- Staat
- MN
- Alter
- 61,0
- Geschlecht
- F
- Eingang
- 10.02.2022
- Impfdatum
- 14.10.2021
- Beginn
- 01.11.2021
- Tage bis Beginn
- 18,0
- Dosis
- 5
- Route/Site
- IM / RA
Tod: ja
Lebensbedrohlich: ja
Hospital: ja
Disable: ja
ER: ja
Erholt: nein
Blood test
Computerised tomogram
Death
Endoscopy
Feeding disorder
Nausea
Pancreatic cyst
Symptomtext
Patient was unable to eat within 2 weeks of the second Covid-19 shot. Her nausea got worse and worse until she went back into the doctor on 12/1 and it was found that she has many large cysts surrounding her pancreas. Patient made several appointments with some having to schedule months out due to availability. Died 1/13/22.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- 13,0
- Labordaten
- Blood work 9/23/21, 12/1/2021, 1/1/2022 CT scan 12/1/2021, 1/2/2022 Endoscopy 1/2/2022
- Aktuelle Erkrankungen
- Gout Fatty Liver Acid Reflux High Blood Pressure Cronic Kidney Disease Stage IV Vitamin D Deficiency Parathyroid Disorders Pancreatitis
- Vorgeschichte
- High Blood Pressure Cronic Kidney Disease Stage IV Pancreatitis
- Andere Medikamente
- allopurinol 100 mg tablet carvedilol 25 mg tablet furosemide 20 mg tablet omeprazole 20 mg delayed release capsule hydrALAZINE 100 mg tablet
- Allergien
- Isosorbide Atorvastatin Simvastatin
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 30,0
- Geschlecht
- U
- Eingang
- 21.09.2021
- Impfdatum
- 17.09.2021
- Beginn
- 18.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Blood test normal
Chest X-ray
Computerised tomogram head
Electrocardiogram
Electrocardiogram ambulatory
Paraesthesia
Syncope
Symptomtext
pt. reported paresthesias of arms and legs the following day and syncope. pt advised by alt med provider to seek ER. has not reacted to prior influenza vaccinations. symptoms have resolved w/o sequelae.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- pt. sought ER neg blood work, cxr, head ct, and reports holter and ekg results unk.
- Aktuelle Erkrankungen
- dysuria, subclinical hypothyroidism.
- Vorgeschichte
- NA
- Andere Medikamente
- albuterol, vitamin d.
- Allergien
- pcn, carrot.
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 17.05.2022
- Impfdatum
- 05.10.2021
- Beginn
- 05.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Arthralgia
Asthenia
Confusional state
Decreased appetite
Dizziness
Fatigue
Malaise
Pain
Polymyalgia rheumatica
Pyrexia
Trigeminal neuralgia
Symptomtext
She was diagnosed with PMR (polymyalgia rheumatica); Four hours later she started to have symptoms of: body and joint pain; Four hours later she started to have symptoms of: body and joint pain; patient had fever; weak; patient had confused; patient had no appetite; patient started to have light headedness; patient had symptom of fatigue; patient had malaise; patient had trigeminal neuralgia; Initial information received on 09-May-2022 regarding an unsolicited valid serious case received from a patient via call center. This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) and patient had trigeminal neuralgia while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2021, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (lot UJ725AA) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for Flu vaccination. On 05-OCT-2021 the patient developed a serious she was diagnosed with pmr (polymyalgia rheumatica) with symptom [body and joint pain (pain and arthralgia), pyrexia, asthenia, confused (confusional state), no appetite (decreased appetite), light headedness (dizziness), fatigue asthenia and malaise] (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine. On 05-OCT-2021 the patient developed a non-serious patient had trigeminal neuralgia (trigeminal neuralgia) (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine. Seriousness- medically significant for polymyalgia rheumatic trigeminal neuralgia (non- serious) Action taken: not applicable. The patient was treated with prednisone for Polymyalgia rheumatica and Trigeminal neuralgia. Outcome- Recovered / Resolved for Polymyalgia rheumatica and Trigeminal neuralgia; Sender's Comments: Sanofi Company Comment dated 16-May-2022: This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV]. The causal role of the company suspect drug cannot be excluded based on the temporal relevance instead of the time to onset is compatible with the role of the vaccine. However, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 45,0
- Geschlecht
- F
- Eingang
- 07.01.2022
- Impfdatum
- 13.12.2021
- Beginn
- 13.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Hypoaesthesia
Injection site mass
Injection site swelling
Injection site warmth
Nausea
Pain in extremity
Symptomtext
After receiving vaccination, individual developed pain/numbness in right arm. Denied any SOB, difficulty breathing, swallowing. Over the course of the day and days following, site became swollen, red, warm to touch. Individual noted a knot at injection site and also complained of nausea.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- No immediate action take by individual but she states she did have a physician/NP look at site.
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Overweight
- Andere Medikamente
- Symbicort 80/4.5 2 Puffs AM and 2 puffs PM due to cough No OTC Medications
- Allergien
- Codeine Oxygen Mask/Oxygen causes nausea/vomiting Eggs
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 70,0
- Geschlecht
- F
- Eingang
- 17.12.2021
- Impfdatum
- 27.09.2021
- Beginn
- 28.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Joint range of motion decreased
Symptomtext
Pt with persistent decreased ROM and pain of L shoulder since the end of September after her flu shot.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Age-related osteoporosis without current pathological fracture ? Subclinical hypothyroidism ? Mood disorder (HCC) ? Multiple chemical sensitivity syndrome ? Multiple food allergies ? Preglaucoma of both eyes ? Chronic kidney disease (CKD), active medical management without dialysis, stage 4 (severe) (HCC) ? Seasonal allergies ? Vitamin D insufficiency ? Oral allergy syndrome ? Dermatographism ? Adverse food reaction ? Seasonal allergic rhinitis due to pollen ? History of allergic contact dermatitis ? Chronic interstitial nephritis
- Andere Medikamente
- amitriptyline (ELAVIL) 10 mg oral tablet TAKE 1 TABLET BY MOUTH EVERYDAY AT BEDTIME 90 tablet 3 ? ascorbic acid, vitamin C, (VITAMIN C) 1,000 mg oral tablet Take 1 tablet by mouth 2 times a day ? b complex vitamins (B COMPLEX) oral e
- Allergien
- Adhesive Penicillin Prochlorperazine Sulfa
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 40,0
- Geschlecht
- F
- Eingang
- 02.11.2021
- Impfdatum
- 27.10.2021
- Beginn
- 28.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Petechiae
Rash
Swelling face
Throat irritation
Throat tightness
Symptomtext
Woke up around 3am on 10/28/21- scratchy throat and tight throat- did not treat, went back to sleep. When got up at 7am had very tiny red dots at eyes and neck (petchial rash), face was swollen somewhat, not excessive. No itching. Did go to Occupational Health on 10/28/21 and decided best to take antihistamine once she got home. Arrived at home at 6pm and took Benadryl 50 mg by mouth, after this, the throat cleared. Rash slowly dissipating over the next few days.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- No labs or x-rays; only physical exam
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Polycystic Ovarian Syndrome, Non-Insulin Dependent Diabetes
- Andere Medikamente
- Metformin 1500mg daily; Azempic weekly; Nexium 20mg daily
- Allergien
- Latex
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 31,0
- Geschlecht
- F
- Eingang
- 29.10.2021
- Impfdatum
- 15.10.2021
- Beginn
- 15.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Fatigue
Injection site erythema
Injection site pruritus
Injection site swelling
Injection site warmth
Lethargy
Symptomtext
swelling, redness , warmth and itching to arm at site of injection x3 days. individual took Benadryl PO for the itching and applied ice packs to the site of injection. Also had c/o of feeling tired/lethargic. Denies having a temperature, SOB, difficulty breathing or difficulty swallowing. States she did not seek medical treatment.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Asthma PTSD/Anxiety Focal Seizures (not on medication)
- Andere Medikamente
- Albuterol PRN
- Allergien
- Egg Whites Citrus Mix Corn Potato
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 60,0
- Geschlecht
- M
- Eingang
- 21.10.2021
- Impfdatum
- 27.09.2021
- Beginn
- 18.10.2021
- Tage bis Beginn
- 21,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Contusion
Incorrect route of product administration
Pain
Pain in extremity
Symptomtext
vaccine was administered too low on the right arm. Bruising, pain was slighty radiating up to the shoulder and down towards the elbow. Patient took ibuprofen often and acetametaphen
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Arthralgia
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- hypothyroidism
- Andere Medikamente
- multivitamin, synthroid, vitamin-c,
- Allergien
- has sensitivity to hazelnuts
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 19.10.2021
- Impfdatum
- 08.10.2021
- Beginn
- 08.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
About 2 hours after receiving the flu vaccine- left arm at injection site became redness about the size of a silver dollar, feverish and swollen. Immediately took Benadryl 25 mg, also had taken Tylenol 500mg prior to vaccine. 7 hours later at bedtime (10:30pm)- beginning to have redness radiate down the arm and redness at injection site was the size of an orange; repeated Benadryl 25mg. Next morning, redness at injection site was size of a grapefruit and repeated Benadryl and additional Tylenol. Afternoon, repeated Tylenol - injection site was about the same, applied ice pack. In PM, repeated Benadryl and tylenol. On next day (Sunday) injection site redness had decreased to the size of an orange, and benadryl and tylenol were repeated. Sunday pm- repeated Benadryl and tylenol. Monday am- took tylenol - color of injection site fading, was pink not red. Monday pm- repeated benadryl and tylenol. Tuesday am- redness had dissipated completely, no swelling present.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Asthma, Hypothyroid
- Andere Medikamente
- Synthroid 100mcg daily; Breo inhaler100/25 -1 puff daily; Ventolin inhaler PRN (not used in over 1 year); Vit D 5, 000 units weekly; Singulair 10mg daily.
- Allergien
- Meds: Omnicef, Keflex (hives); previous reaction to Influenza fluzone Food: Carrotts Enovironmental: None
- Vorherige Impfungen
- 2019 -age 52; Injection site redness, feverish and swelling
- Staat
- PA
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 12.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- 12.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Pruritus
Symptomtext
PATIENT'S ARM WAS BECOMING RED AND ITCHY.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pruritus
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 30,0
- Geschlecht
- F
- Eingang
- 29.09.2021
- Impfdatum
- 28.09.2021
- Beginn
- 28.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal discomfort
Erythema
Injection site erythema
Pain in extremity
Rash macular
Vomiting
Symptomtext
Patient developed large red circle around the area of the Flublock injection on right deltoid/arm - approximately 4 inches across . patient developed blotches on skin of neck/chest - mostly on right side of body and some redness of whole face. Patientwas given benadryl 25mg oral tablet x 1 dose immediately and about 20 - 30 minutes later- she complained of upset stomach, vomited and then felt better shortly afterward. Patient was observed until 4:15pm when she stated she had to go home- patient was advised by physician to take another dose of 25 mg of benadryl when arrived home along with 40 mg of pepcid . A medrol dose pack was sent to the pharmacy for patient to get Just in case she needs it/ if symptoms do not subside with first recommendations. 9-29-21 followed up with patient, no further Gi symptoms , rash or flushing. patient does still have some soreness in right arm today 9-29-21
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- Allergic Rhinitis- seasonal
- Andere Medikamente
- Flonase nasal spray, Mirena IUD and Epi-PEN prn; Tubersol PPD mantoux test
- Allergien
- Strawberries, bee venom/stings, seasonal allergies
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 25.04.2022
- Impfdatum
- 22.04.2022
- Beginn
- 22.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Symptomtext
Patient was given Flu Block due to egg allergy. Patient is 17 and Flu Block recommended for patients 18 and over.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 10.02.2022
- Impfdatum
- 28.10.2021
- Beginn
- 28.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No adverse events. Vaccine was administered to 16 year old. Approved for 18+
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 23.12.2021
- Impfdatum
- 16.12.2021
- Beginn
- 16.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product administered to patient of inappropriate age
Symptomtext
a 17 years old patient received a dose of Flublok Quadrivalent vaccine/ No AE; Initial information received on 16-Dec-2021 regarding an unsolicited valid non-serious case from an other health professional via Physician. This case involves a 17 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations and family history were not provided. No other concomitant vaccines. On 16-Dec-2021, the patient received a 0.5 ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE strength: standard, frequency: once, lot number: UJ725AA, Expiry date: 30-Jun-2022 via an unknown route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day). It was reported "Calling in regard to a 17 year receiving a dose of FLUBLOK. Caller would like to know if there are any side effects/ safety information available." Product used: Used, First time product used: Yes, Still using product: No and Was Device Used: Yes. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 26.11.2021
- Impfdatum
- 11.11.2021
- Beginn
- 11.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Symptomtext
a 15 months old patient received a dose of FLUBLOK vaccine by accident/ No AE; Initial information received on 12-Nov-2021 regarding an unsolicited valid non-serious case from a physician via consumer via Global Medical Information (GMI) number: 00856152. This case involves a 15 months old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by accident (product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for prophylactic vaccination. On 11-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Injection, time interval unit: total, frequency: once, strength: standard lot number: UJ725AA, expiry date: 30-JUN-2022 via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day). It was reported "Physician is calling to advise that a 15 months old child received FLUBLOK by accident. Doctor is wanting to know what they should do. Doctor is also asking if it would increase patients Hydronephrosis." Product used, First time product used : Yes and Still using product : No. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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
- PENTACEL
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 13.11.2021
- Impfdatum
- 06.11.2021
- Beginn
- 06.11.2021
- 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
Product administered to patient of inappropriate age
Symptomtext
17 year old female patient received Flublock, with no reported adverse event; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a Physician via other health care professional via non-healthcare professional via Medical Information (Reference number- 00844192). This case involves a 17-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (product administered to patient of inappropriate age). The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 06-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ725AA and expiry date: 30-Jun-2022) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day). It was reported "nurse requests counseling regarding FLUBLOK; on 06NOV2021, a female 17 year old patient received FLUBLOK; caller would like to know adverse events to look out for and counseling regarding dosage meant for adults". 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
- PA
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 23.10.2021
- Impfdatum
- 15.10.2021
- Beginn
- 15.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Wrong product administered
Symptomtext
Patient received FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and physician via agency under reference number 00814649). This case involves a 8 months old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included a dose of Hepatitis B vaccine (lot number and expiry date and other dosing details were not reported) on an unknown date for prophylactic vaccination. On 15-Oct-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once in total, lot UJ725AA and expiry date :30-Jun-2022) instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medical error case due to wrong vaccine administered (same day latency). It was reported "Medical assistant calling to report that a 8 month old child received the FLUBLOK QUADRIVALENT instead of the FLUZONE QUADRIVALENT. Caller is wanting to know what to do." No corrective treatment was provided. At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS B VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 60,0
- Geschlecht
- F
- Eingang
- 23.10.2021
- Impfdatum
- 11.10.2021
- Beginn
- 10.10.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product storage error
Symptomtext
product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius, no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non- health care professional via Agency (Under reference number 00814299). This case involves a 60 years old female patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that had a product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius (Product storage error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to patient. On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, lot UJ725AA and expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to product storage error temperature too low. Details of laboratory data were not provided. It was reported "Practice Administrator calling in a temperature excursion for FLUBLOK. Excursion started on 10-Oct-2021 and ended on 11-Oct-2021, dose of the FLUBLOK was administered. Caller is inquiring if the products are still suitable for use and if not should they revaccinate?' At time of reporting, no adverse event was reported, and the outcome was unknown for the reported 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 13,0
- Geschlecht
- M
- Eingang
- 09.10.2021
- Impfdatum
- 30.09.2021
- Beginn
- 30.09.2021
- 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
Product administered to patient of inappropriate age
Symptomtext
a 13 years old patient received FLUBLOK QIV vaccine/ No AE; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via consumers via regulatory authority number: 00793359. This case involves a 13 year old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and Human papillomavirus (HPV) VACCINE for prophylactic vaccinations. On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number: UJ725AA, expiry date: 30-Jun-2022, frequency: once, strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day). It was reported "Office Manager stated FLUBLOK was given to a child and wanted to know what needed to be done. States the child received the product yesterday and they notified the mom who did not report any issues." Product used: Used and First time product used: Yes. Adverse event (AE) symptoms or no 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
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -