VAERS Reports UJ798AB

VAERS 2463154

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

mild

Staat: WI
Alter: 1,3
Geschlecht: M
Eingang: 28.09.2022
Impfdatum: 16.09.2022
Beginn: 23.09.2022
Tage bis Beginn: 7,0
Dosis: 4
Route/Site: IM / RL

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

Diarrhoea Fatigue Hypophagia Irritability Pyrexia Rash

Symptomtext

Patient received his HIB, MMR, and flu vaccinations. She started to notice the rash on 9/23 and it was very light. The fever broke and he is finally eating more. The rash has now spread to his face and torso. When asked about the face, Mom reports it is up around his hairline and a little bit on his cheeks. "It definitely looks like a measle rash". No new detergents etc. "Injection sites don't look worse than the rest of his body". He is still somewhat fussy. Intervention Tried (OTC, Rx, Other): Monitoring symptoms. Pain Intensity: Denies Fever: Afebrile. I&O: Appetite better than it had been. Drinking fluids. Stools are a little loose. Having wet diapers. Activity/Functional Status: Acting more like himself today.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: bronchiolitis, infection due to bordetella parapertussis
Andere Medikamente: none
Allergien: No known drug or food allergies.
Vorherige Impfungen: -

VAERS 2708008

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: CA
Alter: 0,2
Geschlecht: F
Eingang: 01.11.2023
Impfdatum: 24.10.2023
Beginn: 24.10.2023
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 No adverse event

Symptomtext

expired vaccine 9-11-2023, dose was given with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 weeks old female patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] 9-11-2023, dose was given 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), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 13v (crm197) (Prevnar 13). On 24-Oct-2023, the patient received an unknown dose (total, once) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB, expiry date: 11-Sep-2023, strength: standard) via unknown route in the right thigh for Immunization and expired vaccine 9-11-2023, dose was given 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. 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: PEDIARIX; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2688273

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: CA
Alter: 1,6
Geschlecht: F
Eingang: 28.09.2023
Impfdatum: 15.09.2023
Beginn: 15.09.2023
Tage bis Beginn: 0,0
Dosis: 4
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

expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves 19 months old female patient who was administered expired haemophilus type B (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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation. On 15-Sep-2023, the patient received a standard expired dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UJ798AB, expiry date- 11-SEP-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks if the efficacy of ACT-HIB is diminished after 11Sep2023, of if it is still good for a certain amount of time after the expiration date? 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: DTAP
Allergien: -
Vorherige Impfungen: -

VAERS 2687627

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: IL
Alter: 2,0
Geschlecht: M
Eingang: 28.09.2023
Impfdatum: 20.09.2023
Beginn: 20.09.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

they have administered ACTHIB that has expired on 11Sep2023 to a patient today with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 years old male patient who was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 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 Vaccine) for Prophylactic vaccination. On 20-Sep-2023, the patient received 0.5 ml (Dose 4) of suspect Haemophilus Type B (Hib) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB) (Expiry date: 11-Sep-2023) via unknown route in unknown administration site for Immunization. On 20-Sep-2023 the patient was administered Haemophilus Type B (Hib) Vaccine (ACT-HIB) that has expired on 11sep2023 with no reported adverse event (expired product administered) (latency: same day). It was reported, Physician asks if there is a grace period for expired ACTHIB, and if there are dosing recommendations for re-vaccination after they have administered ACTHIB that has expired on 11Sep2023 to a patient today 20Sep2023. This situation is reported as a medication error due to a patient was administered with expired ACTHIB. Action taken: not applicable. Outcome: Recovered / Resolved on an unknown date 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 VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2686449

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj798ab

gering

Staat: ND
Alter: 1,0
Geschlecht: F
Eingang: 26.09.2023
Impfdatum: 25.09.2023
Beginn: 25.09.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: SYR / OT

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

Expired product administered

Symptomtext

patient was given expired vaccine

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 2686177

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: NY
Alter: -
Geschlecht: U
Eingang: 25.09.2023
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

given the ACTHIB expired with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demographics who was given the HIB (PRP/T) vaccine [ACT-HIB] expired 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 a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection dose, strength: not reported lot UJ798AB expiry date: 11-Sep-2023 via unknown route in unknown administration site for Immunization and given the acthib expired 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 given the acthib expired 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 2686175

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: HI
Alter: 1,3
Geschlecht: M
Eingang: 25.09.2023
Impfdatum: 18.09.2023
Beginn: 18.09.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

given an expired ACT-HIB to a patient (with no reported adverse event); Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was given an 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. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for prophylactic vaccination (Immunisation). On 18-Sep-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ798AB expiry date: 11-sep-2023 via intramuscular route in Right Quad Muscle for immunization and given an expired 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 given an expired 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: DAPTACEL; PNEUMOCOCCAL CONJUGATE VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2685418

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: HI
Alter: 1,3
Geschlecht: F
Eingang: 22.09.2023
Impfdatum: 13.09.2023
Beginn: 13.09.2023
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

15 month old patient received an expired ACTHIB with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 month old patient received an expired acthib 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 (DTAP) for Prophylactic vaccination. On 13-Sep-2023, the patient received 0.5 ml (1X) dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ798AB, expiry: 11-Sep-2023 via intramuscular route in the left thigh for immunization (strength: unknown), patient received an expired acthib 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: DTAP
Allergien: -
Vorherige Impfungen: -

VAERS 2683335

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: IL
Alter: 0,3
Geschlecht: F
Eingang: 18.09.2023
Impfdatum: 13.09.2023
Beginn: 13.09.2023
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 ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old female patient to whom expired act-hib was administered 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 7V (CRM197) (Prevnar) and hepatitis b vaccine for Prophylactic vaccination. On 13-Sep-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UJ798AB, expiry date- 11-Sep-2023) via intramuscular route in the left vastus lateralis for prophylactic vaccination (strength: unknown), expired act-hib was administered 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: PREVNAR; HEPATITIS B VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2682532

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: NH
Alter: 1,0
Geschlecht: F
Eingang: 15.09.2023
Impfdatum: 13.09.2023
Beginn: 15.09.2023
Tage bis Beginn: 2,0
Dosis: 4
Route/Site: IM / RL

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

Expired product administered

Symptomtext

Patient was administered ActHib that had expired on 9/11/23, 2 days prior to her appointment in the office. Called Immunization Program and spoke with nurse who advised there were no health concerns for the child, however, she would have to repeat the dose of Act Hib.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: None.
Aktuelle Erkrankungen: None
Vorgeschichte: none
Andere Medikamente: None
Allergien: No known allergies
Vorherige Impfungen: -

VAERS 2656564

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: UT
Alter: 17,0
Geschlecht: M
Eingang: 14.07.2023
Impfdatum: 10.07.2023
Beginn: -
Tage bis Beginn: -
Dosis: 1
Route/Site: IM / LA

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

Tuberculin test positive

Symptomtext

No symptoms have been reported

Weitere VAERSDATA-Felder

Praegender Schweregrund: Tuberculin test positive
Hospital-Tage: -
Labordaten: Patient also had a PPD test done at the time of vaccine administration. Patient came back after 48 hours for a PPD reading and came back positive. Pt was ordered a chest X-ray.
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/a
Andere Medikamente: N/A
Allergien: N/A
Vorherige Impfungen: -

VAERS 2618049

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: CA
Alter: 0,8
Geschlecht: F
Eingang: 19.04.2023
Impfdatum: 19.04.2023
Beginn: 19.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Extra dose administered

Symptomtext

ADMINSTRATION ERROR- PATIENT CAME IN FOR HER 10 MONTH WELL EXAM. AFTER GIVING VACCINES TO THE PATIENTS, FOUND OUT THAT ALL DOSES HAD ADMINISTERED PRIOR RO TODAY'S VISIT.

Weitere VAERSDATA-Felder

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

VAERS 2609975

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: MI
Alter: 1,7
Geschlecht: M
Eingang: 05.04.2023
Impfdatum: 30.03.2023
Beginn: 30.03.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

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

Incorrect product formulation administered

Symptomtext

When pulling out medication did not mix powder with diluent inadvertently gave the diluent not the vaccine medication to client. Powder portion of vaccine was not administered to client.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: No allergies per mom
Vorherige Impfungen: -

VAERS 2609964

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ798AB

gering

Staat: MI
Alter: 1,0
Geschlecht: M
Eingang: 05.04.2023
Impfdatum: 30.03.2023
Beginn: 30.03.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

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

Product preparation error

Symptomtext

When pulling out medication did not mix powder with diluent inadvertently gave the diluent not the vaccine medication to client. Powder portion of vaccine was not administered to client.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product preparation error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: no allergies per Mom
Vorherige Impfungen: -