Sex: M
Vaccine: RV5
Symptoms: Haemoglobin normal, IL-2 receptor assay, Lymphocyte count, Mitogen stimulation test normal, Neutrophil count
Clinical narrative: diarrhea; Information has been received from the authors in a published literature article titled as stated below, concerning a 2-month-old male patient.  The patient's pertinent medical history was not reported. Concurrent conditions included secondhand smoke exposure and he was reported to be a full-term baby. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (strength, dose, lot #, and expiry date were not provided) administered orally for prophylaxis.  It was reported that he presented with concerns of non-bloody, loose, and watery diarrhea for two weeks after receiving the vaccine. The diarrhea began three days after he received the initial vaccine dose. Stool pathogen panel testing was positive for the rotavirus antigen. Despite having several episodes of loose, watery bowel movements per day, the child did not have a decrease in weight, length, or head circumference velocity. He also continued to meet all his developmental milestones at age-appropriate time points. As a result, supportive cares were recommended with no additional treatments at that time.  On an unspecified date, a complete blood count with differential showed a hemoglobin of 11.2 g/dL (normal range: 9.612.4), hematocrit of 32.7 % (normal range 32.7), leukocytes 9.4 x10(9)/L (normal range 6.513.3) with neutrophils 2.66x10(9)/L (normal range 0.975.45), and platelets 669x10(9)/L (normal range 244529); fecal HemoQuant was negative; fecal alpha-1-antitrypsin was less than 13 mg/dL (normal range less than 54); fecal calprotectin was mildly elevated at 91.3 mcg/g (normal range less than 50). On an unknown date, the following tests were performed: repeated Stool pathogen panel demonstrated persistent rotavirus antigen positivity; the fecal HemoQuant was Negative; T- and B Lymphocyte quantitative subsets and lymphocyte proliferation assays to mitogen and anti-CD3 were obtained, and testing was grossly normal, except for mildly decreased CD45+ total lymphocyte and CD3+ T cell proliferative responses to soluble anti-CD3 alone. These studies were repeated one month later (two months following his vaccinations), which demonstrated decreased lymphocyte proliferative responses to soluble anti-CD3, anti-CD3+ anti-CD28 and anti-CD3+ IL-2. Also, an immunodeficiency workup was obtained (Primary Immunodeficiency Panel) which was negative for genes associated with hereditary forms of primary immunodeficiencies; lymphocyte proliferation done 6 months after vaccinations were found to be normal, indicating that his immune system function had improved as the diarrhea cleared.  At the reporting time, the outcome of patient's diarrhea was recovered around for months after receiving his vaccinations.   The reporting authors considered diarrhea to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  A copy of the published article is attached as further documentation of the patient's experience.  This is an amended report. The country of incidence has been updated.; Sender's Comments: Reporter Comments: (13-JUL-2023) receipt date: 13-JUL-2023 [Literature] Reporter's and Patient's Personal Identifiable Information (PII) should be privatized, per local requirements. Therefore, please enter all PII as anonymized. Sender Comments:[Lit]