- Staat
- PA
- Alter
- 40,0
- Geschlecht
- M
- Eingang
- 05.05.2023
- Impfdatum
- 10.01.2023
- Beginn
- 10.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Mobility decreased
Pain in extremity
Symptomtext
decreased mobility in left upper arm and some pain
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 15.08.2023
- Beginn
- 17.08.2023
- Tage bis Beginn
- 2,0
- Dosis
- UNK
- Route/Site
- - / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site induration
Injection site pain
Injection site rash
Injection site swelling
Injection site warmth
Product use issue
Rash erythematous
Symptomtext
hard; Rash; It's warm; red; Spreading down my puffy swollen; Underneath the shot i got a fire burning sensation that doesn't go away it's warm red rash that keeps spreading down my arm puffy swollen hard.; Product administered to patient of 55years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674209-1. The original narrative from the sender is the following: "Underneath the shot I got a fire burning sensation that doesn't go away its warm red rash that's spreading down my arm puffy swollen hard. The case is considered as off label use due to Product use issue (product use in unapproved population). The reporter assessed the casual relationship between Vaxelis and the events " "underneath the shot I got a fire burning sensation that doesn't go away "it's warm and "red rash that's spreading down my arm "puffy swollen hard "as related. The causal relationship between Vaxelis and the event " Product administered to patient of 55years" was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site induration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Drug allergy (Sulfur); Migraine; Scoliosis (COP scoliosis)
- Andere Medikamente
- LOSARTIN; PERCET; VITAMIN D [COLECALCIFEROL]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.12.2023
- Impfdatum
- 15.08.2023
- Beginn
- 17.08.2023
- Tage bis Beginn
- 2,0
- Dosis
- UNK
- Route/Site
- SYR / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site induration
Injection site pain
Injection site rash
Injection site swelling
Injection site warmth
Product use issue
Rash erythematous
Symptomtext
hard; Rash; It's warm; red; Spreading down my puffy swollen; Underneath the shot i got a fire burning sensation that doesn't go away it's warm red rash that keeps spreading down my arm puffy swollen hard.; Product administered to patient of 55years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674209-1. The original narrative from the sender is the following: "Underneath the shot I got a fire burning sensation that doesn't go away its warm red rash that's spreading down my arm puffy swollen hard. The case is considered as off label use due to Product use issue (product use in unapproved population). The reporter assessed the casual relationship between Vaxelis and the events " "underneath the shot I got a fire burning sensation that doesn't go away "it's warm and "red rash that's spreading down my arm "puffy swollen hard "as related. The causal relationship between Vaxelis and the event " Product administered to patient of 55years" was assessed as not applicable due to the nature of the event. No further information is expected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site induration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- Medical History/Concurrent Conditions: Drug allergy (Sulfur); Migraine; Scoliosis (COP scoliosis)
- Andere Medikamente
- LOSARTIN; PERCET; VITAMIN D [COLECALCIFEROL]
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 71,0
- Geschlecht
- M
- Eingang
- 26.10.2023
- Impfdatum
- 28.08.2023
- Beginn
- 29.08.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Pain
Symptomtext
Patient reports pain to R arm where Prevnar 20 was given. Symptoms started the day after vaccine was given and still continues 2 months later. Patient using Tylenol as needed. Patient reports pain when moving arm not when at rest.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Coronary artery disease involving native coronary artery of native heart without angina pectoris Acute MI Laceration to finger
- Vorgeschichte
- Bradycardia Hypertension Hyperlipidemia
- Andere Medikamente
- Aspirin 81 mg Atorvastatin 80 mg Plavix 75 mg Metoprolol 12.5 mg Fish oil Sertraline 25 mg
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 36,0
- Geschlecht
- M
- Eingang
- 08.08.2023
- Impfdatum
- 20.07.2023
- Beginn
- 21.07.2023
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Pain
Symptomtext
Patient received Td vaccination on 7/20/2023 as part of his annual work physical. Call received from employer on 8/4/2023 stating that patient is still experiencing mild arm pain. Contacted provider for treatment recommendation. Provider recommends OTC ibuprofen or aleve for 7-10 days. Attempted to contact patient to provide treatment recommendation. Unable to reach patient and unable to leave voicemail due to full inbox. Sent message to patient through EHR.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 36,0
- Geschlecht
- M
- Eingang
- 24.05.2023
- Impfdatum
- 17.05.2023
- Beginn
- 17.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Discomfort
Injection site pain
Musculoskeletal stiffness
Product administered at inappropriate site
Symptomtext
Administered vaccine closer to left shoulder than full deltoid muscle. Patient reported increased pain during administration. Pain reported 1/10 later in the day. 3/10 the following day with ibuprofen. Today at day 7, discomfort improved to 1/10 without medication, complaints of stiffness, discomfort with putting on clothing shirt. Full passive ROM on exam. Discomfort reported with flexion and extension.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 28,0
- Geschlecht
- F
- Eingang
- 18.05.2023
- Impfdatum
- 17.03.2023
- Beginn
- 17.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Nausea
Symptomtext
nausea sweating lightheadedness
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none known
- Aktuelle Erkrankungen
- unknown
- Vorgeschichte
- ADHD Asthma allergy anemia anxiety raynauds
- Andere Medikamente
- cabergoline adderall loestrin FE
- Allergien
- tree nut wild cherry apple soy
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 82,0
- Geschlecht
- F
- Eingang
- 08.05.2023
- Impfdatum
- 12.04.2023
- Beginn
- 12.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Injection site discharge
Injection site haemorrhage
Injection site pain
Injection site vesicles
Musculoskeletal stiffness
Skin warm
Symptomtext
Tenderness to left upper arm. Sore, blister like, with bleeding and drainage. Left arm warm, stiffness to the neck. Appointment 4/27/23: Pt advised to apply warm compress 3-4x a day, use Tylenol PRN. Medrol dose pak Pt reported on 5/1/23 sxs improving
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site discharge
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- HTN GERD IBS Obesity Vitamin D def Vitamin B def 11/11 osteoporosis of hips Hearing Loss Diverticulosis Depression 7/12 elevated ALK PHOS 2/14 Low Magnesium 11/13 severe Osteopeonia of hips and HIGH FRAX-(3/21/14-wants to hold on bone builders) 7/14 diarrhea with culture positive for Campylobacter AND shiga-toxin producing E.coli 6/16 Fatty Liver - GI 6/16 Gilberts disease - GI 6/16 IBS with diarrhe prominent - GI 8/16 chronic and mild compression T7,8,9 11/16 LEFT HIP FX 11/16 anemia after hip fracture 11/16 low magnesium (1.5) 11/16 EMERGENT EGD- foreign body stuck in esoph-emerg EGD- underlying esophagitis on scope 1/17 HOLD ON PROLIA DUE TO DENTAL WORK 7/17 FATTY LIVER - GI 3/18 B12 def (357), 9/19 (294) 3/18 Vit D def (19) 4/19 vascular malformation of Liver- on MRI 4/19 renal cysts on MRI 5/19 egd- gastritis and duodenitis 6/19 liver lesions and hepatic duct stricture 6/19 EGD/ERCP normal 12/19 CATARACTS
- Andere Medikamente
- Medrol 4 mg take taper by mouth as directed on package with food and water. No anti-inflammatories, Cephalexin 500 mg take 2 cap by mouth twice a day x 7 days, Flonase Allergy Relief 50 mcg/Act spray 1 spray into each nostril once daily-gen
- Allergien
- Prevacid - diarrhea, Boniva - headache, Protonix - abdominal pain, Ranitidine - abd pain, itching
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 24.04.2023
- Impfdatum
- 17.04.2023
- Beginn
- 18.04.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diarrhoea
Injection site erythema
Injection site swelling
Nausea
Pruritus
Symptomtext
Diarrhea, nausea, itching to both arms, redness and swelling to both sites
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Metformin, Levothyroxine, Trazodone, Meloxicam., Krill oil , Vitamin D3, Ozempic, Flovent HFA. Montelukast, Clonazepam, Garlic caps, Vitamin C, Qnasl, Tumeric, Zinc, Loratadine
- Allergien
- Cipro, Duloxetine, ASA, sun, IVP dye, Sulfa, PCN, Buprinorphine, Fentanyl, Ziprasidone, Midazolam, Meperidine, Iodine, Codeine, Arthrotec, Wellbutrin, Latex, Versed, Diclofenac, Diazepam, environmental
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 22.04.2023
- Impfdatum
- 22.04.2023
- Beginn
- 22.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Urticaria
Symptomtext
About 90 minutes after vaccination, patient returned to the pharmacy reporting hives. She reported she had already taken benadryl. Pharmacist recommended patient immediately seek evaluation at nearby urgent care for further evaluation
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- unknown
- Aktuelle Erkrankungen
- None reported
- Vorgeschichte
- None reported
- Andere Medikamente
- None reported
- Allergien
- None reported
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 75,0
- Geschlecht
- F
- Eingang
- 12.03.2023
- Impfdatum
- 08.03.2023
- Beginn
- 08.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site pruritus
Injection site swelling
Symptomtext
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Gave pt ice pack, symptoms significantly improved after apx 15 min.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 29,0
- Geschlecht
- M
- Eingang
- 04.12.2022
- Impfdatum
- 10.09.2022
- Beginn
- 10.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- ID / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Burning sensation
Chills
Erythema
Injection site pain
Injection site pruritus
Pain
Peripheral swelling
Symptomtext
Pt had red raised bump on L forearm, Pt complained of pain/burning day of vaccination. 2 days post vaccinations pt c/o of itching/burning at injection site that lasted 1 week. Pt also reported red streak at site that spread to armpit. Pt also c/o of body aches and chills 1 week post vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 21,0
- Geschlecht
- F
- Eingang
- 12.09.2022
- Impfdatum
- 02.09.2022
- Beginn
- 02.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fatigue
Headache
Hot flush
Influenza like illness
Pyrexia
Respiratory tract congestion
Symptomtext
On 09/07/2022, donor disclosed to medical personnel that she was experiencing a reaction following a Tetanus immunization that was administered on 09/02/2022. Donor stated the onset of the reaction occurred later that day at approximately 6pm. Donor states that she first experienced a head ache that would not resolve with hydration or eating. Donor stated that the next day (09/03/2022) around 7am, she felt fatigued and experienced some congestion accompanied by some hot flashes and a head ache. She also stated to having a 'very mild fever' with a temperature reading of approximately 99.8 degrees Fahrenheit, Donor denied being in the presence of anyone exhibiting flu-like symptoms and denies receiving any other immunizations within the las 30 days. Donor admitted to having a history of reactions to immunizations that would provoke flu-like symptoms in the past. Donor stated signs and symptoms resolved by 09/04/2022.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None reported
- Vorgeschichte
- None reported
- Andere Medikamente
- None reported.
- Allergien
- None reported, however, donor did state upon completion that she had history of reactions to immunization that would provoke flu-like symptoms in the past.
- Vorherige Impfungen
- Donor did state upon completion that she had history of reactions to immunization that would provoke flu-like symptoms in the pa
- Staat
- ND
- Alter
- 38,0
- Geschlecht
- F
- Eingang
- 24.06.2022
- Impfdatum
- 21.06.2022
- Beginn
- 22.06.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Headache
Injection site erythema
Injection site pain
Injection site swelling
Injection site warmth
Pyrexia
Symptomtext
Fever to 102F, local redness, warmth, swelling, tenderness right upper arm, headache
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- pt denies
- Vorgeschichte
- asthma, PTSD, Depression, lumbar radiculopathy, headache, insomnia, menorrhagia, hx kidney stones
- Andere Medikamente
- albuterol MDI, mometasone 200MCG/actuat oral inhaler, hydroxyzine hcl 25 mg po 3x daily prn anxiety, acetaminophen prn, multivitamin/iron once daily, ibuprofen prn
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 83,0
- Geschlecht
- M
- Eingang
- 15.12.2023
- Impfdatum
- 25.09.2023
- Beginn
- 25.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
No adverse event
Symptomtext
Reported Symptoms: 10029436:NO DVERSE EFFECT; Narrative: The expiration date of the Tenivac vaccine led to nursing inadvertently administering and expired vaccine. The format is 24SEP23 (expired 9/24/2023) and the vaccine was administered on 9/25/2023. Sanofi was contacted and they couldn't recommend administering the vaccine after expired but they didn't expect a loss of immune response one day after expiration. They stated that if a repeated dose was given to wait 28 days after the expired vaccine was given. Nursing discussed it with the patient's provider and they decided that a repeat dose was not necessary for the patient. Nursing educated their staff on the vaccine format and Sanofi filed a report on the confusing format of the expiration date. Other Relevant HX: Other: No Adverse Effects Noted
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 67,0
- Geschlecht
- M
- Eingang
- 04.12.2023
- Impfdatum
- 26.11.2023
- Beginn
- 26.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
staff gave tenivac that expired with no reported adverse event; Initial information received on 27-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 years old male patient to whom staff gave tenivac that expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7183AA, expiry date- 24-Sep-2023 via unknown route in the left deltoid for immunization, staff gave tenivac that expired with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 83,0
- Geschlecht
- M
- Eingang
- 30.11.2023
- Impfdatum
- 25.09.2023
- Beginn
- 25.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 4
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
No adverse event
Symptomtext
Reported Symptoms: 10029436:NO ADVERSE EFFECT; Narrative: The expiration date of the Tenivac vaccine led to nursing inadvertently administering an expired vaccine. The format is 24SEP23 (expired 9/24/2023) and the vaccine was administered on 9/25/2023. Sanofi was contacted and they couldn't recommend administering the vaccine after expired but they didn't expect a loss of immune response one day after expiration. They stated that if a repeated dose was given to wait 28 days after the expired vaccine was given. Nursing discussed it with the patient's provider and they decided that a repeat dose was not necessary for the patient. Nurse educated their staff on the vaccine format and Sanofi filed a report on the confusing format of the expiration date. Othe Relevant HX: Other: No adverse effects noted
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
expired dose of tenivac that was administered to a patient with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient who received expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Vaccine [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 expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Vaccine ,Suspension for injection (lot U7183AA and expiry 24-Sep-23) (expired product administered) (dose and strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 20.11.2023
- 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
No adverse event
Symptomtext
medication error due to possible administration of TENIVAC after its expiration date with no reported adverse event; Initial information received on 09-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had medication error due to possible administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults [TENIVAC] after its 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 an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults Suspension for injection (lot U7183AA, expiry date: 24-Sep-2023 with unknown dose, strength) via unknown route in unknown administration site as Immunization which was a medication error due to possible administration of tenivac after its expiration date with no reported adverse event (expired product administered) (latency: same day). It was reported "a nursing supervisor reports that they had vials of TENIVAC which had the expiration dates printed on them as 24SEP23 and 24JUN23; reports that they found this dating method confusing and it caused 3 doses from LOT U7183AA, EXP 24SEP23 and 5 doses from LOT U7092AA, EXP 24JUN23 to possibly be administered to patients after the expiration. She states that this is the only medication that they have which shows the expiration date in that format. The nursing supervisor is unable to provide any additional AE information; she states that they will need to run an internal report to confirm how many doses of expired TENIVAC were actually administered and to which patients. The nursing supervisor reports that the way that the expiration date is printed on the tenivac vials is confusing and easily misinterpreted. she reports that it was confusing to them whether they should read the expiration date printed on the vial, 24sep23, as september 24th, 2023 or september 23rd, 2023. the same issue occurred with the second vial of tenivac with expiration dated as 24jun23. the way that the expiration date was printed may have caused them to use the product after its expiration" 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 10.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expanded disability status scale
No adverse event
Symptomtext
expired TENIVAC was given with no reported adverse event; Initial information received on 31-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional (Pharmacy intern). This case involves a patient of unknown age and gender to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received expired dose 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength not reported) (lot U7183AA; Expiration Date: 24-Sep-23) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (unknown latency). Action taken: not applicable. 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
- Expanded disability status scale
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- M
- Eingang
- 31.10.2023
- Impfdatum
- 29.09.2023
- Beginn
- 29.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
received an expired TENIVAC/vaccine was administered 5 days after the expiration date with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 50 years old male patient who received an expired tenivac/vaccine was administered 5 days 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 29-Sep-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U7183AA, expiry date: 23-Sep-2023 via intramuscular route in the right deltoid for immunization, an expired tenivac/vaccine was administered 5 days after the expiration date with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.10.2023
- 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
No adverse event
Symptomtext
expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information was received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient to whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (lot U7183AA, expiration date: 24-Sep-2023 , unknown strength) via unknown route in unknown administration site for Immunization and expired dose of tenivac was administered to a patient 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
- -
- Staat
- TX
- Alter
- 60,0
- Geschlecht
- F
- Eingang
- 26.10.2023
- Impfdatum
- 18.10.2023
- Beginn
- 18.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
a patient had been administered with an expired dose of TENIVAC with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 60 years old female patient who had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2023, the patient received 0.5 ml total (1X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA) (Expiry date: 24-Sep-2023) (Strength: standard) (Frequency: once) via intramuscular route in the left deltoid for immunization. On 18-Oct-2023, the patient had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event (expired product administered) (latency: same day). It was reported, Medical assistant called to ask about precautions that they need look out for as well as if the vaccine needs to be repeated after a patient had been administered with an expired dose of TENIVAC. This situation is reported as a medication error due to administration of expired medication. No adverse reactions has been reported by the patient. 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- HI
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.10.2023
- 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
administration of expired Tenivac to a patient with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml total (1 X) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) via unknown route in unknown administration site for immunization. On an unknown date, the patient was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult to a patient with no reported adverse event (expired product administered) (latency: same day). It was reported, Pharmacist requests to confirm the expiration date for TENIVAC. Is it the day, month, year! HCP reports that the tenivac was administered past expiration. The caller declined to provide additional information about the administration of expired Tenivac to a patient. Action taken: not applicable. Outcome: Unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 54,0
- Geschlecht
- M
- Eingang
- 18.10.2023
- Impfdatum
- 12.10.2023
- Beginn
- 12.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
administration of an expired vaccine with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 54-year-old male patient and the reporter stated administration of an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids No preservative adult [Tenivac]with no reported adverse event. The patient's past medical history included Injury NOS. The patient's past medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 12-Oct-2023, the patient received a 0.5 ml total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids No preservative adult, Suspension for injection (strength: unknown) (lot: U7183AA, expiry date: 24-Sep-2023) via intramuscular route in the left deltoid for immunization and administration of an expired vaccine with no reported adverse event (expired product administered) (latency: same day). Action taken with diphtheria and tetanus toxoids (Tenivac) was 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
- Medical History/Concurrent Conditions: Injury NOS
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.10.2023
- Impfdatum
- 28.09.2023
- Beginn
- 28.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
administered tenivac that has expired on 24Sep2023 to a patient with no reported adverse event; Initial information was received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that has expired on 24sep2023 to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Sep-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) (lot U7183AA, strength, expiry date unknown) via unknown route in unknown administration site for Immunization. On 28-Sep-2023 the patient was administered tenivac that has expired on 24sep2023 to a patient 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 administered tenivac that has expired on 24sep2023 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
- -
- Staat
- HI
- Alter
- 74,0
- Geschlecht
- F
- Eingang
- 13.10.2023
- Impfdatum
- 13.10.2023
- Beginn
- 13.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
Administered expired vaccine, currently per patient no adverse events. Administration date on 10/13/2023 vaccine expiration date 09/24/2023.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- High cholesterol High blood pressure
- Andere Medikamente
- Lisinopril 20mg Atorvastatin 40mg Hydralazine 100mg
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 11.10.2023
- Impfdatum
- 29.09.2023
- Beginn
- 29.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023 no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA301830. This case involves 11 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA B VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Immunisation; POLIO VACCINE (POLIO VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation. On 29-Sep-2023, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for Immunisation. On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day). It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered. Action taken: not applicable. Outcome: Unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPA B VACCINE; MMR; FLU [INFLUENZA VACCINE]; POLIO VACCINE; HPV VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 10.10.2023
- Impfdatum
- 27.09.2023
- Beginn
- 27.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Product label confusion
Symptomtext
expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of TENIVAC no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 66 years old female patient and expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Sep-2023, the patient received a dose 1 dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7183AA expiry date: 24-Sep-2023 via intramuscular route in the left deltoid for Immunization and expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of tenivac no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. Reportedly, Healthcare professional called to report that they have been given a near expiry shipment of TENIVAC vaccine on the last week of June 2023. HCP reported that they were given a 3 month window before the TENIVAC vaccine expires. HCP reported that the expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of Tenivac. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event expiration date format on the vaccine was confusing that it led to one staff giving an expired dose of tenivac 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 06.10.2023
- Impfdatum
- 29.09.2023
- Beginn
- 29.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
nurse called reported that tenivac was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA301831. This case involves a 8 years old male patient and nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; and POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination. On 29-Sep-2023, the patient received 0.5 ml total (1x) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA; Expiry date: 24-Sep-2023) (Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation). On 29-Sep-2023, the nurse called reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was given to 2 patients but the tenivac was expired on 24sep2023 with no reported adverse event (expired product administered) (latency: same day). It was reported, A nurse called reported that TENIVAC was given to 2 patients on 29Sep2023 but the TENIVAC was expired on 24Sep2023. Caller asked if it is a valid dose. This situation is reported as a medication error due to expired vaccine administered. Action taken: not applicable. Outcome: Unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS B VACCINE; MMR; INFLUENZA VACCINE; POLIO VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 56,0
- Geschlecht
- M
- Eingang
- 06.10.2023
- Impfdatum
- 25.09.2023
- Beginn
- 25.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
administration of tenivac that was expired for 1 day with no adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 56 years old male patient who was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day 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 Inact Split 4v (Fluzone Quadrivalent) for Prophylactic vaccination. On 25-Sep-2023, the patient received 0.5 ml total (1 X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) (Frequency: Once, Strength: Standard) via intramuscular route in the left arm for prophylactic vaccination (Immunisation). On 25-Sep-2023, the patient was administered Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired for 1 day with no adverse event (expired product administered) (Latency: same day). It was reported, HCP called to report about the administration of TENIVAC that was expired for 1 day. No adverse reaction was reported by the patient. 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
- FLUZONE QUADRIVALENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 10,0
- Geschlecht
- M
- Eingang
- 05.10.2023
- Impfdatum
- 26.09.2023
- Beginn
- 26.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
health center manager gave TENIVAC that expired on 23Sep2023 to a patient with no reported adverse event; Initial information received from on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old male patient to whom health center manager gave Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that expired on 23sep2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination. On 26-Sep-2023, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot U7183AA) via intramuscular route in the left deltoid as prophylactic vaccination that expired on 23-Sep-2023 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
- POLIO VACCINE; MMR; VARICELLA VACCINE; HEPATITIS B VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 35,0
- Geschlecht
- M
- Eingang
- 05.10.2023
- Impfdatum
- 27.09.2023
- Beginn
- 27.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
vaccine expired on 24Sep2023 and was given to a patient today with no reported adverse event; Initial information was received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 35 years old male patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] vaccine expired on 24sep2023 and was given to a patient today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine; measles vaccine, MUMPS VACCINE, rubella vaccine (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). On 27-Sep-2023, the patient received a Booster dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) (Frequency : Once, lot U7183AA, Expiry date : 24-Sep-2023, strength was unknown) via intramuscular route in the right deltoid for Immunization and vaccine expired on 24sep2023 and was given to a patient today 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 vaccine expired on 24sep2023 and was given to a patient today 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; MMR; VARICELLA VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 53,0
- Geschlecht
- M
- Eingang
- 04.10.2023
- Impfdatum
- 26.09.2023
- Beginn
- 26.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
patient was administered with expired TENIVAC with no adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves 53 years old male patient who was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2023, the patient was administered with expired standard dose of 0.5 ml total of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7183AA, expiry date- 24-SEP-2023) via intramuscular route in the deltoid NOS (not otherwise specified) for Immunization with no adverse event (expired product administered) (latency- same day). Reportedly, Nurse asks for recommendations on safety and re-vaccination following administration of tenivac. 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
- -
- Staat
- GA
- Alter
- 24,0
- Geschlecht
- F
- Eingang
- 04.10.2023
- Impfdatum
- 27.09.2023
- Beginn
- 27.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
expired tenivac vaccine was giving to a patient with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 24 years old female patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine was giving to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 27-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7183AA) via intramuscular route in the arm nos (dose, strength, and expiration date: not provided) for Immunisation (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
- -
- Staat
- IN
- Alter
- 70,0
- Geschlecht
- F
- Eingang
- 04.10.2023
- Impfdatum
- 26.09.2023
- Beginn
- 26.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
tenivac that expired on 24Sep2023 was administered to a patient today with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 70 years old female patient who reported that diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that expired on 24sep2023 was administered to a patient today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U7183AA, Expiry date : 24-Sep-2023,strength was unknown) via intramuscular route in unknown administration site for Immunization . On 26-Sep-2023 the patient developed a non-serious event of tenivac that expired on 24sep2023 was administered to a patient today 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 tenivac that expired on 24sep2023 was administered to a patient today with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.10.2023
- Impfdatum
- 25.09.2023
- Beginn
- 25.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
patient being administered an expired dose of Tenivac with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient with unknown demographics who was being administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7183AA expiry date: 24-Sep-2023 via unknown route in unknown administration site for immunization. On 25-SEP-2023 the patient being administered an expired dose of tenivac with no reported adverse event (expired product administered) on the 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 patient being administered an expired dose of tenivac with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 56,0
- Geschlecht
- M
- Eingang
- 02.10.2023
- Impfdatum
- 25.09.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
Patient was administered an expired Td. Vaccine had expired one day prior to administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 26.07.2023
- Impfdatum
- 21.07.2023
- Beginn
- 21.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Wrong product administered
Symptomtext
Patient was suppose to receive Tdap but was given Td (Tenivac) instead. Patient is to return and receive the correct vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 25,0
- Geschlecht
- F
- Eingang
- 02.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Wrong product administered
Symptomtext
inadvertent administration of TENIVAC instead of the intended TDAP vaccine with no reported adverse event; Initial information was received on 30-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 25 years old female patient who reported that inadvertent administration of tenivac instead of the intended tdap vaccine with no reported adverse event after receiving vaccines DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE and 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 unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U7183AA via intramuscular route in the left deltoid (Suspension for injection) (with unknown strength., expiry date) for prophylactic vaccination (Immunization). On an unknown date, the patient received a unknown dose of suspect DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization). On an unknown date the patient developed a non-serious event of inadvertent administration of tenivac instead of the intended tdap vaccine with no reported adverse event (wrong product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT, (unknown latency) following the administration of DIPHTHERIA and TETANUS and not otherwise specified PERTUSSIS VACCINE. Action taken with DIPHTHERIA and TETANUS TOXOIDS (Tenivac) and DIPHTHERIA, TETANUS and PERTUSSIS (not otherwise specified) VACCINE (DIPHTHERIA, TETANUS and not otherwise specified PERTUSSIS VACCINE) was not applicable. At time of reporting, the outcome was Unknown for the event inadvertent administration of tenivac instead of the intended tdap vaccine 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 6,0
- Geschlecht
- M
- Eingang
- 05.05.2023
- Impfdatum
- 02.05.2023
- Beginn
- 03.05.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Aggression
Cognitive disorder
Symptomtext
Pt. is more aggressive and impulsive than pre-injection condition. He also has less cognitive focus as compared to pre-injection condition. Additionally, Item 21 Response is for current 72 hours only. Item 21 Response is subject to change.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Aggression
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 23.12.2022
- Impfdatum
- 15.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Off label use
Symptomtext
accidentally administered TENIVAC and Boostrix together with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 11 years old female patient who was accidentally administered tenivac and boostrix together 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. On 15-Dec-2022, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult 0.5 ML 1X and Drug Treatment Duration: ONCE (batch number: U7183AA) in unknown administration site for Immunization. On 15-Dec-2022 the patient diagnosed with a non-serious accidentally administered tenivac and boostrix together with no reported adverse event (off label use) 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
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 36,0
- Geschlecht
- M
- Eingang
- 04.12.2022
- Impfdatum
- 10.09.2011
- Beginn
- 10.09.2022
- Tage bis Beginn
- 4.018,0
- Dosis
- 3
- Route/Site
- ID / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Incorrect dose administered
Swelling
Symptomtext
Pt was given TD intradermally 0.5ml, pt developed red raised bump size of quarter 2 days post vaccination. No other symptoms that pt reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Levetircacam
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 12.09.2022
- Impfdatum
- 09.08.2022
- Beginn
- 09.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
patient was supposed to have Tdap, but instead received Tenivac, with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68 years old female patient who was supposed to have tdap, but instead received tenivac, with no reported adverse event ,while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past vaccination(s) included DAPTACEL in 2013. The patient's past medical history, medical treatment(s) and family history were not provided. On 09-Aug-2022, the patient received a total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT( lot U7183AA and expiration date: 24-Sep-2023) at a dose of 0.5ml via unknown route at an unknown administration site for immunization. On 09-Aug-2022 (Latency: same day), the patient was supposed to have tdap, but instead received tenivac, with no reported adverse event (wrong product administered) 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 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
- -
- Staat
- MT
- Alter
- 47,0
- Geschlecht
- M
- Eingang
- 10.06.2022
- Impfdatum
- 26.05.2022
- Beginn
- 29.05.2022
- Tage bis Beginn
- 3,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Herpes zoster
Symptomtext
pt experienced shingles outbreak to his top left head , face and neck with left eye involvement
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Herpes zoster
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- DM I, LBP, methamphetamine user
- Andere Medikamente
- lisinopril, buproprion, metformin, gabapentin,
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 06.05.2022
- Impfdatum
- 21.04.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
No known adverse outco me. Child was given Tenivac at age 5. Child is otherwise unimmunized. He should have received an Infanrix.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -