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Reporte zur Charge UJ604AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2 OK 1 MI 1

VAERS 2540259

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AAA

gering
Staat
-
Alter
1,3
Geschlecht
F
Eingang
22.12.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

the diluent of of ACTHIB vaccine was expired and was administered to patient, with no reproted adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves the diluent of of HIB (PRP/T) VACCINE [ACT-HIB] vaccine was expired and was administered to 15 months old female patient, 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 pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for prophylactic vaccination. On an unknown date, the patient received a 0.5ml dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection; strength: standard) (lot: UJ604AAA; expiry date; 29-Oct-2022, 13-Mar-2023) via intramuscular route in unknown administration site for prophylactic vaccination. On an unknown date the diluent of of acthib vaccine was expired and was administered to patient, with no reported adverse event (expired product administered). Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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 guidelines. 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.; Sender's Comments: US-SA-2022SA511721:01408917

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

VAERS 2408260

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AAA

gering
Staat
CA
Alter
0,5
Geschlecht
F
Eingang
11.08.2022
Impfdatum
06.07.2022
Beginn
06.07.2022
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 storage error

Symptomtext

temperature excursion involving ACTHIB, were administered twice post excursion, The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who had temperature excursion involving HIB (PRP/T) VACCINE [ACT-HIB], were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 06-Jul-2022, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ604AAA and expiry date: 29-Oct-2022) via intramuscular route in the left thigh for Immunization. On 06-Jul-2022 the patient developed a non-serious event of temperature excursion involving acthib, were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction (not human error) with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of HIB (PRP/T) VACCINE. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. Outcome: Unknown 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 guidelines. 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 2404219

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AAA

gering
Staat
CA
Alter
1,0
Geschlecht
F
Eingang
08.08.2022
Impfdatum
13.07.2022
Beginn
13.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Poor quality product administered Product storage error

Symptomtext

vaccines being administered post excursion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient to whom vaccine was being administered post excursion, with no reported adverse event , and it involved vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The reporter stated that the condition was 31.5F for 1 hour and 58 a refrigerator malfunction (not human error). The product was not supported by the extended stability data. On 13-Jul-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, ( lot: UJ604AAA; expiry date: 29-Oct-2022) via intramuscular route in the right thigh for immunization. It was reported that on 13-Jul-2022, the vaccine was being administered post excursion, with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. Action taken : not applicable. Outcome: unknown 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2250408

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AAA

gering
Staat
OK
Alter
0,5
Geschlecht
F
Eingang
25.04.2022
Impfdatum
18.04.2022
Beginn
18.04.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered No adverse event Vaccination error

Symptomtext

Patient came in for WCC and 6 month vaccinations. The patient was given a pentacel that contains DTAP, HIB, IPV. and a single dose of HIB resulting in double vaccination of HIB. This error was discovered when putting vaccine in system on 04/18/2022. Mother was notified of vaccine error and stated patient has had no adverse reactions.. Dr. and Clinic Supervisor made aware of.

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

VAERS 1679039

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AAA

gering
Staat
MI
Alter
4,0
Geschlecht
F
Eingang
07.09.2021
Impfdatum
03.09.2021
Beginn
03.09.2021
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered No adverse event Wrong product administered

Symptomtext

Patient was due for 4 year vaccines (MMR, Varicella, IPV and DTaP) at her physical and was given an extra dose of HIB along with the 4 year vaccines. Nurse practitioner was immediately notified when the HIB was given instead of the IPV and she went and spoke with mom about the extra dose of HIB being given and the patient needed to receive one more vaccine which was the IPV. This was given that same day before they left the office. No reports of any side effects after vaccines were given. Nurse practitioner also spoke with mother later in the afternoon, Patient was doing well.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
None.
Vorgeschichte
None.
Andere Medikamente
Multi-vitamin
Allergien
None.
Vorherige Impfungen
-