Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013.

“Includes 29 747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records.”
Journal of Pediatrics 2015

An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: more than intussusception alone?

“CONCLUSIONS: Intussusception and gastroenteritis were the most commonly reported outcomes; however, a substantial number of reports indicate signs and symptoms consistent with either illness, possibly suggestive of a spectrum of gastrointestinal illness(es) related to RRV-TV. Although VAERS data have recognized limitations such as underreporting (that may differ by vaccine) and are nearly always insufficient to prove causality between a vaccine and an adverse event, this safety profile of RRV-TV may aid better understanding of the pathophysiology of intussusception as well as development of future safer rotavirus vaccines.” Pediatrics  2004

A case-control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events.

Previous case series of SAAEs and biological plausibility support the observed results. Additional studies should be conducted to further evaluate the potential biological mechanisms involved in HPV4 vaccine-associated SAAEs in animal model systems, and to examine the potential epidemiological relationship between HPV4 vaccine-associated SAAEs in other databases and populations.
Clinical Rheumatology 2015

Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine.

“Studies on rotavirus vaccine shedding and its potential transmission within households including immunocompromised individuals are needed to better define the potential risks and benefits of vaccination.” Vaccine 2011

Gastrointestinal adverse reactions following anthrax vaccination: an analysis of the Vaccine Adverse Events Reporting System (VAERS) database.

“RESULTS: Anthrax vaccine was one of the most reactogenic vaccines included in VAERS {Vaccine Adverse Events Reporting System}. The incidence of adverse reactions reported following anthrax vaccine was higher for every reaction analyzed in comparison to the adult vaccine control groups.” Hepatogastroenterology 2004

Gastrointestinal immunopathology and food allergy.

“In contrast to the beneficial expressions of gastrointestinal-associated lymphoid tissue, which are seen with relevance to newer methods of delivery of vaccines directly applied to the gastrointestinal mucosal surfaces (eg, oral poliovirus, rotavirus, Salmonella typhi vaccines), the adverse consequences of a mucosal immune response gone astray are evidenced in many diseases such as FA {food allergy}.” Annals of Allergy, Asthma & Immunology 2004

Hepatitis B vaccination and adult associated gastrointestinal reactions: a follow-up analysis

“CONCLUSIONS: Hepatitis B vaccination was statistically associated by chi 2 analysis with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to our vaccine control groups. The reaction rate observed is outweighed by the benefits of the vaccine. Further analysis is needed to determine the mechanisms by which hepatitis B vaccine is associated with gastrointestinal reactions.” Hepato-gastroenterology 2002

Horizontal transmission of rhesus monkey rotavirus-based quadrivalent vaccine during a phase 3 clinical trial in Caracas, Venezuela.

“Twenty-nine (14%) of 213 rotavirus-positive stools contained at least 2 distinct rotavirus strains: a low-titered vaccine strain(s) and a second strain that, when possible, was studied further and found to be a wild-type rotavirus strain. The titer of vaccine viruses in 19 stools that plaqued directly in cell cultures ranged from 10(1) to 10(3) plaque-forming units/0.5 mL of a 10% stool suspension.” The Journal of Infectious Diseases 2003

Is measles vaccination a risk factor for inflammatory bowel disease?

These findings suggest that measles virus may play a part in the development not only of Crohn’s disease but also of ulcerative colitis.Lancet. 1995.

Measles-mumps-rubella vaccination induced thrombocytopenia: a case report and review of the literature.

“We report a case of ITP {Immune thrombocytopenia} after measles-mumps-rubella (MMR) vaccination in a 10-month-old male infant who presented with purpura and acute gastrointestinal bleeding.” The Southeast Asian Journal of Tropical Medicine and Public Health 2014

Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden.

“Relative risks were significantly increased for Bell’s palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign.” BMJ 2011

Persistent rotavirus vaccine shedding in a new case of severe combined immunodeficiency: A reason to screen.

“Risks of the vaccine to immunocompromised hosts do not negate its widespread use, but rather reinforce the need for neonatal screening measures of SCID {severe combined immune deficiency} in particular.”  Allergy, Asthma & Immunology 2009

Pertussis adjuvant prolongs intestinal hypersensitivity.

“CONCLUSIONS: Our findings indicate nanogram quantities of PT, when administered with a food protein, result in long-term sensitization to the antigen, and altered intestinal neuroimmune function. These data suggest that exposure to bacterial pathogens may prolong the normally transient immune responsiveness to inert food antigens.” Int Arch Allergy Immunol.International Archives of Allergy and Immunology 1999

Poliovirus Infections in Four Unvaccinated Children — Minnesota, August–October 2005

“On September 29, 2005, the Minnesota Department of Health (MDH) identified poliovirus type 1 in an unvaccinated, immunocompromised infant girl aged 7 months (the index patient) in an Amish community whose members predominantly were unvaccinated for polio. The patient has no paralysis; the source of the patient’s infection is unknown. Subsequently, poliovirus infections in three other children within the index patient’s community have been documented.”  CDC 2004

A possible central mechanism in autism spectrum disorders, part 1

The autism spectrum disorders (ASD) are a group of related neurodevelopmental disorders that have been increasing in incidence since the 1980s. Despite a considerable amount of data being collected from cases, a central mechanism has not been offered. A careful review of ASD cases discloses a number of events that adhere to an immunoexcitotoxic mechanism. This mechanism explains the link between excessive vaccination, use of aluminum and ethylmercury as vaccine adjuvants, food allergies, gut dysbiosis, and abnormal formation of the developing brain.Alternative Therapies in Health and Medicine 2008

Post-rotavirus vaccine intussusception in identical twins: A case report.

“Two infants aged 3 months, vaccinated against rotavirus. After about a week, one of the 2 identical infants presented inconsolable crying, vomiting, loose stools mixed with blood, and was diagnosed with bowel obstruction with intussusception. He was operated in urgency. After a few hours, his brother presented vomiting, and was admitted to our Hospital for suspected intussusception.” Human Vaccines & Immunotherapeutics 2016

Rectal Bleeding and Abdominal Pain Following Vaccination in a 4-Month-Old Infant

“We report a case of a 4-month-old female with intussusception requiring hemicolectomy one week following rotavirus vaccination.” Case Reports in Pediatrics 2017

Risk of intussusception following rotavirus vaccination: An evidence based meta-analysis of cohort and case-control studies. (2017)

“CONCLUSIONS: Findings of this meta-analysis suggest that the rotavirus vaccine is associated with an increased risk on the development of intussusception, principally seen after administration of the first dose of vaccine.” Vaccine 2017

RotaTeq vaccine adverse events and policy considerations.

“CONCLUSIONS: These observations, coupled with limited rotavirus disease burden, cost-effectiveness, and potential contact viral transmission concerns, raise serious questions regarding the use of RotaTeq in the US. Healthcare providers should diligently report adverse events following RotaTeq vaccination to VAERS, and those who have experienced a vaccine-associated adverse event should be made aware that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP).” Medical Science Monitor 2008

Rotavirus shedding in premature infants following first immunization.

We describe the natural history of rotavirus shedding in premature infants in the 2-week period following first immunization with RotaTeq(®), the pentavalent rotavirus vaccine (RV5), and the risk for symptomatic transmission to household contacts (HHC).” Vaccine 2011

Rotavirus vaccine-derived shedding and viral reassortants.

“Using active postvaccination monitoring, passive surveillance and state-of-the-art laboratory techniques, Donato et al. report that RotaTeq rotavirus vaccine and vaccine-derived strains were detected actively in stool samples from 13 out of 61 (21.3%) infants having diarrhea within 2 weeks of rotavirus vaccination, and among three out of 460 (0.7%) cases with acute gastroenteritis captured via the Australian Rotavirus Surveillance Program. Six (37.5%) of these 16 vaccine-derived viral specimens were associated with a G1P[8] strain thought to be the result of genetic reassortment between two component RotaTeq strains.” Expert Review of Vaccines 2012

Rotavirus vaccines: viral shedding and risk of transmission.

Rotavirus causes gastroenteritis in almost all children by 5 years of age. Immunity to rotavirus is incomplete, with potential for recurrent infections occurring throughout life.” The Lancet Infectious Diseases 2008

Severe combined immunodeficiency (SCID) and rotavirus vaccination: reports to the Vaccine Adverse Events Reporting System (VAERS).

“Stool rotavirus testing was positive in all cases and the virus was identified as the vaccine strain in six cases. Prolonged viral shedding was documented in five cases.” Vaccine 2010

Sibling transmission of vaccine-derived rotavirus (RotaTeq) associated with rotavirus gastroenteritis.

We document here the occurrence of vaccine-derived rotavirus (RotaTeq [Merck and Co, Whitehouse Station, NJ]) transmission from a vaccinated infant to an older, unvaccinated sibling, resulting in symptomatic rotavirus gastroenteritis that required emergency department care.Pediatrics 2010