- Staat
- IL
- Alter
- 22,0
- Geschlecht
- F
- Eingang
- 22.07.2021
- Impfdatum
- 12.07.2021
- Beginn
- 12.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Anaphylactic reaction
Anaphylactic shock
Symptomtext
anaphylactic reaction/anaphylactic shock; The vial has a warning in very tiny print. Why is it not clearly marked on the package; Initial information was received on 15-Jul-2021 regarding an unsolicited valid serious case from a other health professional (Inquiry number: 00684271).. This case involves a 22-year-old female patient who experienced anaphylactic reaction/anaphylactic shock (anaphylactic reaction) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Latex allergy. On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6737AA, expiry date: 09-Jul-2022] via an intramuscular route at right deltoid for prophylactic vaccination. On 12-Jul-2021 the patient developed a serious anaphylactic reaction/anaphylactic shock (anaphylactic reaction) and was transported by ambulance to the ER for treatment on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. It was reported that they were not aware at the time that the tip was latex and the patient had a severe latex allergy and also the vial had a warning in very tiny print (Product use complaint). Reporter states that the incident could have been avoided if the latex content was clearly noted. Reporter also says on other manufacturers boxes, it boldly states the latex content, the patient is a college student who came in to satisfy requirements and she ended up in the hospital. She has no way of paying the hospital and ambulance bill. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment for the event. At the time of reporting, the patient was recovered from the event anaphylactic reaction.; Sender's Comments: This case involves a 22-year-old female patient who experienced anaphylactic reaction on the same day after vaccination with ADACEL. The ADACEL vial had a warning in very tiny print (Product use complaint). The time to onset was compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Latex allergy
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 14,0
- Geschlecht
- F
- Eingang
- 24.06.2021
- Impfdatum
- 23.06.2021
- Beginn
- 23.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Dizziness
Extremity contracture
Fall
Fatigue
Feeling cold
Flushing
Gaze palsy
Inappropriate schedule of product administration
Loss of consciousness
Muscular weakness
Musculoskeletal stiffness
Pallor
Respiratory arrest
Seizure like phenomena
Somnolence
Syncope
Vision blurred
Symptomtext
6/23/21 @ 0830 14 y/0 F came to clinic for TDAP, IPV, MMRV, Hep A, and Hep B vaccinations. Pt has NKDA and no PSH/PMH. 6/18/21 pt had her 2nd Pfizer vaccine, no side effects verbalized. Approximately 2 minutes after administration pt was standing against padded pediatric exam table and fell back onto table, her legs buckled and she gently slid down onto floor in sitting position with head slumped down causing her eye glasses to fall off. Pt did not hit head. Syncopal episode lasted 5 seconds. When pt regained consciousness she was alert and oriented, pale and c/o of dizziness and blurred vision. The patients mother and I assisted her to a chair. After 1-2 minutes pt?s eyes rolled back, her left arm contracted up, her entire body stiffened and she was having seizure like activity lasting 5-10 seconds. Pt was flushed and did not breathe during this episode. 911 was called at this time. When patient regained consciousness she c/o of fatigue, feeling cold, dizziness and blurred vision. She was AAOx3 and very pale. After applying her eye glasses her vision improved some, still c/o dizziness and stated she just wanted to go to sleep. Pt was provided a cool rag and was kept awake and talking until EMS arrived. Report given to EMS. F/U call made to pt?s mother whom reported pt was discharged from ER. No lab work or radiology was performed. MD stated that ?this was a normal anxiety related reaction for a patient her age.? Since discharge from hospital pt has been asymptomatic and back to her baseline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Respiratory arrest
- Hospital-Tage
- -
- Labordaten
- Pt was provided a cool rag and was kept awake and talking until EMS arrived. Report given to EMS. F/U call made to pt?s mother whom reported pt was discharged from ER. No lab work or radiology was performed. MD stated that ?this was a normal anxiety related reaction for a patient her age.? Since discharge from hospital pt has been asymptomatic and back to her baseline.
- Aktuelle Erkrankungen
- None.
- Vorgeschichte
- None.
- Andere Medikamente
- None.
- Allergien
- None.
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 50,0
- Geschlecht
- F
- Eingang
- 15.11.2021
- Impfdatum
- 18.10.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Facial paralysis
Facial paresis
Symptomtext
bell's palsy; facial weakness; drooping; Initial information regarding an unsolicited valid serious case was received from a nurse via consumer/non-healthcare professional via Medical Information (Reference number- 00847325) and transmitted to sanofi on 08-Nov-2021 . This case involves a 50 year old female patient who experienced bells palsy, facial weakness (facial paresis) and drooping (facial paralysis) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination. On 18-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE produced by Sanofi Pasteur (lot number: U6737AA and expiry date: 09-Jul-2022) via intramuscular route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious bells palsy with symptoms facial weakness (facial paresis) and drooping (facial paralysis) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events were assessed as medically significant. A Nurse stated they had a patient have an adverse reaction to the ADACEL vaccine. Nurse was looking to report the adverse event (AE) as well as for more information into the Bells Palsy side effect of ADACEL. She was seen in the emergency department (ED) on 05-Nov-2021 for left sided facial weakness and drooping. She was diagnosed with bells palsy and it was attributed to ADACEL. She was followed up on 08-Nov-2021. Caller stated that she called the office to get more information to see how it is being linked. She was also told the patient recently received the flu shot but she did not see it documented. She will contact. She asked whether there was a correlation between Adacel and Bells Palsy and a correlation between flu vaccine and bells palsy. No laboratory data was reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome of the events was unknown.; Sender's Comments: This case involves a 50 year old female patient who experienced bell's palsy, facial paresis and facial paralysis after receiving ADACEL. The time to onset is compatible. Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 50,0
- Geschlecht
- F
- Eingang
- 08.11.2021
- Impfdatum
- 18.10.2021
- Beginn
- 05.11.2021
- Tage bis Beginn
- 18,0
- Dosis
- UNK
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Arthralgia
Bell's palsy
Ecchymosis
Fatigue
Headache
Facial paresis
Hemiparesis
Myalgia
Swelling
Symptomtext
Pt. reported to the emergency room on 10/28/2021 with Left side facial weakness. There is documentation that she recently received an influenza vaccine in the ED note, but I do not have any additional information on this vaccine. Pt. received a Tdap vaccine on 10/18/2021.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- Unsure. Pt. was seen on 10/28/2021 in the Emergency Room for evaluation and followed up with her Primary Care Provider on 11/4/2021.
- Aktuelle Erkrankungen
- Unsure
- Vorgeschichte
- Unsure
- Andere Medikamente
- Unsure
- Allergien
- Unsure
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 63,0
- Geschlecht
- M
- Eingang
- 26.10.2021
- Impfdatum
- 29.09.2021
- Beginn
- 30.09.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injected limb mobility decreased
Pain in extremity
Sleep disorder
Symptomtext
Patient stated that the morning after he got the shot his arm started hurting (~ 4 weeks now). Patient states his right arm constantly hurts and that he cannot lift his arm. He is also having trouble sleeping because of the pain.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injected limb mobility decreased
- Hospital-Tage
- -
- Labordaten
- None so far. He called his doctor 10/26/21 - the same day he contacted the pharmacy.
- Aktuelle Erkrankungen
- None Reported
- Vorgeschichte
- ADHD, Hypertension, Acid Reflux
- Andere Medikamente
- Omeprazole Spironolactone Cholestyramine Alprazolam Trimacinolone 0.1% Cream
- Allergien
- No Known Allergies
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 12.01.2021
- Impfdatum
- 07.01.2021
- Beginn
- 07.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal pain
Asthenia
Bradycardia
Dizziness
Headache
Hyperhidrosis
Hypotension
Lethargy
Pulse abnormal
Vomiting
Symptomtext
Within 3-4 minutes of receiving Tdap, HPV, Men4, and influenza vaccine, patient developed dizziness, frontal headache, vomiting (3x), abdominal pain, lethargy, and diaphoresis. Initial vitals demonstrated hypotension (79/50's), bradycardia (50's) with weak/thready pulse, and oxygen saturations 80's (returned to high 90's within minutes and by the time oxygen was in room). No hives, wheezing, lip/tongue edema, difficulty breathing. Symptoms improved over the next 5-10 minutes with patient being more responsive, BP 90s/60s-100s/70s, HR in the 90's, alert/interactive and no longer diaphoretic and vomiting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hypotension
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None noted
- Vorgeschichte
- Father then remembered in 2018 (received influenza, HPV, and Tdap) when patient had a similar episode after vaccines, but this episode being more severe. Patient was observed by a provider.
- Andere Medikamente
- Tylenol PRN
- Allergien
- None
- Vorherige Impfungen
- 11/13/2018; Adacel, Tdap 0.5 mL LEFT ARM IM PMC U5850AA 11/13/2018;Fluzone Quadrivalent 0.5 mL RIGHT ARM IM PMC UT6301KA Short
- Staat
- IL
- Alter
- 31,0
- Geschlecht
- M
- Eingang
- 10.01.2021
- Impfdatum
- 06.01.2021
- Beginn
- 06.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chest pain
Chills
Injection site erythema
Injection site hypoaesthesia
Injection site pain
Pyrexia
Tremor
Symptomtext
Patient had fever, chills, shaking, slight chest pain. Also experienced numbness, redness & pain at injection site. Currently there is a little bit of redness and pain in the morning.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chest pain
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 11.01.2022
- Impfdatum
- 18.06.2021
- Beginn
- 25.06.2021
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Symptomtext
Received the 3 vaccines on 06/18/2021, approximately 1 week afterwards started to develop rash to body worsening over time with no improvements now has rash to Head/Neck region, both eye lids, both limbs abdomen, back of knees and lower legs. Denied shortness of breath or difficulty breathing. Has no PCP at the time. was seen today at a Walk-in clinic. Not poison oak per Health Provider. Given injection of Cortisone and a oral preparation was also referred to a Dermatologist for follow up care.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- Not at this time
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- No
- Allergien
- none noted
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 72,0
- Geschlecht
- M
- Eingang
- 12.12.2021
- Impfdatum
- 17.09.2021
- Beginn
- 17.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Joint range of motion decreased
Limb discomfort
Pain in extremity
Symptomtext
Patient received the vaccine in September and is still having pain in his arm. It is affecting his range of motion and his pain when lifting his arm and when putting his arm behind his back
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- diabetic and heart disease
- Andere Medikamente
- Januvia 100mg QD, losartan 100mg QD, metoprolol ER25mg 0.5 QD, HCTZ 12.5mg QD, glimepiride 4mg BID, omeprazole 20mg QD, Jardiance 25mg QD, amlodipine 5mg 1.5 QD, terazosin 5mg QD
- Allergien
- sulfa antibiotics
- Vorherige Impfungen
- patient stated he has felt dizzy following vaccinations in the past
- Staat
- VA
- Alter
- 25,0
- Geschlecht
- F
- Eingang
- 31.10.2021
- Impfdatum
- 08.10.2021
- Beginn
- 08.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: unbekannt
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
SWOLLEN, RED, WARMTH AT INJECTION SITE
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 52,0
- Geschlecht
- M
- Eingang
- 28.06.2021
- Impfdatum
- 21.06.2021
- Beginn
- 25.06.2021
- Tage bis Beginn
- 4,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site pain
Injection site swelling
Symptomtext
Rt deltoid, area of discreet swelling, tender faint erythema below swelling . Cold therapy, monitoring
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- AUD Seizure history HTN Depression. elevated lipids
- Andere Medikamente
- folic acid, thiamine, gabapentin, Vimpat, rouvastatin, loratidine, amlodipine, acetaminophen,, chlorthalidone, Vitamin D
- Allergien
- PCN
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 45,0
- Geschlecht
- F
- Eingang
- 20.05.2021
- Impfdatum
- 10.05.2021
- Beginn
- 10.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Symptomtext
She felt dizzy as though the room was spinning. The feeling it was strong enough that she needed to support herself to walk and not to fall. Started about 12 hours post vaccination. Symptoms continued for about 12 hours prior to resolution.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- None. Gait observed normal on 5/19/2021 when at clinic for separate procedure
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- NOne reported
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 18.05.2021
- Impfdatum
- 01.09.2020
- Beginn
- 01.10.2020
- Tage bis Beginn
- 30,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood test
Headache
Henoch-Schonlein purpura
Immediate post-injection reaction
Injection site inflammation
Injection site reaction
Injection site swelling
Injection site warmth
Laboratory test
Rash
Rash macular
Symptomtext
Swollen at the injection site, Injection site inflammation , site warm, severe head aches on 9/14. I took her to doctor on that date. Shortly after she started to have red dots all over her. He has now been diagnosed with Henoch-Schonlein Purpa. I tried to report this around the time that this first happened and Dr.'s office refused to give me the information on the vaccine until recently when i called again. My daughter is still suffering with the HSP.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- 1,0
- Labordaten
- Yes she had alot of blood work and tests . She was in the ER on 4/10/21 due to the rash getting severe. Her new Dr. mD and Dermatologist have all of the bloodwork reports.
- Aktuelle Erkrankungen
- She first had a site reaction . Swelled arm, warm at the site and that head aches right after TDAP vaccine. I had to take her to the clinic.
- Vorgeschichte
- no
- Andere Medikamente
- none
- Allergien
- Make up
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- 11,0
- Geschlecht
- U
- Eingang
- 15.04.2021
- Impfdatum
- 07.04.2021
- Beginn
- 07.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Immediate post-injection reaction
Throat tightness
Symptomtext
1. IMMEDIATE HEADACHE. DIZZY. AND TIGHTNESS OF THROAT FOR 15 MINUTES
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- intermittent asthma well controlled
- Vorgeschichte
- intermittent asthma well controlled
- Andere Medikamente
- -
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 08.02.2021
- Impfdatum
- 08.02.2021
- Beginn
- 08.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Vomiting
Symptomtext
Vomiting, given Zofran, then vomited again. Patient denies dizziness, abdominal pain, eye and lip swelling, and rash
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vomiting
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none reported
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 03.02.2021
- Impfdatum
- 01.02.2021
- Beginn
- 02.02.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site swelling
Symptomtext
Swelling + redness to L deltoid
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 25.01.2021
- Impfdatum
- 25.01.2021
- Beginn
- 25.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Fatigue
Injection site erythema
Injection site pain
Injection site swelling
Symptomtext
Patient has had increased tiredness and significant tenderness over the immunization area associated with mild swelling and redness of the area.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 14.05.2022
- Impfdatum
- 02.05.2022
- Beginn
- 02.05.2022
- 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
vaccines given post excursion with no reported adverse event; vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 11 years old male patient to whom vaccines given post excursion with no reported adverse event and vaccines being given post temperature excursion with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE) for Prophylactic vaccination. On 02-May-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , once (lot: U6737AA; expiry date: 09-Jul-2022) via intramuscular route in the left deltoid for immunization. It was reported that vaccines were given post temperature excursion (product storage error) (Poor quality product administered) (latency: same day). Action taken: not applicable. Corrective treatment: not reported 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.; Sender's Comments: 01090544: 01092869: 01092879: 01092814: 01092832: 01092891: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- MENACTRA; HPV VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 3,0
- Geschlecht
- F
- Eingang
- 18.04.2021
- Impfdatum
- 11.03.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Wrong product administered
Symptomtext
The practice was out of Daptacel and the MA got confused and instead administered Adacel /No AE; Initial information was received on 24-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional. (Inquiry number: 00533623). It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA).(Suspension For Injection) was administered to a 3 years old female patient, instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 11-Mar-2021 via intramuscular route for prophylactic vaccination (wrong product administered). It was a case of actual medication error due to wrong vaccine administered. At the time of report, no adverse event 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. 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
- IA
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.02.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syringe issue
Underdose
Symptomtext
Adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe; The nurse reported that the leak was noted while injecting into a patient; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves patient (unknown demography) who while injection with a dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6737AA and expiration date 09-Jul-2022) had the leak that was noted by nurse while injecting and also adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe via unknown route in unknown administration site for prophylactic vaccination on an unknown date (underdose). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of syringe leak (syringe issue) and vaccine underdose. Also reported that: How purchased: Direct ;Number of units affected: 1- Adacel ; dose not used or not available: not used ; Whether product was available for return: Yes ; Leaking ; Where is it leaking from? Tip of the needle ;Diluent or vaccine leaking? Vaccine; During withdrawal from vial? NA (not applicable) ;Sanofi Pasteur prefilled syringe or your syringe? Pasteur prefilled syringe; Was air injected into vial? NA (not applicable) ; Was there a vacuum in the vial? Yes ;Was vial punctured multiple times? not applicable; Did the product spray out of the vial? not applicable; Any signs of damage or tampering with the vial, stopper, flip seal or carton? No ; How often was vial punctured? not applicable. No laboratory data reported. No information on the corrective treatment was reported. Outcome for both the reported events were not applicable.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syringe issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 57,0
- Geschlecht
- F
- Eingang
- 03.02.2021
- Impfdatum
- 03.02.2021
- Beginn
- 03.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incorrect route of product administration
No adverse event
Symptomtext
MMR vaccination was accidentally administered via IM route instead of needed SC route. Pt was informed of this immediately, all questions and concerns were answered. Pt sustained no injuries, was monitored for 15 minutes post-vaccination. Pt encouraged to call with questions or concerns.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect route of product administration
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Diabetes and High Cholesterol
- Andere Medikamente
- Metformin Humalog 75/25 Sumatriptan Tylenol Vitamin D3
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 04.01.2021
- Impfdatum
- 09.09.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Wrong product administered
Symptomtext
Given ADACEL instead of DTaP; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number-00381714) and transmitted to Sanofi on 04-Dec -2020 via call-center. This case involves a 4-years-old male patient who received a vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA and expiry date: 07-Sep -2022) on 09-Sep-2020 via an unknown route in Left Deltoid instead of DTaP (Wrong product administered) for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. The patient's concomitant medication included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). It was an actual medication error case due to wrong vaccine administered (latency: unknown). 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 in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- IPOL [POLIO VACCINE INACT 3V (VERO)]; MMR; VARICELLA VACCINE
- Allergien
- -
- Vorherige Impfungen
- -