Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK109AA | IM / LL |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 4D333 | SYR / RL |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | Y002963 | IM / RL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | Y005907 | PO / MO |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK109AA | OT |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4D333 | — |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | Y002963 | OT / RL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | Y005907 | OT |
the patient was diagnosed with urticaria; Infant irritability; Crying; This case was downloaded from Vaccine Adverse Event Reporting System (VAERS) (agency#: 2822244) on 25-MAR-2025. This spontaneous report was referring to an infant female patient (reported as 0.17 years). The patient's medical history was not reported. On 01-Jan-2025 (on Wednesday), the patient had low grade fever (99.6 F). THE patient was given infant tylenol every 4 hours for 3 doses until there is was no more fever (also reported as 30 three doses). On 02-Jan-2025 (on Thursday), the patient was doing better. On 03-Jan-2025 (on Friday), the patient was taken to the primary provider to get vaccines. On that day, she was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered intramuscularly (IM) in the right leg (RL) (lot #Y002963, expiration date: 04-Oct-2026); with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) administered orally (lot #Y005907, expiration date: 16-Nov-2025); with the second dose of Engerix b (Hepatitis b vaccine rHBsAg (yeast)) administered via "SYR" route in the RL (lot #4D333); and with the first dose of Pentacel (Diphtheria vaccine toxoid;HIB vaccine conj (tet tox);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (MRC 5);Tetanus vaccine toxoid) administered IM in the left leg (LL) (lot #UK109AA) (exact dosages were not provided). All vaccines were administered for prophylaxis. On 04-Jan-2025 (on Saturday), the patient became very fussy and cried a lot, however, she was consolable. On 05-Jan-2025 (on Sunday), in the morning the patient was still fussy, but now had a rash on her. It was on both elbows, left pinkie and middle finger, right ring finger and left foot and knee were red, hot and swollen. The parents took the patient to the emergency room (ER) for further evaluation. The patient had shots a couple of days ago. In the ER the patient was diagnosed with urticaria and was prescribed prenisolone 15mg/5ml solution - in a step-down regimen for 6 days. The Moc was advised to follow-up with patient's primary provider. When she went the patient was referred to an allergist for further evaluation. The patient recovered on an unknown date. The causal relationship between the suspected vaccines and the adverse events was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2822244-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Low grade fever
Infant Tylenol