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Reporte zur Charge UJ414AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 2 FL 2 OK 1 TX 1 NJ 1

VAERS 1801684

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

mild
Staat
OK
Alter
1,3
Geschlecht
M
Eingang
20.10.2021
Impfdatum
07.10.2021
Beginn
07.10.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Agitation Decreased appetite Diarrhoea Fatigue Gait disturbance Injection site swelling Pyrexia Rhinorrhoea Somnolence Wrong product administered

Symptomtext

PATIENT WAS BROUGHT IN ON 10/7/21 FOR 1 YEAR VACCINATIONS. I ASSISTED THE ADMINISTERING NURSE TO PULL VACCINES AS HE WAS UNFAMILIAR WITH OUR PROTOCOL. I PULLED THE COMBINATION (PENTACEL) AND IN ERROR PULLED AN EXTRA HIB VACCINE INSTEAD OF HEPB. I DID NOT NOTICE THE ERROR WHEN DOUBLE CHECKING THE VACCINES AGAINST THE RECOMMENDATIONS LIST. THE NURSE THEN DREW UP THE VACCINES AND ADMINISTERED TO THE PATIENT. HE DID NOT HAVE ACCESS SO I ENTERED THEM INTO THE SYSTEM ON 10/8/21 AND IT WAS AT THIS TIME THAT I NOTICED THE ERROR. I CONTACTED THE MOTHER AND LEFT A VOICEMAIL, I ALSO HELD THE INFORMATION TO THE ATTENDING PHYSICIAN, AS IT WAS LATER IN THE DAY FRIDAY. DR. WAS ABLE TO REACH THE PATIENTS MOTHER AFTER HOURS AND HIS DOCUMENTATION IS AS FOLLOWS: "I spoke with the patient's mother this evening and she stated since last night patient has had increased fussiness, fevers with Tmax of 103 F last night, treating with alternating Tylenol and Motrin, Temperature when on the phone today is 98.1; last dose of Advil/Tylenol given 1 hour ago; only drinking water and juice today, not eating at all today. Patient is having increased runny nose, loose stools, more fatigued and very fussy, sleeping more during the day. Mother reports patient's leg is very swollen from injections, pt. walking "funny" per mother but no headaches/seizures/convulsions or NV reported." ON 10/11/21 THE MOTHER CALLED TO MAKE NOTE OF ISSUES/MISTREATMENT WHEN AT THE ER OVER THE WEEKEND. I ATTEMPTED TO CONTACT THE MOTHER TO FOLLOWUP AND AGAIN RECEIVED A VOICEMAIL, ONE OF OUR CLINIC SUPERVISORS WAS ABLE TO MAKE CONTACT AND TAKE NOTE OF HER COMPLAINT. FOLLOWUP APPOINTMENT SCHEDULED FOR 10/12/21 WAS NOT KEPT AND, TO MY KNOWLEDGE, AT THIS TIME THERE HAS BEEN NO FURTHER CONTACT WITH THE MOTHER OF THE PAITENT.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
9/14/21- PATIENT BROUGHT IN TO CLINIC FOR FEVER, COUGH AND DIARRHEA. TEST NEGATIVE FOR FLU/RSV/STREP/COVID. PROVIDER DOCUMENTED OTITIS MEDIA, BILATERAL. NOTHING REPORTS AT TIME OF VACCINE
Vorgeschichte
ECZEMA
Andere Medikamente
NONE
Allergien
NKA
Vorherige Impfungen
-

VAERS 2277671

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
14.05.2022
Impfdatum
04.04.2022
Beginn
04.04.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

patient was given expired doses of pentacel with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 4-month-old male patient who was given expired doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no adverse event. The patient's past medical history, medical treatment, vaccination, and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13). On 04-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ414AAA and expiry date: 12-Mar-2022) via intramuscular route in the left thigh for Immunization. On 04-Apr-2022 the patient developed a non-serious event, patient who was given expired doses of pentacel with no adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event patient who was given expired doses of pentacel with no 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 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
ROTAVIRUS VACCINE; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 2267199

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
FL
Alter
0,2
Geschlecht
F
Eingang
09.05.2022
Impfdatum
25.03.2022
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient was treated with expired doses of pentacel with no reported adverse event; Initial information was received on 05-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center. This case involves a 2 months old female patient who experienced patient was treated with expired doses of pentacel with no reported adverse event while 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 pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and rotavirus vaccine for Immunisation. On 25-Mar-2022, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, and strength: unknown) (batch number: UJ414AAA Expiry date- 12-MAR-2022) via Intramuscular route in left thigh for immunization. On an unknown date the patient developed a non-serious patient was treated with expired doses of pentacel with no reported adverse event (expired product administered) (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 the event patient was treated with expired doses of pentacel 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 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 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2208876

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
IL
Alter
1,0
Geschlecht
F
Eingang
31.03.2022
Impfdatum
21.03.2022
Beginn
21.03.2022
Tage bis Beginn
0,0
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

expired dose of PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 1 years old female patient had expired dose of pentacel was inadvertently administered to a patient with no reported adverse event while 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 Pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Immunisation. On 21-Mar-2022, the patient received a dose of 0.5 ml (millilitre) suspect Diphtheria/tetanus/5 hybrid ac pertussis/IPV(mrc5)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) lot UJ414AAA via intramuscular route in unknown administration site for prophylactic vaccination. On 21-MAR-2022 the expired dose of pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day) 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. 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 13
Allergien
-
Vorherige Impfungen
-

VAERS 2020336

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
10.01.2022
Impfdatum
-
Beginn
03.01.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

The temperature range was from 37.5F to 48.2F; Initial information received on 03-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown demographics whos temperature range was from 37.5f to 48.2f while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL]. 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 IPV (VERO) lot U1C571M via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774BA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ414AAA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ583ABA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7191AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6900AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot C5779AA via unknown route in unknown administration site. On 03-JAN-2022 the patient developed a non-serious the temperature range was from 37.5f to 48.2f (product storage error) (unknown latency) following the administration of IPV (VERO), , TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL), HAEMOPHILUS TYPE B (HIB) VACCINE (ActHIB), MENINGOCOCCAL VACCINE (MENACTRA), DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. It was not reported if the patient received a corrective treatment for the event (The temperature range was from 37.5F to 48.2F). At time of reporting, the outcome was Unknown for the event the temperature range was from 37.5f to 48.2f. 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1713157

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
18.09.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A temperature excursion because the dial in the refrigerator was turned too low, reached up to Negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds/no AE;Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (Reference number- 00762504). This case involves vaccines that undergoes a temperature excursion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot UJ414AAA, expiry date 12-MAR-2022), HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ405AAA, expiry date 08-OCT-2021 ) and IPV (VERO) [IPOL] (lot R1G101M, expiry date 08-OCT-2021) because the dial in the refrigerator was turned too low reached up to negative 3.4 Celsius for a total of 17 hours, 7 minutes, and 30 seconds (product storage error). It was reported, "caller states that a temperature excursion occurred because the dial in the refrigerator was turned too low. The lowest temperature reached was Negative 3.4C for a total of 17 hours, 7 minutes, and 30 seconds. The products involved were a punctured MDV of IPOL as well as unopened: ACTHIB, IPOL, and PENTACEL. Caller requested stability information for these products". It was a case potential medication error due to product storage error temperature too low (same day). At time of reporting no adverse was 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1398801

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ414AAA

gering
Staat
NJ
Alter
0,1
Geschlecht
F
Eingang
15.06.2021
Impfdatum
05.05.2021
Beginn
05.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Eye movement disorder Nystagmus Ophthalmological examination abnormal

Symptomtext

I spoke to mom the next day regarding the start of abnormal eye movements the next day mom did not bring her in until 6/1- sent to ophthalmologist- diagnosed with nystagmus

Weitere VAERSDATA-Felder
Praegender Schweregrund
Eye movement disorder
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
2 days prior to vaccinations 101 temporal temp- no other symptoms, elevated temp x 1- resolved without treatment
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-