VAERS Reports UJ543AA

VAERS 1854388

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ543AA

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Staat: CA
Alter: 0,3
Geschlecht: F
Eingang: 09.11.2021
Impfdatum: 03.11.2021
Beginn: 04.11.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / -

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

Body temperature increased Choking Crying Eye movement disorder Infantile back arching Irritability Musculoskeletal stiffness Posture abnormal

Symptomtext

11/3/2021 had wcc and 4 mo vaccines, pentacel, prevnar and rotavirus vaccines temperature to 100.4 after vaccines. 11/4/2021 at 1230 am seemed fussy. temperature to 102 (temporal and tympanic), gave Tylenol. Then in AM temp noted to be 100.2. Tylenol given at 10am. Seemed fine at this time but a little fussy. 11/4/2021 3 pm: Temperature was normal. Started to fuss. Crying and then eyes rolled back and choking on saliva, threw head back. arched back, stiff. episode lasted 5 seconds. stopped and then was fine. smiled. After episode seemed fine but more quiet.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Body temperature increased
Hospital-Tage: -
Labordaten: Seen 11/4/2021 for office evaluation. no testing or labs completed
Aktuelle Erkrankungen: -
Vorgeschichte: no
Andere Medikamente: -
Allergien: none
Vorherige Impfungen: -

VAERS 1744251

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ543AA

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Staat: IN
Alter: -
Geschlecht: U
Eingang: 29.09.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error Wrong technique in product usage process

Symptomtext

patient has received the Diluted portion of the Pentacel and they have the patient coming in to received the powder form of the Pentacel with no adverse event reported.; Initial information regarding an unsolicited valid non serious case was received from another health professional via Medical Information (Reference number- 00778419) and transmitted to Sanofi on 21-Sep-2021. This case involves an unknown demographic (unknown age and unknown gender) patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was "patient has received the diluted portion of the pentacel and they have the patient coming in to received the powder form of the pentacle" (wrong technique in product usage process). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ543AA, expiry date 10-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong technique in product usage process (latency unknown). It was reported "patient has received the Diluted portion of the PENTACEL and they have the patient coming in to received the powder form of the Pentacel and now what can they use instead of the diluent that come with the Pentacel? Can she use sterile water? Healthcare professional (HCP) asks what can be used to mix the HIB part of Pentacel? Also, what amount of 0.4% NaCl is used?" At time of reporting, 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1713138

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ543AA

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Staat: OH
Alter: 0,8
Geschlecht: M
Eingang: 18.09.2021
Impfdatum: 02.09.2021
Beginn: 02.09.2021
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / RL

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

Extra dose administered No adverse event

Symptomtext

patient received both Pentacel and Ipol in error with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00752128) and transmitted to Sanofi on 02-Sep-2021. This case involves a nine-month-old male patient who received third 0.5 mL (total, once) dose of IPV (VERO) [IPOL] (suspension for injection) [lot RIS97, expiry date 03-Oct-2021] at right thigh and third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (suspension for injection) [lot UJ543AA, expiry date not reported] at right thigh (route not reported for both suspects) on 02-Sep-2021 for prophylactic vaccination (extra dose administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was a case of actual medication error due to extra dose (polio vaccine) administered (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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: RECOMBIVAX; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 1678478

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ543AA

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Staat: OH
Alter: 0,8
Geschlecht: M
Eingang: 07.09.2021
Impfdatum: 02.09.2021
Beginn: 02.09.2021
Tage bis Beginn: 0,0
Dosis: 5
Route/Site: IM / RL

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

Extra dose administered

Symptomtext

Pt was given two doses of polio vaccine during well child visit. One dose in pentacel, one dose of IPOL. Pt did not exhibit any negative signs or symptoms while in office. Pt parent contacted by provider approx 2 hours after and no negative signs or symptoms were reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -