VAERS Reports UJ614AAA

VAERS 2400397

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ614AAA

mild

Staat: TX
Alter: 1,0
Geschlecht: M
Eingang: 03.08.2022
Impfdatum: 18.07.2022
Beginn: 31.07.2022
Tage bis Beginn: 13,0
Dosis: 2
Route/Site: IM / RL

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

Rash Rash macular

Symptomtext

Pt evaluated at minor care for red spotty rash noted on abdomen. Pt does not exhibit fever, cough or runny nose. Advised possible reaction or virus due to vaccine. advised on Hydrocortisone cream as needed and avoid immunocompromised pt and or pt's unvaccinated.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: pt mother denies
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2590723

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ614AAA

gering

Staat: TX
Alter: 0,3
Geschlecht: F
Eingang: 03.03.2023
Impfdatum: 27.02.2023
Beginn: 27.02.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Expired product administered Medication error No adverse event

Symptomtext

PENTACEl was given today and expired on Saturday with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine [Pentacel (Vero)] which was given today and expired on saturday with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination; and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 27-Feb-2023, the patient received a dose of 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml of suspect Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine Suspension for injection which was expired on saturday with no reported adverse event (expired product administered) of standard strength for one day (QD) (lot: UJ614AAA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization. Action taken: not applicable. Outcome: Unknown. 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: ROTARIX; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2455736

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ614AAA

gering

Staat: TX
Alter: 3,0
Geschlecht: M
Eingang: 23.09.2022
Impfdatum: 09.08.2022
Beginn: 09.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Extra dose administered No adverse event

Symptomtext

No adverse eventreceived both a pentacel dose and a dose of acthib, on the same day with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination. On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation. On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine. Action taken: Not applicable. Outcome: Unknown. 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 guidelines. 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.; Sender's Comments: 01275067:

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2450466

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ614AAA

gering

Staat: TX
Alter: 3,0
Geschlecht: M
Eingang: 17.09.2022
Impfdatum: 09.08.2022
Beginn: 09.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Extra dose administered No adverse event

Symptomtext

receiving both a Pentacel dose and a dose of ACTHIB, on the same day with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old male patient who received both a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose and a dose of HIB (PRP/T) VACCINE [ACT-HIB], on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) both for Prophylactic vaccination. On 09-Aug-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml (lot UJ575AAA, expiry date: 20-Sep-2022) and suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml (lot UJ614AAA, expiry date: 25-Feb-2023) both via intramuscular route in the left arm for immunisation. On 09-Aug-2022 the patient received both a pentacel dose and a dose of acthib, on the same day with no reported adverse event (extra dose administered) same day latency. It was unknown if the consumer was to receive the combo of DTAP and Hib in the same vaccine or if the consumer was to receive a stand alone DTap and a stand alone HIB vaccine. Action taken: Not applicable. Outcome: Unknown. 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: HEPATITIS A; MMRVAXPRO
Allergien: -
Vorherige Impfungen: -