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Reporte zur Charge UJ585AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
TX 2 MO 2 NC 1

VAERS 2021599

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj585aa

schwer
Staat
TX
Alter
5,0
Geschlecht
F
Eingang
10.01.2022
Impfdatum
06.01.2022
Beginn
06.01.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: ja Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Anaphylactic reaction Breath sounds abnormal Cough Dyspnoea

Symptomtext

anaphylaxis within 10 minutes of immunizations administered - acute onset of cough without ability to catch breath, diminished lung sounds with bilateral breathing, epinephrine 0.2 mg IM administered with improvement but not resolution in lung sounds. Sent immediately to ED where patient received dose of albuterol nebulized.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Anaphylactic reaction
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
underimmunization status
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2088190

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AA

gering
Staat
NC
Alter
1,0
Geschlecht
F
Eingang
04.02.2022
Impfdatum
11.01.2022
Beginn
19.01.2022
Tage bis Beginn
8,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product preparation issue

Symptomtext

ActHib, Lot # UJ585AA was administered on 01/11/22. A vaccine inventory was completed on 01/19/22 where it was noted that the remaining ActHib carton contained an additional diluent. Upon review of vaccine inventory and discussion with other vaccinators in clinic, it was found that a Merck vial of Sterile water was used to dilute the ActHib vaccine prior to administration for this patient. The Immunization Registry was contacted and, per RN, I was informed that the ActHib vaccine would be considered an "Inadequate Dosing" and would need to be repeated as soon as possible. Further information from Nurse relayed was that this "would have no anticipated adverse effects" to patient, with only a "slight increase of normal vaccine administration side effects upon repeat administration." Mother was notified via phone by Dr. and questions were asked and answered. Mother stated no adverse reactions noted at time of call.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
Avoids Peanut and Egg
Vorherige Impfungen
-

VAERS 1964312

UNKNOWN MANUFACTURER · HIB (NO BRAND NAME) · Charge UJ585AA

gering
Staat
MO
Alter
0,1
Geschlecht
F
Eingang
20.12.2021
Impfdatum
20.10.2021
Beginn
20.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Crying High-pitched crying

Symptomtext

4 hours after vaccine of 2mo visit patient developed high pitch cry > 3 hrs. Both parents detected unusual cry inconsolable seen in ER due to that. By the time seen in ER patient was acting normal.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Crying
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
No
Vorgeschichte
GERD and milk allergy
Andere Medikamente
None at the time of vaccine
Allergien
-
Vorherige Impfungen
-

VAERS 1890297

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AA

gering
Staat
TX
Alter
4,0
Geschlecht
M
Eingang
22.11.2021
Impfdatum
22.11.2021
Beginn
22.11.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered

Symptomtext

Pt brought by father was brought in this morning to catch up on vaccines due to parents delaying immunizations. Patient came in to receive DTAP, MMRV, and HIB I prepared vaccines and noticed after vaccines where given, when inputting in system I made a mistake. I informed my office manager, Father and Dr. as well. I contacted Human and resource to inform and to get advice on what next step I needed to follow. Dr. spoke with parent as well. I monitored patient and there was no reaction to the extra DTap vaccine given. Patient left with parent and I also contacted Mother to inform of the mistake.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1744252

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AA

gering
Staat
MO
Alter
0,5
Geschlecht
M
Eingang
29.09.2021
Impfdatum
14.09.2021
Beginn
14.09.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

Vaccine was reconstituted with sterile water with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00778472) and transmitted to Sanofi on 21-Sep-2021. This case involves a six-month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] vaccine was reconstituted with sterile water (product preparation error). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) for Immunisation, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. On 14-Sep-2021, the patient received a third dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection, Powder: lot: UJ585AA expiry date: 22-Oct-2022, Diluent: lot: U7146AB expiry date: 16-Oct-2022) via an unknown route in the right thigh (VASTUS) for prophylactic vaccination. It was an actual medication error due to product preparation error (latency: same day). It was reported "ACT-HIB being administered to a patient. Vaccine was reconstituted with sterile water and would like to know if this dose would count as valid? Would also like to know how to proceed if not counted as a valid dose?" At 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PENTACEL; PREVNAR 13; ROTATEQ
Allergien
-
Vorherige Impfungen
-