Report #2867962

Overview

Sex

Male

Age

0.3 yrs

State

PA

Recovered

Not recovered

Vaccinated

Oct 20, 2025

Onset

Oct 20, 2025

Days to onset

0

Hospital days

—

Symptoms (2)

Symptom narrative

red swelling around the inject site; red swelling around the inject site; This spontaneous report was received from a Consumer or other non health professional and refers to a 4 month-old male patient. The patient's medical history and concurrent conditions were not reported. Historical drugs included Vaxelis (Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);HIB vaccine conj (menigococcal protein);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid). Concomitant therapies were not reported. On 20-Oct-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), lot #2142138, expiration date: 28-Jun-2026 as prophylaxis (dose and route of administration were not reported), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), lot #U7829AA, expiration date: 14-Jul-2026, dose number 2, 1 dosage form, as prophylaxis (route of administration was not reported) and Pneumococcal vaccine conj 7v (CRM197)(PREVNAR) (dose, route of administration, indication, expiration date, and lot # were not reported). On the same day at 03:00 pm, the patient experienced red swelling around the inject site, it was also stated that it was a "large reaction". Tylenol was provided as treatment for the event. At the reporting time, the patient had not recovered from red swelling around the inject site and red swelling around the inject site. The causal relationship between the event of red swelling around the inject site and the suspect vaccines was unknown. Lot # is being requested for Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) and will be submitted if received.; Reporter's Comments: Keywords : BP