- Staat
- IN
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 31.03.2022
- Impfdatum
- 29.03.2022
- Beginn
- 29.03.2022
- 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 the Lobby approximately 10 minutes after being vaccinated, the patients mother stated earlier during the visit that the patient has never passed out during or after vaccinations when asked by the Medical Assistant.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 03.11.2021
- Impfdatum
- 03.07.2021
- Beginn
- 07.07.2021
- Tage bis Beginn
- 4,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: ja
Erholt: nein
Cardiac stress test
Dizziness
Echocardiogram
Electroencephalogram
Electromyogram
Fatigue
Feeling abnormal
Laboratory test
Magnetic resonance imaging head
Magnetic resonance imaging neck
Syncope
Tilt table test
Symptomtext
Her symptoms started with dizziness, fatigue, then became worsened with fainting, The dizziness, brain fog, fatigue is a daily problem that happens every time she in upright position. She has fainted now a handful of times.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- Labwork October 2021 Stress test, Echocardiogram, EMG, EEG, Autonomic Test, Tilt table test all the week of October 11th- 15th Brain, head , neck MRI's 10-6-21 Fainted with ER visit late september 2021
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- penicillin
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 13.08.2021
- Impfdatum
- 06.08.2021
- Beginn
- 06.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
syncope for few seconds/vagal episode. Did well in few minutes
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 29.07.2021
- Impfdatum
- 29.07.2021
- Beginn
- 29.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Amnesia
Chills
Eye movement disorder
Immediate post-injection reaction
Syncope
Symptomtext
Pt experienced sycope immediately after injecting the HPV vaccine. The menactra was administered first. Patient lost conciousness for 10-15 seconds, eyes rolled back and her body experienced rigors. Patient was placed supine for recovery. Patient does not remember episode. MD immediatley brought to check on patient . Patient allowed to recover and was released without issue.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- BP-110/72 Pulse 85 O2sat 99
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Trimcinolone Cream for dental irritation
- Allergien
- None noted
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 22.07.2021
- Impfdatum
- 19.07.2021
- Beginn
- 19.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
FAINTED, RECOVERED QUICKLY
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NONE THAT WE ARE AWARE OF
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE THAT WE ARE AWARE OF
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 22.06.2021
- Impfdatum
- 22.06.2021
- Beginn
- 22.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
Vasovagal syncope. occurred within 1-3 minutes after vaccine, resolved within 3-5 minutes with supine position and legs up
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Back pain
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 11.08.2021
- Impfdatum
- 11.08.2021
- Beginn
- 11.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Nausea
Pallor
Symptomtext
pt became dizzy, nausea, pale pallor, and diaphoretic
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 04.08.2021
- Impfdatum
- 02.08.2021
- Beginn
- 03.08.2021
- 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 pruritus
Symptomtext
The pt showed mom the area at the right arm injection site evening of 8-3, the red area was about the size of a quarter and was itchy. Today the area that is red is 9cm long, about 9cm wide at the top, tapering down to 6cm on the bottom. The reaction has been assessed this afternoon and is a large local reaction, no treatment given.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- no
- Vorgeschichte
- asthma
- Andere Medikamente
- Singulair 5mg, Zoloft 50mg
- Allergien
- dust mites, dog dander
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 02.08.2021
- Impfdatum
- 30.07.2021
- Beginn
- 01.08.2021
- Tage bis Beginn
- 2,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Muscular weakness
Pain in extremity
Urticaria
Symptomtext
Hives on legs and arms Pain in shoulders bilat, hips bilat, R wrist feeling generally weak
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Exercise Induced Asthma
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 19.07.2021
- Impfdatum
- 12.07.2021
- Beginn
- 17.07.2021
- Tage bis Beginn
- 5,0
- Dosis
- 2
- Route/Site
- SYR / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Injection site erythema
Pain in extremity
Symptomtext
MOM STATES HER DAUGHTER REPORTED SORENESS TO THE LEFT ARM ALL WEEK. SATURDAY, RED "SPLOTCHES" BEGAN APPEARING BELOW THE INJECTION SITE, "ABOVE AND BELOW THE ELBOW." THERE IS NO DRAINAGE OR SWELLING NOTED. MOM STATES THESE SPOTS BEGAN TO APPEAR WORSE ON SUNDAY, BUT SEEM TO HAVE MAINTAINED THEIR APPEARANCE TODAY. SORENESS IS STILL PRESENT; OTC ANALGESICS HAVE NOT SEEMED TO HELP. IT WAS ADVISED BY THIS NURSE AND RN TO USE HEAT TO HELP ALLEVIATE PAIN AND USE OF DIPHENHYDRAMINE. IF THE AREA CONTINUES TO GET WORSE OR DOES NOT IMPROVE, SEEK MEDICAL ATTENTION FROM PRIMARY CARE. I ALSO TALKED TO MOM ABOUT PATIENT'S SECOND DOSE. IT WAS ENCOURAGED FOR HER TO HAVE A DISCUSSION WITH PATIENT'S PRIMARY DOCTOR IF HE FELT THE BENEFITS OUTWEIGHED THE RISKS OF RECEIVING THE SECOND DOSE. OF COURSE, PATIENT AND HER MOM ALSO HAVE THE OPTION TO REFUSE THE 2ND DOSE OF BEXSERO ALTOGETHER WITHOUT CONSULTATION. SHE WAS ALSO INFORMED TO CALL IF SHE HAD ANY ADDITIONAL QUESTIONS OR CONCERNS.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 09.07.2021
- Impfdatum
- 08.07.2021
- Beginn
- 08.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Diarrhoea
Pain
Pyrexia
Sleep disorder
Symptomtext
Pt was administered the MCV4 vaccine @ 1000 on 7/8/2021, about 2000 on 7/8/21, pt complained about low grade fever of 100, and b/l UE and b/l LE pain. pt went to sleep, woke up about 2200 and then could not sleep well the rest of the night. Was up on 7/9/21 about 0630 with sxs of Diarrhea and still having b/l UE and LE pain still with a low grade fever. Advised mother to take pt to the ER to be evaluated.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 44,0
- Geschlecht
- M
- Eingang
- 06.07.2021
- Impfdatum
- 02.07.2021
- Beginn
- 03.07.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Pyrexia
Rash
Rash macular
Rash papular
Skin irritation
Symptomtext
Assessment: rash to face, trunk. Patient stated that after he received the Adacel and Menactra vaccines in Friday he went back to work moving dumpsters. then after work he stated that he went home and played with his 6 year old child. did not eat anything that he would not normally eat. Rash to face is reddened non raised blotchy areas located to face and neck. Rash to chest and back Reddened raised bumps with white tops to each bump. rash areas to under arms is reddened raised blotchy areas. Patient stated that he has had now Fever over weekend. Patient stated that it is not painful rash just irritating, and only relief from the irritation was powder to the rash. PA instructed Patient to take Claritin orally daily in mornings and Benadryl 25mg orally at nights daily. Follow up on 7/8/2021
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- Denies any Illness
- Vorgeschichte
- Denies any health conditions
- Andere Medikamente
- Denies taking any Medications
- Allergien
- denies any Allergies
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 06.07.2021
- Impfdatum
- 01.07.2021
- Beginn
- 01.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Oedema peripheral
Rash
Symptomtext
rash on right arm and swelling under the arm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 24.06.2021
- Impfdatum
- 21.06.2021
- Beginn
- 23.06.2021
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Erythema
Pain in extremity
Peripheral swelling
Symptomtext
Localized redness and pain with swelling to left arm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 09.06.2021
- Impfdatum
- 02.06.2021
- Beginn
- 03.06.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Injection site erythema
Injection site swelling
Injection site warmth
Pain
Pain in extremity
Pruritus
Swelling
Symptomtext
06-02-21 Started with itching and small area of swelling 5 hours after vaccine. 06-03-21 Redness and swelling increase along with pain in right arm with movement. 06-04-21 Seen in clinic with 11.5cm x 11.5cm area of redness, swelling and warm to touch right arm at injection site. Treated with Benadryl, cool compresses and Augmentin. 06-09-21 Mom states no more redness or swelling.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- NKA
- Vorgeschichte
- Chronic headaches, pineal cyst removal
- Andere Medikamente
- Nexplanon Implant, Sirolimus Solution topical
- Allergien
- NKA at time of vaccine
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 15.08.2023
- Impfdatum
- 06.07.2021
- Beginn
- 06.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Symptomtext
Pt received Menactra prior to 16th birthday.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 07.07.2022
- Impfdatum
- 05.07.2022
- Beginn
- 07.07.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
No adverse events or treatment required. Vaccine was expired at time of administration. Case has had no issues or trouble since given vaccine. Vaccine expired 4/13/2022
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none needed
- Aktuelle Erkrankungen
- none noted
- Vorgeschichte
- none noted
- Andere Medikamente
- unknown
- Allergien
- none noted
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- 16.06.2022
- Beginn
- 16.06.2022
- 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
nurse gave an expired dose of menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 17 years old male patient got expired dose of INGOCOCCAL 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 16-Jun-2022, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6920AA exp date: 15-Apr-2022 (formulation, strength: unknown) via intramuscular route in the right arm for Immunization. On 16-JUN-2022 the patient developed a non-serious event "nurse gave 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 nurse gave an expired dose of 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
- MA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 06.06.2022
- Impfdatum
- 23.07.2021
- Beginn
- 23.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
patient received the extra dose of menactra with no adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 16 years old male patient who received the extra 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. On 23-Jul-2021, the patient received suspect at a dose of 0.5 ml total meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6920AA, expiry date: 15-Apr-2022, form, strength: not reported) via intramuscular route in the left arm for immunisation. On 23-Jul-2021 the patient received the extra dose of menactra with no adverse event (extra dose administered, latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine. It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of menactra. Action taken: not applicable. Outcome: Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 01116730:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 06.06.2022
- Impfdatum
- 22.06.2021
- Beginn
- 23.07.2021
- Tage bis Beginn
- 31,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
received an extra dose of MENACTRA with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old female patient who received an extra dose of menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Jun-2021, the patient received a dose of suspect Menactra vaccine Solution for injection dose: 0.5 ml frequency: once lot U6920AA and expiry date: 15-Apr-2022 (strength: unknown) via intramuscular route in the left arm for immunisation. On 23-Jul-2021 she also received a dose of the same vaccine 0.5 ml once. On 23-Jul-2021 the patient developed a non-serious event "received an extra dose of menactra with no reported adverse event" (extra dose administered) (latency: 1 month 1 day). It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of Menactra. Action taken 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 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.; Sender's Comments: 01116793:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 13.05.2022
- Impfdatum
- 28.04.2022
- Beginn
- 28.04.2022
- 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
No adverse event
Off label use
Symptomtext
expired MENACTRA was administered to a 66 year old post-splenectomy patient (with no reported adverse event); off-label use as per local labelling due to administering MENACTRA to a patient who is 66 years old and outside of the approved age group (with no reported adverse event); Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 66 years old female patient to whom expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. was administered post-splenectomy (with no reported adverse event) and off-label use as per local labelling due to administering menactra to a patient who is 66 years old and outside of the approved age group (with no reported adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2022, the patient received 0.5 mL Dose (if series -2) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] lot U6920AA, expiry date: 15-Apr-2022 (strength and formulation not reported) via intramuscular route in the left deltoid for Prophylactic vaccination. Practice manager stated that they administered an expired dose of MENACTRA to a patient (expired product administered) on 28-Apr-2022, latency same day. Practice manager asked how they should proceed and if they would need to re-administer the dose? Practice manager also mentioned that the expired MENACTRA was administered to a 66-year-old post-splenectomy patient. This situation was reported as a medication error due to administering expired MENACTRA to a patient. This situation was reported as an off-label use as per local labelling due to administering MENACTRA to a patient who was 66 years old and outside of the approved age group (product administered to patient of inappropriate age) (onset date 28-Apr-2022, latency same day). First time product used : No Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both 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
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 77,0
- Geschlecht
- M
- Eingang
- 17.12.2021
- Impfdatum
- 21.10.2021
- Beginn
- 21.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Off label use
Product administered to patient of inappropriate age
Symptomtext
This case involves a 77-year-old male patient who was accidently given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Off label use). The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included ECULIZUMAB (SOLIRIS). On 21-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6920AA and expiry date: 15-Apr-2022) (Frequency once) via intramuscular route in the left arm for prophylactic vaccination. It was reported "The clinic reported that a dose of MENACTRA was accidently given to a 77-year-old male but with further research it was discovered the consumer was prescribed the MENACTRA due to being prescribed an upcoming therapy that needed the vaccination. The clinic reported that the consumer is needing to have a series of 2-doses of Menactra due to starting the therapy Soliris (eculizumab); that the MENACTRA was prescribed to be given 8-weeks apart; that the Nephrologist prescribed the Menactra and the Soliris (eculizumab); that the Soliris (eculizumab) will be performed with the nephrologist; that the clinic reached out to the nephrologist and confirmed the need for the MENACTRA; and that the consumer is now planning to get the second dose at his pharmacy". It was a case of actual medication error due to Off label use in unapproved age group (same day latency). At the time of report no adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- SOLIRIS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 17.08.2021
- Impfdatum
- 17.08.2021
- Beginn
- 17.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Unresponsive to stimuli
Symptomtext
Patient felt well and completed school sports physical exam prior to vaccination; vaccination well tolerated; patient with significant anxiety prior to vaccination; approximately 5 minutes after vaccination patient leaned head back while still on examination chair where he received vaccine and was seen sliding off table and unresponsive for approximately 10 seconds; improved mental status without treatment; legs elevated, water provided, blood pressure checked; improvement in symptoms 30 seconds after onset; A x 0 x 4 30 seconds after event
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Unresponsive to stimuli
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 18.07.2021
- Impfdatum
- 28.06.2021
- Beginn
- 28.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
Menactra was given to a patient instead of Meningitis B with no reported adverse event; Initial information received on 28-Jun-2021 regarding an unsolicited valid non-serious case from other health professional via Medical Information (Reference number- 00659311). This case involves a 15 year old female patient who received 0.5ml dose (dose 3) of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6920AA; expiry date: 15-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination instead of MENINGOCOCCAL VACCINE B (lot number and expiry date: not reported) on 28-JUN-2021 (wrong product administered). The patient's past medical history, medical treatment(s), concomitant medication(s), and family history were not provided. It was an actual medication error due to wrong vaccine administered (same day). It was not reported that the patient experienced any 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
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- MENINGOCOCCAL VACCINE B
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 29.06.2021
- Impfdatum
- 25.06.2021
- Beginn
- 25.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Swelling
Symptomtext
Mom reported seeing swelling on Friday night, 6/25/21 and gave 1 dose of Benadryl. Then noticed the following morning that it was bigger so she gave more Benadryl and used a cool compress on it. Monday 6/28/21 she called to have him checked today. Swelling is down and we advised to continue Benadryl
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Swelling
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 28.06.2021
- Impfdatum
- 28.06.2021
- Beginn
- 28.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Admin error: wrong vaccine given Was supposed to get the Meng B
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 17.06.2021
- Impfdatum
- 11.06.2021
- Beginn
- 11.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood thyroid stimulating hormone normal
Full blood count normal
Lipids normal
Metabolic function test
Peripheral swelling
Thyroxine free normal
Vitamin D
Symptomtext
Discussed that patient is experiencing swelling in both feet every since receiving Menactra and Meningitis B vaccine a week ago. Labs were ordered yesterday and discussed that all the results were normal. Form filled out to report swelling after vaccines. Discussed that patient may be retaining water in her feet due to the summer heat and lack of physical activity. Encouraged propping feet up when resting to help decrease the swelling. Discussed cutting sodium in daily diet and increasing physical activity. Please continue to monitor symptoms and call if symptoms are persisting or worsening over the weekend. Today's instructions / counseling include(s) Patient plan given. Follow-up As needed. Reason for referral: As needed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Blood thyroid stimulating hormone normal
- Hospital-Tage
- -
- Labordaten
- Routine labs ordered 6/10/21 during wellness exam. CBC, CMP, TSH, Free T4, Lipid panel, and vitamin D. Pt had labs drawn on 6/16/21, contacted our office on 6/17/21 with swelling and in both feet, Left greater than Right. Got patient in for appt. (See evaluation above with APRN)
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Obesity, eczema
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -