VAERS Reports UJ412AB

VAERS 2305172

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

mild

Staat: NM
Alter: 45,0
Geschlecht: M
Eingang: 01.06.2022
Impfdatum: 13.05.2022
Beginn: 19.05.2022
Tage bis Beginn: 6,0
Dosis: 1
Route/Site: SYR / UN

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

Alanine aminotransferase increased Aspartate aminotransferase increased Blood bilirubin increased Jaundice Malaise Pyrexia

Symptomtext

Developed fevers and malaise on 5/19, went on the develop jaundice. Admitted to hospital then quickly transferred to another hospital for liver consult.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Malaise
Hospital-Tage: -
Labordaten: tbili 15.9 AST 356 ALT 412
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2255199

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

mild

Staat: OR
Alter: 28,0
Geschlecht: M
Eingang: 27.04.2022
Impfdatum: 22.04.2022
Beginn: 24.04.2022
Tage bis Beginn: 2,0
Dosis: 1
Route/Site: SC / LA

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

Chromaturia Fatigue Hypophagia Injection site rash Pain Pruritus

Symptomtext

Patient called today stating noticed a rash at site of injection yesterday with itching and pain starting 2 days prior to that. Patient states size of rash is 3 quarters length and 1 quarter in width. He also noticed some fatigue and urine darker than normal yesterday, better today. States could be due to not drinking a lot of water. I advised patient to contact provider to describe above symptoms especially dark urine to see if they want to run some labs.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Fatigue
Hospital-Tage: -
Labordaten: None at the moment.
Aktuelle Erkrankungen: unknown
Vorgeschichte: unknown, patient states not immunosuppressed or taking immunosuppressive medications.
Andere Medikamente: unknown
Allergien: Pollen, cats
Vorherige Impfungen: -

VAERS 2650123

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: DC
Alter: 14,0
Geschlecht: M
Eingang: 28.06.2023
Impfdatum: 20.10.2022
Beginn: 20.10.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Medication error No adverse event Product preparation error Product preparation issue

Symptomtext

medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2022SA489108, 2022SA502558 and 2022SA503839. This case involves a 14-year-old male patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event with yellow fever vaccine [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included typhoid vaccine (Typhoid) and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) both for Prophylactic vaccination. On 20-Oct-2022, the patient received suspect yellow fever vaccine at a dose of 0.5 ml total (lot UJ412AB, expiry date: 22-Nov-2025) via subcutaneous route in the left arm for immunization. On 20-Oct-2022 the patient had a non-serious medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event (product preparation error, latency: 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: TYPHOID; ADACEL
Allergien: -
Vorherige Impfungen: -

VAERS 2557080

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: CA
Alter: -
Geschlecht: U
Eingang: 11.01.2023
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 Medication error No adverse event

Symptomtext

patient received an expired dose of YF-VAX (with no reported adverse event); Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received via physician. This case involves an unknown age and unknown gender patient received an expired dose of yellow fever vaccine - [YF-VAX] (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine - Solution for injection (strength: unknown) (batch number: UJ412AB) (expiry date: 25-Nov-2022) via unknown route in unknown administration site for immunization. On an unknown date the patient received an expired dose of yf-vax (with no reported adverse event) (expired product administered) (unknown latency) following the administration of yellow fever vaccine. Action taken with yellow fever vaccine (YF-VAX) was 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 2530632

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: DC
Alter: 17,0
Geschlecht: M
Eingang: 14.12.2022
Impfdatum: 18.11.2022
Beginn: 18.11.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / RA

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

No adverse event Poor quality product administered Product preparation error

Symptomtext

administration of vaccine that was reconstituted with wrong diluent with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a health professional. This case is linked to cases 2022SA502558 and 2022SA489108. This case involves a 17 years old male patient who was administered with Yellow Fever Vaccine - YF-VAX] that was reconstituted with wrong diluent 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 Typhoid Vaccine (Typhoid) for Prophylactic vaccination; and Rabies Vaccine (Imovax) for Prophylactic vaccination. On 18-Nov-2022, the patient received 0.5 ml Total (Dose 1) of suspect Yellow Fever Vaccine - Solution for injection that was reconstituted with wrong diluent with no reported adverse event (product preparation error) (latency: same day) (lot number UJ412AB) (Expiry date: 22-Nov-2025) via subcutaneous route in the right arm for prophylactic vaccination. It was reported She also provided information for the 4 patients who received the vaccine, She confirmed that each patient was contacted and none of them had safety issues nor side effects reported. Patients declined revaccination despite knowledge that the vaccine was invalid. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2529446

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: DC
Alter: 11,0
Geschlecht: F
Eingang: 13.12.2022
Impfdatum: 18.11.2022
Beginn: 18.11.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / RA

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

Medication error No adverse event Product preparation error

Symptomtext

medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old female patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Immunisation; and RABIES VACCINE (RABIES VACCINE) for Immunisation. On 18-Nov-2022, the patient received a 1 dose of suspect YELLOW FEVER VACCINE at a dose of 0.5 ml (lot no. UJ412AB and expiry date: 22 Nov-2025) via subcutaneous route in the right arm for immunisation. On 18-Nov-2022 the patient had a non-serious event of medication error due to administration of vaccine that was reconstituted with wrong diluent, with no reported adverse event (product preparation error)(latency: 1 day) following the administration of YELLOW FEVER VACCINE. 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: TYPHOID VACCINE; RABIES VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2397797

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: MD
Alter: 56,0
Geschlecht: F
Eingang: 01.08.2022
Impfdatum: 26.07.2022
Beginn: 26.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

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

Medication error

Symptomtext

inadvertently administered a YF-VAX to a severely immunocompromised patient with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid serious case received from a other health professional. This case involves a 56 years old female patient who was inadvertently administered a yf-vax vaccine to a severely immunocompromised patient, while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX]. At the time of event , the patient had an ongoing history of severely immunocompromised. 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 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Immunisation. On 26-Jul-2022, the patient received a dose of suspect YELLOW FEVER VACCINE ( lot UJ412AB and expiration date: 25-Nov-2022) at a dose of 0.5ml once via unknown route at unknown administration site for immunization. On 26-Jul-2022 (latency: same day), the patient inadvertently administered a yf-vax ( Contraindicated product administered) to a severely immunocompromised patient that currently receives IV immune therapy following the administration of YELLOW FEVER VACCINE. Action taken: not applicable Outcome: 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Immunocompromised
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2366378

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: IL
Alter: 41,0
Geschlecht: F
Eingang: 12.07.2022
Impfdatum: 05.07.2022
Beginn: 05.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

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

Incorrect route of product administration No adverse event

Symptomtext

This nurse administered Thypoid vaccine in the right deltoid, IM, with no adverse reactions noted. This nurse inadverintaly gave the Yellow Fever vaccine IM in right arm, instead of SC, one inche from the previous vaccine. No adverse reaction noted. Patient waited in the waiting area for her family while they received their vaccines. No adverse reactions noted or reported while waiting.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2249503

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ412AB

gering

Staat: IL
Alter: 49,0
Geschlecht: M
Eingang: 23.04.2022
Impfdatum: 15.04.2022
Beginn: 15.04.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Incorrect route of product administration

Symptomtext

Yellow Fever vaccine was given IM instead of SQ.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -