- Staat
- SC
- Alter
- 62,0
- Geschlecht
- F
- Eingang
- 16.07.2022
- Impfdatum
- 19.03.2022
- Beginn
- 19.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Asthenia
Injection site pain
Musculoskeletal chest pain
Pain
Pain in extremity
Symptomtext
weakness/has massive bouts of weakness; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. She states that then it affected her legs as well; she received a TENIVAC from Sanofi-Pasteur and it hurt really bad; Initial information received on 05-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via call center. This case involves a 62 years old female patient who received a TENIVAC from sanofi-pasteur and it hurt really bad; the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well and weakness/has massive bouts of weakness after receiving vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided. On 19-Mar-2022, the patient received a 0.5 ml (total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA, frequency: once (unknown: strength, formulation and expiry date) via intramuscular route in the right deltoid for immunization. On 19-MAR-2022 the patient developed a non-serious event she received a TENIVAC from sanofi-pasteur and it hurt really bad (injection site pain) latency: same day. On 20-MAR-2022 the patient developed non-serious events the pain got worse and worse and it went from her arm and shoulder to both arms and shoulders and then to her ribs and then it was in her entire upper body from her waist up. she states that then it affected her legs as well (pain) with symptom Pain worsened (pain) and weakness/has massive bouts of weakness (asthenia) latency: 1 day following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. It was reported that the patient cut her hand in clean dishwater and she went to urgent care. Patient states that she was always had a high tolerance for pain but patient said "that is definitely not the case". The patient states that she has massive bouts of weakness which reduces her functionality as well. The patient states that this has been happening since 19Mar2022 but it has only gotten worse and it was worse towards the middle of May but it has never gotten better. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for the events asthenia, injection site pain and Not Recovered / Not Resolved for pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Musculoskeletal chest pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 22,0
- Geschlecht
- F
- Eingang
- 14.07.2022
- Impfdatum
- 11.07.2022
- Beginn
- 11.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site induration
Injection site oedema
Symptomtext
Erythema, edema, hardened area at site of injection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 62,0
- Geschlecht
- F
- Eingang
- 17.06.2022
- Impfdatum
- 19.03.2022
- Beginn
- 20.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: ja
Erholt: nein
Fatigue
Injection site pain
Loss of personal independence in daily activities
Pain
Pain in extremity
Symptomtext
Time of injection much pain, next day more pain in arm. Pain and extreme fatigue continued to progress daily/weekly until by May(2 months later) pain and fatigue intolerable and unable to function in normal capacity. Now 3 months later only getting worse, intolerable and no one seems to know how to help. I cannot go on like this.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None, No medical facility have yet to perform test or know of any.
- Aktuelle Erkrankungen
- Respiratory infection (sinus, throat and lung) for which I had just had a 5 day Z-pack and vancomycin for c-difficile 7 days. Illness onset Mar. 8,2022
- Vorgeschichte
- Asthma/centrilobular Emphasema, Venous insufficiency
- Andere Medikamente
- Ativan, Hydrocodone/acetaminophen 7.5-3.25, Adderall 10mg., Provigil, Protonix, Edarbi Blood pressure medicine . AsthmaLung deterioration.
- Allergien
- Garlic
- Vorherige Impfungen
- COVID Booster, 11/15/2021 swollen Lymph nodes, one month of extreme fatigue and illness
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- 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
tetanus vaccine was given to a patient that with expiration date of 1/22/2023 with no reported adverse events; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient and expired Tetanus Toxoid was given to a patient with no reported adverse events. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor. On an unknown date, the patient received an unknown dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number: U6922AA, Expiry date: 22-Jan-2023) (With an unknown formulation, strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date, expired Tetanus toxoid was given to a patient with no reported adverse events (expired product administered) (latency: same day). It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available. It was reported, expiration date of 1/22/2023 NDC 49281- 215-88, Lot: U6922AA. Please advise of step that should be taken to care for patient if detrimental. 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.07.2023
- Impfdatum
- 19.07.2023
- Beginn
- 19.07.2023
- 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
Symptomtext
expired tenivac was given to a patient with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Jul-2023, the patient received expired dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date: 22-Jan-2023) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation) 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
- -
- Staat
- FL
- Alter
- 36,0
- Geschlecht
- M
- Eingang
- 20.07.2023
- Impfdatum
- 18.07.2023
- Beginn
- 18.07.2023
- 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
expired TENIVAC was administered to a patient with no reported adverse event; Initial information received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 36 years old male patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] 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 18-Jul-2023, the patient received an expired dose of 0.5 ml (1x) (Frequency = once) of standard strength suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date: 31-Jan-2023) via intramuscular route in the right deltoid 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 56,0
- Geschlecht
- M
- Eingang
- 01.04.2023
- Impfdatum
- 14.03.2023
- Beginn
- 14.03.2023
- 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
No adverse event
Symptomtext
expired dose of tenivac was administered to a patient, with no reported adverse event; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 56 years old male patient who received expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Mar-2023, the patient received 0.5 ml dose (total) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids NO Preservative Adult Suspension for injection lot U6922AA and expiry: 22-Jan-2023 via intramuscular route in the right deltoid for immunization. On 14-Mar-2023, the patient developed a non-serious event expired dose of tenivac was administered to a patient, with no reported adverse event (expired product administered) same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. No lab data was reported. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (expired dose of tenivac was administered to a patient, with no reported adverse event). At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered to a patient, 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 22,0
- Geschlecht
- F
- Eingang
- 24.03.2023
- Impfdatum
- 16.03.2023
- Beginn
- 16.03.2023
- 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
patient received expired TENIVAC with no reported adverse event; Initial information received on 17-Mar-2023 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves a 22 years old female patient who received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 16-Mar-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, Suspension for injection (strength - standard, frequency - once, lot U6922AA, expiry date - 22-Jn-2023) via intramuscular route in the deltoid NOS for prophylactic vaccination (Immunization) that was expired with no reported adverse event (expired product administered) (Latency: same day) 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 67,0
- Geschlecht
- M
- Eingang
- 18.03.2023
- Impfdatum
- 07.03.2023
- Beginn
- 07.03.2023
- 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
an expired dose of TENIVAC was administered to a patient, with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult [Tenivac], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CNJ 20V (CRM197) (PREVNAR 20). On 07-Mar-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoid no preservative adult, Suspension for injection (strength - standard, frequency - once, lot - U6922AA, expiry date - 22-Jan-2023) via intramuscular route in the right deltoid for immunization. On 07-Mar-2023 the patient received expired dose of tenivac with no reported adverse event (expired product administered) (latency: same day) 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 56,0
- Geschlecht
- M
- Eingang
- 14.03.2023
- Impfdatum
- 14.03.2023
- Beginn
- 14.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Patient accidentally given Td vaccine that had expired January 22nd of 2023. Patient's last vaccine was 6-7 years ago.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 77,0
- Geschlecht
- M
- Eingang
- 24.02.2023
- Impfdatum
- 21.02.2023
- Beginn
- 21.02.2023
- 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
Symptomtext
blister; Received expired dose of tenivac; Initial information was received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves 77 years old male patient who had blister and received expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2023, the patient received a standard dose (booster) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL total (lot U6922AA, expiry date- 22-Jan-2023) via intramuscular route in unknown administration site for Immunization. On an unknown date the patient developed a non-serious event of blister (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. On 21-Feb-2023 the patient developed a non-serious event of expired dose was received for diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expired product administered) (latency- same day). It was reported, patient received and expired dose of TENIVAC. The patient had a blister on his finder. The caller is wanting to know if the patient needs to be revaccinated. No further information provided by reporter. Still using product : No Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (blister). 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 18.02.2023
- Impfdatum
- 10.02.2023
- Beginn
- 10.02.2023
- 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
an expired tenivac was given with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 17-year-old male patient to whom an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine; HPV VACCINE VLP RL1 4V (YEAST) (Gardasil); measles vaccine, mumps vaccine, rubella vaccine (MMR) and polio vaccine (Polio) all for Prophylactic vaccination. On 10-Feb-2023, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult at a dose of 0.5 ml once (lot U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the left deltoid for immunization. On 10-Feb-2023, an expired tenivac was given with no reported adverse event (expired product administered, latency: same day). 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS B VACCINE; GARDASIL; MMR; POLIO
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 21,0
- Geschlecht
- M
- Eingang
- 14.02.2023
- Impfdatum
- 06.02.2023
- Beginn
- 06.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Student was given an expired dose (1 week expired) prior to documentation & medical assistant did not check expiration prior to giving injection. Sanofi was notified & advised to give repeat dose, which was given same day as initial booster dose. Patient reported no adverse reactions in subsequent follow-ups x1 week.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- anxiety/depression
- Andere Medikamente
- Zoloft 100mg
- Allergien
- Penicillin
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.02.2023
- Impfdatum
- 08.02.2023
- Beginn
- 08.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
expired ADACEL was given to a 16-year-old male patient with no reported adverse event; Initial information received on 09-Feb-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 16 years old male patient who was administered expired diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra) for Immunisation; and polio vaccine INACT 3V (vero) (Ipol) for Immunisation. On 08-Feb-2023, the patient received an expired 0.5 mL dose 4 of suspect diphtheria-2/ tetanus/5 AC pertussis vaccine, suspension for injection (lot: U6922AA; expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired adacel was given to a 16-year-old male patient 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
- MENACTRA; IPOL [POLIO VACCINE INACT 3V (VERO)]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 58,0
- Geschlecht
- M
- Eingang
- 11.02.2023
- Impfdatum
- 08.02.2023
- Beginn
- 08.02.2023
- 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
No adverse event
Symptomtext
patient was administered expired tenivac with no reported adverse event; Initial information was received on 08-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 58 years old male patient who was received expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Concomitant medications included tozinameran (Pfizer biontech covid-19 vaccine) for Immunisation. On 08-Feb-2023, the patient was received expired suspect of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength: standard, formulation: Unknown) at dose of 0.5 ml once (lot: U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for Immunisation with no reported adverse event (expired product administered) (latency: same day) No lab data reported. Action taken: not applicable. Outcome: Unknown for the event patient was administered expired tenivac 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 04.02.2023
- Impfdatum
- 01.02.2023
- Beginn
- 01.02.2023
- 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
administered an expired dose of Tenivac with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 66 years old male patient who administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Feb-2023, the patient received 0.50 mL of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength: standard) (Frequency: once) (lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization. On 01-Feb-2023, the patient was administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired product administered). It was reported that "The clinic is wanting to know do they need to repeat the dose." 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 93,0
- Geschlecht
- F
- Eingang
- 02.02.2023
- Impfdatum
- 28.01.2023
- Beginn
- 28.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Vaccine was given on 1/28/23 and Td expired on 1/22/23. Pt did not have any adverse reactions as she monitored site vaccine was given in. She came back in a new vaccine was administered on 2/2/2023.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- Cellulitis
- Vorgeschichte
- Hypertension Hypothyroid Diabetes TypeII
- Andere Medikamente
- Amlodipine 5mg daily Trulicity 1.5mg/0.5ml 1ml weekly Amaryl 2mg daily Synthroid 50mcg daily Lisinopril 40mg daily
- Allergien
- No Known Allergies
- Vorherige Impfungen
- -
- Staat
- DC
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 01.02.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired Td vaccine was administered. Vaccine was administered on 1/26/23, expiration date was 1/22/23. Clinic has been unable to reach parent to notify expired vaccine was administered. No further adverse events known at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 40,0
- Geschlecht
- M
- Eingang
- 01.02.2023
- Impfdatum
- 27.01.2023
- Beginn
- 27.01.2023
- 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
No adverse event
Symptomtext
expired dose of TENIVAC was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40 years old male patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Jan-2023, the patient received a 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no adverse event (frequency: once, strength: standard, expiry date: 22-Jan-2023 and lot U6922AA) via intramuscular route in the left deltoid as Immunization (expired product administered). 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 80,0
- Geschlecht
- F
- Eingang
- 01.02.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- 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
expired dose of Tenivac was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 80 years old female patient who was administered with expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jan-2023, the patient received 0.5 ml total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (Strength: Standard; lot number: U6922AA, expiry date: 22-Jan-2023, frequency: once) via intramuscular route in the right deltoid for immunization. On 26-Jan-2023, the patient was administered with expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired product administered) (latency: same day). Action taken: not applicable. It was reported Caller reported an expired dose of TENIVAC was administered and is requesting validity and safety information. At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 31.01.2023
- Impfdatum
- 26.01.2023
- Beginn
- 26.01.2023
- 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
Expired TENIVAC was administered with no reported AE; Initial information received on 26-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 66 years old male patient who experienced expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] was administered with no reported AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jan-2023, the patient received a 0.5 ml (frequency: once), dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no reported AE (strength and formulation: unknown, expiry date: 22-Jan-2023, lot U6922AA) via intramuscular route in the left deltoid as immunization (expired product administered). No lab data was reported. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 31.01.2023
- Impfdatum
- 25.01.2023
- Beginn
- 25.01.2023
- 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
No adverse event
Symptomtext
expired dose of TENIVAC was administered ,with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old female patient tp whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] 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 25-Jan-2023, the patient received a expired 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) with no reported adverse event (expired product administered) (lot U6922AA, expiry date: 25-JAN-2023 and strength not reported) via intramuscular route in left deltoid as immunization. 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.01.2023
- Impfdatum
- 25.01.2023
- Beginn
- 25.01.2023
- 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
administered TENIVAC that expired 3 days ago with no reported adverse event; Initial information was received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that expired 3 days ago with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Jan-2023, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry 22-Jan-23) (expired product administered, latency same day) (dose formulation and strength: unknown) via unknown route in unknown administration site for prophylactic vaccination. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. At time of reporting, the outcome was Unknown for the event administered tenivac that expired 3 days ago 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 75,0
- Geschlecht
- F
- Eingang
- 30.01.2023
- Impfdatum
- 24.01.2023
- Beginn
- 24.01.2023
- 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
administered an expired dose of TENIVAC with no reported adverse event; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 75 years old female patient who was administered an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Jan-2023, the patient received 0.5 of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry 22-Jan-23) (expired product administered, latency same day) (formulation and strength: unknown) via intramuscular route in deltoid NOS for prophylactic vaccination. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. At time of reporting, the outcome was Unknown for the event administered an expired dose of tenivac 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.01.2023
- Impfdatum
- 25.01.2023
- Beginn
- 25.01.2023
- 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
we gave a vaccine to a patient today and it expired with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient where we gave a vaccine to a patient today and it expired with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac]. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On 25-Jan-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (batch number- U6922AA) via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) as Immunization. On 25-Jan-2023 the patient had developed a non-serious we gave a vaccine to a patient today and it expired with no reported adverse event (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Action taken- Not applicable. At time of reporting, the outcome was Unknown for the event we gave a vaccine to a patient today and it expired 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 28.01.2023
- Impfdatum
- 23.01.2023
- Beginn
- 23.01.2023
- 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
No adverse event
Symptomtext
Tenivac that expired yesterday, was given today with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that expired yesterday, was given today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO) for Immunisation. On 23-Jan-2023, the patient received ).5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization. On 23-Jan-2023 the patient developed a non-serious event of tenivac that expired yesterday, was given today with no reported adverse event (expired product administered) (Latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. It was not reported if the patient received a corrective treatment for the event . 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 21,0
- Geschlecht
- F
- Eingang
- 26.01.2023
- Impfdatum
- 23.01.2023
- Beginn
- 23.01.2023
- 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
2 expired doses of tenivac were administered today 9with no reported adverse event); Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 year old female patient who was administered expired doses of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 23-Jan-2023, the patient received an 0.5 mL dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength - unknown, frequency - once (1x), lot U6922AA and expiry date - 21-Jan-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event) (expired product administered) (unknown 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 48,0
- Geschlecht
- M
- Eingang
- 26.01.2023
- Impfdatum
- 23.01.2023
- Beginn
- 23.01.2023
- 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
No adverse event
Symptomtext
patient received an expired TENIVAC/ that expired yesterday (with no reported adverse event); Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 48 years old male patient who received an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] that expired yesterday with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jan-2023, the patient received 0.5 mL expired dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength: standard) (lot: U6922AA; expiry date: 22-Jan-2023) via intramuscular route in the left arm for immunization with no reported 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 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 48,0
- Geschlecht
- M
- Eingang
- 23.01.2023
- Impfdatum
- 23.01.2023
- Beginn
- 23.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
Symptomtext
pt was given td injection 1/23/23. expiration date was 1/22/23
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- diabetes
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 37,0
- Geschlecht
- F
- Eingang
- 23.01.2023
- Impfdatum
- 23.01.2023
- Beginn
- 23.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Expired vaccine administered to patient. No adverse reactions noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 22,0
- Geschlecht
- M
- Eingang
- 22.11.2022
- Impfdatum
- 22.11.2022
- Beginn
- 22.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Circumstance or information capable of leading to medication error
Wrong product administered
Symptomtext
Patients were mentally delayed brothers with similar names and they told me the wrong name. The patient's mother stated that they do this all the time and she apologized for not catching it. Patient received an HPV vaccine that his brother should have received. They both also received tetanus and flu vaccines.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Circumstance or information capable of leading to medication error
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Mental delay
- Andere Medikamente
- Unknown
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 77,0
- Geschlecht
- M
- Eingang
- 25.10.2022
- Impfdatum
- 25.10.2022
- Beginn
- 25.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
Symptomtext
Vaccinated too early
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 65,0
- Geschlecht
- M
- Eingang
- 26.08.2022
- Impfdatum
- 22.08.2022
- Beginn
- 22.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
Pt received Tenivac vaccine instead of Prevnar 20 vaccine. No adverse reactions noted at time of administration. Pt notified via telephone 30 min following, denied adverse reaction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- HTN, HLD, arthritis, basal cell carcinoma of skin, depression, diverticulitis, irregular heartrate, direct inguinal hernia
- Andere Medikamente
- Gabapentin, Pantoprazole, Flonase, Losartan-HCTZ, fluoxetine, ciprofloxacin, atorvastatin, Vit D3, Co-Q
- Allergien
- Demerol, latex
- Vorherige Impfungen
- -
- Staat
- DE
- Alter
- 9,0
- Geschlecht
- M
- Eingang
- 23.03.2022
- Impfdatum
- 18.03.2022
- Beginn
- 18.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
Child was seen in clinic 9/16/2021 and RN administering vaccines did not document in system, so no record was made. He received immunizations 2/18/2022. Error was found after immunizations were administered 3/18/2022. He received Td/Tdap 3rd dose 5 months too early on 3/18/2022. No Adverse events, treatment, and or outcomes were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.02.2022
- Impfdatum
- 21.02.2022
- Beginn
- 21.02.2022
- 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
No adverse event
Symptomtext
employees gave someone expired Tenivac with no reported adverse event.; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age male patient who reported employees gave someone expired tenivac with no reported adverse event. while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA via unknown route in unknown administration site for immunization.. On 21-FEB-2022 the patient developed a non-serious employees gave someone expired tenivac with no reported adverse event. (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Latency: same day). Action taken: Not applicable. At time of reporting, the outcome was Unknown for the event employees gave someone expired tenivac 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- 12.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
14 year old female was given Tenivac instead of Boostrix, with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00814581). This case involves a 14-years-old female patient who was by mistake given dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [BOOSTRIX]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccination. On 12-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6922AA and expiry date:22-Jan-2023) (Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (latency on same day). It was reported caller would like to know how long to wait before administering the proper vaccine for patient's age range. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml. 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
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HPV VACCINE; MENVEO
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- 67,0
- Geschlecht
- M
- Eingang
- 10.08.2021
- Impfdatum
- 10.08.2021
- Beginn
- 10.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
Patient called the pharmacy after receiving these 2 vaccines to state he had already received 2 shingrix doses and we just administered a 3rd. Upon review it was discovered his 2nd shingrix dose on 11-17-20 was not put in our state reporting database WIR. Upon review of pharmacy records it was discovered patient had received Shingrix on 9-18-20, 11-17-20 and 08-10-21
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 47,0
- Geschlecht
- F
- Eingang
- 05.08.2021
- Impfdatum
- 29.07.2021
- Beginn
- 01.08.2021
- Tage bis Beginn
- 3,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Skin mass
Symptomtext
3 days after vaccination, patient developed subcutaneous tissue swelling (small subcutaneous nodules) over her left arm, right upper arm, and neck area. No overlying rash on the skin. Symptoms resolved after 3 days of Ibuprofen.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin mass
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -