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Reporte zur Charge UJ835AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
GA 2 NY 1 IA 1 OH 1

VAERS 2590318

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ835AA

mild
Staat
NY
Alter
37,0
Geschlecht
F
Eingang
02.03.2023
Impfdatum
01.03.2023
Beginn
02.03.2023
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Arthralgia Injection site pain

Symptomtext

On 03/01/2023 - Hib vaccine given first in right deltoid, then Hep. A given in left deltoid. After Hep. A was given, patient reported to writer/vaccinator that she "felt that one." Writer/vaccinator stated to patient that the Hep. A vaccine is 1.0ml, compared to the Hib vaccine which is 0.5ml, which may be attributing to the immediate sensation felt. Patient stated she was feeling well and was escorted to the waiting room by writer/vaccinator. On 03/02/2023 - Patient called agency and reported that she is having pain in her left shoulder and is having trouble moving her left arm out to the side. Patient stated she was in contact with her primary care doctor, who will be prescribing a steroid for her. It was explained to patient that a report will be sent in regarding these side effects, and agency will be following up with her - Patient stated understanding.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
History of splenectomy - unknown date.
Andere Medikamente
Amoxicillin, Propranolol & Wellbutrin - Per patient.
Allergien
Body soap & Reglan - Per patient.
Vorherige Impfungen
-

VAERS 2690932

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ835AA

gering
Staat
IA
Alter
1,0
Geschlecht
M
Eingang
04.10.2023
Impfdatum
30.08.2023
Beginn
30.08.2023
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

ACT-HIB was reconstituted with a different diluent than what it is supplied with with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 years old male patient for whom act-hib was reconstituted with a different diluent than what it is supplied 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 3-component, tetanus vaccine toxoid (Infanrix), Hepatitis A Vaccine Inact (Havrix), pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination. On 30-Aug-2023, the patient received suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ835AA via intramuscular route in the left thigh for prophylactic vaccination (strength, dose, expiry date: unknown), was reconstituted with a different diluent than what it is supplied with with no reported adverse event (product preparation error) (latency same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event product preparation error. 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
INFANRIX; HAVRIX; PREVNAR 13; MMR; VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]
Allergien
-
Vorherige Impfungen
-

VAERS 2682993

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ835AA

gering
Staat
GA
Alter
0,2
Geschlecht
M
Eingang
18.09.2023
Impfdatum
05.09.2023
Beginn
05.09.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product storage error

Symptomtext

ActHib vaccine was involved in a temperature excursion and was advised to be pulled from stock and to not be given. One of the nurses was not aware of the instructions given and administered the vaccine before being notified . Patient did not have any adverse effects/reactions. Sanofei, the vaccine company was contacted and told what happened, the case worker from the vaccine company stated patient would just need to be re-vaccinated. Patient has an appointment to do so.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
Vitamin D Infant 10 MCG/ ML Liquid 1mL, orally, once a day Saline Nasal Spray 0.65 % solution
Allergien
KNDA
Vorherige Impfungen
-

VAERS 2680749

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ835AA

gering
Staat
GA
Alter
0,2
Geschlecht
U
Eingang
11.09.2023
Impfdatum
05.09.2023
Beginn
05.09.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Poor quality product administered

Symptomtext

ACTHIB was included in an excursion and was not viable anymore but it was administered to a patient before it was pulled out (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. This case involves acthib that was included in an excursion and was not viable anymore but it was administered to a 2 months old and unknown gender patient before it was pulled out (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, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and rotavirus vaccine LIVE ORAL 1V (Rotarix) for Prophylactic vaccination. On 05-Sep-2023, the patient received a dose 1, 0.5 ml of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection lot UJ835AA, expiry- 22-Feb-2024 via intramuscular route in the right thigh for Immunization, acthib was included in an excursion and was not viable anymore but it was administered to a patient before it was pulled out (with no reported adverse event) (poor quality product administered) (latency same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event poor quality product administered 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
PEDIARIX; PREVNAR 13; ROTARIX
Allergien
-
Vorherige Impfungen
-

VAERS 2551443

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ835AA

gering
Staat
OH
Alter
0,6
Geschlecht
F
Eingang
05.01.2023
Impfdatum
28.12.2022
Beginn
28.12.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect route of product administration No adverse event

Symptomtext

A 7-month-old female was admitted into the hospital on 12/25/2022. On 12/28/22, it was planned for the patient to be discharged. Prior to discharge, staff wanted to administer 4 catch-up vaccines (3 IM, 1 oral- Rotarix)- all 2nd doses. With notice that the patient's ride was suddenly here, nurses grabbed the 4 vaccinations to administer. Rotarix was mixed at bedside and administered in a specialized vial with a different tip than the typical system. Nurse administered Rotarix vaccine intranasally instead of the standard oral route. Patient did not experience any apparent adverse effects. Current plan is for patient to receive another dose of Rotarix through the recommended oral route before the age of 8 months.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-