- Staat
- CT
- Alter
- 49,0
- Geschlecht
- F
- Eingang
- 01.10.2021
- Impfdatum
- 28.09.2021
- Beginn
- 29.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Headache
Muscle twitching
Pain in extremity
Pyrexia
Seizure like phenomena
Symptomtext
7 pm aching legs 12:30 am fever 102 12:30 twitching, teeth chattering, seizure like movements, 2:00am headache
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure like phenomena
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- autoimmune
- Vorgeschichte
- -
- Andere Medikamente
- aspirin,vit d
- Allergien
- lamictal
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 72,0
- Geschlecht
- F
- Eingang
- 14.12.2021
- Impfdatum
- 04.12.2021
- Beginn
- 05.12.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Condition aggravated
Tinnitus
Symptomtext
exacerbated pulsatile tinnitus; This case was reported by a consumer via call center representative and described the occurrence of pulsatile tinnitus in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 4th December 2021, the patient received the 1st dose of Fluarix Tetra 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 5th December 2021, 1 days after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced pulsatile tinnitus. On an unknown date, the outcome of the pulsatile tinnitus was recovered/resolved. It was unknown if the reporter considered the pulsatile tinnitus to be related to Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The case was reported by the patient. The patient stated that she woke up the morning following her flu shot with exacerbated pulsatile tinnitus in her right ear. She also asked about getting a booster and what strains the vaccines covered. The reporter was given medical disclaimer and referred to health care professional. The reporter was provided a copy of the product information (PI). The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Condition aggravated
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WV
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 03.12.2021
- Impfdatum
- 03.11.2021
- Beginn
- 04.11.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Burning sensation
Inflammation
Injection site pain
Mobility decreased
Pain in extremity
Tissue injury
Symptomtext
The injection did not go quickly or painlessly on 11/3/2021. I had time to look over at the RN administering and asked what was wrong, felt a mild burning, and I was told that it was going in more slowly than normal. I was not given a reason. For the next four days I had arm pain so severe that I did not want to lift my arm to get out of bed. As of today, 12/3/2021, I continue to experience a sharp pain in my shoulder during certain arm motions, when reaching for objects and putting on clothes, lifting things in certain directions. I have been evaluated by my PCP, and a physical therapist who suspect tissue damage and inflammation leading to issues with my shoulder nerve. I should be able to get better with treatment is what I am told, but the timetable for this is unknown. I am taking ibuprofen daily (400 mg 2X a day), icing daily and doing exercises provided by my PT. This has greatly impacted me, disrupted my time, energy and daily activities.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Mobility decreased
- Hospital-Tage
- -
- Labordaten
- PCP evaluation 12/1/2021 and PT evaluation 12/2/2021, no imaging done to date
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- prenatal vitamin, flonase, zyrtec, advil
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 37,0
- Geschlecht
- F
- Eingang
- 08.10.2021
- Impfdatum
- 06.10.2021
- Beginn
- 06.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hypoaesthesia
Pain
Paraesthesia
Symptomtext
PAIN; ARM TINGLING, NUMBNESS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paraesthesia
- Hospital-Tage
- -
- Labordaten
- Physical exam
- Aktuelle Erkrankungen
- denied
- Vorgeschichte
- denied
- Andere Medikamente
- denied
- Allergien
- denied
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 56,0
- Geschlecht
- F
- Eingang
- 26.09.2021
- Impfdatum
- 24.09.2021
- Beginn
- 24.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Delirium
Disturbance in attention
Feeling cold
Head discomfort
Headache
Injection site pain
Migraine
Pain
Polyuria
Pyrexia
Symptomtext
Severe headache, shaking chills, fever (103), diuresis, moderate local pain at injection site, body aches. I have migraines yet the headache experienced was like no other headache I've had. The pain was intense squeezing pressure deep in the center of head where pressure was felt in cheekbones, jaw and upper neck. I also felt like I was delirious and couldn't concentrate.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Migraine
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- hyperlipidemia obesity vitamin D deficiency
- Andere Medikamente
- atorvastatin aspirin
- Allergien
- Welbutrin Viibryd
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 6,0
- Geschlecht
- F
- Eingang
- 17.09.2021
- Impfdatum
- 14.09.2021
- Beginn
- 15.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Angiogram normal
Blood magnesium normal
Differential white blood cell count normal
Diplegia
Full blood count normal
Hypoaesthesia
Lipase normal
Liver function test normal
Magnetic resonance imaging head normal
Metabolic function test
Monoplegia
Paraesthesia
SARS-CoV-2 test negative
Troponin normal
Symptomtext
Woke up at 2am out of my sleep with numbness/tingling/paralysis of left arm and leg. Was rushed in an ambulance to the hospital ruled out for cardiac and stroke event, all was negative. Test and labs were done. Had a CT Angio of head and neck, MRI of bran and blood work. CBC and differential, Basic Metabolic Panel, LFT's, magnesium, Troponin T, Lipid panel, Also tested for COVID and was negative. All blood work and tests came back as normal. I was hospitalized for 1 day at Hospital
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paraesthesia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 32,0
- Geschlecht
- F
- Eingang
- 15.11.2021
- Impfdatum
- 29.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Pain
X-ray limb
Symptomtext
Felt pain in Right shoulder after flu inection into deltoid. Thought the pain would resolve after 2-3 days but continued to feel sore. Hurts with any over head motions or with internal rotation. Denies swelling or erythema
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- X-Ray of right shoulder on 11/11/2021
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 34,0
- Geschlecht
- M
- Eingang
- 22.10.2021
- Impfdatum
- 01.10.2021
- Beginn
- 11.10.2021
- Tage bis Beginn
- 10,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood lactate dehydrogenase
Blood thyroid stimulating hormone
Emotional distress
Full blood count
Insomnia
Metabolic function test
Musculoskeletal stiffness
Neck mass
Neck pain
Red blood cell sedimentation rate increased
Swelling
Symptomtext
Pain of the neck behind the angle of the jaw started in the evening on 10/11/2021. Thought to be just stiffness from awkward nap taken after 28 hour work shift ending that morning. Next morning the pain was worse and associated with a new swelling/mass about 2x1cm in that same space. Pain worse at the end of the day requiring ibuprofen to help with sleep for the subsequent 2 nights. Made appointment to see oncologist for 10/18/2021. Pain subsided over subsequent days, but mass remained. Labs drawn at appointment were mostly reassuring other than slightly elevated ESR (was 16, previously 4 when healthy earlier this year, 86 when diagnosed with cancer). Plan to follow clinically and if mass doesn't resolve, to obtain CT and biopsy. Significant psychological unease throughout this time, since a second cancer would have very poor prognosis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Neck pain
- Hospital-Tage
- -
- Labordaten
- Labs and physical exam at oncology clinic on 10/18/2021, including CBC w/ diff, CMP, TSH, LDH, ESR.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- Pfizer-BioNTech COVID-19, second shot, 01/12/2021, age 33, lot EL0142, left arm site , mild left axillary lymphadenopathy post-v
- Staat
- PA
- Alter
- 64,0
- Geschlecht
- M
- Eingang
- 22.10.2021
- Impfdatum
- 18.09.2021
- Beginn
- 19.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Injection site joint pain
Joint range of motion decreased
Product storage error
Shoulder injury related to vaccine administration
X-ray
Symptomtext
The day after injection: pain inside the shoulder joint (not muscular); significantly reduced range of motion especially in lifting arm over head. Treated with heat and ibuprofen. No improvement. It felt like the needle was still in the joint. No progress for 3 weeks, at which point pharmacy called me to say the lot of vaccine had been recalled by CDC for improper storage and I needed another shot. I did get that, and also started physical therapy, at which point I was advised that I probably had SIRVA. Saw an orthopedist 10/21/21 who confirmed this and prescribed more physical therapy and a course of oral steroids.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- Xray 10/21/21
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Pantoprazole 40mg; finasteride 1mg
- Allergien
- penicillin
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 53,0
- Geschlecht
- F
- Eingang
- 19.10.2021
- Impfdatum
- 30.09.2021
- Beginn
- 30.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Urticaria
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Urticaria
- Hospital-Tage
- -
- Labordaten
- Steroid injection and prescription
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Wellbutrin, estrogen, vitamin D, Ritalin, Claritin
- Allergien
- Lexapro, Prevacid, Paba in lotions
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 30,0
- Geschlecht
- M
- Eingang
- 30.09.2021
- Impfdatum
- 28.09.2021
- Beginn
- 29.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Injection site pruritus
Injection site swelling
Symptomtext
Erythema, itching swelling at injection site + surrounding 3 cm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pruritus
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 28,0
- Geschlecht
- F
- Eingang
- 24.09.2021
- Impfdatum
- 22.09.2021
- Beginn
- 22.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Diarrhoea
Rash
Urticaria
Symptomtext
Had flu shot at 1145, continued work. Around 1345 to develop hives and diarrhea. Hives primarily head/neck/upper back but also in groin, back of legs and arm pits. Was sent to walk in care by supervisors. Was seen at walk in care and given Benadryl/famotidine and DC. Rash and other symptoms dissipated by 6 PM.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Diarrhoea
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- N/A
- Andere Medikamente
- None known
- Allergien
- Hx of similar reaction but never to a vaccine
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 30,0
- Geschlecht
- F
- Eingang
- 10.10.2022
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Product storage error
Symptomtext
Fluarix was administrated and person is also PREGNANT.; Fluarix exposed to freezing temperature was administrated; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, COVID-19 AAPC VACCINE for prophylaxis, INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis and TOZINAMERAN (COVID 19 VACCINE BOOSTER PFIZER) for prophylaxis. Concurrent medical conditions included migraine (from 2013) and hypothyroidism (from 2008). On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th November 2021, the patient received COVID-19 AAPC VACCINE. On 11th October 2021, the patient received FLUARIX TETRA. On 20th November 2021, the patient received COVID 19 VACCINE BOOSTER PFIZER. The patient's last menstrual period was on 18th February 2021 and estimated date of delivery was 25th November 2021. The patient received Fluarix Quadrivalent 2021-2022 season at week 26 of the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season, Fluarix Tetra Pre-Filled Syringe Device and Aspirin (Baby), the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. The patient was treated with anti-d immunoglobulin (Rhogan), acetylsalicylic acid (Aspirin (Baby)) and acetylsalicylic acid (Aspirin (Baby)). On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. The pregnancy was lost to follow up. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of vaccine. The patient was pregnant at the time of vaccination which led to vaccine exposure during pregnancy. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter. Follow up information received from other health professional on 24th November 2021: The patient's demographics details were updated. The patient's concurrent condition includes Migraine (from 2013) and Hypothyroid (from 2008). The patient received Fluarix vaccine at 26th week, Rhogan on 29th October 2021 at 28 week, Aspirin (BABY) on 21st July 2021 at 14th week, COVID-19 AAPC VACCINE on 20th November 2021 at 32 week. The number of fetus was 1. The reporter stated the estimated delivery date was 17th January 2022. The reporter also stated that this was a normal conception (includes fertility drugs). Its unclear date of LMP and due date. This case includes Data merged from duplicate case USCH2021AMR085292 on 25-JUN-2022 Follow-up information received on 28-SEP-2022: This follow-up was considered significant. Reporters comment: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up. Summary of Changes: Pregnancy outcome was updated.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Hypothyroidism (from 2008); Migraine (from 2013)
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- F
- Eingang
- 16.08.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Symptomtext
is currently pregnant; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself who was also the physician. The patient received a dose of Fluarix during pregnancy, which led to vaccine exposure during pregnancy. The patient was not sure whether the dose given was expired or not and wanted to confirm for the season of the dose she received. The dose was confirmed as 2020-2021 and the patient was currently pregnant wanted to know if she could receive a second dose. Since no information was available patient did not confirm she would get another dose of the Fluarix vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 29,0
- Geschlecht
- F
- Eingang
- 21.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR215096:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215097:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:Different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:Different patient, same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 27,0
- Geschlecht
- F
- Eingang
- 21.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR215097:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:Different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:Different patient, same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 47,0
- Geschlecht
- M
- Eingang
- 20.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 47-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: It was reported that the Fluarix QIV that was exposed to freezing temperature was administrated to the patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to be contacted for follow-up. This is one of eight cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR215097:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215096:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215095:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215094:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215093:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215098:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215092:Original Case : US2021214412
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 26,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 32,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 30,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Product storage error
Symptomtext
Fluarix was administrated and person is also PREGNANT.; Fluarix exposed to freezing temperature was administrated; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. The pregnancy was ongoing. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. The patient was pregnant at the time of vaccination which led to vaccine exposure during pregnancy. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Fluarix Tetra Pre-Filled Syringe Device
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 31,0
- Geschlecht
- F
- Eingang
- 20.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR215096:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215097:different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:different patient, same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 46,0
- Geschlecht
- M
- Eingang
- 20.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR215097:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:different patient, same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
stored outside of recommended temperature range; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Fluarix, 2021-2022 formulation at her local pharmacy. The pharmacy called the patient after the administration of the dose at the pharmacy, and informed her that the dose she was administered may be a part of a recall due to the vaccine being stored outside of recommended temperature range which led to incorrect storage of drug. The patient did not mention that she has had any adverse reactions from the dose administered. The date of the vaccine administration was not reported. The reporter gave consent to contact her health care professional.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
patients were vaccinated with Fluarix after being out of range; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that 300 patients were vaccinated with Fluarix after being out of range for 2 weeks. The reporter did not consent to follow-up. The health care professional provided limited information since didn't have expiration date of the vaccine, or any other demographic details from vaccinated.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Symptomtext
is currently pregnant; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself who was also the physician. The patient received a dose of Fluarix during pregnancy, which led to vaccine exposure during pregnancy. The patient was not sure whether the dose given was expired or not and wanted to confirm for the season of the dose she received. The dose was confirmed as 2020-2021 and the patient was currently pregnant wanted to know if she could receive a second dose. Since no information was available patient did not confirm she would get another dose of the Fluarix vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Exposure during pregnancy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of product storage error in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown. It was unknown if the reporter considered the product storage error to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information was provided as follows: On 27th September 2021 the retail pharmacy called medical information to obtain temperature excursion data because theirwholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to 3 individuals. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 4th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler ia but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the FLUARIX product back in the refrigerator and subsequently shipped it to the pharmacy. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose each to 3 individual patients. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021AMR208519:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. On 27th September 2021, the retail pharmacy called GSK medical information to obtain temperature excursion data because their wholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to the patient. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 04th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler via, but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the Fluarix product back in the refrigerator and subsequently shipped it to the pharmacy. Fluarix Quadrivalent (Influenza Vaccine) injectable suspension was available in 0.5 mL single-dose, disposable, prefilled Tip-Lok syringes (packaged without needles). GlaxoSmithKline (GSK) employee (Director for GSK, retail) called GSK response center on 6th October 2021 to report that the patient was vaccinated with Fluarix (FLU.QIV PRTC X10 CT FS US NH21, NDC: 59160-0887-52) which had been stored outside of the refrigerator for 2 weeks, which led to incorrect storage of drug. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose to the patient. The GSK employee (Director for GSK, retail) did not have any specific patient information (example: gender). This is 1 of the 3 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021208229:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Product distribution issue
Product storage error
Symptomtext
temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. On 27th September 2021, the retail pharmacy called GSK medical information to obtain temperature excursion data because their wholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to the patient. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 04th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler via, but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the Fluarix product back in the refrigerator and subsequently shipped it to the pharmacy. Fluarix Quadrivalent (Influenza Vaccine) injectable suspension was available in 0.5 mL single-dose, disposable, prefilled Tip-Lok syringes (packaged without needles). GlaxoSmithKline (GSK) employee (Director for GSK, retail) called GSK response center on 6th October 2021 to report that the patient was vaccinated with Fluarix (FLU.QIV PRTC X10 CT FS US NH21, NDC: 59160-0887-52) which had been stored outside of the refrigerator for 2 weeks, which led to incorrect storage of drug. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose to the patient. The GSK employee (Director for GSK, retail) did not have any specific patient information (example: gender). This is 1 of the 3 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021208229:same reporter US-GLAXOSMITHKLINE-US2021AMR208519:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -