Received Mar 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 4CA34C1 | — |
| OPV | POLIO VIRUS, ORAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y1D49Pl | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UK360AB | — |
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 is a spontaneous report received from a Nurse. Other Case identifier(s): 2026SA037087 (SANOFI). A 6-month-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Feb2026 as dose number unknown, single (Batch/Lot number: unknown) at the age of 6 months, in left leg for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), on 02Feb2026 as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS), on 02Feb2026 as dose number unknown, single (Lot number: 4CA34C1, Expiration Date: 31May2027) for immunisation; hib vaccine conj (HAEMOPHILUS INFLUENZAE TYPE B VACCINE CONJUGATED), on 02Feb2026 as dose number unknown, single (Lot number: UK360AB, Expiration Date: 30Nov2026), in left leg for immunisation; polio vaccine inact 3v (vero) (INACTIVATED POLIOMYELITIS VACCINE MADE FROM SABIN STRAINS (VERO CELL)), on 02Feb2026 as dose number unknown, single (Lot number: Y1D49Pl, Expiration Date: 30Sep2027) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 02Feb2026, outcome "recovering", described as "hives on the face, near the mouth, then up the forehead and down the trunk into the left leg"; ERYTHEMA (non-serious) with onset 02Feb2026, outcome "recovering", described as "left leg area was red"; PERIPHERAL SWELLING (non-serious) with onset 02Feb2026, outcome "recovering", described as "left leg area was swollen". Therapeutic measures were taken as a result of peripheral swelling, erythema, urticaria. Additional information: 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. The patient was treated hydrocortisone cream and cold compresses for all events. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.