- Staat
- AK
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 03.08.2021
- Impfdatum
- 03.08.2021
- Beginn
- 03.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Loss of consciousness
Symptomtext
The patient passed out after the second vaccine (HPV vaccine) and had to lay down for over an hour due to dizziness.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 22.07.2021
- Impfdatum
- 12.07.2021
- Beginn
- 19.07.2021
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Amnesia
Gaze palsy
Loss of consciousness
Pallor
Seizure
Skin discolouration
Symptomtext
My daughter has never had anything remotely close to this happening before and is generally very healthy. My most healthy child. After the vaccines, she turned pale, then green, and as I stepped out to get her juice (no one else in the room) she passed out head first, landed on her head. We rolled her over, her eyes were rolled back into her head and she went into convulsions. She has no recollection of this. She convulsed for several seconds before she came out of it.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 08.09.2021
- Impfdatum
- 22.07.2021
- Beginn
- 01.08.2021
- Tage bis Beginn
- 10,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Asthenia
C-reactive protein increased
Inflammation
Joint range of motion decreased
Laboratory test normal
Loss of personal independence in daily activities
Magnetic resonance imaging neck
Magnetic resonance imaging normal
Mobility decreased
Muscular weakness
Peripheral swelling
Rash erythematous
Skin lesion
Spinal X-ray normal
Urticaria
X-ray limb normal
Symptomtext
7/22/21 Meningitis Vaccine. 8/1/21 Small welts began on bilateral elbows (started oral bendryl), progressed to red rash and large welts on bilateral arms (worst on underside of forearms) and severe bilateral hand swelling on 8/2/21. Steroid injection and steroid cream started on 8/2/21 with little improvement and new target lesions on palms of bilateral hands in the evening. 8/4/21 mild improvement in swelling and rash. 8/5/21 hand lesions began to improve with continued improvement in rash and swelling over next several days. 8/6/21 right shoulder and knee became very painful in evening and unable to lift arm; shoulder pain, weakness, decreased ROM much more severe on 8/7/21. (continued...)8/8/21 continued with severe pain, weakness, and decreased right shoulder ROM. 8/9/21 Doctor appointment with PCP, ordered lab work and x-ray of right shoulder. 8/10/21 Awoke with new left shoulder severe pain, weakness, and decreased ROM; unable to lift left arm. By this time he has weakness throughout Bilateral UEs, unable to lift either arms, and now required maximal assist with dressing, reaching head / face for grooming, preparing / cutting food, opening doors, etc..., he was no longer able to drive. 8/11/21 recheck with physician: lab work WNL except CRP elevated to 13.64mg/L, Normal right arm x-ray. PCP sent referral to orthopedic surgeon. 8/12/21 appointment with Ortho: left shoulder and cervical spine x-rays orders, results normal; MRI of bilateral shoulders and cervical spine ordered, also normal. Ortho sent referral to neurologist. 8/13/21 appointment with Neurologist: diagnosed with pain and weakness from inflammation due to meningitis vaccine. Oral steroid ordered x8 days. Gradual improvement in symptoms over next 3 weeks with minor residual weakness of bilateral shoulders with external rotation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- Lab work 8/9/21, Right shoulder x-ray 8/9/21, Left shoulder and cervical spine x-rays 8/12/21, bilateral shoulder and cervical spine MRIs 8/12/21
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- PANDAS
- Andere Medikamente
- Fish Oil, Flonase, Turmeric, Vitamin D,
- Allergien
- Seasonal Allergies
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 13.08.2021
- Impfdatum
- 12.08.2021
- Beginn
- 13.08.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pain
Injection site swelling
Injection site warmth
Symptomtext
12 year old complains of pain and swelling to Right upper arm x 1 day. Patient mother stated that he went to a friends house the night of vaccine. When he returned home the next day she noticed swelling and redness to site, upon visual examination right upper arm was swollen and warm to touch, cool pack was applied to site and patient was referred to urgent care to rule out cellulitis and if any antibiotics are needed. Patients mother verbalized understanding
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 06.08.2021
- Impfdatum
- 25.07.2021
- Beginn
- 25.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Fall
Symptomtext
10 minutes after patient received the vaccine she walking around the store with her mother became lightheaded and fell to the floor. Patient was transferred to a wheelchair by a store employee and was brought to TLC for further evaluation. No injuries or bruised noted, patient's mother declined EMS services, patient was able to walk out without difficulties
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
- 12,0
- Geschlecht
- F
- Eingang
- 26.07.2021
- Impfdatum
- 23.07.2021
- Beginn
- 23.07.2021
- 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
Pallor
Symptomtext
Patient was asked if she had eaten anything and answered that she had not. With mom's permission, nurse gave patient lollipop which she begin to eat. Nurse also instructed patient to wait in chair after vaccinations for a few minutes before going to lobby to continue waiting 15 minutes. At approximately 11:15 a.m, within a minute of receiving the last vaccination (HPV), patient put her head in her lap and appeared to be fainting. Nurse supported patient so she would not fall on floor, mom got paper towels and wet them, nurse applied cold wet paper towels to patient's face, neck, arms, and hands. After several minutes, patient begin to open her eyes and get color back in her face. Chair was moved into place, and patient raised her legs onto chair. Mom supported patient while nurse went and got cold water bottle and crackers. Patient sipped slowly on cold water for several minutes. Nurse continued to apply wet towels, cold pack (brought by other nurse), and assist patient with cold water bottle sips and lollipop. At no time did patient fall to floor or become injured. At 11:45 a.m. mom determined that patient had recovered. Nurse and mom assisted patient as she ambulated into lobby where she continued to wait, observed by front office staff. At approximately 11:50 a.m. mom and patient walked from lobby after front office staff asked if patient was feeling better, and they stated she was o.k.---RN
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- Unknown
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 23.07.2021
- Impfdatum
- 20.07.2021
- Beginn
- 20.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Headache
Joint contracture
Muscle spasms
Pain in extremity
Pyrexia
Symptomtext
Headache, Fever, chills, muscle spasms, left arm pain, left hand contracture onset one hour post vaccination administration. Resolved after 400mg Ibuprofen administered. Pt returned to office after onset of symptoms. Tylenol 650mg administered and patient symptoms continued to improve. Patient remained in office from 3:15-4:45 and then discharged home. Phone call by MD at 9:00pm and symptoms completely resolved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Oral contaceptives
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 19.07.2021
- Impfdatum
- 14.07.2021
- Beginn
- 15.07.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Diarrhoea
Discomfort
Dizziness
Fatigue
Headache
Muscular weakness
Nausea
Symptomtext
"Bad" Headache, nausea, dizziness, diarrhea, weak/wobbly legs, generalized fatigue. Treatment included increasing fluid intake, Motrin for Headhace/discomfort and close monitoring. Mom reports the Advil did not help with the headache at all. By day #2 after vaccines pt was still extremely fatigued and severe headache. Headache continued through day #3 post vaccination, but other symptoms have improved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Anxiety
- Andere Medikamente
- None
- Allergien
- Codeine; Hydrocodone; Zyrtec
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 14.05.2022
- Impfdatum
- 03.05.2022
- Beginn
- 03.05.2022
- 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 received an expired dose of menactra, with no adverse event; Initial information received on 04-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who experienced patient received an expired dose of menactra, with no 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 (Hpv Vaccine) for Immunisation. On 03-May-2022, the patient received a dose (dose: 0.5ml )of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot U6921AB) via intramuscular route in the left deltoid for Immunisation. On 03-May-2022 the patient developed a non-serious patient received an expired dose of menactra, with no adverse event (expired product administered) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine. Action taken with: not applicable. It was not reported if the patient received a corrective treatment for the event (patient received an expired dose of menactra, with no adverse event). Outcome: Unknown for the event patient received an expired dose of menactra, with no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HPV VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 29.04.2022
- Impfdatum
- 26.04.2022
- Beginn
- 26.04.2022
- 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
dose of menactra given after the expiration date with no reported adverse event; Initial information was received on 26-APR-2022 regarding an unsolicited valid non-serious case received from other health care professional via call center. This case involves a 17 years old female patient who experienced dose of menactra given after the expiration date 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. On 26-Apr-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot-U6921AB, expiry-17-Apr-2022) via intramuscular route in the left deltoid for immunization. On 26-APR-2022 the patient developed a non-serious dose of menactra given after the expiration date 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 dose of menactra given after the expiration date 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
- FL
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 29.04.2022
- Impfdatum
- 26.04.2022
- Beginn
- 26.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
an expired dose of MENACTRA was inadvertently administered to a patient. The dose expired on 17APR2022, with no reported AE; Initial information received on 26-Apr-2022 regarding an unsolicited valid non-serious case received from an other health professional via nurse. This case involves a 17 years old male patient who took an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was inadvertently administered to a patient, the dose expired on 17-Apr-2022, with no reported AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Apr-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection once (total) (lot U6921AB, expiry date: 17-Apr-2022; strength: unknown) via intramuscular route in the right upper arm as Immunization. On 26-Apr-2022, an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine which was inadvertently administered to the patient and the dose expired on 17-Apr-2022, with no reported AE (expired product administered). 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
- AR
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.04.2022
- Impfdatum
- 22.04.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
received a dose of expired MENACTRA today with no reported adverse event; Initial information received on 22-Apr-2022 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves an unknown age and unknown gender patient who received a dose of expired menactra today with no reported adverse event while receiving 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 22-Apr-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot number: U6921AB ,Expiration date : 17-Apr-2022)(strength, formulation, dosage, route, administration site :unknown for the suspect) for immunization. On an unknown date the patient developed non-serious sevent received a dose of expired menactra today with no reported adverse event (expired product administered) (unknown latency) 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 (received a dose of expired MENACTRA today with no reported adverse event). At time of reporting, the outcome was Unknown for the event received a dose of expired menactra today with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
- IA
- Alter
- 74,0
- Geschlecht
- F
- Eingang
- 25.04.2022
- Impfdatum
- 25.04.2022
- Beginn
- 25.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
Symptomtext
The vaccine given was expired. Had an expiration date of 4/17/2022.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Lovastatin, Olmesartan, Alendronate
- Allergien
- Compazine
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 23.04.2022
- Impfdatum
- 22.04.2022
- Beginn
- 22.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Expired product administered
No adverse event
Symptomtext
Expired dose given; no adverse reaction reported by patient
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
5 patient received Menactra vaccine which was store at minus 8 degrees Celsius for 7 hours and 24 minutes/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from another health professional via consumer (under Medical Information Inquiry Number:00727996). This case is linked to case 2021SA275306 (Same reporter). This case involves five patients with an unknown age and gender who were administered dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had stored at minus eight degrees Celsius for seven hours and 24 minutes (product storage error). The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On an unknown date, the patients received dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution lot number: U6921AB, U7087AA and expiry date:17-Apr-2022, 05-Oct-2022 via an unknown route in unknown administration site for prophylactic vaccination respectively. It was case of an actual medication error due to product storage error temperature too low (latency: same day). It was reported "Nurse calling back to ask specifically about MENACTRA and IPOL that was administered yesterday after temperature. Is re-vaccination needed and if so, when should it be given. Caller states they do not think they had a real temperature excursion but had a faulty data logger because none of the other vaccines were frozen. States he provided minus eight degrees Celsius for seven hours and 24 minutes. Caller states 1 patient had received the IPOL. Caller thinks he had 5 patients between the two lots for the Menactra but is looking through his computer now to gather all the information. Product used." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 29.07.2021
- Impfdatum
- 14.07.2021
- Beginn
- 14.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
18 year old male patient administered dose of Menactra instead of Bexsero with no reported avderse event; Initial information received on 15-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 year old male patient who was by mistake given dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 14-Jul-2021, the patient received a 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AB and expiry date: 17-Apr-2022) (Frequency: once) instead of BEXSERO not produced by Sanofi Pasteur via an intramuscular route at an unknown administration site for (Wrong product administered) prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (latency on same day). It was reported that "Nurse Practitioner stated that a gave Menactra by mistake instead of Meningococcal B it was given to 3 triplets. Is there any harm done with them getting a third Menactra vaccine. Is is alight for them to come back in to get the Meningococcal B in a few days. Nurse practitioner states triplets were given an extra dose of Menactra instead of Meningococcal B dose of Bexsero. What should they look for and can they get the Bexsero so they can go to college. Patient Information Patient age greater than one year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5ml, Strength: standard except for Fluzone HD-standard TB skin test-immunization. Event Information treatment- none at this time and they have spoken with the father who doesn't report any problems, dose if series-they had the first dose in childhood and one at 15-16 years and now this one by accident. They were in the clinic for school shots. Reporter relationship: HCP (health care professional) Product used: used First time product used: no still using product: no". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 22.07.2021
- Impfdatum
- 09.07.2021
- Beginn
- 09.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
No adverse event
Symptomtext
Immunization given Early, Monitored patient who has reported not signs or symptoms at this time. Outcome is positive.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- None at this time
- Aktuelle Erkrankungen
- None at this time
- Vorgeschichte
- None at this time.
- Andere Medikamente
- None at this time
- Allergien
- None at this time
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 18.07.2021
- Impfdatum
- 08.07.2021
- Beginn
- 08.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
Doses of Menactra and Adacel were administered to patient post temperature excursion of 32-degrees Fahrenheit temperatures with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00676408) and transmitted to Sanofi on 09-Jul-2021. This case is linked to cases 2021SA229197 and 2021SA230017. (Same reporter) This case involves a 4 month old male patient who was received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] post temperature excursion of 32-degrees Fahrenheit temperatures (product storage error). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL). On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [total, once, lot U6927AA, expiry date: 28-Jan-2023] via an intramuscular route at the left arm and a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6921AB, expiry date: 17-Apr-2022] via an intramuscular route at the right arm for prophylactic vaccination. It was a case of actual medication error due to product storage error temperature too low. (Latency: on the same day of vaccination) At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- GARDASIL
- Allergien
- -
- Vorherige Impfungen
- -