Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Erythema, Irritability, Lethargy, Pyrexia
Clinical narrative: This case was reported by a consumer (subject's grandmother) and described the occurrence of low grade fever in a 3-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included constipation, drug reaction and thrush. Concurrent medical conditions included celiac symptoms nos, flour sensitivity and sensitive to chemicals. Historic vaccination included Hib; manufacturer unspecified; unknown given on 16 December 2008; DTaP; manufacturer unspecified; unknown given on 16 December 2008; DTaP-polio-Hib (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; Hep A; manufacturer unspecified; unknown given on 23 March 2010; live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 16 December 2008; MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; IPV (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010. Concurrent medications included unknown (suppository). On 9 March 2012 the subject received 2nd dose of HAVRIX (unknown route, unknown thigh). On 9 March 2012, less than one day after vaccination with HAVRIX, the subject experienced low grade fever and not eating properly. On 13 March 2012, 4 days after vaccination with HAVRIX, the subject experienced. On 14 March 2012, 5 days after vaccination with HAVRIX, the subject experienced cranky, acting out ("acting out by throwing rocks and toys"), stares "off" and blank appearance. On 15 March 2012, 6 days after vaccination with HAVRIX, the subject experienced gastric problem ("holding his stomach"), crying, decreased speech, lethargy, sleep (nos) and reluctant to attend school. The subject did not have a bowel movement on 14 March 2012. The grandmother has not contacted the subject's physician and has not treated the fever. She has provided suppositories, given prunes, soup and mangos for the constipation. The subject receives suppositories for constipation, but the constipation was worse on 14 March 2012 than previously. The grandmother reported that the subject has history of "doesn't detoxify". The grandmother is the subject's caregiver. At the time of reporting the events were unresolved. Prior to these vaccinations, the subject was vaccinated with DTaP on 16 December 2008 and experienced some of the same events plus some different events. See case A0970857A for details. On 23 March 2010, the subject was vaccinated with DTaP/IPV/HIB combination vaccine and experienced some of the same events plus different events. See case A0970857B for details. Follow-up information was received on 27 April 2012 via consumer (subject's grandmother) who provided the subject's immunization record. It was clarified that 3-year-old male subject's historic vaccinations included DTaP-polio-Hib (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008, 20 March 2009, 10 July 2009 and 23 March 2010; Hep A; manufacturer unspecified; unknown given on 23 March 2010; Hep B; GlaxoSmithKline; unknown; unknown given on 16 October 2008, 16 December 2008 and 10 July 2009; influenza virus vaccine; manufacturer unspecified; unknown, unknown given on 10 September 2009; live attenuated human rotavirus vaccine; GlaxoSmithKline; unknown given on 20 March 2009; MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008, 20 March 2009, 10 July 2009 and 23 March 2010; rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008 and 10 July 2009; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010. Concurrent medications included unknown (suppository) and Probiotics. It was reported that "The subject has had a long history of reactions to vaccines. He will be taking vaccine (more) as he approaches his 4th birthday as required by law. He is attending special school and has improved almost 90 percent. He did experience a 'set back' this time after the Hepatitis A vaccine 105 degrees temperature reaction (same autistic symptoms). The next set of vaccine will be given on a 'slow schedule', one at a time and without preservatives." The subject still has sensory processing difficulties and eating disability. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. Follow-up information was received on 18 May 2012 via healthcare professional. The subject was seen by healthcare professional on 16 March 2012, vitals were 99.8 temperature, respiratory 20, pulse 112. According to the progress notes on 16 March 2012, the subject presented with a temperature of 104 axillary last night (15 March 2012), rash from Hepatitis A; described as "hep A vaccine on Friday; low grade fever since Friday. Last night 104 axillary, treated with ibuprofen. At 2 am the fever decreased. Voiding - 'stomach ache'; constipation last BM (bowel movement) was three days ago; tried glyc. Prunes, fructolose. No c/o ears. Eating." The subject's exam showed he had 'no acute distress (NAD), nourished, developed, neck was supple, cardiovascular was regular rate and rhythm (RRR) with mild erythema. Clear to auscultation and bilaterally (CTAB); gastrointestinal exam was positive for bowel sounds (BS), soft non tender (NT); psych was noted to be normal affect." The subject underwent a rapid strep test that was negative. Assessment and plan noted a constipation/ probable viral syndrome; rapid strep was negative, TYLENOL or ibuprofen for fever. Discussed hepatitis A reactions, increase fluids, push vegetables, fruit, fiber if remains constipated call clinical for comfort measures. If signs and symptoms worsen 'RTC'." At the time of the report no other information was provided.