Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ, TDAP
Symptoms: Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count normal
Clinical narrative: Based on addition information received on 22 May 2015, this case became medically confirm. Initial unsolicited report received from a non healthcare professional (medical assistant) on 21-Apr-2015. A 11 years old female patient had received a second dose of MENACTRA in the right deltoid (batch number: U5058AA, expiry date: 07-Sep-2016, route of administration not provided) and second dose of ADACEL in the right deltoid (batch number UI081AA, expiry date, route of administration not provided) on 16-Apr-2015. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient had previously received first dose of MENACTRA and first dose of ADACEL. Concomitant medications were not reported. On 16-Apr-2015, the patient was very nervous and crying before and after the injection. Upon arriving home, the patient told his mother that she could not breathe and her mother felt that she had slurred speech hence she transported her to the emergency room as she feared an allergic reaction. The emergency room only monitored the patient where the patient slept most of the hour. Laboratory investigations included Complete Blood Count (CBC) and Urinalysis (UA). No corrective treatment was provided. At the time of this report, the patient had recovered from all the events on an unspecified date. List of documents held by sender: none. Follow up information received from a physician on 22 May 2015. The patient received ADACEL and MENACTRA via intramuscular route. The patient did not have any known allergies. Social history include denies alcohol use, smoking past 12 months, substance abuse. Patient history included lactose intolerance, acute pharyngitis since 4 February 2014, Cellulitis since 21 October 2014, Fever since 12 September 2012, Molluscum contagiosum since 04 November 2013, Rash since 7 June 2013, vaccine allergy and smoker. Familial history includes Maternal side Disease was Hypercholesterolemia, Hypertension, Diabetes mellitus Type 2 Recorded Date: 1 February 2013 and anxiety. Paternal side disease was asthma, hypertension, and diabetes mellitus type 2 recorded date: 1 February 2013 and anxiety. Patient's concomitant medication include BACTROBAN 2% topical ointment, (1 application TOP TID, for a total of 30) and start on 21 October 2014 and ELOCON 0.1% topical ointment, (1 application TOP daily and for a total of 30g). On 16 April 2015 few min after vaccination the patient experienced shortness of breath, chest pain, altered mental status, mild edema to lips oriented but "anx" tachypnea, crying (due to injections), lip swelling. No other signs, symptoms, or modifying factors. Within 20 min after vaccination the patient confused/slurred words/babbling speech. On an unspecified date patient had gas and abdominal pain with some constipation issues, atopic dermatitis. The patient required emergency room visit and released after a few hours. Patient previous medication includes amoxicillin 500 mg-potassium clavulanate 125 mg tablet, 1 tablet(s). PO, BID and 10 days. Inactive amoxicillin 600 mg-potassium clavulanate 42.9 mg/5 mL oral suspension, 2 teaspoon(s). PO, BID and 10 days, Inactive hydroxyzine 10 mg/5 mL (5 mL) syrup, 1-2 teaspoon(s), PO, QID and 10 days, DTAP on 05 November 2007, DTAP on 24 February 2005, DTAP on 15 April 2004, DTAP on 16 February 2004, DTAP on 17 December 2003, Influenza vaccine on 04 November 2013, Influenza on 22 January 2013, Influenza on 13 December 2011, Influenza vaccine 01 December 2004, Hepatitis B on 15 July 2004, Hepatitis B- 21 November 2003, Hepatitis B on 14 October 2003, Hepatitis A- 14 November 2006, Hepatitis A- 10 November 2005, Haemophilus influenza type b- 24 February 2015, Haemophilus influenza type b-15 April 2004, Haemophilus influenza type b-16 February 2004, Haemophilus influenza type b-17 December 2003, Inactivated Poliovirus-05 November 2007, Inactivated Poliovirus -15 July 2004, Inactivated Poliovirus-16 February 2004, Inactivated Poliovirus-17 December 2003, Influenza type: LAIV-21 October 2014, MMR on 05 November 2007, MMR-on 18 October 2004, Pneumococcal type: PCV on 14 November 2004, Pneumococcal Type: PCV-24 on February 2005, Pneumococcal type: PCV- on 15 July 2004, Pneumococcal type: PCV-17 December 2003, Varicella on 058 November 2007, Varicella on 18 October 2004. Patient's physical examination include patient was awake and alert oriented but anxious, skin was warm and dry, head was normocephalic/atraumatic. Other laboratory test on 16 April 2015 includes body temperature 97.3, pulse 89, blood pressure-141/85 and 100/50mmhg, respiration-20, pulse oxygen- 98%, chest x-ray impression showed negative portable chest. Laboratory test on 16 April 2015 at 12:55:00 include white blood count- 8.5 x10E3/uL, Red blood count-5.06 x10E6/ul, Hemoglobim-14.8g/dl, Hematocrit-43.5%, Mean Corpuscular Volume-86.0 fl, Mean Corpuscular Hemoglobin-29.2 DO, Mean Corpuscular Hemoglobin Concent - 34./0 g/dl, Red Cell Distribution Width-12.4%, Platelet count - 389 x10E3/ul, Mean Platelet volume-9.3 fL, Immature Granulocyte % (Auto) - 0.0%, Neutrophils-61.7%, Lymphocytes-27.3%, Monocytes- 8.3%, Eosinphils-0.6%, Basophils-0.6%, Immature Granulocyte-0.0010*3/ul, Neutrophils-5.2 10E3/ul, Lymphocytes-2.3 10E3/ul, Monocytes-0.7 10E3/ul, Eosinaphils-0.2 10E3/ul, Basophils-0.1 10E3/uL, Urine color-yellow, urine appearance-clear, urine pH-7.0, Urine specific gravity-1.010, Urine protein, urine glucose, urine ketones, urine nitrite, urine bilirubin, urine leukocyte esterase, urine bacteria were negative, urine blood-large, urine urobilinogen- 0.2 E.U./dL, Urine RBC-10-25/HBF, Urine WBC 0-2/HPF. Urine squamous epithelial cells- 0-2/HPF. The patient was treated with BENADRYL, steroid and PEPCID. At the time of this report patient was recovered from the events except the events gas and abdominal pain with some constipation issues outcome were unknown. Documents held by sender none.