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M² logo Monitoring Communication: Myocarditis – a potential adverse reaction to Comirnaty (Pfizer COVID-19 vaccine)

Medsafe is investigating a potential risk of myocarditis following vaccination with Comirnaty. The aim of this communication is to encourage further reports to obtain more information on this potential safety concern. Monitoring finishes on 31 December 2021.

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News and Events

Date Type Title
16/06/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #11 – 15 May 2021
14/06/2021CommitteesAgenda for the 111th meeting of the Medicines Assessment Advisory Committee - 15 June 2021
9/06/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #10 – 8 May 2021
9/06/2021Monitoring CommunicationM² Logo Myocarditis – a potential adverse reaction to Comirnaty (Pfizer COVID-19 vaccine)
3/06/2021PublicationsPrescriber Update - Vol. 42 No. 2 June 2021
2/06/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #9 – 1 May 2021
31/05/2021Monitoring CommunicationM² Logo Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions - Monitoring closes 25 November 2021
28/05/2021COVID-19Comirnaty (Pfizer COVID-19 vaccine) storage conditions updated
27/05/2021CommitteesAgenda for the 186th Medicines Adverse Reactions Committee meeting - 10 June 2021
26/05/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #8 – 24 April 2021
19/05/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #7 – 17 April 2021
12/05/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #6 – 10 April 2021
5/05/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #5 – 3 April 2021
29/04/2021NoticesUnapproved COVID-19 vaccines - restriction on importation, manufacture, supply and use
29/04/2021Alert CommunicationFluad Quad - a newly funded influenza vaccine for people aged 65 years and older
28/04/2021COVID-19Adverse events following immunisation with COVID-19 vaccines: Safety Report #4 – 27 March 2021
27/04/2021Monitoring CommunicationCOVID-19 vaccines and rare cases of blood clots with bleeding: no current risk with Comirnaty (Pfizer/ BioNTech) vaccine
23/04/2021CommitteesComments on agenda items for the 66th meeting of the Medicines Classification Committee to be held on 11 May 2021