Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal inflammation, Hypersensitivity, Insomnia, Muscle twitching, Neurological symptom
Clinical narrative: This spontaneous report has been received from a patient's mother and refers to a currently 5-year-old female patient. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 13-AUG-2012, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date, (reported as a few weeks later), the patient developed rash which was classified as "baby acne". The second dose of RECOMBIVAX HB (strength, dose, route of administration, indication, lot # and expiration date were not reported) was administered on an unknown date in 2012. Other suspect therapies included vaccination: on 18-DEC-2012 with a TDAP (strength, dose, route of administration, indication, lot # and expiration date were not reported), two doses of PREVNAR 13 (strength, dose, route of administration, lot # and expiration date were not reported) on unspecified dates in 2012, two doses of ROTATEQ orally (strength, dose, lot # and expiration date were not reported), on unspecified dates in 2013, a combination vaccine consisting of TDAP (strength, dose, route of administration, lot # and expiration date were not reported) and INFLUENZA B (strength, dose, route of administration, lot # and expiration date were not reported), on 17-OCT-2017 on dose of hib conj vaccine (unspecified carrier)(PRP-T) (strength, dose, route of administration, lot # and expiration date were not reported) and another hib conj vaccine (unspecified carrier)(PRP-T) (strength, dose, route of administration, lot # and expiration date were not reported) in 2013, in August 2013 a dose of  M-M-R II (strength, dose, route of administration, lot # and expiration date were not reported), in 2013 a VARIVAX (strength, dose, route of administration, lot # and expiration date were not reported), on 09-MAY-2013 a dose of VAQTA and on 28-SEP-2015 influenza quadrivalent (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date in July 2015, the patient was having difficulty swallowing solid foods and physician diagnosed the daughter with having a medical symptom known as "Dysphagia" however, the underlining root cause of this serious symptom could not be determined. The patient's mother started to puree all of her daughter's solid food to help her eat and digest the food more easily since she got very concerned about her daughter having difficulty swallowing her food. On an unknown date in 2015, the reporter noticed other odd symptoms, her daughter was having to food because she started to develop "sensory issues" with certain flavors and textures and so the mother decided to change her diet in 2015 and she removed all dairy based foods from her diet. On 12-SEP-2017, the patient had an endoscopy procedure done and her current physician diagnosed her with having "allergies in her Gut" and she was showing signs of "inflammation" in the Gut as well after the endoscopy was performed. On an unknown date in 2017 (reported as more recently), the patient experienced some neurological symptoms like "muscle twitches" and sometimes she went all night without being able to sleep which causes her to "bang her head" around uncontrollably. On an unknown date, the mother noticed was that her daughter's urine was "smelling bad". On an unknown date (reported as in the last few years), the patient had multiple ear infections and was prescribed an antibiotic called amoxicillin 600 mg but she also had an unknown allergic reaction to the amoxicillin so she had to be switched to another unspecified antibiotic to treat the ear infections. On an unknown date, the patient experienced "some damage" in her esophagus and was prescribed with an unspecified omeprazole. The patient also received melatonin for a some of her sleeping problems. The outcome of the event of sensory issues was recovering/resolving (reported as daughter has recovered a little bit since making those dietary changes although the patient is still having difficulty with swallowing food to the present date). The outcome of baby acne, dysphagia, gut allergy, gut inflammation, muscle twitches, sleeping problems, head banging, smelling bad urine, ear infections and allergy reaction to amoxicillin was not provided. Causality assessment was not provided. Upon internal review, the event of damage of esophagus was considered to be medically significant.