- Staat
- CO
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 18.09.2023
- Impfdatum
- 18.09.2023
- Beginn
- 18.09.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
Client was standing and stated she felt dizzy at 2:50pm before brief syncopal event. This nurse and MOC caught client and slowly lowered her to the ground and raised her legs. No injury noted by RN or stated by client. Client awake and oriented within seconds. 2nd nurse called in for further assistance. Client had sips of juice while laughing and texting grandmother. Client sitting and standing again by 2:54pm without any dizziness. Client walked out of clinic with MOC by 2:59pm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Not reported by client.
- Andere Medikamente
- Unknown
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 16.08.2023
- Impfdatum
- 15.08.2023
- Beginn
- 16.08.2023
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fall
Feeling hot
Loss of consciousness
Symptomtext
Client passed out in clinic after receiving vaccines - though stated he had only 'eaten a donut at 8am'. Father of client called the following day to say that client also passed out at home at 1am - 'was feeling hot and fell over'.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 30.03.2023
- Impfdatum
- 23.03.2023
- Beginn
- 23.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fall
Incoherent
Musculoskeletal stiffness
Syncope
Symptomtext
Patient was sitting chair after receiving vaccine and begin to stiffen while falling to the left onto the floor. Help was called and Patient's vitals were taken BP 120/70, P 88, Temp 97.2 Patient was given water to sip with a cold compress applied to the forehead and back of neck. Patient was more coherant at this time and stated that she believed that she fainted. Patient stated that she had not eaten since breakfast and was given a lollipop. Mother verbalized that she understood the need to feed the child immediately and to watch for signs of lethargy, complaints of headache and abdominal pains and to go to the ER as soon as these are suspected.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none reported
- Vorgeschichte
- none reported
- Andere Medikamente
- none reported
- Allergien
- none reported
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 14.03.2023
- Impfdatum
- 14.03.2023
- Beginn
- 14.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Laboratory test
Pallor
Presyncope
Symptomtext
Near syncopal episode post immunization. Pt reported dizziness, visibly became pale. Was assisted to a laying position for about 5 minutes, given juice also. Pt became sweaty. Resolved about 5 minutes later without fully fainting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- Did have labs checked just prior to having immunizations, may have played a role. Did not have additional labs done as a result.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- ADHD
- Andere Medikamente
- None today
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 03.01.2023
- Impfdatum
- 13.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Brain oedema
Seizure
Symptomtext
2 days after receiving TdaP, MCV4, and HPV9 patient had a new onset seizure. Found to have swelling of the brain per mother in hospital. Now taking prednisone and valproic acid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- Hospitalized. Medical records are pending and have not been recieved yet
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Depression
- Andere Medikamente
- lorazepam and olanzapine
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 28.12.2022
- Impfdatum
- 22.12.2022
- Beginn
- 22.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Head injury
Loss of consciousness
Syncope
Symptomtext
Post vaccination for about 10 minutes patient started feeling dizzy and fainted. As she fainted she hit her head on the wall. Patient was unconscious for about 1 minute before provider was able to render aid. Blood Pressure was 101/65 and pulse was 73. Patient left ambulating and parent was instructed to take patient to ER if patient was vomiting, sleepy or had a headache.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- -
- Andere Medikamente
- n/a
- Allergien
- n/a
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 16,0
- Geschlecht
- M
- Eingang
- 13.12.2022
- Impfdatum
- 12.12.2022
- Beginn
- 12.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Erythema
Face injury
Fall
Feeling hot
Nausea
Seizure
Vomiting
Symptomtext
1640 male here to receive school vaccines Bexsero, HPV and Menquafi. Child was accompanied by his mother. Patient was very anxious prior to vaccine administration. RN gave child phycological reassurance. After child received 3rd vaccine (HPV), without warning he fell to the floor, hitting his face forward to the floor. The chair fell on top of the child. After the child hit the floor, he convulsed for 5 secs. RN and mother attempted to raise his head of off the floor. RN and mother held the child and yelled out for assistance. Tech took child's vitals. 106/64 - 78 RN and mother was able to get child in sitting position. Child vomited x2 C/O nausea. Cool wet compress applied to child's head, along with ice pack to back of his Neck. Clerk called emergency services. Fan turned on to cool child due to C/O feeling hot. Observed a reddened area about a half dollar sized circle to child's forehead. 0 hematoma or lump noted. Child was alert and talkative after in sitting position. Patient stated his Name, date, day of week and location correctly. Child denied dizziness or any weakness or headaches. EMT arrived @ 1:50pm. Vital Signs taken by EMT staff. EMT assisted child off of floor to standing position where his BP was taken again.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- UNKNOWN
- Vorgeschichte
- UNKNOWN
- Andere Medikamente
- UNKOWN
- Allergien
- NONE NKDA
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 08.08.2023
- Impfdatum
- 24.07.2023
- Beginn
- 24.07.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injected limb mobility decreased
Injection site cellulitis
Injection site induration
Injection site warmth
Symptomtext
Assessment 3" x 3" area of cellulitis and induration, and warm to the touch noted in left deltoid. Limited motion of left arm also noted. Referred to Pediatrician or ER for further evaluation. Telephone call to client's mom to follow up regarding swelling and limited motion left arm, mom stated child is much improved and that it went away using warm compresses and Tylenol.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- No
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 11.05.2023
- Impfdatum
- 11.05.2023
- Beginn
- 11.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Symptomtext
patient got dizzy after vaccine administration vitals signs assessed BP=68/40 HR=87 T=97.7 Second set BP=97/65 HR=82 Ox=97% RR=16 patient were hydrated with a 240ml of water and after 15 min Resident verbalized feeling better and vitals' stable; patient walk out of the office accompanied by mother
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- N/A
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 02.05.2023
- Impfdatum
- 28.04.2023
- Beginn
- 28.04.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Dyskinesia
Eye movement disorder
Hyperreflexia
Neurological examination normal
Posture abnormal
Unresponsive to stimuli
Urinary incontinence
Symptomtext
After immunizations while I was completing paperwork, pt. stated she was feeling like she might faint. She was sitting on exam table. I opened the window for some air and offered her some water. She drank the water. I told her to take deep breaths. Pt. then slumped backwards, had eye fluttering and arms flexed and jerking movements. She did not respond to her name, she was incontinent of urine. This lasted about 10 seconds and then she immediately opened her eyes. She remembered where she was when asked (in health center) and why she was there (for shots). She asked if she passed out. We called her mother to inform her of the incident and she is coming to pick her up. Pt. admitted she did not have breakfast. Was given snacks and juice and monitored. We gave her a change of clothes. She states this has never happened before, no hx of seizures in chart. She denies headache, dizziness, or sleepiness now. Neuro exam completely normal. = grip strength, normal speech, steady gait.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- NA
- Aktuelle Erkrankungen
- denies
- Vorgeschichte
- asthma
- Andere Medikamente
- Albuterol MDI prn
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 27.03.2023
- Impfdatum
- 21.02.2023
- Beginn
- 21.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Symptomtext
Left shoulder pain for approximately 4 days. She took Tylenol for pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 17.03.2023
- Impfdatum
- 28.02.2023
- Beginn
- 02.03.2023
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pain
Injection site pruritus
Injection site swelling
Injection site warmth
Symptomtext
Pt returned to clinic 2 days after vaccination with left Deltoid Area swelling, warm to touch & redness. Also C/o Itching & burning as well as tenderness. Denies respiratory Distress
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 16.03.2023
- Impfdatum
- 14.03.2023
- Beginn
- 15.03.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Erythema
Myalgia
Oedema
Pain
Pruritus
Symptomtext
Surrounding erythema and edema starting the day after the vaccine, with extensive itching and pain with movement of muscle.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myalgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- ADHD
- Andere Medikamente
- -
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 14.02.2023
- Impfdatum
- 14.02.2023
- Beginn
- 14.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Headache
Nausea
Nervousness
Vision blurred
Symptomtext
Pt. started to feel dizzy and HA started while waiting in clinic x15 min. Pt. able to walk to room to lay down with legs elevated. Pt. reported feeling better/HA resolved but had him wait in clinic for the remaining 5 min. Felt fine upon leaving with mom but returned before getting to the car as pt. was feeling shaky, dizzy, nauseous and vision blurriness returned. Returned to clinic at 5:23 pm and had pt. lay down again with legs elevated. Took BP/HR at 5:29 pm while supine and WNL. Had pt. transition to sitting and at 5:51 pm BP/HR again WNL. Stood without difficulty and discharged at 5:52 pm.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- cats, dogs, grass pollen, dust mites
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 23.01.2023
- Impfdatum
- 16.01.2023
- Beginn
- 17.01.2023
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- SYR / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Injection site swelling
Peripheral swelling
Symptomtext
Pt with swelling report by parent from shoulder to wrist of right arm, and dizziness. Mom states patient has never had an adverse reaction to any vaccinations previously.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- Referred to ED for evaluation. Family choose not to complete ED eval and monitored at home. Pt's mom took off work one day to be home with him and monitor. F/U phone call to patient's mom on 1/23/23, mom states patient returned to school and is back to his baseline.
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- NA
- Andere Medikamente
- Omeprazole, MVI
- Allergien
- Pollen extract
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 30.12.2022
- Impfdatum
- 30.12.2022
- Beginn
- 30.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Headache
Symptomtext
Patient had adverse reaction to HPV. She had headache and dizziness. Vitals was taken BP 118/68 RR16 temp 97.3 HR 66 oxygen 99% . Cold water was given and stabilized by Nurse. Discharged after 20 minutes with some instructions.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 16.12.2022
- Impfdatum
- 14.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pain
Injection site swelling
Symptomtext
erythema, swelling and pain at the site
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- hypovitaminosis D upper back pain
- Vorgeschichte
- back pain
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 01.12.2022
- Impfdatum
- 18.11.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Headache
Influenza A virus test positive
Pyrexia
Symptomtext
fever, chills, headache
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- flu test today (11/21) positive flu A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- Peanuts, corn
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 18.07.2023
- Impfdatum
- 13.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Product storage error
Symptomtext
Patient was given a nonviable vaccine. The vaccine was exposed to cold holding temperatures. Patient had no adverse symptoms from the nonviable vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 26.05.2023
- Impfdatum
- 10.05.2023
- Beginn
- 10.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
Menquadfi reached a low temperature of 32.9F with no reported adverse event; vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2023SA157696(CLUSTER) and 2023SA157204(CLUSTER). This case involves a 18 years old and unknown gender patient who was administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] after the excursion that reached a low temperature of 32.9f 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 VLP RL1 4V (YEAST) (Gardasil) and meningococcal vaccine B (Meningococcal Vaccine B) for Prophylactic vaccination (immunization). On 10-May-2023, the patient received 0.5 mL dose 2 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) and on an unknown date underwent excursion, reached a low temperature of 32.9f with no reported adverse event (product storage error) (unknown latency). Action taken: not applicable. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- GARDASIL; MENINGOCOCCAL VACCINE B
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 15.05.2023
- Beginn
- 15.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
Menquadfi reached a low temperature of 32.9F with no reported adverse event; the vaccine was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2023SA157204 and 2023SA157696. This case involves a 11 years old and unknown gender patient who was administered with vaccine meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] that reached a low temperature of 32.9f 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for prophylactic vaccination (Immunisation). On 15-May-2023, the patient received a dose 1 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) that on an unknown date, had underwent temperature excursion as a low temperature of 32.9f was reached with no reported adverse event (product storage error) (unknown latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event menquadfi reached a low temperature of 32.9f with no reported adverse event and was Unknown for the event the vaccine was administered 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TDAP
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 12,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 17.05.2023
- Beginn
- 17.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2023SA157122, 2023SA157746, 2023SA157755, 2023SA157204, 2023SA156938, 2023SA157726 and 2023SA157752. This case involves a 12 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-May-2023, the patient received a dose of 0.5 ml (dose 1) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for Immunization. On 17-May-2023, the patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day). It was reported, "Nurse says that the vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop." Action taken was not applicable. 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 13,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 15.05.2023
- Beginn
- 15.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus vaccine Toxoid (TDAP) for Immunisation. On 15-May-2023, the patient received an unknown dose (series 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for immunization. On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency). On 15-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for both 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 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 15.05.2023
- Beginn
- 15.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C and was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old and unknown gender patient who had nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-May-2023, the patient received a dose 2, 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot U7576AB, 28-FEB-2025 via intramuscular route in the left arm for Immunization. On 15-May-2023 the patient developed a non-serious event nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event (poor quality product administered) (latency: same day). On an unknown date the patient developed a non-serious nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event (product storage error) (unknown latency). Action taken was not applicable. Outcome: 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 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 08.05.2023
- Beginn
- 08.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported AE; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse). This case is linked to cases 2023SA157204 and 2023SA157696. This case involves a 18 years old and unknown gender patient who was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-May-2023, the Meningococcal A-C-Y-W135 (T CONJ) vaccine underwent temperature excursion with low temperature of 0.5 degrees C (product storage error) and patient received a dose of 0.5 ml dose 1 of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) with unknown strength via intramuscular route in the left arm for Immunization with no reported adverse event (poor quality product administered) (latency: same day). Action taken: not applicable. 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 25.05.2023
- Impfdatum
- 01.05.2023
- Beginn
- 01.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Symptomtext
MENQUADFI underwent temperature excursion was administered to patient with no reported adverse event; Menquadfi reached a low temperature of 32.9F with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 18 years old patient of unknown gender who was administered the Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that underwent temperature excursion and reached a low temperature of 32.9 F with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-May-2023, the patient received dose 2 dose 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7576AB and expiry: 28-Feb-2025 via intramuscular route in the left arm for prophylactic vaccination (immunization). On an unknown date, it was reported that Meningococcal A-C-Y-W135 (T CONJ) vaccine reached a low temperature of 32.9 F with no reported adverse event (product storage error) (unknown latency). On 01-May-2023, the patient was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine that underwent temperature excursion with no reported adverse event (poor quality product administered) (latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for both 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 18,0
- Geschlecht
- U
- Eingang
- 24.05.2023
- Impfdatum
- 08.05.2023
- Beginn
- 08.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Poor quality product administered
Product storage error
Symptomtext
MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; MENQUADFI administered to patient which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2023SA157122(CLUSTER), 2023SA157726(CLUSTER), 2023SA157696(CLUSTER), 2023SA157752(CLUSTER), 2023SA157746(CLUSTER), 2023SA156938(CLUSTER), 2023SA157755(CLUSTER) and 2023SA157696(CLUSTER). This case involves a 18 years old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-May-2023, the patient received a dose of 0.5 ml (dose 2) of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot: U7576AB; expiry date: 28-FEB-2025) via intramuscular route in the left arm for Immunization. On 08-May-2023, the patient was administered menquadfi which underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day). It was reported, "Nurse says that the excursion was caused by additional gel packs being placed in the refrigerator. She asked for appropriate follow-up. The vaccines had been transported due to power outage and then cold packs were put into refrigerator and apparently made the refrigerator temperature drop." Action taken was not applicable. 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 29.03.2023
- Impfdatum
- 29.03.2023
- Beginn
- 29.03.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Vaccine was not due at time of visit. Pt needed meningococcal 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
- -
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 08.03.2023
- Impfdatum
- 06.03.2023
- Beginn
- 08.03.2023
- Tage bis Beginn
- 2,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Erythema
Peripheral swelling
Skin warm
Symptomtext
left arm red swelling with warmth, no itchness, no pain. Patient noticed the sx this morning (03/08/23)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 01.03.2023
- Impfdatum
- 22.02.2023
- Beginn
- 22.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
The temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; MENQUADFI being administered post excursion with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 11 years old female patient who was being administered by meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion and the temperature reached was 32.2f for a total excursion time of 39 hours with no reported adverse event. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for immunisation; and HPV vaccine VLP RL1 9V (yeast) (Gardasil 9) for immunisation. On an unknown date, the temperature reached was 32.2f for a total excursion time of 39 hours (product storage error) (latency: Unknown) and on 22-Feb-2023, the patient received 0.5 ml Total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number: U7576AB, expiration date: 28-Feb-2025, strength: unknown) via intramuscular route in the right deltoid for Immunization (immunization) post excursion with no reported adverse event (poor quality product administered) (latency: same day). It was reported that "The caller advised the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP. The temperature reached was 32.2F for a total excursion time of 39 hours. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI. The caller advised there were 3 patient to receive MENQUADFI post-excursion and reported above temperature excursion, along with 4 patients that received MENQUADFI post excursion." No lab data reported. Action taken: not applicable. Outcome: 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 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: US-SA-2023SA064856:01504785
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 01.03.2023
- Impfdatum
- 14.02.2023
- Beginn
- 14.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
temperature reached to 32.2F for a total excursion time of 39 hours with no reported adverse event; patient was treated with MENQUADFI post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case is linked to cases 2023SA065072, 2023SA064856 and 2023SA064145. This case involves a 11 years old male patient who experienced patient was treated with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion with no reported adverse event and temperature reached to 32.2f for a total excursion time of 39 hours 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 VLP RL1 9V (YEAST) (GARDASIL 9) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation. On 14-Feb-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency, once (1x), strength - standard, expiry date- 28-Feb-2025, lot U7576AB) via intramuscular route in right deltoid for prophylactic vaccination. On 14-FEB-2023 the patient developed a non-serious patient was treated with menquadfi post-excursion with no reported adverse event (poor quality product administered) (latency same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. It was reported that temperature reached to 32.2f for a total excursion time of 39 hours with no reported adverse event (product storage error). Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable. At time of reporting, the outcome was Unknown for both 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 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: US-SA-2023SA064856:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 28.02.2023
- Impfdatum
- 17.02.2023
- Beginn
- 17.02.2023
- 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
temperature reached was 32.2F for a total excursion time of 39 hours with no reported adverse event; patient to receive MENQUADFI post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 11 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post-excursion whose temperature reached 32.2f for a total excursion time of 39 hours 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 diphtheria vaccine toxoid, pertussis vaccine acellular3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination. On 17-Feb-2023, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (frequency, once (1x), strength - standard, expiry date - 28-Feb-2025, lot U7576AB) via intramuscular route in right deltoid for prophylactic vaccination. On 17-FEB-2023 meningococcal A-C-Y-W135 (T CONJ) vaccine temperature reached 32.2f for a total excursion time of 39 hours with no reported adverse event (product storage error) and patient receive dmenquadfi post-excursion with no reported adverse event (poor quality product administered) (latency: 1 day) Reportedly, the temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop. The products involved are MENQUADFI, PENTACEL, and FLUZONE QIV NP. Action taken: not applicable. 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.; Sender's Comments: US-SA-2023SA065072:01504785 US-SA-2023SA064145:01504843 US-SA-2023SA065058:01504849
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- BOOSTRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 18,0
- Geschlecht
- F
- Eingang
- 28.02.2023
- Impfdatum
- 06.02.2023
- Beginn
- 06.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Poor quality product administered
Product storage error
Symptomtext
temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2F for a total excursion time of 39 hours, with no reported adverse event; patient to receive menquadfi post-excursion with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves an 18-year-old female patient who receives MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion and temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Feb-2023, the patient received dose 1, at 0.5ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: standard) (lot number: U7576AB and expiry date: 28-Feb-2025) via intramuscular route in the left deltoid for Immunization and on the same day patient received menquadfi post-excursion with no reported adverse event (poor quality product administered). On an unknown date, a non-serious event reported, temperature dropped down to -30 degrees outside causing the building temperature and refrigerators to drop, temperature reached was 32.2f for a total excursion time of 39 hours, with no reported adverse event (product storage error). It was reported, Caller reporting a temperature excursion at their facility. The caller requested stability data. Extended stability data covers the excursion with the exception of the MENQUADFI. Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable. At time of reporting, the outcome was Unknown for both 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 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 11.02.2023
- Impfdatum
- 08.12.2022
- Beginn
- 11.01.2023
- Tage bis Beginn
- 34,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
patient received an extra dose of TDAP (BOOSTRIX) and MENQUADFI with no reported adverse event; ended up receiving extra dose of menquadfi and boostrix with no reported AE; Initial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 16 years old female patient who experienced patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and ended up receiving extra dose of menquadfi and boostrix with no reported ae while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix) for Prophylactic vaccination; and althaea officinalis root, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL). On 08-Dec-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine lot U7576AB via intramuscular route in unknown administration site for Immunisation. On 11-Jan-2023 the patient developed a non-serious event of patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event (extra dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine. On 11-Jan-2023 the patient developed a non-serious event of ended up receiving extra dose of menquadfi and boostrix with no reported ae (incorrect dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine. Action taken with meningococcal vaccine (Menquadfi) was not applicable. It was not reported if the patient received a corrective treatment for the events (patient received an extra dose of TDAP (Boostrix) and Menquadfi with no reported adverse event, ended up receiving extra dose of menquadfi and boostrix with no reported AE). At time of reporting, the outcome was Unknown for the event patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and was Unknown for the event ended up receiving extra dose of menquadfi and boostrix with no reported ae. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- BOOSTRIX; GARDISIL
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NH
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 23.01.2023
- Impfdatum
- 09.12.2022
- Beginn
- 09.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Patient was given the wrong vaccine, she should of been given the Meningococcal B (Bexsero) second dose and not a third dose of Meningococcal Conjugate (MenQuadFi)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 11.01.2023
- Impfdatum
- 09.01.2023
- Beginn
- 09.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Extra dose administered
No adverse event
Symptomtext
MenQuadfi was inadvertently administered to a 14-year-old male patient who had already received his Menveo vaccine at age 13. No side effects noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 03.01.2023
- Impfdatum
- 03.01.2023
- Beginn
- 03.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Symptomtext
PT WAS GIVEN DOSE OF MENQUADFI THAT IS NOT INDICATED AT THIS TIME
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NONE
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 03.01.2023
- Impfdatum
- 03.01.2023
- Beginn
- 03.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect dose administered
Symptomtext
This child was given Pfizer Bivalent 12 and up dose (0.3ml) instead of Pfizer Bivalent 5-11 years (0.2ml)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- Zofran
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 21.12.2022
- Impfdatum
- 15.12.2022
- Beginn
- 15.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect product formulation administered
Symptomtext
Administration error of Pfizer Bivalent given as first primary dose
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Miralax, Zyrtec and Hydrocortisone
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 15.12.2022
- Impfdatum
- 14.12.2022
- Beginn
- 14.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
No adverse event
Symptomtext
2nd Meningococcal Conjugate vaccine was given too early according to vaccine schedule. No symptoms or reactions noted at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- No medications, supplements, or herbal remedies being taken
- Allergien
- Denies any allergies to medications, food, or other.
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 11,0
- Geschlecht
- U
- Eingang
- 25.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Medication error
No adverse event
Wrong product administered
Symptomtext
one of them was given bexsero instead of menquadfi,with no reported adverse event; inappropriate dose of vaccine administered with no reportedadverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non serious case received from a other health professional. This case involves a 11 years old and unknown gender patient who had given bexsero instead of(Meningococcal)A-C-Y-W135 (T CONJ) vaccine) MENQUAFDI with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of Meningococcal)A-C-Y-W135 (T CONJ) vaccine, Solution for injection(lot no- U7576AB, expiry date-28-Feb-2025 ) (with unknown , frequency, strength, dose, route and administration site) for prophylactic vaccination(immunization). On an unknown date, Patient had given bexsero instead of (Meningococcal)A-C-Y-W135 (T CONJ) vaccine menquadfi(latency:same day),with no reported adverse event (wrong product administered) and Inappropriate dose of vaccine administered(Incorrect dose administered). It was also reported that nurse said they have two (2) patients, both 11 years old.As per nurse they are not sure at this time which of the two patients were given Bexsero instead of MENQUAFI and needs to look into it. Action taken:not applicable. 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.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AR
- Alter
- 15,0
- Geschlecht
- M
- Eingang
- 24.11.2022
- Impfdatum
- 15.11.2022
- Beginn
- 15.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Medication error
No adverse event
Symptomtext
have administered menquadfi to a patient 6 months earlier with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who have been administered to meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 6 months earlier 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and HPV vaccine, both for prophylactic vaccination. On 15-Nov-2022, the patient was administered with dose 2 of meningococcal A-C-Y-W135 (T CONJ) vaccine of dose 0.5 milliliter (ml) with (lot: U7576AB & expiry date: 28-Feb-2025), 6 months earlier with no reported adverse event (inappropriate schedule of product administration) via intramuscular route in the right deltoid, (formulation, strength: unknown) for immunization. Action taken was not applicable. 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.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -