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An increase in accident and emergency presentations for adverse events following immunisation after introduction of the group B meningococcal vaccine: an observational study
  1. Viveka Nainani1,2,3,
  2. Ushma Galal4,
  3. Jim Buttery2,3,5,6,
  4. Matthew D Snape1,7
  1. 1 Department of Paediatrics, University of Oxford, Oxford, UK
  2. 2 Department of Infection and Immunity, Monash Children’s Hospital, Clayton, Victoria, Australia
  3. 3 Department of Paediatrics, Monash University, Clayton, Victoria, Australia
  4. 4 Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK
  5. 5 SAFEVIC, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia
  6. 6 Monash Immunisation, Monash Health, Clayton, Victoria, Australia
  7. 7 NIHR, Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK
  1. Correspondence to Viveka Nainani, Oxford Vaccine Group, University of Oxford, Department of Paediatrics, Oxford OX3 7LJ, UK; vknai2{at}


Objectives To determine whether the introduction of the capsular group B meningococcal vaccine (4CMenB) in the UK has increased presentations of infants to emergency departments with adverse events following immunisation (AEFI).

Participants, design and setting A retrospective review of hospital records of infants aged 1–6 months presenting to Oxford University Hospitals NHS Trust’s emergency departments from September 2013 to August 2016 with discharge diagnoses of vaccine reactions or non-specific conditions. Immunisation history was checked by reference to centralised immunisation records.

Main outcome measures Presentation classifications were ‘probable vaccine reaction’ (ie, symptoms within 48 hours of immunisation; no alternative cause found), ‘possible vaccine reaction’ (symptoms within 48 hours of immunisation with a possible alternative cause) or ‘not related’ (clear alternative diagnosis or not immunised within previous 48 hours).

Results Prior to 4CMenB introduction (2013–15), an annual average of 12 infants presented with probable or possible AEFIs, increasing to 38 infants in the year following 4CMenB introduction (2015/2016). Rates of AEFIs per 1000 immunisation episodes increased post-4CMenB introduction from 1.03 to 3.4 (p<0.001) at 2 months and from 0.14 to 1.13 (p=0.005) at 4 months. At 3 months, when 4CMenB is not given, no increase was seen (p=0.380). 4CMenB introduction was also associated with increased AEFI-related hospital admissions, invasive investigations and intravenous antibiotic use.

Conclusions The increase in emergency department attendances, investigations and antibiotic use for AEFIs following 4CMenB immunisation may influence the cost-effectiveness of the 4CMenB immunisation campaign.

  • immunisation
  • general paediatrics
  • 4cmenb
  • fever
  • aefi

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  • Contributors MDS conceived the study. VN wrote the initial draft as well as all subsequent drafts, which were all edited by UG, MS and JB.

  • Funding This project was internally funded. We have received support from the NIHR Oxford Biomedical Research Centre and a travel grant from Monash University Department of Paediatrics.

  • Competing interests MDS is currently, or has been, a principal investigator on clinical trials funded and/or sponsored by vaccine manufacturers including GlaxoSmithKline, Pfizer, Medimmune and Johnson and Johnson. MDS has also spoken at industry sponsored symposia and contributed to advisory boards. This work is undertaken on behalf of the University of Oxford. JB is an investigator on clinical vaccine trials or observational studies sponsored by vaccine manufacturers including Novavax, Pfizer and MedImmune. JB also serves on data safety monitoring committees for Sequiris. This work was undertaken on behalf of Monash Health.

  • Ethics approval Permission to conduct this study as a service evaluation was obtained through the OUH NHS trust, thus the study did not require approval from an NHS ethics committee. Low-risk ethical approval was granted by Monash University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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