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.