VAERS Reports UJ404AAB

VAERS 1493759

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ404AAB

mild

Staat: NY
Alter: 0,2
Geschlecht: F
Eingang: 22.07.2021
Impfdatum: 18.06.2021
Beginn: 19.06.2021
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein

Blood culture negative Blood glucose normal Blood immunoglobulin G normal C-reactive protein increased CSF culture negative CSF protein normal Chest X-ray normal Conjunctivitis Culture urine negative Echocardiogram normal Electrocardiogram normal Haematocrit decreased Haemoglobin normal Irritability Kawasaki's disease Lip erythema Lip exfoliation Lumbar puncture normal

Symptomtext

Starting on 6/19 in the middle of the night, baby developed fever ~ 101 which responded to tylenol. Continued fever through 6/20 but rising up to 103 and more irritable. Admitted to ER overnight 6/20 due to persistent high fever in 2 month old. Full Rule out sepsis done with lumbar puncture, blood culture, urine testing and started empiric antibiotics. Respiratory viral panel negative. Persistent fever despite negative CSF/ Blood/ urine and antibiotics. On 6/20 into 6/21 also developed rash on body and on palms and soles. On 6/21 overnight into 6/22 with non-purulent conjunctivitis and peeling red lips. Tuesday 6/22 diagnosed with Kawasaki disease. Treated with IVIG and Aspirin for Kawasaki with immediate improvement in fever and irritability. Discharged on aspirin for 6 weeks

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: 5,0
Labordaten: 6/20 CSF culture, Blood culture and Urine culture all negative. CSF protein 51, glucose 64, meningitis panel negative, cell count 3 RBC, 7 nucleated cells, (21%neutrophil, 37% lymph, 42% monocyte) 6/20 Respiratory viral panel and COVID pcr negative 6/20 CBC : WBC 11> 10.3/30.8 Hb/ Hct < Platelets elevated 650 6/20 Chests xray normal 6/21, 6/22 EKG normal 6/21 COVID IgG negative 6/22 CRP 217.6, 6/24 CRP 147.4 6/23 Echocardiogram normal
Aktuelle Erkrankungen: No
Vorgeschichte: No
Andere Medikamente: No
Allergien: No
Vorherige Impfungen: -

VAERS 1814227

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ404AAB

gering

Staat: NY
Alter: 0,5
Geschlecht: F
Eingang: 25.10.2021
Impfdatum: 18.10.2021
Beginn: 18.10.2021
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

expired ACTHIB was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00818652) and transmitted to Sanofi on 19-Oct-2021. This case involves a six-month-old female patient who vaccinated with third 0.5 mL (once) dose of expired HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ404AAB and expiry date 04-Oct-2021) via intramuscular route in the left thigh on 18-Oct-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination 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) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PEDIARIX; PNEUMOCOCCAL 13 VALENT VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 1774879

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ404AAB

gering

Staat: IN
Alter: 1,0
Geschlecht: M
Eingang: 09.10.2021
Impfdatum: 05.10.2021
Beginn: 05.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

patient received an ACTHIB vaccine in the office that had expired with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under the reference 00799026). This case involves a 1 years old male patient who received an HIB (PRP/T) VACCINE [ACT-HIB] vaccine in the office that had expired (expired product administered). 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 Immunisation. On 05-Oct-2021, the patient received a dose of suspect ACT-HIB (0.5 ml, total, Once Frequency-1X, lot UJ404AAB and expiration date: 04-oct-2021) via intramuscular route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine administered (same day latency). It was reported "Caller states that a patient received an ACTHIB vaccine in the office on 05OCT2021 that had expired on 04OCT2021 and wanted to know how soon the patient could be revaccinated. Caller states that only 1 patient received expired ACTHIB and requested that information on expired products be emailed to her." 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 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: -
Andere Medikamente: PREVNAR
Allergien: -
Vorherige Impfungen: -

VAERS 1774821

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ404AAB

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 09.10.2021
Impfdatum: 24.09.2021
Beginn: 24.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product preparation error

Symptomtext

patient received ACT-HIB with wrong diluent; mixed with diluent used for MMR with no reported adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional via Medical Information (MI) (Reference number- 00787088). This case involves patient (unknown demographics) who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB], which was mixed with MMR (measles, mumps, and rubella) wrong diluent (Product preparation error). The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided. On 24-Sep-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ404AAB and expiry date: 04-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to Wrong solution used in drug reconstitution (latency on same day). At the time of report no adverse reactions were reported. It was reported "Caller stated that they mixed ACTHIB with wrong diluent before administration. ACTHIB was mixed with diluent used for MMR. Caller wanting to know what they should do.Caller states that on Friday, 24 Sep 2021, an ACTHIB vaccine was given that had been improperly reconstituted. The ACTHIB was reconstituted with the diluent from an MMR vaccine. Caller does not have patient information at this time, she states that she could obtain it". 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: -