VAERS Reports UJ591AA

VAERS 2196485

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ591AA

schwer

Staat: AR
Alter: 1,5
Geschlecht: M
Eingang: 24.03.2022
Impfdatum: 09.03.2022
Beginn: 20.03.2022
Tage bis Beginn: 11,0
Dosis: UNK
Route/Site: SYR / LL

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

Balance disorder Disturbance in attention Ear infection Febrile convulsion Feeling abnormal Heart rate increased Pyrexia

Symptomtext

My son received these vaccines on 03/09/2022 and on 03/20/2022, 11 days later, he had a febrile seizure. His fever reached 104.6 on this day and it came on very quickly. He has never had a seizure before this. It is now 03/24/2022, and while he has not had another febrile seizure, I am seeing issues in his balance, and his ability to pay attention/awareness of his space. He has moments of what appears to be spacing out for up to 30 seconds.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Febrile convulsion
Hospital-Tage: -
Labordaten: He was taken by ambulance to Hospital shortly after the seizure. His fever broke after a few hours, and his heart rate lowered after being over 200 in the ambulance. He was released once both the fever and heart rate went down and he could keep fluids down. He was also diagnosed with an ear infection.
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: Soy
Vorherige Impfungen: -

VAERS 2243142

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ591AA

gering

Staat: FL
Alter: 1,0
Geschlecht: F
Eingang: 20.04.2022
Impfdatum: 08.04.2022
Beginn: 08.04.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

No adverse event Product preparation issue

Symptomtext

patient was given the Hib powder portion of Pentacel that had been reconstituted with sterile water rather than the DTap-IPV liquid diluent with no adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 1-year-old female patient who was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (prevnar 13) for Immunisation. On 08-Apr-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine with unknown dosage form and strength with lot number UJ591AA and expiration date 18-Dec-2022 via intramuscular route in the left thigh for immunization. On 08-APR-2022 the patient was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event (product preparation error) during the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. It was reported "office supervisor states that a medical assistant recently noticed that there was still one liquid DTap-IPV vial of PENTACEL remaining in the box and discovered that a patient was given the Hib powder portion of PENTACEL on 08APR2022 that had been reconstituted with sterile water provided by Varivax rather than the DTap-IPV liquid diluent from the PENTACEL box. Caller wanted to know whether the Hib portion would count as valid or if the patient needed to be revaccinated with PENTACEL". Action taken with diphtheria, tetanus, ac pertussis, ipv and hib vaccine (pentacel) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient was given the Hib powder portion of Pentacel that had been reconstituted with sterile water rather than the DTap-IPV liquid diluent with no adverse event). At time of reporting, the outcome was Unknown for the event patient was given the hib powder portion of pentacel that had been reconstituted with sterile water rather than the dtap-ipv liquid diluent with no adverse event. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13
Allergien: -
Vorherige Impfungen: -