Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Haemoglobin normal, Infantile spitting up, Influenza A virus test negative, Influenza B virus test, Irritability
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2012081072 concerning a 9 week female who on 26-MAR-2012 at 16:23 p.m. was vaccinated with a dose of ROTATEQ (lot# 671576/1240AA). Concomitant vaccine included PENTACEL (lot# C3928AA) and PREVNAR 13 (lot# F24141). The relevant medical history and relevant concomitant medications were unknown. The nurse mentioned that the patient experienced extra puffiness, and was crying excessively since 26-MAR-2012 after receiving the first dose of PENTACEL, ROTATEQ and PREVNAR 13 therapies. She also mentioned that after receiving the first dose PENTACEL, ROTATEQ and PREVNAR 13 therapies the patient experienced fever since 26-MAR-2012 which she elaborated that her temperature was found 100.4 on rectal observation on 26-MAR-2012 and on 27-MAR-2012 her temperature was found between 100.5 to 101 on rectal observation due to which she was hospitalized on 27-MAR-2012 and was not discharged at the time of report. The relevant laboratory data included blood work on an unknown date in March 2012 while being in hospital however the results of the test were unknown and she also had temperature checked on 26-MAR-2012 after the administration of vaccines and her temperature was found 100.4 on rectal observation and also had temperature checked on 27-MAR-2012 and her temperature was found between 100.5 and 101 on rectal observation. The status of the vaccines was unknown at the time of the report. Therapeutic measures taken for the reported events were unknown. The consumer was recovering from the reported events at the time of the report. Follow up information has been received from a physician in the form of medical records and a nurse concerning a two month old female born thirty-eight weeks without complications (weight: 10 pounds, 14 ounces) with 4 siblings, and no known allergies who on 26-MAR-2012 at 17:04 p.m. was vaccinated with a dose of ROTATEQ (lot# 671576/1240AA). Suspect secondary vaccines included PENTACEL (lot# C3928AA) and PREVNAR 13 (lot# F24141) (both vaccinations given on 26-MAR-2012 at 17:04 and 17:06). It was also reported the patient received her second dose of RECOMBIVAX (lot# 670943/1260AA) on 24-FEB-2012. The nurse reported the patient's mother called her physician office on 26-MAR-2012 at 22:03 and reported the patient had increased fussiness and 100.4 temperature. The patient was seen in the office the following day (27-MAR-2012) with a rectal temperature of 101, vomiting and fussiness. The nurse reported the patient had no known pre-existing allergies, birth defects and/or medical conditions. The nurse also reported there was no illness at the time of the vaccination. The patient's laboratory results were nonconclusive and the patient was admitted to the hospital for observation. On 27-MAR-2012, the patient was admitted to the hospital for a fever, rule out sepsis. The patient's mother reported her previously healthy 2 month old baby was seen for her 2 month well child check on the day prior to admission where she received her two months vaccines. The patient returned home and woke up from a nap fussier than usual, though the patient was consolable. The patient's mother took her temperature and measured it to be 100.7 degrees Fahrenheit rectally. The patient's mother phoned the patient's primary care provider's office who advised her to give TYLENOL and reevaluate the patient shortly thereafter. The patient's mother reported she had burped the patient and the patient settled and fell asleep. The patient continued to be fussy on the day of admission and was seen in the primary care provider's office where the patient was again found to be febrile to 100.4 F. The primary care provider ordered the following laboratory test: urinalysis and culture which were both within normal limits, CBC w differential (WBC: 14.9, 6% bands, 27% neutrophils, HGB 11.2, HCT 34.3, plt 397), CRP 4.4, ESR 15, RSV antigen: negative and influenza A and B antigens: negative. The patient had a elevated C-reactive protein of 4.44 mg/dl. The patient's temperature upon admission was 98.6 degrees Fahrenheit. The patient's mother reported that the patient had been acting well but has had mild nasal congestion and a slight purulent eye discharge for the last few days prior to her vaccinations. The physician noted that the patient's respiratory symptoms and/or recent vaccination represented the most likely etiologies for the patient's fever. The patient was diagnosed with a yeast diaper rash one week prior to admission and thrush on the day prior to admission. The patient's mother reported that the patient had increased spittiness over the last few days but continued to eat well, void and had normal stool. The patient's past medical history noted: a positive hip click per her primary care provider (hip ultrasound was pending), born at thirty-eight weeks via normal spontaneous vaginal delivery; patient's mother reported no complications and the patient was discharged to home two days following delivery with no complications. The patient's social history noted that she had started day care one week prior to hospital admission. The patient was observed overnight without antibiotics. The patient remained afebrile overnight and continued to feed well with good urine output. The following morning the mother reported that the patient was spitting up again, much more than usual. The patient was observed until her next feed which she tolerated well. The patient was not noted to have significant diaper rash or thrush during this admission. The patient's mother was advised to use nystatin for a couple of more days and then stop. On 28-Mar-2012, the patient was discharged to home well, with a temperature of 97.3 degrees Fahrenheit, and instructed to follow up with her pediatrician. This was originally reported by a nurse. All available medical records will be provided upon request. Additional information has been requested.