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Reporte zur Charge UJ587AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OH 1 VT 1 HI 1

VAERS 1317029

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj587AA

schwer
Staat
OH
Alter
0,8
Geschlecht
M
Eingang
14.05.2021
Impfdatum
04.05.2021
Beginn
08.05.2021
Tage bis Beginn
4,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
C-reactive protein Full blood count Injection site irritation Injection site rash Pyrexia SARS-CoV-2 test Seizure like phenomena Staring Urine analysis

Symptomtext

On 5/8/21, patient went to Urgent Care clinic for fever, discharged home. On 5/9/21, patient was admitted to ER for 24hrs for "staring spells" and fever. Suspected seizure activity. Parents of patient state child has rash and irritation at injection site and wanted reaction reported and allergy to "hib" to be placed in chart.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure like phenomena
Hospital-Tage
1,0
Labordaten
CBC, Covid test, C-reactive protein, urinalysis
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
NA
Vorherige Impfungen
-

VAERS 2424361

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ587AA

mild
Staat
-
Alter
4,0
Geschlecht
F
Eingang
30.08.2022
Impfdatum
29.08.2022
Beginn
30.08.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site erythema Injection site induration Injection site warmth

Symptomtext

Site reaction on right arm- redness, warmth, and hard- less than 24 hours after given.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1776404

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ587AA

mild
Staat
-
Alter
76,0
Geschlecht
M
Eingang
11.10.2021
Impfdatum
16.08.2021
Beginn
25.08.2021
Tage bis Beginn
9,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Arthralgia Induration Joint swelling Skin warm Tenderness

Symptomtext

the left shoulder/deltoid area was firm, swollen, and warm to touch. Patient reports pain 2/10 when nothing is touching it, and 7/10 when the area is touched.

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

VAERS 2010628

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ587AA

gering
Staat
VT
Alter
0,3
Geschlecht
F
Eingang
06.01.2022
Impfdatum
06.01.2022
Beginn
06.01.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product administered to patient of inappropriate age Wrong patient

Symptomtext

Family arrived to office with 2 children (ages 2yr and 4mo) for well child visits. The mom asked for flu vaccine for the 2yr old and nurse misunderstood and thought that request was for the 4mo old. Vaccine given erroneously to the 4mos old patient. Provider has discussed incident with family.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Vitamin D infant drops
Allergien
None
Vorherige Impfungen
-

VAERS 1958097

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ587AA

gering
Staat
-
Alter
0,1
Geschlecht
M
Eingang
17.12.2021
Impfdatum
07.12.2021
Beginn
07.12.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

a dose of ACTHIB was reconstituted with sterile water and administered to a patient, with no AE; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency number: 00891537. This case involves a 1 months old male patient who was administered a dose of acthib was reconstituted with sterile water after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE for Immunisation. On 07-Dec-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: UJ587AA and expiry date: 17-SEP-2022) via intramuscular route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to wrong solution used in drug reconstitution (latency: same day). 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 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1958094

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ587AA

gering
Staat
HI
Alter
0,6
Geschlecht
M
Eingang
17.12.2021
Impfdatum
03.12.2021
Beginn
03.12.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation issue

Symptomtext

ACTHIB being reconstituted with sterile water with no adverse event; Initial information received on 07-Dec-2021 regarding an unsolicited valid non-serious case from nurse via regulatory agency (under reference number 00888121). This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] that was being reconstituted with sterile water (product preparation issue) . 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 REASSORT ORAL 5V (ROTATEQ) via unknown route in unknown administration site for prophylactic vaccination on an unknown date. On 03-Dec-2021, the patient received a third 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ587AA and expiry date: 17-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (same day latency). It was reported " (Registered Nurse) RN calling in regards to ACTHIB being reconstituted with sterile water. Caller would like advise to know how to proceed after product was administered to a patient." At 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 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-