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Data source: VAERS (Vaccine Adverse Event Reporting System)

Data through 2026 · Updated quarterly

Built by TheDataProject.ai · © 2026 VaccineWatch

Important: VAERS accepts reports of adverse events following vaccination. For any given report, there is no certainty that the reported event was caused by the vaccine. Reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they are subject to biases. This data cannot be used to determine if vaccines cause or contribute to adverse events.

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Important: VAERS reports alone cannot determine if a vaccine caused an adverse event. Reports may contain incomplete, inaccurate, or unverified information. Correlation does not equal causation.

  1. Home
  2. Vaccine Side Effects
  3. Rotavirus Vaccine
5 min read
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Rotavirus Vaccine Side Effects

Rotavirus vaccines (RotaTeq and Rotarix) protect infants against severe diarrhea caused by rotavirus — the leading cause of severe gastroenteritis in young children worldwide. Given orally starting at 2 months of age, these vaccines have dramatically reduced rotavirus hospitalizations.

30,268
Total Reports
858
Deaths Reported
5,399
Hospitalizations
8,580
ER Visits

💡 Key Insights

→Rotavirus vaccine has prevented an estimated 40,000–50,000 hospitalizations per year in U.S. children since its introduction in 2006 — one of the most dramatic impacts of any childhood vaccine.
→VAERS death reports in this age group primarily reflect SIDS timing. Rotavirus vaccine is given during the same months as the peak SIDS window (2–4 months), making temporal coincidence expected.
ℹ️ Historical context: The first rotavirus vaccine (RotaShield) was withdrawn in 1999 due to an association with intussusception. Current vaccines (RotaTeq, approved 2006; Rotarix, approved 2008) have a much smaller risk and are carefully monitored.

Most Commonly Reported Side Effects

The following symptoms are most frequently reported after rotavirus vaccination:

#1No adverse event
8,701
#2Intussusception
4,665
#3Vomiting
4,052
#4Incorrect product storage
3,964
#5Pyrexia
3,365
#6Product storage error
3,071
#7Diarrhoea
3,013
#8Irritability
2,230
#9Haematochezia
2,171
#10Crying
1,871
#11Inappropriate schedule of drug administration
1,185
#12Surgery
1,172

Intussusception: The Key Safety Concern

Intussusception — a type of bowel obstruction where one segment of the intestine telescopes into another — is the most closely monitored adverse event for rotavirus vaccines. The first rotavirus vaccine (RotaShield) was withdrawn in 1999 because it caused intussusception in about 1 in 10,000 infants.

Current vaccines (RotaTeq and Rotarix) have a much smaller risk — estimated at 1-5 additional cases per 100,000 infants vaccinated, primarily within the first week after the first dose. This is why there's a strict age limit: the first dose must be given before 15 weeks of age, and the series must be completed by 8 months.

RotaTeq vs Rotarix

  • RotaTeq (RV5): 3-dose series at 2, 4, and 6 months. Made by Merck.
  • Rotarix (RV1): 2-dose series at 2 and 4 months. Made by GSK.

Both are oral vaccines (drops, not shots), which is why common side effects differ from injectable vaccines.

Expected Side Effects

Common:

  • Irritability and fussiness
  • Mild, temporary diarrhea
  • Vomiting (usually mild)
  • Fever

Less common:

  • Flatulence
  • Decreased appetite
  • Runny nose

Rare but serious:

  • Intussusception (see above — about 1-5 per 100,000)
  • Kawasaki disease (monitoring ongoing, not confirmed)
  • Severe allergic reaction

Death Reports in Context

The relatively high number of death reports for rotavirus vaccine reflects that it's given to very young infants (2-8 months) during the peak window for SIDS (Sudden Infant Death Syndrome). Large-scale studies have found no increased risk of death from rotavirus vaccination — the temporal association with SIDS is coincidental.

Rotavirus vaccine has a strict age window and is given orally in infancy. See exact timing on the CDC vaccine schedule and our 2026 vaccine schedule analysis.

⚠️ Remember: VAERS reports show correlation, not causation. Many death reports in young infants coincide with the age window for SIDS. Always consult your healthcare provider for medical advice.

How Effective Is the Rotavirus Vaccine?

Before the introduction of rotavirus vaccines in 2006, rotavirus caused an estimated 400,000 doctor visits, 200,000 emergency room visits, 55,000–70,000 hospitalizations, and 20–60 deaths in children under 5 each year in the United States alone. Since routine vaccination began, hospitalizations for rotavirus gastroenteritis have dropped by more than 80%.

Clinical trials showed RotaTeq prevented about 74% of all rotavirus gastroenteritis cases and 98% of severe cases. Rotarix showed similar efficacy. The vaccines also provide indirect protection to unvaccinated older children and adults through reduced community transmission — a benefit confirmed in post-licensure studies.

Timing and Administration

Rotavirus vaccines have a strict age window that is important to understand:

  • First dose: must be given by 14 weeks and 6 days of age
  • Final dose: must be completed by 8 months and 0 days of age
  • Minimum interval: at least 4 weeks between doses

These age restrictions exist because the risk of intussusception from rotavirus vaccine is highest when vaccination is delayed beyond the recommended window. Providers should not initiate the series if an infant is older than 15 weeks.

Global Impact of Rotavirus Vaccination

Rotavirus remains a major killer of children worldwide, causing an estimated 128,500 deaths per year among children under 5, primarily in low-income countries. The WHO recommends rotavirus vaccination for all infants globally. As of 2026, over 120 countries have incorporated rotavirus vaccines into their national immunization programs, contributing to significant declines in childhood diarrhea mortality worldwide.

Frequently Asked Questions

Can a baby who received the rotavirus vaccine still get rotavirus?

Yes, but vaccinated children who get rotavirus typically have much milder illness. The vaccine is most effective at preventing severe, dehydrating gastroenteritis that leads to hospitalization.

Can the rotavirus vaccine spread to other family members?

The vaccine contains live, weakened virus, so vaccinated infants can shed virus in their stool for several days after vaccination. Standard hand hygiene (especially after diaper changes) is recommended but no special precautions are needed for healthy household contacts. Caution is advised around severely immunocompromised individuals.

What if a baby spits up or vomits the dose?

If a significant amount of the dose is spit up or vomited, a replacement dose may be given at the same visit. The decision is made by the healthcare provider based on the circumstances. Regardless, the schedule should continue as planned.

Key Takeaways

  • 1.Rotavirus vaccines have reduced hospitalizations for severe gastroenteritis by over 80%
  • 2.Intussusception risk is very small (1–5 per 100,000) and much lower than the previous RotaShield vaccine
  • 3.Strict age windows exist to minimize the small intussusception risk
  • 4.Death reports in young infants primarily reflect the coincident age window for SIDS, not vaccine causation

Explore This Data

RotaTeq Detail →
Full VAERS profile
Pediatric Analysis →
Children's vaccine data
DTaP Side Effects →
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Data note: Rotavirus vaccine data in VAERS should be interpreted with special attention to the infant population receiving these vaccines. The 2–8 month age window overlaps with the peak period for SIDS, febrile seizures, and other infant health events that occur regardless of vaccination. For this reason, temporal associations with rotavirus vaccination are particularly prone to coincidental events. For a detailed look at infant-age VAERS data, see our pediatric analysis.