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Reporte zur Charge U6603AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

11Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OR 2 IN 2 NC 1 MN 1 WV 1 KY 1 NJ 1 MI 1 CT 1

VAERS 1290395

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

mild
Staat
OR
Alter
17,0
Geschlecht
F
Eingang
05.05.2021
Impfdatum
03.05.2021
Beginn
03.05.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Fatigue Hyperaesthesia Injection site erythema Injection site pruritus Injection site swelling Injection site warmth Pyrexia

Symptomtext

2 days after vaccine administration right arm swollen, red, hot to the touch. Has been feeling generally fatigued, slight fever. Arm started swelling right away after shots, slowly worsening, worse in the evening, may be getting worse still 2 days later. Very sensitive to touch, itching "like crazy". Left arm slightly swollen but much less so. Treating at home with ice, acetaminophen, and diphenhydramine which do help temporarily.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Fatigue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
unknown, reports arm swelling with previous vaccinations

VAERS 2289169

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
NC
Alter
-
Geschlecht
F
Eingang
21.05.2022
Impfdatum
18.05.2022
Beginn
18.05.2022
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

give a TENIVAC dose today after it expired, with no reported adverse event; Initial information received on 18-May-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 60 years old female patient who was given a tenivac dose today after 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), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 18-May-2022, the patient received dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, ( lot: U6603AA ; expiry date: 05-Mar-2022) via intramuscular route in the left deltoid for immunization. It was reported that the patient was given a tenivac dose that day after it expired, with no reported adverse event (expired product administered) (onset date: 18-May-2022; latency: same day) 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 give a tenivac dose today after it expired, with no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
SHINGRIX
Allergien
-
Vorherige Impfungen
-

VAERS 2262032

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
MN
Alter
60,0
Geschlecht
M
Eingang
03.05.2022
Impfdatum
03.05.2022
Beginn
03.05.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered

Symptomtext

Vaccine expired on 03/05/2022

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
Toradol
Allergien
None
Vorherige Impfungen
-

VAERS 2209426

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
WV
Alter
74,0
Geschlecht
M
Eingang
31.03.2022
Impfdatum
31.03.2022
Beginn
31.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Expired dose of Td (tetanus & diphtheria) given. Expired 3/5/22, lot U6603AA. Notified poison control, advised to repeat dose. Patient notified of vaccine error, agreeable to have dose repeated.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none listed
Vorgeschichte
none listed
Andere Medikamente
unknow
Allergien
NKA
Vorherige Impfungen
-

VAERS 2183959

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
KY
Alter
-
Geschlecht
U
Eingang
17.03.2022
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

Patient was administered an expired Tenivac with no reported adverse event; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional via call center. This case involves an unknown age and unknown gender patient who was administered an 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 an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6603AA; expiry date: 05-Mar-2022; strength, frequency: unknown) at an unknown dose via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was administered an expired tenivac with no reported adverse event (expired product administered) (unknown latency) 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. 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 2179474

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
NJ
Alter
12,0
Geschlecht
M
Eingang
15.03.2022
Impfdatum
09.03.2022
Beginn
09.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

administered an expired dose of TENIVAC to a patient with no adverse event; Initial information received on 10-Mar-2022 regarding an unsolicited valid non-serious case from other health professional. This case involves a 12 years old male patient who was administered an expired dose of tenivac with no 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. Concomitant medications included Varicella zoster vaccine (Varicella vaccine); Hepatitis B vaccine; Polio vaccine and Measles, Mumps, Rubella vaccine (MMR)for Immunization. On 09-Mar-2022, the patient received a 0.25 mL to 2 mL dose of suspect Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot number: U6603AA; expiry date: 05-Mar-2022) via intramuscular route in the right arm for immunization. On 09-MAR-2022, the patient was administered an expired dose of tenivac with no adverse event (expired product administered) (latency: same day) following the administration of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event expired product administered.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
VARICELLA VACCINE; HEPATITIS B [HEPATITIS B VACCINE]; POLIO; MMR
Allergien
-
Vorherige Impfungen
-

VAERS 2179471

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
MI
Alter
57,0
Geschlecht
F
Eingang
15.03.2022
Impfdatum
07.03.2022
Beginn
07.03.2022
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 Medication error No adverse event

Symptomtext

An expired dose of TENIVAC was inadvertently administered, with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from the health care professional. This case involves a 57 years old female patient who was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (Tenivac), with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. No other vaccines administered. On 07-Mar-2022, the patient was inadvertently administered with an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids (dosage: 0.5 ml once; strength and formulation: not provided) (lot number: U6603AA, expiration date: 05-March-2022) via intramuscular route in the left deltoid for immunization (expired product administered) (latency: same day). The reporter asked whether dose needed repeating. No adverse event was reported. Action taken with diphtheria-2/tetanus-5 adsorbed toxoids 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 2128194

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
OR
Alter
-
Geschlecht
U
Eingang
19.02.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

temperature excursion due to the refrigerator door being left opened; Initial information received on 31-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2022SA036034. This case involves Adult and unknown gender patient who experienced temperature excursion due to the refrigerator door being left opened while receiving vaccines influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent], diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] and ipv (vero) [ipol] and while treated with caffeine, chlorphenamine maleate, dextromethorphan hydrobromide, ginger powder, hesperidin, licorice extract, methylephedrine hydrochloride, paracetamol [s. tac general] and althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil ([gardisil) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking S. TAC GENERAL (CAFFEINE, CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GINGER POWDER, HESPERIDIN, LICORICE EXTRACT, METHYLEPHEDRINE HYDROCHLORIDE, PARACETAMOL) Film-coated tablet dosage unknown (with an unknown batch number) and GARDISIL (ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL) formulation unknown dosage unknown (with an unknown batch number). On an unknown date, the patient received a dose of suspect IPV (VERO) lot T1D481M. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6603AA.Exp.date: 05MAR2022 On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ765AB. On an unknown date the patient developed a non-serious event " temperature excursion due to the refrigerator door being left opened" (product temperature excursion issue) (unknown latency) following the first dose intake CAFFEINE, CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GINGER POWDER, HESPERIDIN, LICORICE EXTRACT, METHYLEPHEDRINE HYDROCHLORIDE, PARACETAMOL, (unknown latency) following the first dose intake of ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL and MENTHA X PIPERITA ESSENTIAL OIL and following the administration of IPV (VERO), (unknown latency) ,DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and (unknown latency) and of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. it was reported " reporting a temperature excursion due to the refrigerator door being left opened resulting in the blower operating continuously causing a low temperature excursion. Caller reporting FLUZONE HIGH-DOSE QUADRIVALENT, GARDISIL, IPOL, and TENIVAC at a low of 0.5C for 405 minutes. Caller unsure if any opened IPOL MDVs. See related case #: 00957378TENIVAC Lot#: U6603AA, Exp.date: 05MAR2022 No further information provided by the reporter. This is reported as potential AE because of temperature excursion. To be evaluated. Reporter relationship : HCP Product used : Not Applicable" Action taken with poliomyelitis vaccine (inactivated) (ipol), diphtheria and tetanus toxoids (tenivac), althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (gardisil) and quadrivalent influenza vaccine (fluzone high-dose quadrivalent) was unknown. action taken with caffeine, chlorphenamine maleate, dextromethorphan hydrobromide, ginger powder, hesperidin, licorice extract, methylephedrine hydrochloride, paracetamol (s. tac general) was not applicable. It was not reported if the patient received a corrective treatment for the event (temperature excursion due to the refrigerator door being left opened). At time of reporting, the outcome was Unknown for the event temperature excursion due to the refrigerator door being left opened.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1908659

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
IN
Alter
32,0
Geschlecht
M
Eingang
30.11.2021
Impfdatum
15.11.2021
Beginn
15.11.2021
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

received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information was received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference:00860371). This case involves a 32-year-old male patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and not the prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to the staff member getting confused on the labeling between the two vaccines (product label confusion, wrong product administered) The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 15-Nov-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (0.5mL, lot U6603AA, expiry date: 05-Mar-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered). It was an actual case of medication error due to product label confusion and wrong vaccine administered (same day latency) It was reported "A clinic reporting a medication error described as a 32-year-old male received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines. The caller did not report a defect with the products but that the clinic was confused and chose the wrong product." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. There will be no information available on the lot number for ADACEL this case.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1901212

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
IN
Alter
32,0
Geschlecht
M
Eingang
26.11.2021
Impfdatum
15.11.2021
Beginn
15.11.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product label confusion Wrong product administered

Symptomtext

Stated that she gave a patient the Tenivac and should have been Adacel with no reported adverse event; staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 32-year-old male patient who stated that she gave a patient the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and should have been DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered) and staff member getting confused on the labeling between the two vaccines (product label confusion). The patient medical history, medical treatment(s), vaccination(s), and family history were not provided. No other concomitant vaccines reported. On 15-Nov-2021, the patient received a 0.50 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot U6603AA, expiry date: 05-Mar-2022] via an intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to wrong product administered and product label confusion [Latency: on the same day]. At time of reporting, the outcome was unknown for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
-

VAERS 1088938

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6603AA

gering
Staat
CT
Alter
39,0
Geschlecht
M
Eingang
10.03.2021
Impfdatum
04.02.2021
Beginn
01.02.2021
Tage bis Beginn
-
Dosis
4
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Inappropriate schedule of product administration

Symptomtext

PT REPORTED TO CLINIC ON 03/10/2021 TO RECIEVE HIS ANTHRAX VACCINATION. AFTER SCREENING THE PATIENTRECORD, WE NOTICED THAT INPUTED INTO SYSTEM TRANSCRIBED FOR A TDAP ON 01/09/2021 AND A TD WAS ADMINISTERED AT CLINIC IMMUNIZATIONS ON 02/04/2021.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-