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Reporte zur Charge U6831AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

38Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 5 VA 3 PA 2 CO 2 CA 2 OH 2 OK 2 AZ 2 GA 2 IL 2 MS 1 IN 1

VAERS 2032634

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge u6831aa

schwer
Staat
MS
Alter
26,0
Geschlecht
F
Eingang
13.01.2022
Impfdatum
11.01.2022
Beginn
12.01.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Mobility decreased Muscle contractions involuntary Seizure like phenomena

Symptomtext

Patient reports she had contractions and seizure-like activity, as if she had tetanus. She said her hands twisted and locked up. This occurred the day following her vaccine. She is fine now.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure like phenomena
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
ADHD
Andere Medikamente
Vyvanse
Allergien
None
Vorherige Impfungen
-

VAERS 1825723

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

schwer
Staat
GA
Alter
21,0
Geschlecht
F
Eingang
28.10.2021
Impfdatum
25.10.2021
Beginn
25.10.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Abdominal pain Dizziness Hypoaesthesia Hypopnoea Laboratory test Muscle spasms Nausea Pain Screaming Syncope Vomiting

Symptomtext

After vaccines given pt felt faint and nauseous, RN placed in supine position, cold wash cloth applied to forehead, neck. Pt stated she had not eaten that morning. After 5 mins in supine position pt placed in semi-supine position, pt fainted and again placed in supine position. Pt opened eyes to name being called. Started vomiting and complaining of numbness in arms, buttocks, and legs. Started screaming reporting severe abdominal pain and positioned self in fetal position. Stated she started menses last night 10/24/21 and stated, "I think the vaccines are causing me to have severe cramps." VS remained stable, O2 was applied at 2 L/NC because pt wasn't taking deep breaths due to pain. EMS was called at 0915 when pain continued to become more severe. Pt's Father called and came and followed ambulance to hospital.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Syncope
Hospital-Tage
-
Labordaten
Labs performed in ER, results uknown by reporter
Aktuelle Erkrankungen
REPORTS STARTED MENSTRUAL CYCLE THE NIGHT BEFORE
Vorgeschichte
ANXIETY
Andere Medikamente
NONE KNOWN
Allergien
BENZYL PEROXIDE-HIVES IBUPROFEN-ANAPHYLAXSIS (FATHER THIS IS ACTUALLY AN ALLERGY FOR PT'S MOTHER BUT THEY LIST UNDER CHILDREN AS WELL BECAUSE THEY AREN'T SURE.)
Vorherige Impfungen
-

VAERS 2278613

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

moderat
Staat
ME
Alter
51,0
Geschlecht
F
Eingang
16.05.2022
Impfdatum
16.05.2022
Beginn
16.05.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Mobility decreased Neuropathy peripheral Pain in extremity

Symptomtext

Vaccine administered by RN in left deltoid. Pt tolerated immunization well and discharged from facility. Pt presented to facility a second time on 5/16/22 at 1505 reporting pain in left arm with some difficulty moving and neuropathy onset after injection. Pt evaluated by PA-C who is concerned for vaccine related injury. Pt allergic to oral NSAIDs. Provider advised trialing topical voltaren gel and placed a referral to orthopedics fro evaluation. Provider instructed pt to follow up with PCP in 1 week if symptoms aren't improved.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Mobility decreased
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
none
Vorgeschichte
Vitamin D deficiency, obesity, hypothyroidism, hypercholesterolemia, anxiety, fibromyalia, Chrons disease, depression
Andere Medikamente
levothyroxine 112 mCg, OTC Tylenol capsules
Allergien
Advil, amitriptyline, augmentin, ceclor, codeine, iodine, Lexapro, NSAIDs, penicillins
Vorherige Impfungen
per nursing note pt had a previous, unspecified reaction to pertussis vaccine. No additional details available.

VAERS 2480618

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
FL
Alter
16,0
Geschlecht
M
Eingang
17.10.2022
Impfdatum
11.10.2022
Beginn
11.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered Injection site pain Pyrexia

Symptomtext

Td vaccine given to the patient that was expired for 3 days. Mother reports that child had low grade subjective fever last night, mother gave him tylenol and he felt better, he woke up well next morning, with mild soreness at injection site, and was able to go to school. Mother advised to monitor child's symptoms. Follow up appointment schedule. All questions and concerns were discussed at length with mother.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2473354

MASS. PUB HLTH BIOL LAB · TD ADSORBED (TDVAX) · Charge U6831AA

mild
Staat
MI
Alter
46,0
Geschlecht
F
Eingang
10.10.2022
Impfdatum
06.10.2022
Beginn
06.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Dizziness postural Gait disturbance

Symptomtext

I received the IM inj and walked out of the room to talk to billing and I was waiting a minute and started feeling dizzy while i was standing. So I decided to get my labs drawn in the other room while i was waiting so that i could sit down. I sat down, dizzy stopped, my blood was drawn and then I stood back up and dizzy returned. Then went back to billing and sat. Once I stood up after talking to billing the dizzy was worse. I was walking sideways to my car. I drank a latte for blood sugar, no difference. Dizzy got worse and it subsided after 6 hours.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness postural
Hospital-Tage
-
Labordaten
None. The doctors office said i could be dehydrated or low sugar from fasting for the labs. But I was not because everyday I drink 1-1.5L of water AND I drank a latte to see if that helped and it didn't. Also, doctors office said it could be vaso-vagel response to seeing my blood drawn. But I see blood all of the time. I am used to it. Plus, vaso-Vogel response doesn't last for 6 hours. The vaccination that I was administered was due to expire at 10/8/22. That's 2 days. Related??
Aktuelle Erkrankungen
None
Vorgeschichte
Hereditary Spherocytosis and Arthritis
Andere Medikamente
Estradiol 0.5mg po @ 0700am and Allegra po @ 0700am
Allergien
None
Vorherige Impfungen
-

VAERS 1959163

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
VA
Alter
69,0
Geschlecht
M
Eingang
17.12.2021
Impfdatum
17.12.2021
Beginn
17.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dizziness Nausea

Symptomtext

After 15 minutes of the vaccination patient became dizzy and nausea. Gave patient water and candy bar. Patient feels better after water and candy bar.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dizziness
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
famotidine, clonazepam, doxazosin, paroxetine, brimonidine, atorvastatin
Allergien
none
Vorherige Impfungen
-

VAERS 1821752

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
TX
Alter
31,0
Geschlecht
F
Eingang
27.10.2021
Impfdatum
15.10.2021
Beginn
16.10.2021
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthralgia Pain in extremity

Symptomtext

Employee reports generalized arm pain after vaccine and then the morning after the vaccine reports pain in the shoulder when reaching above shoulder height or across her midline.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
Endometriosis
Andere Medikamente
None
Allergien
Ciprofloxacin
Vorherige Impfungen
-

VAERS 1818735

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
CA
Alter
59,0
Geschlecht
F
Eingang
26.10.2021
Impfdatum
20.10.2021
Beginn
21.10.2021
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site macule Injection site pain Injection site reaction Macule

Symptomtext

Day after vaccine she had pain from area of inmunization down to elbow and 2 days ago it became red to a diameter size of about 3 1/2 to 4/12 inches and it has an erythethous macule

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
hypothyroid, well controlled
Vorgeschichte
as above
Andere Medikamente
Euthyrox and collagen OTC/latter
Allergien
none known
Vorherige Impfungen
-

VAERS 1788162

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
NY
Alter
57,0
Geschlecht
F
Eingang
15.10.2021
Impfdatum
13.10.2021
Beginn
13.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain

Symptomtext

pain at the injection site resolving

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
unknown
Vorgeschichte
unkown
Andere Medikamente
unkown
Allergien
unkown
Vorherige Impfungen
-

VAERS 1653387

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
OK
Alter
34,0
Geschlecht
F
Eingang
29.08.2021
Impfdatum
13.08.2021
Beginn
13.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Chills Injection site pain Injection site swelling Injection site warmth Joint range of motion decreased Joint stiffness Myalgia Pain Pyrexia

Symptomtext

aches and pains; patient has decreased range of motion of left arm; joint stiffness; chills; myalgia; fever; progressively worsening swelling at injection site; patient was positive for 3 centimeter raised injection site reaction that is tender to palpation; patient was positive for 3 centimeter raised injection site reaction that is warm to touch; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a physician via Medical Information (Reference number- 00727956). This case involves a 34 year old female patient who experienced myalgia, fever (pyrexia), chills, joint stiffness, aches and pains, (pain), decreased range of motion of left arm (mobility decreased), progressively worsening swelling at injection site (vaccination site swelling), patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch (vaccination site pain) and (vaccination site warmth), while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 13-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date: 08-Oct-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. On 13-Aug-2021, the patient developed a non-serious event "She returned to office on 17-Aug-2021 with complaints of progressively worsening swelling at injection site" (vaccination site swelling), myalgia, fever (pyrexia), "physician states on physical exam patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch" (vaccination site pain) and (vaccination site warmth), on same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. On an unknown date, the patient developed a non-serious decreased range of motion of left arm (mobility decreased), joint stiffness and aches and pains (pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Physician reports patient has no hives or urticaria, no airway compromise, and no shortness of breath. It was reported that "Physician states patient is not pregnant -Last menstrual period: 30-Jul-2021. Due date AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement". Details of laboratory data not reported. Physician also states he recommended Ibuprofen, Tylenol (Paracetamol) and rest. At the time of reporting, the patient had not recovered from the all events.

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

VAERS 1653383

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
OK
Alter
-
Geschlecht
F
Eingang
29.08.2021
Impfdatum
13.08.2021
Beginn
13.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Chills Injection site swelling Myalgia Pyrexia

Symptomtext

chills; myalgias; fever; progressively worsening swelling at injection site; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case (under reference number : 00727839) from a physician. This case involves a 34 years old female patient who experienced chills, myalgias (myalgia), fever (pyrexia) and progressively worsening swelling at injection site (vaccination site swelling), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Solution for injection, once, total, lot U6831AA and expiration date :08-Oct-2022) via intramuscular route in the left deltoid for prophylactic vaccination. On 13-Aug-2021, the patient developed a non-serious chills, myalgias (myalgia), fever and progressively worsening swelling at injection site (vaccination site swelling), on the same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. It was reported as " Physician reported that a patient received TENIVAC on 13AUG2021. She returned to office on 17AUG2021 with complaints of progressively worsening swelling at injection site, fever, chills, and myalgias. Physician asking if there are any recommendations on how to proceed, and the ingredients of TENIVAC. Physician was unable to provide all information for AE report at time of call. Physician given case number and states he will call back when he has all information to complete AE report. Physician declined to provide email." No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for all the reported events.

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

VAERS 1641393

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
AZ
Alter
21,0
Geschlecht
F
Eingang
27.08.2021
Impfdatum
26.08.2021
Beginn
26.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Urticaria

Symptomtext

EMPLOYEE STATES SHE STARTED TO DEVELOP HIVES ON HER LEFT HIP AROUND 7 PM 26 AUG 2021. SHE STATES HIVES THEN STARTED DEVELOPING ON HER RIGHT THIGH DESCENDING DOWN HER RIGHT LEG. EMPLOYEE (PT) STATES SHE THEN DEVELOPED HIVES ALL OVER HER BODY MINUS THE LEFT DELTOID AREA WHERE TD VACCINE WAS ADMINISTERED. DENIES SHORTNESS OF BREATH OR DIFFICULTY BREATHING. STATES SHE TOOK OTC BENADRYL AND BEGAN TO NOTICE IMPROVEMENT IN SYMPTOMS.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKDA
Vorherige Impfungen
-

VAERS 1577977

SANOFI PASTEUR · TETANUS TOXOID (NO BRAND NAME) · Charge U6831AA

mild
Staat
AZ
Alter
65,0
Geschlecht
F
Eingang
17.08.2021
Impfdatum
19.04.2021
Beginn
20.04.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Alopecia Arthralgia Decreased appetite Headache Muscle spasms Nausea Neck pain

Symptomtext

I received the vaccination on Monday April 19, 2021 at approximately 2:30 in the afternoon. The rest of the week I suffered from muscle spasms, severe headaches, neck and shoulder pain, nausea, lack of appetite. It was so severe that weekend that on Monday April 26, went to see my chiropractor thinking that my back was out. Doc took one look and asked if I'd had a vaccination. On Tuesday, April 20, 2021 when I washed my hair around 9 pm I noticed that I was loosing large amounts of hair! This continued well into June. About Mid June I started taking a product called Biosil. My hair loss continued into July, slowed down and at this reporting , has finally stopped.I had long thick naturally curly hair, that when wet was at my behind. Now there's almost nothing to put in a braid.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
Celiac
Andere Medikamente
Compounded Thyroid , vitamins & probiotics
Allergien
Wheat, corn, soy, chicken eggs, shrimp, coconut, preservatives
Vorherige Impfungen
-

VAERS 1374161

UNKNOWN MANUFACTURER · TD ADSORBED (NO BRAND NAME) · Charge U6831AA

mild
Staat
OR
Alter
32,0
Geschlecht
M
Eingang
04.06.2021
Impfdatum
25.05.2021
Beginn
26.05.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site pain Peripheral swelling

Symptomtext

Typical injection site pain and mild swelling in right arm on day of injection. Also reported pain at site of COVID 19 (Johnson & Johnson) vaccine administered on 3/16/21 in left arm and severe hip pain.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
Exam with mild tenderness at Td site on 5/28 thought to be typical of mild injection site reaction. No findings on left arm.
Aktuelle Erkrankungen
Acute on chronic sinusitis with flare of allergies, dog bite wound to hand
Vorgeschichte
Chronic psoriasis, chronic abdominal pain/stool changes, depression, anxiety
Andere Medikamente
Omeprazole, Singulair, Fluticasone nasal spray, Cetrizine, Trintellix, Azelastine nasal spray, Sudafed, Cephalexin, Naltrexone, Miralax
Allergien
Nitroglycerin (flushing, headache)
Vorherige Impfungen
-

VAERS 1102176

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

mild
Staat
NC
Alter
37,0
Geschlecht
M
Eingang
15.03.2021
Impfdatum
10.03.2021
Beginn
12.03.2021
Tage bis Beginn
2,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pruritus Rash erythematous

Symptomtext

Vaccines received Wednesday morning. On Friday night, patient noticed pruritic, red rash to right arm. Took Benadryl with relief. No further issues.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pruritus
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
Eczematous dermatitis, Elhers-Danlos Syndrome, ADHD, anxiety
Andere Medikamente
fluoxetine hcl, methylphenidate, Clobetasol ointment, hydrocerin topical.
Allergien
penicillins
Vorherige Impfungen
-

VAERS 2630169

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
11.05.2023
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

an expired shot of Tenivac was administered to a patient with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and gender patient who had an expired shot 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 was administered with an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (batch number: U6831AA; expiry date: 08-Oct-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency). Action taken with diphtheria and tetanus toxoids (Tenivac) was not applicable. At time of reporting, the outcome was Unknown for the event an expired shot 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 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 2576880

UNKNOWN MANUFACTURER · TETANUS DIPHTHERIA (NO BRAND NAME) · Charge U6831AA

gering
Staat
CA
Alter
29,0
Geschlecht
F
Eingang
07.02.2023
Impfdatum
02.02.2023
Beginn
02.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

an expired TENIVAC was administered (with no reported adverse event); Initial information was received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 29 years old female patient who experienced an expired tenivac was administered (with no reported adverse event) while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Feb-2023, the patient received a Dose 1 dose of 0.5 ml suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U6831AA of expiry date 08-Oct-2022 via intramuscular route in the deltoid not otherwise specified for Immunization. On 02-Feb-2023 the patient developed a non-serious event of an expired tenivac was administered (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. It was not reported if the patient received a corrective treatment for the event (an expired Tenivac was administered (with no reported adverse event)). At time of reporting, the outcome was Not Recovered for the event an expired 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 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 2541538

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
PA
Alter
68,0
Geschlecht
M
Eingang
23.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
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

received an expired tenivac,with no reported adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 68 years old male patient who was administered an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] and experienced no adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Dec-2022, the patient received a dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (with lot U6831AA, expiry date: 08-Oct-2022, strength, formulation: unknown) via intramuscular route in the left deltoid (expired product administered). Action taken : Not Applicable. At time of reporting, the outcome was Unknown for the event received an 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
-

VAERS 2528287

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
-
Alter
50,0
Geschlecht
F
Eingang
10.12.2022
Impfdatum
05.12.2022
Beginn
05.12.2022
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

patient was administered expired TENIVAC with no reported adverse event; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 50 years old female patient who stated patient was administered expired tenivac with no reported adverse event after 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 hepatitis B vaccine; varicella zoster vaccine RGE (CHO) (Shingrix); and influenza vaccine for prophylactic vaccination. On 05-Dec-2022, the patient received a 0.5 ml dose (1 x) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6831AA, expiry date 08-Aug-2022, strength not reported) via unknown route in unknown administration site for Immunization. On 05-Dec-2022 the patient was administered expired tenivac with no reported adverse event (expired product administered) (latency: same day) Action taken was not applicable. At time of reporting, the outcome was 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 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; SHINGRIX; INFLUENZA
Allergien
-
Vorherige Impfungen
-

VAERS 2518297

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
VA
Alter
-
Geschlecht
U
Eingang
28.11.2022
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

administered an expired TENIVAC to a patient with no reported adverse event; Initial information was received from on 22-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered an expired vaccine 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 received an expired total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection standard (lot U6831AA, expiry date- 30-Oct-2022) via unknown route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (unknown latency). 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 2503949

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
PA
Alter
24,0
Geschlecht
F
Eingang
10.11.2022
Impfdatum
01.11.2022
Beginn
01.11.2022
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

nurse administered dose of Tenivac on 01NOV2022 and it had expired 08OCT2022 with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 24 years old female patient whose nurse administered dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) on 01nov2022 and it had expired 08oct2022 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications: none On 01-Nov-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022, via intramuscular route in the right arm as Immunization On 01-NOV-2022 the nurse administered dose of tenivac on 01nov2022 and it had expired 08oct2022 with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Caller wanted to know if it will cause any effects for the patient. Should the re-administer with non expired TENIVAC? Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event 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 2502869

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
TN
Alter
40,0
Geschlecht
M
Eingang
09.11.2022
Impfdatum
29.10.2022
Beginn
29.10.2022
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

patient received an expired dose of TENIVAC with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 40 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event while receiving vaccine The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On 29-Oct-2022, the patient received 0.5ml, once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6831AA and expiry date: 08-Oct-2022) via intramuscular route in Deltoid NOS for Immunization. On 29-Oct-2022 the patient developed a non-serious event of patient received an expired dose of tenivac 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: 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
-

VAERS 2502860

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
MN
Alter
59,0
Geschlecht
F
Eingang
09.11.2022
Impfdatum
19.09.2022
Beginn
19.09.2022
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

was given an expired tenivac with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 59 years old female patient who was given an 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) and family history were not provided. On 19-Sep-2022, the patient received standard diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT suspension for injection at a dose of 0.5 ml once (lot U6831AA, expiry date - 10-Aug-2022) via unknown route in unknown administration site for Immunization and was given an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT with no reported adverse event (expired product administered) (latency: same day). 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 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 2498808

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
GA
Alter
36,0
Geschlecht
M
Eingang
04.11.2022
Impfdatum
28.10.2022
Beginn
28.10.2022
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

Symptomtext

TENIVAC administered after the expiration date with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 36 years old male patient and it was reported that tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) administered after the expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right deltoid as Immunization. On 28-OCT-2022 the tenivac administered after the expiration date with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken was not applicable. Treatment: none. 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 2498806

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
FL
Alter
22,0
Geschlecht
M
Eingang
04.11.2022
Impfdatum
19.10.2022
Beginn
19.10.2022
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

an expired dose of TENIVAC was given to a patient with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22 years old male patient and an expired dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) 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. Concomitant medications: None On 19-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right arm as Immunization. On 19-OCT-2022 an expired dose of tenivac was given 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. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event ( an expired dose of TENIVAC was given to a patient with no reported adverse event). 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 2490902

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
FL
Alter
42,0
Geschlecht
F
Eingang
27.10.2022
Impfdatum
19.10.2022
Beginn
19.10.2022
Tage bis Beginn
0,0
Dosis
2
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

HCP gave a patient TENIVAC on 19Oct2022 that expired on 08Oct2022 with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 42 years old female patient to whom healthcare professional (HCP) gave DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC on 19-Oct-2022 that expired on 08-Oct-2022 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Oct-2022, the patient received a expired second dose 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: Standard (lot U6831AA, exp date:08-Oct-2022 ) via intramuscular route in the left 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 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 2489789

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge U6831AA

gering
Staat
VA
Alter
25,0
Geschlecht
M
Eingang
26.10.2022
Impfdatum
24.10.2022
Beginn
24.10.2022
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 No adverse event

Symptomtext

None- Expired vaccine administered

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

VAERS 2486157

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
OH
Alter
60,0
Geschlecht
M
Eingang
22.10.2022
Impfdatum
13.10.2022
Beginn
13.10.2022
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

Tenivac that was administered had expired, with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 60-year-old male patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] that was administered had expired, with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine for Prophylactic vaccination. On 13-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Drug Treatment Duration: once) (strength, formulation: unknown) (lot number: U6831AA and expiry date: 08-Oct-2022) via intramuscular route in the left deltoid for Immunization and that was administered had expired, with no adverse event (expired product administered; latency: same day). Vaccine was administered by a medical assistant. Action taken was Not applicable. At time of reporting, the outcome was Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

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

VAERS 2484152

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge u6831aa

gering
Staat
OH
Alter
60,0
Geschlecht
M
Eingang
20.10.2022
Impfdatum
13.10.2022
Beginn
13.10.2022
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

Symptomtext

The adverse event was that the Td (tenivac) was administered after the dose expired (vaccine administration error). Td vaccine expired 10-8-22 and was administered 10-13-22. Error was discovered right after administration and reason for error was misreading the small printed expiration date on label. When documenting administration, error discovered. The manufacturer was contacted and advised re-vaccination as soon as possible. Ordering provider called patient and informed of error, encouraged re-vaccination. Patient declined revaccination, despite acknowledging that the Td dose he received 10-13-22 is not considered a valid dose. Patient has no signs/symptoms of any negative physical effects.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none required
Aktuelle Erkrankungen
sinus symptoms
Vorgeschichte
migraine headaches
Andere Medikamente
N/A prescribed sumatriptan to use as needed
Allergien
none known
Vorherige Impfungen
-

VAERS 2483773

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
FL
Alter
-
Geschlecht
U
Eingang
20.10.2022
Impfdatum
13.10.2022
Beginn
13.10.2022
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

accidentally administered an expired tenivac vaccine to a patient yesterdaywith no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves an unknown age and unknown gender patient and reporter stated that expired tenivac vaccine administered accidentally to a patient yesterday 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 13-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection total (lot U6831AA, expiry date 08-Oct-2022) (with an unknown strength, dose, route, administration site) for Immunization. On 13-Oct-2022 the patient accidentally administered with an expired tenivac vaccine yesterday 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 reported. 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 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 2482618

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
CT
Alter
21,0
Geschlecht
M
Eingang
19.10.2022
Impfdatum
12.10.2022
Beginn
12.10.2022
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

patient received a tenivac immunization that was later noted to have expired with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 years old male patient who received a -2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] immunization that was later noted to have expired with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Oct-2022, the patient received expired 0.5 ml, dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength: standard, formulation: unknown) (lot U6831AA, expiry date: 08-Oct-2022) via intramuscular route in the deltoid NOS (not otherwise specified) with no 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 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.; Sender's Comments: US-SA-2022SA422490:

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

VAERS 2481280

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
IN
Alter
81,0
Geschlecht
M
Eingang
18.10.2022
Impfdatum
12.10.2022
Beginn
12.10.2022
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

TENIVAC vaccine expired on 08Oct2022 and it was given today 12Oct2022 with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves a 81 years old male patient and reporter reported tenivac vaccine expired on 08oct2022 and vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given today 12oct2022 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (Lot: U6831AA, expiry date 08-Oct-2022) (unknown administration site)(strength:standard) 0.5 ml total at once via intramuscular route for immunization On 12-Oct-2022 the patient was administered with tenivac vaccine expired on 08oct2022 with no reported adverse event (expired product administered) following the administration of vaccine. No lab data reported. 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 2109254

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
FL
Alter
-
Geschlecht
F
Eingang
12.02.2022
Impfdatum
04.02.2022
Beginn
04.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

received TENIVAC instead of ADACEL WITH NO REPORTED ADVERSE EVENT; Initial information received on 04-Feb-2022 regarding an unsolicited valid non-serious case was received from an other health professional. This case involves a 36 year old female patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) instead of adacel with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Feb-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult vaccine once (lot U6831AA, expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination instead of Adacel (wrong product administered, latency: same day). The reporter was questioning on how long the patient needed to wait until administration of adacel. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (received tenivac instead of adacel with no reported adverse event). At time of reporting, the outcome was Unknown for the event received tenivac instead of adacel 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2091417

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
CO
Alter
0,3
Geschlecht
F
Eingang
05.02.2022
Impfdatum
25.01.2022
Beginn
25.01.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

PA reporting a dose of TENIVAC was inadvertently administered to a 4 month old, with no Adverse Event; Initial information received on 25-Jan-2022 regarding an unsolicited valid non-serious case received from health professional. This case involves a physician assistant (pa) reporting a dose of tenivac was inadvertently administered to a 4 month old, 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. On 25-Jan-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with Standard strength (unknown: formulation) at dose 0.5mL once via intramuscular route in the left thigh (lot U6831AA, expiry date: 25-Jan-2022) for Immunization. On 25-JAN-2022 (latency same day), the patient developed a non-serious pa reporting a dose of tenivac was inadvertently administered to a 4 month old, with no ae (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. At time of reporting, the outcome was Unknown for the event pa reporting a dose of tenivac was inadvertently administered to a 4 month old, 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1931701

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
NJ
Alter
-
Geschlecht
U
Eingang
08.12.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product storage error

Symptomtext

This case involves an unknown age and unknown gender patient for whom it was reported temperature excursion of pentacel, ipol and tenivac total excursion time was 128.25 hours after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product storage error). The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ466AAA expiry date: 21-May-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect IPV (VERO) [lot T1E872M, expiry date: 10-Oct-2022, Lot: T1D481M, expiry date: 25-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot U6831AA and expiry date: 08-Oct-2022] via an unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to product storage error [Latency: on the same day]. It was reported "Caller stated the first excursion was on one day in august which was for 47 hours. On 01-Sep-2021 for 18 minutes and the temperature in the refrigerator was 46.1-50.2 degrees Fahrenheit. On 18-Oct-2021 the excursion lasted for 72 hours and the refrigerator temperature was 41.0-41.7 degrees Fahrenheit. On 22-Oct-2021 the excursion was for 1 hour and the refrigerator temperature was 39.7-41.8 degrees Fahrenheit. On 25-Oct-2021 the excursion was for 1 hour and 2 minutes. The temperature of the refrigerator was 39.9-40.9 degrees Fahrenheit. On 28-Oct-2021 the excursion was for 30 minutes and the temperature of the refrigerator was 40.2-40.9 degrees Fahrenheit. On 29-Oct-2021 the excursion lasted for 1 hour and 1 minute and the temperature reached 40.2-41.2 degrees Fahrenheit. On 01-Nov2-021 the excursion lasted for 48 minutes the temperature reached 40.0-40.8 degrees Fahrenheit. On 02-Nov-2021 the excursion lasted for 55 minutes and the temperature reached 39.8-40.7 degrees Fahrenheit. On 05-Nov-2021 the excursion lasted for 57 minutes and the temperature reached 40.9-41.7 degrees Fahrenheit. On 09-Nov-2021 the excursion lasted for 59 minutes and the temperature reached 41.3-42.3 degrees Fahrenheit. All vaccines were involved in the excursion and caller stated the vaccines have been given to patients post excursion. Caller stated she will call back when the patient information is gathered. Total excursion time was 128.25 hours". 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 1923103

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
CO
Alter
-
Geschlecht
U
Eingang
04.12.2021
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

vaccine were exposed to negative 7.7 degree celsius for 30 days /no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00864804. This case involves an unknown age and unknown gender patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UJ702AC and expiry date: 30-JUN-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U7055BA and expiry date: 03-JUN-2023 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5774BA and expiry date: 18-SEP-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number: U6831AA and expiry date: 08-OCT-2022 via unknown route in unknown administration site and a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2110 and expiry date: 01-JUN-2022 via unknown route in unknown administration site for prophylactic vaccination respectively. It was case of an actual medication error due to Product storage error temperature too low (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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1923102

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
-
Alter
-
Geschlecht
U
Eingang
04.12.2021
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

vaccine were exposed to negative 7.7 degree celsius for 30 days/no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional and consumer or non health care professional via Medical Information (MI) (under reference: 00864731). This case involves an unknown age and unknown gender patient who was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD], INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE [TENIVAC] (product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE lot number: U6831AA and expiry date: 08-Oct-2022 via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site and a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. It was reported "stated that the vaccines were administered to patients, with an estimate of maybe 50 patients. Want to know what to do". It was case of an actual medication error due to product storage error temperature too low (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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1518323

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6831AA

gering
Staat
IL
Alter
79,0
Geschlecht
F
Eingang
31.07.2021
Impfdatum
-
Beginn
08.07.2021
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Product was out of range at 75 fahrenheit for 960 hours with no reported adverse event; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Global Medical Information under reference -00694728. This case involves a 79 year-old female patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was out of range at 75 fahrenheit for 960 hours because product was left out of refrigeration (Product storage error). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given. On an unknown date, the patient received 0.5 mL once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was reported that "Pharmacist is requesting to know if the patient needs to be revaccinated". It was a case of a potential medication error due to incorrect product storage. At the time of reporting, no adverse event reported. Outcome of event 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-