cb‐Sharma 2010.

Study characteristics
Methods	Cohort study carried out in Egypt, assessing reaction observed after immunisation with MMR in occasion of compulsory vaccinations
Participants	Children aged 16 to 24 months (N = 73,745) from 9 Egyptian governorates and aged 5 to 7 years (N = 371,184) from 8 Egyptian governorates
Interventions	Immunisation with MMR vaccine containing Leningrad‐Zagreb mumps strain (Tresivac, Serum Institute of India) This contains 1000 TCID50 live attenuated measles Edmonston‐Zagreb strains, 5000 TCID50 of mumps strain Leningrad‐Zagreb, 1000 TCID50 of rubella strain Wistar RA 27/3 in each 0.5 mL dose. Partially hydrolysed gelatin (2.5%), sorbitol (5%), neomycin (≤ 15 μg), and water as diluent are also vaccine components. 24 different lots (EU 615V, EU 618V ‐ EU 640V) were used in the study. Younger children were immunised in the thigh; older children were immunised in the deltoid.
Outcomes	Pain, redness, swelling, fever, rash, parotitis, arthralgia, lymphadenopathy. Data collected by means of a structured questionnaire within 42 days after vaccination.
Funding Source	Mixed (government and pharmaceutical industry)
Notes	One main purpose of the study was to investigate the association between MMR and aseptic meningitis. No disease cases have been identified.
Risk of bias
Bias	Authors' judgement	Support for judgement
PCS/RCS ‐ exposed cohort selection	Unclear risk	Adequate ‐ representative of exposed
PCS/RCS ‐ non‐exposed cohort selection	Unclear risk	Adequate ‐ drawn from the same community
PCS/RCS ‐ comparability	Unclear risk	There was insufficient information ‐ probable residual confounding.
PCS/RCS ‐ assessment of outcome	High risk	Self‐reported ‐ there was insufficient information
Summary Risk of Bias assessment	High risk	We had concerns regarding multiple domains such that our confidence in the result is substantially lowered.