chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 24 year old female who on 26-AUG-2008 was vaccinated with a first dose of GARDASIL (lot # 660620/0571X). There was no concomitant medication. On an unspecified date, she became pregnant. The date of last menstrual period was 09-SEP-2008. On 05-NOV-2008, approximately 7 weeks from the date of last menstrual period, the patient experienced spontaneous abortion. No product of conception was examined. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyspnoea, Intensive care, Rash generalised, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 20 year old female patient with polycystic ovarian syndrome, depression, asthma and insulin resistance, and no known drug reactions or allergies who on 16-SEP-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL (lot# 660618/0572X). Concomitant therapy included ZOVIA, GLUCOPHAGE, spironolactone, XANAX, PROZAC, trazodone HCl and METADATE. The medical assistant reported that the patient experienced rash all over her body a week after getting vaccinated (approximately 23-SEP-2008). On 11-NOV-2008 the patient received the second dose of GARDASIL (lot# 661044/0548X) and reported the rash. On the night of 11-NOV-2008 the patient had trouble breathing and fainted. On 12-NOV-2008 the patient experienced 2 seizures at school and went to the emergency room and was hospitalized. During her hospitalization, the patient had 8 to 10 seizures and was transferred to the intensive care unit. On 18-NOV-2008 the patient was released because she was seizure-free. On the weekend of 22-NOV-2008 the patient was admitted to the hospital because of more seizures. She was still in the care of the hospital. Rash all over her body, trouble breathing, fainted, and seizures were considered to be other important medical events. Additional information has been requested.  12/31/08 Reviewed hospital medical records of 11/12-11/14/2008 FINAL DX: possible pseudoseizures vx seizure disorder Records reveal patient experienced fever, chills, felt unwell after HPV#2, 0548X, received 11/11/2008.  Had cold sore on day of vaccination.  Had witnessed tonic-clonic seizure activity w/tongue biting, loss of consciousness, & postictal confusion. Neuro consult done & tx w/antiseizure meds.  ICU stay.  D/C to home w/neuro & psych f/u.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified medical assistant concerning a 20 year old female patient with polycystic ovarian syndrome, depression, asthma and insulin resistance, and no known drug reactions or allergies who on 16-SEP-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 ml dose of GARDASIL (lot# 660618/0572X). Concomitant therapy included ZOVIA, GLUCOPHAGE, spironolactone, XANAX, PROZAC, trazodone HCl and METADATE. The medical assistant reported that the patient experienced rash all over her body a week after getting vaccinated (approximately 23-SEP-2008). On 11-NOV-2008 the patient received the second dose of GARDASIL (lot# 661044/0548X) and reported the rash. On the night of 11-NOV-2008 the patient had trouble breathing and fainted. On 12-NOV-2008 the patient experienced 2 seizures at school and went to the emergency room and was hospitalized. During her hospitalization, the patient had 8 to 10 seizures and was transferred to the intensive care unit. On 18-NOV-2008 the patient was released because she was seizure-free. On the weekend of 22-NOV-2008 the patient was admitted to the hospital because of more seizures. She was still in the care of the hospital. Rash all over her body, trouble breathing, fainted, and seizures were considered to be other important medical events. Additional information has been requested.  12/31/08 Reviewed hospital medical records of 11/12-11/14/2008 FINAL DX: possible pseudoseizures vx seizure disorder Records reveal patient experienced fever, chills, felt unwell after HPV#2, 0548X, received 11/11/2008.  Had cold sore on day of vaccination.  Had witnessed tonic-clonic seizure activity w/tongue biting, loss of consciousness, & postictal confusion. Neuro consult done & tx w/antiseizure meds.  ICU stay.  D/C to home w/neuro & psych f/u.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a certified nurse midwife (C.N.M.) concerning a 21 year old female who on 18-SEP-2007 (lot # 658558/1061U), 13-NOV-2007 (lot # 659435/1265U) and 25-MAR-2008 (660387/1967U) was vaccinated with the first, second and third dose of GARDASIL in the deltoid respectively. The patient had 3 negative pap smears results since 2006. She was determined to HPV high risk on 03-NOV-2008 with a positive result. The patient underwent a colposcopy procedure related to abnormal paps. The patient had been sexually active prior to GARDASIL and described "occl" condom use. The C.N.M. considered the positive HPV to be disabling. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechial rash started 7 days after flu shot.  Dx with ITP.  12/17/2008 MR received for DOS 11/17-18/2008 with DX:  ITP. Pt presented several day hx of rash and bleeding lesions.  Petechial rash and bruising noted on lower extremities, small sclera bleed, and lip bleeding on PE.  Treated with WinRho and developed vomiting H/A and chills which resolved.  D/C to f/u as outpt.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Aggression, Confusional state, Fungal infection, Irritability, Local swelling
Clinical narrative: Extreme red splotches that ran together.  Extreme pain and became giant splotches covered from head to toes.  Groin area very swollen, face swollen, fungal infection in mouth & on mouth.  Extreme irritability, close to combative, face some swollen, confusion.  ETC, fever 103.9 first day 11/27/08. 12/3/08-records received-11/27/08-admitted with diffuse rash all over after taking Bactrim and hypoglycemic episode.  DX: Stevens-Johnson syndrome due to mostly likely Bactrim. 1/13/09-Discharge summary received for DOS 11/27-12/6/08-DC DX: Primary Cause of Death-Toxic epidermal necrolysis secondary to either Bactrim or Dilantin. Other diagnoses: Acute renal failure/chronic renal failure. Diabetes mellitus. Coronary artery disease. Atrial fibirllation.  Patient expired 12/6/08.  3/10/09-death certificate received-COD-toxic epidermal necrolysis. Exposure to either Bactrim or Dilantin. other significant conditions:Acute and chronic renal failure, CAD, A fibrillation. Diabetes Mellitus.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Extreme red splotches that ran together.  Extreme pain and became giant splotches covered from head to toes.  Groin area very swollen, face swollen, fungal infection in mouth & on mouth.  Extreme irritability, close to combative, face some swollen, confusion.  ETC, fever 103.9 first day 11/27/08. 12/3/08-records received-11/27/08-admitted with diffuse rash all over after taking Bactrim and hypoglycemic episode.  DX: Stevens-Johnson syndrome due to mostly likely Bactrim. 1/13/09-Discharge summary received for DOS 11/27-12/6/08-DC DX: Primary Cause of Death-Toxic epidermal necrolysis secondary to either Bactrim or Dilantin. Other diagnoses: Acute renal failure/chronic renal failure. Diabetes mellitus. Coronary artery disease. Atrial fibirllation.  Patient expired 12/6/08.  3/10/09-death certificate received-COD-toxic epidermal necrolysis. Exposure to either Bactrim or Dilantin. other significant conditions:Acute and chronic renal failure, CAD, A fibrillation. Diabetes Mellitus.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Stomatitis, Swelling face
Clinical narrative: Extreme red splotches that ran together.  Extreme pain and became giant splotches covered from head to toes.  Groin area very swollen, face swollen, fungal infection in mouth & on mouth.  Extreme irritability, close to combative, face some swollen, confusion.  ETC, fever 103.9 first day 11/27/08. 12/3/08-records received-11/27/08-admitted with diffuse rash all over after taking Bactrim and hypoglycemic episode.  DX: Stevens-Johnson syndrome due to mostly likely Bactrim. 1/13/09-Discharge summary received for DOS 11/27-12/6/08-DC DX: Primary Cause of Death-Toxic epidermal necrolysis secondary to either Bactrim or Dilantin. Other diagnoses: Acute renal failure/chronic renal failure. Diabetes mellitus. Coronary artery disease. Atrial fibirllation.  Patient expired 12/6/08.  3/10/09-death certificate received-COD-toxic epidermal necrolysis. Exposure to either Bactrim or Dilantin. other significant conditions:Acute and chronic renal failure, CAD, A fibrillation. Diabetes Mellitus.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received ZOSTAVAX on 2/13/08 and had reported having shingles. Anti-viral and pain meds were given for ADR
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain
Clinical narrative: TDAP given 11/19/2008. 11/21/2008 general achiness all over arms, legs muscles hurt to take MOTRIN.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Started with tingling in face-right side of tongue and throat started feeling swollen-then felt pressure in (L) ear. -> Took BENADRYL 50 mg at 0900 and then 1300 but symptoms had resolved. Vitals WNL
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Severe body aches & pains.  Chills & sweats. Headache. Extreme fatigue. Slight sore throat. Suspect slight fever, but did not measure. Onset = 18hr after vaccine duration = 3 days.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Severe body aches & pains.  Chills & sweats. Headache. Extreme fatigue. Slight sore throat. Suspect slight fever, but did not measure. Onset = 18hr after vaccine duration = 3 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain
Clinical narrative: Headache, overall aches, nausea - 8hrs after lasted about - 30hrs.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Injection site erythema, Pyrexia
Clinical narrative: Immunization given 11-7-08. 11-21-08 office call for red mark on legs fever x4 days- cough. Doctor felt red mark was from a bite. Kenalog.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood product transfusion, Computerised tomogram abnormal, Cough, Diplopia
Clinical narrative: Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Miller Fisher syndrome, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Upper respiratory tract infection, Vision blurred
Clinical narrative: Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Ataxia, Blood product transfusion, Diplopia
Clinical narrative: Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diplopia, Dysarthria, Guillain-Barre syndrome, Lumbar puncture, Nasopharyngitis
Clinical narrative: Developed double vision, weakness and unsteady gait on 11/13/08 and was admitted to Hospital. History of URI for 2 days with cough. CVA was r/o by MRI and CT. Transferred to Hospital on 11/17/08 and diagnosed with GBS - Miller Fisher variant. Given IV Ig. Discharged 11/25/08 to Rehab. Still requiring maximum assistance and still with blurred vision and diplopia. 12/04/08-records received for DOS 11/18-11/25/08-DC summary not available. Prsented with C/O numbness to upper extremities progressing upwards and blurred vision. Unable to stand. Numbness descending. IVIG treatment.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt. waited in administration room for approximately 5 minutes after administration because of history of dizziness following another vaccine.  after she left room and walked down hallway she fainted.  She was unconscious very briefly.  She was  fully recovered after resting for 15 minutes and drinking juice
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Eschar, Induration, Lymphadenopathy, Paronychia
Clinical narrative: Pt received smallpox vaccine in L deltoid. He reports scratching the vaccination site with his R hand and developed induration with eschar formation on his R thumb. Eschar similar in appearance to L detoid innoculation site eschar. Pt reports biting his fingernails. He has a R thumb paronychia with cellulitis and lymphatic streaking proximally to R forearm and B/L axillary and inguinal LAD. Clinical diagnosis of R thumb autoinoculation with paronychia/cellulitis presumed to be GAS. Treated with IM ceftriaxone and PO clindamycin.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Pt received smallpox vaccine in L deltoid. He reports scratching the vaccination site with his R hand and developed induration with eschar formation on his R thumb. Eschar similar in appearance to L detoid innoculation site eschar. Pt reports biting his fingernails. He has a R thumb paronychia with cellulitis and lymphatic streaking proximally to R forearm and B/L axillary and inguinal LAD. Clinical diagnosis of R thumb autoinoculation with paronychia/cellulitis presumed to be GAS. Treated with IM ceftriaxone and PO clindamycin.
Age: 0.17
Sex: M
Vaccine: DTPPHIB, HEP, PNC
Symptoms: Crying, Injection site erythema, Irritability
Clinical narrative: VERY LG RED AREA OVER RIGHT THIGH. IRRITABLE, BUT CONSOLABLE. CRYING
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Dysphagia, Eye discharge, Eye swelling
Clinical narrative: Extreme bilat eye redness and swelling with purulent drainage. Asthma attack, coughing, trouble swallowing.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Extreme bilat eye redness and swelling with purulent drainage. Asthma attack, coughing, trouble swallowing.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Rhinorrhoea
Clinical narrative: Patient was 3 year old male with known history of asthma.  Parent provided documentation to day care informing them not to allow him to receive the intranasal flu vaccine due to contraindications and guidance from child's pediatrician.  During the schools annul flu vaccine program, the patient was given the intranasal vaccine.  As a result, the patient's mother has self reported moderate subsequent symptoms of headache and runny nose.  At this time, the patent has not sought medical care to address the symptoms noted above.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: 2 hours after vaccine given, patient had itchy 2" wheal on arm.  At 5:30 PM was 4" wheal.  Took Benadryl 50 mg po at 9:30PM.  Was still itchy but not much larger wheal.  Took Benadryl 50 mg po again.  By 7AM next morning was swollen from bottom of shoulder to top of elbow, very sensitive to touch but not as tight.  Over course of day, it went away.  No doctor contacted.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 3PM noticed itchy at site, orange sized swelling and hot to touch.  By 5PM swelled to 2" above elbow and up to site.  by 6PM took Benadryl 50 mg po.  by 7 PM entire arm swollen to just below elbow.  Next AM swelling to mid forearm, hot and red.  Ached--Tylenol for pain.  (Had taken another dose Benadryl 50 mg po at 10PM).  Stayed red, hot and swollen for 4 days and went away.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Urticaria
Clinical narrative: 11-25-08 HIVE ON KNEES, ARMS & BEHIND KNEES.  MOM INSTRUCTED TO GIVE BENADRYL.  AS OF 12-02-08 STILL HAD A FEW SMALL HIVES BUT NOT AS BAD AND NOT NEEDING BENADRYL BUT TWICE A DAY.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Heart rate normal, Pallor, Syncope
Clinical narrative: After receiving Tdap,IPV, Varicella & HepB(in that order)child bcame pale & fainted. Episode lasted approx 5 seconds-with child responding, alert & oriented.BP-90/60; Pulse-60. After 15 minutes: BP 90/60; Pulse 66. Child stated that she looked @ needle & felt "funny".
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Apnoea, Blood culture negative, Blood test normal, Convulsion, Electroencephalogram normal
Clinical narrative: 11/28 - went in for 15 month visit.  She had been congested for a couple of days, but no fever.  She was given the pneumococcal conjugate vaccine, the diphtheria tetanus & pertussis vaccine and a flu shot. She was running a low grade fever on Friday.  By Saturday afternoon, temp was running high 102's.  We called clinic who told us probaby just from vaccines, but if did not go away by Sunday to come in.  Sunday still high 102's - was giving Tylenol every 4 hours which was not reducing it at all, stopped drinking fluids.  Took to clinic around 6 pm - they told us to try alternating the Tylenol w/Ibuprofen.  Gave her Ibuprofen around 8 pm and she had a seizure at 10 pm.  She was sitting on my lap watching Elmo and had laid her head down on my lap when I heard a gurgling sound.  I pulled her back and her eyes rolled back in her head and her body was stiff.  She did not shake at that point.  She didn't appear to be breathing.  My husband grabbed her and took her our neighbor, who is a nurse.  I called 911 and went to nbr's house.  She said she was turning purple, not breathing, seizing, and said her head and maybe arms were shaking.  She said her heart was beating, but wasn't breathing so gave her some breaths.  It seems like it lasted around 5 to 10 mins.  She just started coming out of it when the EMT's got here.  They put an oxygen mask on her when they got her and took to ER. 12/04/08-records received for DOS 11/30/08-presented to ED with fever and febrile seizure became unresponsive. Decreased oral intake and decreased urine output. Fussy and crying. Overnight observation.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Fluid intake reduced, Gaze palsy, Musculoskeletal stiffness, Pyrexia, Skin discolouration
Clinical narrative: 11/28 - went in for 15 month visit.  She had been congested for a couple of days, but no fever.  She was given the pneumococcal conjugate vaccine, the diphtheria tetanus & pertussis vaccine and a flu shot. She was running a low grade fever on Friday.  By Saturday afternoon, temp was running high 102's.  We called clinic who told us probaby just from vaccines, but if did not go away by Sunday to come in.  Sunday still high 102's - was giving Tylenol every 4 hours which was not reducing it at all, stopped drinking fluids.  Took to clinic around 6 pm - they told us to try alternating the Tylenol w/Ibuprofen.  Gave her Ibuprofen around 8 pm and she had a seizure at 10 pm.  She was sitting on my lap watching Elmo and had laid her head down on my lap when I heard a gurgling sound.  I pulled her back and her eyes rolled back in her head and her body was stiff.  She did not shake at that point.  She didn't appear to be breathing.  My husband grabbed her and took her our neighbor, who is a nurse.  I called 911 and went to nbr's house.  She said she was turning purple, not breathing, seizing, and said her head and maybe arms were shaking.  She said her heart was beating, but wasn't breathing so gave her some breaths.  It seems like it lasted around 5 to 10 mins.  She just started coming out of it when the EMT's got here.  They put an oxygen mask on her when they got her and took to ER. 12/04/08-records received for DOS 11/30/08-presented to ED with fever and febrile seizure became unresponsive. Decreased oral intake and decreased urine output. Fussy and crying. Overnight observation.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, PNC
Symptoms: Tremor, Urine analysis normal
Clinical narrative: 11/28 - went in for 15 month visit.  She had been congested for a couple of days, but no fever.  She was given the pneumococcal conjugate vaccine, the diphtheria tetanus & pertussis vaccine and a flu shot. She was running a low grade fever on Friday.  By Saturday afternoon, temp was running high 102's.  We called clinic who told us probaby just from vaccines, but if did not go away by Sunday to come in.  Sunday still high 102's - was giving Tylenol every 4 hours which was not reducing it at all, stopped drinking fluids.  Took to clinic around 6 pm - they told us to try alternating the Tylenol w/Ibuprofen.  Gave her Ibuprofen around 8 pm and she had a seizure at 10 pm.  She was sitting on my lap watching Elmo and had laid her head down on my lap when I heard a gurgling sound.  I pulled her back and her eyes rolled back in her head and her body was stiff.  She did not shake at that point.  She didn't appear to be breathing.  My husband grabbed her and took her our neighbor, who is a nurse.  I called 911 and went to nbr's house.  She said she was turning purple, not breathing, seizing, and said her head and maybe arms were shaking.  She said her heart was beating, but wasn't breathing so gave her some breaths.  It seems like it lasted around 5 to 10 mins.  She just started coming out of it when the EMT's got here.  They put an oxygen mask on her when they got her and took to ER. 12/04/08-records received for DOS 11/30/08-presented to ED with fever and febrile seizure became unresponsive. Decreased oral intake and decreased urine output. Fussy and crying. Overnight observation.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, similar to hives, 24hrs after administration of first Fluzone vaccine
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: I am experiencing continued pain in upper arm and shoulder.  I can't lift my arm above my head without searing pain.
Age: 37.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site became raised & hot after vaccine administration.
Age: 37.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Injection site became raised & hot after vaccine administration.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, warm, & began to itch.  NP observed raised, red site.  Oral antihistamine & topical corticosteroid administered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Pruritus
Clinical narrative: Patient received flu vaccination in left arm.  Immediately began itching within a few minutes....the next day arm began to be red. She didn't take anything and let it run its course.  She asked what strains the flu vaccine covered and I gave her the information and mailed her a copy.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neuritis
Clinical narrative: Patient received the flu shot on 10/22/08.  Felt pain at the site.  A few days later pain continued at injection site.  Saw PCP.  Referred to specialit who diagnosed her 10 days later with neuritis.  Had physical therapy.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: 2 days after vaccination in left thigh, pt started with a maculopapular rash on same thigh. Family given reassurance and requested to apply 1% hydrocortisone to rash.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Patient received flu vaccination in left arm.  Patient says she started to get a red knot the size of a baseball , hot and itching.  She didn't experience problems until day after flu shot.  She didn't seek medical attention, she called the Director and called healthcare center. We advised her to contact the physician if further problems.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ
Symptoms: Abdominal pain, Chills, Dizziness, Pyrexia, Tremor
Clinical narrative: Patient presented to Hospital Emergency room with fever, compalin of chills, shaking, dizziness, abdominal pain and vomiting.  12/26/2008 ER record received 12/02/2008 with DX: Fever s/p immunizations. Pt presented with c/o general malaise, back pain and nausea since immunizations. PE (+) for suprapubic tenderness and bilateral CVA tenderness, T=102.0. Given IVF bolus, Zofran and Tylenol. Pt felt better and d/c
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ
Symptoms: Vomiting
Clinical narrative: Patient presented to Hospital Emergency room with fever, compalin of chills, shaking, dizziness, abdominal pain and vomiting.  12/26/2008 ER record received 12/02/2008 with DX: Fever s/p immunizations. Pt presented with c/o general malaise, back pain and nausea since immunizations. PE (+) for suprapubic tenderness and bilateral CVA tenderness, T=102.0. Given IVF bolus, Zofran and Tylenol. Pt felt better and d/c
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood product transfusion, Electromyogram abnormal, Gait disturbance, Intensive care, Muscular weakness
Clinical narrative: On 11/3, recieved influenza vaccine.On approx 11/21, presented with signs of an upper respiratory tract infection with cough,mucus, and sore throat.  He was started on amoxicillin.On 11/28, pt became weak in the legs and had trouble walking.  On 11/29, he was crawling around the house as he could not walk due to weakness.  He was admitted to the hospital on 11/30 with dx Guillian-Barre. He is presently in Intensive Care receiving IVIG 1/22/09-records received for DOS 11/30-12/26/08. DC DX:Guillain Barre Syndrome. Pulmonary embolus. Transaminitis. Hypertension. Presented with developing progressive parapersis and weakness of upper and lower extremities to point unable to walk around and began crawling. Treated with IV gamma globulins. Developed acute pulmonary embolus.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: On 11/3, recieved influenza vaccine.On approx 11/21, presented with signs of an upper respiratory tract infection with cough,mucus, and sore throat.  He was started on amoxicillin.On 11/28, pt became weak in the legs and had trouble walking.  On 11/29, he was crawling around the house as he could not walk due to weakness.  He was admitted to the hospital on 11/30 with dx Guillian-Barre. He is presently in Intensive Care receiving IVIG 1/22/09-records received for DOS 11/30-12/26/08. DC DX:Guillain Barre Syndrome. Pulmonary embolus. Transaminitis. Hypertension. Presented with developing progressive parapersis and weakness of upper and lower extremities to point unable to walk around and began crawling. Treated with IV gamma globulins. Developed acute pulmonary embolus.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Vaccinated during pregnancy. Pregnancy resulted in full term healthy delivery.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Convulsion, Laboratory test
Clinical narrative: HAD SEIZURE APPROX 4 HOURS AFTER IMMUNIZATIONS.  QUESTIONABLE HISTORY OF SEIZURE THE DAY BEFORE SHOTS AS PER HISTORY GIVEN BY PARENTS 12/15/08-records received for DOS 11/15-11/20/08. DC DX:Abnormal movements, seizure disorder, reflux. Presented to ED with epsiodes consistent with changing sensorium, smacking of lips and generalized movements of arms and legs. Occurred day prior to admission. Video  pH probe and pneumogram showed significant reflux.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site streaking, Injection site swelling
Clinical narrative: Redness and swelling at injection site which took in the left arm from upper arm to left wrist aread.  Almost cellulitis appearance with itching and red streaks.  Resolved in 5 days.
Age: 1.42
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Insomnia, Irritability, Psychomotor hyperactivity, Pyrexia
Clinical narrative: After 24 hrs, developed fever.  Hyperactive and irritable, unable to sleep at night (usually an exceptionally sound sleeper).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Urticaria, Wheezing
Clinical narrative: Client called and stated she had difficulty breathing with wheezing started in the even after receiving the flu shot.  She stated that she also broke out in hives and rash the following day.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Influenza, Malaise, Pain
Clinical narrative: Received Afluria Influenza Vaccine on Sunday, Nov 2, 2008. On Thursday, November 6, I began feeling ill. I developed a full blown case of the flu with fever, chills, aches, respiratory symptoms etc.  By the beginning of the following week I was unable to go to work.  I AM RARELY SICK & NEVER MISS WORK. I was really sick.  Since this reaction I have heard other anedotal stories of more than a few people getting the flu within a week after receiving a flu shot. I will not get a flu shot in the future and I wanted the reaction reported!
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Received Afluria Influenza Vaccine on Sunday, Nov 2, 2008. On Thursday, November 6, I began feeling ill. I developed a full blown case of the flu with fever, chills, aches, respiratory symptoms etc.  By the beginning of the following week I was unable to go to work.  I AM RARELY SICK & NEVER MISS WORK. I was really sick.  Since this reaction I have heard other anedotal stories of more than a few people getting the flu within a week after receiving a flu shot. I will not get a flu shot in the future and I wanted the reaction reported!
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Feeling hot, Pyrexia
Clinical narrative: I received the Flu vaccine at 11:00am-felt fine all day. At 7:00pm I was at home-began getting chills. abd felt feverish. By 9:00pm temperature was 102.9. Used ice pack on forehead, cold washcloth on my chest, back, and neck and by 11:15pm fever was down below 100 and the next day I was fine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Asthenopia, Blood culture, Blood urine present, Bone pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Gastroenteritis, Haemoglobin decreased, Influenza like illness, Malaise, Night sweats
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pharmaceutical product complaint, Platelet count increased, Pyrexia, Urinary casts present
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling sick in a 66-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CRESTOR, ALLEGRA D, FEMARA and RECLAST. On 3 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 4 November 2008, one day after vaccination with FLULAVAL, the subject experienced feeling sick, feel flu like, fever, body pain, and gastroenteritis. At an unspecified time after vaccination with FLULAVAL, the subject experienced possible kidney problems, heaviness in eyelid, lower left quadrant pain, night sweat and pharmaceutical product complaint. The subject received a dose of FLULAVAL and one day later reported feeling like she had the flu. She reported gastrointestinal (GI) symptoms, which the physician noted as gastroenteritis. Labs were performed at the healthcare providers once on 01 December 2008, white blood cell (WBC) count was elevated and platelets elevated. Physician reported a decrease in hemoglobin from 12.7 to 9.4. Physician questions whether there was also kidney function involvement due to casts and red blood cells in urine. Other adverse events reported were bone aches, eyelids feel heavy, left lower quadrant pain and night sweats. Blood cultures were done today (02 December 2008) after the results of elevated WBC. The physician also referred the subject to an infectious disease doctor. Physician was questioning remainder to product since all from same lot number. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Fatigue, Feeling cold, Headache, Heart rate increased
Clinical narrative: A serious spontaneous report of passed out, increased heart rate, shaking, feeling tired, lethargy, headache, feels cold, chills, and nausea has been received from a consumer concerning a 17-year-old female subsequent to FLUMIST. Neither past medical history nor concomitant medications have been reported. The patient received FLUMIST on 31-Oct-2008. One week after receiving FLUMIST, the patient started feeling tired and having headaches. On 09-NOV-2008, the patient passed out while at work and paramedics transported her to the hospital. She had symptoms of increased heart rate and lethargy. While at the ER, all tests were normal and the patient was released. The following week, the patient still felt tired, reported feeling cold, had chills with shaking and nausea. The patient was taken back to the physician on 20-Nov-2008 who indicated that the patient could be experiencing stress and gave her something for her stomach. The outcome was not reported.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Lethargy, Loss of consciousness, Nausea, Tremor
Clinical narrative: A serious spontaneous report of passed out, increased heart rate, shaking, feeling tired, lethargy, headache, feels cold, chills, and nausea has been received from a consumer concerning a 17-year-old female subsequent to FLUMIST. Neither past medical history nor concomitant medications have been reported. The patient received FLUMIST on 31-Oct-2008. One week after receiving FLUMIST, the patient started feeling tired and having headaches. On 09-NOV-2008, the patient passed out while at work and paramedics transported her to the hospital. She had symptoms of increased heart rate and lethargy. While at the ER, all tests were normal and the patient was released. The following week, the patient still felt tired, reported feeling cold, had chills with shaking and nausea. The patient was taken back to the physician on 20-Nov-2008 who indicated that the patient could be experiencing stress and gave her something for her stomach. The outcome was not reported.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional
Clinical narrative: Vaccinated with SPV and AVA on 25 Nov.  During run on 02 Dec became fatigue with SOB and chest discomfort.  Symptoms: Chest Pain, sub-sternal, Dyspnea on exertion, Fatigue, Malaise<60 Days.  Pos enzymes and ekg. DX. myopericarditis 12/29/08-records received-presented to ED 12/2/08- with C/O upper respiratory infection, atypical chest pain, breathing difficulty while running, DX: myopericarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram PR shortened, Electrocardiogram ST segment elevation, Fatigue, Malaise, Myopericarditis
Clinical narrative: Vaccinated with SPV and AVA on 25 Nov.  During run on 02 Dec became fatigue with SOB and chest discomfort.  Symptoms: Chest Pain, sub-sternal, Dyspnea on exertion, Fatigue, Malaise<60 Days.  Pos enzymes and ekg. DX. myopericarditis 12/29/08-records received-presented to ED 12/2/08- with C/O upper respiratory infection, atypical chest pain, breathing difficulty while running, DX: myopericarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Vaccinated with SPV and AVA on 25 Nov.  During run on 02 Dec became fatigue with SOB and chest discomfort.  Symptoms: Chest Pain, sub-sternal, Dyspnea on exertion, Fatigue, Malaise<60 Days.  Pos enzymes and ekg. DX. myopericarditis 12/29/08-records received-presented to ED 12/2/08- with C/O upper respiratory infection, atypical chest pain, breathing difficulty while running, DX: myopericarditis.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Apnoea, Death
Clinical narrative: 5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation.  3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: 11/16/08 developed numbness tingling" saddle area".  Saw primary care Physician 11/20.  Numbness, tingling progressed to lower extremities.  Difficulty walking, admitted to hospital. 1/8/09-records received for DOS 11/21-11/26/08-DC DX: Acute autoimmune myelitis. Presented to ED with C/O bilateral calf pain and leg pain. Passing gas uncontrollably. Anus and penis numb, urinating problems. Calf pain and numbness. Received flu vaccine 11/9/08.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Cardiac arrest, Convulsion, Dizziness, Dyspnoea exertional
Clinical narrative: Received 1st AVA 4/17/2007 with flu like s/s in 1-2 days x 1 wk.  2nd AVA 5/12/07 with same s/s X 1 wk.  3rd AVA 2/6/08 with nausea, sore throat, flu s/s, fever, sweaty, myalgia, fatigue, arthralgia, slept alot X 1-2 weeks.  PRN numbness w/wt loss, sweating, dizziness, DOE over next 6 months.  8/22-26/08 admitted w/syncopal episode, 16 secnds asystole w/sz like activity.  Still under neuro/cardiac evaluation for ?dx new onset epilepsy. 12/10/08-records received-after each vaccine C/O worsening fatigue, nauseas, felt out of it, groggy, sore throat, flu like symptoms, muscle aches, fever, numbness, weight loss, dizziness, shortness of breath. 8/21/08-C/O tingling, numbness in bilateral arms, hands, increased dizziness, nausea, headache, increased thirst and urination.Admitted 8-23-8/26/08-vasodepressor epidsode in ER 8/22/08 while having blood drawn. DX: vertigo. Two events of asystole associated with seizure-like activity both assoicated with sinus tachycardia. Vasovagal episode.9/10/08-fever, dizzy, low blood sugar, felt lightheaded/dizzy with difficulty breathing, chest pain.presented on 10/31/08 C/O recurrent scrotal pain x 1.5 months. Treated for epidiymitis. Symtpoms returned 3 days ago. DX: inguinal groin pain, scrotal pain.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Epilepsy, Fatigue, Hyperhidrosis, Hypersomnia, Hypoaesthesia
Clinical narrative: Received 1st AVA 4/17/2007 with flu like s/s in 1-2 days x 1 wk.  2nd AVA 5/12/07 with same s/s X 1 wk.  3rd AVA 2/6/08 with nausea, sore throat, flu s/s, fever, sweaty, myalgia, fatigue, arthralgia, slept alot X 1-2 weeks.  PRN numbness w/wt loss, sweating, dizziness, DOE over next 6 months.  8/22-26/08 admitted w/syncopal episode, 16 secnds asystole w/sz like activity.  Still under neuro/cardiac evaluation for ?dx new onset epilepsy. 12/10/08-records received-after each vaccine C/O worsening fatigue, nauseas, felt out of it, groggy, sore throat, flu like symptoms, muscle aches, fever, numbness, weight loss, dizziness, shortness of breath. 8/21/08-C/O tingling, numbness in bilateral arms, hands, increased dizziness, nausea, headache, increased thirst and urination.Admitted 8-23-8/26/08-vasodepressor epidsode in ER 8/22/08 while having blood drawn. DX: vertigo. Two events of asystole associated with seizure-like activity both assoicated with sinus tachycardia. Vasovagal episode.9/10/08-fever, dizzy, low blood sugar, felt lightheaded/dizzy with difficulty breathing, chest pain.presented on 10/31/08 C/O recurrent scrotal pain x 1.5 months. Treated for epidiymitis. Symtpoms returned 3 days ago. DX: inguinal groin pain, scrotal pain.