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Reporte zur Charge UJ524AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 4 WA 1

VAERS 1393222

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ524AAA

mild
Staat
CA
Alter
0,5
Geschlecht
F
Eingang
11.06.2021
Impfdatum
07.06.2021
Beginn
08.06.2021
Tage bis Beginn
1,0
Dosis
3
Route/Site
- / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site rash Injection site reaction Rash papular

Symptomtext

non-pruritic rash to B/L lower extremities developed the day of after receiving vaccines. Vaccines admin on 6/7/2021, sx reported to have started on 6/8/2021. On 6/11/2021, mom made initial contact w/ our office regarding the rash, at which point, it was mostly resolved per her account. Baby did not develop fever or rash to other parts of her body. Rash per photos emailed on 6/11/2021 was flesh color papules localized to the lower extremities only.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site rash
Hospital-Tage
-
Labordaten
None ordered. Instructed to monitor + provide supportive care.
Aktuelle Erkrankungen
Viral GE 4/23/2021.
Vorgeschichte
No
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1540609

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ524AAA

gering
Staat
CA
Alter
0,2
Geschlecht
F
Eingang
10.08.2021
Impfdatum
07.07.2021
Beginn
07.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Lip discolouration Skin discolouration

Symptomtext

Infant came in for her 2-month well child exam and received the following vaccinations: DTap-Hep B-IPV; Haemophilus b; pneumococcal 13-valent conjugate vaccines; and rotavirus vaccine (oral) vaccination. Child was observed for 15 minutes and caregiver then took child to her vehicle. At that time, the caregiver returned the infant to the clinic and reported dark marks to her forehead along infant's forehead just below the hair line and one next to her lips. Child was observed her for an additional 30 -minutes and her spots started to go away. No other symptoms were noted. Infant then left the clinic with caregiver.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Lip discolouration
Hospital-Tage
-
Labordaten
none.
Aktuelle Erkrankungen
Infant came in for her 2-month well child exam and received the following vaccinations: DTap-Hep B-IPV; Haemophilus b; pneumococcal 13-valent conjugate vaccines; and rotavirus vaccine (oral) vaccination. Child was observed for 15 minutes and caregiver then took child to her vehicle. At that time, the caregiver returned the infant to the clinic and reported dark marks to her forehead along infant's forehead just below the hair line and one next to her lips. Child was observed her for an additional 30 -minutes and her spots started to go away. No other symptoms were noted. Infant then left the clinic with caregiver.
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1467322

GLAXOSMITHKLINE BIOLOGICALS · HIB (HIBERIX) · Charge UJ524AAA

gering
Staat
WA
Alter
1,0
Geschlecht
F
Eingang
13.07.2021
Impfdatum
12.07.2021
Beginn
12.07.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Vaccination error

Symptomtext

Pt was given a Pediarix instead of a prevnar. This was a vaccination administration error. No adverse reactions. The patient's mother was notified. Staff has been retrained accordingly and will triple check vaccinations in the future.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Vaccination error
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1456714

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ524AAA

gering
Staat
CA
Alter
-
Geschlecht
M
Eingang
08.07.2021
Impfdatum
28.06.2021
Beginn
28.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient was administered with an expired dose of the ActHib single-dose vial into the left deltoid , no reported adverse event; Initial information received on 30-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional via Information (reference number: 00663528). This case involves an unknown age male patient who was vaccinated with an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (1x single-dose vial in total, lot number UJ524AAA and expiration date 14-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Jun-2021 (expired product administered). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had medical history of bone marrow transplant and reported that he had 5 other vaccines along with the Act-HIB (names of the vaccine available) on 28-Jun-2021. It was a case of an actual medication error due to expired vaccine used (same day latency). At time of reporting, it was unknown whether the patient had any adverse event. It was reported that upon transfer, caller asked if there were any "cushion" after the expiration date of ActHib, where the product would still be good. Caller asked how to proceed if patient received an expired ActHib dose, and any safety concerns with having given an expired ActHib in a patient with his history. At the time of reporting, the outcome was unknown for the reported event patient. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Medical History/Concurrent Conditions: Bone marrow transplant
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1440132

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ524AAA

gering
Staat
CA
Alter
0,5
Geschlecht
F
Eingang
01.07.2021
Impfdatum
23.06.2021
Beginn
23.06.2021
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 Product preparation error

Symptomtext

the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Medical Information (Reference number- 00653853) and transmitted to Sanofi on 23-Jun-2021. This case involves a six-month-old female patient who was vaccinated with 0.5 mL (total) dose of HIB (PRP/T) VACCINE [ACT-HIB] [lot number UJ425AAA, expiry date25-Jun-2022] via intramuscular route in right vastus lateralis on 23-Jun-2021 for prophylactic vaccination and reported that the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine with no adverse event (product preparation error). 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. The caller had a minor patient receive the ACHIB vaccine, however, the sterile diluent for frozen vaccines was mixed in rather than the packaging that comes with the vaccine. The caller did not have patient information available during time of call. It was a case of actual medication error due to wrong solution used in drug reconstitution (latency was on same day). At the time of reporting, patient had no adverse 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 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
PREVNAR
Allergien
-
Vorherige Impfungen
-