VAERS Reports UJ786AA

VAERS 2682004

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

mild

Staat: GA
Alter: 1,3
Geschlecht: M
Eingang: 14.09.2023
Impfdatum: 01.08.2023
Beginn: -
Tage bis Beginn: -
Dosis: 4
Route/Site: IM / RL

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

Extra dose administered Pyrexia

Symptomtext

On 8/1/23, Patent was due to receive the Dtap and Hib vaccines. However, he received two doses of Dtap in the forms of Daptacel and Pentacel. He did have the normal side-effect of fever, but did not suffer any adverse reactions to receiving the double dose of Dtap. We continued to follow-up with the family in the following days and next week and he continued to be free from any other reaction.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2681998

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

mild

Staat: GA
Alter: 1,3
Geschlecht: M
Eingang: 14.09.2023
Impfdatum: 01.08.2023
Beginn: -
Tage bis Beginn: -
Dosis: 4
Route/Site: IM / RL

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

Extra dose administered Pyrexia Wrong product administered

Symptomtext

On 8/1/23, pt was due to receive the Dtap and Hib vaccines. However, he received two doses of Dtap in the forms of Daptacel and Pentacel. He did have the normal side-effect of fever, but did not suffer any adverse reactions to receiving the double dose of Dtap. We continued to follow-up with the family in the following days and next week and he continued to be free from any other reaction.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: otitis media
Vorgeschichte: none
Andere Medikamente: Cefdinir
Allergien: none
Vorherige Impfungen: -

VAERS 2718378

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786aa

gering

Staat: PA
Alter: 0,8
Geschlecht: M
Eingang: 28.11.2023
Impfdatum: 30.06.2023
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: IM / LL

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

Unevaluable event

Symptomtext

none

Weitere VAERSDATA-Felder

Praegender Schweregrund: Unevaluable event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: no
Vorgeschichte: no
Andere Medikamente: -
Allergien: no
Vorherige Impfungen: -

VAERS 2712645

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: NV
Alter: 1,3
Geschlecht: F
Eingang: 10.11.2023
Impfdatum: 01.11.2023
Beginn: 01.11.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Expired product administered No adverse event

Symptomtext

administered an expired dose with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from via other health professional. This case involves a 15-month-old female patient who had administered an expired dose of vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 01-Nov-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via unknown route in the left thigh for immunization and administered an expired dose with no reported adverse event (expired product administered) (latency: same day). Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (pentacel (VERO)) was not applicable. It was not reported if the patient received a corrective treatment for the event. Outcome: Unknown for the 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2711222

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: MO
Alter: -
Geschlecht: U
Eingang: 07.11.2023
Impfdatum: 24.10.2023
Beginn: 24.10.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

administration of PENTACEL that has expired on 12Oct2023 to a patient on 24Oct2023 with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves administration of pentacel that has expired on 12oct2023 to a patient on 24oct2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Oct-2023, suspect diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ786AA, expiry date: 12-Oct-2023 via unknown route in unknown administration site for immunization (strength, dose: unknown) was administered administration to a patient with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable. 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: -

VAERS 2708456

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: TX
Alter: 1,4
Geschlecht: F
Eingang: 01.11.2023
Impfdatum: 20.10.2023
Beginn: 20.10.2023
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 Incorrect route of product administration No adverse event

Symptomtext

nurses administered a PENTACEL vaccine that was expired with no reported adverse event; administration of the medication through subcutaneous route with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] that was expired and administration of the medication through subcutaneous route with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Oct-2023, the patient received 0.5 ml total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA) (Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via subcutaneous route in the right thigh (Right Vastus Lateralis) for immunization. On 20-Oct-2023, the patient was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine that was expired and administration of the medication through subcutaneous route with no reported adverse event (expired product administered) (incorrect route of product administration) (latency: same day). It was reported, Caller stated last Friday one of their nurses administered a PENTACEL vaccine that was expired. She said it was only about 8 days past the expiration date and is asking if there is any kind of "grace period" MIA told her that it is not recommended by Sanofi to use any expired products, no matter how far past the expiration date. Nurse supervisor reporting that an expired PENTACEL was administered and is seeking guidance. This situation is reported as a medication error due to the administration of an expired vaccine. This situation is reported as an off-label use as per local labelling due to the administration of the medication through an unapproved route. subcutaneous. 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: -

VAERS 2708006

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: CA
Alter: 0,3
Geschlecht: M
Eingang: 01.11.2023
Impfdatum: 23.10.2023
Beginn: 23.10.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 4 months old male patient who got administered an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] 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 reassort oral 5v (Rotateq) for Prophylactic vaccination and Vaxudence. On 23-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ786AA and expiration date- 10-Dec-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day). Action taken- not applicable. At time of reporting, the outcome was Unknown for the 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: ROTATEQ
Allergien: -
Vorherige Impfungen: -

VAERS 2707102

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: CA
Alter: 0,3
Geschlecht: M
Eingang: 31.10.2023
Impfdatum: 16.10.2023
Beginn: 16.10.2023
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 No adverse event

Symptomtext

administered an expired pentacel with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4-month-old male patient who was administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PentaceL (VERO)] 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 reassort oral 5V (Rotateq) and Vaxudence for Prophylactic vaccination. On 16-Oct-2023, the patient received a dose 2 of 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the right thigh for Immunization and administered an expired pentacel with no reported adverse event (expired product administered) (latency: same day). 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: ROTATEQ
Allergien: -
Vorherige Impfungen: -

VAERS 2707100

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: TN
Alter: 0,2
Geschlecht: F
Eingang: 31.10.2023
Impfdatum: 23.10.2023
Beginn: 23.10.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / LL

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

Expired product administered No adverse event

Symptomtext

an expired dose of PENTACEL was inadvertently administered today with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today 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 pneumococcal vaccine conj 20v (crm197) (prevnar 20) for immunisation; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]) for immunisation; and rotavirus vaccine (rotavirus vaccine) for immunisation. On 23-Oct-2023, the patient received 0.5 ml (Dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA, Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via intramuscular route in the left thigh immunization. On 23-Oct-2023, the patient was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today with no reported adverse event (expired product administered) (latency: same day). 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: PREVNAR 20; HEPATITIS B [HEPATITIS B VACCINE]; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2701260

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

gering

Staat: TX
Alter: 1,3
Geschlecht: M
Eingang: 25.10.2023
Impfdatum: 16.10.2023
Beginn: 16.10.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

Expired product administered Medication error No adverse event

Symptomtext

expired dose of Pentacel was administered to a patient (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient to whom expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2023, the patient received 4th dose of expired 0.5 mL dose of suspect suspension for injection of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Batch number: UJ786AA, expiry date: 12-Oct-2023) via intramuscular route in the left thigh as immunization (expired product administered; Latency: same day) The caller was not aware of any adverse reactions, treatment, Doctor or Emergency Room visit necessary post administration. Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2700289

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

gering

Staat: CA
Alter: 0,3
Geschlecht: M
Eingang: 23.10.2023
Impfdatum: 23.10.2023
Beginn: 23.10.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

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

Expired product administered

Symptomtext

Pentacel dose was expired on 10/12/2023 and patient received it on 10/23/2023. We noticed about an hour after administration. Sanofi was contacted, no need for special treatment but dose needs to be repeated.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: no
Aktuelle Erkrankungen: no
Vorgeschichte: no
Andere Medikamente: no
Allergien: no
Vorherige Impfungen: -

VAERS 2700272

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

gering

Staat: CA
Alter: 0,3
Geschlecht: M
Eingang: 23.10.2023
Impfdatum: 16.10.2023
Beginn: 23.10.2023
Tage bis Beginn: 7,0
Dosis: 2
Route/Site: IM / RL

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

Expired product administered

Symptomtext

Pentacel was expired on 10/12/2023, no additional treatment needed but recommended to parents to repeat the dose.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: URI
Vorgeschichte: no
Andere Medikamente: no
Allergien: no
Vorherige Impfungen: -

VAERS 2697059

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ786AA

gering

Staat: TX
Alter: 1,3
Geschlecht: M
Eingang: 17.10.2023
Impfdatum: 16.10.2023
Beginn: 16.10.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Expired product administered

Symptomtext

On 10/16/2023 MA gave expired dose of Pentacel to patient on Left Thigh. I have contacted the manufacturer company to receive information and indications about vaccine. Dr. has contacted parent to notify about the incident. Mother of child stated patient is doing fine and will just keep a close eye on him and was very understanding. I have also contacted the compliance department of the company to notify them about incident that occured and incident is also recorded in patients chart.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2635215

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ786AA

gering

Staat: TX
Alter: 4,0
Geschlecht: M
Eingang: 23.05.2023
Impfdatum: 11.05.2023
Beginn: 11.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Medication error No adverse event Single component of a two-component product administered

Symptomtext

received only the diluent part of PENTACEL and not the powder with no reported adverse event; Initial information was received on 17-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 4 years old male patient who reported received only the diluent part of Pentacel and not the powder with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 11-May-2023, the patient received 0.5 ml, total (once) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot:UJ786AA, expiration date:12-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunization. On 11-May-2023 the patient had received only the diluent part of Pentacel and not the powder with no reported adverse event (Single component of a two-component product administered) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event administration of the pentacel components separately with no reported 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 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.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -