Medical Editor: John P. Cunha, DO, FACOEP
- crying or irritability,
- mild fever,
- runny nose,
- sore throat,
- wheezing or coughing, and
- ear infection.
The risk of serious side effects of RotaTeq is low. Call your doctor immediately if your child experiences serious side effects of RotaTeq such as seizure, severe diarrhea, high fever (greater than 102 degrees F/39 degrees C, redness of skin or eyes, pain in their stomach or chest, or pain while urinating.
The Rota Teq vaccination consists of three doses given throughout a 4 to 10 week interval with the third dose given before the child is 32 weeks old. Rota Teq should not be given to your child while they have a severe illness, a history of intestinal problems, or have a weak immune system. Rota Teq may interact with other drugs including medication that can weaken the immune system such as a steroid medication, chemotherapy, medications to treat psoriasis or medication to prevent organ transplant rejection. Always wash your hands after handling the diapers of a child who has been given Rota Teq. This drug is not indicated for women who are of child bearing age and should not be given to a woman who is pregnant or breastfeeding.
Our Rota Teq (rotavirus vaccine, live, oral, pentavalent) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
Rotavirus oral vaccine may cause intussusception in some people. Intussusception is when a section of the intestine folds over into itself, creating an obstruction in the bowel. Call your doctor as soon as possible if your child has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.
Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Call your doctor at once if the child has:
- seizure (black-out or convulsions);
- severe or ongoing diarrhea;
- ear pain, swelling, or drainage;
- fever, chills, cough with yellow or green mucus;
- stabbing chest pain, wheezing, feeling short of breath;
- pain or burning with urination; or
- high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.
Common side effects may include:
- mild fussiness or crying;
- mild diarrhea;
- vomiting; or
- stuffy nose, sinus pain, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.
Read the entire detailed patient monograph for RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
Clinical Studies Experience
71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants in the group that received RotaTeq and 35,560 infants in the group that received placebo. Parents/guardians were contacted on days 7, 14, and 42 after each dose regarding intussusception and any other serious adverse events. The racial distribution was as follows: White (69% in both groups); Hispanic-American (14% in both groups); Black (8% in both groups); Multiracial (5% in both groups); Asian (2% in both groups); Native American (RotaTeq 2%, placebo 1%); and Other ( < 1% in both groups). The gender distribution was 51% male and 49% female in both vaccination groups.
Because clinical trials are conducted under conditions that may not be typical of those observed in clinical practice, the adverse reaction rates presented below may not be reflective of those observed in clinical practice.
Serious Adverse Events
Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq. The most frequently reported serious adverse events for RotaTeq compared to placebo were:
bronchiolitis (0.6% RotaTeq vs. 0.7% Placebo),
gastroenteritis (0.2% RotaTeq vs. 0.3% Placebo),
pneumonia (0.2% RotaTeq vs. 0.2% Placebo),
fever (0.1% RotaTeq vs. 0.1% Placebo), and
urinary tract infection (0.1% RotaTeq vs. 0.1% Placebo).
Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was sudden infant death syndrome, which was observed in 8 recipients of RotaTeq and 9 placebo recipients.
In REST, 34,837 vaccine recipients and 34,788 placebo recipients were monitored by active surveillance to identify potential cases of intussusception at 7, 14, and 42 days after each dose, and every 6 weeks thereafter for 1 year after the first dose.
For the primary safety outcome, cases of intussusception occurring within 42 days of any dose, there were 6 cases among RotaTeq recipients and 5 cases among placebo recipients (see Table 1). The data did not suggest an increased risk of intussusception relative to placebo.
Table 1: Confirmed cases of intussusception in
recipients of RotaTeq as compared with placebo recipients during REST
|Confirmed intussusception cases within 42 days of any dose||6||5|
|Relative risk (95% CI) *||1.6 (0.4, 6.4)|
|Confirmed intussusception cases within 365 days of dose 1||13||15|
|Relative risk (95% CI)||0.9 (0.4, 1.9)|
|* Relative risk and 95% confidence interval based upon group sequential design stopping criteria employed in REST.|
Among vaccine recipients, there were no confirmed cases of intussusception within the 42-day period after the first dose, which was the period of highest risk for the rhesus rotavirus-based product (see Table 2).
Table 2: Intussusception cases by day range in
relation to dose in REST
|Day Range||Dose 1||Dose 2||Dose 3||Any Dose|
All of the children who developed intussusception recovered without sequelae with the exception of a 9-month-old male who developed intussusception 98 days after dose 3 and died of post-operative sepsis. There was a single case of intussusception among 2,470 recipients of RotaTeq in a 7-month-old male in the phase 1 and 2 studies (716 placebo recipients).
Hematochezia reported as an adverse experience occurred in 0.6% (39/6,130) of vaccine and 0.6% (34/5,560) of placebo recipients within 42 days of any dose. Hematochezia reported as a serious adverse experience occurred in < 0.1% (4/36,150) of vaccine and < 0.1% (7/35,536) of placebo recipients within 42 days of any dose.
All seizures reported in the phase 3 trials of RotaTeq (by vaccination group and interval after dose) are shown in Table 3.6
Table 3: Seizures reported by day range in relation to
any dose in the phase 3 trials of RotaTeq
Seizures reported as serious adverse experiences occurred in < 0.1% (27/36,150) of vaccine and < 0.1% (18/35,536) of placebo recipients (not significant). Ten febrile seizures were reported as serious adverse experiences, 5 were observed in vaccine recipients and 5 in placebo recipients.
In the phase 3 clinical trials, infants were followed for up to 42 days of vaccine dose. Kawasaki disease was reported in 5 of 36,150 vaccine recipients and in 1 of 35,536 placebo recipients with unadjusted relative risk 4.9 (95% CI 0.6, 239.1).
Most Common Adverse Events
Solicited Adverse Events
Detailed safety information was collected from 11,711 infants (6,138 recipients of RotaTeq) which included a subset of subjects in REST and all subjects from Studies 007 and 009 (Detailed Safety Cohort). A Vaccination Report Card was used by parents/guardians to record the child's temperature and any episodes of diarrhea and vomiting on a daily basis during the first week following each vaccination. Table 4 summarizes the frequencies of these adverse events and irritability.
Table 4: Solicited adverse experiences within the
first week after doses 1, 2, and 3 (Detailed Safety Cohort)
|Adverse experience||Dose 1||Dose 2||Dose 3|
|Elevated temperature*||n=5,616 17.1%||n=5,077 16.2%||n=5,215 20.0%||n=4,725 19.4%||n=4,865 18.2%||n=4,382 17.6%|
|* Temperature ≥ 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures|
Other Adverse Events
Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the Vaccination Report Card for 42 days after each dose.
Fever was observed at similar rates in vaccine (N=6,138) and placebo (N=5,573) recipients (42.6% vs. 42.8%). Adverse events that occurred at a statistically higher incidence (i.e., 2-sided p-value < 0.05) within the 42 days of any dose among recipients of RotaTeq as compared with placebo recipients are shown in Table 5.
Table 5: Adverse events that occurred at a
statistically higher incidence within 42 days of any dose among recipients of
RotaTeq as compared with placebo recipients
|Diarrhea||1,479 (24.1%)||1,186 (21.3%)|
|Vomiting||929 (15.2%)||758 (13.6%)|
|Otitis media||887 (14.5%)||724 (13.0%)|
|Nasopharyngitis||422 (6.9%)||325 (5.8%)|
|Bronchospasm||66 (1.1%)||40 (0.7%)|
Safety in Pre-Term Infants
RotaTeq or placebo was administered to 2,070 pre-term infants (25 to 36 weeks gestational age, median 34 weeks) according to their age in weeks since birth in REST. All pre-term infants were followed for serious adverse experiences; a subset of 308 infants was monitored for all adverse experiences. There were 4 deaths throughout the study, 2 among vaccine recipients (1 SIDS and 1 motor vehicle accident) and 2 among placebo recipients (1 SIDS and 1 unknown cause). No cases of intussusception were reported. Serious adverse experiences occurred in 5.5% of vaccine and 5.8% of placebo recipients. The most common serious adverse experience was bronchiolitis, which occurred in 1.4% of vaccine and 2.0% of placebo recipients. Parents/guardians were asked to record the child's temperature and any episodes of vomiting and diarrhea daily for the first week following vaccination. The frequencies of these adverse experiences and irritability within the week after dose 1 are summarized in Table 6.
Table 6: Solicited adverse experiences within the
first week of doses 1, 2, and 3 among pre-term infants
|Adverse event||Dose 1||Dose 2||Dose 3|
|* Temperature ≥ 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures|
The following adverse events have been identified during post-approval use of RotaTeq from reports to the Vaccine Adverse Event Reporting System (VAERS).
Reporting of adverse events following immunization to VAERS is voluntary, and the number of doses of vaccine administered is not known; therefore, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to vaccine exposure using VAERS data.
In post-marketing experience, the following adverse events have been reported following the use of RotaTeq:
Immune System Disorders
Intussusception (including death)
Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)
Skin and Subcutaneous Tissue Disorders
Infections and Infestations
Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts.
Post-Marketing Observational Safety Surveillance Studies
The temporal association between vaccination with RotaTeq and intussusception was evaluated in the Post-licensure Rapid Immunization Safety Monitoring (PRISM) program², an electronic active surveillance program comprised of 3 US health insurance plans.
More than 1.2 million RotaTeq vaccinations (507,000 of which were first doses) administered to infants 5 through 36 weeks of age were evaluated. From 2004 through 2011, potential cases of intussusception in either the inpatient or emergency department setting and vaccine exposures were identified through electronic procedure and diagnosis codes. Medical records were reviewed to confirm intussusception and rotavirus vaccination status.
The risk of intussusception was assessed using self-controlled risk interval and cohort designs, with adjustment for age. Risk windows of 1-7 and 1-21 days were evaluated. Cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days. Based on the results, approximately 1 to 1.5 excess cases of intussusception occur per 100,000 vaccinated US infants within 21 days following the first dose of RotaTeq. In the first year of life, the background rate of intussusception hospitalizations in the US has been estimated to be approximately 34 per 100,000 infants.3
In an earlier prospective post-marketing observational cohort study conducted using a large US medical claims database, the risks of intussusception or Kawasaki disease resulting in emergency department visits or hospitalizations during the 30 days following any dose of vaccine were analyzed among 85,150 infants receiving one or more doses of RotaTeq from February 2006 through March 2009. Medical charts were reviewed to confirm these diagnoses. Evaluation included concurrent (n = 62,617) and historical (n=100,000 from 2001-2005) control groups of infants who received diphtheria, tetanus and acellular pertussis vaccine (DTaP) but not RotaTeq.
Confirmed intussusception cases in the RotaTeq group were compared with those in the concurrent DTaP control group and in the historical control group. The data were analyzed postdose 1 and post any dose, in both 7 day and 30 day risk windows. A statistically significant increased risk of intussusception after RotaTeq vaccination was not observed.
One confirmed case of Kawasaki disease (23 days post-dose 3) was identified among infants vaccinated with RotaTeq and one confirmed case of Kawasaki disease (22 days post-dose 2) was identified among concurrent DTaP controls (relative risk = 0.7; 95% CI: 0.01-55.56).
In addition, general safety was monitored by electronic search of the automated records database for all emergency department visits and hospitalizations in the 30-day period after each dose of RotaTeq compared with: 1) days 31-60 after each dose of RotaTeq (self-matched controls) and 2) the 30-day period after each dose of DTaP vaccine (historical control subset from 2004-2005, n=40,000). In safety analyses which evaluated multiple follow-up windows after vaccination (days: 0-7, 1-7, 8-14 and 0-30), no safety concerns were identified for infants vaccinated with RotaTeq when compared with self-matched controls and the historical control subset.
Reporting Adverse Events
Parents or guardians should be instructed to report any adverse reactions to their health care provider.
Health care providers should report all adverse events to the U.S. Department of Health and Human Services' Vaccine Adverse Events Reporting System (VAERS).
VAERS accepts all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report on line to www.vaers.hhs.gov.4
Read the entire FDA prescribing information for RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)