VAERS Reports UJ604AA

VAERS 2215909

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

schwer

Staat: MD
Alter: 0,6
Geschlecht: F
Eingang: 05.04.2022
Impfdatum: 29.03.2022
Beginn: 30.03.2022
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LL

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

Blood culture Body temperature increased Computerised tomogram head Full blood count Metabolic function test Musculoskeletal stiffness SARS-CoV-2 test Seizure Staring Urine analysis

Symptomtext

Seizure : generalized stiffening with starring that lasted about 7 minutes after which her mother gave her Diastat then was taken to the ED by EMS. In the ED was found to have a temperature of 102 F, although mom had given her Tylenol ~ 6h prior to the event.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure
Hospital-Tage: -
Labordaten: In the ED has CBC, CMP, CT brain, UA , blood cultures x2, SARS-COV-2 on 3/30/22.
Aktuelle Erkrankungen: None
Vorgeschichte: Previous febrile seizure on 1/29/22
Andere Medikamente: Acetaminophen infant
Allergien: NKDA
Vorherige Impfungen: Febrile Seizure on 1/29/22. She was 5 mo and had received Pediarix #2, Hib#2, Rotateq#2 and Prevanr-13#2.

VAERS 2131522

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

mild

Staat: CA
Alter: 0,4
Geschlecht: F
Eingang: 22.02.2022
Impfdatum: 17.02.2022
Beginn: 17.02.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RL

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

Diarrhoea Pyrexia Rash erythematous Respiration abnormal Urticaria

Symptomtext

103 fever and urticaria, given tylenol for infants At 8am 02/18/2022 had 'hives' on back, stomach, and arms; red spots; unknown if itchy Seems resolved now Breathing 'looked a little funny yesterday'-no wheezing 'or anything like that' but later mom said she seemed like trying to catch her breath but breathing fine Diarrhea on 02/17/2022 after vaccines

Weitere VAERSDATA-Felder

Praegender Schweregrund: Diarrhoea
Hospital-Tage: -
Labordaten: None.
Aktuelle Erkrankungen: Acute URI of multiple sites.
Vorgeschichte: None.
Andere Medikamente: Vitamin D3.
Allergien: Dairy.
Vorherige Impfungen: -

VAERS 2559179

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: CA
Alter: 1,3
Geschlecht: U
Eingang: 13.01.2023
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

was administered ACTHIB that was reconstituted with expired diluent, with no reported adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received via physician. This case involves a 16-month-old and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with expired diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (batch lot: UJ604AA) (expiry date: 31-Mar-2023) (strength: unknown) via unknown route in unknown administration site for Immunization. On an unknown date the patient had a non-serious event of was administered ACT-HIB that was reconstituted with expired diluent, with no reported adverse event (expired 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2509271

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: ME
Alter: 1,3
Geschlecht: F
Eingang: 16.11.2022
Impfdatum: 01.11.2022
Beginn: 01.11.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Expired product administered Medication error No adverse event

Symptomtext

administered ACTHIB that was reconstituted with expired diluent with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent 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); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP). On 01-Nov-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ604AA and expiry date: 13-Mar-2023) which was reconstituted with diluent (lot U7172AB and expiry date: 29-Oct-2022) via intramuscular route in the right leg for prophylactic vaccination. On 01-Nov-2022, (latency: same day) the patient was administered acthib that was reconstituted with expired diluent with no reported adverse event (expired product administered). It was reported, they gave a patient an expired ACT-HIB vaccine. The caller stated the box says 29-Oct-2022 but the diluent part does not expire until 13-Mar-2023. A patient was administered ACTHIB that was reconstituted with expired diluent. The ACTHIB portion of the vaccine was not expired but the diluent was, which expired 29-Oct-2022. This situation is reported as a medication error due to a patient being administered ACTHIB that was reconstituted with expired diluent. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) 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 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; DTAP
Allergien: -
Vorherige Impfungen: -

VAERS 2322995

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: ME
Alter: 0,5
Geschlecht: M
Eingang: 17.06.2022
Impfdatum: 10.06.2022
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / LL

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

Medication error No adverse event Product preparation error

Symptomtext

ACTHIB that was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient to whom given HIB (PRP/T) VACCINE [ACT-HIB] that was diluted with a different diluent aside from the diluent associated with the vaccine 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) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation. On 10-Jun-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ604AA) via intramuscular route in the left thigh vaccine was diluted with a different diluent aside from the diluent associated with the vaccine with no reported adverse event (product preparation error). Action taken : not applicable. At time of reporting, the outcome was Unknown for the event acthib that was diluted with a different diluent aside from the diluent associated with the vaccine with no reported 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 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: -

VAERS 2258583

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: MA
Alter: 1,5
Geschlecht: M
Eingang: 29.04.2022
Impfdatum: 29.04.2022
Beginn: 29.04.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Patient was due for fourth vaccine in DTaP series but was given TDaP.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2251861

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: TX
Alter: 0,4
Geschlecht: F
Eingang: 26.04.2022
Impfdatum: 13.04.2022
Beginn: 13.04.2022
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

Used sterile water as the diluent for Acthib instead of the 0.4% normal saline with no reported adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 month old female patient who used sterile water as the diluent for acthib instead of the 0.4% normal saline with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib) and water for injection (Sterile Water). 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, tetanus vaccine toxoid (Daptacel); polio vaccine inact 3v (vero) (Ipol)and Rotavirus Vaccine. On an unknown date, the patient started taking sterile water (water for injection) with unknown dose (route, strength, formulation, frequency, batch number, expiry date, indication was unknown). On 13-Apr-2022, the patient received 0.5 ml dose of suspect hib (prp/t) vaccine (strength, frequency, , formulation was unknown, lot UJ604AA and expiry date: 13-Mar-2023) via intramuscular route in unknown administration site for prophylactic vaccination. On 13-Apr-2022, (Latency: same day) stating that an RN(registered nurse) at the clinic used sterile water as the diluent for ACTHIB instead of the 0.4% normal saline with no reported adverse event (product preparation error) Action taken with water for injection (Sterile Water) and haemophilus type b (hib) vaccine (Act-Hib): 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: DAPTACEL; IPOL [POLIO VACCINE INACT 3V (VERO)]; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2218106

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ604AA

gering

Staat: CT
Alter: 0,3
Geschlecht: M
Eingang: 06.04.2022
Impfdatum: 30.03.2022
Beginn: 31.03.2022
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / LL

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

Blood culture negative Fontanelle bulging Full blood count abnormal Magnetic resonance imaging head normal Metabolic function test normal Poor feeding infant SARS-CoV-2 test negative Scan with contrast normal Somnolence Ultrasound head abnormal White blood cell count increased

Symptomtext

Notable poor feeding and more sleepy and bulging anterior fontanelle on 3/31/2022 - send to the Pediatric ED for further evaluation - negative head US, admitted for sedated brain MRI - discharge on 4/1 after negative brain MRI and notable improvement

Weitere VAERSDATA-Felder

Praegender Schweregrund: Blood culture negative
Hospital-Tage: 1,0
Labordaten: 3/31/2022 - CBC with elevated WBC 19.4, negative blood culture, CMP within normal limits, negative covid swab, head US no hydrocephalus but with mild prominence of the extra-axial CSF spaces overlying the bilateral cerebral convexities 4/1/2022 - brain MRI with/without contrast - unremarkable
Aktuelle Erkrankungen: reflux - stopped prescribed pepcid on 3/2/2022 eczema - treated for 1 week with hydrocortisone 2.5% on 2/25/2022
Vorgeschichte: prematurity - 29.6 week twin - retinopathy of prematurity sickle cell trait hx of covid 12/29 - mild symptoms of congestion
Andere Medikamente: Poly- vi-sol drops
Allergien: None noted
Vorherige Impfungen: -