Received Mar 19, 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. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y1D49P1 | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 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; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of swelling of legs in a 6-month-old female patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis, DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;TETANUS VACCINE TOXOID (DAPTACEL) (batch number 4CA34C1, expiry date 31-MAY-2027) for prophylaxis, POLIO VACCINE INACT (IPV) (batch number Y1D49P1, expiry date 30-SEP-2027) for prophylaxis and HIB VACCINE CONJ (TET TOX) (ACT-HIB) (batch number UK360AB, expiry date 30-NOV-2026) for prophylaxis. Additional patient notes included The patient past medical history, medical treatment, vaccination and family history were not provided. On 02-FEB-2026, the patient received Rotavirus vaccine, PREVNAR 20, DAPTACEL, IPV and ACT-HIB. On 02-FEB-2026, less than a day after receiving Rotavirus vaccine, an unknown time after receiving PREVNAR 20 and an unknown time after receiving DAPTACEL, IPV and ACT-HIB, the patient experienced swelling of legs (Verbatim: left leg area was swollen), erythema (Verbatim: left leg area was red) and urticaria (Verbatim: hives on the face, near the mouth, then up the forehead and down the trunk into the left leg). The patient was treated with hydrocortisone. The outcome of the swelling of legs, erythema and urticaria were resolving. It was unknown if the reporter considered the swelling of legs, erythema and urticaria to be related to Rotavirus vaccine and Rotarix Pre-Filled Oral Applicator Device. The reporter considered the swelling of legs, erythema and urticaria to be not reported if related to PREVNAR 20, DAPTACEL, IPV and ACT-HIB. It was unknown if the company considered the swelling of legs, erythema and urticaria to be related to Rotavirus vaccine and Rotarix Pre-Filled Oral Applicator Device. The company considered the swelling of legs, erythema and urticaria to be not reported if related to PREVNAR 20, DAPTACEL, IPV and ACT-HIB. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-MAR-2026 Treatment medication included cold compresses. The batch number was not provided and a request for this information has been made.
Comments: The patient past medical history, medical treatment, vaccination and family history were not provided