Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hypersomnia, Irritability, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable reporter who reported on the behalf of a physician for a patient. This is second of the two reports reported by the same reporter. A 3-month-old, male patient (Birth weight: 3326 grams) received first dose of PREVNAR 13 (Lot #G92622 and Expiration date: 12/2014) intramuscularly on right anterolateral thigh at a dose of 0.5 ml on 05Jun2013 at 3:04 pm for immunization. Concomitant vaccine included first dose of ACTHIB, Sanofi Pasteur (Lot # UH770AA) intramuscularly on left anterolateral thigh on 05Jun2013. Relevant medical history included eruption consistent with acne (non comedonal over chin, cheek, upper neck) on 02Apr2013 and Eating difficulties (Spitting up) on 01May2013. Patient had 1 sibling. On 02Apr2013 patient took Vitamin D3 (400UNIT/ML Liquid), 1 Oral daily. Previously, on 01May2013 patient received first dose of DTAP/DAPTACEL) (Sanofi) intramuscularly, on left Anterolateral thigh and first dose of ROTATEQ (Merck) Oral. On 05Jun2013 patient became irritable and slept a lot. On 06Jun2013 had a temperature as high as 101-102 (up to 101.5). The temperature was taken with a rectal thermometer. The symptoms have been associated with nasal discharge/stuffy nose, not with cough or eye congestion. Lab test performed on 05Jun2013 included: Weight: 12 lbs, 12.5 oz; Height 24.5 in; Head Circ.: 16.25 in; Body Surface Area: 0.32 m2 Body Mass Index: 14.97 kg/m2; Temp.: 97.6 degree F (axillary) Pulse: 145 (Regular) Resp.: 30 (Unlabored) P. OX: 98% (Room air). The patient visited to the doctor on 06Jun2013 in morning in response to the reported event fever, the patient was not hospitalized. On 06Jun2012 lab results showed: weight: 12 lbs, 11.5 oz. Temp.: 98.1 degrees F (Axillary) Pulse: 141 (Regular) Resp.: 28 (Unlabored) P. OX: 98 percent (Room air). Patient was active, alert and bright eyed. skin Color pink and Patches c/w seborrheic dermatitis (mild cradle crap). On 05Jun2013 and 06Jun2013 same exams performed and same results obtained: Head and jaw shape: mild flattening right occiput, mild right sided head tilt. Anterior Fontanelle: Soft; Tympanic Membrane (Bilateral) normal; Fundi Eye (Bilateral): red reflex present bilaterally; Oropharynx, Nose and Sinuses Normalneck: Supple, No Masses or Torticollis. Trachea- Midline. Chest and lung exam revealed quiet, even and easy respiratory effort with no use of accessory muscles and on auscultation, clear breath sounds with no adventitious sounds. Cardiovascular examination: normal heart sounds, regular rate and rhythm with no murmurs. Abdomen: no masses, no hepatosplenomegaly and soft, non tender. Sexual Maturity: infant, Circumcised. Genitourinary system: normal; Peripheral Vascular of Upper Extremity Bilateral - Pink nail beds; Brachial pulse (Bilateral) Normal; Lower Extremity Pink skin and Rapid capillary refill. Femoral pulse- Bilateral- Normal. Neurologic: normal for age. No Palpable hip click. Neurological General- normal for age. Musculoskeletal Hips (Bilateral) No Palpable hip click. The patient recovered from fever on 07Jun2013 and clinical outcome of the other reported events was unknown. Reporter stated fever was mot likely due to PREVNAR 13. Follow-up (08Jul2013): New information received from a contactable physician includes: patient details (Birth weight, history), event details, vaccination history, lab test, assessment.