chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site mass
Clinical narrative: Parent reports large football sized lump (larger than a baseball) on left thigh, hard to the touch, red, warm, painful, itches.  Afebrile.  Sent to Urgent Care.  Treated with Keflex in case the reaction was cellulitis.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site warmth, Pain, Pruritus
Clinical narrative: Parent reports large football sized lump (larger than a baseball) on left thigh, hard to the touch, red, warm, painful, itches.  Afebrile.  Sent to Urgent Care.  Treated with Keflex in case the reaction was cellulitis.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Face oedema, Injection site reaction, Periorbital oedema, Rash
Clinical narrative: In less than 1 hour after receiving Pro Quad Infanrix, and IPV pt developed red rash and hives. Hive size of half dollar on right arm where ProQuad was given. Periorbital and lip swelling, no heart rate increase no breathing difficulty.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: In less than 1 hour after receiving Pro Quad Infanrix, and IPV pt developed red rash and hives. Hive size of half dollar on right arm where ProQuad was given. Periorbital and lip swelling, no heart rate increase no breathing difficulty.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Started with one lesson on the left temple, next day developed more in axillae and also under the breast. On exam the lesions look like varicella.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Pt came in on Sept 14 with rash on body. Dr gave child a BENADRYL, child also came in on Sept 5, for cough, and congestion. Dr gave child there RX for amoxicillin 125/5 one TOP PO TID X 10 Day.
Age: 91.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Arm pain, swelling, redness, warmth, itchiness started 1-2 days after injection in left arm, redness, warmth continued 6 days later. Required oral systemic steroids.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pain
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Abdominal tenderness, Asthenia, Blood test normal, Chills
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Disorientation, Dry throat, Dyspnoea, Faecal incontinence
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Hypokinesia
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypotension, Malaise, Neuralgia, Pyrexia, Sensory disturbance
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tremor, Urine analysis normal, Visual disturbance
Clinical narrative: Patient received Chiron Influenza Vaccine at 10:30am on 9/15/2006 on left deltoid.  Within approximately 2 hours patient felt electrical sensation running down the posterior of his left arm to the elbow from the axillary attachement of the left pectoralis.  Shortly thereafter patient experience diarrhea and a slight disorientation accompanied by neuralgia and general malaise.  Approximately 4pm, patient began have extreme chills and uncontrollable shaking.  Patient went home with severe abdominal cramping via subway.  Took some benedryl in transit.  Began sweating profusely, experiencing numbness in the extremities and dyspnea, blackened vision, weakness, difficulty sitting, or standing.  Fever 104, dry throat, repeated diarrhea and abdominal cramping, unable to control bowels.  Patient went to Mount Sinai ER in NYC around 11pm.  Received blood tests and urinalysis.  Patient had extremely tender lower abdomen  Received 3 bags of Saline fluid, 1 bag of Reglin, Tylenol.  Patient released home around 7am the following morning. ER doctors reported that patient had fever, low blood pressure and rapid pulse.  Patient still experiences diarrhea and cramping.  Patient experienced 2 days of migraine like headaches within days following ER release, extreme fatigue.  Missed 1 weeks classes and work.   On 9/20/2006, Patient visited his PCP with vitals of 99.7 temperature, pulse of 56, and BP of 97/70.  Patient still experience fatigue, lack of appetite, diarrhea, abdominal cramping and lower abdoominal tenderness.
Age: 1.04
Sex: F
Vaccine: HBHEPB, IPV, MMR, PNC
Symptoms: Autism, Crying, Injection site swelling, Laboratory test abnormal, Pyrexia
Clinical narrative: Extreme swelling in spot of vaccinations. High fever. Constant crying. Within 2 weeks, stopped speaking, interacting, and made no eye contact. She sat and rubbed a blanket on her face all day and wouldn't eat to communicate. She started receiving speech, occupational, and developmental therapy. We also started her on chelation therapy.
Age: 1.04
Sex: F
Vaccine: HBHEPB, IPV, MMR, PNC
Symptoms: Speech disorder
Clinical narrative: Extreme swelling in spot of vaccinations. High fever. Constant crying. Within 2 weeks, stopped speaking, interacting, and made no eye contact. She sat and rubbed a blanket on her face all day and wouldn't eat to communicate. She started receiving speech, occupational, and developmental therapy. We also started her on chelation therapy.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Gastroenteritis, Vomiting
Clinical narrative: Vomiting, bloody diarrhea. 10/5/06 Received medical records from PCP which included ER medical records of 9/21-9/22/06.  ER records indicate patient seen after 2 nights of vomiting & diarrhea which started approx 1 wk after vaccine.  Parent noted blood in stool 9/21/06.  Patient seen following day 9/22 by PCP & DX: acute gastroenteritis.  PCP note of 9/29 indicates patient continued to have vomiting with bowel movement but was otherwise improved clinically & eating well with no further diarrhea./ss
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Erythema, warmth, mild discomfort of left medial arm.  Apparent cellulitis not located at reported injection site in deltoid but rather on inside of patients arm extending from axilla to elbow.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, TTOX
Symptoms: Convulsion, Demyelination, Encephalitis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Tetanus toxoid/MMR vaccine: Acute Disseminating Encephalomyelitis (ADEM) reported one week post vaccination in a 24 yo female; presented with generalized tonic/clonic seizures. EEG and MRI of brain, which showed scattered multiple white matter lesions, were indicative demyelination. Patient improved after treatment with prednisolone and levetiracetam; the case was self-limiting.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site oedema, Injection site rash, Medication error
Clinical narrative: Rash/swelling on right arm and possible reaction to vaccine VS cellulitis, treated with antibiotic Keflex 10 days.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: Gave ProQuad MMR/V on left leg, left room to get AVS, when I came in the room mom stated left leg started to get red after shot. Noticed and reported findings. Benadryl given PO observed x 30 min after med.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site rash, Myalgia
Clinical narrative: Donor stated she experienced generalized muscle tenderness one day following and 1 day after (NAIR) hair removal to both upper ext noticed rash to immunization arm 2 days after shot. Visualized by staff on 9/5/06.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cough, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Redness and swelling at the left thigh. coughing x 1 day, Dtap.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had a 50mm oval shape of redness and tenderness at the site of S.C. injection.  Area of concern is also identical to that of erythema migrans.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Anaemia, Convulsion, Laboratory test abnormal
Clinical narrative: On 9/13/2006 patient went to emergency room at hospital after having a seizure.  She had a second seizure in th emergency room witnessed by emergency room doctor.  She was started on Cerebyx and had MRI.  She was slightly anemic she will have a follow up MRI prolactin level and TSH (thyroid stimulating hormone) done on follow up visits.  She was placed on DILANTIN 100 mg three times a day with follow up in three weeks.  Dismissed 9-14-06. 10/06/06-records received for DOS 09/13-09/14/2006 DC DX: Seizure activity related to meningitis vaccine. HX of Present Illness: presented to ER after having a possible seizure, received immunization day before ER visit. Began feeling funny this morning. Her roommate said she looked to the left and then collapsed to floor with a grand mal seizure that lasted less than two minutes. States she want non incontinent and did not bite her tongue, denies any trauma. Review of Systems: WNL. PE: WNL During ER visit while talking to physician she tells physician that she feels funny and gazes off to the left, she then begins a focal seizure on the left side of her body with complete loss of consciousness, she then has a generalized tonic clonic movement over the rest of her body. It lasted about 2 minutes. Treated with 1mg of Ativan, she had a normal post ictal phase. Suctions, placed on oxygen and loaded with Cerebyx 1 gram IV.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Adjustment disorder, Alcohol abuse, Alopecia, Amnesia, Arthralgia
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Back pain, Blood cholesterol increased, Bone pain, Cardiovascular disorder, Cardiovascular disorder
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Deafness neurosensory, Depressed mood, Eczema, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Headache, Hypercholesterolaemia, Hypertension, Hypertension, Muscle spasms
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Muscular weakness, Osteosclerosis, Presbyopia, Rash, Refraction disorder
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 42.0
Sex: M
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Spinal osteoarthritis, Tobacco user, Visual disturbance
Clinical narrative: High blood pressure, skin rash, vision change, joint pain, muscular weakness, headache, bone pain, fatigue, hair loss, memory loss. Radilogy reports demonstrate osteogenic processes in iliac joint, CXR tortuous descending aorta. Lumbar spondylosis. DX: dated 7/25/06: low back pain, GERD, Smoker, Refraction error, Presbyopia, Hypertension, Hypercholesterolemia. Eczema, Sensorineural hearing loss of combined types. Hypertensive Cardiovascular Disease. Osteosclerosis, right iliac crest. Muslce Spasm.  DX: dated 1/15/04-adjustment disorder with depressed  mood; alcohol abuse.I have problems with my blood high cholesterol. 02/01/2010 High blood pressure, skin rash, vision change, joint pain, muscular weakness. Headache, bone pain, fatigue, hair loss, memory loss.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient was administered pneumococcal vaccine intramuscularly 4/3/2006.  Patient experienced severe swelling/edema left arm muscle post injection.  Local redness and increased skin temperature.  Complaint of pain.  Medicated for pain with relief.  Ice/warm soaks applied to swelling as needed.  BENADRYL give as needed. (OMIC)
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Medication error, Purpura, Rash pruritic
Clinical narrative: Pt presented 2 days following Zostavax administration with pruritic, purpuric rash, rash extended after tx with Benadryl. 9/10/06 placed on Prednisone at which time rash resolved. Extension was generalized to body. CBC 6/11/06, Platelets 236, HCT 34.4. HBG 11.8.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Dizziness, Erythema, Full blood count, Full blood count normal
Clinical narrative: Pt presented 2 days following Zostavax administration with pruritic, purpuric rash, rash extended after tx with Benadryl. 9/10/06 placed on Prednisone at which time rash resolved. Extension was generalized to body. CBC 6/11/06, Platelets 236, HCT 34.4. HBG 11.8.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Idiopathic urticaria, Lymphocyte count decreased, Neutrophil count increased, Pruritus
Clinical narrative: Pt presented 2 days following Zostavax administration with pruritic, purpuric rash, rash extended after tx with Benadryl. 9/10/06 placed on Prednisone at which time rash resolved. Extension was generalized to body. CBC 6/11/06, Platelets 236, HCT 34.4. HBG 11.8.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Pt presented 2 days following Zostavax administration with pruritic, purpuric rash, rash extended after tx with Benadryl. 9/10/06 placed on Prednisone at which time rash resolved. Extension was generalized to body. CBC 6/11/06, Platelets 236, HCT 34.4. HBG 11.8.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Received a Zostavax shot on 8/22/06, shingles rash appeared on 8/30/06.  10/26/06 Requested by FDA to contact reporter to clarify which vaccine given. 10/27/06 T/C to reporter/provider to request missing info.  Letter faxed to PCP to request medical records/ss 10/27/06 Received medical records from PCP which reveal that patient was new patient at this MD & he received Zotavax per the vax records.  However, the MD note indicates a different lot number.  T/C to PCP to confirm which vax lot number is correct as record is unclear.  T/C to manufacturer to inquire what lot number for which vax.  Stated lot number on report is for Gardisil & that lot number in MD records is correct for Zostavax.  Notified FDA of same./ss
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster, Viral infection
Clinical narrative: Received a Zostavax shot on 8/22/06, shingles rash appeared on 8/30/06.  10/26/06 Requested by FDA to contact reporter to clarify which vaccine given. 10/27/06 T/C to reporter/provider to request missing info.  Letter faxed to PCP to request medical records/ss 10/27/06 Received medical records from PCP which reveal that patient was new patient at this MD & he received Zotavax per the vax records.  However, the MD note indicates a different lot number.  T/C to PCP to confirm which vax lot number is correct as record is unclear.  T/C to manufacturer to inquire what lot number for which vax.  Stated lot number on report is for Gardisil & that lot number in MD records is correct for Zostavax.  Notified FDA of same./ss
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: 09/13/2006 pt received vaccinations, Rotavirus, Prevnar, Dtap, IPV, Comvax. beginning that evening pt having frequent stools diarrhea. Beginning on 9/17/06 mom noticed flecks of blood in diarrhea stool x 2 episodes, pt continues with diarrhea. OV pending for 9/19/06. Pt febrile, normal activity normal appetite Diet similac advance.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Heart rate increased, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: One hour after the immunization redness, swelling, heat and pain developed at the site left arm deltoid. Clt noted a rapid heart rate as she went to bed at 10:30pm. She awoke at 1:00am from pain at the site. She noted the rapid heart rate also at that time. She fainted and her husband helped her recover from the faint and the went to ER for care.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Sleep disorder, Syncope
Clinical narrative: One hour after the immunization redness, swelling, heat and pain developed at the site left arm deltoid. Clt noted a rapid heart rate as she went to bed at 10:30pm. She awoke at 1:00am from pain at the site. She noted the rapid heart rate also at that time. She fainted and her husband helped her recover from the faint and the went to ER for care.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Hypokinesia, Injection site pain, Oedema
Clinical narrative: Client states after receiving influenza inj 11/17/05 felt a soreness in her left arm throughout. Client felt soreness was normal until 11/19/05, felt pain under her left arm. Client states her underarm was swollen and felt hot to the touch, she also noticed redness there. These symptoms have continued everyday since then. Client states it is difficult to dress herself, she usually asks her husband to assist her. Client states she received the flu shot approx 5 inches down from the top of her shoulder, on 11/17/05. Client was advised to call her physician to evaluate her arm and under arm client states she will do so.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Client states after receiving influenza inj 11/17/05 felt a soreness in her left arm throughout. Client felt soreness was normal until 11/19/05, felt pain under her left arm. Client states her underarm was swollen and felt hot to the touch, she also noticed redness there. These symptoms have continued everyday since then. Client states it is difficult to dress herself, she usually asks her husband to assist her. Client states she received the flu shot approx 5 inches down from the top of her shoulder, on 11/17/05. Client was advised to call her physician to evaluate her arm and under arm client states she will do so.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Pruritus
Clinical narrative: I have pain in joints, headache, itching in abdominal area.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Skin ulcer
Clinical narrative: As per mom child had skin lesions on face, hands, feet, chest and abdomen since 9/17/06. Also she stated that child had Hep B and PPD done at the clinic on 9/14/06. Child was seen in the clinic for follow up on 9/18/06, was given Diphen 1/2 tsp TID, and calamine lotion. Advised to return to clinic on 9/22/06.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Skin discolouration, Skin ulcer
Clinical narrative: On 6/5/06 parents noticed a blister type lesion on pts left shin close to the ankle. She saw Dr on 6/12/06. Dr diagnosed her with one focal area blister (Vesicle) and TX her with Benadryl cream. Mom said it never botherd her as in itching or hurting. It took 3-4 weeks to resolve and has left a small discoloration of the skin where the lesion was.
Age: 1.31
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site rash
Clinical narrative: Small rash at vaccine site
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2-3 cm area that is erythematous and that's quite hot. Apparently  a localized reaction to the shots.
Age: 1.96
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3.5 X 3.5" redness site of vaccination.
Age: 0.26
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Cried for 24 hours after vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anorexia, Cough, Eye discharge, Eye inflammation, Irritability
Clinical narrative: Was seen in clinic 9/15/06 with temp follow up from ER 9/14/06. Was admitted to the hospital on 9/16/06 with temp 104.  10/12/06 Received medical records from provider which reveal patient had mild wheezing & candida rash on day of vax.  RTC 2 days later with fever, cough & congestion.  Bilateral TMs had tubes.  Treatment for symptoms advised.  On 9/19 was notified by MD that patient was hospitalized with temp 104 which MD felt was due to AE from immunizations.  Note indicates elevated WBC./ss  10/27/06 Received medical records from hospital which reveal patient had throat infection & OM approx 12 days prior to AE.  Completed 10 day course of antibiotics 2 days prior to receiving vax.  On 9/15 had left eye redness & drainage, decreased appetite & was very fussy.  Temp max 104.4.  Exam showed congested nose, clear lungs.  Admitted to hospital on 9/16-9/19/06 & started on IV antibiotics. Afebrile by next day & continued to progress well.  Final dx: fever, probable s/p immunizations.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Leukocytosis, Nasal congestion, Pyrexia, Rash
Clinical narrative: Was seen in clinic 9/15/06 with temp follow up from ER 9/14/06. Was admitted to the hospital on 9/16/06 with temp 104.  10/12/06 Received medical records from provider which reveal patient had mild wheezing & candida rash on day of vax.  RTC 2 days later with fever, cough & congestion.  Bilateral TMs had tubes.  Treatment for symptoms advised.  On 9/19 was notified by MD that patient was hospitalized with temp 104 which MD felt was due to AE from immunizations.  Note indicates elevated WBC./ss  10/27/06 Received medical records from hospital which reveal patient had throat infection & OM approx 12 days prior to AE.  Completed 10 day course of antibiotics 2 days prior to receiving vax.  On 9/15 had left eye redness & drainage, decreased appetite & was very fussy.  Temp max 104.4.  Exam showed congested nose, clear lungs.  Admitted to hospital on 9/16-9/19/06 & started on IV antibiotics. Afebrile by next day & continued to progress well.  Final dx: fever, probable s/p immunizations.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Wheezing
Clinical narrative: Was seen in clinic 9/15/06 with temp follow up from ER 9/14/06. Was admitted to the hospital on 9/16/06 with temp 104.  10/12/06 Received medical records from provider which reveal patient had mild wheezing & candida rash on day of vax.  RTC 2 days later with fever, cough & congestion.  Bilateral TMs had tubes.  Treatment for symptoms advised.  On 9/19 was notified by MD that patient was hospitalized with temp 104 which MD felt was due to AE from immunizations.  Note indicates elevated WBC./ss  10/27/06 Received medical records from hospital which reveal patient had throat infection & OM approx 12 days prior to AE.  Completed 10 day course of antibiotics 2 days prior to receiving vax.  On 9/15 had left eye redness & drainage, decreased appetite & was very fussy.  Temp max 104.4.  Exam showed congested nose, clear lungs.  Admitted to hospital on 9/16-9/19/06 & started on IV antibiotics. Afebrile by next day & continued to progress well.  Final dx: fever, probable s/p immunizations.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Ecchymosis, Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Left upper arm erythema 11.5 cm x 12cm at IPV site with vesicles 2cm x 1cm. Ecchymosis 2cm x 1.5cm at DTaP site (itches) tight red, warm.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child brought into health department due to 50mm by 60mm edematous, reddened area, circumscribed left deltoid. Warm to touch. Denies pain or difficulty movement.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Pain, Pruritus, Rash, Swelling
Clinical narrative: 8/10/06 Mom noticed rash on left thigh from waist. Rash looked yellow and had pus in it. Mom noticed child scratching rash - swelling and pain noticed in area. Mom noticed fever 8/11/06. Child was taken to ER room 8/10/06.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm edema, tenderness, erythema at injection site. Fever, chills, body aches, headache.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Arm edema, tenderness, erythema at injection site. Fever, chills, body aches, headache.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Erythema, Injection site induration, Rash papular
Clinical narrative: Skin reaction with induration, erythema, papules without vesicles.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Whelps to entire body the next morning after immunizations.
Age: 49.0
Sex: F
Vaccine: HEP, TYP, YF
Symptoms: Diplopia, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial information received on 18/Sep/2006 from a consumer.  It was reported that a 49-year-old female patient received a first dose of YF-VAX, lot number UE888AA, administered in the left arm, a dose of Hepatitis B vaccine (manufacturer unknown) and a dose of oral Typhoid vaccine (manufacturer not reported) on 05/Sep/2006.  Two days later, the patient developed double vision in her left eye.  She also experienced numbness and tingling on the left side of her face and in her left arm.  A computerized axial tomography scan was performed on 16/Sep/2006 but no results were provided.  The patient was scheduled to see an opthoneurologist on 18/Sep/2006.  At the time of this report she had not recovered from the events.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope, Visual disturbance, Visual field defect
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report receive on 9/13/06 from a health care professional. A 39 year old female pt had received a left deltoid injection of Fluzone SV 2006-2007, lot number U2204AA, on 9/12/06. Immediately post vaccination, she felt light headed, dizzy and faint. Later the day at home she experienced visual disturbances (floaters) and a blind spot in the visual field of her right eye. Per the reporter, the eye symptoms and dizziness is persisting. The pt has also received a left deltoid first dose injection of Hepatitis A vaccine, lot number 0144F, on 8/24/06. At the time of this report, the pt has not recovered.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103 for 24 hours after injection 9/15/06. Began new daycare. Small bumps on face.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an unspecified adverse reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  On an unspecified date, the subject received an unspecified dose of Flu vaccine. At an unspecified time after vaccination Flu vaccine, the subject experienced an unspecified adverse reaction.  At the time of reporting, the outcome of the event was unspecified.  This report was received.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of severe arm pain in a 42-year-old female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history, concurrent conditions and concurrent medications were not provided.  On am unspecified date, approximately two years from the time of reporting, the subject received an unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced severe pain and numbness in her left arm.  She thought she was having a heart attack.  She presented to the emergency room where it was determined that she did not have a heart attack.  At the time of reporting, the outcome of the events was unspecified.
Age: 60.0
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: The following report was received from another manufacturer.  This case was reported by a physician and described the occurrence of an unspecified reaction in a 50-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine 9Flu vaccine, manufacturer unspecified for prophylaxis.  On an unspecified date the subject received an unspecified dose of Flu vaccine.  At an unspecified after vaccination with Flu vaccine, the subject experienced an unspecified reaction.  The type of reaction to the flu vaccine was unknown.  The flu vaccine was not given by the reporter.  At the time of reporting the outcome of the event was unspecified.  No further information was available.
Age: 80.0
Sex: M
Vaccine: FLU3
Clinical narrative: This case was reported by a nurse and described the occurrence of worsened arm arthralgia in a 81-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis.  The subject's medical history included arm arthralgia prior to receiving the vaccination with Fluarix. His allergies included penicillin, terazosin (Hytrin), clopidogrel (Plavix), hydrochlorothiazide and possibly prednisolone, dexamethasone 9Decadron) and methylprednisone (Depo Medrol).  Concurrent mediations included Aspirin and cholestyramine (Questran lite). The subject had not experienced any reactions after vaccination with previous influenza virus vaccines.  On 11 November 2005, the subject received an unspecified dose of Fluarix (0.5 ml, intramuscular, left arm).  The lot number was ASLUA141BA and the expiration date was 26 July 2006.  At an unspecified time after vaccination with Fluarix, the subject experienced worsened arm arthralgia, which required medical attention at his doctor's office.  At the time of reporting the outcome of the event was worse. Follow-up information on 26 September 2006 indicated that the subject's condition was still not resolved. The subject's physician felt that the event could possibly be related to treatment with FLUARIX.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Had fever for 3 days then red spots/welts all over body.
Age: 1.03
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: received varicella immunization 10/2/00. office vist 9/24/06 with diagnosis of chicken pox after md assessment.  atarax for comfort
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Pruritus, Sleep disorder
Clinical narrative: 24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: 24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Pruritus, Tenderness
Clinical narrative: 24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Pyrexia
Clinical narrative: Received 2 month shots on 8/31/06:  Pediarix, Prevnar, Acthib, and Rotateq. Office visit on 9/5/06 presenting with fever of unknown origin.  Family stated fever as high as 102.3 rectally.  At time of visit temp was 100.3 rectally post tylenol.  LP and CBC performed in office.  Admitted to Hospital.  10/13/06 Received D/C Summary from hospital which reveals the primary Dx as meningitis, cardiac arrest & seizures.  Patient had neurologic devastation s/p cardiac arrest, family requested palliative care & comfort measures.  Patient expired on 10/8/06