- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
Symptomtext
Good afternoon Our MA gave an expired Td Wrong or expired product- VFC TD single dose 0.5 mL, vaccine -expired XX/XX/2021 Lot # U6265AA Manufacture - Sanofi Pasteur
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.07.2021
- Impfdatum
- 30.06.2021
- Beginn
- 30.06.2021
- 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
No adverse event
Symptomtext
patient was administed an expired dose of TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00663918) and transmitted to Sanofi on 30-Jun-2021. This case involves a 58 year old female patient who was administered an expired dose (0.5ml) of the suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-Apr-2021; form: solution for injection) via unknown route in the right deltoid for prophylactic vaccination on 30-Jun-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter wanted information as to repeat the vaccination or not. At the time of report, no adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 73,0
- Geschlecht
- F
- Eingang
- 03.07.2021
- Impfdatum
- 28.06.2021
- Beginn
- 28.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
A patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00659835) and transmitted to Sanofi on 28-Jun-2021. This case involves a 73-year-old female patient who received 0.5 mL of expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an intramuscular route in the left arm for prophylactic vaccination on 28-Jun-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was reported that "Caller would like to know if this dose is considered a valid dose or whether the dose needs to be repeated." This was a case of actual medication error due to expired vaccine used (latency same day). At time of reporting, no adverse events were 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 75,0
- Geschlecht
- F
- Eingang
- 12.06.2021
- Impfdatum
- 24.05.2021
- Beginn
- 24.05.2021
- 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
No adverse event
Symptomtext
medical assistant had administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00628493) and transmitted to Sanofi on 04-Jun-2021. This case involves a 75 years old female patient who received 0.5 ml of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 24-May-2021 (Expired product administered) Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to Expired vaccine used (latency same day) At the time of report, no adverse event was reported. Caller stated a medical assistance accidentally administered the diphtheria tetanus (TD) vaccine. Caller asked if there is anything they need to do, were there any adverse effects and what were the next steps 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
- -
- Staat
- UT
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.06.2021
- Impfdatum
- 18.05.2021
- Beginn
- 18.05.2021
- 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
No adverse event
Symptomtext
patient inadvertently administered expired Tenivac vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Agency (Reference number- 00610121) and transmitted to Sanofi on 20-May-2021. This case involves a patient (unknown demographics) who received inadvertently administered expired vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number: U6265AA and expiry date: 19-Apr-2021 via unknown route at an unknown administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). Reporter want to know what need to know and which actions to take for the affected donors At the time of reporting, no adverse event 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 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
- -
- Staat
- OR
- Alter
- -
- Geschlecht
- M
- Eingang
- 22.05.2021
- Impfdatum
- 07.05.2021
- Beginn
- 07.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
Symptomtext
14 year old patient was given an expired TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via agency (Reference number- 00592731) and transmitted to Sanofi on 07-May-2021. This case involves a 14 year old male patient who was administered 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-APR-2021) via unknown route in the left deltoid for prophylactic vaccination on 07-MAY-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to expired vaccine used (latency same day). At the time of report, no adverse event 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 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
- -
- Staat
- OK
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 18.05.2021
- Impfdatum
- 21.04.2021
- Beginn
- 21.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Pt. received Tenivac on 4/21/21 that expired on 4/19/21. Parent was contacted by voicemail and letter. Awaiting response to schedule a repeat dose. No known adverse events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None disclosed on immunization worksheet.
- Vorgeschichte
- None disclosed on immunization worksheet.
- Andere Medikamente
- None disclosed on immunization worksheet
- Allergien
- None disclosed on immunization worksheet.
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 7,0
- Geschlecht
- M
- Eingang
- 17.05.2021
- Impfdatum
- 20.04.2021
- Beginn
- 20.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
Symptomtext
patient received expired dose of TENIVAC/no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 year-old male patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE [TENIVAC] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) and HEPATITIS A VACCINE INACT (HAVRIX) for prophylactic vaccination. On 20-Apr-2021, the patient received a first dose 0.5 mL of suspect DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE (strength: standard; lot U6265AA and expiry date 19-Apr-2021) via an intramuscular route in the right arm for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Result of assessment was not 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 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
- IPOL POLIO VACCINE; PROQUAD; FLULAVAL; ENGERIX-B; HAVRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 12.05.2021
- Impfdatum
- 20.04.2021
- Beginn
- 20.04.2021
- 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
Product administered to patient of inappropriate age
Symptomtext
Patient received expired Tenivac vaccine with no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from physician. This case involves a 7-year-old male patient who received expired 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6265AA, expiry date: not reported] via an intramuscular route in the right arm for prophylactic vaccination on 20-Apr-2021 [expired product administered]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B); and HEPATITIS A VACCINE INACT (HAVRIX). It was also a case of actual mediation error due to expired vaccine used administered (latency: on the same day). 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
- IPOL [POLIO VACCINE INACT 3V (VERO)]; PROQUAD; FLULAVAL; ENGERIX-B; HAVRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 56,0
- Geschlecht
- F
- Eingang
- 11.05.2021
- Impfdatum
- 21.04.2021
- Beginn
- 21.04.2021
- 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
No adverse event
Symptomtext
patient received an expired dose of TENIVAC/no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Apr-2021 from a health care professional via Medical Information (Reference number- 00571113) and transmitted to Sanofi on 21-Apr-2021. This case involves a 56 year-old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) on 21-Apr-2021 for prophylactic vaccination. On 21-Apr-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date 19-Apr-2021) via an intramuscular route at the right deltoid for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (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 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
- SHINGRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.05.2021
- Impfdatum
- 23.04.2021
- Beginn
- 23.04.2021
- 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
Product storage error
Symptomtext
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00575182) and transmitted to Sanofi on 23-Apr-2021. This case involves a male patient (age not reported) who received a 0.5 mL dose of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an unknown route in the deltoid for prophylactic vaccination on 23-Apr-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient did not receive any other medications or vaccinations at the time of reporting. This was a case of actual medication error case due to expired vaccine used (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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
- -
- Staat
- NE
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 07.05.2021
- Impfdatum
- 04.05.2021
- Beginn
- 07.05.2021
- Tage bis Beginn
- 3,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
No adverse event
Product storage error
Symptomtext
No adverse reaction is noted. Patient was given vaccine that was past expiration date.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 29,0
- Geschlecht
- F
- Eingang
- 06.05.2021
- Impfdatum
- 26.04.2021
- Beginn
- 26.04.2021
- 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
Symptomtext
29 year old female patient was administered expired dose of TENIVAC, with no adverse event; Initial information received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 29 year old female patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 26-Apr-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date: 19-Apr-2021) (Frequency: Once) via an intramuscular route at an the deltoid NOS (not otherwise specified) for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that this case was placed in proxy as there was no one available during the time of the attempted transfer. A call back is needed for assistance. The caller stated that her previous call was disconnected and is calling back because she wanted to know if there is any data supporting the use of expired TENIVAC. The caller stated that the product expired last week and was administered today. The caller would like to know if the patient must be revaccinated. The TENIVAC was given in the deltoid, but they not sure if it was left or right deltoid. No further information was provided. At the time of report no adverse event 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 06.05.2021
- Impfdatum
- 20.04.2021
- Beginn
- 20.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
patient inadvertently received an expired dose of TENIVAC with no reported adverse event; Initial information was received on 20-Apr-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a 17-year-old male patient who inadvertently received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered). Medical history, medical treatment(s) and family history were not provided. The patient's past vaccination(s) included DIPHTHERIA TETANUS ACELLULAR PERTUSSIS on 12-FEB-2021. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 20-Apr-2021, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA, expiry date-19-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (on the same day). At the time of report, no adverse event 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- IPOL [POLIO VACCINE INACT 3V (VERO)]; MMR; HEPATITIS B VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.05.2021
- Impfdatum
- 21.04.2021
- Beginn
- 21.04.2021
- 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
No adverse event
Symptomtext
patient received an expired dose of TENIVAC with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00572564) and transmitted to Sanofi on 22-Apr-2021. This case involves a female patient with age 65 or above who was administered with 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 21-Apr-2021. Medical history, past medical treatment(s), past vaccination(s), concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter wanted to know if there is a grace period? At the time of reporting, the patient experienced no specific 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 25.04.2021
- Impfdatum
- 10.04.2021
- Beginn
- 10.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
a 12 years old patient received TENIVAC instead of ADACEL/ No AE; Initial information received on 12-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse via (Reference number: 00557053). This case involves a 12 years old male patient who received a 0.5 ml first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6265AA, Frequency: once, Strength: Standard, Expiry date: 19-Apr-2021 via intramuscular route in the left deltoid on 10-Apr-2021 for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). The patient's past vaccination included Diphtheria, Tetanus, and Acellular Pertussis (DTAP) for which patient had completed five doses. The patient's medical history, medical treatments and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (latency: same day). Potential Product Technique Complain: No. Caller with question on whether dose of ADACEL needs to be administered. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 23.04.2021
- Impfdatum
- 21.04.2021
- Beginn
- 21.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Patient was given an expired Td dose. State consultant consulted and informed us to repeat the dose. We called and informed the parent and she voiced understanding.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -