VAERS Reports UJ316AA

VAERS 1115363

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ316AA

moderat

Staat: NJ
Alter: 0,3
Geschlecht: F
Eingang: 19.03.2021
Impfdatum: 28.01.2021
Beginn: 28.01.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / RL

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

Breath sounds abnormal Dyspnoea

Symptomtext

had difficulty breathing; making choking sounds; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case from other health professional (Medical Assistant (MA)) via Media Information (MI- under reference- 00495848). This case involves a 3 months old female patient who experienced had difficulty breathing (dyspnea) and was making choking sounds (breath sounds abnormal), after receiving HIB (PRP/T) VACCINE [ACT-HIB]. 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) via unknown route in the left thigh on 28-Jan-2021. On 28-Jan-2021, the patient received 0.5 ml first dose of suspect HIB (PRP/T) VACCINE (solution for injection, lot UJ316AA and expiration date: 08-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination. On 28-Jan-2021, the patient developed a non-serious had difficulty breathing (dyspnoea) and was making choking sounds (breath sounds abnormal), 1 day following the administration of HIB (PRP/T) VACCINE. Also reported that the patient and her father came in yesterday, that is on 25-Feb-2021, and reported this events. The parents never called the office or went to the emergency department. It lasted a few hours. MA (medical assistant) states they were not going to give ACTHIB or prevnar 13 to the patient. Also to be noted, inadvertently submitted a PTC (product technical complaint) and to be considered this case AE (adverse event) only. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the reported events. The caller stated the doctor was away for a month so if additional information needed, safety can email her and she will forward it to the doctor covering for him.

Weitere VAERSDATA-Felder

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

VAERS 1501924

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj316aa

gering

Staat: NY
Alter: 1,3
Geschlecht: F
Eingang: 26.07.2021
Impfdatum: 21.07.2021
Beginn: 21.07.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Expired product administered No adverse event

Symptomtext

ActHib administered on 7/21/21 expired on 6/8/21. No adverse effects noted from the patient as of this time.

Weitere VAERSDATA-Felder

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

VAERS 1416559

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ316AA

gering

Staat: -
Alter: 0,3
Geschlecht: M
Eingang: 22.06.2021
Impfdatum: 14.06.2021
Beginn: 14.06.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Expired product administered Medication error

Symptomtext

expired dose of ActHib was administered with no adverse event; Initial and additional information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from other health professional via physician via Regulatory authority (Reference number- 00639997 and 00640595). This case involves a 4 months old male patient who administered 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ316AA and expiry date: 08-Jun-2021) via intramuscular route in right thigh for prophylactic vaccination on 14-Jun-2021 for prophylactic vaccination (expired product administered). Relevant medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was an actual medication error case due to expired vaccine used (latency was same day). It was reported that nurse administered Acthib to a patient and noticed that the dilute and vaccine has two completely different expiration dates. The powder/vaccine portion expired 6 days ago on June 8 2021 and the dilute expires Jan 2022. A caller calling back in to get an answer to how to proceed after an expired dose of ActHib was administered. The caller reported that it was unknown to the clinic that the two components of the ActHib have different expiration dates. The clinic would have administered Pentacel but the family wanted individual vaccines; that the clinic does not usually administer ActHib alone; and that the family were very cautious of vaccines for their children. Diluent: LOT: U6849AB and expiry date:22-Jan-2022 Hib Portion: LOT: UJ316AA and expiry date: 08-Jun-2021. At the time of reporting, no adverse event 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)
Allergien: -
Vorherige Impfungen: -