VAERS Reports U7311AA

VAERS 2578031

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7311AA

mild

Staat: LA
Alter: 1,0
Geschlecht: F
Eingang: 08.02.2023
Impfdatum: 06.02.2023
Beginn: 06.02.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

Pyrexia Single component of a two-component product administered

Symptomtext

Patient received the Pentacel vaccine. With the Pentacel vaccine, only the blue top vial containing DTap and IPV were administered to the patient. The green top vial containing the HIB was not mixed with the blue top vial. Pt did not receive the HIB green top vial. Mother contacted the office today, 2/08/2023, to inform us that the patient has been running a fever since Monday after the vaccines were given. Also stated that she brought the patient to an ER today, 2/08/2023, which the staff at the ER informed mom that fever is normal after receiving vaccines.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Ear infection, atopic dermatitis
Vorgeschichte: N/a
Andere Medikamente: No
Allergien: NKA
Vorherige Impfungen: -

VAERS 2683328

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7311AA

gering

Staat: WY
Alter: 0,1
Geschlecht: F
Eingang: 18.09.2023
Impfdatum: 11.09.2023
Beginn: 11.09.2023
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

expired dose of pentacel was administered with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-month-old female patient for whom expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2023, the patient received an expired dose of 0.5 ml (frequency: once) suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength Suspension for injection (lot: DTAP/IPV: U7311AA, HIB: UJ757AA, Expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2607058

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7311AA

gering

Staat: CO
Alter: 0,3
Geschlecht: F
Eingang: 31.03.2023
Impfdatum: 27.03.2023
Beginn: 27.03.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

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

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

Symptomtext

administered Pentacel without the HIB patient only received the liquid portion with no adverse event; Initial information received on 28-Mar-2023 regarding an unsolicited valid non-serious case received via medical assistant. This case involves 4 months old female patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was administered without the hib patient only received the liquid portion 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 13V (PNEUMOCOCCAL 13) for Prophylactic vaccination, and Rotavirus Vaccine for Immunization. On 27-Mar-2023, the patient was administered suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine at dose 0.5ml once (lot: U7311AA, expiry date: 09-Sep-2023) via intramuscular route in the left thigh for prophylactic vaccination with administered Pentacel without the hib patient only received the liquid portion with no adverse event (single component of a two-component product administered) at same day latency. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event single component of a two-component product administered. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2588127

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7311AA

gering

Staat: MO
Alter: -
Geschlecht: U
Eingang: 28.02.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
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

In the office gave the DTAP-IPV mixed with sterile water to two patients but did not give the HIB portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event; Initial information received on 22-Feb-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves 2 patient with unknown demographics who reported in the office gave the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection strength, dose, expiry date: unknown lot U7311AA via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "In the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event in the office gave the dtap-ipv mixed with sterile water to two patients but did not give the hib portion of the vaccine at all/ medication error due to not mixing the vaccine as prescribed 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 2583575

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7311AA

gering

Staat: ND
Alter: 1,0
Geschlecht: M
Eingang: 17.02.2023
Impfdatum: 17.02.2023
Beginn: 17.02.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

Circumstance or information capable of leading to medication error Extra dose administered

Symptomtext

Adverse Event: Mother and Provider were both under the impression that patient was receiving dose #2 in a year of the influenza. Order was placed by Dr.. While RN was entering the vaccines and noticed that patient chart had documented that he had received his 1st dose on 9/19/2022 and 2nd does on 10/31/2022. Patient did receive dose #3 on 02/17/2023. Mother wrote on Vaccine paper work that this was dose #2. Treatment: informed provider, mother and supervisor. Mother was also informed that if patient is to experience abnormal responses to vaccine to call or seek evaluation. Mother stated that "this is miscommunication due to paper work being faxed from previous provider". Mother also stated that "she was under the impression that this was only patients second influenza vaccine" Outcome: When informing Dr. she stated "Patient will be extra protected."

Weitere VAERSDATA-Felder

Praegender Schweregrund: Circumstance or information capable of leading to medication error
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: n/a
Vorgeschichte: n/a
Andere Medikamente: n/a
Allergien: amoxicillin
Vorherige Impfungen: -

VAERS 2574751

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7311AA

gering

Staat: FL
Alter: 1,4
Geschlecht: F
Eingang: 03.02.2023
Impfdatum: 16.11.2022
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / LL

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

No adverse event Product preparation error

Symptomtext

patient was administered the diluent only, with no reported adverse event; only gave the diluent of PENTACEL, with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 months old female "patient who was administered with the diluent only, with no reported adverse event" and "only gave the diluent of pentacel, with no reported adverse event" after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunization. On 16-Nov-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7311AA) via unknown route in the left thigh (expiry date, strength, form: unknown) for prophylactic vaccination. On an unknown date the patient was administered the diluent only, with no reported adverse event (single component of a two-component product administered) and only gave the diluent of pentacel, with no reported adverse event(product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken- not applicable. At time of reporting, the outcome was Unknown for both the events. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2482608

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7311AA

gering

Staat: UT
Alter: 0,4
Geschlecht: F
Eingang: 19.10.2022
Impfdatum: 15.09.2022
Beginn: 15.09.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

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

Symptomtext

medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 5-month-old female patient who experienced medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event while 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. This case is linked to case 2022SA418088. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination. On 15-Sep-2022, the patient received suspect Pentacel (VERO) Vaccine at dose 0.5 ml once (lot: U7311AA, 09-Sep-2022) via intramuscular route in the right thigh for prophylactic vaccination. On 15-SEP-2022, the medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event (single component of a two-component product administered)(Product preparation error) at same day latency following the administration of Pentacel (VERO). Action taken: Not applicable for both events. At time of reporting, the outcome was Unknown for both 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13; ROTAVIRUS VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2482607

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7311AA

gering

Staat: UT
Alter: -
Geschlecht: F
Eingang: 19.10.2022
Impfdatum: 15.09.2022
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / RL

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

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

Symptomtext

medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient whose medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event , it involved 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 ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13). On 15-Sep-2022, the patient received dose of 0.5m once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , with an unknown formulation and strength, (lot: U7311AA ; expiry date: 09-Sep-2023) via intramuscular route in the right thigh for immunization. It was reported that on 15-Sep-2022, the medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event , (single component of a two-component product administered, product preparation error) (latency: same day). Action taken: not applicable for both the events. Outcome: unknown for both the events. 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: ROTAVIRUS VACCINE; PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2450428

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U7311AA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 17.09.2022
Impfdatum: -
Beginn: 01.09.2022
Tage bis Beginn: -
Dosis: 1
Route/Site: - / -

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

Incorrect dose administered Product preparation issue

Symptomtext

they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves an unknown age and gender patient who was administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event , after receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB] and 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. On an unknown date, the patient received once a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (U7311AA and expiration date: 09-Sep-2023) and a dose of suspect HIB (PRP/T) VACCINE ( lot UJ757AA and expiration date: 09-Sep-2023) at an unknown dose via unknown route at unknown administration site for immunization. On 01-Sep-2022 t(latency: same day), the patient developed a non-serious event" they administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event" (single component of a two-component product administered) (product preparation error) following the administration. Action taken :not applicable. It was not reported if the patient received a corrective treatment for the events. Outcome: unknown for both events 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 dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2440288

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7311AA

gering

Staat: CA
Alter: 1,3
Geschlecht: M
Eingang: 12.09.2022
Impfdatum: 29.08.2022
Beginn: 29.08.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

No adverse event Product preparation error

Symptomtext

administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old male patient who was administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Aug-2022, the patient received a 0.5 ml only the liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) (lot U7311AA, exp date: 09-Sep-2023) via intramuscular route in the left thigh as Immunization. On 29-Aug-2022 (latency: same day), the patient developed a non-serious event of "administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) with no reported adverse event (single component of a two-component product administered" (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -