Reports of lower respiratory tract infection following dose 1 of RotaTeq and Rotarix vaccines to the Vaccine Adverse Event Reporting System (VAERS), 2008–2016

Figures & data

Figure 1. LRTI Reports Following Rotavirus Vaccines, VAERS 2008–2016.

Table 1. Clinical Reviews of LRTI Death Reports Following RV1 or RV5 Vaccination, VAERS 2008–2016.

No.	Age (weeks)	Sex	Year	Vaccine Group	Other vaccines	Onset Interval (days)	Past Medical History/ Family History	Pre-existing Conditions	Cause of Death
1	9	F	2008	RV5 and PCV7	DTaP HepB IPV Hib	3	Sick contacts at home, tobacco smoking at home	RSV bronchiolitis, tinea corporis	Viral pneumonia
2	8	M	2012	RV5 and PCV7	DTaP HepB IPV Hib	1	None	Congestion, cough 3 days prior to vaccination	Sudden unexplained infant death. Other findings: parainfluenza (type 3) bronchiolitis
3	7	M	2012	RV5 and PCV13	DTaP HepB IPV Hib	1	None	None	Bilateral pneumonia (Group A, Streptococcus pyogenes)
4	11	F	2014	RV5 and PCV13	DTaP HepB IPV Hib	13	Unknown	Unknown	Respiratory insufficiency secondary to early bronchopneumonia and chronic interstitial pneumonitis, SIDS

RSV, respiratory syncytial virus; SIDS, sudden infant death syndrome

Table 2. Clinical Review of LRTI Non-Death Serious Reports Following RV1 or RV5 Vaccination, VAERS 2008–2016.

RV1 and PCV13
No.	Age (weeks)	Sex	Year	Other Vaccines	Onset Interval (days)	Past Medical History/Family History	Pre-existing Conditions	Primary Diagnosis	Outcome
1	8	F	2014	DTaP HepB IPV Hib	0	None	URTI at the time of vaccination	Non-RSV bronchiolitis, gastroesophageal reflux	Recovered
2	8	M	2015	DTaP HepB IPV Hib	2	Neonatal transient tachypnea	Influenza-like symptoms for 4 days PTA	RSV bronchiolitis, acute otitis media	Recovered
3	9	M	2016	DTaP HepB IPV Hib	0	None	Rhinorrhea, cough, congestion for 3 past days	Viral bronchitis	Recovered
RV5 and PCV7
No.	Age (weeks)	Sex	Year	Vaccines	Onset Interval (days)	Past Medical History/Family History	Pre-existing Conditions	Primary Diagnosis	Outcome
1	8	M	2008	DTaP HepB IPV	1	Premature birth at 32 weeks	None	Pneumonia	Recovered
RV5 and PCV13
No.	Age (weeks)	Sex	Year	Vaccines	Onset Interval (days)	Past Medical History/Family History	Pre-existing Conditions	Primary Diagnosis	Outcome
1	9	F	2011	DTaP IPV Hib HepB	1	Down Syndrome, congenital heart disease	Rhinorrhea, nasal congestion, wheezing 3 days PTA. Several family members had respiratory illness	Bronchiolitis	Recovered
2	7	F	2011	DTaP HepB IPV Hib	0	None	None	Pneumonia, viral URTI	Recovered
3	9	M	2011	DTaP HepB IPV Hib	14	Sickle cell trait	Rhinorrhea	Pneumonia, Sweet Syndrome	Recovered
4	8	M	2012	DTaP IPV Hib	5	Neonatal jaundice FH: Graves’ disease	Mother has had URTI symptoms	Acute bronchiolitis	Recovered
5	7	F	2012	DTaP IPV Hib HepB	2	Eczema	Sibling with congestion at home	Bronchiolitis, enterococcal bacteremia	Recovered
6	8	M	2013	DTaP IPV Hib	23	None	Rhinorrhea for 1–2 weeks PTA	RSV bronchiolitis	Recovered
7	9	M	2015	DTaP HepB IPV Hib	0	FH: asthma, allergies	Bronchiolitis (cough, congestion and wheezing) 1 week PTA	Acute bronchitis due to rhinovirus	Recovered
8	8	F	2015	DTaP HepB IPV Hib	1	Gastroesophageal reflux and prior ED visit for acute life-threatening event due to gastroesophageal reflux, ‘noisy breathing” noted since birth	Nasal congestion for 4 days PTA	Viral bronchiolitis	Recovered
9	8	M	2015	DTaP IPV Hib	0	FH: diabetes mellitus	Nasal congestion 2 days PTA	Aspiration pneumonia, bilateral pneumothorax, upper GI bleed,	Recovered
10	8	M	2016	DTaP IPV Hib	2	Premature birth at 30 weeks. NICU inpatient from birth for 20 days Maternal history of hepatitis C, IVDU	None	Bronchiolitis due to rhinovirus	Recovered

URTI, upper respiratory tract infection; RSV, respiratory syncytial virus; PTA, prior to admission; FH, family history; ED, emergency department; GI, gastrointestinal tract; NICU neonatal intensive care unit; IVDU, intravenous drug use.