COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. This temporary authorisation grants permission for the medicine to be used for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.
As with any new medicine in the UK this product will be closely monitored to allow quick identification of new safety information. You can help by reporting any side effects you may get.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. If you are concerned about an adverse event, it should be reported on a Yellow card. Reporting forms and information can be found at the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play and include the vaccine brand and batch/Lot number if available.
Alternatively, adverse events of concern in association with Pfizer BioNTech COVID-19 mRNA vaccine BNT 162b2 can be reported to Pfizer Medical Information on 01304 616161 or via Pfizer Safety Reporting.
Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymized form) and dual reporting will create unnecessary duplicates.
By reporting side effects, you can help provide more information on the safety of this vaccine.
Like all vaccines, COVID-19 mRNA Vaccine BNT162b2 can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.
Side effects may occur with following frequencies:
Very common: may affect more than 1 in 10 people
- pain at injection site
- tiredness
- headache
- muscle pain
- chills
- joint pain
- fever
Common: may affect up to 1 in 10 people
- injection site swelling
- redness at injection site
- nausea
Uncommon: may affect up to 1 in 100 people
- enlarged lymph nodes
- feeling unwell
Rare side effects: may affect up to 1 in 1,000 people
- temporary one sided facial drooping
Not known (cannot be estimated from the available data)
- severe allergic reaction