Age: 0.34
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Influenza virus test negative, Plasma protein metabolism disorder, Protein total decreased, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Information has been received from an investigator concerning a 19 week old male with no medical history or concurrent conditions who entered a study. No secondary suspect therapy and no concomitant medications were taken. Previous therapy history on 01-JUN-2011 included ENGERIX-B IM 0.5 ml injection one dose. On 02-AUG-2011, (confirmed by site) the subject was randomized to be vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (+) HIB (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (injection site not reported). Other study vaccines included: the first dose of 0.5 ml IM dose of PREVNAR 13 (injection site not reported) and the first dose of 2.0 ml po dose of ROTATEQ. On 03-OCT-2011, the subject was vaccinated with the second 0.5 ml IM dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (+) HIB (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (injection site not reported). Other study vaccines included: the second 0.5 ml IM dose of PREVNAR 13 (injection site not reported) and the second 2.0 ml po dose of ROTATEQ to complete the childhood immunization series. On 13-OCT-2011, the subject experienced viral syndrome (intensity severe) (previously reported as 14-OCT-2011) and was hospitalized on 14-OCT-2011. The investigator considered both fever (intensity severe)(onset 13-OCT-2011) and vomiting (intensity moderate)(onset 14-OCT-2011) as secondary symptoms of viral syndrome and not SAEs (previously reported as SAEs). It was reported the subject was seen for a sick visit on 14-OCT-2011. The subject's fever (secondary symptom) was treated with TYLENOL 0.4ml, oral, every 4 hours (13-OCT-2011 to 15-OCT-2011). A RSV swab was negative and the subject was diagnosed with fever (secondary symptom of viral syndrome, previously unspecified) and bronchiolitis (symptom of viral syndrome). The subject was prescribed the following: ACCUNEB 0.63mg/3ml solution for nebulization every 4 to 6 hours (14-OCt-20111 to 08-NOV-2011), amoxicillin 400mg/5ml suspension, 3 cc oral twice a day (14-OCT-2011 to 26-OCT-2011). In the evening on 14-OCT-2011, the subject was taken to the ER due to a rectal temperature of 103.5 F, unrelieved by TYLENOL. In the ER, the subject had the following lab/diagnostic tests and results: respiratory syncytial virus was negative, influenza A and B were negative and strep was negative, chest x-ray was consistent with possible bronchiolitis "but was not consistent with clinical exam, in my opinion". The subject was admitted for observation with the following diagnoses: viral syndrome, fever and vomiting. The subject was treated with the following: for fever: acetaminophen 0.95 ml, po, twice a day (15-OCT-2011 to 15-OCT-2011), acetaminophen 95 mg supp, one time dose (15-OCT-2011), for injection (not further specified) ceftriaxone 0.3 G, IV, one dose (14-OCT-2011) and for dehydration (symptom of vomiting) dextrose 5%, 0.25% saline, potassium chloride, 500 ml IV one time (15-OCT-2011). The subject was discharged on 15-OCT-2011 at 16:21, discharge diagnosis (previously not reported), with instructions to continue with treatment given in the office on 14-OCT-2011. Medical records received at the site from the hospital do not have a clear diagnosis noted. The diagnosis from the hospital stated fever to 10 104, decreased oral intake with vomiting times four and low protein noted. Clarification regarding these diagnoses was obtained by the physician on 29-NOV-2011. On 29-NOV-2011, the investigator stated diagnoses should be: viral syndrome, fever, and vomiting. Further clarification from the investigator considered viral syndrome an SAE and both fever and vomiting secondary (and not SAEs as previously reported). On 09-DEC-2011, the investigational site designee spoke to the billing department and a claim had been submitted under the following diagnosis: fever, other disorder of plasma protein metabolism and bronchiolitis. In the opinion of the investigator on 09-DEC-2011, the "low protein" was not considered a diagnosis and the diagnosis of bronchiolitis did not meet medical criteria to support the diagnosis. On 15-OCT-2011, the subject recovered from the vomiting. On 18-OCT-2011, the subject recovered from the fever. On 21-OCT-2011, the subject recovered from the viral syndrome. There was no action taken with study therapy. The reporting investigator considered viral syndrome as possibly related to all study vaccine therapy. On 28-NOV-2011 (after SAE stop date), the subject was vaccinated with the third 0.5 ml IM dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (+) HIB (+) pertussis acellular 5-component (+) poliovirus vaccine inactivated (+) tetanus toxoid (injection site not reported). Other study vaccines included:the third dose of 0.5 ml IM dose of PREVNAR 13 (injection site not reported) and the third dose of 2.0 ml po dose of ROTATEQ. The reporting investigator no longer considers viral syndrome as an other important medical event. Follow-up information was received on 29-NOV-2011 from the investigator, the following fields were update: the source and the narrative. Follow-up information was received on 02-DEC-2011 from the investigator, the following fields were update: therapy screen, past therapy screen, episode profile and the narrative. Follow-up information was received on 09-DEC-2011 from the investigator, the following fields were update: episode profile and the narrative. Follow-up information was received on 14-DEC-2011 from the investigator, the following fields were updated: AE screen, episode profile and the narrative. Follow-up information was received on 16-DEC-2011 from the investigator, the following fields were update: AE information screen and narrative. Additional information is not expected. This is an amended report it was requested to add relationship to ROTATEQ and Pneumococcal 13 as related.