VAERS Reports U7331AA

VAERS 2494866

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7331AA

mild

Staat: FL
Alter: 0,5
Geschlecht: M
Eingang: 01.11.2022
Impfdatum: 27.10.2022
Beginn: 28.10.2022
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LL

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

Injection site bruising Petechiae Platelet count decreased

Symptomtext

Petechial rash beginning 10/28/22 1 day after vaccination & significant bruising on body on body @ injection site. Twin sibling vaccinated same day (not identical) is fine.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site bruising
Hospital-Tage: -
Labordaten: 10/31 Platelet ct 15K, PT 13.7/PTT 44.3 see attached lab results
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: Probiotic
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2686329

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7331AA

gering

Staat: IL
Alter: 0,2
Geschlecht: F
Eingang: 26.09.2023
Impfdatum: 19.09.2023
Beginn: 19.09.2023
Tage bis Beginn: 0,0
Dosis: 1
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

inadvertent administration of an expired product to a patient with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2-months-old female patient who had inadvertent administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no 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); rotavirus vaccine live reassort oral 5V (Rotateq); and hepatitis B vaccine for Prophylactic vaccination (immunization). On 19-Sep-2023, the patient inadvertently received 0.5 mL (Dose 1) of expired suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Frequency: once; Strength: standard) (batch number: U7331AA; expiry date: 16-SEP-2023) via intramuscular route in the right thigh for Immunization with no adverse event (expired product administered) (same day latency). Action taken: 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; ROTATEQ; HEPATITIS B VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2589016

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7331AA

gering

Staat: PA
Alter: 1,0
Geschlecht: M
Eingang: 01.03.2023
Impfdatum: 06.02.2022
Beginn: -
Tage bis Beginn: -
Dosis: 4
Route/Site: OT / RL

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

Incorrect product formulation administered Medication error No adverse event

Symptomtext

pt was given only the dtap ipv component of pentacel and it was not reconstituted with acthib with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who reported was given only the DTAP IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] and it was not reconstituted with ACT HIB with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Feb-2022, the patient received a Dose 4 dose 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Suspension for injection strength not reported lot U7331AA expiry date 16-Sep-2023 via intramuscular route in the right thigh for Immunization. On an unknown date the patient developed a non-serious event "patient was given only the dtap ipv component of pentacel and it was not reconstituted with act hib with no reported adverse event" (incorrect product formulation administered) (unknown latency). Action taken was not applicable. At time of reporting, the outcome was Unknown for the event patient was given only the dtap ipv component of pentacel and it was not reconstituted with act hib 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: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2582711

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7331AA

gering

Staat: ID
Alter: 0,4
Geschlecht: M
Eingang: 16.02.2023
Impfdatum: 13.02.2023
Beginn: 13.02.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

Medication error No adverse event Single component of a two-component product administered

Symptomtext

potential medication error due to the administration of only the liquid DTAP-IPV portion to a patient, not the ACTHIB portion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 5-month-old male patient who had potential medication error due to the administration of only the liquid dtap-ipv portion to a patient, not the acthib portion with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ (pneumococcal conjugate vaccine); rotavirus vaccine and Hepatitis B Vaccine all for Prophylactic vaccination. On 13-Feb-2023, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE at a dose of 0.5 ml once (lot U7331AA, expiry date: 16-Sep-2023) via intramuscular route in the left thigh for immunization. On 13-Feb-2023 there was administration of only the liquid dtap-ipv portion to a patient, not the acthib portion with no reported adverse event (single component of a two-component product administered, same day latency) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Action taken: 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: PNEUMOCOCCAL CONJUGATE VACCINE; ROTAVIRUS VACCINE; HEPATITIS B VACCINE
Allergien: -
Vorherige Impfungen: -