VAERS Reports UJ474AA

VAERS 1800808

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ474AA

schwer

Staat: FL
Alter: 0,5
Geschlecht: F
Eingang: 20.10.2021
Impfdatum: 19.10.2021
Beginn: 19.10.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Blood test Chest X-ray Culture urine Electrocardiogram Lumbar puncture Seizure Skull X-ray

Symptomtext

The patient received 3 Vaccines total. Pentacel in the right thigh, Fluarix in left thigh- upper, and PCV13 in left thigh- lower. After the child had been vaccinated a seizure occurred and mom took the child to the hospital.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure
Hospital-Tage: -
Labordaten: Once arrived to the ER she has had Blood work, EKG, Medication, Urine cultures, Lumbar puncture, and XRay on her chest and head all done on 9/19/21.
Aktuelle Erkrankungen: no
Vorgeschichte: none
Andere Medikamente: Tylenol 3ML
Allergien: None
Vorherige Impfungen: Seizure

VAERS 1923110

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ474AA

gering

Staat: CT
Alter: 0,1
Geschlecht: F
Eingang: 04.12.2021
Impfdatum: 23.11.2021
Beginn: 23.11.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

This case involves a 5 weeks and 5 days old female patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination. On 23-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE produced by Sanofi Pasteur (lot number: UJ474AA and expiry date: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "Physician states a dose of PENTACEL was administered to a patient on 23Nov2021, and it was realized the patient was just under 6 weeks old. Physician is looking for information on how to handle, and if there are any issues as the patient will be turning 6 weeks old soon. The physician reported that a patient received a dose of PENTACEL at 5 weeks and 5 days old. The caller would like to know if this is considered a valid dose and whether it should be repeated". No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTARIX
Allergien: -
Vorherige Impfungen: -

VAERS 1774830

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ474AA

gering

Staat: CO
Alter: 0,2
Geschlecht: F
Eingang: 09.10.2021
Impfdatum: 27.09.2021
Beginn: 27.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue Underdose

Symptomtext

unsure how much of the dose with no AE; good portion of the dose squirted out from the syringe with no AE;Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case received from physician and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00789259). This case involves a 2-month-old female patient who experienced "good portion of the dose squirted out from the syringe" (syringe issue) and "unsure how much of the dose" (underdose) when received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination. On 27-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ474AA and expiry date: 09-Jul-2022) via an intramuscular route in a right thigh for prophylactic vaccination. It was reported "Caller with question on whether dose needs repeating" This case include syringe issue and underdose (latency: same day). It was not reported if the patient received a corrective treatment for the events. At time of reporting no clinical adverse event reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR; ROTAVIRUS VACCINE; HEPATITIS B VACCINE
Allergien: -
Vorherige Impfungen: -