VAERS Reports UJ342AAA

VAERS 1518322

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ342AAA

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Staat: TX
Alter: 0,3
Geschlecht: M
Eingang: 31.07.2021
Impfdatum: 19.07.2021
Beginn: 19.07.2021
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

Symptomtext

expired dose of Pentacel administered with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional and physician via Global Media information (under reference 00694720). This case is linked to cases 2021SA247614 and 2021SA247618 (Cluster). This case involved a 4 months old male patient who received an expired dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (expired product administered). 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) and PNEUMOCOCCAL VACCINE 13V [Lot number and expiration date were not reported] for prophylactic vaccination. On 19-Jul-2021, the patient received a dose of suspect PENTACEL (lot UJ342AAA and expiration date: 22-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement". It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTARIX; PNEUMOCOCCAL VACCINE 13V
Allergien: -
Vorherige Impfungen: -

VAERS 1512088

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ342AAA

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Staat: TX
Alter: 0,3
Geschlecht: M
Eingang: 29.07.2021
Impfdatum: 06.07.2021
Beginn: 06.07.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / RL

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

Expired product administered

Symptomtext

4 month old male patient received expired dose of Pentacel was given with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician (Reference number- 00694718). This case involves a four month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation. On 06-Jul-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an intramuscular route in the right thigh (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported that "Patient Information patient age less than year enter as 2-month 4month etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, strength: standard except for Fluzone HD-STANDARD , Pregnancy-not applicable, last menstrual period, due date, AE (adverse event) symptoms or no AE, vaccine presentation. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement". At the time of reporting, 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: ROTARIX; PNEUMOCOCCAL CONJUGATE VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 1512087

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ342AAA

gering

Staat: TX
Alter: 0,6
Geschlecht: M
Eingang: 29.07.2021
Impfdatum: 24.06.2021
Beginn: 24.06.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / LL

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

Expired product administered

Symptomtext

7 m onth old male patient received expired dose o f PENTACEL vaccine, no AE; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician(Reference number- 00694713). This case involves a 7 month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination. On 24-Jun-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an intramuscular route in the left vastus lateralis (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). At the time of reporting, no adverse event was reported. It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement". 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; PNEUMOCOCCAL CONJUGATE VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 1483685

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ342AAA

gering

Staat: TN
Alter: -
Geschlecht: M
Eingang: 18.07.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / RA

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

Medication error Wrong product administered

Symptomtext

This case involves adult male patient (age unknown) who was supposed to get DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but was mistakenly given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant were given to the patient. On an unknown date, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiration date :21-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported). It was a case of an actual medication error due to wrong vaccine administered (same day latency) and they want to know what to do now. Later, states that the physician looked at the comparison and they know patient got more antigen than he needed. At time of reporting, it was unknown whether the patient experienced any 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 924938

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ342AAA

gering

Staat: AZ
Alter: 0,6
Geschlecht: M
Eingang: 07.01.2021
Impfdatum: 17.12.2020
Beginn: 17.12.2020
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / RL

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

Incorrect route of product administration Product preparation issue

Symptomtext

patient was administered with liquid portion, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (Reference number- 00401074) and transmitted to Sanofi on 21-Dec-2020. This case involves a 7 months old male patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ342AAA, expiration date 22-Jun-2021, second dose, strength-standard) via intramuscular route in the right thigh for prophylactic vaccination on 17-Dec-2020 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for prophylactic vaccination. It was a case of actual medication error due to Inappropriate reconstitution technique (latency-same day). At the time of report, no adverse event was reported. Reporter stated that while training new medical assistant (MA), got box of Pentacel. New MA gave only vial containing liquid portion (IPOL and Daptacel) and reporter did not check Pentacel box for any other components and just injected patient. Reporter discovered this error while documenting the dose when noticed that ActHB component was in the box. Reporter asked if the dose was valid and if patient need to revaccinate and when. 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 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: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PNEUMOCOCCAL VACCINE CONJ 13V (CRM197); FLUARIX QUADRIVALENT
Allergien: -
Vorherige Impfungen: -