VAERS Reports U6945AA

VAERS 2283276

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6945AA

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Staat: NM
Alter: 0,3
Geschlecht: F
Eingang: 18.05.2022
Impfdatum: 17.05.2022
Beginn: 18.05.2022
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / LL

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

Incorrect product formulation administered

Symptomtext

Pentacel was given on 5/17/22 with diluent only RNcalled mom back and was given full dose of pentacel today.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2258370

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6945AA

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Staat: OR
Alter: 0,5
Geschlecht: M
Eingang: 29.04.2022
Impfdatum: 27.01.2022
Beginn: 27.01.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

Body temperature increased Hypersomnia Hypophagia Influenza A virus test negative Influenza B virus test Irritability Pharyngeal erythema Respiratory viral panel Rhinorrhoea SARS-CoV-2 test negative Sleep disorder

Symptomtext

He received these vaccines at about 09:00 on 1-27-22. He was fine until about 11:55 that day when he went to sleep, awakening only a bit at which times he was fussy and he would reposition himself. Temp was 102. No respiratory difficulties. The next morning temp was 101, mom gave acetaminophen. By 12:30 on 1/28/22 he finally drank 3 ounces of pedialyte, was smiling some and jumping some. Because of poor p.o. intake he was seen at ER on 1-28-22. Respiratory panel was normal, COVID-19 and flu tests were normal. He had a slightly red throat. The assessment was that Noah was having a vaccine reaction. On 1-31-22 mom noted that he had mostly just slept for 48 hours starting at 11:55 on the day of the shots, he also had a 103 temperature on 1/29 at night, he would occasionally take formula but not much, and if alert wanted to be held. At the time of exam on 1-31-22 he was alert and drooling, had normal behavior, no rash, slight rhinorrhea?... It appeared that he was back to normal by the time of the exam. Noah had no difficulty with his previous shots.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Body temperature increased
Hospital-Tage: -
Labordaten: Only the tests at the ER as noted above (COVID-19, flu tests A & B, and panel for respiratory viruses).
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: Vitamins with iron
Allergien: None
Vorherige Impfungen: -

VAERS 1756433

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6945AA

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Staat: TX
Alter: 0,3
Geschlecht: M
Eingang: 02.10.2021
Impfdatum: 24.09.2021
Beginn: 24.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

No adverse event Product preparation issue

Symptomtext

A patient was administered with a dose of PENTACEL vaccine without reconstituting with diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Agency (Reference number- 00784846) and transmitted to Sanofi on 24-Sep-2021. This case involves a 4-month-old male patient who was administered with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without reconstituting with diluent (Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 24-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 U6945AA, expiry: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day). It was reported "Caller stating they administered a patient a dose of PENTACEL without reconstituting with diluent. Caller wanting to know if they can administer the diluent separately. Caller clarifies that the DAPTACEL/IPOL portion of the PENTACEL vaccine was administered, however they forgot to administer the powdered ACT-HIB portion. She asks what diluent can be used with the ACT-HIB portion of the PENTACEL vaccine so it can be administered." No additional adverse event (AE) 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -