Received Feb 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4CA34C1 | RL |
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y1D49P1 | RL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MM0534 | LL |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z015203 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UK360AB | LL |
hives/she developed first few little kind of red hives on near her mouth and then they moved up to her forehead; she developed some redness and swelling of her left thigh where she received the Prevnar 20; she developed some redness and swelling of her left thigh where she received the Prevnar 20; This is a spontaneous report received from a Physician and an Other HCP from medical information team. A 4-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Feb2026 at 08:45 as dose number unknown, 0.5 ml single (Lot number: MM0534, Expiration Date: 28Feb2027) at the age of 4 months, in left thigh for immunisation; haemophilus influenzae b bacteria (HAEMOPHILUS INFLUENZAE B BACTERIA), on 02Feb2026 at 08:45 as dose number unknown, 0.5 ml single (Lot number: UK360AB, Expiration Date: 30Nov2026), in left thigh for immunisation; polio vaccine (POLIO VACCINE), on 02Feb2026 at 08:45 as dose number unknown, 0.5 ml single (Lot number: Y1D49P1, Expiration Date: 30Sep2027), in right thigh for immunisation; diphtheria vaccine toxoid;pertussis vaccine acellular;tetanus vaccine toxoid (DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;TETANUS VACCINE TOXOID), on 02Feb2026 at 08:45 as dose number unknown, 0.5 ml single (Lot number: 4CA34C1, Expiration Date: 31May2027), in right thigh for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), on 02Feb2026 at 08:46 as dose number unknown, 2 ml single (Lot number: Z015203, Expiration Date: 11Apr2027) oral for immunisation. The patient's relevant medical history included: "upper respiratory infection" (unspecified if ongoing); "oral thrush" (unspecified if ongoing); "Cow's milk allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nystatin, notes: had finished probably about a week prior to the events. The following information was reported: URTICARIA (non-serious) with onset 02Feb2026 at 09:45, outcome "unknown", described as "hives/she developed first few little kind of red hives on near her mouth and then they moved up to her forehead"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 02Feb2026 at 09:45, outcome "unknown" and all described as "she developed some redness and swelling of her left thigh where she received the Prevnar 20". Therapeutic measures were taken as a result of urticaria, vaccination site swelling, vaccination site erythema. Additional information: A 4-month-old female patient developed hives within an hour after administration with prevnar20. It was a four-month-old baby who came in for vaccine. It was a vaccine kind of follow up. It was not with the well visit because she was ill at the well visit. She came in, still had some mild lingering upper respiratory symptoms and some oral thrush in her mouth, still healthy enough to get the vaccine. She got all the four months vaccines. She did get Prevnar 20, Haemophilus influenza B, DTaP, Polio and the oral Rotavirus vaccine. Roughly about an hour after she got the vaccines, when she was at home, she developed first few little kind of red hives on near her mouth and then they moved up to her forehead and then down her trunk and then she developed some redness and swelling of her left thigh where she received the Prevnar 20 and the Haemophilus influenza B. She received 5 vaccines, two were in the left leg where she has had the redness and swelling. Age at the time of event was 4 months and 3 weeks. Weight: 15 pounds, 10 ounces (Ethnicity redacted). No diabetes or hypertension. She currently did not have chronic medical issues; she did currently have an upper respiratory infection and oral thrush. When clarified if patient had this after taking the vaccine and reporter was stated that she had both of those going on before the vaccines. Nothing for the respiratory infection, the thrush she had not taken any medication, like today or but she had previously taken Nystatin, but had finished probably about a week prior to this event. Date of vaccination: 2 February 2026. When clarified if vaccine was prescribed by any doctor: Reporter stated, it was prescribed by me today. Causality: Reporter stated, "I do not think it is from all five. I think it was either the Prevnar or the Hib vaccine( Haemophilus influenza B vaccine) that was in the left leg. Treatment: They did a cool compress, an oatmeal bath and applied some Hydrocortisone cream. It was a topical cream. Time of vaccination: 8:45 AM, 8:46 AM, EST. When clarified if patient took all five vaccines on same day: Reporter stated, correct. Reporter stated we have no known drug allergies. She has an allergy to Cow's milk. Indication: It was just routine vaccination.
Medical History/Concurrent Conditions: Cow's milk allergy; Oral thrush; Upper respiratory infection