VAERS Reports UJ319AAA

VAERS 1049317

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AAA

mild

Staat: NY
Alter: 0,3
Geschlecht: M
Eingang: 23.02.2021
Impfdatum: 01.02.2021
Beginn: 01.02.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

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

Crying Irritability Pain in extremity Poor feeding infant Screaming Somnolence Vomiting

Symptomtext

Immunizations given at 12:06 pm. Child slept until approximately 3:30 pm after feeding. Gave tylenol when had the immunizations and again when awoke crying. Poor po intake during this time and vomited. Fed better the next morning, still irritable for the next 2 days. Mother reported after the 2 month visit, baby took a nap then awoke screaming. He was not consolable for 3 hours. His leg seemed sore to touch. He ate less that day. Acetaminophen did not alter cry or inconsolably. He went to sleep and woke the next day and returned to improved eating. There were no concurrent illnesses. Mom did not call the office after the 2 month visit, but did bring this up just prior to the 4 month shots at the office. Six days

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain in extremity
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: NKA
Vorherige Impfungen: 2 month visit similar episode. 3 hours of crying, sleeping, poor po. Date of vaccines 11/28/20. He recei

VAERS 1423199

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ319AAA

gering

Staat: NY
Alter: -
Geschlecht: M
Eingang: 24.06.2021
Impfdatum: 07.06.2021
Beginn: 07.06.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Expired product administered Medication error

Symptomtext

patient received expired dose of PENTACEL vaccine, with no reported adverse event; Initial information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 07-Jun-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ319AAA and expiry date: 04-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that Office manager states that a patient received PENTACEL 3 days after it had been expired, is it still viable. Does the patient need to get another shot. Caller states that a pentacel was given in the left arm intramuscularly on 07-jun-2021 that expired 04-jun-2021. Caller states that she does not feel comfortable giving any other information and declined to provide additional information. 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -