VAERS Reports UJ736AAA

VAERS 2690937

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ736AAA

gering

Staat: OH
Alter: -
Geschlecht: F
Eingang: 04.10.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

stating that they have administered an expired PENTACEL to a patient with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient to whom they have 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. On an unknown date, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ736AAA; Expiration Date :18-SEP-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day). 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2687248

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj736AAA

gering

Staat: OH
Alter: 0,3
Geschlecht: F
Eingang: 27.09.2023
Impfdatum: 26.09.2023
Beginn: 26.09.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

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

Expired product administered No adverse event

Symptomtext

no adverse reaction, vaccine was expired by 8 days

Weitere VAERSDATA-Felder

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

VAERS 2686169

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: VA
Alter: 1,1
Geschlecht: F
Eingang: 25.09.2023
Impfdatum: 19.09.2023
Beginn: 19.09.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

inadvertent administration of an expired dose of pentacel to a patient with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 13-month-old female patient who was inadvertently administered an expired dose of pentacel 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 and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 19-Sep-2023, the patient received total 0.5 ml of suspect diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine, Suspension for injection dose 3 (lot UJ736AAA and expiry 18-Sep-23) via intramuscular route in right leg for prophylactic vaccination (strength, expiry date: unknown), inadvertent administration of an expired dose of pentacel to a patient with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired product administered. 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: HEPATITIS B VACCINE; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2683496

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: VA
Alter: 1,1
Geschlecht: F
Eingang: 19.09.2023
Impfdatum: 19.09.2023
Beginn: 19.09.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

Expired product administered

Symptomtext

Administered expired vaccine. Expired 09/18/2023 given 09/19/2023. No signs or symptoms as of yet.

Weitere VAERSDATA-Felder

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

VAERS 2652000

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: WI
Alter: 0,5
Geschlecht: M
Eingang: 03.07.2023
Impfdatum: 27.06.2023
Beginn: 27.06.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RL

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

No adverse event Product preparation error

Symptomtext

The diluent was administered to the patient instead of the diluted vaccine. The patient did not have any adverse reaction following the administrations. The patient's parent has been notified. The patient is scheduled to receive the vaccine at their 9-month well-child visit. The RN administering the vaccine has been educated.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: None known
Vorgeschichte: None known
Andere Medikamente: None known
Allergien: None known
Vorherige Impfungen: -

VAERS 2591946

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: NJ
Alter: -
Geschlecht: M
Eingang: 26.06.2023
Impfdatum: 03.02.2023
Beginn: 02.03.2023
Tage bis Beginn: 27,0
Dosis: 1
Route/Site: IM / RL

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

Circumstance or information capable of leading to medication error Extra dose administered Vaccination site erythema

Symptomtext

Vaccination site erythema; Circumstance or information capable of leading to medication error; Extra dose administered; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary 2591946-1. The original narrative from the sender is as follows: Patient here for 12 month well child exam. Originally physician ordered Pentacel, Prevnar and Varivax but after chart review it was determined that child missed the 6 month well child exam and was in need of 3rd dose of Vaxelis. The consent form (paper) had been prepared based on the original orders of Pentacel, Prevnar and Varivax. When the medical assistant asked the MD to sign the order, the MD said (per the MA) we are giving VAXELIS, instead of Varivax. Per the MA, the MD watched the MA cross out VARIVAX and add VAXELIS as well as having the PENTACEL checked off. The MD then signed the order. MA administered the vaccines and upon documentation in the medical record, noted a different set of orders in the chart that DID NOT include the Pentacel but did include the Varivax. The MA did notify the physician and myself right away. The parent was notified of the event and was advised to monitor for increase in fever, irritability, or local reaction. I apologized for the experience and that I would be looking into how this occurred in spite of our careful attention to safety. I gave her my name to call for any additional questions. Parent did bring child to the ED for evaluation about 2 hrs after the incident. ED diagnosis of 'parental concern'. after the dual vaccinations received. Vital signs at that visit WNL with no fever. All other physical exam WNL except for '3 Vaccine sites notes with mild surrounding erythema but no tenderness'. The department on call physician was notified in case there were any further concern overnight which there were not. No subsequent calls were made to the office since then and no further ED evaluations noted. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Circumstance or information capable of leading to medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2591946

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: NJ
Alter: -
Geschlecht: M
Eingang: 26.06.2023
Impfdatum: 03.02.2023
Beginn: 02.03.2023
Tage bis Beginn: 27,0
Dosis: UNK
Route/Site: IM / RL

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

Circumstance or information capable of leading to medication error Extra dose administered Vaccination site erythema

Symptomtext

Vaccination site erythema; Circumstance or information capable of leading to medication error; Extra dose administered; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary 2591946-1. The original narrative from the sender is as follows: Patient here for 12 month well child exam. Originally physician ordered Pentacel, Prevnar and Varivax but after chart review it was determined that child missed the 6 month well child exam and was in need of 3rd dose of Vaxelis. The consent form (paper) had been prepared based on the original orders of Pentacel, Prevnar and Varivax. When the medical assistant asked the MD to sign the order, the MD said (per the MA) we are giving VAXELIS, instead of Varivax. Per the MA, the MD watched the MA cross out VARIVAX and add VAXELIS as well as having the PENTACEL checked off. The MD then signed the order. MA administered the vaccines and upon documentation in the medical record, noted a different set of orders in the chart that DID NOT include the Pentacel but did include the Varivax. The MA did notify the physician and myself right away. The parent was notified of the event and was advised to monitor for increase in fever, irritability, or local reaction. I apologized for the experience and that I would be looking into how this occurred in spite of our careful attention to safety. I gave her my name to call for any additional questions. Parent did bring child to the ED for evaluation about 2 hrs after the incident. ED diagnosis of 'parental concern'. after the dual vaccinations received. Vital signs at that visit WNL with no fever. All other physical exam WNL except for '3 Vaccine sites notes with mild surrounding erythema but no tenderness'. The department on call physician was notified in case there were any further concern overnight which there were not. No subsequent calls were made to the office since then and no further ED evaluations noted. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Circumstance or information capable of leading to medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2626650

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: NY
Alter: 0,5
Geschlecht: F
Eingang: 04.05.2023
Impfdatum: 15.02.2023
Beginn: 15.02.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

Expired product administered

Symptomtext

None. The pfizer covid 19 was administered after the beyond use by date after being in the refrigerator for more than 10 weeks.

Weitere VAERSDATA-Felder

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

VAERS 2625821

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: VA
Alter: 0,2
Geschlecht: M
Eingang: 03.05.2023
Impfdatum: 25.04.2023
Beginn: 26.04.2023
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / LL

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

Flatulence Infant irritability Infantile spitting up

Symptomtext

no symptoms in office-mom called on 5/3/2023 to report to our office baby was fine and having normal daily bowel movements through April 25, 2023 which is when he received his 2 month vaccines, she states on April 26, 2023 he began with very bad gas and fussiness with this gas, he has had episodes of spitting up, he is fine in between these spells, no reports were made to our clinic until 5/3/2023 and mom feels his symptoms are a reaction from the vaccines, we have explained to mom also that the age 1 month - 3 month could be a time to develop colic as well, offered mom to come in to bring baby to be seen by Dr., she asked for walk in times and was given those, advised mom she could bring him in as a walk in or we could put him on the schedule at a time that may suit her best, no apts. were made before mom hung the phone up

Weitere VAERSDATA-Felder

Praegender Schweregrund: Flatulence
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none reported
Vorgeschichte: none
Andere Medikamente: infant vitamin D drops
Allergien: none known
Vorherige Impfungen: -

VAERS 2605705

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ736AAA

gering

Staat: PA
Alter: 1,6
Geschlecht: M
Eingang: 29.03.2023
Impfdatum: 09.03.2023
Beginn: 09.03.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

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

Symptomtext

Patient accidentally received a PENTACEL vaccine with only the diluent DTAP/IPV portion and not the HIB powder component with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old male patient who accidentally received a diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] vaccine with only the diluent dtap/ipv portion and not the hib powder component 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 13V (CRM197) (PREVNAR 13) for Immunisation; and hepatitis A vaccine (Hepatitis A) for Immunisation. On 09-Mar-2023, the patient received a 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection (frequency - once, strength - standard, lot UJ736AAA, expiry date - 18-Sep-2023) via intramuscular route in the upper right thigh for Immunisation. On 09-Mar-2023 the patient accidentally received a pentacel vaccine with only the diluent dtap/ipv portion and not the hib powder component with no reported adverse event (single component of a two-component 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 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2474472

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ736AAA

gering

Staat: AZ
Alter: 1,3
Geschlecht: F
Eingang: 11.10.2022
Impfdatum: 23.09.2022
Beginn: 23.09.2022
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 Poor quality product administered

Symptomtext

Pentacel was found out to be used on a patient post excursion with no adverse event; Initial information was received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 15 months old female patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was found out to be used post excursion with no 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 7V (CRM197) (PREVNAR) for Immunisation. On 23-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ736AAA expiry-30-09-23) (strength and formulation; unknown) via intramuscular route in the left upper thigh for Immunization. On 23-SEP-2022 the patient developed a non-serious pentacel was found out to be used on a patient post excursion with no adverse event (poor quality product administered) (latency same day). Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. At time of reporting, the outcome was Unknown for the event pentacel was found out to be used on a patient post excursion 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR
Allergien: -
Vorherige Impfungen: -