VAERS Reports U6952AB

VAERS 1936287

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6952AB

mild

Staat: AL
Alter: 11,0
Geschlecht: F
Eingang: 09.12.2021
Impfdatum: 09.12.2021
Beginn: 09.12.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

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

Rash Rash pruritic

Symptomtext

After leaving clinic patient returned with lacy rash on bilateral hands that extended up forearms? no rash at injection sits? patient described the rash as itchy, but denies any other symptoms? denies any SOB or itchy throat? O2 sat is 100% with clear lung sounds

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: None
Vorgeschichte: Obesity
Andere Medikamente: Cetirizine, levocetirizine, flonase
Allergien: No known allergies
Vorherige Impfungen: -

VAERS 2356746

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6952AB

gering

Staat: MA
Alter: 46,0
Geschlecht: F
Eingang: 03.07.2022
Impfdatum: 16.06.2022
Beginn: 16.06.2022
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 No adverse event

Symptomtext

administered expired menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center. This case involves a 46 years old female patient who was administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Jun-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine(unknown formulation, strength (batch lot number: U6952AB expiry date :09-Jun-2022) via unknown route in unknown administration site for immunization. On 16-Jun-2022 (latency :same day)the patient developed a non-serious event of administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine. 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 1531178

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6952AB

gering

Staat: KS
Alter: 11,0
Geschlecht: M
Eingang: 06.08.2021
Impfdatum: 29.07.2021
Beginn: 29.07.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / LA

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

Device deployment issue No adverse event Underdose

Symptomtext

patient received Menactra 0.4 mL (instead of 0.5 mL) with no reported adverse event; when patient retracted the syringe 0.1mL came back into the syringe with no reported adverse event; Initial information was received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a physician via Agency under reference number-0702910). This case involves a 11 year-old male patient who was vaccinated with 0.4 mL dose (instead of 0.5 mL) of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] due to while retracting the syringe 0.1 mL came back into the syringe (underdose) (Device deployment issue). The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On 29-Jul-2021, the patient received 0.4 mL first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AB and expiry date 06-Sep-2022) via an intramuscular route at the left deltoid for prophylactic vaccination. It was reported that "The caller would like to know if the injection was valid. Caller asking if the MENACTRA dose would need to be re-administered since the patient will be receiving a booster as well. Caller states that the provider thinks that the patient will be fine since it was such a small volume that the patient did not receive". It was a case of an actual medication error due to vaccine underdose (latency was on same day). It was also a case of device retraction issue. At the time of report, no adverse event reported. Outcome of event 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 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: Device deployment issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -