VAERS Reports UJ803AA

VAERS 2640492

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj803aa

mild

Staat: DC
Alter: 4,0
Geschlecht: M
Eingang: 06.06.2023
Impfdatum: 31.05.2023
Beginn: 31.05.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RA

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

Anger Blood glucose normal Blood pressure decreased Chills Echocardiogram normal Consciousness fluctuating Electrocardiogram normal Erythema Feeling of body temperature change Flushing Headache Feeling cold Feeling hot Hyporesponsive to stimuli Hypotonia Injection site erythema Injection site pruritus Miosis

Symptomtext

About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Chills
Hospital-Tage: -
Labordaten: EKG, heart ultrasound. Questionable finding of hypertrophy but ruled out
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2715396

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: VA
Alter: 69,0
Geschlecht: F
Eingang: 18.11.2023
Impfdatum: 06.11.2023
Beginn: 06.11.2023
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 Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 69 years old female patient who was administered expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Nov-2023, the patient of 69 years old was administered 0.5 mL dose of expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event (expired product administered) and (product administered to patient of inappropriate age) (Powder and solvent for solution for injection) (Frequency = once) (Strength = Standard) (latency: same day) (lot UJ803AA and expiry date: 13-Aug-2023) via intramuscular route in unknown administration site for pre-operative immunization (Immunization). 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 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 2689994

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: -
Alter: 1,3
Geschlecht: M
Eingang: 03.10.2023
Impfdatum: 03.10.2023
Beginn: 03.10.2023
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

Symptomtext

Expired vaccine given. no s/s noted at this time with patient.

Weitere VAERSDATA-Felder

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

VAERS 2680737

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: VA
Alter: 1,2
Geschlecht: F
Eingang: 11.09.2023
Impfdatum: 05.09.2023
Beginn: 05.09.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Expired product administered Product preparation error

Symptomtext

ACTHIB was reconstituted with an incorrect diluent (with no reported adverse event); product had expired on 13AUG2023 (with no reported adverse event); Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse). This case involves a 14-month-old female patient for whom administered expired HIB (PRP/T) vaccine [ACT-HIB] which was reconstituted with an incorrect 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination. On 05-Sep-2023, the patient received an expired dose of 0.5 ml 1x (frequency: once) suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength (lot: UJ803AA, Expiry date: 13-Aug-2023) via intramuscular route in the left thigh for Immunization which was reconstituted with an incorrect diluent with no reported adverse event (expired product administered) (product preparation error) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for both the 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 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: DTAP; VARICELLA VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2675985

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: MD
Alter: 1,3
Geschlecht: M
Eingang: 24.08.2023
Impfdatum: 17.08.2023
Beginn: 17.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

Expired product administered Medication error No adverse event

Symptomtext

a consumer got an expired dose of ACTHIB with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse). This case involves a 15 months old male patient who got an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Aug-2023, the patient received an expired dose of 0.5 ml dose 4 of suspect of standard strength HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (lot: UJ803AA, Expiry date: 13-Aug-2023) via intramuscular route in the right vastus lateralis for Immunisation with no reported adverse event (expired product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome 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 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 2675981

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: MD
Alter: 1,0
Geschlecht: F
Eingang: 24.08.2023
Impfdatum: 14.08.2023
Beginn: 14.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

nurse reports that they administered an expired ACT-HIB today with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] today 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, tetanus vaccine toxoid (DTAP) for prophylactic vaccination (Immunisation). On 14-Aug-2023, the patient received a dose of 0.5 ml (dose 4) once total of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (strength: standard) (lot: UJ803AA; expiry adte : unknown) via intramuscular route in left leg for Immunisation. On 14-Aug-2023 the patient was administered an expired act-hib today with no reported adverse event (expired product administered) (latency: same day). It was reported, "Nurse declined to provide email. Nurse asks for information regarding the expired dose; asks if there are any recommendations about how to document the expired dose on the patient's vaccine record." Action taken was 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: DTAP
Allergien: -
Vorherige Impfungen: -

VAERS 2675268

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: CA
Alter: 1,6
Geschlecht: U
Eingang: 22.08.2023
Impfdatum: 15.08.2023
Beginn: 15.08.2023
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 Medication error No adverse event

Symptomtext

expired ACT-HIB was administered to a patient 2 days past the expiration date, with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 19-month-old and unknown gender patient, expired HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient 2 days past the expiration date, 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 pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination. On 15-Aug-2023, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ803AA) via intramuscular route in unknown administration site for Immunization and expired act-hib was administered to a patient 2 days past the expiration date, with no reported adverse event (expired product administered) (latency: same day). It was unknown if nay lab data/test results available. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) 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 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 2675111

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: NJ
Alter: 1,0
Geschlecht: M
Eingang: 22.08.2023
Impfdatum: 15.08.2023
Beginn: 15.08.2023
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

No adverse event occurred. The HIB vaccine was administered 2 days after the expiration date.

Weitere VAERSDATA-Felder

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

VAERS 2674469

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 21.08.2023
Impfdatum: 16.08.2023
Beginn: 16.08.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Expired product administered Medication error No adverse event

Symptomtext

giving an expired dose of ACT-HIB with no advese event; Initial information was received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 34 years old patient of unknown gender who received an expired dose of hib (prp/t) vaccine [Act-hib] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included polio vaccine (Polio) for Prophylactic vaccination; hpv vaccine vlp rl1 4v (yeast) (Gardasil) for Prophylactic vaccination (immunisation); and pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination (Immunisation). On 16-Aug-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at dose of 0.5 ml (strength: standard) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in the left deltoid for Immunization (immunisation) with no adverse event (expired product administered) (latency: same day). No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event giving an expired dose of act-hib. 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: POLIO; GARDASIL; PREVNAR
Allergien: -
Vorherige Impfungen: -

VAERS 2674460

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: PA
Alter: 1,3
Geschlecht: F
Eingang: 21.08.2023
Impfdatum: 14.08.2023
Beginn: 14.08.2023
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 Medication error No adverse event

Symptomtext

expired dose of ActHIB was inadvertently administered to a patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event; Initial information was received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered to 1 years old female patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination. On 14-Aug-2023, the patient received an expired dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (strength: standard, dose: Unknown) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in unknown administration site for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day). No lab data reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired dose of acthib was inadvertently administered to a patient, administered on 14-aug-2023 but expired on 13-aug-2023 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.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2673626

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: CA
Alter: 1,3
Geschlecht: M
Eingang: 18.08.2023
Impfdatum: 14.08.2023
Beginn: 14.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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 acthib with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient who received an expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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, tetanus vaccine toxoid (DTAP); and pneumococcal vaccine (Pneumococcal 15) for Prophylactic vaccination. On 14-Aug-2023, the patient received 0.5 mL dose 4 of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event patient received an expired dose of acthib 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.

Weitere VAERSDATA-Felder

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

VAERS 2673482

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: CO
Alter: 1,3
Geschlecht: F
Eingang: 18.08.2023
Impfdatum: 17.08.2023
Beginn: 17.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Expired product administered

Symptomtext

Patient was given an expired dose of ACTHIB on 08/17/23 the expired date was on 08/13/2023, We have a call out to the patients mother to get a new valid dose given .

Weitere VAERSDATA-Felder

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

VAERS 2667129

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: MD
Alter: 1,5
Geschlecht: F
Eingang: 07.08.2023
Impfdatum: 01.08.2023
Beginn: 01.08.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

Medication error No adverse event Product preparation error

Symptomtext

nurses has administered ACTHIB that has been reconstituted with sterile water instead of the saline diluent, with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 1 year old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that has been reconstituted with sterile water instead of the saline 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization). On 01-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the right thigh for Immunization that had been reconstituted with sterile water instead of the saline diluent, with no reported adverse event (product preparation error) (same day latency) following the administration of HIB (PRP/T) vaccine. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event nurses has administered acthib that has been reconstituted with sterile water instead of the saline 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 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: PREVNAR
Allergien: -
Vorherige Impfungen: -

VAERS 2639066

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ803AA

gering

Staat: NJ
Alter: 1,5
Geschlecht: M
Eingang: 31.05.2023
Impfdatum: 23.05.2023
Beginn: 23.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LL

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

Product preparation issue

Symptomtext

The CMA did not use the correct diluent to mix the vaccine

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product preparation issue
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: N/A
Allergien: N/A
Vorherige Impfungen: -