- Staat
- DC
- Alter
- 29,0
- Geschlecht
- F
- Eingang
- 27.11.2021
- Impfdatum
- 04.10.2021
- Beginn
- 05.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- 3
- Route/Site
- IM / AR
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyspnoea
Lip swelling
Throat irritation
Urticaria
Symptomtext
I received the vaccine in the morning. Later in the evening, I felt short of breath. The next morning (24 hr after the vaccine), I woke up covered in hives all over my body. I took 180 mg Allegra, the hives diminished, and I went about my day. The next morning (48 hr after the vaccine), I woke up covered in hives again, with swollen lips and an itchy throat. I reached out to my doctor, who prescribed prednisone (40 mg / 2x daily); Benadryl every 4-6 hours; Pepcid as needed; and continued use of Allegra (180 mg/day). I took all of these medications on that day. The itchiness in my throat and swelling in my lips went away. Throughout the following five days, I continued to take this combination of medications, but reduced Benadryl to once a day. The hives persisted throughout the week, but finally went away about seven days after the vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- IBS; depression; anxiety; dysautonomia
- Andere Medikamente
- Sertraline, Acetazolamide, Levothyroxine
- Allergien
- Sulfa, cats
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 45,0
- Geschlecht
- M
- Eingang
- 16.11.2022
- Impfdatum
- 08.11.2022
- Beginn
- 08.11.2022
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Erythema
Injection site mass
Pigmentation disorder
Symptomtext
Patient presented to the pharmacy concerned... had decent erythema and demarcations all along his deltoid and lower arm. Also had a lump from injection site still present one 1 week later. Explained to let us know if does not improve.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site mass
- Hospital-Tage
- -
- Labordaten
- None at this time.
- Aktuelle Erkrankungen
- NONE KNOWN
- Vorgeschichte
- -
- Andere Medikamente
- CLOMID, ANASTROZOLE, SILDENAFIL
- Allergien
- NONE KNOWN
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 28,0
- Geschlecht
- M
- Eingang
- 31.03.2022
- Impfdatum
- 03.03.2022
- Beginn
- 03.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Headache
Impaired work ability
Nausea
Productive cough
Retching
Symptomtext
Within 10 minutes of vaccine, employee had complaints of a temporal headache and nausea. Employee had dry heaves with phlegm. Pt. was sent to Occupational Medicine where he was seen. Employee was unable to return to work on the day of receiving the injection but was to return to work the next day (3/4/2022). Liquids, rest and tylenol prn.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- Treatment unknown as employee was sent to Occupational Medicine clinic.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Obese- 6'1" @ 300 pounds
- Andere Medikamente
- Unknown
- Allergien
- Unknown
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 50,0
- Geschlecht
- F
- Eingang
- 31.03.2022
- Impfdatum
- 18.03.2022
- Beginn
- 19.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site mass
Injection site pain
Symptomtext
injection site redness; injection site pain; lump at the site; more redness today and it is still there but was worse on Sunday; Initial information received on 21-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 50 years old female patient who experienced injection site redness, injection site pain and lump at the site 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. On 18-Mar-2022, the patient received a dose of 0.5 ml injection of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot: U7187AA)(expiry date :28-Sep-2023) via intramuscular route in the left arm for immunization. On 19-MAR-2022 (latency :1 day) the patient developed non-serious events of injection site redness (vaccination site erythema) injection site pain (vaccination site pain),lump at the site (vaccination site mass) more redness today and it is still there but was worse on Sunday (condition aggravated) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine. Action taken : not applicable. The patient was treated with Ibuprofen. At time of reporting, the outcome was Unknown for all the events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 32,0
- Geschlecht
- F
- Eingang
- 15.03.2022
- Impfdatum
- 11.03.2022
- Beginn
- 12.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Injection site erythema
Injection site induration
Injection site warmth
Symptomtext
Approximately 5cm x 4cm area of erythema with warmth and induration on the left shoulder following TDAP vaccine G3P2 vaccinated at 28 weeks as part of routine prenatal care. EDD is 5/26/22. At time of report, patient is still pregnant.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Lipoprotein deficiency Hx of covid 19 infection Depression
- Andere Medikamente
- Prenatal vitamin
- Allergien
- Pollen
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 48,0
- Geschlecht
- M
- Eingang
- 04.03.2022
- Impfdatum
- 10.12.2021
- Beginn
- 01.12.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Pain in extremity
Symptomtext
left arm pain
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain in extremity
- Hospital-Tage
- -
- Labordaten
- na
- Aktuelle Erkrankungen
- na
- Vorgeschichte
- na
- Andere Medikamente
- na
- Allergien
- na
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 75,0
- Geschlecht
- F
- Eingang
- 21.02.2022
- Impfdatum
- 14.02.2022
- Beginn
- 20.02.2022
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Injection site erythema
Injection site pain
Injection site swelling
Oropharyngeal pain
Symptomtext
Pt had swelling, redness, tenderness at injection site. Reports no trouble breathing, swallowing, non-localized rash = not indicative of allergic reaction. Pt only reports sore throat at time as well (pt thinks due to allergies). Started last night, 6 days after getting shot. Pt went to ER and they apparently told them it was an allergic rxn despite no signs to indicate this. Pt reports that today, next day after it started, that it is starting to improve slightly and that the ER did not actually give her anything.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- unknown, pt on clindamycin
- Vorgeschichte
- -
- Andere Medikamente
- tramadol, clindamycin, OTC unknown
- Allergien
- promethazine, sulfa
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- 43,0
- Geschlecht
- M
- Eingang
- 07.01.2022
- Impfdatum
- 03.01.2022
- Beginn
- 04.01.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Fatigue
Full blood count normal
Headache
Metabolic function test normal
Oedema peripheral
Pain in extremity
Pyrexia
Symptomtext
fever of 101-1028*F, chills, fatigue, headache, arm pain, and underarm swelling.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- CBC and CMP drawn on 01/06/2022 both normal
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- History of prostate cancer
- Andere Medikamente
- tadalafil 5mg
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 16.12.2021
- Impfdatum
- 25.10.2021
- Beginn
- 27.10.2021
- Tage bis Beginn
- 2,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Headache
Injection site pain
Injection site swelling
Injection site warmth
Pain
Pyrexia
Vomiting
Symptomtext
The injection site is swollen and hot to the touch. The size of the swelling is the size of my palm and protrudes about 1". It is very tender to the touch. Fever, chills, body ache and headache. Improved with Tylenol. Experienced some dizziness. In the evening, Vomited, but after the initial episode, it ceased.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- chronic kidney disease stage 3; mixed hyperlipidemia; postmenopausal atrophic vaginitis; vit d deficiency; anxiety disorder
- Andere Medikamente
- centrum silver once daily; vit d 50 mcg once daily; viactiv 500 once daily; estrace 0.1mg/gm twice weekly; wellbutrin xl 300mg once daily
- Allergien
- trazodone - bad dreams
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 09.12.2021
- Impfdatum
- 06.12.2021
- Beginn
- 07.12.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Confusional state
Crying
Delusion
Dizziness
Fatigue
Headache
Influenza virus test negative
SARS-CoV-2 test negative
Streptococcus test negative
Urine analysis
Vertigo
Symptomtext
dizziness and headache and extreme fatigue "the most tired I have ever felt in my life." He described vertigo. Then yesterday, he struggled to wake up in the morning, was very tired and came downstairs crying around 10:30, he felt like he was still extremely tired. Then became confused, like he was seeing things that weren't there -eg bananas looked like a dog
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- Went to urgent care on 12/8/21. Had testing done for strep, COVID, flu - all negative. Also had UA done and was normal.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 55,0
- Geschlecht
- M
- Eingang
- 16.11.2021
- Impfdatum
- 20.10.2021
- Beginn
- 20.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Audiogram normal
Headache
Myalgia
Pyrexia
Vertigo
Symptomtext
patient noted myalgias and fever later in the day, then headache and vertigo started the next day. Initial symptoms resolved in 3 days but vertigo ,rocking sensation remains. ENT consult has started prednisone therapy and ordered physical therapy. Audiogram is normal and VNG is pending
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Headache
- Hospital-Tage
- -
- Labordaten
- audiogram 11-8-21
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Hyperlipidemia
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 03.11.2021
- Impfdatum
- 01.11.2021
- Beginn
- 01.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site erythema
Injection site swelling
Injection site warmth
Symptomtext
Red, swollen and hot to touch area on left deltoid, spreading down arm
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- None
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 21.10.2021
- Impfdatum
- 21.10.2021
- Beginn
- 21.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Injection site erythema
Injection site swelling
Macule
Rash macular
Symptomtext
After receiving Menactra in her left arm, she immediately started with swelling and erythema around the Menactra injection. I was called into the room by the medical assistant and patient was upset and crying that her arm hurt. She had an approx. 4 inch diameter area of erythema around the injection site and it was swollen. We immediately applied an ice pack. Then a few minutes later, mom noted three small red macules on her right forehead and a splotchy red rash on her chest. Her chest was clear, there were no respiratory symptoms, no mouth or facial swelling. Vitals were stable the entire time. She was given 300mg ibuprofen for the pain and 37.5mg benadryl for the rash. Even before giving the benadryl, the chest rash disappeared and the forehead rash started to improve. Patient was observed for approx. 45-50 minute after the vaccine and rash, swelling, and pain had completely resolved prior to leaving the office. Lungs were clear the entire time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Left discoid meniscus of knee, osteochondritis dissecans of left knee
- Andere Medikamente
- None
- Allergien
- Bee stings
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 26,0
- Geschlecht
- F
- Eingang
- 15.10.2021
- Impfdatum
- 12.10.2021
- Beginn
- 13.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- N/A
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Axillary pain
Fatigue
Oedema peripheral
Pain
Symptomtext
States local pain and, she felt very tired that day (attributed it to blood draw that happened the same day_. Next day, anterior axillary area became swollen and painful. Moving the arm hurts, because it manipulates the area. Taking OTC medication (she thinks ibuprofen) which does help with the pain. Wearing her back pack over the left side only right now
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Axillary pain
- Hospital-Tage
- -
- Labordaten
- None Documented
- Aktuelle Erkrankungen
- None Documented
- Vorgeschichte
- Anxiety
- Andere Medikamente
- None documented
- Allergien
- None Documented
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 1,5
- Geschlecht
- F
- Eingang
- 28.04.2022
- Impfdatum
- 28.04.2022
- Beginn
- 28.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 5
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
Patient came in for 4th dose of Dtap series but was mistakenly given Tdap vaccine. Patient did not immediately have any symptoms or signs after the vaccination - to my knowledge patient still has not shown any reaction. The patient's mother was notified of the mistake later the same day of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Patient was seen 04/15/22 for cough and runny nose thought to be allergies.
- Vorgeschichte
- None.
- Andere Medikamente
- None
- Allergien
- No known allergies
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 28.01.2022
- Impfdatum
- 20.01.2022
- Beginn
- 20.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event; Initial information received from United States on 20-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 5 years old male patient who was administered the adacel (tdap) prefilled syringe instead of dtap today 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. On 20-Jan-2022, the patient received a dose (0.5 ml 1X (once) prefilled syringe ) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot: U7187AA, expiry date: 28-Sep-2023 via intramuscular route in unknown administration site for immunization. On 20-JAN-2022 the patient developed a non-serious administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported, Pharmacist stated that a male patient, who she believes was 5 years old, was inadvertently administered intramuscularly the Adacel (Tdap) prefilled syringe instead of DTaP today (20 Jan 2022). Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event). At time of reporting, the outcome was Unknown for the event administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 14.01.2022
- Impfdatum
- 13.01.2022
- Beginn
- 13.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 5
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product administration error
Product preparation error
Symptomtext
Administration error-Patient was given 0.2 mL of the UNDILUTED pediatric (orange top) Covid Vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administration error
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 15.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
They were at 32.0F for less than 72 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00885507) and transmitted to Sanofi on 06-Dec-2021. This case involves a 19-year-old female patient who administered the one dose of the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and TUBERCULIN TEST [TUBERSOL] 32.0f for less than 72 hours after excursion (product storage error). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection (with and unknown batch number and expiry date) for tuberculin test and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U7187AA and expiry date: 28-Sep-2023) via unknown route in unknown administration site for prophylactic vaccination (product storage error). It was reported "The caller is requesting stability info for a temp excurision caused by unknown reason". This case was potential medication error due to product storage error temperature too low (latency: same day). At the time of reporting, no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TUBERSOL
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- -
- Geschlecht
- M
- Eingang
- 04.12.2021
- Impfdatum
- 19.11.2021
- Beginn
- 19.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Symptomtext
This case involves a 78 years old male patient whom administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was left in the box (product storage error). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect ADACEL (0.5 ml, total, lot U7187AA expiration date: 28-SEP-2023) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to incorrect product storage (same day latency). It was reported "Caller would like to know how ADACEL is suppose to look before you shake it. Caller stated that he notice a cloudy white appearance. Caller stated that the ADACEL was brought out of the fridge and he noticed a white, cloudy, clumped particulate at the bottom of the vial prior to shaking it. The caller had never seen the medication sediment. The solution became a homogenous liquid after it was shaken. The remaining supply of ADACEL all looked similar with the same white, cloudy, clumped particulate. Caller would like to know whether these ADACEL vials are suitable for use?" 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 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
- -