Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Laboratory test normal, Neurological examination normal, Pain, Reflex test normal
Clinical narrative: This is a spontaneous report received from a contactable physician via a Pfizer Sales representative. A 4-month-old male patient of unspecified ethnicity received the first dose of PREVNAR 13 via an unspecified route of administration, at single dose, the second dose of IPV, the first dose of PEDVAXHIB, the second dose Hep B, of the second dose of DTaP, all on 24Feb2014, vaccinated at doctor's office (vaccine purchased with public funds). The patient received the previous first doses of Hep B on an unknown date, of DTaP and IPV on 30Dec2013. The relevant medical history was not reported. No Known Allergies. The patient was in good health and was bottle-feeding at visit before vaccination on 24Feb2014. The concomitant medications taken within two weeks of the event included ZANTAC 15mg/mL Syrup 1/2 mL bid ongoing. On an unknown date the patient was holding the breath 3 hours after the administration of PREVNAR 13, due to which the patient was taken to the emergency room and admitted for observation on 24Feb2014. The relevant laboratory data and the therapeutic measure taken for the reported event were provided in the following discharge summary. Clinical outcome of the reported event was unknown at the time of the report. The reporter assessment was not provided. The reporter was provided with the information regarding the reported adverse events. The reporter confirmed the occurrence of the events reported by the patient and was willing to be contacted again by Pfizer on the reported adverse events. Additional information was received from the DISCHARGE SUMMARY: Date of Admission: 24Feb2014; Date of Discharge: 25Feb2014. PHYSICAL FINDINGS: Vitals taken on 24Feb2014 11:32 am: Body Length: 24 in, Weight: 11 lbs 14 oz, Head Circumference: 16 in, Body Mass Index: 14.5 kg/m2. Body Surface Area: 0.29 m2, Well developed. Well nourished, Head normocephalic; Neck: Cervical Mass: No cervical mass was seen, no strabismus was observed, eye showed no abnormalities; Sclera showed no icterus; red retinal reflex was elicited; external auditory meatus normal; tympanic Membrane was Normal; no nasal discharge seen, no external nose deformities; Oral Cavity: Teeth: showed no abnormalities; Oropharynx was normal; lymph Nodes were normal; no thoracic asymmetry was noted; Lungs Clear to auscultation; Cardiovascular: Heart Rate and Rhythm: Normal, Heart Sounds: Normal, no murmurs were heard, Arterial Pulses: Equal bilaterally and normal; Back: Normal, Abdomen was normal on visual inspection; Palpation: No mass was palpated in the abdomen; Liver Not enlarged. Spleen: Not enlarged; Genitalia: Penis: Normal; Scrotum: Did not demonstrate a hydrocele; Testes: Normal; Genitalia: External: Genitalia showed no abnormalities; Musculoskeletal System: General/bilateral: Overall findings were normal; Hips: General/bilateral: No dislocation of the hips was noted; An Ortolani test of the hips was negative: Barlow's test of the hips was negative; Neurological: Cranial Nerves: Normal; Reflexes: Primitive reflexes were absent; Skin: Normal. Color and pigmentation were normal; Obstetrical: Cord: Umbilical cord was normal; Growth and Development: Normal 4-month milestones turns to sound; Normal 4-month milestones laughs, squeals: Normal 4-month milestones smiles. Babbles. Document: History and Physical. Date of Admission: 24Feb2014. CHIEF COMPLAINT: Breath-holding. HISTORY OF PRESENT ILLNESS: The patient is a 4-month male previously healthy who was brought to the emergency room by parents complaining of breath-holding spells. As per the parents he was in his usual state of health and he went for his 4-month-old visit today for immunizations and injections including a PCV 13, Hib, DTaP and IPV. He got a prophylactic dose of TYLENOL about an hour prior to the receiving of vaccinations. After returning home around four hours later he was crying continuously with pain and the parents noticed that he was holding his breath for brief periods of time for a few seconds, but one spell was longer to the point that he turned a little blue and the mother had to shake him. He was awake all the time crying. Denies any vomiting, diarrhea, any fever, anybody sick in the family or any other complaint. Denied any abnormal movement, seizures, excessive sleepiness, excessive tiredness, twitching or any other complaints. He is crying but consolable when the mother rocks him. He is drinking less of his formula. Normally he drinks 4-6 ounces every 3-4 hours but since he got his shots he is crying and not drinking his formula. REVIEW OF SYSTEMS: All other systems reviewed and are negative. PAST HISTORY: He is a full-term baby born by normal spontaneous vaginal delivery. Birth weight 3115 g, Apgar 9 and 9. Discharged within two days of life. Newborn screen is negative. All maternal labs including GBS and HIV are negative and the mother is immune to rubella. Had influenza diagnosed and was treated with TAMIFLU for five days. Denies any complications from that. Has been well since that. The reporter denies any prior hospitalizations or any surgeries. He underwent circumcision as a newborn. The reporter any allergies to food or medications. MEDICATIONS: Not on any medications at home. FAMILY HISTORY: Denies any significant health problems in the family. Denies any seizure disorders, any cardiac problems or any other problems. SOCIAL HISTORY; Lives with father, mother, 10-year-old brother, 8-year-old sister. Denies anybody being sick at home. Denies anybody smoking at home. Denies any pets. Sleeps in a cradle. Back to sleep. EMERGENCY ROOM COURSE: On presentation to the ER the patient was afebrile, was evaluated and was found to be crying a lot, minimally consolable by the mother. Was put on a cardiorespiratory monitor and we were consulted to evaluate the patient for further management. PHYSICAL EXAMINATIONS: VITAL SIGNS: On evaluation temperature 98.8 Fahrenheit, respiratory rate 36 per minute, O2 sat 98-100% on room air, pulse rate 145 per minute, blood pressure 71/35 mmHg. He is awake in the father's arms, crying but is consolable by the parents. Head atraumatic. Anterior fontanelle open and flat. Eyes PERRL. Bilateral red reflex seen. Ears: Normal tympanic membranes bilaterally. Nose: Normal mucosa. Mouth: Normal moist mucous membranes. NEUROLOGICAL: Moro symmetrical, strong suck reflex, equal movement of extremities bilaterally, deep tendon reflexes are 2+. NECK: No masses noticed. CHEST: Symmetrical chest expansion, no retractions. LUNGS: Good air entry bilaterally, clear breath sounds. HEART: S1, S2 heard. Regular rate and rhythm. No murmurs. ABDOMEN: Soft, nontender, bowel sounds are present. No organomegaly. GENITALIA: Normal external male genitalia, Tanner stage 1, circumcised, testes descended bilaterally. EXTREMITIES: Capillary refill is less than two seconds. Peripheral pulses 2+. SKIN: Erythema and induration noticed at the site of injections bilateral anterolateral aspect of the thigh. Superficial hemangioma noticed on the occipital area of the scalp. Otherwise, skin unremarkable. ASSESSMENT AND PLAN: A 4-month-old male with breath-holding spells probably secondary to pain associated with the vaccinations. The reporter discussed with the parents that considering that the patient is having breath-holding spells and one of them being for a prolonged period with cyanosis we will recommend to admit the patient for observation. The parents agreed with the plan. HISTORY OF THE PRESENT ILLNESS: This is a 4 month old admitted for observation secondary to possible apneic spells after receiving several immunizations. This was found to be not true apnea. He was afebrile, well-appearing, tolerated all intake, had normal vital signs, remained stable on the monitor overnight. PHYSICAL EXAMINATION: He, on exam was asleep and in no distress. HEENT: Anterior fontanelle, opened soft and flat. Tympanic membranes clear. CARDIAC: S1 and S2 normal, regular rate and rhythm, 2+ pulses. LUNGS: Clear and unlabored bilaterally with regular breathing and regular breathing pattern. ABDOMEN: Soft, nondistended, with active bowel sounds. SKIN: Otherwise warm and clear. NEUROLOGIC: The baby is easily arousable and otherwise appears well. DISCHARGE PLAN: the reporter discussed with dad that this is not likely related to immunizations, nor have we found any true apnea during this visit and he is otherwise a healthy baby. He will be discharged home and given reasons to return including difficulty breathing, fever, or other concerns. Appointment will be made to follow up in 48 hours. Dad verbalized understanding of a plan. MEDICATIONS CURRENT AT THE TIME OF DISCHARGE: TYLENOL liquid, 84.6 MG = 2.644 ML, Oral, Every 4 hours PRN from 24Feb2014 to 25Feb2014 for Pain or Temp >100.4 and MOTRIN, 56.4 MG = 2.82 ML, Oral Every six hours PRN for Pain if TYLENOL not effective from 24Feb2014 to 25Feb2014. Follow-up (28Mar2014): New information received from a contactable Other HCP, on behalf of physician, includes: patient age/gender/data; course of events; concomitant medications; Discharge Summary. Follow-up (23May2014): Follow-up attempts completed. No further information expected.