VAERS Reports UJ456AAA

VAERS 1371191

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ456AAA

moderat

Staat: MN
Alter: 1,3
Geschlecht: M
Eingang: 03.06.2021
Impfdatum: 25.05.2021
Beginn: 28.05.2021
Tage bis Beginn: 3,0
Dosis: 4
Route/Site: IM / LL

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

Body temperature increased Chills Cough Ear infection Hypopnoea Illness Lethargy Moaning Respiratory rate increased Rhinorrhoea Sleep disorder Tremor

Symptomtext

Hib Sanofi Lot # UJ456AAA was giving during Well Child Check-up on 5/25/2021. Starting showing signs of illness on Friday 5/28 and 5/29. High temperatures, moaning while sleeping curled up in ball when usually child lays with arms stretched out, rapid, shallow breathing, very lethargic, chills (mild shaking), runny nose, mild cough. Administered children's liquid ibuprofen at 6:00pm, but by 10:00p the temperature rose to 103.5. Took to Emergency Room. Diagnosed as Rt Ear infections. Given antibiotics and instruction to alternate Tylenol and ibuprofen to keep fever down. F/U after completion of antibiotics to recheck ear infection. The CDC website states: Haemophilus influenzae type b can cause many different kinds of infections. These infections usually affect children under 5 years of age, but can also affect adults with certain medical conditions. Hib bacteria can cause mild illness, such as ear infections or bronchitis, or they can cause severe illness, such as infections of the bloodstream. Severe Hib infection, also called invasive Hib disease, requires treatment in a hospital and can sometimes result in death.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Tremor
Hospital-Tage: -
Labordaten: See description in Item 18
Aktuelle Erkrankungen: Treated for Exudative tonsillitis on May 9th. Was on Amoxicillin for 10 days.
Vorgeschichte: Mastocytosis
Andere Medikamente: Daily: 2.5 ML - Cetirizine HCl (Children's Zyrtec) 1 Mg/Ml Solution PRN: Diphenhydramine (Benadryl Allergy) 12.5 Mg/5 Ml Liquid PRN: Epinephrine Auto-Inject 0.15 Mg/0.15 Ml Auto.injct
Allergien: NKA. Nothing diagnosed. Does have reactions to banana, tomato, chemical, & environmental reactions.
Vorherige Impfungen: -

VAERS 2416934

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ456AAA

gering

Staat: MA
Alter: 32,0
Geschlecht: F
Eingang: 22.08.2022
Impfdatum: 16.08.2022
Beginn: 16.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RA

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

Expired product administered Medication error No adverse event

Symptomtext

reporting an expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 16-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 32-year-old female patient who reports an expired dose of acthib was inadvertently administered with no reported adverse event while receiving vaccine hib (prp/t) vaccine [act-hib]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine b rfhbp/nada/nhba omv (bexsero) for Prophylactic vaccination; and meningococcal vaccine a/c/y/w (meningococcal vaccine a/c/y/w) for Prophylactic vaccination. On 16-Aug-2022, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection of dose 0.5 ml total (lot no.- UJ456AAA) via intramuscular route in the right deltoid region (expiry date: 03-May-2022 and 13-May-2022) for Immunization (Immunisation). On 16-AUG-2022 the patient reports an expired dose of acthib was inadvertently administered with no reported adverse event (expired product administered) (one day latency) following the administration of HIB (PRP/T) VACCINE. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: BEXSERO; MENINGOCOCCAL VACCINE A/C/Y/W
Allergien: -
Vorherige Impfungen: -