 vaccine recipients in clinical trials,3 4 although these symptoms often indicate an appropriate immune response to vaccination.5 More severe potential adverse effects in the open-label phase of vaccine roll-outs are being collected through national surveillance systems. In the USA, roughly 372 adverse events have been reported per million doses, which is a lower rate than expected based on the clinical trials.6

In the UK, adverse events are reported via the Coronavirus Yellow Card reporting website. As of early June 2021, approximately 250 000 Yellow Cards have been submitted, equating to around three to seven Yellow Cards per 1000 doses.7 For comparison, the 2010 Pandemrix vaccination had a rate of around 0.6 Yellow Card submissions per 1000 doses.8 Increased pharmacovigilance surrounding SARS-CoV-2 vaccinations may lead to surveillance bias,9 safety alerts may lead to notoriety bias10 and recall bias may also occur. Nevertheless, with large numbers of people being vaccinated, often with a two-dose schedule, rare complications …