VAERS Reports U6669AA

VAERS 902185

UNKNOWN MANUFACTURER · TD ADSORBED (NO BRAND NAME) · Charge U6669AA

moderat

Staat: VA
Alter: 68,0
Geschlecht: M
Eingang: 28.01.2021
Impfdatum: 11.12.2020
Beginn: 11.12.2020
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

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

Body temperature increased Fatigue Injected limb mobility decreased Injection site pain Loss of personal independence in daily activities Malaise Myalgia Pain Pain in extremity Sleep disorder

Symptomtext

Unable to do regular activities; Could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper atm to 90 degrees; Could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper atm to 90 degrees; Soreness right arm/pain left upper arm; Myalgias; Elevation of temperature; Malaise; Fatigue; Cannot sleep on left side; This spontaneous case was retrieved on 14-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS), reported by other non-health professional (consumer) and concerned a 68-year-old, male patient. The patient's concurrent conditions included latex allergy. The patient's concomitant medications included B12 (cyanocobalamin), unspecified vitamin A, unspecified vitamin D, Osteo Bi-Flex (chondroitin sulfate; glucosamine hydrochloride), all used for an unreported indication. On 11-Dec-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 279799. On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax (pneumococcal vaccine polysacch 23v; dose: reported as one, route of administration: intramuscular, anatomical location: left arm, batch number: s012247 and indication: not reported) and tetanus and diphtheria toxoids adsorbed (brand not specified; dose: reported as one, route of administration: intramuscular, anatomical location: left arm, batch number: U6669AA and indication: not reported). On the same day after receiving Fluad Quadrivalent and co-suspects Pneumovax and tetanus and diphtheria toxoids adsorbed, the patient developed malaise, myalgias, mild elevation of temperature and fatigue. He was unable to do regular activities. The patient used Tylenol (paracetamol) at unknown dose as corrective treatment and it helped. He spent following day on the couch. Also, the patient had mild soreness in his right arm, moderate to severe pain in his left upper arm, he could not raise his arm beyond 20 degrees without increased pain and could not abduct his upper arm to 90 degrees. The patient still could not sleep on left side for at least three nights. At the time of initial reporting, the patient had not recovered from the events. The reporter did not provide causality assessment. The event of 'activities of daily living impaired' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 68-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax and tetanus and diphtheria toxoids adsorbed. On the same day after vaccination, the patient developed malaise, myalgias, pain in extremity, mobility decreased, mild elevation of temperature and fatigue. Reportedly, the patient was unable to do regular activities (Loss of personal independence in daily activities). The patient still could not sleep on left side due to pain. Sleep disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for remaining events.; Sender's Comments: A 68-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, the patient was also vaccinated with non-company, co-suspect vaccines: Pneumovax and tetanus and diphtheria toxoids adsorbed. On the same day after vaccination, the patient developed malaise, myalgias, pain in extremity, mobility decreased, mild elevation of temperature and fatigue. Reportedly, the patient was unable to do regular activities (Loss of personal independence in daily activities). The patient still could not sleep on left side due to pain. Sleep disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for remaining events.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injected limb mobility decreased
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Latex allergy
Vorgeschichte: -
Andere Medikamente: B12 [CYANOCOBALAMIN]; VITAMIN A NOS; VITAMIN D [VITAMIN D NOS]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]
Allergien: -
Vorherige Impfungen: -

VAERS 2261813

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge u6669aa

mild

Staat: CA
Alter: 57,0
Geschlecht: M
Eingang: 03.05.2022
Impfdatum: 22.10.2021
Beginn: 22.10.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SYR / LA

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

Pain in extremity Sleep disorder Wrong product administered

Symptomtext

This patient received separate shots of Hep A and Hep B in the R Deltoid (2 mL of fluid) rather than Twinrix. The patient is already vaccinated for Hep B per records. The patient also received Tdap in the L Deltoid. Patient is complaining of constant 2-3/10 pain in the right arm since 10/22/21. Patient states that the pain spikes to 7-9/10 with motion or laying on the limb. It wakes him out of a dead sleep if he rolls onto the right side.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain in extremity
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: None known at this time
Allergien: NKDA
Vorherige Impfungen: -

VAERS 1984908

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

mild

Staat: KY
Alter: 28,0
Geschlecht: F
Eingang: 28.12.2021
Impfdatum: 27.12.2021
Beginn: 27.12.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RA

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

Pruritus Urticaria

Symptomtext

Patient developed hives on back and neck 4 hours and 30 minutes after receiving injection. Took Benadryl 25mg but itching did not subside, went to Clinic and received steroid injection.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pruritus
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: Penicillin
Vorherige Impfungen: -

VAERS 1415441

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

mild

Staat: MN
Alter: 48,0
Geschlecht: F
Eingang: 21.06.2021
Impfdatum: 20.07.2020
Beginn: 20.07.2020
Tage bis Beginn: 0,0
Dosis: N/A
Route/Site: IM / LA

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

Injection site pain X-ray limb

Symptomtext

left upper arm/shoulder pain started at time of vaccine, waxed and waned over subsequent 11 months. Treated with NSAIDs and ice and activity modification without resolution. Currently referred to orthopedics for management.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site pain
Hospital-Tage: -
Labordaten: XRay 6/21/2021
Aktuelle Erkrankungen: none
Vorgeschichte: complex regional pain syndrome right foot, adjustment disorder with anxious mood, migraines, developmental delay
Andere Medikamente: sertraline, Calcium, vitamin D, multivitamin, micronor
Allergien: penicillin, oxybutynin, augmentin
Vorherige Impfungen: -

VAERS 922746

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6669AA

mild

Staat: VA
Alter: 38,0
Geschlecht: F
Eingang: 05.01.2021
Impfdatum: 31.12.2020
Beginn: 01.01.2021
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: IM / RA

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

Erythema Pain in extremity Pyrexia SARS-CoV-2 test negative

Symptomtext

01/01/2021 - pt developed R arm pain, fever up to 102+ on 01/02/2021 seen in MedXpress - neg covid & rapd covid. Developed significant redness in L upper arm that spread. Fever continued but controlled with tylenol & ibuprofen. Redness, temp & pain improving on visit 01/04/2021.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pain in extremity
Hospital-Tage: -
Labordaten: Rapid covid; send off covid.
Aktuelle Erkrankungen: Left ear pain & tenderness 4-5 days - erythma tender on targus
Vorgeschichte: Asthma; Hx ITP- sphenectomy
Andere Medikamente: Singulair; Zyrtec; NuvaRing; ARnuity Elipta; Albuterol inh.
Allergien: Bactrim
Vorherige Impfungen: -

VAERS 2440286

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: OH
Alter: -
Geschlecht: F
Eingang: 12.09.2022
Impfdatum: 29.08.2022
Beginn: 29.08.2022
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

Patient was administered with an expired dose of Tenivac with no reported adverse events; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center. This case involves an 80 years old female patient who was administered with an expired dose of Tenivac with no reported adverse events 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 29-Aug-2022, the patient was administered with an expired dose of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac] (batch/lot number: U6669AA; expiration date: 15-May-2022; formulation, strength, dose: unknown) via intramuscular route in unknown administration site (expired product administered) (latency: same day). No adverse event was reported following expired product administered. Seriousness criteria: non-serious 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: -

VAERS 2440284

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 12.09.2022
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 No adverse event

Symptomtext

an expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was had an expired dose of tenivac was administered to a patient 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 an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength, dose, route and administration site not reported; lot U6669AA, expiry date: 15-May-2022) for prophylactic immunization. On an unknown date, the patient developed a non-serious event of an expired dose of tenivac was administered to a patient with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. It was reported, "an expired dose of TENIVAC was administered to a patient. The TENIVAC had expired on 15MAY2022". Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2424154

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: OH
Alter: 80,0
Geschlecht: F
Eingang: 30.08.2022
Impfdatum: 29.08.2022
Beginn: 29.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / -

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

Expired product administered

Symptomtext

TENIVAC WAS GIVEN ON 8-29-22 BUT WAS EXPIRED ON MAY 15 2022. PER CDC GUIDELINES DOSE WAS REPEATED ON 8-30-22.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2404212

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: MD
Alter: 64,0
Geschlecht: M
Eingang: 08.08.2022
Impfdatum: 29.07.2022
Beginn: 29.07.2022
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

given an expired Tenivac to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 64 years old male patient and it was reported that an expired Tenivac to a patient with no reported adverse event , and the case involves a 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. No other concomitant was used On 29-Jul-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, (frequency: once) ( lot: U6669AA ; expiry date: 15-May-2022) via intramuscular route in the left deltoid for immunization. It was reported that on 29-Jul-2002, an expired Tenivac was given to a patient 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 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: -

VAERS 2341802

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge u6669aa

gering

Staat: KS
Alter: 60,0
Geschlecht: M
Eingang: 29.06.2022
Impfdatum: 28.06.2022
Beginn: 28.06.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

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

Expired product administered

Symptomtext

The patient made an appointment with the pharmacy to receive a Td of Tdap vaccine following the possibility of a recent exposure to tetanus. The patient also made an appointment to receive a fourth dose of the Pfizer Covid booster. They stated they recently had surgery on their right arm and wanted both vaccines in their left arm. The Td vaccine was administered first, followed by the Pfizer. The patient waited in the pharmacy for 15 minutes following the Pfizer vaccine. The documentation was filled out and it was discovered that the Td vaccine that was administered expired 05.15.22. The manufacturer was contacted and they stated the patient should be revaccinated. The patient was notified of the mistake and made an appointment to be revaccinated on 06.30.22.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2322986

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: IA
Alter: 70,0
Geschlecht: F
Eingang: 17.06.2022
Impfdatum: 09.06.2022
Beginn: 09.06.2022
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

received a Tenivac immunization that was later noted to have already expired with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 70 years old female patient who experienced received a tenivac immunization that was later noted to have already 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), vaccination(s) and family history were not provided. On 09-Jun-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, once ( lot: U6669AA ; Expiry date: 15-May-2022) via intramuscular route in the right deltoid for immunization. Medical assistant reported that the patient received a Tenivac immunization that was later noted to have already expired with no reported adverse event (expired product administered) (onset date: 09-Jun-2022; 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 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: -

VAERS 2322956

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: NC
Alter: -
Geschlecht: U
Eingang: 17.06.2022
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

received an expired dose of TENIVAC with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received 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 an unknown date, the patient an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; expiry date:15-May-2022) 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 received 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: -

VAERS 2309803

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: IA
Alter: 26,0
Geschlecht: F
Eingang: 06.06.2022
Impfdatum: 24.05.2022
Beginn: 24.05.2022
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

an expired dose of TENIVAC was inadvertently administered to a patient with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 26 years old female patient whom an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was inadvertently 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 24-May-2022, the patient received an expired dose 0.5 ml of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; Expiry date: 15-May-2022) via intramuscular route in unknown administration site for Immunization inadvertently with no reported adverse event (expired product administered). Action taken : not applicable. At time of reporting, the outcome was Unknown for the event an expired dose of tenivac was inadvertently 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: -

VAERS 2289168

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: IA
Alter: 65,0
Geschlecht: F
Eingang: 21.05.2022
Impfdatum: 17.05.2022
Beginn: 17.05.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

states that they had a dose of tenivac which expired 15may2022/states they administered the tenivac to a patient today,with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional via Physician. This case involves a 65 years old female elderly patient who states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,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) and family history were not provided. No patient history and risk factors provided. The patient's past vaccination(s) included TDaP in 2007 for Prophylactic vaccination. Concomitant medications included Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20) for Prophylactic vaccination. On 17-May-2022, the patient received 0.5 ml (TOTAL) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (lot U6669AA; expiry date: 15-May-2022) (strength, formulation: unknown) via intramuscular route (administration site: Left upper extremity) for Immunization. On 17-MAY-2022 the patient states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,with no reported adverse event (expired product administered) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. No lab data was reported. Action taken with Diphtheria and Tetanus Toxoids (Tenivac) was not applicable. At time of reporting, the outcome was Unknown for the event (expired product administered). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2109234

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: NY
Alter: -
Geschlecht: U
Eingang: 12.02.2022
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

No adverse event Product storage error

Symptomtext

temperature excursion/ The excursion lasted for 80 hours instead of the 15 hours previously reported/ The maximum temperature of the refrigerator reached 59.1 degrees Fahrenheit not 52.2 degrees Fahrenheit with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited processed from non case to valid non-serious case received from a other health professional. This case involves a patient with unknown demographics who had temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit with no reported adverse event while receiving vaccines [DAPTACEL],[ADACEL], [FLUZONE QUADRIVALENT], [IPOL] and [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656 via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7055AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot 5RM39 via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6669AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPV (VERO) lot T1E872M via unknown route in unknown administration site. On an unknown date the patient had temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (temperature excursion/ The excursion lasted for 80 hours instead of the 15 hours previously reported/ The maximum temperature of the refrigerator reached 59.1 degrees Fahrenheit not 52.2 degrees Fahrenheit with no reported adverse event). At time of reporting, the outcome was Unknown for the event temperature excursion/ the excursion lasted for 80 hours instead of the 15 hours previously reported/ the maximum temperature of the refrigerator reached 59.1 degrees fahrenheit not 52.2 degrees fahrenheit 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. Additional information was received on 31-Jan-2022 from other health care professional:Case updated from non case to valid case.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2087713

SANOFI PASTEUR · TD ADSORBED (NO BRAND NAME) · Charge U6669AA

gering

Staat: PA
Alter: 90,0
Geschlecht: F
Eingang: 04.02.2022
Impfdatum: 08.10.2021
Beginn: 14.10.2021
Tage bis Beginn: 6,0
Dosis: UNK
Route/Site: IM / RA

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

Confusional state Contusion Fall Sudden onset of sleep

Symptomtext

Prior to the tetanus shot, the patient was very active and alert, doing word searches, Bible study and reading, watching TV, going out to eat with family and friends, etc. Since the shot was given, she has become confused and keeps falling asleep more often while eating at the table, reading the newspaper, watching TV, etc. She fell asleep in church two Sundays in a row with her head on her lap and has fallen asleep at home while sitting in her chair quite often. She fell asleep while folding clothes, fell to the floor, and bruised her legs. She was admitted to the hospital and everyone was informed that she had received the tetanus shot. It was not as noticeable at first but has progressively become worse.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Confusional state
Hospital-Tage: 11,0
Labordaten: Although everyone at the hospital was informed the shot had been given, there were no tests administered to see why the patient keeps falling asleep since the injection.
Aktuelle Erkrankungen: High Blood Pressure, Goiter
Vorgeschichte: -
Andere Medikamente: Amlodipine, Cholecalciferol, Irbesartan, Pravastatin Sodium, Propranolol, Preservision, Omega, Vitamin E
Allergien: Penicillins
Vorherige Impfungen: -

VAERS 1756441

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: TX
Alter: 28,0
Geschlecht: M
Eingang: 02.10.2021
Impfdatum: 27.09.2021
Beginn: 27.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RA

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

No adverse event Wrong product administered

Symptomtext

patient received TENIVAC rather than ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00787288) and transmitted to Sanofi on 27-Sep-2021. This case involves a 28-year-old male patient who received a 0.5 mL (total, once) dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6669AA, expiry date 15-May-2022) via intramuscular route in the right deltoid on 27-Sep-2021 for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to wrong vaccine administered (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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1299381

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6669AA

gering

Staat: FL
Alter: 22,0
Geschlecht: F
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

Medication error No adverse event Wrong product administered

Symptomtext

patient received Tenivac instead of Adacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (Reference number- 00574999) and transmitted to Sanofi on 23-Apr-2021. This case involves a 22-year-old female patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6669AA and expiry date: 15-May-2022) via an intramuscular route in the left deltoid for prophylactic vaccination on 23-Apr-2021 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error case due to wrong vaccine administered (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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -