- Staat
- OH
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 09.10.2021
- Impfdatum
- 08.10.2021
- Beginn
- 08.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Anxiety
Booster dose missed
Hyperhidrosis
Inappropriate schedule of product administration
Malaise
Pallor
Presyncope
Product administered to patient of inappropriate age
Symptomtext
On 10/8/21 patient presented to clinic with mother to receive first dose of Menactra and Tdap booster because she missed those when they were due for her age. School is requiring documentation of their administration. Patient received Menactra U6921AA exp 4/17/22 in left deltoid and Tdap Boostrix 57GJ2 exp 5/29/23 in right deltoid at 4:33pm. Patient was advised to wait in waiting area for 15min. About 4:46pm pt started to feel unwell. Mother approved provider with pt?s symptoms of pallor, sweating, unease, and pt was brought into exam room to lay down with feet up. Cold compress placed on pt?s forehead. Provider explained to patient and mother about vasovagal response and that it was a response many people had two vaccines, and there was no issue with the vaccines themselves. Pt was told to lay down until feeling better and mother stayed at pt?s side. Around 5:00pm pt was able to walk out of clinic with mom feeling better with no more pallor or sweating.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 30.08.2021
- Impfdatum
- 30.08.2021
- Beginn
- 30.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Tremor
Symptomtext
After injection, LOC for about 5-10 seconds, some shakiness, layed flat, mom at bedside, patient a/o x 3 after waking, pale, BP 82/48, PR 68, layed flat for at least 10 minutes 86/50, feels good, gradually sat up, drank water, left with mom ambulated well, no concerns, will monitor
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Previous febrile seizures, several eval by neuro, no abnormal findings
- Andere Medikamente
- None noted
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 18,0
- Geschlecht
- M
- Eingang
- 20.07.2021
- Impfdatum
- 13.07.2021
- Beginn
- 13.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Anticoagulant therapy
Chest pain
Dyspnoea
Electrocardiogram ST segment elevation
Myocarditis
Aspartate aminotransferase increased
Blood calcium decreased
Blood creatine phosphokinase increased
Laboratory test
Pyrexia
Troponin increased
SARS-CoV-2 test negative
Sleep disorder
Troponin
Symptomtext
18 y/o man who was seen on 16 JUL complaining of chest pain. Reports that his symptoms started on the afternoon of 13 JUL, after receiving the COVID-19 Janssen vaccine and other P4 vaccines in the AM. The pain was initially mild, located substernal, and constant. Pain worsened as days progressed. On 16 JUL, at 0200 the pain woke him up from his sleep and was subsequently brought to the ED. Associated symptoms include a fever of 101 F on 15JUL that resolved spontaneously, and mild shortness of breath. In the ED his EKG showed diffuse ST elevations and troponin was 17.5. He was transferred to outside hospital with diagnosis of acute myopericarditis. Admitted for 3 nights, echocardiogram was normal, troponin was trended and peaked at 36, discharge troponin 16. COVID testing negative. Was started on colchicine 0.6mg daily and aspirin 325mg TID.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocarditis
- Hospital-Tage
- 3,0
- Labordaten
- COVID testing negative on 16 JUL EKG showed diffuse ST elevations on 16 JUL Troponin was 17.5 on 16 JUL Troponin was trended and peaked at 36 Discharge troponin was 16 on 18JUL
- Aktuelle Erkrankungen
- No illness at time of vaccine; unknown one month prior
- Vorgeschichte
- Denies
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 02.04.2021
- Impfdatum
- 02.04.2021
- Beginn
- 02.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Seizure
Syncope
Tonic clonic movements
Urinary incontinence
Symptomtext
vasovagal syncope with suspected seizure (tonic-clonic jerks observed by staff as well as loss of bladder control)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- anxiety; eczema
- Vorgeschichte
- anxiety, eczema
- Andere Medikamente
- none
- Allergien
- squash; sulfa
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 12.12.2021
- Impfdatum
- 27.04.2021
- Beginn
- 28.04.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Dyspnoea
Inappropriate schedule of product administration
Urticaria
Symptomtext
Pt. received her first Pfizer covid 19 vaccination on April 21, 2021. During her well-child visit, she was told that she needed to take the meningococcal vaccination for college requirements. In error, the doctor did nor ask if she had received any vaccinations within the last two weeks. They gave her the meningococcal vaccine that day, which was six day after her first covid 19 vaccine. At 10pm on 4/27, she pointed out hives that were erupting on the upper part of her body. Are few minutes later, she pointed out more hives and said she was having difficulty breathing. I gave her Benadryl and drover her to the emergency room. They gave her oral steroids and steroids through an IV. She c Cc on tied to have hives three months afterward.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 09.02.2022
- Impfdatum
- 07.02.2022
- Beginn
- 07.02.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Fatigue
Headache
Injection site pain
Musculoskeletal stiffness
Pruritus
Skin warm
Urticaria
Symptomtext
Patient experienced fatigue and headache about 5 minutes after receiving vaccine, which subsided later that afternoon. Same day evening, patient noticed hives all over chest which were warm to touch and itchy. Next day, she noticed soreness at site of injection and stiffness in the ipsilateral hand of injection. Left hand is still stiff and hives have reduced but not gone away.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Obesity, chronic migraines, ADHD, OCD, major depression.
- Andere Medikamente
- Vyvanse 40 mg
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 13.09.2021
- Impfdatum
- 10.09.2021
- Beginn
- 10.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anxiety
Axillary pain
Discomfort
Induration
Lymph node pain
Lymphadenopathy
Pain
Pain in extremity
Tenderness
Symptomtext
Patient reports significant left arm tenderness and pain with ROM of left since Friday after administration of vaccines. Patient is worse under arm in axillary region. He notes that "glands" of neck are bigger, in clusters, feel like balls, and are painful. Mom has been administering Tylenol and Motrin prn for pain which is only offering mild relief of symptoms. Patient also using ice pack under arm for entirety of day when he was awake this weekend. Seen in office for evaluation today (9/13/2021). Mildly enlarged, significantly tender cervical lymphadenopathy bilaterally and left axillary node. Full ROM with pain. Neurological exam intact. Patient with significant anxiety during entirety of visit. May continue to administer NSAIDs q6-8prn for pain and discomfort. Continue with ice. To follow-up in 2 days if pain persists.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Axillary pain
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- Recently seen (8/10/21) for localized enlarged cervical nodes, seborrheic capitis, and allergic rhinitis.
- Vorgeschichte
- Anxiety, allergic rhinitis
- Andere Medikamente
- Flonase nasal spray
- Allergien
- Cefdinir (hives), seasonal/environmental
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 23.08.2021
- Impfdatum
- 23.08.2021
- Beginn
- 23.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Feeling jittery
Nausea
Pain
Pallor
Skin discolouration
Symptomtext
Pt was jittery, nauseous, and started to discolor (pale) at the face. Pt had severe pain and needed to lay down. After pt was given apple juice, he felt better.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- BP 102/58 prone position at right arm.
- Aktuelle Erkrankungen
- Growth hormone deficiency, Anxiety
- Vorgeschichte
- Anxiety, growth hormone deficiency
- Andere Medikamente
- Fluoxetine, Norditropin
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 18.08.2021
- Impfdatum
- 17.08.2021
- Beginn
- 17.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Rash
Symptomtext
Was seen at ER on 8/17/2021 16:39. Patient is 11-year-old who presents with an allergic reaction. He just received his HPV, TDAP, MENINGITIS vaccine and he broke out in a rash primarily on his face. Denies any throat, tongue, or mouth swelling. No difficulty breathing, no wheezing, no nausea, or vomiting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- Was treated at ER with Benadryl with his symptoms resolving. Was observed for some time, then was discharged home with a prescription of prednisone 20mg, 1.5 tab(s) oral every day for 7 days. 0 refills.
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- Seasonal Allergies
- Andere Medikamente
- Ascorbic Acid (Vitamin C) 0.5 tab(s) chewed every day Multivitamin 1 tab oral every day.
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 23,0
- Geschlecht
- M
- Eingang
- 10.08.2021
- Impfdatum
- 04.08.2021
- Beginn
- 04.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Pyrexia
Urticaria
Symptomtext
Patient was given vaccine at another medical facility but our facility received the nurse advice line note, perhaps because the patient just moved. He received a 3rd meningococcal vaccine (2 previous in 2011 and 2016, unknown type) on 4 Aug and later that night developed hives on his arms. Resolved with benadryl. The next day he felt feverish and like he had the chills - resolved. 3 days later developed hives again - resolved with benadryl. This promptoed his call to the nurse advice line. No further symptoms. Denies any other new exposure or illnesses. I recommended he ask his new primary doctor for a referral to allergy for further evaluation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- denies
- Vorgeschichte
- denies
- Andere Medikamente
- denies taking any
- Allergien
- no known allergies
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 08.04.2021
- Impfdatum
- 07.04.2021
- Beginn
- 08.04.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Fatigue
Pyrexia
Vomiting
Symptomtext
Developed fatigue, fever up to 103, and vomiting within 12-15 hours of vaccine administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- SARSCOV2 positive in mid March 2021
- Vorgeschichte
- Atopic dermatitis, Food allergies
- Andere Medikamente
- none
- Allergien
- red dye, morphine, sunflower oil, tree nuts
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 26.03.2021
- Impfdatum
- 26.03.2021
- Beginn
- 26.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Nausea
Symptomtext
Patient developed dizziness, nausea, lightheadedness, and felt like he was going to pass out. Resolved after about 5 minutes of sitting down and sipping water.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- G6PD
- Andere Medikamente
- none
- Allergien
- Sulfa medications (patient has G6PD)
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 24,0
- Geschlecht
- F
- Eingang
- 21.06.2022
- Impfdatum
- 14.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
administration of expired MENACTRA with no reported adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 24 years old female patient who got expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event. The patient's past vaccination(s) included MENACTRA in 2021. The patient's past medical history, medical treatment(s) and family history were not provided. On 14-Jun-2022, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AA expiry date: 14-Apr-2022) via intramuscular route in the right deltoid for immunization. On 14-JUN-2022 the patient developed a non-serious event of administration of expired menactra with no reported adverse event (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 20,0
- Geschlecht
- F
- Eingang
- 17.06.2022
- Impfdatum
- 09.06.2022
- Beginn
- 09.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
administering Menactra after expiration with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 20 years old female patient who experienced administering menactra after expiration with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 09-Jun-2022, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6921AA; expiry date: 07-Apr-2022) (strength, formulation: unknown) via intramuscular route in the left deltoid for immunization. On 09-JUN-2022 the patient reported administering Meningococcal A-C-Y-W135 (D CONJ) vaccine (Menactra) after expiration with no reported adverse event (expired product administered). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event (expired product administered). 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS B VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 17.06.2022
- Impfdatum
- 20.05.2022
- Beginn
- 20.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
what to do moving forward after they have administered expired MENACTRA with no reported adverse event; Initial information received on 01-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old female patient who experienced what to do moving forward after they have administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-May-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine [Menactra] (batch lot : U6921AA,Expiry date : 17-Apr-2022) (unknown strength, formulation) via unknown route in unknown administration site for immunization. On 20-May-2022 (latency :same day) the patient developed a non-serious event of what to do moving forward after they have administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine. Action taken : not applicable. It was not reported if the patient received a corrective treatment for the event . At time of reporting, the outcome was Unknown for the event . This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 03.05.2022
- Impfdatum
- 21.04.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
had administered an expired MENACTRA with no reported adverse event; Initial information received on 22-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 11-year-old male patient who had administered an expired menactra with no reported adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) and HPV vaccine VLP RL1 9V (Yeast) (Gardasil 9) both for Prophylactic vaccination. On 21-Apr-2022, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U6921AA, expiry date: 17-Apr-2022 with unknown formulation, strength via intramuscular route in the left deltoid for Immunization. On an unknown date the patient developed non-serious had administered an expired menactra with no reported adverse event (expired product administered) (latency same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine. Action taken: Not applicable. It was not reported if the patient received a corrective treatment. 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 21,0
- Geschlecht
- M
- Eingang
- 28.04.2022
- Impfdatum
- 18.04.2022
- Beginn
- 18.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
received a MENACTRA vaccine at her pharmacy that had expired with no reported adverse event; Initial information received on 20-Apr-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 21 years old male patient who received a menactra vaccine at her pharmacy that had expired with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Apr-2022, the patient received once a first dose, o.5ml of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] (strength: standerd, form: unknown) via intramuscular route (lot: U6921AA, expiry date: 17-Apr-2022) in the left arm for immunization. On 18-APR-2022 the patient reported that, received a menactra vaccine at her pharmacy that had expired with no reported adverse event (expired product administered) (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. It was reported that, Pharmacist stated that a patient received a MENACTRA vaccine on 18APR2022 at her pharmacy that had expired on 17APR2022. Pharmacist asked if there was a 1 day grace period for expired products. Pharmacist asked how to proceed. This situation was reported as a medication error due to administration of expired Menactra. Action taken: not applicable. Outcome: Unknown This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 26.04.2022
- Impfdatum
- 20.04.2022
- Beginn
- 20.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
expired MENACTRA was accidentally given to a patient with no adverse event; Initial information received on 20-Apr-2022 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 11 years old female patient who experienced expired menactra was accidentally given to a patient with no adverse event while receiving Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Apr-2022, the patient received a 0.5 ml of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] (frequency: once) (lot number : U6921AA,Expiration date:17-04-2022) (route, administration site :unknown) for immunization. On 20-APR-2022 the patient developed non-serious event expired menactra was accidentally given to a patient with no adverse event (expired product administered) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] . Action taken : not applicable. It was not reported if the patient received a corrective treatment for the event (expired MENACTRA was accidentally given to a patient with no adverse event). At time of reporting, the outcome was Unknown for the event expired menactra was accidentally given to a patient with 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 22.03.2022
- Impfdatum
- 30.11.2021
- Beginn
- 30.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Product storage error
Symptomtext
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored. Treatment: Not required, patient did not report any adverse reactions to the Vaccine. Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature. Signs, Symptoms course, etc. None reported by the patient?s guardian
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 26.09.2021
- Impfdatum
- 25.09.2021
- Beginn
- 25.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Product administered to patient of inappropriate age
Symptomtext
17 year and 8 month old male patient was inadvertently given the Flublok vaccine instead of the Fluarix vaccine. No immediate reaction noted. Attempted to call patient/parent to follow up, but unable to reach at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 13,0
- Geschlecht
- F
- Eingang
- 11.09.2021
- Impfdatum
- 02.09.2021
- Beginn
- 02.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
Menactra was given to a patient at an earlier interval than it should have been with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via regulatory agency (Reference number- 00752061) and transmitted to Sanofi on 02-Sep-2021. This case involves a 13 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at an earlier interval than it should have been (inappropriate schedule of product administration). The patient's past vaccination(s) included MENACTRA primary dose injection on 23-AUG-2019. The patient's medical history, past medical treatment(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation. On 02-Sep-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Injection, lot U6921AA and expiry date was not reported) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration). It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency: same day). It was reported "patient received primary MENACTRA injection on 23AUG2019; clinic did not have the documentation of the primary shot and administered second primary shot today, 02SEP2021." "Asked if there were any side effects to be concerned about." This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- F
- Eingang
- 09.09.2021
- Impfdatum
- 09.08.2021
- Beginn
- 09.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Wrong product administered
Symptomtext
Per hospital event report "gave a menactra instead of Bexaro"
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 29.08.2021
- Impfdatum
- 16.08.2021
- Beginn
- 16.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
Wrong product administered
Symptomtext
patient was supposed to receive Prevnar and was given MENACTRA by mistake, no AE; Initial information received on 16-Aug-2021 regarding an unsolicited valid non-serious case received from a physician via Global Media Information (under the reference 00726178). This case involved a 6 months old female patient who was supposed to receive PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR)and was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) by mistake (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (lot number and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination. On 16-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AA and expiration date :17-Apr-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). It was reported that "nurse supervisor asking if there are any adverse events reported in 6 month olds who are given MENACTRA, and how they should proceed". At time of reporting, 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 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PEDIARIX; PEDVAXHIB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 24.08.2021
- Impfdatum
- 24.06.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
No adverse event
Wrong product administered
Symptomtext
no Reaction Nor Symptoms. Received wrong vaccine accidentally MCV4.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- n/a
- Vorgeschichte
- n/a
- Andere Medikamente
- n/a
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 20.08.2021
- Impfdatum
- 19.08.2021
- Beginn
- 19.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
The patient was at the clinic to receive her second dose of the Serogroup B meningococcal (Bexsero). She had previously received her first dose at the clinic pharmacy on 7/20/2021. At her visit on 8/19/2021 the patient received a dose of 0.5ml Menactra in error administered by CMA. No adverse reactions noted. The patient and her mother were both informed of administration error. The incident was immediately reported to the Clinical Coordinator, the Chief Operations Officer and the Pharmacy Director. The Pharmacy Director contacted company, and was told the following: They have data that demonstrates safety (no adverse effects when Bexsero and Menveo (Menactra's substitute that company manufactures). You are able to simultaneously administer the 2 vaccines, just at separate sites. The patient will, however, need to complete the series to obtain full protection. These recommendations have been approved by the agency, according to company.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- Clindamyacin, Larissia, Melatonin, Wellbutrin XL
- Allergien
- NKDA
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 16,0
- Geschlecht
- F
- Eingang
- 19.08.2021
- Impfdatum
- 18.08.2021
- Beginn
- 18.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Ear discomfort
Hyperhidrosis
Pallor
Symptomtext
Patient stated she had cottons in her ears. Patient was sweating and pale after administration of 3 vaccines. Patient was placed in her back with knees bent. Patient stated she feels much better after 5 minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ear discomfort
- Hospital-Tage
- -
- Labordaten
- 3 Vitals were taken on 8/18/2021.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 05.08.2021
- Impfdatum
- 28.07.2021
- Beginn
- 28.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
No adverse event
Symptomtext
receiving an extra dose with no reported adverse event; Initial information received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media Information (under the reference). This case involved a 18 years old male patient who had an extra dose with no reported adverse event (extra dose administered) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation. On 28-Jul-2021, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (o.5 ml, solution for injection, lot U6921AA and expiration date: 17-apr-2021) via intramuscular route in the right deltoid for prophylactic vaccination. On 28-JUL-2021 the patient developed a non-serious receiving an extra dose with no reported adverse event (extra dose administered) following the administration vaccine. It was an actual medication error due to extra dose administered. It was not reported if the patient received a corrective treatment for the event (receiving an extra dose with no reported adverse event). No laboratory data reported. At time of reporting, 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- TRUMENBA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 02.08.2021
- Impfdatum
- 02.08.2021
- Beginn
- 02.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Wrong product administered
Symptomtext
Wrong vaccines given to Patient - mistakenly was given vaccines meant for sibling who was not in the room
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Wrong product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- Vyvanse 20mg q day - off meds for the summer
- Allergien
- Amoxicillin
- Vorherige Impfungen
- -