- Staat
- PA
- Alter
- 26,0
- Geschlecht
- F
- Eingang
- 31.01.2021
- Impfdatum
- 29.01.2021
- Beginn
- 29.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Loss of consciousness
Pallor
Symptomtext
Became dizzy and pale and experienced LOC <3seconds. Recovered well after oral fluids and comfort care.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Dicyclomine, Sumatriptan, Depoe-Shot
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 50,0
- Geschlecht
- F
- Eingang
- 08.02.2022
- Impfdatum
- 29.01.2021
- Beginn
- 29.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injected limb mobility decreased
Injection site pain
Loss of personal independence in daily activities
Magnetic resonance imaging abnormal
Tendon injury
Tendonitis
X-ray
Symptomtext
Patient complaint of pain in left shoulder and inability to move arm, same day after vaccine given 1/29/2021. Pt reported she couldn't perform activities of daily life. she requested Physical Therapy referral in Feb 2021 which help but pain was not getting better. April 1, 2021 Patient had a left shoulder MRI which showed Left RC tendon and tendonitis as well as a tear noted in MRI.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- Pt had an Xray, PT referral, MRI done.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 61,0
- Geschlecht
- F
- Eingang
- 22.03.2021
- Impfdatum
- 16.02.2021
- Beginn
- 16.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Mobility decreased
Pain in extremity
Sleep disorder
Symptomtext
her arm from shoulder to the elbow is so sore that she can't use it or lay on it/ pain immediately after receiving vaccine and if she forgets and use her left arm accidently she experiences that pain; Initial information received on 05-Mar-2021 regarding an unsolicited valid non-serious case from a consumer via Agency (under reference 00506632). This case involves a 61 years old female patient whose arm from shoulder to the elbow was so sore, that she cannot use it or lay on it and it cause pain immediately if she forgets and use her left arm accidently, she experiences that pain (pain in extremity), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient's states that she cut herself pretty bad while cutting fabric and she went to the urgent care. On 16-Feb-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and Expiration date:07-Oct-2022) via unknown route in the left arm for prophylactic vaccination. On 16-Feb-2021, the patient developed a non-serious sore arm from shoulder to the elbow that she can't use it or lay on it (pain in extremity). Also reported that she experienced the pain immediately after receiving the vaccine and if she forgets and use her left arm accidently she experiences that pain. Patient also wanted to know if that was normal and she thinks they may have hit a bone when administering the shot. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the reported event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Cut wound (she cut herself pretty bad while cutting fabric and she went to the urgent care.)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 61,0
- Geschlecht
- F
- Eingang
- 05.03.2021
- Impfdatum
- 16.02.2021
- Beginn
- 16.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Injection site pain
Loss of personal independence in daily activities
Pain in extremity
Sleep disorder
Symptomtext
This pain is interfering with my daily activities. The pain is from the injection to just above my elbow. I cannot lift my arm or sleep on my arm. Sanofi told me they had never heard of this complaint. This is day 18
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- hypertension, diabetes, high cholesterol.
- Andere Medikamente
- AM- metformin, lisinopril, januvia, hctz, loraadine PM- metformin, atorvastin, doxazosin, amlodiine
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 27.06.2022
- Impfdatum
- 21.06.2022
- Beginn
- 23.06.2022
- Tage bis Beginn
- 2,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
X-ray limb
Symptomtext
Patient recieved 3 vaccines on each deltoid in the peds office as a courtesy because adult practice doesn't have state vaccines Two days later returned to PCP in Family Medicine with right shoulder pain it is assumed this side effect is from Bexsero but this is unknown
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- X ray of shoulder and referral to Ortho
- Aktuelle Erkrankungen
- Food reaction
- Vorgeschichte
- winged scapula Getting PT for right Shoulder pain received prior to vaccine
- Andere Medikamente
- Epipen and Flonase
- Allergien
- Cephalexin and Zithromax
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 23.06.2022
- Impfdatum
- 22.06.2022
- Beginn
- 22.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Limb discomfort
Pain in extremity
Symptomtext
On June 22, 2022, pt. arrived around 9:00AM with mother and 2 siblings for immunization visit. Pt did not receive any immunizations until age 12 due to mother's beliefs against vaccines. Mother reports they have moved and he needs all his vaccines to enroll in school. Mother desires pt. to receive all vaccines that he is due for. Nurse attempted to reduce cost to patient by suggesting combination vaccine MMRV proquad without checking age range for vaccine. Patient was checked in around 9:30 AM and Nurse began preparing vaccines for both children. After counseling, mother agreed for vaccines and signed for them around 9:45AM. Vaccination of pt. began around 9:50AM and MMRV proquad was given in right arm subcutaneous. Nurse realized error at 10:00AM and patient stayed in office until 10:15AM. Pt denies SOB, swelling of throat or tongue. Pt reports only heavy, sore arm feeling due to multiple vaccines.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 9,0
- Geschlecht
- M
- Eingang
- 05.04.2022
- Impfdatum
- 04.04.2022
- Beginn
- 04.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Rash
Rash erythematous
Symptomtext
Ten minutes after receiving immunization client broke out with red wipes on both right and left arms and red rash on both right and left hands. The symptoms disappear within ten seconds. Later father did not want him to have BENADRYL at present given him two capsules to take with him to give every four hours if needed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- UNKNOWN
- Andere Medikamente
- NONE
- Allergien
- UNKNOWN
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 10.01.2022
- Impfdatum
- 03.01.2022
- Beginn
- 04.01.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash macular
Symptomtext
Patient husband is reporting that the patient has red, blotchy, spots all over her left arm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash macular
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- -
- Allergien
- Aleve
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 14.10.2021
- Impfdatum
- 22.07.2021
- Beginn
- 22.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anxiety
Disturbance in attention
Fatigue
Insomnia
Muscle spasms
Neuropathy peripheral
Symptomtext
Patient reports neuropathy hands & feet, spreading to lower extremities with muscle spasm in legs, fatigue difficulty sleeping and difficulty concentrating & Symptoms have gotten progressively worsen. Increase in anxiety injection given 7/22/21 - Symptoms unchanged on 10/11/21 - has been seen by urologist.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- See attached
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 04.10.2021
- Impfdatum
- 13.09.2021
- Beginn
- 13.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / AR
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Dizziness
Oropharyngeal pain
Respiratory tract congestion
Symptomtext
Following tetanus shot after leaving center, donor experienced chills, sore throat, dizziness, and congestion through next day.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Did have Covid just over one month before tetanus imm.
- Vorgeschichte
- -
- Andere Medikamente
- none
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.09.2021
- Impfdatum
- 30.08.2021
- Beginn
- 01.08.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Injection site rash
Insomnia
Joint range of motion decreased
Loss of personal independence in daily activities
Pain in extremity
Sleep disorder
Symptomtext
Pain in shoulder/ joint pain in that shoulder; pain in left upper arm; a rash under the arm she had the injection in (left); Decrease in range of motion/ trouble getting dressed; Trouble sleeping because of the pain; Initial information received on 09-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Information Media.. This case involves a 61 years old female patient who had pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), after receiving 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. patient did not received concomitant medication(s). On 30-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiration date: not reported) via unknown route in the left arm for prophylactic vaccination. On 30-in Aug-2021, the patient developed a non-serious pain in left upper arm (pain in extremity), pain in shoulder/ joint pain in that shoulder (arthralgia) , rash under the arm she had the injection (vaccination site rash), on the same day following vaccination. In Aug-2021, The patient developed a non-serious trouble sleeping because of the pain (insomnia) and decrease in range of motion/ trouble getting dressed (joint range of motion decreased), [unknown latency] following the administration of vaccine. It was reported "The caller stated that she is having side effects from a tetnus vaccine she received on 8-30-2021. She does not have the brand name of the vaccine. She did say that Pasteur is the manufacturer. She stated that the decrease in range of motion and pain are still present today, 10 days later. She has been in contact with her Dr about the issues. The patient is also not sure of the dose she received." No laboratory data reported. The patient was given Cold Packs and PARACETAMOL (TYLENOL) as a corrective treatment. At time of reporting, the patient did not recovered from the reported events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 01.09.2021
- Impfdatum
- 01.09.2021
- Beginn
- 01.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Nausea
Symptomtext
Following tetanus shot while still in center, donor c/o nausea, lightheadedness. s/s subsided w/in @15min.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 49,0
- Geschlecht
- M
- Eingang
- 01.09.2021
- Impfdatum
- 30.08.2021
- Beginn
- 30.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fatigue
Influenza like illness
Symptomtext
Approx 24 hrs post tetanus vaccine, donor had flu like symptoms and fatigue.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- none
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 19.08.2021
- Impfdatum
- 18.08.2021
- Beginn
- 18.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Nausea
Vomiting
Symptomtext
Client became nauseous and vomited about 5 minutes after all vaccines administered. Only 1 vomiting episode and nausea lasted about 10 minutes. Client vital signs were taken and client remained seated in a chair. All vital signs were stable and client verbalized feeling ok and back to normal about 10 minutes after incident began.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 04.08.2021
- Impfdatum
- 30.07.2021
- Beginn
- 30.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Burning sensation
Injection site bruising
Neuralgia
Symptomtext
Nerve pain, burning, bruising at site
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site bruising
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 41,0
- Geschlecht
- F
- Eingang
- 01.07.2021
- Impfdatum
- 04.06.2021
- Beginn
- 04.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Injection site pain
Joint range of motion decreased
Symptomtext
Injection site and shoulder sore, difficulty lifting arm above shoulder. painful shoulder 3 out of 10. no radiating pain, no redness or swelling.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Vivance, Buspur, lexapro,
- Allergien
- none known
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 25,0
- Geschlecht
- M
- Eingang
- 17.02.2021
- Impfdatum
- 15.02.2021
- Beginn
- 17.02.2021
- Tage bis Beginn
- 2,0
- Dosis
- 7+
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Muscular weakness
Pain in extremity
Vaccine positive rechallenge
Symptomtext
Complain of bilat arm pain & weakness to biceps.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- none known
- Vorgeschichte
- none known
- Andere Medikamente
- celecoxib 100 mg capsule T capsule BID cephalexin 500 mg capsule T capsule QID
- Allergien
- NKDA
- Vorherige Impfungen
- Similar symptoms same vaccine about 4 years ago
- Staat
- WA
- Alter
- 33,0
- Geschlecht
- F
- Eingang
- 11.02.2021
- Impfdatum
- 11.02.2021
- Beginn
- 11.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Electrocardiogram normal
Fatigue
Nausea
Symptomtext
Approximately 1 hour after receiving her vaccination, patient began feeling "nauseated, lightheaded, and fatigued." She did not lose consciousness and was able to ambulate normally while in the medical clinic.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- Vital signs (normal/stable); EKG (normal); Monitoring/Observation- 3 hours in clinic; Ultimately, patient was sent home under her own power, and advised to seek medical treatment if her symptoms worsened.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 55,0
- Geschlecht
- M
- Eingang
- 14.01.2021
- Impfdatum
- 12.01.2021
- Beginn
- 12.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Flushing
Hyperhidrosis
Nausea
Pruritus
Symptomtext
Flushed, diaphoretic, itching, and nausea. Vitals obtained (below). Vitals within normal limits. Patient denied dyspnea or SOB. Evaluated by a Primary Care Physician. Monitored for a total of 30 min until symptoms went away on their own. No medications given. Vaccine was given around 10AM. Patient presented back to immunizations clinic at approximately 10:40 AM. Was discharged from clinic at 11:10 AM. Instructed to follow-up with primary care provider.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- VS: BP 139/89, HR 75, SPO2 98% on room air, temp 97.7 F.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 24.11.2022
- Impfdatum
- 14.11.2022
- Beginn
- 14.11.2022
- 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 TENIVAC today, with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 76 years old female patient who experienced patient received an expired tenivac today, 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), concomitant medication and family history were not provided. On 14-Nov-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection dose 0.5 ml, lot U6852AA expiry date: 07-Oct-2022 via intramuscular route in unknown administration site for immunization (strength unknown). On 14-Nov-2022 the patient received an expired tenivac today, with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable It was not reported if the patient received a corrective treatment for the event Outcome was Unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.11.2022
- Impfdatum
- 26.10.2022
- Beginn
- 26.10.2022
- 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
administered expired TENIVAC 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 85 years old female patient who was administered 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. It was reported that on 26-Oct-2022 , the patient was administered expired dose of 0.5 ml once of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, ( lot : U6852AA ; expiry date: 07-Oct-2022) with no reported adverse event (expired product administered) , given via intramuscular route in right deltoid for immunization 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
- WA
- Alter
- 20,0
- Geschlecht
- M
- Eingang
- 08.11.2022
- Impfdatum
- 25.10.2022
- Beginn
- 25.10.2022
- 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
No adverse event
Symptomtext
patient that received an expired dose of Tenivac with no adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from other health professional. This case involves a 20 years old male patient who received an expired dose of 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), concomitant medication and family history were not provided. On 25-Oct-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U6852AA, expiry date: 07-Oct-2022) via intramuscular route in the left deltoid for immunization. On 25-Oct-2022 the patient developed a non-serious patient that received an expired dose of tenivac with no adverse event (expired product administered, latency: same day). Action taken: Not applicable. Outcome: Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 32,0
- Geschlecht
- F
- Eingang
- 29.10.2022
- Impfdatum
- 20.10.2022
- Beginn
- 20.10.2022
- 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
she pulled TENIVAC out of the refrigerator and accidentally gave a patient, TENIVAC today, 20-Oct-2022 that expired on 07-Oct-2022 with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 32 years old female patient who experienced she pulled tenivac out of the refrigerator and accidentally gave a patient, tenivac today, 20-oct-2022 that expired on 07-oct-2022 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. On 20-Oct-2022, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA expiry date-07-Oct-2022) (expired product administered, latency same day) (formulation and strength: unknown) via intramuscular route in the right deltoid for prophylaxis vaccination. 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 28.10.2022
- Impfdatum
- 21.10.2022
- Beginn
- 21.10.2022
- 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
medication error due to the administration of an expired product,with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40 years old female patient who experienced medication error due to the administration of an expired product 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 21-Oct-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and expiry 17-Oct-22) (expired product administered, latency same day) (dose, formulation and strength: unknown) via intramuscular route in the left deltoid for immunization. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. At time of reporting, the outcome was Unknown for the event medication error due to the administration of an expired product,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
- OR
- Alter
- 67,0
- Geschlecht
- F
- Eingang
- 21.10.2022
- Impfdatum
- 11.10.2022
- Beginn
- 11.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
Expired TENIVAC was administered to a patient after the expiration date, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 67-year-old female patient to whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient 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. Concomitant medications included pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine) PCV 23 for Immunisation. On 11-Oct-2022, the patient received 2nd dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: standard, at 0.5ml (formulation, route: unknown) (lot number: U6852AA and expiry date: 07-Oct-2022) in unknown administration site for Immunization and an expired tenivac was administered to a patient after the expiration date, with no reported adverse event (expired product administered) (latency: same day). This situation is reported as a medication error. Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 14.07.2022
- Impfdatum
- 27.04.2022
- Beginn
- 27.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product storage error
Symptomtext
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The requested that a form be submitted for this patient.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 84,0
- Geschlecht
- M
- Eingang
- 09.03.2022
- Impfdatum
- 18.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skin lesion
Symptomtext
Patient reported adverse reaction (dry lesion) from Tenivac given over 4 months ago.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Skin lesion
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- Hypertension
- Vorgeschichte
- Unknown
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics who had cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 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 an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6852AA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7207AA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ601AAA in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (formulation, strength: unknown) lot T1D482M in unknown administration site as prophylactic vaccination. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5787AA in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2f with no reported adverse event" (product storage error) (unknown latency) following the administration of all suspect vaccines. It was reported "Caller states that a cold temperature excursion occurred because the refrigerator door was not closed. The total excursion time was for 54 minutes and the lowest temperature reached was 31.2F. The products involved were unopened: TENIVAC, MENACTRA, PENTACEL, IPOL, and ADACEL. Caller asked for stability information for these products." Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2F with no reported adverse event). At time of reporting, the outcome was Unknown for the event cold temperature excursion refrigerator door was not closed 54 minutes and the lowest temperature reached was 31.2f 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 08.11.2021
- Impfdatum
- 08.11.2021
- Beginn
- 08.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- 7+
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
Client received dose of DT ahead of scheduled dose. No adverse or symptoms noted. Client Mother informed
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MT
- Alter
- 44,0
- Geschlecht
- F
- Eingang
- 27.01.2021
- Impfdatum
- 20.01.2021
- Beginn
- 20.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
Pt given Td before the 2 week recommended time period
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Covid - 19 vaccination given on 1-14-21
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -