chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Streptococcus test positive, Thyroxine free normal, Troponin, Upper respiratory tract infection, Vision blurred
Clinical narrative: Received AVA 12/7/2009 c/o fever, ha, nasal/chest congestion, malaise resolving with MUCINEX and TYLENOL 2 days later. In Jan 2010 c/o 4 days mid sternal chest pain worse w/cough, breathing and supine. Unsure if before or after H1N1 IM vaccine. Self treated with NSAID x4day before resolving. Med Records show treated for pharyngitis on PCNVK sometime in Jan 2010. Pt traveled Jan-Mar 2010 c/o URI, fatigue, subjective fevers prn. On prophylactic doxycycline. Tx 3/30/10 for strep throat (GAS +) and c/o SOB, fever, cold sweats, pain left arm w/numbness x 12 hr easing with MOTRIN. No medical care for chest pain, only ST. Approximately 5/21/2010 he was awakened again about 3 am with another episode of chest pain (similar to above). However this pain caused him to "pass out" (pain made him drop to knees, blurry vision, weak). He advised positional changes did not affect his pain. He was taken by ambulance to a nearby ER being treated with IV TORADOL, DILAUDID, NTG SL and INDOCIN. His physical exam was normal with cardiology noting a possible faint pericardial rub. He was admitted for 5 days with diffuse ST elevation on EKG in peripheral leads, a negative echo for effusion/wall motion abnormalities and EF60%, and a negative CTA for dissection. Cardiac lab studies, including Troponin levels, were normal. ESR was elevated at 41. His diagnosis was pericarditis and HTN. He was readmitted 8/28/10, 9/22/10 with cyclic fevers, headaches, chest pain, fatigue, etc. Rheumatology eval neg. As of 12/7/2010, he continued to experience sharp anterior chest pains about every 2 weeks lasting 2 days with fevers of 103 degree F. He treats with VICODIN for pain/sleep and takes colchicine 0.6 mg BID regularly and MOTRIN TID only with flares. Cardiology instructed him to take MOTRIN 800 mg 4 times a day with current medications and then to go to ER with next flare for echo and evaluation for pericardial fluid (consider pericardiocentesis or biopsy).
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: White blood cell count increased
Clinical narrative: Received AVA 12/7/2009 c/o fever, ha, nasal/chest congestion, malaise resolving with MUCINEX and TYLENOL 2 days later. In Jan 2010 c/o 4 days mid sternal chest pain worse w/cough, breathing and supine. Unsure if before or after H1N1 IM vaccine. Self treated with NSAID x4day before resolving. Med Records show treated for pharyngitis on PCNVK sometime in Jan 2010. Pt traveled Jan-Mar 2010 c/o URI, fatigue, subjective fevers prn. On prophylactic doxycycline. Tx 3/30/10 for strep throat (GAS +) and c/o SOB, fever, cold sweats, pain left arm w/numbness x 12 hr easing with MOTRIN. No medical care for chest pain, only ST. Approximately 5/21/2010 he was awakened again about 3 am with another episode of chest pain (similar to above). However this pain caused him to "pass out" (pain made him drop to knees, blurry vision, weak). He advised positional changes did not affect his pain. He was taken by ambulance to a nearby ER being treated with IV TORADOL, DILAUDID, NTG SL and INDOCIN. His physical exam was normal with cardiology noting a possible faint pericardial rub. He was admitted for 5 days with diffuse ST elevation on EKG in peripheral leads, a negative echo for effusion/wall motion abnormalities and EF60%, and a negative CTA for dissection. Cardiac lab studies, including Troponin levels, were normal. ESR was elevated at 41. His diagnosis was pericarditis and HTN. He was readmitted 8/28/10, 9/22/10 with cyclic fevers, headaches, chest pain, fatigue, etc. Rheumatology eval neg. As of 12/7/2010, he continued to experience sharp anterior chest pains about every 2 weeks lasting 2 days with fevers of 103 degree F. He treats with VICODIN for pain/sleep and takes colchicine 0.6 mg BID regularly and MOTRIN TID only with flares. Cardiology instructed him to take MOTRIN 800 mg 4 times a day with current medications and then to go to ER with next flare for echo and evaluation for pericardial fluid (consider pericardiocentesis or biopsy).
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, CSF glucose normal, CSF protein normal
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Chills, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Convulsion, Cough, Dizziness, Drug screen, Echography normal
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Fatigue, Full blood count normal, Headache
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Intracranial haemangioma, Laboratory test, Laboratory test normal, Lipoma
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Liver function test, Lumbar puncture normal, Malaise, Mental status changes, Movement disorder
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging brain abnormal, Photophobia, Pyrexia
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Red blood cells CSF positive, Rhinorrhoea, Syncope, Tonic clonic movements, Tremor
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Unresponsive to stimuli, Vertigo, Visual impairment, Vomiting, Weight decreased
Clinical narrative: Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Local reaction
Clinical narrative: Initial report received from a health care professional on 20 Aug 2010: This patient was vaccinated with MENVEO (batch number unknown), on an unspecified date. Following administration with the vaccine, the patient developed local reaction where the arm "turned red all the way" on an unspecified date. The outcome of the event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Initial report received from a health care professional on 20 Aug 2010: This patient was vaccinated MENVEO (batch number unknown), on an unspecified date. Following administration with the vaccine, the patient developed hives on an unspecified date. The outcome of the event, seriousness and causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 20 Aug 2010: On 18 Aug 2010, this child received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number 100022) that was reconstituted with a sterile diluent. The child had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration. Follow up report received from the health care professional on 02 Sep 2010: The child had received the MenCWY-135 liquid component of MENVEO and not MenA lyophilized conjugate component as reported previously.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 23 Aug 2010: On 19 Aug 2010, this adolescent received a intramuscular dose of only the MenCWY liquid conjugate component of MENVEO ( batch number: 090701, (dose unknown). The adolescent did not receive the MenA lyophilized component of MENVEO. No adverse reaction had occurred following this administration. Follow up report received from the physician's nurse on 25 Aug 2010: The patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO without reconstituted with the MenA component of MENVEO at dose 0.5 ml and batch number: 100022 on 19 Aug 2010.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial report received from a health care professional (nurse) on 24 Aug 2010: This child was vaccinated with MENVEO (batch number: 100022), 0.5 ml intramuscularly on 18 Aug 2010. On 19 Aug 2010, the child experienced injections site reactions, consistent with swelling, redness and pain. On 20 Aug 2010, the child was treated in the emergency room as the symptoms had worsened. The outcome of the event was reported as condition improving.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Initial report received from a physician on 26 Aug 2010: On 25 Aug 2010, this patient inadvertently received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration. Follow up physician report received on 13 Oct 2010: The patient had received powdered constituent of MENVEO (batch number: 023011) by reconstitution rather than liquid component, intramuscularly in upper arm. The patient did not experience any adverse event following this drug administration error.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Gait disturbance
Clinical narrative: Initial report received from a consumer's parent on 09 November 2010. A 15 month-old female child received on 20 October 2010 a left thigh injection (route not reported) of PENTACEL, lot number not reported. The patient had no illness at the time of vaccination. The patient had received 2 or 3 prior doses. Her medical history and concomitant medications were not reported. The patient's parent reported that on the evening after the injection, the patient started limping. She continued to limp for 4 or 5 days. No other reactions were noted and the patient had no other problems. The patient was reported as "okay now" and no further limping was noted. The outcome was reported as recovered. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Pyrexia
Clinical narrative: Non-serious case received from a healthcare professional on 28 September 2010 under the local reference number 10-0607. A 02-year-old male patient, with a medical history of development delay, speech therapy and allergy to ZITHROMAX, had received his first dose of PENTACEL (batch number C3747AA, route of administration not reported) in the right arm and his third dose of Hepatitis B vaccine (other manufacturer, batch number 1991Y, route of administration not reported) in the left arm on 22 September 2010. The patient had received his two previous doses of Hepatitis B (other manufacturer) on an unspecified date. The patient had no reported illness at the time of vaccination and no reported history of adverse reaction post-vaccination. On 23 September 2010, the patient developed right upper arm area red and swollen. He also had one large blister and several smaller blisters within redness area of upper arm but lower than injection site. He experienced fever to 102 degrees F. The patient's outcome was unknown. Documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional on 26 Oct 2010: On 08 Oct 2010, this patient received a intramuscular dose of only the MenCYW-135 liquid conjugate component of MENVEO (batch number: 100001(box) 090901), (dose unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse effect occurred. The outcome of the event was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 27 Oct 2010: On 26 Oct 2010, this patient received a intramuscular dose of only MenCYW-135 liquid conjugate component of MENVEO (batch number 091101), (dose unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse effect occurred. The outcome of the event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from an health care professional on 28 Oct 2010: This patient was vaccinated intramuscularly with only the MenCYW-135 component of MENVEO (batch numbers: (box lot 100022) without the lyophilized Men A conjugate compound. No adverse events reported following this administration.
Age: 2.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from the nurse on 28 Oct 2010: This patient was vaccinated with both FLUVIRIN (lot number 111625A05) suspension, intramuscularly and MENVEO (batch number unknown) on 20 Oct 2010. The patient experienced the event inappropriate age at vaccine administration. No adverse event other than this was reported. The outcome of event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a consumer on 28 Oct 2010: This patient was vaccinated intramuscularly with only the MenCYW-135 component of MENVEO (batch numbers unknown) without the lyophilized Men A conjugate compound. On an unspecified date, the patient received full dose of MENVEO. No adverse events reported following this administration.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a nurse on 29 Oct 2010: This patient was vaccinated with MENVEO (batch number 091201) on an unspecified date. The patient only received MenA powder component after it was reconstituted with a saline solution. No adverse event was reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial health care professional report received on 29 Oct 2010: This patient was vaccinated with MENVEO (batch 090601A), at an unknown dose intramuscularly on 21 Oct 2010. Patient was administered only the MenCYW -135 liquid component, no adverse reaction was reported. The treating physician details were not reported. Causality assessment was not reported.
Age: 38.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Combined initial and follow-up report received on 29 Oct 2010 and 08 Nov 2010: This patient was trying to draw up and administer MENVEO on 29 Oct 2010. Some of vaccine accidentally squirted in her eye while trying to draw it up. The eye was burning. Eye wash flushing was given. Pain subsided in 45 minutes. No further treatment was given.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial HCP (health care professional) report was received on 02 Nov 2010: This patient was vaccinated with MENVEO (batch number X100027) on an unspecified date. The patient received only the menCYW-135 liquid conjugate component of MENVEO. Patient did not receive MenA lyophilized conjugate of MENVEO. No adverse event occurred.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial health care professional report received on 02 Nov 2010: This patient was vaccinate4d with MENVEO (batch number: 100001) 0.5 ml intramuscularly on 01 Nov 2010. The patient was vaccinated with only the Men CWY component of the MENVEO instead of being reconstituted with lyophilized Men A component. No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial health care professional report received on 09 Nov 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 100027) 0.5 ml on 03 Nov 2010. The patient inadvertently received only Men CWY liquid conjugate, instead of being reconstituted with Men A lyophilized powder conjugate component. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 09 Nov 2010: This child patient was vaccinated with MENVEO (batch number: unknown) with unknown dose intramuscularly on unspecified date. On 05 Nov 2010, the patient's arm swelled from injection site down to elbow after administration of MENVEO. The patient's affected area was red, swollen and hot to touch. Final outcome of the patient and causality was not reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a nurse on 10 Nov 2010: This patient was vaccinated with only the lyophilized MenA powder of MENVEO batch numbers: (lot number: 00026) after being reconstituted with saline solution on 10 Nov 2010. No adverse events had occurred following this administration.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from the nurse on 11 Nov 2010: This patient was vaccinated with MENVEO (batch number 091201) intramuscularly on 29 Oct 2010. It was stated that, the patient only received the CYW-135 liquid component without the lyophilized MenA component. No adverse event other than this was reported. The outcome of event was not reported.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial health care professional (medical assistant) report received on 15 Nov 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 100023) 0.5 ml intramuscularly on 15 Nov 2010. During vaccination the patient received only Men CWY liquid conjugate component of MENVEO without being reconstituted with the Men A conjugate component. No adverse event was reported following this drug administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from health care professional on 21 Sep 2010: On 16 Sep 2010, this patient received a 0.5 ml of only MenCWY liquid conjugate component of MENVEO (batch no. 090101), intramuscularly instead of being reconstituted with the lyophilized MenA component. No adverse events were noted following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial healthcare professional report received on 23 Sep 2010: This patient was vaccinated with MENVEO (batch number 04012012) intramuscularly on 15 Sep 2010. It was reported that the patient received MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent and did not receive the MenCYW-135 liquid conjugate component of MENVEO. No adverse event was reported. Follow up report received from the health care professional on 13 Oct 2010: The child did not have any medical history of allergies and did not have any other chronic conditions.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a nurse on 29 Sep 2010: On 31 Aug 2010, this patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose: 0.5 ml) intramuscularly without lyophilized component. No adverse events were noted following this medication error. Follow up report received from a nurse on 08 Oct 2010. Reporter stated that, medication was not mixed both vials so only part of the vaccine was given. The patient was revaccinated since then and was doing fine.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional (nurse) on 29 Sep 2010: On 01 Sep 2010, this child was vaccinated with only the MenCWY liquid conjugate component of MENVEO, (batch number not reported), (dose unknown) without being reconstituted with the MenA conjugate component. On an unspecified date, the child was revaccinated with the full dose of MENVEO.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional on 06 Oct 2010: This patient was received only a intramuscular dose of MenA liquid conjugate component of MENVEO (batch number 024011) powder and diluent on 30 Sep 2010. He had not received the MenCYW-135 liquid conjugate component of MENVEO. The outcome of the event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Initial report received from a health care professional on 07 Oct 2010: This patient was vaccinated with MENVEO 0.5 ml, subcutaneously on 02 Oct 2010. On 04 Oct 2010, the patient presented red, bumpy appearance of injection site. The outcome was reported as condition unchanged.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional (medical technician) on 13 Oct 2010: This patient with an unknown medical history was vaccinated MENVEO (batch number unknown) intramuscularly on 15 Sep 2010. It was reported that, MENVEO vaccine was not reconstituted and the patient only received the MenCYW-135 component and not the Men A lyophilized powder on 15 Sep 2010. No adverse events were reported. The outcome of the event was not reported. Follow up report received from a health care professional on 26 Oct 2010. It was reported that the patient was inadvertently administered only the Men CYW-135 liquid conjugate component of MENVEO. The patient did not receive the MenA lyophilized conjugate of MENVEO. The patient received a complete dose of MENVEO on next day. Follow up report received from a nurse on 16 Nov 2010. Patient demographics added. The batch no: of MENVEO was reported as 090701. The patient took FLUZONE concomitantly.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 14 Oct 2010: On 01 Oct 2010, the patient received a intramuscular dose of only the MenCYW-135 conjugate component of MENVEO (batch number: 090701), (dose unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported. The outcome of the event was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a nurse on 29 Sep 2010: On 31 Aug 2010, this patient was inadvertently vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose 0.5 ml, intramuscularly) without being reconstituted with the MenA lyophilized conjugate component. On an unspecified date, the patient was revaccinated with the full dose of MENVEO. The outcome of the event was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional at physician's office on 19 Oct 2010: On 13 Oct 2010, this patient received a intramuscular dose of only the MenCYW-135 liquid conjugate component of MENVEO (batch number: 100026), (dose: unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported. The outcome of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from health care professional on 25 Aug 2010: On 23 Aug 2010, this child received a intramuscular dose of only the MenCWY liquid conjugate component of MENVEO (batch number 090701) without being reconstituted with the MenA conjugate component. No adverse reaction had occurred following this administration. Follow up report received from physician on 07 Sep 2010: It was reported that the child received 0.5 ml dose of only the MenCWY liquid conjugate component of MENVEO on right arm and the physician will repeat the MENVEO in one or two months.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 25 Aug 2010: On 25 Aug 2010, this child received a intramuscular dose of only the MenCYW-liquid conjugate component of MENVEO (batch number: 100003) without being reconstituted with MenA lyophilized conjugate component. Subsequently, after this medication error was recognized the child was administered a full dose of MENVEO after reconstituting the MenCYW-135 liquid conjugate component with the MenA lyophilized component. No adverse reaction had occurred following this administration. Follow up report received from the physician's nurse on 03 Sep 2010: The patient with medical history of asthma and allergy (unspecified) was vaccinated only the MenCYW-135 liquid conjugate component of MENVEO without being reconstituted with MenA lyophilized conjugate component at dose 0.5 ml and batch number: 100003 on 25 Aug 2010.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 26 Aug 2010: On 20 Aug 2010, this child received a intramuscular dose of only the MenCYW-135 liquid conjugate component of MENVEO (batch number: 1000022) without being reconstituted with the MenA conjugate component. The child did not receive the MenA lyophilized conjugate component. No adverse reaction had occurred following this administration.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional on 01 Sep 2010: On 01 Sep 2010, this patient inadvertently received intramuscular dose of lyophilized A powder reconstituted with liquid from HEP B vaccine MENVEO (batch number 023011, expiry date 20 Apr 2010). The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. The outcome of the event was not reported. Follow up report received from a health care professional on 28 Sep 2010. The outcome of the event was reported as complete recovery.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from 01 Sep 2010: On 01 Sep 2010, this patient inadvertently received intramuscular dose of lyophilized A powder reconstituted with liquid a health care professional on from Hep B vaccine MENVEO (batch number 023011, expiry date 20 Apr 2011). The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. The outcome of the event was not reported. Follow up report received from a health care professional on 28 Sep 2010. The outcome of the event was reported as complete recovery.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Initial report received from a health care professional (nurse) on 01 Sep 2010: This adolescent was vaccinated with MENVEO (batch number 022011), 0.5 ml intramuscularly in the upper arm on 24 Aug 2010. On 24 Aug 2010, the adolescent's upper arm became red and was warm to touch. The adolescent was treated with antibiotics. The outcome of the event was reported as completely recovered.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Neck pain, Pyrexia, Vomiting
Clinical narrative: Initial report received from a health care professional (nurse) on 01 Sep 2010: This child was vaccinated with MENVEO (batch number 022011), 0.5 ml intramuscularly on 22 Aug 2010. On 31 Aug 2010, the child experienced severe neck pain, tightness in chest, fever (temperature 102 F) and vomiting. The child was treated with antibiotics. The outcome of the event was reported as completely recovered.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, Medication error, No adverse event
Clinical narrative: Initial report received from a health care professional on 01 Sep 2010: On 01 Sep 2010, this patient was vaccinated with only the Men CWY-135 liquid conjugate component of MENVEO (batch number: 028011), unknown intramuscularly without being reconstituted with the Men A conjugate component. No adverse events were noted following this medication error. Follow up report received from the nurse on 20 Sep 2010: It was reported that the patient received 0.5 ml, Men CWY-135 liquid conjugate component of MENVEO on 25 Aug 2010. The patient had not experienced any adverse events post vaccination. The case was assessed as non serious.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional (nurse) on 02 Sep 2010: This patient was vaccinated with only the lyophilized A powder component of MENVEO, (batch number not reported), (dose: unknown) intramuscularly, along with a sterile diluent. The patient did not receive the MenCWY-135 liquid component.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial report received from a health care professional on 10 Sep 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: 100022). No other information provided at the time of this report.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Initial physician report received on 15 Sep 2010: This patient was vaccinated with only the Men A lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient did not receive the MenCWY-135 liquid conjugate component of MENVEO.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a nurse on 16 Sep 2010: This patient received a intramuscular 0.5 ml dose of MenA lyophilized conjugate component of MENVEO (batch number 100022) that was reconstituted with a sterile water instead of MenCYW-135 component on 16 Sep 2010. The patient had not received the MenCYW-135 liquid conjugate component of MENVEO. No adverse events were reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 16 Sep 2010: This child was vaccinated with only the MenA conjugate component of MENVEO (batch number 100022) 0.5 ml, intramuscularly that was reconstituted with sterile water instead of the MenCWY liquid conjugate. The child did not receive the MenCWY component. No adverse event had occurred following this administration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 20 Sep 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch no 090701) at an unspecified dose intramuscularly on 17 Sep 2010. No adverse events were noted following this medication error.