chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Fine motor skill dysfunction, Flavivirus test negative, Fungal test negative
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Gross motor delay, HIV test negative, Hemiparesis, Hepatitis, Hepatitis viral test negative
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Human metapneumovirus test, Hyperhidrosis, Hypersomnia, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immunology test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Lethargy, Mitral valve incompetence, Motor dysfunction, Muscle tightness
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscle twitching, Musculoskeletal disorder, Musculoskeletal stiffness, Mycoplasma test negative, Mydriasis
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Myocarditis, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Ocular hyperaemia, Pallor
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Palpitations, Parasite urine test negative, Polymerase chain reaction, Postictal state, Posture abnormal
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Respiration abnormal, Respiratory arrest, Respiratory syncytial virus test negative, Roseolovirus test positive
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Seizure, Skin warm, Somnolence, Supraventricular tachycardia, Tonic clonic movements
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Toxoplasma serology negative, Transaminases increased, Tremor, Trismus, Troponin increased
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Typhus rickettsia test, Unresponsive to stimuli, Varicella virus test negative, Viral test negative, West Nile virus test negative
Clinical narrative: 8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026829 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 22 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site mass, Injection site reaction
Clinical narrative: Case number PHEH2015US023193, is an initial spontaneous report received from a consumer on 05 Nov 2015 and follow up received on 05 Nov 2015 (combined report). This report refers to a 51 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157102) intramuscularly on 18 Sep 2015. On the same day after vaccination, the patient experienced a small lump on arm with light burning sensation around injection site since shortly after receiving the shot. The outcome of the events was not reported. The seriousness and causality of the events were unknown.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026839, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 24 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026840, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026841, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 56 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 08 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Product leakage
Clinical narrative: Case number PHEH2015US024595, is an initial spontaneous report from a pharmacist (also patient) received on 20 Nov 2015. This report refers to a 33 years old female patient. Medical history and concomitant medications were not reported. On 06 Nov 2015 when the pharmacist was withdrawing the first dose from MDV of FLUVIRIN (batch number: 1514801) the vial leaked on to her skin. The vial leaked from area of metal collar. After exposure the pharmacist washed her hands and had no redness or other symptoms. No additional information was available.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US024663 is a spontaneous report initially received from a pharmacist on 20 Nov 2015. This report refers to a 61 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514801, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up information received from a pharmacist on 20 Nov 2015: Expiry date of vaccine updated.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024664 is an initial spontaneous report received from a pharmacist on 20 Nov 2015. This report refers to a 62 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN(batch number: 1514801) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the maladministration.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Abdominal pain upper, Cardiomegaly, Decreased appetite, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: KAWASAKI SYNDROME; Fever for more than 9 days high of 104.  Blood shot eyes. True Lethargy; anorexic, stomach pain.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Lethargy, Ocular hyperaemia, Pyrexia
Clinical narrative: KAWASAKI SYNDROME; Fever for more than 9 days high of 104.  Blood shot eyes. True Lethargy; anorexic, stomach pain.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Hypoaesthesia, Injection site pain
Clinical narrative: Patient received Tdap on Right Arm and experienced extreme muscle pain around the injection site. The forearm began to feel numb. Eventually the pain spread to the armpit and became painful in that region. Pt took Tylenol and the pain has improved. He had to be seen by a urgent care clinic whose providers suggested careful monitoring for the next couple days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain upper, Bacterial test negative, Diarrhoea, Faecal calprotectin abnormal
Clinical narrative: Watery diarrhea, stomach cramps, gas, and bloating that lasted 4 weeks!! He had to go to urgent care twice. He got stool and blood tests for bacteria and parasites that came out negative. He also got stool Calprotectin test that showed inflammation of the intestines.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Flatulence, Gastrointestinal inflammation, Parasite blood test, Parasite stool test negative
Clinical narrative: Watery diarrhea, stomach cramps, gas, and bloating that lasted 4 weeks!! He had to go to urgent care twice. He got stool and blood tests for bacteria and parasites that came out negative. He also got stool Calprotectin test that showed inflammation of the intestines.
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Presented to ER with whole body shaking along with fever 102.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Headache, Musculoskeletal disorder, Nausea, Pain in extremity
Clinical narrative: Severe soreness to left arm, could not use extremity at all, weakness, headache, severe nausea. Took 800 mg po of Motrin every 8 hrs. Thereafter. Symptoms have continued for more than 24 hrs.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 4inch in diameter raised red area around injection site, warmth and hardness to site. States it does itch Employee has no other complaints associated with site or health.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Faeces discoloured, Restlessness, Vomiting
Clinical narrative: Mom called on 12/15/2016 @11:50 AM and said that patient was having  diarrhea and vomiting a lot last night about 4-6 times she said it was a lot like everything for the past 2 days. His diarrhea was an orange rusty color. He hasn't had any fever, he was very restless last night 12/14/2016 more than normal. He hasn't thrown up this morning 12/15/2016 but he did have the diarrhea this morning. He is acting more normal today 12/15/2016. He is taking his nap right now but other than that he seems pretty normal, he did want to lay on the couch a little but right before his nap. Mom was wondering if it could be from the vaccine from yesterday 12/14/2016 or if he caught something at the daycare at the gym yesterday. Medical Assistant spoke to Physician and she informed me to let mom know that it could possibly be from the vaccine, or could possibly be that he caught something from the daycare at the gym. Physician also said to let mom know to bump up his probiotic and make sure to keep him nice and hydrated, and if he is not getting better by tomorrow to give us a call. Mom was happy with the call and said that she will let us know how he is doing and i told her i would call her in the am to check and see how patient was doing. She said she is making him soup right now and she will call us if anything changes. 12/16/2016  Medical Assistant called mom and asked her how patient doing and she said that he is better hasn't thrown up but has had the really bad diarrhea still. He had two yesterday that were super full, one was a rusty color and the other one was a yellowish color. Before he went to bed he did have a little fever it was 100 but he slept ok. He didn't want to eat anything yesterday and this morning he only ate toast. Yesterday every time she tried to feed him he gagged like he was going to vomit. He is still drinking great and taking his probiotics. They are going to be traveling starting Sunday and mom wanted to know if she should give patient anything else to kind of support his immune system like the immunogen(immune support Homeopathic) because he always seems to catch something when they travel.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Posture abnormal, Staring, Unresponsive to stimuli
Clinical narrative: Child slumped over, unresponsive, stared blankly, lasted under 30 seconds/this happened two times after and then not since.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt, reported to me on am of 1/19/2017 that experienced pain at inj. site then swelling began in evening and continued through next day. Reported pain gone now and swelling not getting worse.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via eye contact, Eye irrigation, Eye pain
Clinical narrative: Case number PHEH2015US025058 is an initial spontaneous report received from a pharmacist on 28 Nov 2015. This report refers to a male patient (also the reporter) of an unknown age. Medical history and concomitant medications were not reported. On an unknown date, the patient was accidently exposed to FLUVIRIN (batch number: not reported) as the vaccine splashed into his eyes while he was trying to draw up FLUVIRIN into a syringe. The patient rinsed out his eyes, but his eyes stung a little bit. The outcome of the events was reported as unknown. Seriousness and causality of the events were not reported.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Eczema, Rash pruritic
Clinical narrative: Case number PHEH2015US025162 is an initial spontaneous report received from a pharmacist on 30 Nov 2015. This report refers to a 60 year old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) last year with no problems. The patient was vaccinated with FLUVIRIN (batch number: 158303) intramuscularly into left arm on 29 Nov 2015. On 30 Nov 2015, the patient experienced itchy rash on right arm between elbow and wrist. The pharmacist reported it as eczema type rash. The patient had no big hives. The outcome of the events was reported was unknown. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025181, is an initial spontaneous report received from a health care professional on 01 Dec 2015. This report refers to a 40-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157104) intramuscularly on 01 Dec 2015 which was stored out of temperature range at 53 Fahrenheit for 24 hours. No adverse event was reported following this medication error.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025186, is an initial spontaneous report received from a medical assistant on 01 Dec 2015. This report refers to a 61-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 173538) at a dose of 0.5 ml intramuscularly on 16 Oct 2015 which was stored out of temperature range first time at 32 Fahrenheit and second time at 48.7 Fahrenheit. No adverse event was reported following this medication error.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026830 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly in to left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked he temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 30-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection (lot # M031557, expiration date: 07-APR-2019) for prophylaxis (strength and route was not provided), rather that the intended VAQTA, due to human error. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.