VAERS Reports UJ648ABA

VAERS 2492571

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

mild

Staat: PA
Alter: 1,6
Geschlecht: M
Eingang: 28.10.2022
Impfdatum: 20.09.2022
Beginn: 21.09.2022
Tage bis Beginn: 1,0
Dosis: 4
Route/Site: IM / LA

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

Decreased appetite Glossodynia Hand-foot-and-mouth disease Pyrexia Rash Rash macular Rash papular Retching Stomatitis Vomiting

Symptomtext

Pt developed fever and rash over body with decreased appetite, sores in mouth/tongue one day after vaccinations. Evaluated in office 2d after vaccination, afebrile after having antipyretics that morning. Appeared in no distress with macular/papular rash to body, hands, feet; could not observe mouth due to patient's physical resistance and gagging/vomiting. Pt was discharged to home with presumptive dx: of Hand foot mouth disease and recommended supportive care and provision to seek emergency room care if worsens. Report done due to proximity of illness to most recent vaccines.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: None.
Aktuelle Erkrankungen: Inflammed ear drums noted at visit.
Vorgeschichte: None.
Andere Medikamente: None noted.
Allergien: History of reaction to Pinapple.
Vorherige Impfungen: -

VAERS 2478352

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

mild

Staat: MD
Alter: -
Geschlecht: M
Eingang: 14.10.2022
Impfdatum: 12.10.2022
Beginn: 12.10.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Infant irritability Injection site erythema Injection site swelling

Symptomtext

Large, raised, red area on leg where DTap was given measuring 4" x 2". Mother noticed about 5 hours after vaccines were given. Slept well, eating and drinking well but fussy. RTC or ER if fussiness does not improve with Ibuprofen and cool compressor or worsing symptoms.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: No
Vorgeschichte: No
Andere Medikamente: No
Allergien: No
Vorherige Impfungen: -

VAERS 2649638

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: ME
Alter: -
Geschlecht: F
Eingang: 27.06.2023
Impfdatum: 31.01.2023
Beginn: 31.01.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

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

Extra dose administered

Symptomtext

Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2573153-1. The original narrative from the sender is the following: Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib". No 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 2607949

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: WV
Alter: 3,0
Geschlecht: M
Eingang: 01.04.2023
Impfdatum: 29.03.2023
Beginn: 29.03.2023
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 Medication error No adverse event

Symptomtext

reported that an expired acthib was administered to a child, with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient and reporter reported that an expired HIB (PRP/T) Vaccine [ACT-HIB] was administered to a child, 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for Immunisation; and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) for Immunisation. On 29-Mar-2023, the patient received 0.3 ml (Dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ648ABA, Expiry date: 16-Mar-2023) (Strength- Standard) via intramuscular route in the left thigh for immunization. On 29-Mar-2023, the reporter reported that an expired HIB (PRP/T) Vaccine was administered to a child, with no reported adverse event (expired product administered) (Latency: same day). It was reported, She wanted to know what her next step will be. Frequency: 3 times ( 1st dose- 2 months old, 2nd dose- 4 months old, and 3rd dose- today. 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 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 2604410

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: WA
Alter: 1,0
Geschlecht: F
Eingang: 28.03.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: 4
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

an expired ACTHIB was administered to a patient with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 years old female patient who received 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 (DTAP) and influenza vaccine (Fluzone) for Prophylactic vaccination. On an unknown date, the patient received 0.25 ml (dose 4) of suspect HIB (PRP/T) vaccine (strength - standard, frequency - once, lot UJ648ABA, expiry date - 16-Mar-2023) via intramuscular route in site for prophylactic vaccination which was expired 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 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 2603142

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: NC
Alter: 2,0
Geschlecht: F
Eingang: 24.03.2023
Impfdatum: 17.03.2023
Beginn: 17.03.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: - / -

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

Expired product administered Medication error No adverse event

Symptomtext

received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2-year-old female patient who received 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 INFLUENZA VACCINE; and HEPATITIS A VACCINE INACT (HAVRIX) for Prophylactic vaccination. On 17-Mar-2023, the patient received dose 4 at 0.5ml total of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: standard) (lot number: UJ648ABA, expiry date: 16-Mar-2023) in unknown administration site for Immunization an expired dose of act-hib with no reported adverse event (expired product administered) (latency: same day). It was reported, asks what the next steps are. Refunds/Credits will not be issued due to adverse events. The Patient waited 15 Minutes in the office, and nothing Happened; However, The patient had left the building before the healthcare professional (Hcp) Office Realized They Had Administered Expired. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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 2599590

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: NC
Alter: 2,0
Geschlecht: F
Eingang: 20.03.2023
Impfdatum: 17.03.2023
Beginn: 17.03.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LG

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

Expired product administered

Symptomtext

The ActHIB vaccine had an expiration date of 3/16/2023 and was not promptly removed from the fridge at the end of the business day nor at the beginning of the next day. At around 11am on 03/17 a clinic nurse pulled the expired vaccine that their patient was due for, and did not check the expiration date. Around 3:30pm an immunization nurse realized the expired ActHIB vaccine had remained in the fridge and immediately removed the vaccine. The nurse checked the vaccine reconciliation form and noticed that a dose had been pulled for administration. The clinic nurse upon attempted to chart the dose noticed that it was not an option in the vaccination dropdown selection. The nurse alerted the primary immunization nurse, and after a brief discussion the conclusion was made that the patient received an expired dose, 0.5mL, of the ActHIB vaccine. To this nurse's knowledge the patient did not experience serious complications.

Weitere VAERSDATA-Felder

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

VAERS 2573153

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: ME
Alter: 0,3
Geschlecht: F
Eingang: 01.02.2023
Impfdatum: 31.01.2023
Beginn: 31.01.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

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

Extra dose administered

Symptomtext

Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib

Weitere VAERSDATA-Felder

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

VAERS 2481276

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648ABA

gering

Staat: FL
Alter: 1,1
Geschlecht: F
Eingang: 18.10.2022
Impfdatum: 11.10.2022
Beginn: 11.10.2022
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 Product administered to patient of inappropriate age

Symptomtext

administrated to a child earlier than recommended in the prescribing information, with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 13 months and 20 days old female patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administrated to a child earlier than recommended in the prescribing information, 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) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination. On 11-Oct-2022, the patient received a 0.5 ml (dose 4) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ648ABA; expiry date; 16-Mar-2023) via intramuscular route in the left thigh for Immunization to a child earlier than recommended in the prescribing information, with no reported adverse event (product administered to patient of inappropriate age). 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13; VARICELLA VACCINE
Allergien: -
Vorherige Impfungen: -