Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eye swelling, Lymphadenopathy, Poor feeding infant, Rash macular, Swelling
Clinical narrative: swelling of tonsils; lymphadenopathy; feed poorly; eye swelling; swelling; blotchy rash; This is a spontaneous report received from a contactable reporter Physician from medical information team.  A 4-month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 13), on 18Mar2022 as dose number unknown, single (batch/lot number: unknown) at the age of 4 months for immunization; rotavirus vaccine live reassort oral 5v (ROTATEQ), on 18Mar2022 as dose number unknown, single (batch/lot number: unknown) for immunization; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), on 18Mar2022 as dose number unknown, single (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (medically significant) with onset 18Mar2022, outcome "recovered" (2022), described as "blotchy rash"; SWELLING (medically significant) with onset 18Mar2022, outcome "recovering"; POOR FEEDING INFANT (hospitalization, medically significant) with onset 20Mar2022, outcome "recovered" (2022), described as "feed poorly"; LYMPHADENOPATHY (hospitalization, medically significant) with onset 23Mar2022, outcome "recovered" (2022); TONSILLAR HYPERTROPHY (hospitalization, medically significant) with onset 23Mar2022, outcome "recovered" (2022), described as "swelling of tonsils"; EYE SWELLING (non-serious) with onset 18Mar2022, outcome "recovering". The patient was hospitalized for poor feeding infant, tonsillar hypertrophy, lymphadenopathy (start date: 23Mar2022, discharge date: 25Mar2022, hospitalization duration: 2 days). The events "eye swelling", "swelling" and "blotchy rash" required emergency room visit. Therapeutic measures were taken as a result of eye swelling, swelling, rash macular.  Additional information: The physician reported that a 4-month-old received Prevnar 13, Rotatech virus and Pentacil on same date (18Mar2022) and several hours later (18Mar2022), the patient developed eye swelling, swelling and a blotchy rash. The patient was treated at the ER with Benadryl. The rash went down, and the baby was fine. The physician informed that days later, the child began to feed poorly (20Mar2022). The patient went back to the hospital, and it was revealed she had swelling of tonsils and lymphadenopathy (23Mar2022). The physician informed that the patient was in hospital for feed poorly, swelling of tonsils and lymphadenopathy from 23Mar2022 to 25Mar2022. The physician wanted to know whether to proceed with her vaccination series based on the patient's reaction. The physician just needed to figure out whether to give shots again.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect PREVNAR 13 may have contributed to the onset of reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate