chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Differential white blood cell count normal, Dyskinesia, Emotional distress, Eosinophil percentage decreased
Clinical narrative: Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Flatulence, Full blood count, Gastritis, Irritability, Monocyte percentage
Clinical narrative: Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage, Opisthotonus, Pyrexia, Screaming, Urine analysis normal
Clinical narrative: Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Pyrexia, Radiography guided aspiration
Clinical narrative: Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.
Age: 13.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Six hours after first dose oral Typhoid developed significant stomach ache and emesis. Followed directions for self administration and maintained the cold chain.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pat. developed a 12cm in diameter red, hot, swollen area on left deltoid on 22nd April where the vaccine had been administered. Pat. received antibiotic treatment for cellulitis of left deltoid and was discharged on 04/23/12.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blindness, Dark circles under eyes, Hyperhidrosis, Hypoaesthesia, Pallor
Clinical narrative: Sudden loss of vision, "seeing dark circles", not being able to feel legs and hands, was reported by patient within seconds of vaccine administration. Pt diaphoretic, pale and trembling. 3-5 minutes after that, patient reported being able to see clear without problem, was able to feel legs and hands, except for some numbness on (R) leg. Vital signs monitored for 30-40 min. Patient taken to family doctor.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Sensory loss, Tremor
Clinical narrative: Sudden loss of vision, "seeing dark circles", not being able to feel legs and hands, was reported by patient within seconds of vaccine administration. Pt diaphoretic, pale and trembling. 3-5 minutes after that, patient reported being able to see clear without problem, was able to feel legs and hands, except for some numbness on (R) leg. Vital signs monitored for 30-40 min. Patient taken to family doctor.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction, Pallor, Sensory loss
Clinical narrative: Sudden loss of vision, "seeing dark circles", not being able to feel legs and hands, was reported by patient within seconds of vaccine administration. Pt diaphoretic, pale and trembling. 3-5 minutes after that, patient reported being able to see clear without problem, was able to feel legs and hands, except for some numbness on (R) leg. Vital signs monitored for 30-40 min. Patient taken to family doctor.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Sudden visual loss, Tremor, Visual impairment
Clinical narrative: Sudden loss of vision, "seeing dark circles", not being able to feel legs and hands, was reported by patient within seconds of vaccine administration. Pt diaphoretic, pale and trembling. 3-5 minutes after that, patient reported being able to see clear without problem, was able to feel legs and hands, except for some numbness on (R) leg. Vital signs monitored for 30-40 min. Patient taken to family doctor.
Age: 0.32
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site reaction, Petechiae
Clinical narrative: Baby rec'd 4mo vaccines - PENTACEL given (R) thigh: w/in 5min -> erythema only. By 10 minutes, increased erythema. By 15min erythema & induration of thigh to midcalf. TYLENOL & ice pack given. By 30-40min, erythema to groin and petechiae to lower leg. BENADRYL given. 20min later - erythema gone/petechiae remained at D/C mild induration O2 sat & BP stable throughout. Of note -> 1 petechiae on opposite calf also.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Patient had localized pain at site of vaccine as expected. She had increased pain and some redness on 4/29/12. Patient came by 4/30/12 localized reaction (L) delt 4x8 cm warm to touch. Called patient today 5/1/12, pain & redness improving.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic hyporesponsive event approx 8-12 hr after receiving vaccine.
Age: 20.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: CSF test, Dyskinesia, Lumbar puncture, Muscular weakness, Tremor
Clinical narrative: Generalized tremors and increasing lower extremity weakness. Body moving as if in a swing.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Decreased appetite, Lethargy, Somnolence
Clinical narrative: After PENTACEL, Hep B, PREVNAR, Rotavirus given at 6 weeks old child had crying, then lethargy -> extreme for 2 d -> hardly ate then sleepy for 5 more days. Not seen by any doctor. Reported by mom now.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: More than usual swelling at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site joint swelling
Clinical narrative: 04/26/2012 Moderate Other Pt had PNUE23 in left arm. Had swelling to elbow. Went to urgent care and received steroids.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen area about 4 inches in diameter around the injection site.  Patient said it felt a little tender, but no more than any other injection site would.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Amino acid level normal, Ammonia normal, Blood cortisol normal, Blood creatine phosphokinase normal, Blood electrolytes normal
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Blood growth hormone normal, Blood lactic acid normal, Bradycardia, CSF culture, CSF glucose normal
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: CSF protein increased, CSF white blood cell count negative, Carnitine decreased, Central venous catheterisation, Condition aggravated
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Culture urine, Culture urine positive, Cytogenetic analysis normal, Electroencephalogram normal, Enterovirus test negative
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Epstein-Barr virus test negative, Herpes simplex serology negative, Hypoglycaemia, Liver function test normal, Lumbar puncture
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Miosis, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Postictal state, Pyrexia
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Red blood cells CSF positive, Somnolence, Thyroid function test normal, Urinary tract infection, Urine analysis normal
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 0.23
Sex: F
Vaccine: IPV, PNC13
Symptoms: Viral test negative
Clinical narrative: Patient is a 3 M female former FT infant (parents are first cousins) with recurrent episodes of desaturations/apnea, hypoventilation, poor feeding, hypersomnia, DI, and suspected GH deficiency. Patient was seen briefly on 3/21 to make recommendations for IZs and patient received HBV#2 (3/23), IPV#1 (3/25), Prevnar-13 #1 (3/25), and Hib #1 (3/23), and synagis on 3/23. Infant has had renal US demonstrating Grade I hydronephrosis and borderline HSM in January and recent US in March shows improvement in hydronephrosis. UTI in January and again at the end of March had a positive urine bag specimen that was rechecked by cath and was negative. The second urine culture was obtained because of persistent hypoglycemia. Has had normal EEGs, normal urine organic acids, plasma amino acids, ammonia, serum cortisol, HGH, electrolytes, CK, LFTs, lactate, TFTs, and so far normal genetic testing except for a low carnitine for which supplementation was started. An MRI was obtained which was not a great study (motion artifact) but no clear pathology. FHx is significant for consanguinuity (first cousins). Started on GH on 4/5 More recently, she developed episodes of abrupt apnea while maintaining normal HR, associated with pinpoint pupils lasting 1-2 minutes with post-ictal sleepiness. Repeat EEG was negative but started on Phenobarb and because of continued issues, this was increased. She had a low-grade fever on 4/11 but spiked on 4/12 to 101.1 and was started on Vancomycin and Cefotaxime. Underwent placement of central line- ultimately a femoral line- and also underwent an LP that had 17 WBC, 35 RBC, a glucose of 62 and a protein of 131. Antimicrobials were stopped around 2200 on 4/14 as CSF culture and HSV/EV PCRs were negative. Viral culture of CSF still pending. Started to have fevers of 100.7 and 100.4 on 4/15 and 4/16 respectively. Several staff have documented that the fevers seem to follow these episodes. A repeat MRI has been ordered for tomorrow. ID was asked to weigh in on potential infectious differentials.  There has been progressive worsening of her episodes of profound apnea/desaturation/bradycardia and in terms of long term outcomes it's not clear as she may die from this illness. Not clear if this is associated with IZs either though timing is concerning. She had not gotten DTaP because of the concern of an evolving neurologic process. Whether there was an underlying metabolic process was then unclear and is currently unclear.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness, Radial pulse abnormal, Slow response to stimuli
Clinical narrative: Received vaccination at the workplace, and returned to his job in the kitchen. Approximately 5 minutes after he received the IZ, patient lost conciousness and fell on the heavy rubber floor mat of the kitchen. He was BP was 90/44 and faint radial pulse, slow to respond. EMT were called.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Chest pain, Fatigue, Gastrointestinal disorder, Insomnia, Muscle spasms
Clinical narrative: EXTREME FATIGUE INVOLUNTARY MUSCLE CRAMPING CHEST PAINS FOCUS ISSUES INTERRUPTIONS IN SLEEP UNABLE TO SLEEP FOR MORE THAN 3 HOURS OR LESS AT A TIME...
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Erythema, swelling, tenderness and itching at site of injection of TdaP and MENACTRA immunizations, as well as fever to 102 degrees F for 3 days.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: Pt erupted in vesicles (shingles) & (L) axilla 3-4 d's after administration of Varicella #2 vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 4/26/12 LA hot to touch, edematous, red down to elbow. No pain on movement. Advised GM to administer ADVIL & BENADRYL as directed, warm compresses to affected area.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Information has been received from a physician concerning a 50 year old female patient who on 17-FEB-2012, was vaccinated at local pharmacy with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that the patient called on Monday 20-FEB-2012, complaining of fever of 101, swelling in left arm (injection site), general aches, headache, coughing, "pleuritis" and also right arm (non injection site arm) pain. The general concern was that the symptoms were systemic and not confined to the injection site. The patient was using TYLENOL and ADVIL alternatively to control fever but the effects wear off and fever returns. The physician stated that the patient did not report any rash or vesicles. No lab diagnostic tests were performed. At the time of the report the patient's events had not improved. Follow up information has been received from a physician concerning a 50 year old house wife with sinusitis, idiopathic neuropathy and a history of febrile infection to tetanus (104 fever in past), past drug therapy of MOBIC (rash), NUERONTIN and BIAXIN who on 18-FEB-2012 (also reported as 15-FEB-2012) was vaccinated IM with ZOSTAVAX (Merck) at pharmacy. Concomitant therapy included MINOCIN. On 19-FEB-2012 the patient experienced tenderness at injection site of inoculation. On 20-FEB-2012 red arm was with swelling, no vesicles. Left axillary was swelling headaches and fever on 102-104 with signs. The patient had idiopathic neuropathy that made neuropathy symptoms worse was on MINOCIN. On 21-FEB-2012, therapy with MINOCIN was discontinued due to fever (for sinusitis). On an unspecified date a work up with in "lnss" and chest x-ray (CXR) was performed (with normal limits). On an unspecified date, amoxicillin was given to the patient. On 08-FEB-2012 fever was gone. Amoxicillin helped sinusitis clear up. New pain symptoms grow. An unspecified prescription drug was given for the treatment of the adverse events. The experienced was not still being treated. At the time of the report, (8 days later), the patient recovered from pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness. Pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness were considered to be an other important medical event by the physician because it required medical/surgical intervention to prevent the outcomes listed. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Cough, Erythema, Headache, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 50 year old female patient who on 17-FEB-2012, was vaccinated at local pharmacy with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that the patient called on Monday 20-FEB-2012, complaining of fever of 101, swelling in left arm (injection site), general aches, headache, coughing, "pleuritis" and also right arm (non injection site arm) pain. The general concern was that the symptoms were systemic and not confined to the injection site. The patient was using TYLENOL and ADVIL alternatively to control fever but the effects wear off and fever returns. The physician stated that the patient did not report any rash or vesicles. No lab diagnostic tests were performed. At the time of the report the patient's events had not improved. Follow up information has been received from a physician concerning a 50 year old house wife with sinusitis, idiopathic neuropathy and a history of febrile infection to tetanus (104 fever in past), past drug therapy of MOBIC (rash), NUERONTIN and BIAXIN who on 18-FEB-2012 (also reported as 15-FEB-2012) was vaccinated IM with ZOSTAVAX (Merck) at pharmacy. Concomitant therapy included MINOCIN. On 19-FEB-2012 the patient experienced tenderness at injection site of inoculation. On 20-FEB-2012 red arm was with swelling, no vesicles. Left axillary was swelling headaches and fever on 102-104 with signs. The patient had idiopathic neuropathy that made neuropathy symptoms worse was on MINOCIN. On 21-FEB-2012, therapy with MINOCIN was discontinued due to fever (for sinusitis). On an unspecified date a work up with in "lnss" and chest x-ray (CXR) was performed (with normal limits). On an unspecified date, amoxicillin was given to the patient. On 08-FEB-2012 fever was gone. Amoxicillin helped sinusitis clear up. New pain symptoms grow. An unspecified prescription drug was given for the treatment of the adverse events. The experienced was not still being treated. At the time of the report, (8 days later), the patient recovered from pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness. Pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness were considered to be an other important medical event by the physician because it required medical/surgical intervention to prevent the outcomes listed. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Oedema peripheral, Pain, Pain in extremity, Pleurisy
Clinical narrative: Information has been received from a physician concerning a 50 year old female patient who on 17-FEB-2012, was vaccinated at local pharmacy with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that the patient called on Monday 20-FEB-2012, complaining of fever of 101, swelling in left arm (injection site), general aches, headache, coughing, "pleuritis" and also right arm (non injection site arm) pain. The general concern was that the symptoms were systemic and not confined to the injection site. The patient was using TYLENOL and ADVIL alternatively to control fever but the effects wear off and fever returns. The physician stated that the patient did not report any rash or vesicles. No lab diagnostic tests were performed. At the time of the report the patient's events had not improved. Follow up information has been received from a physician concerning a 50 year old house wife with sinusitis, idiopathic neuropathy and a history of febrile infection to tetanus (104 fever in past), past drug therapy of MOBIC (rash), NUERONTIN and BIAXIN who on 18-FEB-2012 (also reported as 15-FEB-2012) was vaccinated IM with ZOSTAVAX (Merck) at pharmacy. Concomitant therapy included MINOCIN. On 19-FEB-2012 the patient experienced tenderness at injection site of inoculation. On 20-FEB-2012 red arm was with swelling, no vesicles. Left axillary was swelling headaches and fever on 102-104 with signs. The patient had idiopathic neuropathy that made neuropathy symptoms worse was on MINOCIN. On 21-FEB-2012, therapy with MINOCIN was discontinued due to fever (for sinusitis). On an unspecified date a work up with in "lnss" and chest x-ray (CXR) was performed (with normal limits). On an unspecified date, amoxicillin was given to the patient. On 08-FEB-2012 fever was gone. Amoxicillin helped sinusitis clear up. New pain symptoms grow. An unspecified prescription drug was given for the treatment of the adverse events. The experienced was not still being treated. At the time of the report, (8 days later), the patient recovered from pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness. Pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness were considered to be an other important medical event by the physician because it required medical/surgical intervention to prevent the outcomes listed. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 50 year old female patient who on 17-FEB-2012, was vaccinated at local pharmacy with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that the patient called on Monday 20-FEB-2012, complaining of fever of 101, swelling in left arm (injection site), general aches, headache, coughing, "pleuritis" and also right arm (non injection site arm) pain. The general concern was that the symptoms were systemic and not confined to the injection site. The patient was using TYLENOL and ADVIL alternatively to control fever but the effects wear off and fever returns. The physician stated that the patient did not report any rash or vesicles. No lab diagnostic tests were performed. At the time of the report the patient's events had not improved. Follow up information has been received from a physician concerning a 50 year old house wife with sinusitis, idiopathic neuropathy and a history of febrile infection to tetanus (104 fever in past), past drug therapy of MOBIC (rash), NUERONTIN and BIAXIN who on 18-FEB-2012 (also reported as 15-FEB-2012) was vaccinated IM with ZOSTAVAX (Merck) at pharmacy. Concomitant therapy included MINOCIN. On 19-FEB-2012 the patient experienced tenderness at injection site of inoculation. On 20-FEB-2012 red arm was with swelling, no vesicles. Left axillary was swelling headaches and fever on 102-104 with signs. The patient had idiopathic neuropathy that made neuropathy symptoms worse was on MINOCIN. On 21-FEB-2012, therapy with MINOCIN was discontinued due to fever (for sinusitis). On an unspecified date a work up with in "lnss" and chest x-ray (CXR) was performed (with normal limits). On an unspecified date, amoxicillin was given to the patient. On 08-FEB-2012 fever was gone. Amoxicillin helped sinusitis clear up. New pain symptoms grow. An unspecified prescription drug was given for the treatment of the adverse events. The experienced was not still being treated. At the time of the report, (8 days later), the patient recovered from pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness. Pain, erythema, headache, injection site swelling, pain in extremity, pyrexia and tenderness were considered to be an other important medical event by the physician because it required medical/surgical intervention to prevent the outcomes listed. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Biopsy bone marrow normal, Biopsy muscle abnormal, Blood lactate dehydrogenase normal, Computerised tomogram abdomen normal, Computerised tomogram normal
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She underwent incisional biopsy that demonstrated B-cell type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Computerised tomogram thorax normal, Extranodal marginal zone B-cell lymphoma (MALT type), Immunohistochemistry, Injection site mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She underwent incisional biopsy that demonstrated B-cell type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.