- Staat
- CA
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 19.08.2021
- Impfdatum
- 10.08.2021
- Beginn
- 10.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Presyncope
Symptomtext
Vasovagal response per facility Parent states patient had seizure
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- NA Parent is waiting on a referral to see specialist.
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- URI Scoliosis
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 30.07.2021
- Impfdatum
- 30.07.2021
- Beginn
- 30.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immediate post-injection reaction
Loss of consciousness
Seizure
Syncope
Symptomtext
This patient is a 16 year old male who had a syncopal episode in the clinic today with his mother present. He received 3 vaccines during this visit, immediately after the 3rd vaccine (HPV9) he slumped over at 10:51am , was caught by the nurse, had convulsion-like movements for 10 seconds at 10:52am, and was safely brought to the ground by 10:53am for continued recovery with the assistance of a second nurse. He regained consciousness before moving him to the ground, he laid with elevated feet and drank juice and was breathing normally. His perfusion improved, color returned to his face, and he showed no other abnormalities. He sat up slowly and waited in the chair, drank water, and conversed normally with the nurses for 15 more minutes before leaving. He was discharged 11:14am accompanied by his mother and stated he ?felt much better?. The client recovered quickly <15 minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- unknown
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 18.03.2021
- Impfdatum
- 02.03.2021
- Beginn
- 02.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
Syncope episode after vaccine was administered.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 04.03.2021
- Impfdatum
- 02.03.2021
- Beginn
- 02.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Computerised tomogram head
Fall
Head injury
Lip injury
Swelling face
Syncope
Toothache
Symptomtext
Patient fell in exam room shortly after vaccine(syncopal episode) and hit head against stool and exam table. There is a laceration to lower lip that appears to go thru completely from inner to outer lip. She has swelling to outer edge of right orbit. She reports pain to teeth but no injury seen. I have referred patient, mother to ER for further management and possible sutures of laceration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- CT Facial Bones on 03/02/2021
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- ADD
- Andere Medikamente
- Vyvanse 60 mg capsules
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 08.01.2021
- Impfdatum
- 08.01.2021
- Beginn
- 08.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Symptomtext
Patient passed out in office while waiting 15min after shots.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 28.07.2021
- Impfdatum
- 27.07.2021
- Beginn
- 27.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Hypotension
Lethargy
Unresponsive to stimuli
Symptomtext
Severe hypotension, sweating, unresponsive, lethargic, "lightheaded"
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hypotension
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Denies
- Vorgeschichte
- Denies
- Andere Medikamente
- denies
- Allergien
- Denies
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 07.02.2021
- Impfdatum
- 30.12.2020
- Beginn
- 08.01.2021
- Tage bis Beginn
- 9,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Bacterial test negative
CSF pressure increased
CSF white blood cell count increased
Dehydration
Headache
Magnetic resonance imaging head abnormal
Magnetic resonance imaging spinal abnormal
Myelitis
Pyrexia
Urinary retention
Symptomtext
Developed fever and headache on 1/8/21. Patient with intermittent fevers and persistent headache. Seen by PCP. Admitted to Facility from 1/21-1/22 for headache and dehydration; symptoms improved with IVF. Increasing headache and complaint of urinary retention then occurred -- readmitted to Facility on 1/25/21. Work-up consistent with myelitis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dehydration
- Hospital-Tage
- 6,0
- Labordaten
- 1/26/21 Brain and spine MRI = lesions of the central spinal gray matter, bilateral thalami, and periaqueductal gray matter. 1/26/21 LP = elevated open pressure; elevated WBC in spinal fluid with negative bacterial culture.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 23.06.2021
- Impfdatum
- 22.06.2021
- Beginn
- 22.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pruritus
Rash
Rash erythematous
Symptomtext
The patient developed diffuse body itching and diffuse body (trunk and extremities) red rash throughout that was not clearly urticarial. This began about an hour after vaccine administration. He denied any symptom of allergy. Symptoms began to improve within 28 hours without intervention but did not resolve. He was advised to trial benadryl and monitor closely.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pruritus
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Insect bites to left leg
- Vorgeschichte
- -
- Andere Medikamente
- Protein milk supplement once daily
- Allergien
- None known
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 29.04.2021
- Impfdatum
- 15.03.2021
- Beginn
- 16.03.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Symptomtext
Left shoulder pain hx of
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- none
- Andere Medikamente
- -
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 29.04.2021
- Impfdatum
- 17.03.2021
- Beginn
- 18.03.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Symptomtext
Left shoulder pain
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 15.04.2021
- Impfdatum
- 13.04.2021
- Beginn
- 13.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site urticaria
Pain in extremity
Pruritus
Skin lesion
Symptomtext
About 4-5 hours after the vaccine the patient started noting itchiness and pain over the right arm. In the morning, Mother noted wheal, raised erythematous circular lesion, present over area vaccine was given. About 6-7 cm in size. The patient also has a smaller lesion, red erythematous wheal over the left arm injection site which is about 1cm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None, prescribed cetirizine.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Obese
- Andere Medikamente
- None
- Allergien
- Had prior allergic reaction [wheal/raised red circular mass] after Kinrix vaccine
- Vorherige Impfungen
- Allergic reaction to Kinrix, given 09/28/2014, 8 cm local reaction
- Staat
- KY
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 26.03.2021
- Impfdatum
- 25.03.2021
- Beginn
- 25.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diarrhoea
Vomiting
Symptomtext
Vomiting and diarrhea started at 11:20pm on 3/25/21. Vomiting subsided at 5:00am, diarrhea started at 6:00am. At present still with diarrhea.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- multi vitamins
- Allergien
- PCN
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 10.03.2021
- Impfdatum
- 08.03.2021
- Beginn
- 09.03.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Headache
Nausea
Pyrexia
Symptomtext
MOTHER REPORTED c/o Head ACHE, DIZZINESS And NAUSEA IN THE Morning LATE AFTERNOON fever 101.3 ? HEAD- ACHE, DIZZINESS- TYLENOL 500mg Administered per Mother
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 25.02.2021
- Impfdatum
- 12.02.2021
- Beginn
- 13.02.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Pain in extremity
Peripheral swelling
Symptomtext
Patient had severe pain and swelling in a large portion of his deltoid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 22.02.2021
- Impfdatum
- 18.02.2021
- Beginn
- 18.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Dysphagia
Oral pruritus
Oropharyngeal pain
Symptomtext
Sore throat & itchines of mouth 1 min. after administration but not told to medical staff. at 3:30am Pt awoke c/o sore throat, trouble swallowing. Given EpiPen, called 911. Seen at ER & given Benadryl, Pepcid AC & steroids. Pt home & doing well.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Oral pruritus
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Vyvanse 30mg capsule Multivitamin
- Allergien
- PCN, Mold, sesame seed oil, Peanuts, Tree nuts
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 17.02.2021
- Impfdatum
- 12.01.2021
- Beginn
- 16.01.2021
- Tage bis Beginn
- 4,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Urticaria
Symptomtext
Developed generalized hives 4 days post vaccination, hives lasted x 24 hours and disappeared with Benadryl. Patient had no other symptoms whatsoever. We need to know if patient can have further doses of vaccines or not.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 12.02.2021
- Impfdatum
- 06.01.2021
- Beginn
- 06.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pruritus
Skin burning sensation
Symptomtext
Pt developed itching and burning on her neck and chest. Mom gave patient Benadryl and Motrin. This helped the itching but then it came back at noon the next day. Mom gave her more Benadryl. It then came back the following day and Mom gave Benadryl again and then it never came back.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pruritus
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Pt did test positive for Covid on Dec 2,2020.
- Vorgeschichte
- Environmental allergies
- Andere Medikamente
- None
- Allergien
- Allergic to environmental things
- Vorherige Impfungen
- Pt received Menactra(Sanofi) on 5/21/15, pt was 11 years old. This was patient's first dose of Menactra. Mom reports that pt was
- Staat
- FL
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 03.02.2021
- Impfdatum
- 01.02.2021
- Beginn
- 02.02.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: unbekannt
Asthenia
Fatigue
Memory impairment
Nausea
Peripheral swelling
Slow speech
Sluggishness
Vomiting
Symptomtext
fatigue , nausea, vomiting, slow speech, memory problems, sluggish, weakness , swelling of the arm, Sent him to hospital ER
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Costochondritis
- Vorgeschichte
- Asthma, allergic rhinitis
- Andere Medikamente
- Zyrtec
- Allergien
- Follows w/allergy unknown. Has Hx of Angioedema/Urticaria
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 12.03.2022
- Impfdatum
- 03.03.2022
- Beginn
- 03.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
received an expired dose of Menactra, with no reported adverse event; Initial information was received on 04-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via call center. This case involves a 13years old male patient who received an expired dose of menactra, with no reported adverse event after receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine (HPV Vaccine) and Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) as Prophylactic vaccination. On 03-Mar-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength: unknown) at a dose of 0.5 ml once (batch number: U6877BA; expiration date: 28-Feb-2022) via intramuscular route in left arm for immunization. On 03-Mar-2022, the patient received an expired dose of menactra, with no reported adverse event (expired product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine. Action Taken: not applicable At time of reporting, the outcome was Unknown for the event (expired product administered). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
- AZ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 27.10.2021
- Impfdatum
- 26.10.2021
- Beginn
- 26.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
No adverse event
Symptomtext
No adverse reactions. Patient received 2 doses of flu on the same visit.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.08.2021
- Impfdatum
- 19.07.2021
- Beginn
- 19.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Vaccine was exposed to 80.6 degree Fahrenheit for 14 hours 15 minutes/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from an Other health professional via Medical Information (Reference number- 00700812) and transmitted to Sanofi on 28-Jul-2021. This case involves a 16-year-old female patient reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was exposed to 80.6-degree Fahrenheit for 14 hours 15 minutes with no adverse event (Product storage error) and the patient administered the vaccine after the temperature excursion with no adverse event (Poor quality product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 19-Jul-2021, the patient received a 0.5 ml (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6877BA and expiry date 28-Feb-2022] via intramuscular route in left deltoid for prophylactic vaccination. It was a case of actual medication error due to incorrect product storage and poor-quality vaccine administered (latency was on same day). It was reported that, " MA calling to report a temperature excursion caused by a fridge malfunction that lasted for 14 hours 15 minutes with a high temperature of 80.6?F. Medical Assistant reporting on behalf of a 16-year-old female receiving a Menactra dose after the Menactra was exposed to a temperature excursion that made the vaccine not suitable for use. The caller reported that the temperature excursion was on 25Jun2021 and the vaccine was administered on 19Jul2021 and she wants to know if anything needs to be done in regard to this. Vaccines. Product used: Used. Still using product: No". At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 22.06.2021
- Impfdatum
- 02.06.2021
- Beginn
- 02.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Wrong product administered
Symptomtext
Patient got an extra dose of the MENACTRA with no adverse event; Patient recieved Menactra instead of the intended Bexsero with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00640413) and transmitted to Sanofi on 14-Jun-2021. This case involves a 17 years old female patient who received 0.5 mL third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6877BA and expiry date: 29-Feb-2022) via unknown route in right deltoid (extra dose administered) for prophylactic vaccination on 02-Jun-2021 instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] (wrong product administered). The patient's past vaccination(s) included Menactra on 08-AUG-2017 and 13-AUG-2020. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. The reporter asked when would be best to give a meningococcal B vaccine. Should they be looking for anything. It was reported that the patient received Menactra on 08Aug2017 and 13Aug2020. She then received a third dose of Menactra in the right deltoid by mistake on 02Jun2021. The intended vaccine on 02Jun2021 was a meningococcal B vaccine, Bexsero. They told a medical assistant (MA) to give a "meningitis vaccine" and the MA chose Menactra instead of the intended Bexsero. It was an actual medication error case due to extra dose administered and wrong vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event and feels fine. 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
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- GARDASIL; HEPATITIS A VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 08.04.2021
- Impfdatum
- 06.04.2021
- Beginn
- 06.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Wrong product administered
Symptomtext
The patient was due for a dose of MMR and I administered Meningococcal instead. There were no adverse reactions. The provider on duty checked to make sure that the vaccine would not harm the patient. According to her contacts, the patient should not have any adverse reactions or long term issues. Then we reached out to the parent to give him this information and reschedule for the correct vaccine to be given.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -