Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA34C1 | — |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK360AB | — |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49P1 | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
left leg area was swollen; left leg area was red; hives on the face, near the mouth, then up the forehead and down the trunk into the left leg; Initial information received on 02-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who experienced left leg area was swollen, left leg area was red and hives on the face, near the mouth, then up the forehead and down the trunk into the left leg after receiving vaccines PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) [PREVNAR 20], ROTAVIRUS VACCINE, IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Feb-2026, the patient received a dose of suspect PREVNAR 20 and Rotavirus Vaccine both were not produced by Sanofi Pasteur (dose, formulation, strength, route, lot, expiry and administration site: unknown) both for prophylactic vaccination (immunization). On 02-Feb-2026, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, suspension for injection (lot 4CA34C1 and expiry 31-May-2027), HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK360AB and expiry 30-Nov-2026) and IPV (VERO) suspension for injection (lot Y1D49P1 and expiry 30-Sep-2027) [dose, strength, route and administration site: unknown] all for prophylactic vaccination (immunization). On 02-FEB-2026 the patient developed left leg area was swollen (peripheral swelling), left leg area was red (erythema) and hives on the face, near the mouth, then up the forehead and down the trunk into the left leg (urticaria) (latency same day). Reportedly:-Caller stated that about an hour after the visit, the mother of the patient called and reported that the patient developed hives on the face, near the mouth, then up the forehead and down the trunk into the left leg, that the left leg area was red and swollen. Caller stated the left leg is where the patient received the Hib by Sanofi and the Prevnar 20.Caller stated that the mother applied hydrocortisone cream and cold compresses and that the redness and swelling had much improved but not resolved Action taken was not applicable for all suspects. The patient was treated hydrocortisone cream and cold compresses for all events. At time of reporting, the outcome was Recovering / Resolving for all events.