chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness
Clinical narrative: Pt stated at her visit for 3rd injection, that after her 2nd injection she "lost her vision x 30 seconds. Blinked a few times and it came back"
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cold sweat, Fatigue, Feeling cold, Gaze palsy, Hypotonia
Clinical narrative: the noc of the day he received shots he fussed like he was hungry and mom went to feed him. He ate part of bottle feeding, and seemed tired; limps somewhat "Lethargic", eyes rolled back a little and he felt cold and clammy. Temp was 97.0 wo color changes. Mom held him awhile and put him back to bed and did fine.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Lethargy
Clinical narrative: the noc of the day he received shots he fussed like he was hungry and mom went to feed him. He ate part of bottle feeding, and seemed tired; limps somewhat "Lethargic", eyes rolled back a little and he felt cold and clammy. Temp was 97.0 wo color changes. Mom held him awhile and put him back to bed and did fine.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: erythematous, warm area at the injection site treated with Benadryl and cool compress
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Food allergy
Clinical narrative: (When at home) After administration of DTaP to left thigh (intramuscular injection) pt had localized skin redness approx 6 inches by 10 inches inner thigh not underneath, but beside injection with slight dependant
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: 4 year old with a history of asthma and a cochlear implant came into our office for a Pneumovax vaccine. 3 hours later mom called and said she was febrile 101, increased respiratory effort and chills.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of swelling, redness, itching to left rear upper arm in area where vaccine was given.  States it started around dose #3 after the vaccine was given, size around 3-4#.  Darkish discoloration - remains to rear of left arm per patient.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient developed and increase amount of swelling at site of injection was red and hot to touch for 2-3 days after shot was given.  Redness was 2" x 2" in size.  On 4/10 patient still has 1/2" x 1" rash.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Initial report received on 03 March 2008 from a health care professional.  A 23-year-old male patient had received a first dose, left deltoid, intramuscular injection of MENACTRA, lot number U2558AA, on 11 February 2008; and a first dose, left deltoid, intramuscular injection of PNEUMOVAX, manufacturer Merck, lot number 0380U, on 29 February 2008.  Eighteen days following vaccination with MENACTRA and three hours following vaccination with PNEUMOVAX, the patient developed numbness from the left forearm to fingers, swelling of the left elbow, and swelling to the left upper arm.  The event did not require medical examination, and diagnostic testing was none.  The swelling of the left upper arm resolved, but swelling to the left elbow remained.  At the time of this report, the patient had not recovered.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Diabetes mellitus, Dysstasia, Guillain-Barre syndrome, Hepatic lesion, Lumbar puncture
Clinical narrative: 2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Pain in extremity, Transfusion
Clinical narrative: 2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Asthenia, Blood product transfusion, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypokinesia, Hypotonia, Muscle atrophy, Muscular weakness, Musculoskeletal pain
Clinical narrative: 2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity
Clinical narrative: 2 wks post receiving flu vaccine Pt. reported pain in legs and weakness and inability to get out of bed or get our of chair without using her arms.  Also pain in her upper limb girdle in her shoulder.  Seen by Dr who made clinical diagnosis of Guillain Barre.  Noted that she had a shuffling gait and was unable to pick up legs on exam.  Treated with IVIG 400mg/kg daily over 5 days.  Total dose 56 gm. 1/25/2010 Follow up: I have in the last few months begun to retain my strength. It is still not where it was before the flu shot. I still have to be very careful with stains and I have great difficulty kneeling. The kneeling issue might be related to insufficent muscle strength due to the atrophy after the Guillain Barre. I am sporadically doing yoga to try to regain my mobility and flexibility. Follow-up: The pt. was discharged from the hospital and no further information is available.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood pressure decreased, Chest pain, Coagulopathy, Disability
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with atrial fibrillation who on 20-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included warfarin sodium (COUMADIN) and metoprolol succinate (TOPROL XL TABLETS).  Seven days after vaccination on 27-DEC-2007 the patient experienced joint pain.  He then experienced his lips and mouth breaking out in a herpes type breakout.  His face, neck, and arms then broke out in a "heavy rash that was thick then would dry and scale off."  A betamethasone (CELESTONE) shot and unspecified pain medication was given to the patient for the joint pain for 3 weeks.  The patient got no relief so he was put in the hospital for testing for 4 days.  On the 3rd day of the hospital stay, the patient was given a betamethasone (CELESTONE) shot and prednisone 10mg daily.  The patient was released from the hospital on 30-JAN-2008 with a reduced dosage of prednisone (7.5mg daily) because he was "doing well."  A few days later the joint pain started again and by March 2008 the prednisone dosage was increased to 10mg daily.  On an unspecified date the patient experienced severe chest pain that put him back into the hospital.  Additional testing was done.  The patient was diagnosed by the Rheumatologist with Drug Induced Lupus.  The patient was also diagnosed by a Cardiologist with inflammation of the pericardium, which was not heart related.  The patient was started on prednisone 60mg in the hospital and then discharged about 2 to 3 weeks ago (in March 2008) with prednisone 40mg (20mg in the morning and 20mg in evening).  The prednisone was taking care of the patient's joint pain, rash and some of the inflammation but it was causing him to have swelling of the feet and legs.  The patient also lost 50 pounds.  It was noted that on 17-DEC-2007 the patient had a complete physical and did not have any problems.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Heart rate increased, Herpes virus infection, Herpes zoster, Immune system disorder
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with atrial fibrillation who on 20-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included warfarin sodium (COUMADIN) and metoprolol succinate (TOPROL XL TABLETS).  Seven days after vaccination on 27-DEC-2007 the patient experienced joint pain.  He then experienced his lips and mouth breaking out in a herpes type breakout.  His face, neck, and arms then broke out in a "heavy rash that was thick then would dry and scale off."  A betamethasone (CELESTONE) shot and unspecified pain medication was given to the patient for the joint pain for 3 weeks.  The patient got no relief so he was put in the hospital for testing for 4 days.  On the 3rd day of the hospital stay, the patient was given a betamethasone (CELESTONE) shot and prednisone 10mg daily.  The patient was released from the hospital on 30-JAN-2008 with a reduced dosage of prednisone (7.5mg daily) because he was "doing well."  A few days later the joint pain started again and by March 2008 the prednisone dosage was increased to 10mg daily.  On an unspecified date the patient experienced severe chest pain that put him back into the hospital.  Additional testing was done.  The patient was diagnosed by the Rheumatologist with Drug Induced Lupus.  The patient was also diagnosed by a Cardiologist with inflammation of the pericardium, which was not heart related.  The patient was started on prednisone 60mg in the hospital and then discharged about 2 to 3 weeks ago (in March 2008) with prednisone 40mg (20mg in the morning and 20mg in evening).  The prednisone was taking care of the patient's joint pain, rash and some of the inflammation but it was causing him to have swelling of the feet and legs.  The patient also lost 50 pounds.  It was noted that on 17-DEC-2007 the patient had a complete physical and did not have any problems.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Pericarditis, Rash, Systemic lupus erythematosus
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with atrial fibrillation who on 20-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included warfarin sodium (COUMADIN) and metoprolol succinate (TOPROL XL TABLETS).  Seven days after vaccination on 27-DEC-2007 the patient experienced joint pain.  He then experienced his lips and mouth breaking out in a herpes type breakout.  His face, neck, and arms then broke out in a "heavy rash that was thick then would dry and scale off."  A betamethasone (CELESTONE) shot and unspecified pain medication was given to the patient for the joint pain for 3 weeks.  The patient got no relief so he was put in the hospital for testing for 4 days.  On the 3rd day of the hospital stay, the patient was given a betamethasone (CELESTONE) shot and prednisone 10mg daily.  The patient was released from the hospital on 30-JAN-2008 with a reduced dosage of prednisone (7.5mg daily) because he was "doing well."  A few days later the joint pain started again and by March 2008 the prednisone dosage was increased to 10mg daily.  On an unspecified date the patient experienced severe chest pain that put him back into the hospital.  Additional testing was done.  The patient was diagnosed by the Rheumatologist with Drug Induced Lupus.  The patient was also diagnosed by a Cardiologist with inflammation of the pericardium, which was not heart related.  The patient was started on prednisone 60mg in the hospital and then discharged about 2 to 3 weeks ago (in March 2008) with prednisone 40mg (20mg in the morning and 20mg in evening).  The prednisone was taking care of the patient's joint pain, rash and some of the inflammation but it was causing him to have swelling of the feet and legs.  The patient also lost 50 pounds.  It was noted that on 17-DEC-2007 the patient had a complete physical and did not have any problems.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Inflammation, Laboratory test, Lupus-like syndrome
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with atrial fibrillation who on 20-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included warfarin sodium (COUMADIN) and metoprolol succinate (TOPROL XL TABLETS).  Seven days after vaccination on 27-DEC-2007 the patient experienced joint pain.  He then experienced his lips and mouth breaking out in a herpes type breakout.  His face, neck, and arms then broke out in a "heavy rash that was thick then would dry and scale off."  A betamethasone (CELESTONE) shot and unspecified pain medication was given to the patient for the joint pain for 3 weeks.  The patient got no relief so he was put in the hospital for testing for 4 days.  On the 3rd day of the hospital stay, the patient was given a betamethasone (CELESTONE) shot and prednisone 10mg daily.  The patient was released from the hospital on 30-JAN-2008 with a reduced dosage of prednisone (7.5mg daily) because he was "doing well."  A few days later the joint pain started again and by March 2008 the prednisone dosage was increased to 10mg daily.  On an unspecified date the patient experienced severe chest pain that put him back into the hospital.  Additional testing was done.  The patient was diagnosed by the Rheumatologist with Drug Induced Lupus.  The patient was also diagnosed by a Cardiologist with inflammation of the pericardium, which was not heart related.  The patient was started on prednisone 60mg in the hospital and then discharged about 2 to 3 weeks ago (in March 2008) with prednisone 40mg (20mg in the morning and 20mg in evening).  The prednisone was taking care of the patient's joint pain, rash and some of the inflammation but it was causing him to have swelling of the feet and legs.  The patient also lost 50 pounds.  It was noted that on 17-DEC-2007 the patient had a complete physical and did not have any problems.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Oral herpes, Pericarditis, Rash, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with atrial fibrillation who on 20-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included warfarin sodium (COUMADIN) and metoprolol succinate (TOPROL XL TABLETS).  Seven days after vaccination on 27-DEC-2007 the patient experienced joint pain.  He then experienced his lips and mouth breaking out in a herpes type breakout.  His face, neck, and arms then broke out in a "heavy rash that was thick then would dry and scale off."  A betamethasone (CELESTONE) shot and unspecified pain medication was given to the patient for the joint pain for 3 weeks.  The patient got no relief so he was put in the hospital for testing for 4 days.  On the 3rd day of the hospital stay, the patient was given a betamethasone (CELESTONE) shot and prednisone 10mg daily.  The patient was released from the hospital on 30-JAN-2008 with a reduced dosage of prednisone (7.5mg daily) because he was "doing well."  A few days later the joint pain started again and by March 2008 the prednisone dosage was increased to 10mg daily.  On an unspecified date the patient experienced severe chest pain that put him back into the hospital.  Additional testing was done.  The patient was diagnosed by the Rheumatologist with Drug Induced Lupus.  The patient was also diagnosed by a Cardiologist with inflammation of the pericardium, which was not heart related.  The patient was started on prednisone 60mg in the hospital and then discharged about 2 to 3 weeks ago (in March 2008) with prednisone 40mg (20mg in the morning and 20mg in evening).  The prednisone was taking care of the patient's joint pain, rash and some of the inflammation but it was causing him to have swelling of the feet and legs.  The patient also lost 50 pounds.  It was noted that on 17-DEC-2007 the patient had a complete physical and did not have any problems.  At the time of the report the patient had not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Gait disturbance, Hemiparesis, Hypoaesthesia
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Oedema peripheral, Swelling face
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Cardiolipin antibody negative, Chest X-ray normal, Chest pain, Computerised tomogram normal, Depressed level of consciousness
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Echocardiogram, Electrocardiogram normal, Factor V Leiden mutation, Hemiparesis, Hypoaesthesia
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration, Lipoprotein (a) increased, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Protein S normal
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Scan brain, Swelling face, Type I hypersensitivity, Ultrasound Doppler normal, Ultrasound scan normal
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Blood cholesterol increased, Chest pain, Dyspnoea, Hypoaesthesia, Laboratory test normal
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Muscular weakness, Swelling face
Clinical narrative: 11:30 AM In for ck-up, also c/o irreg menses and no menses x 4 mos. Pt given: DTaP-adult, Menactra, Hep A #1, and PPD CBC-nl, U/A-tr leuk, Glu-82, Chol-249, obese. Diet and exercise discussed, referred to GYN. 1:00 PM Called office, c/o chest pain, told to take Motrin March 28, 2008 3:00 AM Awakened and c/o R sided weakness and numbness. Mom also noted R facial swelling. 11:00 AM Seen in office with above complaints and referred to ED See ED note-pt admitted. March 28 through April 2, 2008-pt hospitalized, given ASA Neuro and cardiac w/u-neg. April 2, 2008 6:30 PM ID consult-poss Type I Hypersensitivity Reaction. pt had improved with good strength and sensation R upper ext but still with some R lower ext weakness and decreased sensation, pt was able to ambulate with assitance, pt d/c'd home to continue PT as outlined in hosp and to follow-up in our office and with neuro. April 5, 2008 9:00 AM phone call to mother-plt slt improved but still with numbness bottom of R foot with weakness-f/u scheduled in our office 4/8. CT of the head-nl; Chest x-ray-nl; 12-lead EKG-nl; MRI of the brain-nl with tract mucosal thickening all sinuses; MRA of the head-nl; Transthoracic ECHO-nl; Bilat Lower Ext Venous Doppler-nl; Bilat Carotid Ultrasound-nl; Prothrombin mutation PCR/ Factor II-neg; Protein S-89; Factor V Leiden PCR-neg; Anticardiolipin IgG-4; Anticardiolipin IgM-7; Lipoprotein A-221
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Anorexia, Hyperhidrosis, Irritability, Lethargy
Clinical narrative: High temperature of 102 degrees for 2 days, 5th & 6th April. 7th of April he work up really thirsty in the middle of the night and although he didn't have a temperature at that time, his clothes were soaked with perspiration so I had to change his shirt and pillow. Lethargic, grumpy, clingy. He said his stomach hurt. (No diarrhea or vomiting.) Loss of appetite for about 4 days around the same time.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis abnormal, Chromosomal analysis, Drug exposure during pregnancy, Foetal disorder, Neonatal aspiration
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a female with a history of "2 full term deliveries and 1 previous pregnancy" with nausea who on 15-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654389/0961F). Concomitant therapy included PHENERGAN TABLETS/SUPPOSITORIES. On 19-FEB-2007 the patient received the second dose of Gardasil (Lot #653736/0014U) and on 19-JUN-2007 received a third dose of (Lot #657005/0314U). The patient found out she was pregnant, with a last menstrual period date of 09-APR-2007. On 27-JUN-2007 and 16-JUL-2007 (IUP 8 weeks 2 days), the patient had an ultrasound which confirmed the dates. The estimated date of deliver is 14-JAN-2008. Follow-up information was received from the physician. Concomitant therapy also included iron supplements. The estimated conception date was 02-JUN-2007, based on 16-JUL-2007 "us". On 16-DEC-2007 the patient had amniocentesis for suspected malformation lower extremities. On an unspecified date a fetal MRI was performed for screening of Pruder Willi, mytonic dystrophy and spinal muscular dystrophy; the results were negative. On 16-FEB-2008 the patient delivered a baby boy weighing 7 pounds and 15 ounces, 19 cm in length, head circumference of 14 mm with an Apgar score of 8/9. The baby was not born normal. The baby was born with club feet, congenital dislocation of the hip and malformation of the knees. On an unspecified date an amniotic fluid analysis was performed and was "PFP" within normal limits and a chromosomal analysis (karotype) was performed and the results were (L46, XY). The physician felt that club feet, congenital dislocation of the hip and malformation of the knees was a congenital anomaly. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a female with a history of "2 full term deliveries and 1 previous pregnancy" with nausea who on 15-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654389/0961F). Concomitant therapy included PHENERGAN TABLETS/SUPPOSITORIES. On 19-FEB-2007 the patient received the second dose of Gardasil (Lot #653736/0014U) and on 19-JUN-2007 received a third dose of (Lot #657005/0314U). The patient found out she was pregnant, with a last menstrual period date of 09-APR-2007. On 27-JUN-2007 and 16-JUL-2007 (IUP 8 weeks 2 days), the patient had an ultrasound which confirmed the dates. The estimated date of deliver is 14-JAN-2008. Follow-up information was received from the physician. Concomitant therapy also included iron supplements. The estimated conception date was 02-JUN-2007, based on 16-JUL-2007 "us". On 16-DEC-2007 the patient had amniocentesis for suspected malformation lower extremities. On an unspecified date a fetal MRI was performed for screening of Pruder Willi, mytonic dystrophy and spinal muscular dystrophy; the results were negative. On 16-FEB-2008 the patient delivered a baby boy weighing 7 pounds and 15 ounces, 19 cm in length, head circumference of 14 mm with an Apgar score of 8/9. The baby was not born normal. The baby was born with club feet, congenital dislocation of the hip and malformation of the knees. On an unspecified date an amniotic fluid analysis was performed and was "PFP" within normal limits and a chromosomal analysis (karotype) was performed and the results were (L46, XY). The physician felt that club feet, congenital dislocation of the hip and malformation of the knees was a congenital anomaly. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a licensed practical nurse (LPN) and a healthcare professional, concerning a 17 year old female patient with no pertinent medical history and no prior pregnancies, who had her LMP on 25-MAY-2007, was unknowingly pregnant, and on 13-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided).  There was no concomitant medication.  Following the vaccination, the patient took a home pregnancy test, and determined that she was pregnant (estimated date of delivery was 29-FEB-2008).  The patient was examined in the office, and the LPN indicated that there were no problems reported.  Follow up information indicated that on 11-SEP-2007, the patient experienced a spontaneous abortion (< 20 weeks).  No other details were provided.  Upon internal review, "spontaneous abortion (< 20 weeks)" was considered to be serious as an other important medical event.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Disorientation, Muscle rigidity
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with two previous doses of Gardasil on unspecified dates (lot number, site and route not reported).  On approximately 22-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot number, site and route not reported).  Subsequently, after the third dose, the patient had a "seizure" according to the physician's office.  The patient had her head slumped in her hands and she was "rigid".  The patient became disoriented and did not know the time and date.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No further information was provided.  Upon internal review seizure was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 mL dose of Gardasil and fainted.  It was also reported that the patient's blood pressure dropped to 20/70 and she had to be taken to the hospital.  No further information was provided.  Outcome was not reported.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with "no seizure history" who on an unknown date was vaccinated with a first dose of GARDASIL at her pediatrician's office. Subsequently, the patient experienced seizures. She was taken to the emergency room. On an unknown date, the patient recovered. No product quality complaint was involved. Upon internal review seizures was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PPV, RV5
Symptoms: Abdominal pain, Dehydration, Intussusception, Malaise, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a 24 week old male with no pertinent medical history who on 16-NOV-2007 and 18-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# 657671/0902U, 657635/0770U).  On 07-MAR-2008 the patient experienced illness with vomiting for 24 hours and was seen in the physician's office on 08-MAR-2008.  On 08-MAR-2008 the patient was diagnosed with intussusception characterized by vomiting, dehydration and abdominal pain and was hospitalized for one night for observation.  There was no diarrhea or blood in the stool reported.  The patient was treated with IV rehydration in the emergency room.  The intussusception was successfully reduced via air enema.  It was noted that on 18-MAR-2008 the patient received the third dose of ROTATEQ (lot# 659917/0017X).  Therapy with ROTATEQ was discontinued.  On 09-MAR-2008 the patient was discharged from the hospital and was recovered.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event by the physician.  Additional information has been requested. 4/28/08-records received for DOS 3/8-3/9/08-DC DX: Intussusception. Presented to ED with 1 1/2 day C/O vomiting, dehydration and fever 101. No currant jelly or bloody stools.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PPV, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 24 week old male with no pertinent medical history who on 16-NOV-2007 and 18-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# 657671/0902U, 657635/0770U).  On 07-MAR-2008 the patient experienced illness with vomiting for 24 hours and was seen in the physician's office on 08-MAR-2008.  On 08-MAR-2008 the patient was diagnosed with intussusception characterized by vomiting, dehydration and abdominal pain and was hospitalized for one night for observation.  There was no diarrhea or blood in the stool reported.  The patient was treated with IV rehydration in the emergency room.  The intussusception was successfully reduced via air enema.  It was noted that on 18-MAR-2008 the patient received the third dose of ROTATEQ (lot# 659917/0017X).  Therapy with ROTATEQ was discontinued.  On 09-MAR-2008 the patient was discharged from the hospital and was recovered.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event by the physician.  Additional information has been requested. 4/28/08-records received for DOS 3/8-3/9/08-DC DX: Intussusception. Presented to ED with 1 1/2 day C/O vomiting, dehydration and fever 101. No currant jelly or bloody stools.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received through the pregnancy registry from a physician concerning a 24 year old female nursing student with attention deficit disorder, seasonal allergies, and no allergies to medications, who on 07-FEB-2008 was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX.  Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS) and cetirizine hydrochloride (ZYRTEC).  The patient became pregnant on 14-FEB-2008.  It was reported that the patient had not experienced any difficulties at the time of the report.  The patient was seen in the office.  No product quality complaint was involved.  No other information was provided.  Follow-up information received from a registered nurse indicated that on 08-MAR-2008 or 08-MAR-2008 the patient had a spontaneous abortion.  Additional information is not expected.  Upon internal review the patient's spontaneous abortion was determined to be an other important medical event.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a registered nurse concerning a 66-year-old male with no pertinent medical history or allergies who on 01-APR-2008 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 659759/1873U).  There was no concomitant medication.  On 02-APR-2008, 1 day post vaccination, the patient developed left-sided Bell's palsy.  It was noted the patient began to have difficulty moving the left side of his lips about one hour and twenty minutes post vaccination.  The patient could not move the entire left side of his face within two hours of receiving Zostavax (Oka/Merck).  The patient sought medical attention and was examined by a nurse.  The patient had been referred for an evaluation by his physician.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Left-sided Bell's palsy is considered an other medically important event (OME).  Additional information has been requested. 4/21/08-records received-4/2/08- Bell's palsy, symptoms began 1 1/2 hours after vaccination. C/O left hand weakness, eye drooping.
Age: 1.2
Sex: M
Vaccine: PNC, MMR
Symptoms: Autism
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer, and verified by a healthcare professional regarding a male patient who experienced autism. The patient received a dose on an unspecified date. The patient's younger brother developed autism in May-2005, see related case: US-WYE-H03437408. Product was administered on an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced autism. The patient's outcome is unknown. See related case(s): US-WYE-H03437408 (adverse event, expedited). No additional information was available at the time of this report.
Age: 1.2
Sex: M
Vaccine: PNC, MMR
Symptoms: Autism, Developmental delay, Sensory disturbance, Speech disorder
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer, and verified by a healthcare professional regarding a male patient who experienced autism. The patient received a dose on an unspecified date. The patient's younger brother developed autism in May-2005, see related case: US-WYE-H03437408. Product was administered on an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced autism. The patient's outcome is unknown. See related case(s): US-WYE-H03437408 (adverse event, expedited). No additional information was available at the time of this report.
Age: 0.7
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC
Symptoms: Autism, Hair metal test, Neuropsychological test
Clinical narrative: This case was considered medically important. Information regarding Prevenar was received from a consumer and verified with a healthcare professional, regarding a 7-year-old male patient who experienced autism. The patient received the third dose of Prevenar on 15-Oct-2001. The patient also received the third dose of Recombivax-Hb (Merck) and the third dose of Infanrix (GlaxoSmithKline) on 15-Oct-2001. The patient's older brother also developed autism (date unspecified). See related case US-WYE-H03499608. Product was administered on 15-Oct-2001. Additional suspect vaccines included Acel-Immune/Wyeth, Infanrix (GlaxoSmithKline), Recombivax-Hb (Merck), Pedvax-Hib (Merck), Poliomyelitis Vaccine Inactivated (manufacturer unknown), Hib-Titer/Wyeth, Varivax (Merck), M-M-R II (Merck) and Ipol (Aventis). Concomitant medications were not reported. The patient experienced autism in May-2005. The patient has not recovered. Neuropsychological test (results: not available) and hair metal test (results: not available) were done on an unspecified date. See related case(s): US-WYE-H03499608 (adverse event, expedited). No additional information was available at the time of this report.