Data on systemic reactions were not solicited from persons aged 16-17 years. Sect. Myocarditis has been observed after vaccination with mRNA vaccines in postauthorization monitoring. Health impacts include whether the vaccine recipient was unable to perform normal daily activities, missed school or work, or received care (i.e., telehealth, clinic or emergency department visit, or hospitalization) from a medical professional because of new symptoms or conditions. Both companies say side effects for babies and toddlers are. No grade 4 local reactions were reported. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. References to non-CDC sites on the Internet are When to vaccinate children and youth. Fourth, this study was not designed to identify all cases of myocarditis; only reports that listed the MedDRA term myocarditis were included. COVID-19 vaccines side effects are generally mild to moderate in children. Pfizer-BioNTech, 2021 personal communication, April 11-May 5, 2021. In addition, efforts were made to obtain unpublished and other relevant data by hand-searching reference lists, and consulting with vaccine manufacturers and subject matter experts. Shay DK, Shimabukuro TT, DeStefano F. Myocarditis occurring after immunization with mRNA-based COVID-19 vaccines. Vaccine recipients reported similar rates of local reactions after dose 1 and dose 2, but slightly lower after dose 3. In clinical trials, enough teens and children participated to show that the vaccine is safe for 12-year-olds and older. She has atube to get her nutrition," De Garay said to Carlson. Abbreviations: RCT = randomized controlled trial; COVID-19 = coronavirus disease 2019. a. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. You can review and change the way we collect information below. Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID-19 vaccination. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients. * VAERS reports are classified as serious if any of the following are reported: hospitalization or prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups. These supplemental immunobridging data indicate that the immune response in adolescents is at least as strong as that observed in adults. Data source: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. Higgins JPT, Green S (editors). They help us to know which pages are the most and least popular and see how visitors move around the site. Thank you for taking the time to confirm your preferences. Reports of lymphadenopathy were imbalanced with 6 more cases in the vaccine group (7) than the placebo group (1); lymphadenopathy is plausibly related to the vaccine. "They need to come up with something that's going to treat these people early because all they're going to do is keep getting worse.". All HTML versions of MMWR articles are generated from final proofs through an automated process. aDeath, life-threatening event, hospitalization, incapacity to perform normal life functions, medically important event, or congenital anomaly/birth defect. aMild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. All children aged 5 (on or before 31 August 2022) and over can get a 1st and 2nd dose of the coronavirus (COVID-19) vaccine. Fatigue, headache, chills, and new or worsened muscle pain were most common. N Engl J Med 2021;385:23950. One participant in the vaccine group reported grade 4 pyrexia (40.4 C). Data were reviewed from one Phase II/III randomized controlled trial using data provided by the sponsor [7]. A small proportion of these reactions are consistent with myocarditis. Fox News' Audrey Conklin contributed to this report. A standard continuity correction of 0.5 was used when zero events were observed in one or both arms [6]. The CDC reviewed the potential link between myocarditis and COVID-19 and found in 12- to 39-year-olds, heart inflammation occurred at a rate of 12.6 cases per million second doses given. What are the implications for public health practice? The. VAERS and v-safe data were assessed by sex, age group, and race/ethnicity for U.S. adolescents aged 1217 years who received Pfizer-BioNTech vaccine during December 14, 2020July 16, 2021. Redness and swelling were slightly more common after dose 2. Among 8.9 million adolescents vaccinated during the study period, VAERS reports were received for approximately one per 1,000 vaccinees, and 90% of these reports were for nonserious conditions. FDA used the Multi-Item Gamma Poisson Shrinker algorithm to calculate the Empirical Bayes Geometric Mean and its associated 90% confidence interval (EB05, EB95). aMild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). URL addresses listed in MMWR were current as of These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. CDC reviewed 14 reports of death after vaccination. One study was reviewed that provided data on outcomes specified for GRADE (Appendix1). Redness and swelling were more common after dose 2 than dose 1 or 3. Sect. No serious adverse events were considered as possibly related to the vaccine. Marshall M, Ferguson ID, Lewis P, et al. A medical expert answers common questions about having children younger than 12 years old vaccinated against COVID-19. Saving Lives, Protecting People, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. 2023 FOX News Network, LLC. bMild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: causes limitation of limb movement; Grade 4: emergency room visit or hospitalization for severe tenderness at the injection site. While the child in the video had just been vaccinated against COVID-19, his fainting was unrelated to side effects from the vaccine. The critical benefit of interest was prevention of symptomatic laboratory-confirmed COVID-19. a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Most recent search conducted April 11, 2021. Children who turned 5 on or after 1 September 2022 can only get a 1st and 2nd dose of a COVID-19 vaccine if they're either: at high risk due to a health condition or . For evaluation of potential harms, data were reviewed from the Phase II/III randomized controlled trial. Finally, v-safe is a voluntary self-enrollment program that requires children aged <15 years be enrolled by a parent or guardian and relies on vaccine administrators to promote the program. Oliver S, Gargano J, Scobie H, et al. Approximately 129,000 U.S. adolescents aged 1217 years enrolled in v-safe after Pfizer-BioNTech vaccination; they reported local (63.4%) and systemic (48.9%) reactions with a frequency similar to that reported in preauthorization clinical trials. No other systemic grade 4 reactions were reported. As part of the process employed by the ACIP, a systematic review and GRADE evaluation of the evidence for Pfizer-BioNTech COVID-19 vaccine was conducted and presented to ACIP. MMWR and Morbidity and Mortality Weekly Report are service marks of the U.S. Department of Health and Human Services. Saving Lives, Protecting People, Advisory Committee on Immunization Practices (ACIP). You can review and change the way we collect information below. All information these cookies collect is aggregated and therefore anonymous. OR exp Coronavirus Infections/, novel coronavir* OR novel corona virus* OR 2019 coronavirus OR coronavirus disease OR coronavirus 2019 OR covid19 OR covid 19 OR nCoV OR novel CoV OR CoV 2 OR CoV2 OR sarscov2 OR sars-cov* OR sarscov OR 2019nCoV OR 2019-nCoV, Ahmed F. U.S. You can review and change the way we collect information below. An EB05 2 (more than twice expected) was considered the threshold for defining a vaccine-event pair reported disproportionately. c Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. Serious adverse events were more common in vaccine recipients, but certainty in the estimate was very low (RR: 2.50; 95% CI: 0.49, 12.84). Children's COVID-19 vaccines are given at different doses than adult vaccines The Pfizer-BioNTech vaccine, called Comirnaty, is the only vaccine authorized for use in children ages 5 to. cMild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. CDC twenty four seven. acip@cdc.gov. The median onset for most systemic events in the 2 4 year age group was 2 days after any dose and all events resolved with a duration of 1 2 days after onset. Sect. The certainty in the estimate of the effect for serious adverse events was downgraded one point due to serious concern of indirectness related to the median two months follow-up and two points for imprecision due to the width of the 95% confidence interval (type 4, very low certainty). Overall, the median onset of local reactions in the vaccine group was 0 (day of vaccination) to 2 days after either dose and lasted a median duration between 1 and 2 days. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. c Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or hospitalization b Mild: decreased interest in eating; moderate: decreased oral intake; severe: refusal to feed; Grade 4: emergency room visit or hospitalization We assessed outcomes and evaluated the quality of evidence using the GRADE approach. CDC established v-safe, a voluntary smartphone-based active safety surveillance system, to monitor adverse events after COVID-19 vaccination. 3501 et seq. Legal Statement. However, their reactions to vaccination are expected to be similar to those of young adults who were included. You will be subject to the destination website's privacy policy when you follow the link. No events were observed in the study identified in the review of evidence for hospitalization or MIS-C. 45 C.F.R. Serious concern of indirectness was noted. Among all vaccine recipients, 66.6% reported at least one systemic reaction in the 7 days after vaccination. FDA used empirical Bayesian data mining to monitor for disproportional reporting of adverse events by vaccine among VAERS reports for persons aged 1217 years (8). On May 10, 2021, the FDA updated the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) vaccine for prevention of symptomatic COVID-19 to include persons aged 12-15 years [5]. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. An Ohio mother is speaking out about her 12-year-old daughter suffering extreme reactions and nearly dying after volunteering for the Pfizer coronavirus vaccine trial. people ages 18 years and older who received the janssen covid-19 vaccine primary series dose are recommended to receive 1 bivalent mrna booster dose (i.e., moderna or pfizer-biontech) at least 2 months after completion of the primary series dose (for people who have not received any booster doses), or at least 2 months after the last monovalent The Pfizer-BioNTech COVID-19 vaccine reduced risk of symptomatic laboratory-confirmed COVID-19 when compared to no COVID-19 vaccination (crude VE: 100%; using continuity correction, VE: 97.1%; 95% CI: 51.0%, 99.8%; based on RR: 0.03; 95% CI: 0.00, 0.49) (Table 3a, Table 4). Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity. https://www.fda.gov/media/144412/download, National Center for Immunization and Respiratory Diseases, Role of the ACIP in CDCs Vaccine Recommendations, Shared Clinical Decision-Making Recommendations, U.S. Department of Health & Human Services. Food and Drug Administration. Among those who met the syncope case definition, 147 (16.3%) reported a history of anxiety around needles, and 145 (16.1%) were transported to an emergency department for further evaluation. In the safety expansion cohort, there were 3 serious adverse events in 3 children (arthritis infective [infection of the knee], foreign body ingestion of a penny; epiphyseal fracture) and none in the placebo group. The critical harm of interest was serious adverse events, including vaccine-associated enhanced disease; reactogenicity grade 3 was deemed an important harm. Articles were included if they provided data on vaccination with the Pfizer-BioNTech COVID-19 vaccine and 1) involved human subjects; 2) reported primary data; 3) included adolescents (ages 12-15) at risk for SARS-CoV-2 infection; 4) included data relevant to the efficacy and safety outcomes being measured; and 5) included data for the specific vaccine formulation, dosage, and timing being recommended (BNT162b2, 30 g, 2 doses IM, 21 days apart). COVID-19 Vaccine Safety in Adolescents Aged 1217 Years United States, December 14, 2020July 16, 2021. The median onset of local reactions in the vaccine group was 1 to 2 days after either dose and lasted a median duration between 1 and 2 days. Evidence certainty ranges from type 1 (high certainty) to type 4 (very low certainty) [1]. After dose 1, the older age group (2 4 years) reported pain/tenderness more frequently than the younger age group (6 23 months) (30.8% vs 16.6%); a similar pattern was observed after dose 2 and 3 (31.0% vs 15.0% and 26.7% vs 16.0%, respectively). VAERS received and processed 9,246 reports of adverse events for adolescents aged 1217 years who received Pfizer-BioNTech vaccine during December 14, 2020July 16, 2021 (Table 1); 5,376 (58.1%) were in adolescents aged 1215 years and 3,870 (41.9%) in persons aged 1617 years. (Table 6). Pfizer and Moderna mRNA vaccines are approved for youth 12 years of age and older. Pediatrics 2021;e2021052478. Maddie described the severity of the pain to her mother as "it feels like my heart is being ripped out through my neck.". bBased on data cutoff March 13, 2021; participants had a median of two months follow-up. Jerusalem, Israel: Israeli Ministry of Health; 2021. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 4 days after either dose and lasted a median duration of 1 day. Market data provided by Factset. Centers for Disease Control and Prevention. 100,000 people each year develop myocarditis . First, VAERS is a passive surveillance system and is subject to underreporting and reporting biases (7); however, under EUA, health care providers are required to report all serious events following vaccination. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Among all study vaccine recipients aged 1215 years, 90.9% reported at least one local injection site reaction in the 7 days after vaccination. These reactions are rare; in one study, the risk of myocarditis after the second . Of the 8.7 million doses of the Pfizer vaccine administered to children ages 5-11 between Nov. 3 and Dec. 19, the CDC said it received 4,249 reports of adverse events after vaccination - 98% of . Centers for Disease Control and Prevention. CDC and FDA will continue to monitor for adverse events, including myocarditis, after mRNA COVID-19 vaccination and share available data with ACIP to guide risk-benefit assessments for all COVID-19 vaccines. Second, medical review of reported deaths following vaccination is dependent on availability of medical records, death certificates, and autopsy reports, which might be unavailable or not available in a timely manner. We have no reason to expect that children would tolerate the vaccine less favorably than adults would. They help us to know which pages are the most and least popular and see how visitors move around the site. Advisory Committee on Immunization Practices (ACIP). Eligibility and timing of vaccination The NHS is offering COVID-19 vaccine to children and young people aged 12 to 17 years. These surveillance activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy.. There were 11 drugs in the singer . a Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). Some reactogenicity outcomes may also have been reported as serious adverse events, and experiences of reactions immediately after vaccination could have influenced recall or reporting of subsequent serious adverse events. The most frequently reported reactions for both age groups after either dose were injection site pain, fatigue, headache, and myalgia. *** Processed VAERS reports are those that have been coded using MedDRA, have been deduplicated, and have undergone standard quality assurance and quality control review. Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine. Carlson asked whether any officials from the Biden administration or representatives from Pfizer company have reached out to the family. Cookies used to make website functionality more relevant to you. The majority of systemic events were mild or moderate in severity, after both doses and in both age groups. bBased on interim analysis, data cutoff March 13, 2021. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization PracticesUnited States, June 2021. Characteristics of the included study are shown in Appendix 1. This was observed with a median follow-up of two months, prompting concern for indirectness due to the short duration of follow-up (i.e., observed outcome of vaccine efficacy at two months does not directly inform vaccine efficacy for any duration longer than two months). Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 3 days after either dose and lasted a median duration of 1 to 2 days. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. ACIP conducted a risk-benefit assessment based in part on the data presented in this report and continues to recommend the Pfizer-BioNTech COVID-19 vaccine for all persons aged 12 years (6). The overall incidence of unsolicited non-serious adverse events from dose 1 to data cutoff (April 29, 2022) were similar in the vaccine and placebo groups in both age groups: 29.1% vs. 26.3% for the younger age group and 18.5% vs. 18.5% in the older age group, respectively. aAmong participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2 infection and had negative NAAT at any unscheduled visit up to one month after dose two. This material may not be published, broadcast, rewritten, Systemic reactions in persons aged 12-15 years, Pfizer-BioNTech COVID-19 vaccine and placebo a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Powered and implemented by FactSet Digital Solutions. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. Vaccine efficacy based on relative risk of 0.03 (95% CI 0.00, 0.49) differs from calculations provided by the sponsor and FDA, which do not include a continuity correction and are based on person-time analyses. This material may not be published, broadcast, rewritten, or redistributed. CDC twenty four seven. Frenck RW Jr, Klein NP, Kitchin N, et al. This was rated as not serious. We take your privacy seriously. De Garay said she had joined a Facebook support group to help people cope with the unexpected events happening from the coronavirus vaccine trial, and she said it was shut down. Side effects should only last a few days. Most cases of lymphadenopathy resolved in 10 days or less. Abbreviations: NT50 = 50% neutralizing titer; GMR= geometric mean ratio; CI = confidence interval; LLOQ = lower limit of quantitation. Research shows that this vaccine is about 91% effective in preventing COVID-19 in this age group. 1 user here now 'Nanobody' Nasal Spray Could Stop Spread Of COVID-19 Virus . These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. A MedDRA-coded event does not indicate a medically confirmed diagnosis. Among all study vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 84.7% reported at least one local injection site reaction. By age group, 88.7% in the younger group (aged 18 to 55 years) and 79.7% in the older group (aged >55 years) reported at least one local reaction. Powered and implemented by FactSet Digital Solutions. After Pfizer-BioNTech vaccine was authorized for adolescents aged 1215 years (beginning May 10, 2021), v-safe enrolled 62,709 adolescents in this age group. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. The initial safety findings of Pfizer-BioNTech vaccine administered to U.S. adolescents aged 1217 years are similar to those described in the clinical trials, with the exception of myocarditis, a rare serious adverse event associated with receipt of mRNA-based COVID-19 vaccines; follow-up of reported myocarditis cases is ongoing (6). Share on Pinterest Twelve-year-old twins Brooklyn (left) and Brielle (right) Lieberman were two participants in Moderna's COVID-19 vaccine trial for children ages 12 to 17. Health and Human Services. On July 30, 2021, this report was posted online as an MMWR Early Release. Among all vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 77.4% reported at least one systemic reaction. One grade 4 fever (>40.0C) was reported in the vaccine group. Third, lack of a statistical safety signal in planned monitoring does not preclude a safety concern. The most commonly observed adverse events were consistent with those reported as local and systemic reactions and/or were consistent with events frequently reported in this age group, including infections and injuries, that were not considered related to vaccination. We conducted a systematic review of evidence on the efficacy and safety of a two-dose regimen of Pfizer-BioNTech COVID-19 vaccine. We take your privacy seriously. Patient-important outcomes (including benefits and harms) for assessment were selected by the Work Group during Work Group calls and via online surveys where members were asked to rate and rank the importance of relevant outcomes. Questions or messages regarding errors in formatting should be addressed to CDC physicians reviewed available information for each decedent to form an impression about cause of death. Absolute risk estimates should be interpreted in this context. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. a larger proportion of those who received a positive test result said they believed receiving a COVID -19 vaccine had made their long-term symptoms better (28. . The Moderna EUA memo included reactions such as nervous system disorders, vascular disorders and musculoskeletal and connective tissue disorders, according to Johnson's letter. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDAs spontaneous reports database. Abbreviation: VAERS=Vaccine Adverse Event Reporting System. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. This conversion might result in character translation or format errors in the HTML version. Surveillance of myocarditis (inflammation of the heart muscle) cases between December 2020 and May 2021 [Press release]. Systemic reactions in persons aged 12-17 years, Moderna mRNA-1273 COVID-19 vaccine and placebo a Severe: prevents daily activity; Grade 4: emergency room visit or hospitalization b Severe: any use of prescription pain reliever or prevents daily activity; Grade 4: emergency room visit or hospitalization part 56; 42 U.S.C. Myocarditis was listed among 4.3% (397) of all VAERS reports. Pfizer and Moderna mRNA vaccines are approved for youth 12 years old vaccinated against COVID-19 with. Myocarditis in seven adolescents following Pfizer-BioNTech COVID-19 vaccine | FDA monitoring in the 7 days vaccination... To be similar to those of young adults who were included the second in adolescents at... Lymphadenopathy occurred in the us FDAs spontaneous reports database for Section 508 compliance ( )... 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