- Staat
- CA
- Alter
- 24,0
- Geschlecht
- F
- Eingang
- 20.10.2022
- Impfdatum
- 20.10.2022
- Beginn
- 20.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Cardio-respiratory arrest
Fall
Syncope
Symptomtext
At 920 pt fainted after receiving vaccines tdap and flu, pt was sitting on the exam table and fall down to the floor code assist was activated staff took over.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardio-respiratory arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 33,0
- Geschlecht
- F
- Eingang
- 21.12.2022
- Impfdatum
- 18.10.2022
- Beginn
- 25.10.2022
- Tage bis Beginn
- 7,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injected limb mobility decreased
Injection site pain
Product administered at inappropriate site
Symptomtext
Patient called clinic and stated that during flu event, she felt like vaccine was administered away from midline. She states she doesn't believe it was higher or lower than usual when she receives vaccines. She states that initially it was painful, but after a week or so her range of motion was impaired. She states she wasn't sure if due to physical activity or injection. She states she saw primary physician who believed it might be due to administration. She states that it is much improved now.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Unknown
- Vorgeschichte
- Unknown
- Andere Medikamente
- Unknown
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 35,0
- Geschlecht
- F
- Eingang
- 13.12.2022
- Impfdatum
- 22.11.2022
- Beginn
- 22.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hypoaesthesia
Impaired work ability
Mononeuropathy
Paraesthesia
Skin discolouration
Symptomtext
Employee started to feel numbness and tingling that was shooting down the arm about an hour after her vaccine was given. Her left arm presented a different color than her right arm, then she complained of her foot on the left side feeling numb also. Employee was immediately sent to the ED for further evaluation and then followed up for continued treatment at clinic. She is currently still being treated at clinic, being referred now to a neurologist and Physiatrist for mononeuropathy and ruling out CRPS and neurotoxicity. She is on restricted duty at work and is currently being accommodated. She is being treated under a claim with insurance.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paraesthesia
- Hospital-Tage
- -
- Labordaten
- No test up to this date.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Unknown
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 53,0
- Geschlecht
- F
- Eingang
- 01.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 04.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Injection site pain
Loss of personal independence in daily activities
Pain
Sleep disorder
Symptomtext
Pt presents with complaints of left shoulder pain for past month since getting Flu shot at AMP flu event on Oct. 4. She notes having greater than usual pain after shot, and poor use of left arm. Since then, difficulty sleeping on L side until now. Unable to paint due to pain when reaching forward. Pain during taking off shirt and bra, bathing (unable to reach behind back and R shoulder, reaching out to side. Pain was rated at 8-9/10 for first week or two, and is slightly better this week, starting week 4. Pain was severe; 8-9/10 and radiating to anterior, posterior and lateral L shoulder; Currently rated at 4/10 at rest and pt is scared to move shoulder. Pt will benefit from skilled PT services in order to reach established goals. Pain medication Has not had A follow-up since Oct 26 th
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Elevated Cholesterol Endometriosis
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 23,0
- Geschlecht
- F
- Eingang
- 07.11.2022
- Impfdatum
- 04.10.2022
- Beginn
- 04.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Pain in extremity
Symptomtext
Persistent pain and limited range of motion in arm where the vaccine was administered. Patient was advised on ice/Voltaren gel/range of motion exercises. She declined physical therapy
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Depression
- Andere Medikamente
- Sertraline 150 mg daily
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 56,0
- Geschlecht
- F
- Eingang
- 05.12.2022
- Impfdatum
- 04.10.2022
- Beginn
- 26.10.2022
- Tage bis Beginn
- 22,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Pain
Symptomtext
Pt given flu vaccine on 10/4. Pt reached out to clinic on 10/26 stating shoulder was still sore with certain movements. Pt was seen virtually by one of our physicians and then followed up with our physical therapist.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 51,0
- Geschlecht
- M
- Eingang
- 30.11.2022
- Impfdatum
- 04.10.2022
- Beginn
- 05.10.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Impaired driving ability
Joint range of motion decreased
Myalgia
Symptomtext
Limited shoulder movement in 24 hours after receiving the shot . Has limitations while driving - while sterring the wheel , States the limitation had improved since then - about 50% but still present . He does cold , warm compresses and Advil once a day . States the pain is not in the shoulder but in the muscle few inches below the shoulder . Was seen by Chiropractor and currently been seen by Accupuncture Seen improvement but not resolved
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myalgia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Back Pain
- Vorgeschichte
- None
- Andere Medikamente
- Multivitamins Vitamin C
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pain in extremity
Symptomtext
arm pain weeks after administration; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who experienced arm pain weeks after administration while receiving vaccine influenza quadrival a-b multidose vaccine preserved [fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection lot UT7695JA via intramuscular route in unknown administration site Prophylactic vaccination. On an unknown date the patient developed a non-serious arm pain weeks after administration (pain in extremity) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (arm pain weeks after administration). At time of reporting, the outcome was Unknown for the event arm pain weeks after administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 42,0
- Geschlecht
- F
- Eingang
- 17.10.2022
- Impfdatum
- 07.10.2022
- Beginn
- 07.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Pain
Symptomtext
Patient stated had pain following administration 10/7/22 and that had improved symptoms but "throbbing" at site still 10/17/22.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 58,0
- Geschlecht
- F
- Eingang
- 10.10.2022
- Impfdatum
- 04.10.2022
- Beginn
- 06.10.2022
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Pain in extremity
Sleep disorder
Symptomtext
Received flu vaccine on 10/4/2022, arm was sore after vaccine but now has pain running down arm to inner elbow that keeps her up at night.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Vitamins only
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 32,0
- Geschlecht
- F
- Eingang
- 24.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SC / OT
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Headache
Symptomtext
Severe right forehead and right top of head headache.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Blau Syndrome
- Andere Medikamente
- Multivitamin, fish oil
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 47,0
- Geschlecht
- F
- Eingang
- 08.02.2023
- Impfdatum
- 03.02.2023
- Beginn
- 03.02.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Laboratory test
No adverse event
Product administration error
Symptomtext
ADMINSTRATION ERROR: Patient forgot she had already received the Bivalent and received a second does. As of today 2/8/23 pt. states no symptoms or side effects at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Laboratory test
- Hospital-Tage
- -
- Labordaten
- Titer done on 2/3/23
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none that I know of
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 28.12.2022
- Impfdatum
- 28.12.2022
- Beginn
- 28.12.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Underdose
Vaccination error
Symptomtext
When the medical assistant was administering the flu shot in the patient's left arm, the patient jerked away and slid off the table, resulting in an incomplete dosage. The vaccine needle bent, and the medical assistant is unsure of the amount that was injected into the patient intramuscularly. The patient's primary care provider informed the patient's parents that it is safe to administer the full dose of the flu vaccine into the right arm on the same day. The mother of the patient did not want to go forward with a full dose in the patient's right arm today, and the patient's parents rescheduled for 1/4/2023 to receive the full dose of the flu vaccine at that time. The medical assistant marked the vaccine as "Not Given" per supervisor.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Underdose
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 38,0
- Geschlecht
- F
- Eingang
- 23.11.2022
- Impfdatum
- 06.10.2022
- Beginn
- 06.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product storage error
Symptomtext
Gave pt a Covid booster vaccine that had been opened more than 12Hrs before administration. Vaccine Opened documenation stated 10/05/2022 13:45 Exp- 10/06/2022 1945. My mistake was that i just verified exp date and time and not opened time and date. Did review this information with Pt pcp and he reviewed the vaccine information and information stated vaccine was good refrigirated for 10 weeks room temperature 12 hrs. Unable to find information for vaccine stability once opened. He stated vaccine should be ok. Manager was also notiifed vial was discarded
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- Diabetes Type II, Hypertension, Mixed anxiety and depression, PTSD, Asthma, hyperlipidemia
- Andere Medikamente
- Bupropion XL, Lisinopril-HCTZ, Dulaglutide, fluticasone propionate, metformin, buspirone, montelukast, albuterol
- Allergien
- Aspirin
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 22.11.2022
- Impfdatum
- 24.10.2022
- Beginn
- 24.10.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect product formulation administered
Symptomtext
Patient received the Covid Pfizer 5-11 Bivalent vaccine for her first dose of her primary series, instead of the Monovalent COVID vaccine as part of the primary series.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- Unknown
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 13.11.2022
- Impfdatum
- 10.11.2022
- Beginn
- 10.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Underdose
Wrong product administered
Symptomtext
Regular dose flu shot administered instead of high dose.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Underdose
- Hospital-Tage
- -
- Labordaten
- na
- Aktuelle Erkrankungen
- na
- Vorgeschichte
- cerebrovascular disease, hypertension, atherosclerosis, history of CVA, hyperthyroid, dyslipidemia, depression, GAD
- Andere Medikamente
- duloxetine, metoprolol, metoclopramide, atorvastatin, lisinopril, trazodone, methimazole,
- Allergien
- Cipro, Fosamax, latex, penicillin, Prolia, sulfa
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 13.11.2022
- Impfdatum
- 10.11.2022
- Beginn
- 10.11.2022
- 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
Influenza vaccine administered instead of Tdap. This was the second influenza immunization given to patient in 2022.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- na
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- OSA, migraines, hypothyroid, obesity, GERD, ADHD, depressive disorder
- Andere Medikamente
- bupropion, trazodone, levothyroxine, fluoxetine, promethazine
- Allergien
- Zolpidem, penicillin, strawberry, bee venom, erythromycin, ibuprofen, NSAIDS
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 36,0
- Geschlecht
- F
- Eingang
- 30.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- 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
vaccine was administered post excursion to patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received via Pediatrician. Agency number: 01286178. This case involves a 36-year-old female patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine was administered post excursion to patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA390611, 2022SA392303, 2022SA391393, 2022SA390948 and 2022SA392531. On 19-Sep-2022, the patient administered post excursion suspect FLUZONE QIV at dose 0.5ml once via intramuscular route in the left upper arm (lot: UT7695JA, expiry: 30-Jun-2023) for immunization with no reported adverse event (poor quality product administered) same day latency. It was reported that "Pediatrician reported the administration of FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion. Caller states she previously reported a temperature excursion and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller states that another physician used the products and administered them to patients post excursion." Action taken: Not applicable. At time of reporting, the outcome was 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 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
- CO
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 28.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- 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
FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2022SA390611, 2022SA390948, 2022SA392303 and 2022SA392234. This case involves a 17 years old male patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after it was not suitable to use post temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2022, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7695JA exp date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization. On 19-Sep-2022 the patient developed a non-serious event "fluzone qiv np to 6 patients after it was not suitable to use post temperature excursion with no reported adverse event (product temperature excursion issue) (poor quality product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for 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
- CO
- Alter
- 1,9
- Geschlecht
- F
- Eingang
- 28.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Poor quality product administered
Product storage error
Symptomtext
Vaccine exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event; Vaccine was administered after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2022SA390611(CLUSTER). This case involves a 23 months old female patient who was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A). On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion and products were determined to be not suitable to use with no reported adverse event (product storage error). On 19-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7695JA and expiry date: 30-Jun-2022) via intramuscular route in the left thigh for prophylactic vaccination. On 19-Sep-2022, (latency: same day) the patient was administered vaccine after it was not suitable to use post temperature excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. 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.; Sender's Comments: 01286160: 01286040: 01286171: 01286178: 01286213:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS A
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 38,0
- Geschlecht
- M
- Eingang
- 28.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- 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
Poor quality product administered
Product storage error
Symptomtext
vaccine was administered post excursion to patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2022SA390611(CLUSTER), 2022SA390948(CLUSTER), 2022SA391393(CLUSTER), 2022SA392234(CLUSTER) and 2022SA392531(CLUSTER). This case involves a 38 years old male patient to whom vaccine was administered post excursion with no reported adverse event for Influenza quadrival A-B vaccine [FLUZONE QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2022, the patient received 0.5 ml dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7695JA: strength and expiry date not reported) via intramuscular route in the right arm for Immunization. It was reported that vaccine was administered post excursion to patient with no reported adverse event (poor quality product administered)(latency; same day) 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 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
- CO
- Alter
- 0,8
- Geschlecht
- F
- Eingang
- 28.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
temperature excursion and products were determined to be not suitable to use with no reported adverse event; another physician used the products and administered them to patients post excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2022SA391393, 2022SA390948, 2022SA392234, 2022SA392303 and 2022SA392531. This case involves a 10 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after temperature excursion and products were determined to be not suitable to use with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Caller states she previously reported a temperature excursion (product storage error) and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller states that on 19-Sep-2022 another physician used the INFLUENZA QUADRIVAL A-B VACCINE and administered them to patients post excursion 0.5 ml dose once of suspect (lot UT7695JA, exp date: 30-Jun-2023) via intramuscular route in the left thigh for Immunization (poor quality product administered). 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 28.09.2022
- Impfdatum
- 19.09.2022
- Beginn
- 19.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
temperature excursion and products were determined to be not suitable to use with no reported adverse event; This situation is reported as a medication error due to FLUZONE QIV NP being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2022SA390611(CLUSTER), 2022SA391393(CLUSTER), 2022SA392303(CLUSTER), 2022SA392303(CLUSTER) and 2022SA392531(CLUSTER). This case involves a 4 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and had temperature excursion and products were determined to be not suitable to use with no reported adverse event and this situation is reported as a medication error due to fluzone qiv np being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2022, the patient received dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7695JA, expiration date: 30-Jun-2023 via intramuscular route in the left thigh as prophylactic vaccination. On an unknown date the vaccine had temperature excursion and products were determined to be not suitable to use with no reported adverse event (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 19-SEP-2022 this situation is reported as a medication error due to fluzone qiv np being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Caller stated she previously reported a temperature excursion and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller stated that another physician used the products and administered them to patients post excursion. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (This situation is reported as a medication error due to FLUZONE QIV NP being administered to patients after it was not suitable to use post temperature excursion with no reported adverse event, temperature excursion and products were determined to be not suitable to use with no reported adverse event). At time of reporting, the outcome was Unknown for all. 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
- -
