VAERS Reports U7908AB

VAERS 2727023

SANOFI PASTEUR · DTAP + IPV (QUADRACEL) · Charge U7908AB

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Staat: FL
Alter: 3,0
Geschlecht: F
Eingang: 22.12.2023
Impfdatum: 13.12.2023
Beginn: 13.12.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

No adverse event Product administered to patient of inappropriate age

Symptomtext

Quadracel was given to a 3 and 1/2 year old patient with no reported adverse event; Initial information received on 15-Dec-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 42 months old female patient where diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] was given to a 3 and 1/2 year old patient 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 for Prophylactic vaccination. On 13-Dec-2023, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection lot U7908AB via intramuscular route in the left deltoid (strength and expiration date: not provided) for Immunisation (product administered to patient of inappropriate age) (latency- same day). 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. 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: HEPATITIS A
Allergien: -
Vorherige Impfungen: -

VAERS 2714787

SANOFI PASTEUR · DTAP + IPV (QUADRACEL) · Charge U7908AB

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Staat: MA
Alter: -
Geschlecht: F
Eingang: 17.11.2023
Impfdatum: 29.08.2023
Beginn: 29.08.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RA

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

No adverse event Product storage error

Symptomtext

vaccines administered after temperature excursion that occurred on 8/1/2023. Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023. Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported. This is a non-valid case due to lack of patient's identifiers. Follow-up information was received from the registered nurse regarding the 4-year-old female patient. The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient's current conditions included functional heart murmur. She had no known drug allergies (NKDA). Concomitant therapies included cetirizine. On 29-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the left upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the right deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion. Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes. She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023. The patient received immunization impacted by excursion prior to notification. There were no known adverse events. This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid. This is one of three cases from the same reporter (2309USA002333 and 2311USA005370).

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Cardiac murmur functional; Prophylaxis; Seasonal allergic rhinitis
Vorgeschichte: -
Andere Medikamente: CETIRIZINE
Allergien: -
Vorherige Impfungen: -

VAERS 2714612

SANOFI PASTEUR · DTAP + IPV (QUADRACEL) · Charge U7908AB

gering

Staat: MA
Alter: -
Geschlecht: F
Eingang: 16.11.2023
Impfdatum: 15.08.2023
Beginn: 15.08.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Device temperature issue No adverse event Product storage error

Symptomtext

vaccines administered after temperature excursion that occurred on 8/1/2023. Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023. Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported. This is a non-valid case due to lack of patient's identifiers. Follow-up information was received from the registered nurse regarding the 10-week-old female patient. The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient had no known drug allergies (NKDA). Concomitant therapies were not provided. On 15-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the right upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the left deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion. Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes. She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023. The patient received immunization impacted by excursion prior to notification. There were no known adverse events. This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid. This is one of three cases from the same reporter (2309USA002333 and 2311USA005371).

Weitere VAERSDATA-Felder

Praegender Schweregrund: Device temperature issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -