- Staat
- TN
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 23.07.2021
- Impfdatum
- 23.07.2021
- Beginn
- 23.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cardio-respiratory arrest
Hypoaesthesia
Incoherent
Musculoskeletal stiffness
Pain in extremity
Posture abnormal
Speech disorder
Tremor
Visual impairment
Symptomtext
Pt complained of pain in left arm.. He stated his arm felt numb. I asked pt to stay in clinic for a few more minutes to assess his status while charting. Patients head lowered and he became stiff and leaned to the left on the desk.. clinched fists and tremors. With help from his mother, he was lowered to the floor on his knees. Code Blue called. Moved all furiture away from pt to prevent injury. Pt only able to mumble and was incoherent when asked questions. Ambulance arrived. Pt moved up to a chair and transferred to gurney. Pt stated he could not see.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardio-respiratory arrest
- Hospital-Tage
- -
- Labordaten
- None in this clinic
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- PCN
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 34,0
- Geschlecht
- M
- Eingang
- 05.08.2021
- Impfdatum
- 04.08.2021
- Beginn
- 04.08.2021
- 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
Patient has syncope
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 17.08.2021
- Impfdatum
- 16.08.2021
- Beginn
- 16.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Abdominal discomfort
Abdominal pain
Diarrhoea
Feeling hot
Paraesthesia
Pruritus
Tryptase
Urticaria
Symptomtext
About 3 hours after the vaccinations (around 7:15 pm) she developed urticaria, feeling of warmth, itching , pins/needles /tickling feeling throughout her body, abdominal pain, single episode of diarrhea. Abdominal discomfort resolved after about 45 minutes. Mother gave Benadryl and Zyrtec at 8:00 pm. In the emergency department she was given dexamethasone at 10:24 pm Her symptoms had resolved by 10:45 pm She never had any lip, tongue, or throat swelling, no shortness of breath or difficulty breathing
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paraesthesia
- Hospital-Tage
- -
- Labordaten
- Tryptase collected 8/16/2021 - result pending
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Celiac sprue
- Andere Medikamente
- -
- Allergien
- amoxicillin gluten cefdinir
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 06.07.2022
- Impfdatum
- 05.07.2022
- Beginn
- 05.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal discomfort
Fatigue
Injection site erythema
Nausea
Neck pain
Pain in extremity
Product administration error
Vaccination site pain
Symptomtext
Intense pain at vaccination site and entire arm/neck. Next morning extreme nausea, upset stomach, exhaustion and continued pain at injection site. Very red spider web looking reaction at injection site. Pharmacist didn't tell us anything about the risks of the meningitis b vaccine and I assumed it was routine as it was on her MI required vaccination card. The pharmacist also gave her both vaccines in the same arm back to back and now I read it should have been separate arms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- Takes 20mg of Prozac daily for anxiety & ocd
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 14.02.2022
- Impfdatum
- 03.02.2022
- Beginn
- 07.02.2022
- Tage bis Beginn
- 4,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Hypoaesthesia
Injection site hypoaesthesia
Symptomtext
Mom called on 2/08/2022 at around 11:38am , Patient feels his right arm and fingers numb. And stating that this happened after receiving the COVID 19 Vaccines
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site hypoaesthesia
- Hospital-Tage
- -
- Labordaten
- the patient visited Urgent Care Center
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NO
- Andere Medikamente
- NONE
- Allergien
- NOT KNOWN DRUG ALLERGY
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 76,0
- Geschlecht
- M
- Eingang
- 11.10.2021
- Impfdatum
- 16.08.2021
- Beginn
- 25.08.2021
- Tage bis Beginn
- 9,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Arthralgia
Induration
Joint swelling
Skin warm
Tenderness
Symptomtext
the left shoulder/deltoid area was firm, swollen, and warm to touch. Patient reports pain 2/10 when nothing is touching it, and 7/10 when the area is touched.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 21.07.2021
- Impfdatum
- 14.07.2021
- Beginn
- 15.07.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Rash erythematous
Rash papular
Rash vesicular
Skin reaction
Symptomtext
significant localized skin reaction, erythematous, raised and almost appeared blister like. Provider instructed pt and mother to use ice and antihistamines. Parent verbalized understanding. On July 20th I spoke with mother and reaction had improved 90%.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash erythematous
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Takes Cetirizine 10mg daily,
- Allergien
- none
- Vorherige Impfungen
- 2016 had a local reaction to fluzone
- Staat
- MN
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 24.05.2021
- Impfdatum
- 24.05.2021
- Beginn
- 24.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Pain in extremity
Pallor
Symptomtext
Patient received all three vaccines. We remained in the room for approximately 3-5 minutes after the vaccines were complete visiting and finishing up questions. There were no signs of distress, lightheadedness or dizziness. Patient left the room and stated to mom that her legs hurt and she was dizzy. Mom was able to get patient to the floor safely by sliding her down the wall and laying her on the floor. Mom stated that the patient did not hit anything on her way down nor when she was laid out on the floor. A pillow was brought to put under the patients head and mom put patients feet above her heart. I grabbed juice for the patient and we let her lay for a few minutes. The team manager Dr. was brought to the patient and we then moved her to a patient room out of the hallway to assess further. she remained with us for another 15 minutes and was able to complete a juice while sitting with mom. She had stopped sweating, had color back to her face and no longer felt dizzy or lightheaded so the patient and mom where let go from the office.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Attention Deficit Disorder Combined Type
- Andere Medikamente
- Tylenol, Vitamin C oral, atropine 0.1mg/ml in BSS ophthalmic solution, Flonase, Ibuprofen, levothyroxine, loratadine, Ritalin LA, multivitamin with iron, Patanol 0.1% ophthalmic solution, OCEAN nasal spray. (none of these were taken at the
- Allergien
- Amoxicillin, Pollen Extracts
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 29.04.2021
- Impfdatum
- 22.04.2021
- Beginn
- 23.04.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Diarrhoea
Headache
Nausea
Pyrexia
Vision blurred
Vomiting
Symptomtext
Patient started having headache, nausea, vomiting, diarrhea, fever (102-103) and blurry vision. Mom called Dr that morning and he stated to continue to give Tylenol and ibuprofen and to report reaction. Mom stated he started feeling better and fever broke about 1500 Friday evening, 4/23/21.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- asthma
- Andere Medikamente
- zrytec, singular
- Allergien
- Omnicef, pork, beef, milk products
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- 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: ja
Dizziness
Flushing
Pain in extremity
Rash
Symptomtext
Patient started with a rash on both arms , face and neck. Her face was flushed. She felt lightheaded and her arms hurt. She also became anxious. Initial VS: pulse ox:97% on RA, pulse: 102, BP: 102/64; 5 minutes later: pulse ox:96% on RA, pulse: 106 5 minutes later: Zyrtec 10 mg po given; 5 minutes later: pulse ox:99% on RA, pulse: 68; 10 minutes later: pulse ox:98% on RA, pulse: 91, BP: 104/62: lungs were CTA the entire time; no tongue swelling. Water given, a lollipop and brownie given. After 30 minutes; rash almost completely gone and pulse ox:97% on RA, pulse: 87. Patient discharged home with Mom and walked out of the office.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Constipation
- Andere Medikamente
- MVI
- Allergien
- Shellfish
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 17.03.2022
- Impfdatum
- 09.03.2022
- Beginn
- 09.03.2022
- 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
a patient was accidentally given expired Menactra with no reported adverse event; Initial information received on 11-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who experienced a patient was accidentally given expired menactra with no reported adverse event 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. On 09-Mar-2022, the patient received a 0.5 ml dosage of meningococcal a-c-y-w135 (d conj) vaccine via intramuscular route in left arm (with unknown strength and formulation) (batch number :U6827BA and expiry date :18 Feb 2022) for immunization. On 09-Mar-2022 (latency: same day)the patient developed a non-serious patient was accidentally given expired menactra with no reported adverse event (expired product administered) 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 (a patient was accidentally given expired Menactra with no reported adverse event). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.03.2022
- Impfdatum
- 10.03.2022
- Beginn
- 10.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
reporting that an expired dose of MENACTRA was inadvertently given to a patient, with no reported adverse event; Initial information received on 10-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center. This case involves an infant patient with unknown demographics who experienced reporting that an expired dose of menactra was inadvertently given to a patient, with no reported adverse event while 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 VLP RL1 4V (YEAST) (GARDASIL), Diphtheria Vaccine toxoid, pertussis vaccine Acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) and Influenza vaccine inact SPLIT 3V (FLUZONE HIGH DOSE) for Prophylactic vaccination. On 10-Mar-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (batch- U6827BA, expiry-13-FEB-2022) (dose, strength and frequency-unknown) via intramuscular route in right deltoid for prophylactic vaccination. On 10-MAR-2022 the patient developed "reporting that an expired dose of menactra was inadvertently given to a patient, with no reported adverse event" (expired product administered) 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 reporting that an expired dose of menactra was inadvertently given 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
- GARDASIL; BOOSTRIX; FLUZONE HIGH DOSE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 12.03.2022
- Impfdatum
- 04.03.2022
- Beginn
- 04.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
Symptomtext
how soon they can give another dose of MENACTRA to a patient that was given an expired dose today.; Initial information received on 04-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who experienced how soon they can give another dose of Menactra to a patient that was given an expired dose today while 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 meningococcal vaccine b rfhbpa/fhbpb (Trumenba) for Immunisation. On 04-Mar-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (d conj) vaccine(formulation unknown) via intramuscular route in the right deltoid (batch number: U6827BA and expiry date :18-Feb-2022) for immunization. On 04-Mar-2022 (latency: same day)the patient developed a non-serious event of how soon they can give another dose of menactra to a patient that was given an expired dose today(expired product administered) following the administration of meningococcal A-C-Y-W135 (d conj) vaccine Action taken : not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 05.03.2022
- Impfdatum
- 24.02.2022
- Beginn
- 24.02.2022
- 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
inadvertently received MENACTRA on 24FEB2022 in the office which had expired on 18FEB2022 with no reported ae; Initial information received on 24-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who inadvertently received Menactra on 24-Feb-2022 in the office which had expired on 18-Feb-2022 with no reported adverse event (AE) while 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 Vaxero, Meningitis B, Flu Shot (Influenza Vaccine). On 24-Feb-2022, the patient was administered 0.5 ml dose of suspect meningococcal A-C-Y-W135 (D Conj.) vaccine subcutaneously by a physician in the office (with lot number U6827BA, Expiry date: 18-Feb-2022) via intramuscular route in the left deltoid as prophylactic vaccination (immunisation). An hour after the administration, the reporter informed that 2 patients had inadvertently received Menactra on 24-Feb-2022 which had expired on 18-Feb-2022. Patient was administered full dose of expired product (expired product administered) (latency: Same day) by the physician, but had not reported any adverse event. Enquiry was made if patient needed to be re-vaccinated or if it was safe to give another full dose of Menactra right away since full doses were given on 24-Feb-2022. Action taken with meningococcal vaccine (MENACTRA) was not applicable. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was Unknown for the event This was reported as potential AE because of use against local labelling. To be evaluated. No further information was provided by the reporter. 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
- FLU
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 05.03.2022
- Impfdatum
- 24.02.2022
- Beginn
- 24.02.2022
- 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
Symptomtext
inadvertently received MENACTRA with no reported adverse event; inadvertently received MENACTRA on 24FEB2022 in the office which had expired on 18FEB2022 with no reported adverse event; Initial information received on 24-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who inadvertently received menactra on 24-Feb-2022 in the office which had expired on 18-Feb-2022 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 HPV vaccine (HPV vaccine); influenza vaccine (flu); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP). On 24-Feb-2022, the patient received a 0.5 ml dose (First Dose) of suspect meningococcal A-C-Y-W135 (D conj) vaccine (lot U6827BA, expiry date: 18-Feb-2022) (strength and formulation not reported) via intramuscular route in the left deltoid as prophylactic vaccination An hour after the administration, the reporter informed that 2 patients had inadvertently received Menactra on 24-Feb-2022 which had expired on 18-Feb-2022 (expired product administered) (accidental exposure to product) (latency same day). Caller asked if these patients needed to be revaccinated and if it was safe to give another full dose of MENACTRA right away since full doses were given on 24FEB2022. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HPV VACCINE; FLU; TDAP
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 23,0
- Geschlecht
- F
- Eingang
- 27.02.2022
- Impfdatum
- 21.02.2022
- Beginn
- 21.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
expired dose of MENACTRA was administered with no adverse event; Initial information was received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center. This case involves a 23years old female patient who was administered an expired dose of vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2022, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (formulation: unknown) (batch number: U6827BA; expiration date: 18-Feb-2022) once (strength: unknown) via intramuscular route in an unknown administration site for immunization. On 21-Feb-2022, the patient experienced no adverse event on administration of an expired dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine (expired product administered) (latency: same day). 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 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
- NH
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 03.07.2021
- Impfdatum
- 09.11.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
No adverse event
Symptomtext
a 11 years old patient has erroneously received a second dose of MENACTRA within a 7 month timeframe with no adverse event; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 11 years old female patient has erroneously received a 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Injection batch number: U6827BA, expiry date: 18-FEB-2022 via intramuscular route in the left deltoid on 09-Nov-2020 and a 0.5 ml second dose batch number not reported, expiry date: 09-JAN-2022 via intramuscular route in the right deltoid on 22-Jun-2021 within a 7 month time frame for prophylactic vaccination (inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) batch number: U6827BA on 09-Nov-2020 for Prophylactic vaccination. It was an actual medication error due to drug dose administration interval too short (latency: same day). It was reported that "The caller stated that an 11 years old patient has erroneously received a second dose of MENACTRA within a 7 months timeframe. Please see the Event Information, additional description of event for further details. Nurse asks if there are adverse effects that they should monitor for and should the child still receive a booster dose at 16 or so. On 09-Nov-2020, the patient received a dose of Menactra. On 22-Jun-2021, the patient reported to the doctor office for a routine annual exam where she was administered Menactra again in error. The caller would like to know if there will be any adverse events as a result of this error. The caller also wants to know if the patient should still receive another dose of Menactra at 16 year of age. Dosage Information Frequency: once, Strength: standard. No adverse events reported. Product used: Used". 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
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- DTAP VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 25.01.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
patient received a dose of Menactra after the vaccine was exposed to a temperature excursion of 22.7?F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418272) and transmitted to Sanofi on 06-Jan-2021. This case is linked with 2021SA005526, 2021SA006661(same reporter). This case involves an 18 year old male patient who received a 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6827BA, expiration date: 18-Feb-2022) once via unknown route at right deltoid for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked. It was an actual medication error due to product storage error temperature too low. The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reporter wanted to know how they should proceed and if they should revaccinate the patient. No adverse event reported to the patient at the time of reporting. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -