VAERS Reports UJ756AAA

VAERS 2610941

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

mild

Staat: CA
Alter: 1,5
Geschlecht: M
Eingang: 06.04.2023
Impfdatum: 03.04.2023
Beginn: 03.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

Pyrexia Urticaria

Symptomtext

Next day woke up with hives on leg and had fever for 101.5 that day Yesterday woke up fine and today he woke up with some hives dispersed all over the body Mom gave zyrtec and rash went away both times Nothing new that mom can think of other than the vaccines

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: NA
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: Tylenol
Allergien: no known allergies
Vorherige Impfungen: -

VAERS 2677502

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: NJ
Alter: 1,7
Geschlecht: F
Eingang: 29.08.2023
Impfdatum: 02.05.2023
Beginn: 02.05.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Expired product administered No adverse event

Symptomtext

Vaccine was administered after the BUD. Parent has not reported any adverse reactions

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: nome
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2676625

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: FL
Alter: 1,5
Geschlecht: F
Eingang: 25.08.2023
Impfdatum: 15.08.2023
Beginn: -
Tage bis Beginn: -
Dosis: 2
Route/Site: IM / RL

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

Expired product administered No adverse event

Symptomtext

HiB vaccine administered on 08/15/2023 was expired on 08/12/2023. I explained to her that that vaccine dose cannot be counted so revaccination at any time is indicated. Mother confirmed child is doing well, no fever and no adverse effects from vaccine reported. Mother agreed to go to office on Monday 8/28/2023 at 11 am to revaccinate child.

Weitere VAERSDATA-Felder

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

VAERS 2656648

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: MI
Alter: 1,0
Geschlecht: F
Eingang: 14.07.2023
Impfdatum: 06.07.2023
Beginn: 06.07.2023
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 preparation error

Symptomtext

administration of ACTHIB that was reconstituted with a normal sterile diluent, not the ACTHIB diluent with no reported adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 1 years old female patient who was administrated HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with a normal sterile diluent, not the acthib 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 measles vaccine, mumps vaccine, rubella vaccine (MMR); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) [PCV-13] for Prophylactic vaccination. On 06-Jul-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Batch number: UJ756AAA; Expiry date: 12-Aug-2023) via intramuscular route in the left thigh for Immunization, reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event administration of acthib that was reconstituted with a normal sterile diluent, not the acthib diluent with no reported adverse 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2624374

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 01.05.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

cold chain break is reported with no reported adverse event; poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves an infant patient of unknown gender and it was reported cold chain break is reported for HIB (PRP/T) vaccine [ACT-HIB] and poor quality vaccine administered with no reported adverse event. It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, cold chain break is reported for HIB (PRP/T) vaccine with no reported adverse event (product storage error) (unknown latency). On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (batch/lot number: UJ756AAA, expiry date: 12-08-2023; strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization) (poor quality product administered) (latency: same day). It was reported that Act-HIB for which cold chain break is reported and excursion vaccine was administered to 30 children were within 2, 4, and 6 months of age. The order contained ActHib (10 boxes or 50 doses) and MenQuadfi (5 boxes or 25 doses). The order was delivered to the facility on 30Mar2023. The facility received email notification on 14Apr2023 at 14:30 that the products should not be used because they were delivered beyond the acceptable shipping time. It was stated that a big frustration is that Sanofi no longer has a cold chain tracker in the boxes. From the information I received, you have a term 'anticipated transaction date' which was 29Mar2023. That term means nothing to the clinical staff as far a cold chain failure. We had no idea this was a broken cold chain until two weeks after the shipment arrived. Because of that, 30 kids received the ActHib and 3 patients received MenQuadfi from this shipment. It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available. 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2624370

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 01.05.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error No adverse event Product storage error

Symptomtext

products were not good and needed to be returned with no reported adverse event; excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant and unknown gender patient who involved in the products haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] were not good and needed to be returned and excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of total (1X) suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA , Expiry date: 12-Aug-2023) (strength: Unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) and was administered were within 2, 4, and 6 months of age with no adverse event (poor quality product administered) (latency: same day). No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event excursion vaccine was administered were within 2, 4, and 6 months of age with no adverse event and was Unknown for the event products were not good and needed to be returned with no reported adverse 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: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2624368

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 01.05.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

No adverse event Poor quality product administered Product storage error

Symptomtext

Poor quality vaccine administered with no reported adverse event; Products were not good and needed to be returned with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2023SA129826. This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization). On an unknown date the patient developed a non-serious products were not good and needed to be returned with no reported (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. No lab data reported. Action taken: not applicable. Outcome: Unknown for both the event products. 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 2624364

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 01.05.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

products were not good and needed to be returned with no reported adverse event; poor quality vaccine administered/excursion vaccine was administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization). On an unknown date the patient developed a non-serious events of "products were not good and needed to be returned with no reported adverse event (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. No lab data reported. Action taken: not applicable. Outcome: Unknown for both the event products. 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2624363

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 01.05.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

No adverse event Poor quality product administered

Symptomtext

Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2023SA129826. This case involves Infant and unknown gender patient who had poor quality vaccine administered with no reported adverse event after receiving vaccine hib (prp/t) vaccine [act-hib]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (unknown strength), lot UJ756AAA, expiration date- 12-aug-2023 via unknown route in unknown administration site for Immunization. On an unknown date the patient developed a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered) (unknown latency). It was unknown if there were lab data/results available. Action taken was not applicable. Outcome: Unknown for the event poor quality vaccine administered with no reported adverse 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.; Sender's Comments: US-SA-2023SA124713:

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2622857

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 28.04.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

Products were not good and needed to be returned with no reported; Poor quality vaccine administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2023SA129826. This case involves Infant and unknown gender patient who involved in the products HIB (PRP/T) VACCINE [ACT-HIB] were not good and needed to be returned and poor quality vaccine administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect products HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ756AAA, expiry date: 12-Aug-2023, strength, route administrative site: Unknown) for prophylactic vaccination (immunization). On an unknown date the patient developed a non-serious products were not good and needed to be returned with no reported (product storage error) and poor quality vaccine administered with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. No lab data reported. Action taken: not applicable. Outcome: Unknown for both the event products. 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: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2619370

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: PA
Alter: -
Geschlecht: U
Eingang: 22.04.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

No adverse event Poor quality product administered Product storage error

Symptomtext

Poor quality vaccine administered with no reported adverse event; products were not good and needed to be returned with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves 30 patients received poor quality vaccine ACT-HIB post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received suspect hib (prp/t) vaccine Powder and solvent for solution for injection lot UJ756AAA , Expiry date: 12-Aug-2023) (strength, dose: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the patient had a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered), products were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) following the administration of hib (prp/t) vaccine. Action taken was not applicable. It was reported Nurse manager reports that 30 doses of ACTHIB and 3 doses of MENQUADFI were administered to patients post-excursion; she asks if they need to re-vaccinate their patients? At time of reporting, the outcome was Unknown for both events. 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 2589302

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ756AAA

gering

Staat: GA
Alter: 1,3
Geschlecht: F
Eingang: 01.03.2023
Impfdatum: 28.02.2023
Beginn: 28.02.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

Product storage error

Symptomtext

Pt was given a non viable vaccine that was in an excursion the night prior. The excursion was not caught before this pt got vaccine. The patients parent was called and rescheduled to come back in the office to repeat vaccine.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -