VAERS Reports UJ602AA

VAERS 2635226

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

mild

Staat: CA
Alter: 7,0
Geschlecht: F
Eingang: 22.05.2023
Impfdatum: 01.05.2023
Beginn: 22.05.2023
Tage bis Beginn: 21,0
Dosis: 1
Route/Site: SC / LA

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

Back pain Cough Throat irritation

Symptomtext

Patient began to experience back pain, coughing and itching throat. No rash, swelling, or significant difficulty breathing occurred. The paramedics were called and epi-pen and benadryl were administered IM by the paramedics. The patient was monitored at had recovered by 3pm the same day.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Back pain
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2440301

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

mild

Staat: CA
Alter: 19,0
Geschlecht: F
Eingang: 12.09.2022
Impfdatum: 22.08.2022
Beginn: 01.08.2022
Tage bis Beginn: -
Dosis: 2
Route/Site: OT / LA

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

Rash Rash erythematous Rash papular

Symptomtext

red dots on neck hands and arms; developed random red bumps not at the injection site but on neck. They went away and got some on arms and hands; Initial information received on 31-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 19 years old female patient who experienced red dots on neck hands and arms and developed random red bumps not at the injection site but on neck. they went away and got some on arms and hands, after receiving vaccine YELLOW FEVER VACCINE - [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2022, the patient received a dose number 2 of suspect YELLOW FEVER VACCINE - injection(lot UJ602AA and expiration date: 13-Jul-2023)at a dose of 0.5ml total via subcutaneous route in the left arm for immunization. In AUG-2022 (latency: approximately a week) , it has been over a week since the patient her yellow fever vaccine and she developed random red bumps not at the injection site but on her neck (rash papular).They went away and she got some on her arms and her hands (rash erythematous). The bumps do not hurt or itch they are just there and she wanted to know if it is associated with the vaccine. It was also reported the first injection the patient received the syringe was a faulty syringe and started leaking as soon as the syringe was injected Action taken :not applicable. It was not reported if the patient received a corrective treatment for the events . Outcome: unknown for both events

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2417747

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: CA
Alter: 19,0
Geschlecht: F
Eingang: 31.08.2022
Impfdatum: 22.08.2022
Beginn: 30.08.2022
Tage bis Beginn: 8,0
Dosis: 1
Route/Site: SC / LA

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

Incorrect dose administered Syringe issue Peripheral swelling Swelling

Symptomtext

Previous submitted VAERs e-report NO: 878901 was in regards to a faulty syringe and followed agency guidelines and patient received proper full dose on 8/22/22. Followed up with patient on 8/23/22 and reported feeling great. No side effects reported that night. I informed her if she feels anything later on in the day or the next couple of days, please call me. Spoke to mom, kept an eye on daughter and confirmed she was doing fine. No symptoms to report. Today, 8/31/22, patient called to report she is experiencing raised little bumps on the neck that disappeared and started showing up on both hands and arms. When I asked her if it itched or was painful, she said NO. I asked her if she was breathing normally, she said YES. I asked her if she experienced any fever, she said NO. I asked her if she touched or ate something in the last week and she can't recall anything that stood out. I asked if she experienced vomiting or diarrhea, she said NO. She said her parents did some research and don't think its due to YF vaccine. I told her I couldn't rule anything definitively out, but I will call SANOFI and report back. I also recommended to her to schedule an appointment with a dermatologist to rule out any ingested or contact reactions.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect dose administered
Hospital-Tage: -
Labordaten: None taken. Patient did not seek medical attention.
Aktuelle Erkrankungen: Recent teeth extraction
Vorgeschichte: Not to pharmacy's knowledge
Andere Medikamente: Antibiotic
Allergien: Not to pharmacy's knowledge
Vorherige Impfungen: -

VAERS 2409571

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: CA
Alter: 30,0
Geschlecht: M
Eingang: 12.08.2022
Impfdatum: 09.08.2022
Beginn: 09.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Incorrect route of product administration

Symptomtext

Yf-vax, was administered intramuscular instead of subcutaneous, with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 30 years old male patient to whom YELLOW FEVER VACCINE - [YF-VAX], was administered intramuscular instead of subcutaneous, 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 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Prophylactic vaccination; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Prophylactic vaccination. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - lot UJ602AA via intramuscular route in unknown administration site. On 09-Aug-2022 the patient developed a non-serious event of YELLOW FEVER VACCINE -, was administered intramuscular instead of subcutaneous, with no reported adverse event (incorrect route of product administration) (latency: same day) (dose:0.5ml, batch number: UJ602AA and expiry date: unknown, strength and formulation was unknown) for Immunization. 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 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: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2405786

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: CA
Alter: 30,0
Geschlecht: F
Eingang: 09.08.2022
Impfdatum: 08.08.2022
Beginn: 08.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

No adverse event

Symptomtext

Yellow Fever (YF-Vax) administered IM in Right Deltoid. Patient monitored for 15 minutes post vaccination. No adverse side effects or outcome experienced by patient.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: NA
Aktuelle Erkrankungen: NA
Vorgeschichte: H/o Anemia, Anxiety
Andere Medikamente: Lutera 0/1/20mg-mcg
Allergien: Eye drops, cough/cold medicine (generic)
Vorherige Impfungen: -

VAERS 2387785

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: VA
Alter: 53,0
Geschlecht: F
Eingang: 24.07.2022
Impfdatum: 14.07.2022
Beginn: 14.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Incorrect route of product administration No adverse event

Symptomtext

YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 53 years old female patient and yf-vax(YELLOW FEVER VACCINE - ) was administered to a patient through the intramuscular route instead of the subcutaneous route with no 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); HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) all for Immunisation. On 14-Jul-2022, the patient received a dose of 0.5 ml of suspect YELLOW FEVER VACCINE - lot UJ602AA, expiration date:13-Jul-2024, via intramuscular route in the left deltoid as Immunization. The patient used the product previously. On 14-JUL-2022 the yf-vax was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event (incorrect route of product administration) same day following the administration of YELLOW FEVER VACCINE - . Caller would like to know if the dose was valid. This situation was reported as a medication error. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event). 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: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: HEPATITIS A; HEPATITIS B VACCINE; TDAP
Allergien: -
Vorherige Impfungen: -

VAERS 2387784

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: VA
Alter: 38,0
Geschlecht: M
Eingang: 24.07.2022
Impfdatum: 14.07.2022
Beginn: 14.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Incorrect route of product administration Medication error No adverse event

Symptomtext

YF-VAX being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 38 years old male patient to whom YELLOW FEVER VACCINE - [YF-VAX] being administered through the intramuscular route instead of the subcutaneous route 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 Hepatitis A; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Hepatitis B; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination. On 14-Jul-2022, the patient received a 0.5ml dose of suspect YELLOW FEVER VACCINE - (formulation , strength was unknown, lot UJ602AA and expiry date: 13-Jul-2023) via intramuscular route in the left deltoid for Immunization. On 14-Jul-2022 the patient developed a non-serious event of yf-vax being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event (incorrect route of product administration, 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: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: HEPATITIS A; HEPATITIS B [HEPATITIS B VACCINE]; TDAP
Allergien: -
Vorherige Impfungen: -

VAERS 2387783

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: VA
Alter: 66,0
Geschlecht: F
Eingang: 24.07.2022
Impfdatum: 14.07.2022
Beginn: 14.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Incorrect route of product administration No adverse event

Symptomtext

YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route, with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 66 years old female patient who was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, 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 5-Component, Tetanus Vaccine Toxoid (Adacel) and Hepatitis A Vaccine (Hepatitis A) for prophylactic vaccination (Immunisation). On 14-Jul-2022, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine (Solution for injection) (lot: UJ602AA; expiry date: 13-Jul-2023) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation). On 14-Jul-2022 the patient was administered Yellow Fever Vaccine [YF-VAX] through the intramuscular route instead of the subcutaneous route, with no reported adverse event (incorrect route of product administration) (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: Incorrect route of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ADACEL; HEPATITIS A
Allergien: -
Vorherige Impfungen: -

VAERS 2320794

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ602AA

gering

Staat: UT
Alter: 19,0
Geschlecht: M
Eingang: 15.06.2022
Impfdatum: 15.06.2022
Beginn: 15.06.2022
Tage bis Beginn: 0,0
Dosis: N/A
Route/Site: SC / LA

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

Fall Feeling hot Head injury Pallor

Symptomtext

When client was checking out at front desk, he fell backwards and hit his head. Client was pale and feeling hot. Client moved to sitting in chair and was given snacks and beverages to eat while resting. Clients head was checked for any signs of injury. No signs noted. Within 5-10 minutes of resting, clients color was back and he stated he was feeling better. Client rested for an additional 10-15 minutes before leaving the clinic in good condition. Facility incident report filled.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Fall
Hospital-Tage: -
Labordaten: None.
Aktuelle Erkrankungen: None.
Vorgeschichte: None.
Andere Medikamente: None.
Allergien: None.
Vorherige Impfungen: -