chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Balance disorder, Blood heavy metal normal, Blood product transfusion, Blood test normal
Clinical narrative: The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia burgdorferi serology negative, CSF protein increased, Electromyogram abnormal, Gait disturbance, HIV test negative
Clinical narrative: The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia, Injected limb mobility decreased, Lumbar puncture, Mononucleosis heterophile test negative
Clinical narrative: The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Oedema peripheral
Clinical narrative: The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: The first signs begin with a pain in my right arm three-four days after my vaccine.  I was not able to raise it above my head.  The pain moved to my shoulder and across to my other arm.  I went to an ER a week after my vaccine and they did blood and a mono test but all came back normal and prescribed ibuprofen.  Within the next week I began having difficulty walking and going up stairs.  I notice pins and needs along with numbness in my toes.  I went to another ER exactly a week following the first visit. They did additional blood test (CBC) and it came back normal.  My blood pressure was high when I came in but it went back down to normal.  They recommended a brain MRI to rule out MS.  However, they stated it would have to be done by my PCP.  I went the following week to my primary care physician and he wanted to do additional blood work prior to a brain MRI. He noticed I did not have any reflexes. He did tests for lupus, Lyme disease, metal, HIV.  After a week waiting, all tests came back negative. At this point numbness, weakness and pins and negatives moved to my fingers and my legs.  I went to a third ER a week after the PCP visit.  They did some additional tests and were led to believe it was Guillain Barre.  They admitted me that night.  They following day I had a Brain MRI, Spinal tap and EMG. The Brain MRI came back negative.  The Spinal tap showed high protein but ruled out meningitis. The EMG showed a decrease in the number of motor units. I was diagnosed with GBS.  They began treating me with IV/IG over the course of 5 days. Physical and Occupational therapy began and I have been doing that ever since. I still have pain and swelling in feet. Have abnormal gait along with balance issues and struggle climbing stairs. I am taking Gabapentin and Hydrocodone for the pain and neuropathy. Records received - 05/04/2009, hosp admission 11/24/2008 to 11/30/2008.  Patient previously seen and discharged by two other ED's.  Admitted for evaluation of progressive weakness and paresthesias post influenza vaccination, inability to climb stairs, difficulty standing.  Areflexa of patellar and Achilles reflex. Bilateral diminished grip strength and lower extremity strength. gross motor and sensory intact.  Diagnosis: Guillain-Barre' syndrome - to follow up with neurologist. Hypertension - to follow up with primary care physician.   Follow-up received on May 11, 2010 states pt did not recover from the adverse events that were reported for this vaccination. Had a relapse still have neuropathy in feet. Pain and numbness. Taking steroids to keep strength.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Exfoliative rash
Clinical narrative: SCALEY RASH THATS GETTING WORSE AND SPREADING
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Pt given injection in deltoid. developed over next 24 hours swelling, erythema, pain, and fever and general mailaise. this lasted for three days.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 27cm from injection site a 15x15cm soft nodule appear while appling pressure to syringe with some resistence noted. Soft nodule with reddnes and no inflmation to surrounding area noted. Client denied pain, itching or any discomfort.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Swelling face
Clinical narrative: headache, facial swelling- in pts temples
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Brain death, Respiratory arrest
Clinical narrative: 4-23-09 Child had respiratory arrest @ home. He was life flighted to hospital where he is currently brain dead. Infant was given vaccines 4-21-09.  5/11/09-records received for DOS 4/24/09-presented to outside in ED in cardiac arrest transferrred to facility with PICU. Found in bed unresponsive and blue.  Parent initiated CPR, intubated and placed on mechanical ventilator. Down time approximated at one hour or more before spontaneous return of circulation.   6/25/09 Autopsy report received DOS 4/25/09.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Condition aggravated, Convulsion, Mental status changes, Pyrexia
Clinical narrative: This female subject was enrolled in non-GSK study. Medical conditions at the time of the event included seizure disorder. Concomitant medications included Phenobarbital and Dilantin. On 29 August 2003, one day after a dose of ENGERIX B, one day after a dose of DAPTACEL, one day after a dose of IPOL, one day after a dose of ACTHIB, one day after a dose of PREVNAR, this seven-month-old subject developed seizure and fever. The subject was hospitalised. Outcome was unknown at the time of reporting. The investigator reported the fever as possibly related to ENGERIX B, DAPTACEL, IPOL, ACTHIB and PREVNAR and that the events were possibly due to medical condition. The seizure disorder was determined as congenital and unrelated. The subject had suffered from seizures since birth (23 January 2009) which were controlled with phenobarbital and Dilantin. Her seizures were described as the subject turning red, giving a loud scream, jerking and stiffness which would last two to three minutes. On 09 July 2003 the subject had a neurology visit. During the visit it was noted that a recent EEG showed a relatively benign background, with photic driving on the left side and not on the right, suggesting an asymmetry of the occipital lobe function on one side, possibly on the right. Developmentally at 6 months she had a high pitch cry as her mode of communication but had some babbling sounds emerging. She was not yet sitting up on her own, but would lie on her stomach and push herself into a V shape with her feet on the floor and then arch herself forward. Exam showed a weight of 7.35 kg, height of 25 inches, head circumference 16.5 inches. Neurological exam showed an alert, happy, interactive child. Facial movement was strong and symmetric. Motor examination showed relatively normal bulk, tone, and strength. MRI to be scheduled later that month and a referral was recommended due to the risk of developmental delays. In addition, hearing and ophthalmology screening tests will be performed due to risk in sensory areas. One day post vaccination, on 29 August 2003, the subject presented with a fever and a change in mental status and was admitted to the hospital. The subject had a spinal tap which was negative and a CT scan of the brain which was normal. Her medication was adjusted and she did well, returning to baseline managed seizure disorder. The subject was discharged on 30 August 2003. On 29 October 2003 the subject had a neurology consultation. The subject continued to make excellent developmental progress and had been weaned off Dilantin. At that time the subject was taking on phenobarbital 4 ml twice a day. Upon assessment, her weight was 8.15 Kg, height was 28 inches, head circumference 17 1/4 inches. Developmentally she was bearing weight, sitting independently, had a pincer grasp bilaterally, and reaching for objects. Impression included normal developmental examination. Follow up was recommended in three to six months.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Idiopathic thrombocytopenic purpura, Lymphadenopathy, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Inpatient consult has been requested on a 20 y/o patient hospitalized for severe thrombocytopenia and ITP in association with the receipt of vaccines.  Symptoms:  Petechiae, Lymphadenopathy, axillary.  7/14/09 Hospital records received DOS 4/27/09 to 7/8/09. Assessment: Thrombocytopenia NOS. Idiopathic thrombocytopenic purpura. Patient presented with mild left axilla pain and axillary lump. Bruise right politeal fossa, followed by mottling bruise / rash on feet, ankles, legs. MUltiple petechiae on lower legs, ecchymotic bruises on calves. Vaccination site - large purplish hued leasion with a darkish scar/old blood central area left deltoid. IVIG administration. Dyspepsia. Headache 'behind eyes', photophobia. 'Feeling terrible'. Not well hydrated, not active, uncomfortable, acutely ill.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Gastrooesophageal reflux disease, Pyrexia, Rotavirus test negative
Clinical narrative: Temp 101. Baby presented the day after receiving his immunizations with fever, vomiting and diarrhea. Baby had been having watery stools 2 to his reflux problem - worse following immunizations. Dr felt maybe ROTATEQ may have contributed to this. Was adm to hospital with dehydration.  5/18/09 Hospital records received DOS 4/22/09 to 4/24/09. FINAL DIAGNOSIS: Gastroenteritis with dehydration Post vaccination: nausea, vomiting, fever, acidosis, respiratory distress syndrome, diarrhea, facial eczema  ICD-9: 9995 serum reaction, 78701 nausea with vomiting, 78791 diarrhea, E8798 other procedure, 7821 rash and nonspecific skin eruption, 53081 Esophageal reflux, 78060 fever unspecified.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Temp 101. Baby presented the day after receiving his immunizations with fever, vomiting and diarrhea. Baby had been having watery stools 2 to his reflux problem - worse following immunizations. Dr felt maybe ROTATEQ may have contributed to this. Was adm to hospital with dehydration.  5/18/09 Hospital records received DOS 4/22/09 to 4/24/09. FINAL DIAGNOSIS: Gastroenteritis with dehydration Post vaccination: nausea, vomiting, fever, acidosis, respiratory distress syndrome, diarrhea, facial eczema  ICD-9: 9995 serum reaction, 78701 nausea with vomiting, 78791 diarrhea, E8798 other procedure, 7821 rash and nonspecific skin eruption, 53081 Esophageal reflux, 78060 fever unspecified.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia
Clinical narrative: 04-27-09 patient came for a well child check, immunizations given at 9:30AM at around 1:30PM patient woke up from sleep cried and turned limp, called 911. 5/13/09 hospital records received DOS 4/27/09 to 4/30/09 FINAL DIAGNOSIS: Apnea, status post immunization Post vaccination crying, limp, vomiting, apnea, fever, nasal congestion, pupils dilated, tachycardia. Agitated, irritable. TM dull. Erythema diaper area.   5/18/09 Discharge summary received DOS 4/27/09 to 4/30/09. FINAL DIAGNOSIS: Apnea resolved, sepsis ruled out Post vaccination cried and became limp, febrile, nasal congestion.  Follow-up states - Pt recovered.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Apnoea
Clinical narrative: 04-27-09 patient came for a well child check, immunizations given at 9:30AM at around 1:30PM patient woke up from sleep cried and turned limp, called 911. 5/13/09 hospital records received DOS 4/27/09 to 4/30/09 FINAL DIAGNOSIS: Apnea, status post immunization Post vaccination crying, limp, vomiting, apnea, fever, nasal congestion, pupils dilated, tachycardia. Agitated, irritable. TM dull. Erythema diaper area.   5/18/09 Discharge summary received DOS 4/27/09 to 4/30/09. FINAL DIAGNOSIS: Apnea resolved, sepsis ruled out Post vaccination cried and became limp, febrile, nasal congestion.  Follow-up states - Pt recovered.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia, Respiratory arrest
Clinical narrative: 04-27-09 patient came for a well child check, immunizations given at 9:30AM at around 1:30PM patient woke up from sleep cried and turned limp, called 911. 5/13/09 hospital records received DOS 4/27/09 to 4/30/09 FINAL DIAGNOSIS: Apnea, status post immunization Post vaccination crying, limp, vomiting, apnea, fever, nasal congestion, pupils dilated, tachycardia. Agitated, irritable. TM dull. Erythema diaper area.   5/18/09 Discharge summary received DOS 4/27/09 to 4/30/09. FINAL DIAGNOSIS: Apnea resolved, sepsis ruled out Post vaccination cried and became limp, febrile, nasal congestion.  Follow-up states - Pt recovered.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, nausea, HA, sore throat, rhinorrhea, + cough.  Sx started hours after typhoid vaccine given.  Given Augmentin 875mg BID x 10d.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Local reaction on R upper arm (injection site) with erythema, warmth and mild tenderness.  Keflex 500 mg PO BID x 7 days BENADRYL 25 ml after 6 hours PRN.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Pt stated arm was sore for 3 days. Then in a week she started having spasms in her arm that continue to happen at night still.  Has gotten a steroid shot.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered on 4/23/09. Immediate bruising noted 1/2 dollar size. Bruising dissipated over weekend but Pt developed site of erythema, raised, warm to touch at site of injection. Negative for hives, dyspnea, rash.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall
Clinical narrative: 950am student in nurses office or immunization clinic. Rec'd 5 vaccines - after several min of sitting looking @ stickers leaned to (L) an fell out of chair = 24 inches hit (L) knee an elbow, eyes open - no sign of injury - sat after an assisted back to chair, water offered, cool cloth applied to neck - no LOC denied pain anywhere assisted to nurses bed to rest - mom called 10:22 arrived informed what to watch for encouraged food/liquids. BP checked 86/62 HR 64. @ 1025 home with mom
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Skin lesion
Clinical narrative: Local Pox 3-4 lesions with cellulitic area on (L) thigh. Topical warm compress and PO Augmentin.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash erythematous
Clinical narrative: Faint erythematous rash under the skin on the anterior aspect of both lower legs, vaccine site normal. Rash was noticed right after vaccination. Observed baby for 30 min and discharged - rash fading at that time.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (R) arm swollen and red about 10 cm X 6 cm within 1-2 hours after getting vaccine - given oral steroids and Antihistamine.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received ADACEL on 4/16/09 and by 4/18/09 the right arm became entirely swollen and the injection site became indurated, reddened, painful and swollen. Additionally, both hands became red, itchy, and swollen. She experienced fever to 101 F and had systemic itching. Took TYLENOL and BENADRYL.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pruritus, Pyrexia, Tuberculin test negative
Clinical narrative: Received ADACEL on 4/16/09 and by 4/18/09 the right arm became entirely swollen and the injection site became indurated, reddened, painful and swollen. Additionally, both hands became red, itchy, and swollen. She experienced fever to 101 F and had systemic itching. Took TYLENOL and BENADRYL.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: Pt broke out in hives face to legs 1 1/2 hour after receiving MMR II vaccine. Parent went to daycare, did confirm hives with moderate wheezing. BENADRYL given and Pt watched for an hour.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count normal, Muscular weakness, Musculoskeletal pain, Pyrexia, Rash
Clinical narrative: Vaccine given 10:15 A and by 12:00 MN 102 deg and 4:00 increased 103.7 vomiting and fever. Seen by Dr later in day 2 pm c/o  pain (R) shoulder, rash (hives) circular radiating into back and down arm and temp. increased 103.4 c/o leg weakness x2 days alternated TYLENOL & MOTRIN for elevated temp. Out of school 2 days. Day 2 no temp felt better. 4/25/09, sl . rash and swelling
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcal identification test negative, Swelling, Urticaria, Vomiting
Clinical narrative: Vaccine given 10:15 A and by 12:00 MN 102 deg and 4:00 increased 103.7 vomiting and fever. Seen by Dr later in day 2 pm c/o  pain (R) shoulder, rash (hives) circular radiating into back and down arm and temp. increased 103.4 c/o leg weakness x2 days alternated TYLENOL & MOTRIN for elevated temp. Out of school 2 days. Day 2 no temp felt better. 4/25/09, sl . rash and swelling
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: .5 cm diameter redness, and warm to touch area surrounding shot site.
Sex: F
Vaccine: RVX, UNK
Symptoms: Discomfort, Haematochezia, Painful defaecation
Clinical narrative: Our infant received the roto vaccine - by mouth - along with her other 2 month vaccinations - injections-.  She had blood in her stool and extreme discomfort for the next 3 days.  It seems the roto vaccine caused the painful and bloody stool.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 2 days after DTAP, arm red & swollen & warm deltoid area. No fever.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Initial report received on 20 April 2009 from a nurse practitioner.  A five-year-old male patient, who weighs 62 pounds, and who had no concurrent illnesses or pre-existing medical conditions, had received on 06 April 2009 at 16:10 pm a fourth subcutaneous injection of IPOL (lot number A0342-2); a fifth intramuscular injection of TRIPEDIA (lot number U2470AA);  a second subcutaneous injection of "MMRII" (Merck, lot number 1209X);  a "PPD" tuberculin test planted in the right forearm;  and a second subcutaneous injection of "VARIVAX" (Merck, lot number H19U).  The sites of administration for all vaccines were not reported.  Five minutes after receiving the vaccines and tuberculin test, the patient started to cough, five minutes later, he had wheezing in the anterior/posterior lungs.  The patient was given 15 mL of BENADRYL (12.5mg/mL).  Five minutes later, the patient was treated with 0.3 mL of EPINEPHRINE 1:1000 subcutaneously.  Fifty five minutes later, the emergency medical team (911) was called and the patient was transported by ambulance to the emergency room.  At the time of transport to the emergency room the patient's lungs were clear to auscultation and the patient had hives on the right arm to the wrist.  Diagnostic tests and laboratory data performed were not reported.  One hour and twenty minutes later, the patient was considered to be stable and was recovered.  Documents held by sender:  None.  V1 was created as a revised version to capture the MIS ID # 09-0191 in the source reporter screen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Eye swelling, Swelling face, Urticaria
Clinical narrative: Initial information was received on 22 April 2009 from a physician. An 11 year old female patient with no known allergies or medical conditions received ADACEL (lot number C3065, lot number UF457CA) and MENACTRA (lot number U2817A) on 16 April 2009. On 17 April 2009, the patient developed hives and angioedema. The patient was treated with BENADRYL, however her symptoms persisted. She was later treated with ORAPRED and ZYRTEC with no change in her symptoms. Next, the patient was treated with Hydralazine. The patient has not yet recovered. List of Documents held by Sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Angioedema, Urticaria
Clinical narrative: Initial information was received on 22 April 2009 from a physician. An 11 year old female patient with no known allergies or medical conditions received ADACEL (lot number C3065, lot number UF457CA) and MENACTRA (lot number U2817A) on 16 April 2009. On 17 April 2009, the patient developed hives and angioedema. The patient was treated with BENADRYL, however her symptoms persisted. She was later treated with ORAPRED and ZYRTEC with no change in her symptoms. Next, the patient was treated with Hydralazine. The patient has not yet recovered. List of Documents held by Sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Convulsion, Disorientation, Headache, Hypoaesthesia
Clinical narrative: Information has been received from a nurse concerning a female with no known drug allergies, asthma, verbal aphasia, sensory integration disturbance, developmental delay and myoclonus and a history of seizure (but the last one was in 2005) who on 21-Apr-2009 at 16:15 was vaccinated with the second dose of GARDASIL (lot# not reported) (lot# 661846/1312X). 0.5ml IM. The nurse reported that there was no adverse event after the patient was vaccinated with the first dose of GARDASIL (lot# not reported). On 21-Apr-2009 at 16:15 the patient experienced mild seizure which lasted about 15 seconds after she was vaccinated with the second dose of GARDASIL. The patient went to a Hospital for a follow up. It was unspecified if she was admitted to the Hospital. Additional information was received from the physician's nurse manager (a registered nurse) reported that this event was probably already reported by the patient's mother (a nurse) or by pharmacist friend of the mother. In follow up the physician reported on 21-Apr-2009 at 16:15 the patient experienced mild seizure. The patient was waiting in the room for 5 minutes. The mother of the patient stated the patient was fine. The patient had no known reaction to the first dose of the vaccine. After her second dose, she went down when nurse got to side and noticed shaking event, eyes rolled back and patient sat up immediately. The patient was responsive to her name. The patient was made to lay down for 15 minutes, secondary to weakness and pallor. The patient wakened sitting up for 10 minutes. The patient required emergency room visit and recovered. Upon internal review, mild seizure was determined to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypokinesia, Malaise, Muscle twitching, Mydriasis, Neurological examination
Clinical narrative: Information has been received from a nurse concerning a female with no known drug allergies, asthma, verbal aphasia, sensory integration disturbance, developmental delay and myoclonus and a history of seizure (but the last one was in 2005) who on 21-Apr-2009 at 16:15 was vaccinated with the second dose of GARDASIL (lot# not reported) (lot# 661846/1312X). 0.5ml IM. The nurse reported that there was no adverse event after the patient was vaccinated with the first dose of GARDASIL (lot# not reported). On 21-Apr-2009 at 16:15 the patient experienced mild seizure which lasted about 15 seconds after she was vaccinated with the second dose of GARDASIL. The patient went to a Hospital for a follow up. It was unspecified if she was admitted to the Hospital. Additional information was received from the physician's nurse manager (a registered nurse) reported that this event was probably already reported by the patient's mother (a nurse) or by pharmacist friend of the mother. In follow up the physician reported on 21-Apr-2009 at 16:15 the patient experienced mild seizure. The patient was waiting in the room for 5 minutes. The mother of the patient stated the patient was fine. The patient had no known reaction to the first dose of the vaccine. After her second dose, she went down when nurse got to side and noticed shaking event, eyes rolled back and patient sat up immediately. The patient was responsive to her name. The patient was made to lay down for 15 minutes, secondary to weakness and pallor. The patient wakened sitting up for 10 minutes. The patient required emergency room visit and recovered. Upon internal review, mild seizure was determined to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor
Clinical narrative: Information has been received from a nurse concerning a female with no known drug allergies, asthma, verbal aphasia, sensory integration disturbance, developmental delay and myoclonus and a history of seizure (but the last one was in 2005) who on 21-Apr-2009 at 16:15 was vaccinated with the second dose of GARDASIL (lot# not reported) (lot# 661846/1312X). 0.5ml IM. The nurse reported that there was no adverse event after the patient was vaccinated with the first dose of GARDASIL (lot# not reported). On 21-Apr-2009 at 16:15 the patient experienced mild seizure which lasted about 15 seconds after she was vaccinated with the second dose of GARDASIL. The patient went to a Hospital for a follow up. It was unspecified if she was admitted to the Hospital. Additional information was received from the physician's nurse manager (a registered nurse) reported that this event was probably already reported by the patient's mother (a nurse) or by pharmacist friend of the mother. In follow up the physician reported on 21-Apr-2009 at 16:15 the patient experienced mild seizure. The patient was waiting in the room for 5 minutes. The mother of the patient stated the patient was fine. The patient had no known reaction to the first dose of the vaccine. After her second dose, she went down when nurse got to side and noticed shaking event, eyes rolled back and patient sat up immediately. The patient was responsive to her name. The patient was made to lay down for 15 minutes, secondary to weakness and pallor. The patient wakened sitting up for 10 minutes. The patient required emergency room visit and recovered. Upon internal review, mild seizure was determined to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Convulsion, Gaze palsy, No reaction on previous exposure to drug, Pallor
Clinical narrative: Information has been received from a nurse concerning a female with no known drug allergies, asthma, verbal aphasia, sensory integration disturbance, developmental delay and myoclonus and a history of seizure (but the last one was in 2005) who on 21-Apr-2009 at 16:15 was vaccinated with the second dose of GARDASIL (lot# not reported) (lot# 661846/1312X). 0.5ml IM. The nurse reported that there was no adverse event after the patient was vaccinated with the first dose of GARDASIL (lot# not reported). On 21-Apr-2009 at 16:15 the patient experienced mild seizure which lasted about 15 seconds after she was vaccinated with the second dose of GARDASIL. The patient went to a Hospital for a follow up. It was unspecified if she was admitted to the Hospital. Additional information was received from the physician's nurse manager (a registered nurse) reported that this event was probably already reported by the patient's mother (a nurse) or by pharmacist friend of the mother. In follow up the physician reported on 21-Apr-2009 at 16:15 the patient experienced mild seizure. The patient was waiting in the room for 5 minutes. The mother of the patient stated the patient was fine. The patient had no known reaction to the first dose of the vaccine. After her second dose, she went down when nurse got to side and noticed shaking event, eyes rolled back and patient sat up immediately. The patient was responsive to her name. The patient was made to lay down for 15 minutes, secondary to weakness and pallor. The patient wakened sitting up for 10 minutes. The patient required emergency room visit and recovered. Upon internal review, mild seizure was determined to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a nurse concerning a female with no known drug allergies, asthma, verbal aphasia, sensory integration disturbance, developmental delay and myoclonus and a history of seizure (but the last one was in 2005) who on 21-Apr-2009 at 16:15 was vaccinated with the second dose of GARDASIL (lot# not reported) (lot# 661846/1312X). 0.5ml IM. The nurse reported that there was no adverse event after the patient was vaccinated with the first dose of GARDASIL (lot# not reported). On 21-Apr-2009 at 16:15 the patient experienced mild seizure which lasted about 15 seconds after she was vaccinated with the second dose of GARDASIL. The patient went to a Hospital for a follow up. It was unspecified if she was admitted to the Hospital. Additional information was received from the physician's nurse manager (a registered nurse) reported that this event was probably already reported by the patient's mother (a nurse) or by pharmacist friend of the mother. In follow up the physician reported on 21-Apr-2009 at 16:15 the patient experienced mild seizure. The patient was waiting in the room for 5 minutes. The mother of the patient stated the patient was fine. The patient had no known reaction to the first dose of the vaccine. After her second dose, she went down when nurse got to side and noticed shaking event, eyes rolled back and patient sat up immediately. The patient was responsive to her name. The patient was made to lay down for 15 minutes, secondary to weakness and pallor. The patient wakened sitting up for 10 minutes. The patient required emergency room visit and recovered. Upon internal review, mild seizure was determined to be an other important medical event. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced apneic episode. The patient received the first dose on 27-Apr-2009. The patient also received a dose of PENTACEL (Aventis-Pasteur) on 27-Apr-2009. On 27-Apr-2009, the patient experienced an apneic episode, 3 hours post-vaccination. The child was hospitalized. Treatment initially included oxygen, and currently ROCEPHIN and ampicillin. The child remains hospitalized. The outcome of the event was not reported. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Apnoea
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced apneic episode. The patient received the first dose on 27-Apr-2009. The patient also received a dose of PENTACEL (Aventis-Pasteur) on 27-Apr-2009. On 27-Apr-2009, the patient experienced an apneic episode, 3 hours post-vaccination. The child was hospitalized. Treatment initially included oxygen, and currently ROCEPHIN and ampicillin. The child remains hospitalized. The outcome of the event was not reported. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Blood culture negative, CSF culture negative, Crying, Hypotonia, Respiratory arrest
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced apneic episode. The patient received the first dose on 27-Apr-2009. The patient also received a dose of PENTACEL (Aventis-Pasteur) on 27-Apr-2009. On 27-Apr-2009, the patient experienced an apneic episode, 3 hours post-vaccination. The child was hospitalized. Treatment initially included oxygen, and currently ROCEPHIN and ampicillin. The child remains hospitalized. The outcome of the event was not reported. No additional information was available at the time of this report.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Vaccine positive rechallenge
Clinical narrative: This case was received from a health professional on 07 November 2008, and represents a cluster of 20 patients. Twenty patients, all employees of a health care facility, reported experiencing adverse reactions after receiving intramuscular injections of FLUZONE SV 2008-2009 (lot number U2762AA). Following vaccination, one female patient "self diagnosed herself with ocular respiratory syndrome". One female patient complained of pain in the vaccinated arm, with ongoing difficulty lifting the arm. Two patients complained of itch and hives. Eleven patients had body aches, chills, and fever six to twelve hours after vaccination; seven of those eleven patients missed one day of work. Five patients reported pain at the injection site, radiating to the neck and down to the fingers. Individual identifiers were not provided, and outcome was unknown. Follow-up information was received from the health care professional on 13 January 2009, and provided patient identifiers for each of the patients reported in the original case. This case now pertains only to a female patient who complained of both arms "itching profoundly" on 14 October 2008 (date of vaccination not reported). Treatment included CLARITIN and hydrocortisone. Outcome was not reported. Follow-up information received on 13 February 2009 from a health care professional. The patient had been vaccinated with a prior dose of flu vaccine (Trade name, manufacturer name, route and site not provided) in 2002 and experienced a rash and itch. The patient was 46-years-old at the time of vaccination with FLUZONE SV 2008-2009 on 14 October 2008. The FLUZONE was administered in the deltoid. The patient recovered; however a recovery date was not provided. No further information is expected. Follow up information received on 20 April 2009 from a health care professional. Based upon new information, this case meets seriousness criteria and has been upgraded to serious. On 14 October 2008, the patient medicated with PEPCID and Prednisone prior to administration of FLUZONE SV 2008-2009 which was administered in the right deltoid, indication not reported. Within hours, the patient developed a rash from head to toe and had to leave work. The patient went to the doctor's office and was prescribed a SOLUMEDROL dose pack, PEPCID, and BENADRYL. The rash lasted for two days and the patient made a full recovery. The patient was instructed to avoid future flu vaccinations. This patient is one of a cluster of 20 patients. The other 19 patients are captured in case numbers 2009-00153 through 2009-00171, and case. The patient also has another adverse event that is reported in case 2009-00681. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Progesterone, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed visiting nurse, for the GARDASIL a Pregnancy Registry concerning a 23 year old female with hypothyroidism and a history of 3 pregnancies: 1 live birth at 39 week from LMP, 2 spontaneous abortions including an ectopic pregnancy in March 2008 (5-6 weeks from LMP), with no birth defects of infant complications in previous pregnancies who on 20-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# 661952/1129X). Concomitant therapy included levothyroxine Na. The nurse reported that the patient was pregnant. Her LMP was 03-MAR-2009 and her EDD was 08-DEC-2009. On 26-MAR-2009 the patient started spotting. The nurse stated that the patient was having heavy bleeding and was in the process of miscarrying. Laboratory tests included urine beta-human chorionic gonadotropin test and progesterone performed on 03-APR-2009. On 06-APR-2009 an ultrasound was performed due to her spotting with result intrauterine pregnancy early vs missed abortion. On the same date an urine beta-human chorionic gonadotropin test was done. Additional ultrasounds performed on 09-APR-2009 due to the patient's spotting revealed fetal cardiac activity as well on 13-APR-2009 there was fetal cardiac activity. On 17-APR-2009 the patient experienced spontaneous abortion (7 weeks from LMP), and she has chosen to wait and see if the fetus will pass on its own. It was reported that the patient has a follow up visit in 2 weeks and will have an ultrasound. If the fetus does not pass the patient will be scheduled for a dilation and curettage. On 21-APR-2009 an ultrasound revealed no fetal cardiac activity, there was no fetal heartbeat. Upon internal review in the process of miscarrying was considered to be an other important medical event. Additional information is not expected.