Age: 1.5
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Constipation, Endocarditis, Feeding intolerance, Globulin, Glucose urine absent
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 8-year-old female patient of an unspecified age and ethnicity received 5 doses of PREVNAR 13 IM at LL or RL at 0.5 ml, single on the following dates: 08Aug2008, 06Oct2008, 17Nov2008, 26Aug2009, 11Feb2011 (Batch/Lot # and expiration date: C57537, C25655, C73446, D81705 / 11Feb2011, L# 914972). Medical history included trisomy 21 showed by Amniocentesis on 12Oct2007 (did not need NICU), atrioventricular septal defect in 2008 repaired, cardiac pacemaker insertion in 2008, ongoing feeding disorder G-tube dependent, recurrent otitis media (s/p tympanostomy tubes x 3), developmental delay from 03Apr2012, Valvular disease: Mitral valve, atrioventricular block complete, cardiac failure congestive, feeding difficulty (not taking oral feeds), urinary incontinence, decreased muscle tone. There were predisposing factors: Down syndrome, Congenital heart disease. Family History/Social History: Parents, 2 brothers, 2 Grandparents live downstairs. No smoke exposure. Surgical history: Procedure: gastric fundoplication on 20Oct2008; gastrostomy tube placement on 20Oct2008, gastrostomy tube removed and replaced with 14 Fr 1.5 cm on 03Aug2010, Chemical cauterization of granul tissue - silver nitrate sticks x 3 for hypergranulation tissue at gastrostomy on 03Aug2010, cardiac surgery - AV canal repair, pacemaker insertion, tympanostomy tube in Fall 2009, strabismus surgery in Sep2010, Myringotomy W/Tubes Ins/Rem W/Wo Patch, EUA on 06Dec2012, dental surgery on: 29Aug2013. Allergies: experienced rash both with TEGADERM occlusive dressing and TEGADERM AG Mesh [Silver]. Vaccination history included: 5 doses of DTP vaccine on 14Apr2008, 08Aug2008, 06Oct2008, 20May2009, 03May2013, KINRIX (SKB; Lot: AC20B221AB IM at LA on 03May2013, 2 doses of Polio vaccine on 08Sep2008 and 04Mar2009, IPOL (Aventis; Lot: D03042 SC at RT on 08Feb2010, MMR on 20May2009, PROQUAD (MSD; Lot: H015782 SC at LA on 03May2013, 3 doses of Hep B on 09Feb2008, 12Mar2008, 08Feb2010, Varicella vaccine on 26Aug2009, 3 doses of HIB on 08Sep2008, 17Nov2008, 27Mar2009, 2 doses of Influenza vaccine 04Nov2008 and 04Nov2009, FLUZONE (Aventis) on 20Jan2010 (Lot: U3273CA), on 15Oct2010 (Lot: UT3570EA), on 26Oct2012 (Lot: UH712AB), Novel H1N1 on 04Nov2009 and 20Jan2010. The patient previously took MOTRIN and experienced drug intolerance, TYLENOL and experienced feeding intolerance, TYLENOL and experienced drug intolerance, TYLENOL and experienced drug ineffective. Concomitant medication included CULTURELLE Kids Packets 1 Packet by Per G Tube route daily add one packet to PEDIASURE and instill via G tube daily, PEDIASURE 1.0 Cal/Fiber orally, Acetaminophen 160 mg/5 ml susp 6.5 ml by mouth every 4 hours as needed. The patient experienced pneumococcal meningitis on 05Mar2016 for which she was hospitalized for 1 week from 14Mar2016 to 20Mar2016. Fever was elevated. Cultures and other diagnostic tests were done in hospital. Serotype of the infecting agent was not done. The patient was treated for pneumococcal meningitis with Antipyretics Ibuprofen/TYLENOL. The outcome of the events was unknown. The patient also experienced invasive pneumococcal disease and endocarditis as primary infection site on 05Mar2016. Course of events. The patient presents with 9 days of fevers and 2 days of increased G-tube residuals. 1-102 F axillary, Tmax of 103.8 approximately 3.5 hours after TYLENOL. She has been tolerating significantly less volume on her G-tube feeds over the same course. Typically takes 320 ml 5 times a day, but is currently only getting 150cc per feed with significant residual. She was bought to hospital on 14March and was felt to have an URI. With decreased tolerance of feeds, mom brought her to hospital. While there a CBC showed leukocytosis to 32.5 with 89% neutrophils is concerning for infectious cause of her fever. UA showed no signs of infection. CMP was WNL. Chest x-ray showed no signs of infection. Blood and Urine Cultures were sent. She has a blood culture currently pending. She was given a bolus and started on IVF. A consult was placed with Paediatrics to assess for admission for persistent fevers without a source. She has had intermittent episodes of retching with minimal vomiting. She has had no cough or rhinorrhea, but had had increased saliva when she gets fussy. Mom has noticed some redness/blistering near G-Tube, but says that this extremely common when she gets sick. There are no sick contacts at home. She has had no recent travel. There are multiple reptiles that live in the house and potential for Salmonella exposure. Hx of AOM but TM look clear with tympanostomy tubes still in place. Her lung exam and CXR both speak against PNA as a source. Joints ranged by attending and not felt to be restricted, therefore less likely a joint infection. She does have a pacer implanted, but her pacer pocket appears without concern currently. Her G-tube does have the small lesion, but does not appear significant enough to produce a systemic response. Potential for her to have a viral URI as previously thought and be clearing it currently. With her cracked lips and fever, discussed Kawasaki's disease, but does not meet the criteria. She also does not meet the criteria for atypical Kawasaki's. She has constipation, but no other concerning GI signs. After receiving a bolus of fluids, she appears more comfortable. Will continue to monitor, follow-up on cultures, and hydrate with a combination of IVF and slowed G-tube feeds. Physical Exam: Vitals: Blood pressure 115/70, pulse 76, temperature 38.5 degrees C (101.3 degrees F), temperature source Axillary, resp. rate 26, weight 18.6 kg (41 lb 0.1 oz), SpO2 98%. Gen: Well appearing female child with features consistent with T21 in no acute distress. Head: NC/AT. ENT: Lips dry and cracked, oropharynx without lesion, TM clear with tympanostomy tubes in place. Neck: Supple, trachea, midline, no thyromegaly or mass. Lungs: Clear to auscultation bilaterally no wheezes, rales, rhonchi, no increased WOB. Heart: Regular rate and rhythm, no murmurs, rubs, gallops. Abdomen G-tube in LUQ with small (-0.5cm), raw, desquamated lesion, No other erythema or signs of infection. Abdomen soft, non-tender, non-distended, no organomegaly or mass, BSx4 normoactive. Lymphatic: No cervical lymphadenopathy. Skin/Hair/Nails: Well healed sternotomy scar and pacer pocket with no redness, fluctuance, or other signs infection. No rashes or abnormal dyspigmentation. Chief complaint: Review of Systems: General ROS: fever, chills, rigors, decreased G-tube feeds. Respiratory ROS: no cough, shortness of breath, or wheezing. Cardiovascular ROS: no tachycardia, mottling, cyanosis. Gastrointestinal ROS: constipation (no BM in 2 days), retching with very intermittent emesis, no diarrhea. Neurological ROS: negative. Dermatological ROS: negative, no rash. The patient underwent lab tests and procedures which included albumin globulin ratio: 0.8, amniocentesis: trisomy 21 on 12Oct2007, anion gap: 21 (h) meq/l on 19Mar2016, blood albumin: 3.0 g/dl on 19Mar2016, blood bilirubin: 0.4 mg/dl on 19Mar2016, blood calcium: 8.7 (l) mg/dl on 19Mar2016, blood chloride: 99 meq/l on 19Mar2016, blood creatinine: 0.56 mg/dl on 19Mar2016, blood culture, blood glucose: 101 (h) mg/dl on 19Mar2016, blood ketone body: negative on 19Mar2016, blood potassium: 3.8 meq/l on 19Mar2016, blood pressure measurement: 115/70. blood sodium: 139 meq/l on 19Mar2016, Leukocytes; Date: 19Mar2016; Result: 32.5 (HH) thou/ul; Erythrocytes; Date 19Mar2016; Result: 3.69(L) mil/ul, Lymphocytes Absolute; Date: 19Mar2016; Result: 0.65 (L), Lymphocytes Percent; Date: 19Mar2016; Result: 2 (L), Mean Corpuscular Volume; Date: 19Mar2016; Result: 93.5 (H); Platelets; Date: 19Mar2016; Result: 258; Erythrocyte Distribution Width SD: Result: 49.1 (H); Component: Erythrocyte Distribution Width CV, 14.4, Test: Protein UR; Result: 25; Metamyelocytes Percent; Result: 3 (H), Neutrophils Absolute; Result: 28.93 (H), Monocytes Absolute; Result: 1.95 (H), Metamyelocytes Absolute; Result: 0.98 (H). Culture performed resulted positive. Other tests performed on 19Mar2016 : Hemoglobin, 12.3, Hematocrit, 34.5, Mean Corpuscular Hemoglobin, 33.3 (H), Mean Corpuscular Hemoglobin Conc, 35.7, Polymorphonuclear Percent, 89 (H), Component: Monocytes Percent, 6, Metamyelocytes Percent, 3 (H), Component: Carbon Dioxide, 19 (L), Component: Glucose Plasma, 101 (H), Component: Blood Urea Nitrogen, 16, Component: BUN Creatinine Ratio: 28.6, Component: Protein, 6.9, Component: Globulin, 3.9 (H); Urine: amber and clear, specific gravity UR, 1.028, leukocyte Esterase Ur Negative Normal. The action taken in response to the events for PREVNAR 13 was not applicable. Therapeutic measures were taken as a result of the events. The reporter assessed that there was a reasonable possibility that the event is related to suspect product, not adverse reaction but child had invasive pneumococcal disease/endocarditis. Not sure if it was a non-covered strain. Follow-up (31May2016): New information reported from a contactable physician included: new events (endocarditis, sepsis), patient age, PREVNAR 13 data; concomitants; event onset date; hospitalization dates; lab tests; history/surgical/vaccination/allergy history; lab tests; course of events, reporter assessment. Follow-up (28Jul2016): Follow-up attempts completed. No further information expected.