VAERS Reports UJ796AA

VAERS 2627011

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

mild

Staat: CA
Alter: 1,0
Geschlecht: F
Eingang: 04.05.2023
Impfdatum: 02.05.2023
Beginn: 03.05.2023
Tage bis Beginn: 1,0
Dosis: 4
Route/Site: IM / LL

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

Injection site erythema Injection site swelling Injection site warmth

Symptomtext

Injection site on left thigh is red, swollen and hot to the touch. Was advice to watch for now, apply cold towel compresses, give Tylenol as needed. Call us back immediately if symptoms worsen or do not get better. Will schedule a doctor visit.

Weitere VAERSDATA-Felder

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

VAERS 2679156

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: GA
Alter: -
Geschlecht: U
Eingang: 05.09.2023
Impfdatum: 29.08.2023
Beginn: 29.08.2023
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 Medication error No adverse event

Symptomtext

expired dose of act-hib was administered with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and gender patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Aug-2023, the patient received unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ796AA; expiry date: 12-Aug-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency). Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event expired dose of act-hib was administered 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2679150

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: MO
Alter: 1,0
Geschlecht: F
Eingang: 05.09.2023
Impfdatum: 29.08.2023
Beginn: 29.08.2023
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

infant was given an expired dose of Act-HIB with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 1-years-old female patient who was given an expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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 A vaccine (Hepatitis A); pneumococcal vaccine; measles vaccine, mumps vaccine, rubella vaccine (MMR); and varicella zoster vaccine for Prophylactic vaccination (Immunization). On 29-Aug-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ796AA; expiry date: 12-Aug-2023) via intramuscular route in right 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 expired product administered. No additional information provided. 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 A; PNEUMOCOCCAL VACCINE; MMR; VARICELLA ZOSTER VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2678044

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: WY
Alter: 1,0
Geschlecht: F
Eingang: 30.08.2023
Impfdatum: 24.08.2023
Beginn: 24.08.2023
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

ACTHIB was given past the expiration date with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-year-old female patient for whom HIB (PRP/T) vaccine [ACT-HIB] was given past the expiration date 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Varicella Zoster Vaccine (Varicella Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), all for Immunisation. On 24-Aug-2023, the patient received an expired dose of 0.5 ml (Frequency = once) of standard strength suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot: UJ796AA, Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization no reported adverse event (expired product administered) (latency: same day). Action taken: not applicable. At time of reporting, the 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 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 2677929

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: GA
Alter: 4,0
Geschlecht: F
Eingang: 30.08.2023
Impfdatum: 29.08.2023
Beginn: 29.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RA

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

Expired product administered Wrong product administered

Symptomtext

Patient received an expired dose of ACTHIB vaccine on 08/29/2023. Upon reconciling vaccine inventory, Nurse Manager, discovered that the vaccine inventory count was not correct. After further review it was discovered that the incorrect lot number was selected for a vaccine administered on 08/29/2023. The actual vaccine lot that was administered was ACTHIB lot UJ796AA that expired on 08/12/2023. Sanofi has been contacted to determine if ACTHIB lot UJ796AA was still viable on 08/29/2023 and their response was no. Attempted to contact patient's mother on 08/30/2023 at 3pm using in house interpreter. Patient's mother did not answer, voicemail was left. Will continue to call patient's mother until contact is made.

Weitere VAERSDATA-Felder

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

VAERS 2676989

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: NY
Alter: -
Geschlecht: U
Eingang: 28.08.2023
Impfdatum: 22.08.2023
Beginn: 22.08.2023
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 Medication error No adverse event

Symptomtext

two patients received expired ACT-HIB with no reported adverse event; Initial information received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender two patients who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2023, the two patients received an expired dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ796AA, expiry date- 12-AUG-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller would like to know how to proceed? 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 2675989

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: LA
Alter: 2,0
Geschlecht: M
Eingang: 24.08.2023
Impfdatum: 21.08.2023
Beginn: 21.08.2023
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 ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 2 years old male patient who was inadvertently administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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 A vaccine (Hepatitis A) for Prophylactic vaccination. On 21-Aug-2023, the patient was inadvertently administered a standard expired total dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 mL (lot UJ796AA, expiry date- 12-AUG-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller with question on whether dose needs repeating. 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: HEPATITIS A
Allergien: -
Vorherige Impfungen: -

VAERS 2675987

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: TX
Alter: 1,0
Geschlecht: M
Eingang: 24.08.2023
Impfdatum: 18.08.2023
Beginn: 18.08.2023
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 Medication error No adverse event

Symptomtext

expired vaccine was administered with no adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient to whom administered expired Hib (PRP/T) Vaccine [Act-Hib] with no adverse event. 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); Varicella Zoster Vaccine (Varicella Vaccine); Hepatitis A Vaccine (Hepatitis A); And Pneumococcal Vaccine (Pneumococcal Vaccine) for Prophylactic vaccination. On 18-Aug-2023, the patient received expired dose of 0.5 ml of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 12-Aug-2023 and lot UJ796AA) via intramuscular route in left vastus lateralis for immunization (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: MMR; VARICELLA VACCINE; HEPATITIS A; PNEUMOCOCCAL VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2673628

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: TX
Alter: 4,0
Geschlecht: M
Eingang: 18.08.2023
Impfdatum: 14.08.2023
Beginn: 14.08.2023
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 No adverse event

Symptomtext

administered an expired dose of ACT-HIB to a patient, with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Aug-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength unknown) lot UJ796AA expiry date: 12-Aug-2023 via intramuscular route in the left thigh for Immunization. On 14-AUG-2023 patient was administered an expired dose of act-hib to a patient, with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event administered an expired dose of act-hib to a patient, 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2653705

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: MI
Alter: 7,0
Geschlecht: F
Eingang: 07.07.2023
Impfdatum: 19.06.2023
Beginn: 07.07.2023
Tage bis Beginn: 18,0
Dosis: UNK
Route/Site: IM / RL

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: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2649647

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: UT
Alter: -
Geschlecht: M
Eingang: 27.06.2023
Impfdatum: 22.03.2023
Beginn: 22.03.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

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

Extra dose administered

Symptomtext

A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB; This non-serious spontaneous Safety Report was received by partner on 19-APR-2023 and forwarded to agency on 21-APR-2023 from other health professional. The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB". Further information is expected.

Weitere VAERSDATA-Felder

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

VAERS 2621904

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: -
Alter: 1,0
Geschlecht: M
Eingang: 27.04.2023
Impfdatum: 22.03.2023
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / LL

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

Extra dose administered No adverse event

Symptomtext

they both administered ACTHIB & VAXELIS to a patient with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient and is reported they both administered HIB (PRP/T) vaccine [ACT-HIB] & vaxelis to a patient 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 diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio VACCINE INACT 3V (VERO), tetanus vaccine toxoid (Vaxelis) for Prophylactic vaccination. On 22-Mar-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection lot UJ796AA via intramuscular route in the left thigh for immunization. On an unknown date the patient developed a non-serious event "they both administered acthib & vaxelis to a patient with no reported adverse event" (Extra dose administered) latency unknown following the administration of HIB (PRP/T) Vaccine. Action taken was not applicable. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event they both administered acthib & vaxelis to a patient 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2621041

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ796AA

gering

Staat: ND
Alter: 0,7
Geschlecht: F
Eingang: 25.04.2023
Impfdatum: 17.04.2023
Beginn: 17.04.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

No adverse event Product administered to patient of inappropriate age

Symptomtext

No symptoms child was over the age of 8 months and one day

Weitere VAERSDATA-Felder

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