VAERS Reports UJ671AA

VAERS 2652502

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ671AA

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Staat: LA
Alter: 1,0
Geschlecht: M
Eingang: 05.07.2023
Impfdatum: 26.06.2023
Beginn: 26.06.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / LL

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

Expired product administered No adverse event

Symptomtext

received an expired dose of pentacel with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 1 years old male patient who had received an expired dose of 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) and family history were not provided. Concomitant vaccinations included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13); and hepatitis A vaccine both for Prophylactic vaccination (immunization). On 26-Jun-2023, the patient received 0.5 mL dose 3 of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (lot: UJ671AA; Expiry date: 13-May-2023) via unknown route in the left thigh for immunization with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event received an expired dose of pentacel 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 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 13; HEPATITIS A VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2651288

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ671AA

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Staat: -
Alter: 1,8
Geschlecht: F
Eingang: 30.06.2023
Impfdatum: 20.06.2023
Beginn: 20.06.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LL

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

Expired product administered No adverse event

Symptomtext

Expired vaccine given. No adverse signs or symptoms of adverse reaction.

Weitere VAERSDATA-Felder

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

VAERS 2649681

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ671AA

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Staat: TX
Alter: 1,0
Geschlecht: F
Eingang: 27.06.2023
Impfdatum: 20.06.2023
Beginn: 20.06.2023
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

administered expired pentacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 1 year old female patient who was administered 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 hepatitis B vaccine for Prophylactic vaccination (immunization). On 20-Jun-2023, the patient received an expired 0.5 mL dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (batch number: UJ671AA; Expiry date: 13-May-2023) via unknown route in the left vastus lateralis for immunization with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event administered expired pentacel 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2585388

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ671AA

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Staat: IL
Alter: 0,1
Geschlecht: M
Eingang: 22.02.2023
Impfdatum: 13.02.2023
Beginn: 13.02.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Medication error No adverse event Product storage error Product temperature excursion issue

Symptomtext

Lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; administered Pentacel after temperature excursion deemed vaccines non-viable for usage with no reported AE; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 1 month old male patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) after temperature excursion deemed vaccines non-viable for usage with no reported AE (adverse event) and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes 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 hepatitis B vaccine (hepatitis B vaccine) for Prophylactic vaccination. On 13-Feb-2023, the patient received a dose of suspect diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Suspension for injection) lot UJ671AA (expiry date: 15-Mar-2023) via intramuscular route in the right vastus lateralis for immunization (strength: unknown). On an unknown date lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product storage error) (latency-same day). On 13-Feb-2023, the patient was administered pentacel after temperature excursion deemed vaccines non-viable for usage with no reported ae (poor quality product administered) (unknown latency). Action taken: not applicable Outcome was 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. Additional information was received on 15-Feb-2023- Patient age, new event (lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product temperature excursion issue) and event onset date were added. Text amended accordingly.; Sender's Comments: 01493844 : 01493845:

Weitere VAERSDATA-Felder

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

VAERS 2584072

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ671AA

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Staat: IL
Alter: 1,0
Geschlecht: M
Eingang: 20.02.2023
Impfdatum: 14.02.2023
Beginn: 14.02.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

No adverse event Poor quality product administered Product storage error

Symptomtext

The lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no adverse event; Patient was administered Pentacel that was non-viable after temperature excursion with no reported AE; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old male patient who experienced patient was administered pentacel that was non-viable after temperature excursion with no reported ae and the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13). On 14-Feb-2023, the patient received a dose 4 of 0.5ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection lot UJ671AA of expiry date: 13-May-2023 via intramuscular route in the left vastus lateralis (with an unknown strength) for Immunization. On 14-Feb-2023 the patient developed a non-serious event of "patient was administered pentacel that was non-viable after temperature excursion with no reported ae" (poor quality product administered) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. On an unknown date the patient developed a non-serious event of "the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no adverse event" (product storage error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. No lab data was reported. It was reported "The lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes. MA calling for stability. Extended stability data does not cover unopened products. MA requests for stability information be emailed. MA reports that patient's were administered the products post temperature excursion and would like guidance if the patient's need to get revaccinated. Informed MA she would also need to report an Adverse event and she understood. Warm transferred for further assist and to submit due to post administration of temperature excursion". Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable. At time of reporting, the outcome was Unknown for the event patient was administered pentacel that was non-viable after temperature excursion with no reported ae and for the event the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13
Allergien: -
Vorherige Impfungen: -