RotaTeq Side Effects

Generic Name: rotavirus vaccine live oral

Please note - some side effects for RotaTeq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of RotaTeq - for the Consumer

RotaTeq

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using RotaTeq:

Mild fever, diarrhea, or vomiting; runny nose; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur when using RotaTeq:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; change in bowel movements; ear pain; high fever; red eyes or mouth; severe or persistent stomach pain, diarrhea, or vomiting; swelling of the hands or feet; swollen glands; wheezing or coughing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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RotaTeq Side Effects - for the Professional

Rotateq

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).

Deaths

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.

Intussusception

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. 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

* Relative risk and 95% confidence interval based upon group sequential design stopping criteria employed in REST.
	Rotateq (n=34,837)	Placebo (n=34,788)
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)

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.

Table 2: Intussusception cases by day range in relation to dose in REST

	Dose 1		Dose 2		Dose 3		Any Dose
Day Range	Rotateq	Placebo	Rotateq	Placebo	Rotateq	Placebo	Rotateq	Placebo
1-7	0	0	1	0	0	0	1	0
1-14	0	0	1	0	0	1	1	1
1-21	0	0	3	0	0	1	3	1
1-42	0	1	4	1	2	3	6	5

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

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.

Seizures

All seizures reported in the phase 3 trials of Rotateq (by vaccination group and interval after dose) are shown in Table 3.

Table 3: Seizures reported by day range in relation to any dose in the phase 3 trials of Rotateq

Day range	1-7	1-14	1-42
Rotateq	10	15	33
Placebo	5	8	24

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.

Kawasaki Disease

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)

* 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
Adverse experience	Dose 1		Dose 2		Dose 3
	Rotateq	Placebo	Rotateq	Placebo	Rotateq	Placebo
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%
	n=6,130	n=5,560	n=5,703	n=5,173	n=5,496	n=4,989
Vomiting	6.7%	5.4%	5.0%	4.4%	3.6%	3.2%
Diarrhea	10.4%	9.1%	8.6%	6.4%	6.1%	5.4%
Irritability	7.1%	7.1%	6.0%	6.5%	4.3%	4.5%

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

Adverse event	Rotateq N=6,138	Placebo N=5,573
	n (%)	n (%)
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

* 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
	Dose 1		Dose 2		Dose 3
Adverse event	Rotateq	Placebo	Rotateq	Placebo	Rotateq	Placebo
	N=127	N=133	N=124	N=121	N=115	N=108
Elevated temperature*	18.1%	17.3%	25.0%	28.1%	14.8%	20.4%
	N=154	N=154	N=137	N=137	N=135	N=129
Vomiting	5.8%	7.8%	2.9%	2.2%	4.4%	4.7%
Diarrhea	6.5%	5.8%	7.3%	7.3%	3.7%	3.9%
Irritability	3.9%	5.2%	2.9%	4.4%	8.1%	5.4%

Post-Marketing Experience

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:

Gastrointestinal disorders:

   Intussusception (including death)

   Hematochezia

   Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)

Skin and subcutaneous tissue disorders:

   Urticaria

Infections and infestations:

   Kawasaki disease

   Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts.

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.{2}

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included intussusception (including death), gastroenteritis, hematochezia, loss of appetite, diarrhea, vomiting, flatulence, abdominal pain, food regurgitation, and constipation. Post marketing experience has included gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).

Dermatologic

Dermatologic side effects have included urticaria.

Nervous system

Nervous system side effects have included seizures, sleep disorder and somnolence.

Other

Other side effects have included dehydration, Kawasaki Disease, fever and fatigue.

Psychiatric

Psychiatric side effects have included fussiness/irritability and crying.

Respiratory

Respiratory side effects have included pneumonia, nasopharyngitis, otitis media, bronchiolitis, cough/runny nose, bronchospasm, upper respiratory tract infection, hoarseness, and rhinorrhea. Apnea has been reported in premature infants.

Genitourinary

Genitourinary side effects have included urinary tract infection.

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