VAERS Reports UJ531AA

VAERS 2209764

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ531AA

moderat

Staat: MI
Alter: 0,3
Geschlecht: M
Eingang: 31.03.2022
Impfdatum: 07.12.2021
Beginn: 10.12.2021
Tage bis Beginn: 3,0
Dosis: 2
Route/Site: IM / LL

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

Abdominal X-ray Blood potassium normal Dehydration Ileus paralytic Lethargy Platelet count increased Ultrasound abdomen normal Urine output decreased Vomiting Weight decreased

Symptomtext

acute onset vomiting and lethargy, starting early morning 12/10/22. Vomited 6-7 times initially and forcefully and after every attempt at feeding over the next several hours. Taken to ER, admitted for forceful vomiting and dehydration, evidenced by poor urine output. Testing in ER showed possible adynamic ileus. Significant weight loss. Subsequently admitted to Hospital with moderate dehydration, recurrent emesis. Hospital course. improved over 24 hours with IV fluid and slowly increasing feedings, discharged 12/11/21 and followed up in office 12/13/22 and found to have had a significant weight loss.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Dehydration
Hospital-Tage: 1,0
Labordaten: 12/10/21 abdominal ultrasound, normal, 12/10/21 x ray of abdomen adynamic ileus Platelet count 594 K, potassium 3.7
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: 400 IU vitamin D daily
Allergien: none
Vorherige Impfungen: -

VAERS 1876122

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ531AA

gering

Staat: MO
Alter: 0,3
Geschlecht: F
Eingang: 17.11.2021
Impfdatum: 27.10.2021
Beginn: 27.10.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / -

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

Medication error No adverse event Product preparation issue

Symptomtext

4 month old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration/ no AE; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a other health care professional via non-healthcare professional/consumer via Medical Information (Reference number- 00832566). This case involves a four-month-old female patient who inadvertently received only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (Product preparation issue). The patient's medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included Pneumococcal Vaccine 13V (Pneumococcal 13 Valent Vaccine) for Immunisation; and Rotavirus Vaccine for prophylactic vaccination. On 27-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ531AA and expiry date: 22-Jul-2022) (Frequency: series of four) via an intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (latency on same day). It was reported "four-month-old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration". At the time of report, 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: PNEUMOCOCCAL 13 VALENT VACCINE; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -