Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

Figures & data

Graph 1. Distribution of MMRV AEFIs, per year of onset and annual reporting rate × 100.000 doses. Apulia Region (Italy), 1/6/2009-31/5/2017

Table 1. Serious AEFIs after MMRV vaccine. Apulia Regio (Italy), 2009–2017.

Case number	Diagnosis*	Interval vaccination-symptoms	Causality assessment
1	Vagal reaction with dizziness and loss of consciousness	Few minutes	Consistent
2	Kawasaky Syndrome	6 days	Indeterminate
3	Allergic reaction	Few minutes	Consistent
4	Fever and erythema on the face, trunk and limbs	7 days	Consistent
5	Fever and hyperpyrexia	Few hours	Not consistent
6	Immune thrombocytopenic purpura	18 days	Consistent
7	Fever, dizziness and erythema on the face, trunk and limbs	5 days	Consistent
8	Fever and hyperpyrexia	7 days	Consistent
9	Hyporesponsive episode in patient with vomiting and metabolic acidosis	7 days	Not consistent
10	Hypotonic-hyporesponsive episode	12 days	Not consistent
11	Iridocyclitis	Not reported	Not-classifiable
12	Thrombocytopenia in Parvovirus B19 infection	20 days	Not consistent
13	Febrile seizure caused by viral pharyngotonsillitis	9 days	Not consisten
14	Immune thrombocytopenic purpura	15 days	Consistent
15	Exanthema post-MMRV vaccine	7 days	Consistent
16	Sepsis and hypertransaminasemia	3 days	Not consistent
17	Immune thrombocytopenic purpura	25 days	Consistent
18	Hypotonic-hyporesponsive episode	24 days	Not consistent
19	Hyperpyrexia and strabismus	10 days	Not consistent
20	Vagal reaction with transient loss of consciousness	Few minutes	Consistent
21	Bronchiolitis caused by Human respiratory syncytial virus (RSV)	Few hours	Not consistent
22	Autism spectrum disorders	1 day	Not consistent
23	Hyperpyrexia with an episode of febrile seizure	Few hours	Not consistent
24	Immune thrombocytopenic purpura	25 days	Indeterminate
25	Atypical uremic hemolytic syndrome	2 days	Not consistent
26	Hyperpyrexia and erythema	Few hours	Not consistent

*All serious AEFIs with a consistent causal association to MMRV vaccine were spontaneously resolved without sequelae.