VAERS Reports UJ636AAA

VAERS 2567564

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ636AAA

mild

Staat: OH
Alter: 1,2
Geschlecht: F
Eingang: 25.01.2023
Impfdatum: 17.01.2023
Beginn: 18.01.2023
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: IM / LG

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

Acne Blister Rash Varicella

Symptomtext

Childs parents stated it started the day after vaccination 1/18/23 with a rash to L inner thigh and spread outward. Childs developed small pimple like blisters with the rash. Parents stated child was taken to local ER on 1/19/23 where physician diagnosed child with chicken pox and provided treatment. Parents did state that they told the physician that the child recently received vaccines.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: none known
Aktuelle Erkrankungen: none known.
Vorgeschichte: none known.
Andere Medikamente: none known.
Allergien: non known.
Vorherige Impfungen: -

VAERS 2548895

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ636AAA

gering

Staat: MN
Alter: 0,8
Geschlecht: F
Eingang: 03.01.2023
Impfdatum: 30.12.2022
Beginn: 30.12.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / RL

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

No adverse event

Symptomtext

Child did not experience adverse effects; parents were reached to check on child's health status. No adverse events on the date of vaccine administration or up to 4 days later.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: Child had a cold 2 weeks prior
Vorgeschichte: None
Andere Medikamente: -
Allergien: None
Vorherige Impfungen: -

VAERS 1980868

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ636AAA

gering

Staat: PA
Alter: 0,2
Geschlecht: M
Eingang: 25.12.2021
Impfdatum: 14.12.2021
Beginn: 14.12.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

No adverse event Product preparation error

Symptomtext

product was reconstituted with 0.7ml of sterile water and administered/no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional and physician via call center via Agency (Reference number- 00898208). This case is linked to case US-SA-2021SA420893(CLUSTER). This case involves a 2-month-old male patient who received HIB (PRP/T) VACCINE [ActHIB] which was reconstituted with 0.7 ml of sterile water (product preparation error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination. On 14-Dec-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot number: UJ636AAA and expiry date: 26-Feb-2023) via an unknown route in the left thigh for prophylactic vaccination. It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day). It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose?" At the time of reporting, no adverse event was reported. 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 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1970880

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ636AAA

gering

Staat: PA
Alter: 1,0
Geschlecht: M
Eingang: 22.12.2021
Impfdatum: 14.12.2021
Beginn: 14.12.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

Product preparation issue

Symptomtext

ACTHIB product was reconstituted with 0.7ml of sterile water and administered with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and physician via Agency (Reference number - 00898182) and transmitted to Sanofi on 14-Dec-2021. This case is linked to case 2021SA421272 (same reporter). This case involves 1 year old male patient administered HIB (PRP/T) VACCINE [ACT-HIB] product was reconstituted with 0.7ml of sterile water (product preparation error). Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 14-Dec-2021, the patient received fourth 0.5ml total dose of suspect HIB (PRP/T) VACCINE (lot: UJ636AAA and expiry date: 26-Feb-2023) (Frequency = once) (Strength = standard) (Dosage form : Single dose Vials) via unknown route in the left thigh for prophylactic vaccination and product was reconstituted with 0.7ml of sterile water (product preparation error). It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose? No further information provided by the reporter". This case was an actual medication error due to wrong solution used in drug reconstitution (latency: same day). At the time of reporting, no 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: Product preparation issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -