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Reporte zur Charge UJ526AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 1 OK 1 AR 1 NY 1 PA 1 OR 1

VAERS 1655714

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

schwer
Staat
TX
Alter
1,0
Geschlecht
F
Eingang
30.08.2021
Impfdatum
27.08.2021
Beginn
27.08.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Febrile convulsion

Symptomtext

FEVER AND SEIZURE ON THE DAY OF THE VACCINE. SEEN AT LOCAL ER AND DIAGNOSED WITH FEBRILE SEIZURE. NO FURTHER EVENTS OR SEIZURES SINCE THE INITIAL

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
MOM GAVE TYLENOL PRIOR TO THE VACCINE VISIT. PATIENT WAS NOT RUNNING FEVER BEFORE THE TYLENOL DOSE OR AT THE TIME OF THE VISIT.
Allergien
NONE
Vorherige Impfungen
-

VAERS 1801684

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

mild
Staat
OK
Alter
1,3
Geschlecht
M
Eingang
20.10.2021
Impfdatum
07.10.2021
Beginn
07.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Agitation Decreased appetite Diarrhoea Fatigue Gait disturbance Injection site swelling Pyrexia Rhinorrhoea Somnolence Wrong product administered

Symptomtext

PATIENT WAS BROUGHT IN ON 10/7/21 FOR 1 YEAR VACCINATIONS. I ASSISTED THE ADMINISTERING NURSE TO PULL VACCINES AS HE WAS UNFAMILIAR WITH OUR PROTOCOL. I PULLED THE COMBINATION (PENTACEL) AND IN ERROR PULLED AN EXTRA HIB VACCINE INSTEAD OF HEPB. I DID NOT NOTICE THE ERROR WHEN DOUBLE CHECKING THE VACCINES AGAINST THE RECOMMENDATIONS LIST. THE NURSE THEN DREW UP THE VACCINES AND ADMINISTERED TO THE PATIENT. HE DID NOT HAVE ACCESS SO I ENTERED THEM INTO THE SYSTEM ON 10/8/21 AND IT WAS AT THIS TIME THAT I NOTICED THE ERROR. I CONTACTED THE MOTHER AND LEFT A VOICEMAIL, I ALSO HELD THE INFORMATION TO THE ATTENDING PHYSICIAN, AS IT WAS LATER IN THE DAY FRIDAY. DR. WAS ABLE TO REACH THE PATIENTS MOTHER AFTER HOURS AND HIS DOCUMENTATION IS AS FOLLOWS: "I spoke with the patient's mother this evening and she stated since last night patient has had increased fussiness, fevers with Tmax of 103 F last night, treating with alternating Tylenol and Motrin, Temperature when on the phone today is 98.1; last dose of Advil/Tylenol given 1 hour ago; only drinking water and juice today, not eating at all today. Patient is having increased runny nose, loose stools, more fatigued and very fussy, sleeping more during the day. Mother reports patient's leg is very swollen from injections, pt. walking "funny" per mother but no headaches/seizures/convulsions or NV reported." ON 10/11/21 THE MOTHER CALLED TO MAKE NOTE OF ISSUES/MISTREATMENT WHEN AT THE ER OVER THE WEEKEND. I ATTEMPTED TO CONTACT THE MOTHER TO FOLLOWUP AND AGAIN RECEIVED A VOICEMAIL, ONE OF OUR CLINIC SUPERVISORS WAS ABLE TO MAKE CONTACT AND TAKE NOTE OF HER COMPLAINT. FOLLOWUP APPOINTMENT SCHEDULED FOR 10/12/21 WAS NOT KEPT AND, TO MY KNOWLEDGE, AT THIS TIME THERE HAS BEEN NO FURTHER CONTACT WITH THE MOTHER OF THE PAITENT.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
9/14/21- PATIENT BROUGHT IN TO CLINIC FOR FEVER, COUGH AND DIARRHEA. TEST NEGATIVE FOR FLU/RSV/STREP/COVID. PROVIDER DOCUMENTED OTITIS MEDIA, BILATERAL. NOTHING REPORTS AT TIME OF VACCINE
Vorgeschichte
ECZEMA
Andere Medikamente
NONE
Allergien
NKA
Vorherige Impfungen
-

VAERS 2240983

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

gering
Staat
AR
Alter
1,0
Geschlecht
F
Eingang
19.04.2022
Impfdatum
13.04.2022
Beginn
12.04.2022
Tage bis Beginn
-
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect dose administered

Symptomtext

Client was given Adult Hep A, but should have been given Pediatric Hep A.

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

VAERS 1653314

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

gering
Staat
NY
Alter
4,0
Geschlecht
F
Eingang
29.08.2021
Impfdatum
30.07.2021
Beginn
30.07.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

reconstituted ACTHIB with sterile water/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Global Medical Information (GMI) (Reference number- 00708161). This case involves a 4-year-old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water (product preparation error). The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) for prophylactic vaccination. On 30-Jul-2021, the patient received a fourth dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (lot number: UJ526AAA and expiry date: 30-Jun-2022) via unknown route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day). It was reported that, "Caller reports that a nurse administered ACTHIB to a patient without reconstituting with proper ACTHIB diluent." 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
VARICELLA VACCINE; MMR; QUADRACEL
Allergien
-
Vorherige Impfungen
-

VAERS 1924413

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

gering
Staat
PA
Alter
0,1
Geschlecht
F
Eingang
06.08.2021
Impfdatum
06.08.2021
Beginn
06.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

NO ADVERSE EVENT- VACCINE WAS GIVEN IN ERROR TO THIS CHILD

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
RUNNY NOSE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 1502946

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ526AAA

gering
Staat
OR
Alter
0,2
Geschlecht
M
Eingang
26.07.2021
Impfdatum
26.07.2021
Beginn
26.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

patient was given double dose of Hep -B vaccine. Patient's Mother has been notified. Patient's Mother was told by this MA to watch for fever, swelling, redness, heat, irritability. If anything abnormal happens, contact this clinic, or go to the ED.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-