chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Maternal exposure during pregnancy, Premature rupture of membranes
Clinical narrative: Initial report received from a health care professional on 17 January 2012. A male neonate received transplacental MENACTRA, sanofi pasteur Inc. lot number U3678A, and transplacental Tdap, manufacturer unknown, lot number C3928AA, which is not a valid sanofi Pasteur lot number, on 18 January 2011. The patient's mother had a maternal aunt with tricuspid atresia and transposition of the great vessels. It was noted that the mother prenatal laboratory testing was as follows: prenatal (PN) profile on 15 February 2011 within normal limits (WNL), negative sexually transmitted diseases (STD) on 23 February 2011, PN 28 week labs on 11 July 2011 were WNL and chorionic villus sampling (CVS) on 04 March 2011 for PN diagnosis. The mothers ultrasound findings were as follows: 02 March 2011 showed thickened nuchal fold and edema; on 04 March 2011, 05 April 2011, 03 May 2011, 25 May 2011 and 13 July 2011 showed cystic hygroma and multiple fetal anomalies. On 08 August 2011, the patient's mother developed premature rupture of membranes (PROM) and had a Cesarean section on 09 August 2011 and subsequent neonatal death. The neonate was delivered at 34 weeks of gestation by a Cesarean section with a weight of 1.915 kilograms (Kg) and an Apgar score of one at one minute and an APGAR score of one at five minutes. The neonate was born with multiple fetal anomalies not compatible with life, myotonic dystrophy or arthrogryposis, dilated bowel, possible bowel obstruction and cystic hygroma. The neonate death was caused by multiple congenital anomalies. The outcome was fatal on 09 August 2011. The mother case is captured in case number 2011-00541. Documents held by sender: Pregnancy form.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper extremity swelling redness and warmth.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Ear infection, Enema administration, Fluid intake reduced, Haematochezia, Ileocolectomy
Clinical narrative: 1/24/12 - 6 mo well check with sinusitis/ear infection - shots given including Rotavirus. Vomiting next day significant. X-Ray nl. 1/26 worse ear infection see in office - not drinking well. ROCEPHIN shot given. 1/26 - 5pm bloody stool. 1/27 3am bilious vomit. 1/27 - U/S, X-Ray positive intussusception. Required ileocolectomy.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Intussusception, Ultrasound scan abnormal, Vomiting, X-ray abnormal
Clinical narrative: 1/24/12 - 6 mo well check with sinusitis/ear infection - shots given including Rotavirus. Vomiting next day significant. X-Ray nl. 1/26 worse ear infection see in office - not drinking well. ROCEPHIN shot given. 1/26 - 5pm bloody stool. 1/27 3am bilious vomit. 1/27 - U/S, X-Ray positive intussusception. Required ileocolectomy.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe diarrhea x1 week, vomiting. Seen at ER. Tx - to keep hydrated, to give PEDIALYTE.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Injection site erythema, Injection site mass, Irritability, Rash
Clinical narrative: Imm given at 12:00 noon 1/5/12. Child awoke 10pm very irritable, temp 102, rash to face and "red knots" at injection sites.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Feeling hot, Myalgia, Paraesthesia, Swelling
Clinical narrative: Developed chills, myalgias, swelling warmth tingling in fingers.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: - Localized inflammatory reaction to left deltoid (injection site); 8 cm X 7 cm area of erythematous, swollen, firm and warm skin; non-tender.
Age: 0.97
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: UNKNOWN- ADVERSE EVENT ONSET TIME IS UNKNOWN.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Urticaria
Clinical narrative: Hives, Sore Throat.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Vomiting
Clinical narrative: Had nap after shots, then intractible vomiting until Benadryl given. No perfusion, angioedema or respiratory/wheezing problems.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Confusional state, Headache, Oedema peripheral, Pyrexia
Clinical narrative: Lower extremity edema, fever, confusion, headache, elevated glucose.  Symptoms lasted 48 hours.  I saw her on 1/31/12, edema was improving and other symptoms had abated.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram abnormal, Culture urine negative, Differential white blood cell count normal
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count normal, Headache, Influenza virus test negative, Injection site erythema, Injection site pain
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Metabolic function test normal, Oedema peripheral, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: X-ray limb normal
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, Computerised tomogram, Erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Recieved two Varivax, then was dx with shingles on 01/12/2012.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: VOMITED CLEAR MUCOUS 2 TIMES, 01/26/2012 VOMITED CLEAR MUCOUS 1 TIME.
Age: 1.43
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Excessive eye blinking, Gaze palsy, Vomiting
Clinical narrative: Both twins were sick throwing up, sisters fever got to 105, but she is fine. They would throw up though everyday for about a week, her more than him. He has some spells where when he is playing he will stop and his eye will go up to the left and he will blink a lot, then stop blinking but his eyes will still be there, then he will stop and go back to playing. The doctors are thinking it is a seizure we are going to be going to a neuro the end of the month at hospital, because it hasn't stopped he is doing it more. It started around the time he got the shot.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Injection site reaction, Macule, Papule, Pruritus
Clinical narrative: Red rash started on right forearm over the next three days the rash spread to trunk, thighs, and groin starting as small red papules growing to macules with areas of violaceous hue seemed pruritic.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous, Skin discolouration
Clinical narrative: Red rash started on right forearm over the next three days the rash spread to trunk, thighs, and groin starting as small red papules growing to macules with areas of violaceous hue seemed pruritic.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Patient had no adverse reaction. Reporting concentrated dose.
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Cheilitis, Cough, Dyspnoea, Pyrexia, Rash generalised
Clinical narrative: The day shots were administered a fever started of 101 Tylenol would keep it down also trouble breathing, that continued for the next 2 days with a good cough and green snot. On the 3rd day still fevers now hives covering the body controlled by Benadryl, then a full body rash with sores now in mouth on mouth and various places on the body. The doctor at the walk-in would not hear me so she gave an antibiotic to him for viral infections although everytime he gets shots the exact same symptoms occur AND NO ONE WILL LISTEN!!!! When he got his 6 month shots he was hospitalized and they called it RSV we now have to use a nebulizer when he gets shots just to open the air ways! He is a twin and his brother has a milder case but same symptoms! Also he has a 4 yr old brother who had the same problems with shots only a milder version!
Age: 1.63
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Rhinorrhoea, Skin ulcer, Stomatitis, Urticaria, Viral infection
Clinical narrative: The day shots were administered a fever started of 101 Tylenol would keep it down also trouble breathing, that continued for the next 2 days with a good cough and green snot. On the 3rd day still fevers now hives covering the body controlled by Benadryl, then a full body rash with sores now in mouth on mouth and various places on the body. The doctor at the walk-in would not hear me so she gave an antibiotic to him for viral infections although everytime he gets shots the exact same symptoms occur AND NO ONE WILL LISTEN!!!! When he got his 6 month shots he was hospitalized and they called it RSV we now have to use a nebulizer when he gets shots just to open the air ways! He is a twin and his brother has a milder case but same symptoms! Also he has a 4 yr old brother who had the same problems with shots only a milder version!
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Eyelid oedema, Lip swelling
Clinical narrative: Child was put to nap after arriving home from clinic. Swelling under left eye and of upper lip described by mother. No other symptoms reported. 1 Dose Benadryl administered by mom and symptoms resolved. No further events noted.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Crying, Irritability postvaccinal, Screaming
Clinical narrative: About 2 hours after receiving immunizations my son became fussy which built up to crying which then progressed to nonstop screaming that lasted approx 3-4 hours. Administered Triaminic acetaminophen.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye pain, Fatigue, Myalgia, Ocular hyperaemia
Clinical narrative: 2-3 hours after vaccination he started to develop muscle aches, dry cough, red sore eyes, fatigue these signs and symptoms lasted 3 days.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Dysarthria, Guillain-Barre syndrome, Headache
Clinical narrative: On about 10/24/11 onset of weakness, headaches, lack of balance. On about 11/13/11, severe headaches, slurring of speech, lack of balance, weakness of tongue, throat & eyes blurry. Emergency rm. Hosp 11/14/11. Another hosp (IVIG) GSB (dia.).
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Tongue paralysis, Vision blurred
Clinical narrative: On about 10/24/11 onset of weakness, headaches, lack of balance. On about 11/13/11, severe headaches, slurring of speech, lack of balance, weakness of tongue, throat & eyes blurry. Emergency rm. Hosp 11/14/11. Another hosp (IVIG) GSB (dia.).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: FEVER 104.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Asthenia, Blood glucose normal, Disorientation, Hypopnoea, Hypotonia
Clinical narrative: Pt received 5 yr kindergarten shots. Tolerated procedure well.  5 minutes post administration pt became weak, disorientated, pale, poor tone, eyes open but not responding to voice.  Respirations shallow, HR 60, mucus membranes normal, hands warm, good capillary refill.  Remained in this state for approximately 40 minutes.  O2 administered  Glucose wnl, no seizure activity.  Gradually regained color, HR 80 and became talkative in one hour after receiving immunizations.  Left office on her own.  Dx prolonged vasovagal response.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Pallor, Presyncope, Unresponsive to stimuli
Clinical narrative: Pt received 5 yr kindergarten shots. Tolerated procedure well.  5 minutes post administration pt became weak, disorientated, pale, poor tone, eyes open but not responding to voice.  Respirations shallow, HR 60, mucus membranes normal, hands warm, good capillary refill.  Remained in this state for approximately 40 minutes.  O2 administered  Glucose wnl, no seizure activity.  Gradually regained color, HR 80 and became talkative in one hour after receiving immunizations.  Left office on her own.  Dx prolonged vasovagal response.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Ran fever of 102F and vomited. Complained of leg pain.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Flushing
Clinical narrative: Patient RTC complaining of facial flushing ten minutes after administration of Hep B. Patient presents with mild facial flush but no rash, no hives, no respiratory distress. Given one Claritin 10mg. Patient requested and was given ice pack for face, and reclined on exam table.   Patient states facial warmth has "almost gone away." Still no respiratory distress, no hives and no rash. Patient checked out by PAC. Patient discharged home with instructions to call 911 if symptoms return. Patient understands and agrees with plan.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Amnesia, Angiogram, Blood test
Clinical narrative: - Involuntary movement - Slurred speech - Inability to speak  - Inability to walk, talk, feed self (can't function on own anymore) - Temporary memory loss  - Migraines  - Inability recognize family and friends - Feelings sometimes went away in certain parts of the body - Numbness and much more
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dysarthria, Dyskinesia, Electrocardiogram, Electroencephalogram, Hypoaesthesia
Clinical narrative: - Involuntary movement - Slurred speech - Inability to speak  - Inability to walk, talk, feed self (can't function on own anymore) - Temporary memory loss  - Migraines  - Inability recognize family and friends - Feelings sometimes went away in certain parts of the body - Numbness and much more
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Migraine, Nuclear magnetic resonance imaging, Sensory loss, Speech disorder
Clinical narrative: - Involuntary movement - Slurred speech - Inability to speak  - Inability to walk, talk, feed self (can't function on own anymore) - Temporary memory loss  - Migraines  - Inability recognize family and friends - Feelings sometimes went away in certain parts of the body - Numbness and much more
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: - Involuntary movement - Slurred speech - Inability to speak  - Inability to walk, talk, feed self (can't function on own anymore) - Temporary memory loss  - Migraines  - Inability recognize family and friends - Feelings sometimes went away in certain parts of the body - Numbness and much more
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood glucose normal, Blood test normal, Computerised tomogram normal, Contusion
Clinical narrative: Patient was home alone. She sent me a text message asking if I was at work. I thought this was odd since I told her when I was leaving that I was just going out to run errands. I called her. She asked me if she was lying on the couch when I left. I said,"no, you were in bed." She became anxious and said she did not feel well. She had a headache and was throwing up. She had no memory of coming downstairs to lie on the couch. When I got home she had a bruise on her head and indicated that she thought she bit her tongue. I discovered a chair in the kitchen knocked over. Because of the bruise on her head, her dad took her to the ER and they did a CT scan and blood work. Everything was fine. It is important to mention that upon checking her glucometer, her blood sugar was at a normal level that morning - 114. Another event occurred on January 12, 2012. I was at home with patient. I was having trouble getting her up for work and I was almost ready to leave for work. I heard her making noises in her bedroom. I went in there and discovered her having convulsions and her eyes rolled back in her head. I called EMS. Because she is diabetic, they took her blood glucose level. It was 73. She was then taken by ambulance to the hospital.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram normal, Gaze palsy, Headache, Malaise
Clinical narrative: Patient was home alone. She sent me a text message asking if I was at work. I thought this was odd since I told her when I was leaving that I was just going out to run errands. I called her. She asked me if she was lying on the couch when I left. I said,"no, you were in bed." She became anxious and said she did not feel well. She had a headache and was throwing up. She had no memory of coming downstairs to lie on the couch. When I got home she had a bruise on her head and indicated that she thought she bit her tongue. I discovered a chair in the kitchen knocked over. Because of the bruise on her head, her dad took her to the ER and they did a CT scan and blood work. Everything was fine. It is important to mention that upon checking her glucometer, her blood sugar was at a normal level that morning - 114. Another event occurred on January 12, 2012. I was at home with patient. I was having trouble getting her up for work and I was almost ready to leave for work. I heard her making noises in her bedroom. I went in there and discovered her having convulsions and her eyes rolled back in her head. I called EMS. Because she is diabetic, they took her blood glucose level. It was 73. She was then taken by ambulance to the hospital.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Tongue biting, Urine analysis normal, Vomiting
Clinical narrative: Patient was home alone. She sent me a text message asking if I was at work. I thought this was odd since I told her when I was leaving that I was just going out to run errands. I called her. She asked me if she was lying on the couch when I left. I said,"no, you were in bed." She became anxious and said she did not feel well. She had a headache and was throwing up. She had no memory of coming downstairs to lie on the couch. When I got home she had a bruise on her head and indicated that she thought she bit her tongue. I discovered a chair in the kitchen knocked over. Because of the bruise on her head, her dad took her to the ER and they did a CT scan and blood work. Everything was fine. It is important to mention that upon checking her glucometer, her blood sugar was at a normal level that morning - 114. Another event occurred on January 12, 2012. I was at home with patient. I was having trouble getting her up for work and I was almost ready to leave for work. I heard her making noises in her bedroom. I went in there and discovered her having convulsions and her eyes rolled back in her head. I called EMS. Because she is diabetic, they took her blood glucose level. It was 73. She was then taken by ambulance to the hospital.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Blood test, Chest X-ray, Chest pain
Clinical narrative: Fever, unusual weakness & tiredness, chills, shortness of breath, severe chest & stomach pain, muscle weakness, nausea, headache, bad stomach ache. Trip to ER on 1/28/2012. Possible 4 shot of a 3 shot series.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Muscular weakness
Clinical narrative: Fever, unusual weakness & tiredness, chills, shortness of breath, severe chest & stomach pain, muscle weakness, nausea, headache, bad stomach ache. Trip to ER on 1/28/2012. Possible 4 shot of a 3 shot series.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, unusual weakness & tiredness, chills, shortness of breath, severe chest & stomach pain, muscle weakness, nausea, headache, bad stomach ache. Trip to ER on 1/28/2012. Possible 4 shot of a 3 shot series.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Per Dr. office note - pt developed red patches all over body, not raised, no swelling, no change in mouth or eye mucosa. Rash went away within 10 minutes.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia, Urticaria
Clinical narrative: Had HPV4 on 1-18-12, that evening developed HA/dizzy, next day had low grade fever; on 1/22/12 developed hives, seen in ambulatory clinic 1/23/12, had taken BENADRYL, with no relief. Started on prednisone 10mg 3 tab daily for 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Musculoskeletal pain
Clinical narrative: Soreness at injection site - very red - extreme itching - painful shoulder to wrist at location and spread slightly down arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Soreness at injection site - very red - extreme itching - painful shoulder to wrist at location and spread slightly down arm.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Periarthritis, X-ray normal
Clinical narrative: I received my annual flu vaccine at hospital as an employee. I received it in my left arm. I had some pain which began a week or so after vaccination. It has now progressed to a frozen left shoulder for which I am now taking medication and physical therapy. The physical therapist says I'm the third patient he has gotten for this same thing in 3 months.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Extra Hepatitis B given to patient. No adverse sxs - pt fine per mom - called CDC.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Brain mass, Brain oedema, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram
Clinical narrative: My parents' physician recommended them to participate in a Efficacy Study of FLUZONE HIGH-DOSE Vaccine compared with FLUZONE Vaccine in Elderly Adults. 9/6/11 The nurse called weekly to check their symptoms, sneezing, sore throat, cough, runny nose. My mom began experiencing migraines, among other symptoms, but did not relate to the shot. Primary doctor treated migraines with medication. On January 1, 2012, my mom was rushed to hospital and this is the series of events; Told she had a stroke and encephalitis. During her first stay, given blood pressure medication, incorrect dose and her blood pressure went to 78/48. She has developed high blood pressure since September. Treated for encephalitis while waiting results. After CT scan, MRI, Lumbar puncture and 5 days later, told her encephalitis test was negative. Sent home on January 5, 2012. Rushed by ambulance on January 7, 2012 experiencing same stroke symptoms. Over the next 4 days, additional tests, misdiagnosis by neurologist, infectious disease doctor we were now told they are checking for brain cancer. Brain swelling, mass, bleeding were many things we were told. On January 11, 2012, I told the nurse that I wanted my mom moved to Cancer Center. The head nurse and case manager told me to take her out and bring her through the emergency room at Cancer Center. Discharged her and I drove her to another city. I phoned Cancer Center when I arrived to find out there was no emergency room and I could not just bring her in. Sitting in city, The Cancer Center doctor I was speaking with, suggested I take her to another hospital. Admitted Mom in hospital, to find out in 12 hours that she had Acute Demyelinating Osteomalacia, a rare condition that is caused by the flu shot.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Demyelination, Encephalitis, Hypertension, Incorrect dose administered
Clinical narrative: My parents' physician recommended them to participate in a Efficacy Study of FLUZONE HIGH-DOSE Vaccine compared with FLUZONE Vaccine in Elderly Adults. 9/6/11 The nurse called weekly to check their symptoms, sneezing, sore throat, cough, runny nose. My mom began experiencing migraines, among other symptoms, but did not relate to the shot. Primary doctor treated migraines with medication. On January 1, 2012, my mom was rushed to hospital and this is the series of events; Told she had a stroke and encephalitis. During her first stay, given blood pressure medication, incorrect dose and her blood pressure went to 78/48. She has developed high blood pressure since September. Treated for encephalitis while waiting results. After CT scan, MRI, Lumbar puncture and 5 days later, told her encephalitis test was negative. Sent home on January 5, 2012. Rushed by ambulance on January 7, 2012 experiencing same stroke symptoms. Over the next 4 days, additional tests, misdiagnosis by neurologist, infectious disease doctor we were now told they are checking for brain cancer. Brain swelling, mass, bleeding were many things we were told. On January 11, 2012, I told the nurse that I wanted my mom moved to Cancer Center. The head nurse and case manager told me to take her out and bring her through the emergency room at Cancer Center. Discharged her and I drove her to another city. I phoned Cancer Center when I arrived to find out there was no emergency room and I could not just bring her in. Sitting in city, The Cancer Center doctor I was speaking with, suggested I take her to another hospital. Admitted Mom in hospital, to find out in 12 hours that she had Acute Demyelinating Osteomalacia, a rare condition that is caused by the flu shot.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Lumbar puncture, Migraine, Nuclear magnetic resonance imaging, Oropharyngeal pain
Clinical narrative: My parents' physician recommended them to participate in a Efficacy Study of FLUZONE HIGH-DOSE Vaccine compared with FLUZONE Vaccine in Elderly Adults. 9/6/11 The nurse called weekly to check their symptoms, sneezing, sore throat, cough, runny nose. My mom began experiencing migraines, among other symptoms, but did not relate to the shot. Primary doctor treated migraines with medication. On January 1, 2012, my mom was rushed to hospital and this is the series of events; Told she had a stroke and encephalitis. During her first stay, given blood pressure medication, incorrect dose and her blood pressure went to 78/48. She has developed high blood pressure since September. Treated for encephalitis while waiting results. After CT scan, MRI, Lumbar puncture and 5 days later, told her encephalitis test was negative. Sent home on January 5, 2012. Rushed by ambulance on January 7, 2012 experiencing same stroke symptoms. Over the next 4 days, additional tests, misdiagnosis by neurologist, infectious disease doctor we were now told they are checking for brain cancer. Brain swelling, mass, bleeding were many things we were told. On January 11, 2012, I told the nurse that I wanted my mom moved to Cancer Center. The head nurse and case manager told me to take her out and bring her through the emergency room at Cancer Center. Discharged her and I drove her to another city. I phoned Cancer Center when I arrived to find out there was no emergency room and I could not just bring her in. Sitting in city, The Cancer Center doctor I was speaking with, suggested I take her to another hospital. Admitted Mom in hospital, to find out in 12 hours that she had Acute Demyelinating Osteomalacia, a rare condition that is caused by the flu shot.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Osteomalacia, Rhinorrhoea, Sneezing
Clinical narrative: My parents' physician recommended them to participate in a Efficacy Study of FLUZONE HIGH-DOSE Vaccine compared with FLUZONE Vaccine in Elderly Adults. 9/6/11 The nurse called weekly to check their symptoms, sneezing, sore throat, cough, runny nose. My mom began experiencing migraines, among other symptoms, but did not relate to the shot. Primary doctor treated migraines with medication. On January 1, 2012, my mom was rushed to hospital and this is the series of events; Told she had a stroke and encephalitis. During her first stay, given blood pressure medication, incorrect dose and her blood pressure went to 78/48. She has developed high blood pressure since September. Treated for encephalitis while waiting results. After CT scan, MRI, Lumbar puncture and 5 days later, told her encephalitis test was negative. Sent home on January 5, 2012. Rushed by ambulance on January 7, 2012 experiencing same stroke symptoms. Over the next 4 days, additional tests, misdiagnosis by neurologist, infectious disease doctor we were now told they are checking for brain cancer. Brain swelling, mass, bleeding were many things we were told. On January 11, 2012, I told the nurse that I wanted my mom moved to Cancer Center. The head nurse and case manager told me to take her out and bring her through the emergency room at Cancer Center. Discharged her and I drove her to another city. I phoned Cancer Center when I arrived to find out there was no emergency room and I could not just bring her in. Sitting in city, The Cancer Center doctor I was speaking with, suggested I take her to another hospital. Admitted Mom in hospital, to find out in 12 hours that she had Acute Demyelinating Osteomalacia, a rare condition that is caused by the flu shot.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Child's mother called the on-call NP 1-26-12 at 9:30pm stating child had redness & swelling at inj site. Mom called the Health Dept the next day 1-27-12 with same complaint. Had child come into the clinic. Left lower arm was red, swollen, & warm to touch. Advised BENADRYL, ibuprofen & ice to area. Size of area 9 1/2 cm in diameter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: (L) arm with large local reaction - redness and swelling. Erythema is 4 in x 3 in hot to touch.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site oedema, Lymphoedema
Clinical narrative: Patient developed edema at injection site at 24 hrs post-injection and lymphedema in (L) hand 48 hours after injection. RPh saw patient had Hx breast CA but gave inject SQ in LA anyway because patient wanted to cook holiday dinner with (R) arm. RPh should have insisted on (R) arm since (L) mastectomy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine site red, slightly swollen, hot to touch. Treated with KEFLEX, site marked. Pt advised to RTC tomorrow for follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth, Skin chapped
Clinical narrative: Mom states rxn began several hours after vaccine given. Sx's included redness, swelling & warmth at site. Sx's persisted x 10d, and became weepy, skin cracked & with d/c & odor.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin odour abnormal
Clinical narrative: Mom states rxn began several hours after vaccine given. Sx's included redness, swelling & warmth at site. Sx's persisted x 10d, and became weepy, skin cracked & with d/c & odor.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Rash generalised
Clinical narrative: Rash over body the next day after vaccine administration.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Sharply demarcated 10 x 20 cm ovoid area of erythema, warmth and sl. induration with tenderness anterior (L) bicipital aspect. Tenderness (L) axilla without discrete nodes. No pustules or inject site infect. Treat with local heat, observation. Notify if fever, malaise.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Fatigue, Irritability, Vomiting
Clinical narrative: Fussy and tired 1-31-12 after shots. 2/1/12 vomiting 2:30AM. No fever or swelling of site. Given vomiting protocol & to call Dr back if pt. worsened.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Red raised rash to chest, trunk, buttocks, and upper arms. 9/25/11 Rash developed later that day. Went to ER & Dr gave her BENADRYL. Required visit to NP & received steroid Rx. Red, itchy rash to chest, trunk, buttocks & upper arms. Few spots to lower inner arms.
Age: 1.61
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Injection site swelling
Clinical narrative: Right thigh swelling.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Circadian rhythm sleep disorder, Dermatitis acneiform, Erythema, Eschar
Clinical narrative: Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Headache, Injection site erythema, Lymphadenopathy, Macule
Clinical narrative: Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Malaise, Papule, Rash pustular, Swelling
Clinical narrative: Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Malaise, Papule, Rash, Rash erythematous, Rash pustular
Clinical narrative: Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Age: 40.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Swelling
Clinical narrative: Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Age: 60.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Tachycardia
Clinical narrative: This is a verbatim narrative as reported on internet accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from on Oct 30, 2007. Female patient, 60 years of age, was vaccinated with FLUMIST on Oct 25, 2007. Given FLUMIST. 15-20 min later c/o dizziness and tachycardia. Mom went to ER. Vital signs normal and was feeling better by time was seen.. . None. Patient recovered."
Age: 42.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP, YF
Symptoms: Unevaluable event
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 397488. A 42-year-old male patient received the following vaccinations on 22 February 2003: a right arm TYPHIM Vi (lot number not reported), yellow fever vaccine (manufacturer and lot number not reported), smallpox vaccine (manufacturer and lot number unknown), anthrax (manufacturer and lot number unknown) and hepatitis B (manufacturer and lot number unknown). Although the smallpox vaccine manufacturer was reported as unknown in the case, ACAM2000 was not available for use at the time of the patient's vaccination. The patient's current illnesses included a fever and chest pain. The patient's medical history and concomitant medications were not reported. He had a prior PPD skin test. The patient had a life threatening unevaluable event. The outcome was reported as unknown. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Blister, Dermatitis, Hypersensitivity, Oedema peripheral, Pruritus
Clinical narrative: This case was received on 11 January 2011 via a third party query tool search on the VAERS database, under reference number 407151. A 39-year-old male patient received the following vaccinations on 02 October 2010: a first left arm dose of ACAM2000 (lot number VV04003A), a third right arm dose of TYPHIM VI (lot number B0706), a third right arm dose of BIOTHRAX (lot number FAV253), and a fourth left arm dose of AFLURIA (lot number 0994911B). He had no illness at time of vaccination, and no medical history. On 19 October 2010, 17 days post-vaccination, the patient's right arm became swollen, itchy, and covered in blisters. He was seen in the emergency room where he was diagnosed with an allergic reaction and dermatitis. He was prescribed a topical hand cream and instructed to follow-up with his primary care physician. The events subsequently recovered.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Laboratory test, Pain in extremity, Rash pruritic
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 423552. A 20-year-old male patient received ACAM2000 (lot number VV04003A), TYPHIM VI (lot number E04421), and BIOTHRAX (lot number FAV273) on 03 March 2011. On 17 March 2011, 14 days post-vaccination, the patient developed an itchy rash with small blisters and drainage, with painful hands and feet. Labs were drawn for generalized vaccinia; results were not reported. The patient presented to emergency room, and subsequently recovered.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, C-reactive protein normal, Chest pain, Dyspnoea
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram P wave biphasic, Electrocardiogram P wave normal, Electrocardiogram normal, Extrasystoles, Full blood count normal
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.