chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Erythema, Induration, Injection site pruritus, Skin warm, Urticaria
Clinical narrative: Patient developed a 3 inch welt with a 2 inch reddened area that was warm and hard to touch within 24 hours of the vaccine. He complained of itching at the site. I applied ice and aloe for relief which did help. The welt was gone on day 4 after the vaccine but still had a 1 inch reddened area that was slightly warm and somewhat firm.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Encephalopathy, Hemiparesis
Clinical narrative: Right-sided weakness at school 4-2-08. Diagnosed with encephalopathy at hospital. Currently at another hospital. Reported to me by ED nurse. 6/30/08-records received for DOS 4/2-4/9/08-DC DX:Right sided weakness and slurred speech, resolved. Acute disseminated encephalomyelitis verus cerebrovascular event. On magnetic reasonce imaging parietal white matter abnormality. Presented with right sided weakness and dysarthria.
Age: 0.53
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Bacterial culture negative, Culture stool negative, Diarrhoea, Parasite blood test
Clinical narrative: Patient developed significant watery diarrhea that lasted for 3 weeks shortly after 3rd dose of Rotateq (began 4 days after vax)
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: swollen, red arm
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site cellulitis
Clinical narrative: soft tissue cellulitis, local to injection site/upper arm. Treated antibiotics
Age: 17.0
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: After HPV and Hep A were administered patient fainted and had a brief seizure lasting approx. 30 seconds.  Patient recovered and left with mom.  HPV isn't listed under vaccines: Merck, lot # 1740U, right arm, IM.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Stated - she had "welts"/rash on abdomen/chest/back - occurred x2 days after vaccine administered.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inappropriate schedule of drug administration, Oedema peripheral
Clinical narrative: Pt had red swelling over entire upper arm.  She took Benadryl and Motrin and it subsided.  Still had a hard red spot about 2 inches in diameter when she showed me on 3/25/08.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Herpes zoster, Hypersensitivity, Local reaction
Clinical narrative: Localized allergic reaction to varicella vaccine possible early cellulitis with herpes zoster vesicles.
Age: 45.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Client c/o continued headaches 2-3 days pain level was about (5).  States temp 102.6 for 2 days.  Also having chills up to present.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Indurated, warm (L) deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling (L) arm. Warm 9 cm x 6 cm very large.
Age: 64.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Erythema, Mass
Clinical narrative: Redness 13 cm lump.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Headache, Nausea
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Asthenia, Basophil count normal
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Carbon dioxide normal, Diarrhoea, Eosinophil count normal, Fatigue, Feeling cold
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Globulin, Haematocrit normal, Haemoglobin normal, Headache, Lymphocyte percentage decreased
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage decreased, Neutrophil count increased
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Neutrophil percentage increased, Platelet count normal, Protein total normal, Red blood cell count normal, Red cell distribution width normal
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 63.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Vomiting, Walking disability, White blood cell count normal
Clinical narrative: Client called states his wife started oral Typhoid vaccine on 3-31-08 she finished regimen 4-6-08. States wife had headaches and nausea on 4-7-08 and he took her to the doctor, she's better now.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion
Clinical narrative: Child given vaccines 4/4/08.  Positive seizure-like activity 4/5/08 1 AM - lasted 1 minute.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm with 13 x 15 cm area of red warmth swelling.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Basophil percentage increased, Blood amylase increased, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage
Clinical narrative: Parotiditis R cheek, fever 101, increased amylase 270.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Neutrophil percentage, Parotitis, Platelet count normal, Pyrexia, White blood cell count normal
Clinical narrative: Parotiditis R cheek, fever 101, increased amylase 270.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Local reaction, Urticaria
Clinical narrative: Varivax was given on 4-3-08, patient developed large local reaction on that night.  Area red, warm to the touch and raised.  Patient has had the same reaction on 8-19-04, age 25 months at the time of first Varivax.  Mom had forgotten 11 x 13 cm.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Td given left deltoid on 4/3/08 and at time of follow up visit left deltoid area red, warm, swollen
Age: 39.0
Sex: F
Vaccine: MMR, TD
Symptoms: Erythema, Headache, Nausea, Oedema, Pain
Clinical narrative: The day after vaccination, experienced severe headache, nausea, edema of left upper arm and left axilla.  Area of redness, slightly elevated approximately 2.5 inches x 1/2 - 1/4 inch in width noted in left upper arm below injection site.  States also radiating pain in left shoulder/neck.  Has applied moist heat to area and to arm.  Ibuprofen for discomfort.
Age: 39.0
Sex: F
Vaccine: MMR, TD
Symptoms: Urticaria
Clinical narrative: The day after vaccination, experienced severe headache, nausea, edema of left upper arm and left axilla.  Area of redness, slightly elevated approximately 2.5 inches x 1/2 - 1/4 inch in width noted in left upper arm below injection site.  States also radiating pain in left shoulder/neck.  Has applied moist heat to area and to arm.  Ibuprofen for discomfort.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Painful upper arm around site of injection General body/muscle aches. Chills. Symptoms lasted about 36 hours. I took aspirin but relief was minimal.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mother child received vaccines Monday March 17 and yesterday was concerned because noticed left arm (deltoid) with redness and swelling. Per mother had never seen this happen to any of the other children so she was concerned. Per mother applied warm compress to child's  arm for comfort. Denies numbness or tingling to left arm or extremities.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The day after receiving immunization arm was swollen and red and warm to touch. Pt did not run a fever, was advised to use ice for swelling. Mom took her to the dr 2 days later. No change in treatment but requested VAERS
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Convulsion, Corrective lens user, Decreased appetite, Diplegia
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Fatigue, Headache, Hypersomnia
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Hypophagia, Loss of consciousness, Nuclear magnetic resonance imaging normal, Oral mucosal blistering, Sensation of heaviness
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Convulsion, Dizziness, Guillain-Barre syndrome, Hyperventilation, Hypoaesthesia
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Laboratory test, Loss of consciousness, Neurological examination, Oropharyngeal blistering, Syncope
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Abasia, Blood test, Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Laboratory test, Loss of consciousness, Malaise, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Stress
Clinical narrative: Information has been received from the mother concerning her 16 year old daughter with no pertinent medical history and no history of drug reactions/allergies who in November 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medications reported.  Toward the end of November 2007, the patient developed symptoms.  On 01-DEC-2007, about 20 days after receiving the first dose of GARDASIL, the patient was hospitalized because her thighs were numb and was diagnosed with Guillian Barre Syndrome.  She was transferred to another hospital.  The patient was in the hospital for about 3 or 4 days and was released because she had feeling back in her legs.  On an unspecified date, the patient was hospitalized a second time because she hyperventilates, had seizures, and was fainting.  The patient had heart tests and neurological tests performed.  It has been 5 months since she received the first dose of GARDASIL and is still passing out, getting dizzy, having seizures, and also gets blisters on the roof of her mouth.  At the time of reporting, the patient had not recovered.  The patient's sister also experienced an adverse event after receiving a first dose of GARDASIL reported in WAES # 0804USA01228.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Dizziness, Injection site pain, Pallor
Clinical narrative: increased pain bilat hips, legs, shins, knees from 12-07, much worse in February '08. ANA= 1:1280
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: increased pain bilat hips, legs, shins, knees from 12-07, much worse in February '08. ANA= 1:1280
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Borrelia burgdorferi serology negative, DNA antibody negative, Pain in extremity
Clinical narrative: increased pain bilat hips, legs, shins, knees from 12-07, much worse in February '08. ANA= 1:1280
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell sedimentation rate normal, Thyroid function test normal, Urine analysis normal
Clinical narrative: increased pain bilat hips, legs, shins, knees from 12-07, much worse in February '08. ANA= 1:1280
Age: 1.1
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL, DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site rash, Injection site streaking, Rash maculo-papular
Clinical narrative: Child noted to have red maculopapular rash to left cheek and neck and around injection site (L) arm 5 min after IMM.  Also few whelps around inj site (L) arm.  Baby eval by FNP.  Benadryl 1 1/2 tsp po given os 20 min.  After Benadryl, rash faded.
Age: 1.1
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL, DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash erythematous, Rash maculo-papular
Clinical narrative: Child noted to have red maculopapular rash to left cheek and neck and around injection site (L) arm 5 min after IMM.  Also few whelps around inj site (L) arm.  Baby eval by FNP.  Benadryl 1 1/2 tsp po given os 20 min.  After Benadryl, rash faded.
Age: 1.1
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL, DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Child noted to have red maculopapular rash to left cheek and neck and around injection site (L) arm 5 min after IMM.  Also few whelps around inj site (L) arm.  Baby eval by FNP.  Benadryl 1 1/2 tsp po given os 20 min.  After Benadryl, rash faded.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye swelling, Rash, Scab
Clinical narrative: 1 Very swollen Rt eye & also later left eye.  2 Red spots on forehead & scalp-then scabs on chest & back & legs.  1 Rx 3-28-08-erythromycin ophthalmolic ointment.  2 Rx 3-29-08-famciclovir 500 mg T.i.d.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Scab
Clinical narrative: 1 Very swollen Rt eye & also later left eye.  2 Red spots on forehead & scalp-then scabs on chest & back & legs.  1 Rx 3-28-08-erythromycin ophthalmolic ointment.  2 Rx 3-29-08-famciclovir 500 mg T.i.d.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: 1 Very swollen Rt eye & also later left eye.  2 Red spots on forehead & scalp-then scabs on chest & back & legs.  1 Rx 3-28-08-erythromycin ophthalmolic ointment.  2 Rx 3-29-08-famciclovir 500 mg T.i.d.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Scab
Clinical narrative: 1 Very swollen Rt eye & also later left eye.  2 Red spots on forehead & scalp-then scabs on chest & back & legs.  1 Rx 3-28-08-erythromycin ophthalmolic ointment.  2 Rx 3-29-08-famciclovir 500 mg T.i.d.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Diarrhoea, Faecal incontinence, Feeling cold, Night sweats
Clinical narrative: Had my baby Dec. 20, 2007. Received postpartum MMR on discharge date Dec. 22, 2007. On Jan. 2, 2008 I was freezing; could not keep warm despite trying to. Went to ER; they sent me home and said it may be from just having a baby, ie: breast infection, and to come back if symptoms persist. On Jan. 4, 2008, I shot up out of bed about 2am and was SOAKED w/ sweat. I had on 2 pairs of long sleeved sweatshirts and sweatpants because I still could not keep warm and both sets were soaked through as if I had jumped in a pool. On Jan. 5, 2008 I was still cold and could not control my bowels. Had runny, uncontrollable loose stools starting at night. Jan. 6, 2008 I took myself back to the ER. I had a high temp., was severel dehydrated and received 2 1/2 bags of IV fluids, Tylenol, an ultrasound and a pelvic exam because the docs thought I might have had a uterine infection. All my tests came back negative for uterine infection. My WBCs were high. Docs still don't know what happened to me. Recently, I did research on vaccinations and remembered that MMR shot I received in Dec. 2007 and linked the ER visit to that. I did not realize it took 10-14 days for adverse reactions to take place after a MMR shot and that is exactly when I started having symptoms and went to the ER.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody test
Clinical narrative: Had my baby Dec. 20, 2007. Received postpartum MMR on discharge date Dec. 22, 2007. On Jan. 2, 2008 I was freezing; could not keep warm despite trying to. Went to ER; they sent me home and said it may be from just having a baby, ie: breast infection, and to come back if symptoms persist. On Jan. 4, 2008, I shot up out of bed about 2am and was SOAKED w/ sweat. I had on 2 pairs of long sleeved sweatshirts and sweatpants because I still could not keep warm and both sets were soaked through as if I had jumped in a pool. On Jan. 5, 2008 I was still cold and could not control my bowels. Had runny, uncontrollable loose stools starting at night. Jan. 6, 2008 I took myself back to the ER. I had a high temp., was severel dehydrated and received 2 1/2 bags of IV fluids, Tylenol, an ultrasound and a pelvic exam because the docs thought I might have had a uterine infection. All my tests came back negative for uterine infection. My WBCs were high. Docs still don't know what happened to me. Recently, I did research on vaccinations and remembered that MMR shot I received in Dec. 2007 and linked the ER visit to that. I did not realize it took 10-14 days for adverse reactions to take place after a MMR shot and that is exactly when I started having symptoms and went to the ER.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry for Gardasil from a Registered Nurse concerning a 15 year old female who on 20-NOV-2007 was vaccinated with the first dose of Gardasil.  Subsequently the patient received the second dose of Gardasil (Lot #658490/0802U) on 24-JAN-2008 and became pregnant.  The patient's estimated LMP is 07-NOV-2007.  Follow-up indicated that the patient had an elective termination six to eight weeks after her last menstrual period.  It was unknown if the products of conception were examined and it was unknown if the fetus was normal.  Upon internal review elective termination was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Neoplasm malignant
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who was vaccinated with Gardasil.  Concomitant therapy included chemotherapy (ABVD) ADRIAMYCIN PFS, bleomycin, vinblastine and dacarbazine.  It was reported that the patient is in the middle of her Gardasil series.  The type of cancer and the date that the cancer was diagnosed was unknown.  Unspecified medical attention was sought.  Additional information has been requested.  Upon internal review cancer is considered to be an other important medical event.  6/27/08 Reviewed medical records from Oncology. FINAL DX: Hodgkin's lymphoma, stage IIA Records reveal patient diagnosed 1/25/2008.  Left cervical lymph nodes had been swollen since previous summer.  Exam revealed left adenopathy: cervical, axillary & supraclavicular.    6/27/08 Reviewed surgeon medical records of 1/25/08.   FINAL DX: Hodgkin's lymphoma, stage IIA Records reveal patient w/left posterior cervical supraclavicular adenopathy worseing over approx 6 mos.  7/11/08 Reviewed PCP medical & vax records. FINAL DX: Hodgkin's lymphoma, stage IIA. Records reveal patient had tender & swollen left neck x 1-2 wks prior to vaccination on 8/2/2007.  Tx w/antibiotics but lymphadenopathy continued unchanged.  Referred to heme/onc. Tx w/chemo & rad tx.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Blood test, Borrelia burgdorferi serology negative, Epstein-Barr virus test negative
Clinical narrative: Information has been received from a dentist concerning his 18 year old daughter with soft sound sensitivity syndrome (Hyperacusis), who, on an unspecified date was vaccinated with a first and second dose of Gardasil (Lot# 656050/0245U).  Subsequently the patient experienced a decline in her energy levels.  On 19-DEC-2007 the patient was vaccinated IM with a third 0.5mL dose of Gardasil (Lot# 656050/0245U).  Concomitant therapy included LEXAPRO and ROZEREM.  Subsequently, in the beginning of January, one to two weeks post vaccination the patient became experienced lethargy characterized by falling asleep in class and sleeping through meals.  It was reported that the patient "could not lift her head off the pillow some days."  The patient was examined by a physician.  A thyroid function test, mononucleosis serology test, complete blood cell count, and Lyme disease enzyme-linked immunosorbent assay were performed and were negative.  A "full blood work-up" was performed.  A sleep study was performed and was negative.  It was reported that the patient has not received any new medications.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  The decreased energy levels and the patient becoming extremely lethargic were considered to be disabling.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Lethargy, Sleep study normal, Somnolence, Thyroid function test normal
Clinical narrative: Information has been received from a dentist concerning his 18 year old daughter with soft sound sensitivity syndrome (Hyperacusis), who, on an unspecified date was vaccinated with a first and second dose of Gardasil (Lot# 656050/0245U).  Subsequently the patient experienced a decline in her energy levels.  On 19-DEC-2007 the patient was vaccinated IM with a third 0.5mL dose of Gardasil (Lot# 656050/0245U).  Concomitant therapy included LEXAPRO and ROZEREM.  Subsequently, in the beginning of January, one to two weeks post vaccination the patient became experienced lethargy characterized by falling asleep in class and sleeping through meals.  It was reported that the patient "could not lift her head off the pillow some days."  The patient was examined by a physician.  A thyroid function test, mononucleosis serology test, complete blood cell count, and Lyme disease enzyme-linked immunosorbent assay were performed and were negative.  A "full blood work-up" was performed.  A sleep study was performed and was negative.  It was reported that the patient has not received any new medications.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  The decreased energy levels and the patient becoming extremely lethargic were considered to be disabling.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received, via the Merck pregnancy registry, from an approximately 20 year old female consumer (date of birth given, but onset of events and vaccination/gestation dates not specified), who was vaccinated with the first and second dose of GRADASIL (dates and lot # not reported). Subsequently, "between my second and third dose I was pregnant and ultimately miscarried." The patient sought medical attention, and was seen in an office visit (details not specified). The consumer questioned if miscarriage was a possible side effect of GARDASIL. The date of the third dose was not clarified as before or after miscarriage. The outcome of miscarriage was not specified. Upon internal review, ultimately miscarried was considered to be serious as an other important medical event. No further information was available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy bone marrow, Blood test, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with an "unremarkable" medical history and no known allergies, who in January 2008, was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included clopidogrel bisulfate (PLAVIX) and simvastatin (MSD).  Subsequently, two weeks after receiving the vaccine the patient was diagnosed with a disease called "transverse myolitis" and was hospitalized for about 4 weeks.  The patient had CT Scans, MRI, Lumbar Puncture, Blood Tests, and a Bone Marrow Biopsy, the results were not reported.  At the time of the report the patient has not recovered.  He has been hospitalized for the past 4 weeks.  Additional information has been requested. 8/25/08-records received for DOS 2/27-3/14/08-DC DX: Transverse myelitis. Anemia. Positive ANA. Hyperlipidemia. Presented to ED with gait disturbance and inability to walk. Difficulty walking for 2-3 days. Felt weak and tired.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Rash erythematous, Skin burning sensation
Clinical narrative: Information has been received from a physician concerning a male consumer with hypertension, hyperlipidemia and allergies to "medications for hypertension and hyperlipidemia" who on 18-MAR-2008 was vaccinated with Zostavax (Oka/Merck) (lot # 659324/1835U).  On 19-MAR-2008 the patient went to the ER for back pain.  He was diagnosed in the ER with a urinary tract infection and was given CIPRO.  The patient developed shingles on his right back and flank.  The rash was erythematous blisters with burning that began on 26-MAR-2008.  It was also noted that the patient was seen in the office.  At the time of the report the patient has not recovered.  There was no product quality complaint involved.  The reporter considered the patient's events to be other important medical events since he was seen in the ER and office.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a male consumer with hypertension, hyperlipidemia and allergies to "medications for hypertension and hyperlipidemia" who on 18-MAR-2008 was vaccinated with Zostavax (Oka/Merck) (lot # 659324/1835U).  On 19-MAR-2008 the patient went to the ER for back pain.  He was diagnosed in the ER with a urinary tract infection and was given CIPRO.  The patient developed shingles on his right back and flank.  The rash was erythematous blisters with burning that began on 26-MAR-2008.  It was also noted that the patient was seen in the office.  At the time of the report the patient has not recovered.  There was no product quality complaint involved.  The reporter considered the patient's events to be other important medical events since he was seen in the ER and office.  Additional information has been requested.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Ascites, Biopsy bone marrow normal, Biopsy liver normal, Biopsy skin normal, Cardiopulmonary failure
Clinical narrative: Patient was a term infant who had had an uneventful delivery.  He did develop a fever in the first 24 hours of life, was treated with IV antibiotics but blood culture was negative so IV abx were stopped after 48 hours.  He was monitored for several days and did well.  He was scheduled for discharge and received HepB vaccine 24 hour prior to scheduled discharge.  12 hours after immunization, parents report his fevers returned and he developed a skin rash.  He also had difficulty breathing requiring supplemental oxygen by nasal cannula.  A few days later, he deteriorated dramatically, required endotracheal intubation and started having seizures.  He then became encephalopathic and had cardiopulmonary collapse as well as multi-system organ failure.  An EXTENSIVE work up was done.  No infectious, endocrinologic, hematologic or neurologic cause was found.  He developed massive ascites, hepatosplenomagaly and renal failure requiring peritoneal dialysis.  He had skin biopsies, liver biopsies, bone marrow biopsies in addition to an exhaustive amount of blood work for common and rare disorders-all were negative.  Patient eventually died at 6 weeks of age from Pseudomonal sepsis.  Lab studies showed on DOL #2 showed a normal CBC and differential.  <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc.  4/11/2008 Autopsy report and Case Summary received for DOD 8/10/2007. Term infant developed fever (T=103'F), respiratory distress and irritability at 4 hrs of age.  Txd with Acyclovir for presumed viral infection, viral cultures (-).  Pt later developed macular rash which resolved. Pt developed fever and increasing respiratory distress ultimately requiring intubation on 7/8/07. Infant became edematous and developed thrombocytopenia and seizures. Transfered to higher level of care. Upon admission pt exibited temperature elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted after admission.  6 wk hospital course was dominated by diffuse edema, respiratory distress, thrombocytopenia and renal failure.  ID consult suspect Neonatal Onset Multisystem Inflammatory Disease (NOMID).   Autopsy revealed anasarca, Pseudomonas pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow, cholestatic hepatopathy, and marked thymic involution.  Presumed COD:  Overwhemling sepsis.  Contributing COD: Pancytopenia.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Convulsion, Death, Dyspnoea, Encephalopathy, Endotracheal intubation
Clinical narrative: Patient was a term infant who had had an uneventful delivery.  He did develop a fever in the first 24 hours of life, was treated with IV antibiotics but blood culture was negative so IV abx were stopped after 48 hours.  He was monitored for several days and did well.  He was scheduled for discharge and received HepB vaccine 24 hour prior to scheduled discharge.  12 hours after immunization, parents report his fevers returned and he developed a skin rash.  He also had difficulty breathing requiring supplemental oxygen by nasal cannula.  A few days later, he deteriorated dramatically, required endotracheal intubation and started having seizures.  He then became encephalopathic and had cardiopulmonary collapse as well as multi-system organ failure.  An EXTENSIVE work up was done.  No infectious, endocrinologic, hematologic or neurologic cause was found.  He developed massive ascites, hepatosplenomagaly and renal failure requiring peritoneal dialysis.  He had skin biopsies, liver biopsies, bone marrow biopsies in addition to an exhaustive amount of blood work for common and rare disorders-all were negative.  Patient eventually died at 6 weeks of age from Pseudomonal sepsis.  Lab studies showed on DOL #2 showed a normal CBC and differential.  <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc.  4/11/2008 Autopsy report and Case Summary received for DOD 8/10/2007. Term infant developed fever (T=103'F), respiratory distress and irritability at 4 hrs of age.  Txd with Acyclovir for presumed viral infection, viral cultures (-).  Pt later developed macular rash which resolved. Pt developed fever and increasing respiratory distress ultimately requiring intubation on 7/8/07. Infant became edematous and developed thrombocytopenia and seizures. Transfered to higher level of care. Upon admission pt exibited temperature elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted after admission.  6 wk hospital course was dominated by diffuse edema, respiratory distress, thrombocytopenia and renal failure.  ID consult suspect Neonatal Onset Multisystem Inflammatory Disease (NOMID).   Autopsy revealed anasarca, Pseudomonas pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow, cholestatic hepatopathy, and marked thymic involution.  Presumed COD:  Overwhemling sepsis.  Contributing COD: Pancytopenia.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: General physical health deterioration, Hepatosplenomegaly, Multi-organ failure, Oxygen supplementation, Peritoneal dialysis
Clinical narrative: Patient was a term infant who had had an uneventful delivery.  He did develop a fever in the first 24 hours of life, was treated with IV antibiotics but blood culture was negative so IV abx were stopped after 48 hours.  He was monitored for several days and did well.  He was scheduled for discharge and received HepB vaccine 24 hour prior to scheduled discharge.  12 hours after immunization, parents report his fevers returned and he developed a skin rash.  He also had difficulty breathing requiring supplemental oxygen by nasal cannula.  A few days later, he deteriorated dramatically, required endotracheal intubation and started having seizures.  He then became encephalopathic and had cardiopulmonary collapse as well as multi-system organ failure.  An EXTENSIVE work up was done.  No infectious, endocrinologic, hematologic or neurologic cause was found.  He developed massive ascites, hepatosplenomagaly and renal failure requiring peritoneal dialysis.  He had skin biopsies, liver biopsies, bone marrow biopsies in addition to an exhaustive amount of blood work for common and rare disorders-all were negative.  Patient eventually died at 6 weeks of age from Pseudomonal sepsis.  Lab studies showed on DOL #2 showed a normal CBC and differential.  <24 hours after the vaccine, showed severe thrombocytopenia which remained low throughout his hospital course despite twice daily platelet transfusions, etc.  4/11/2008 Autopsy report and Case Summary received for DOD 8/10/2007. Term infant developed fever (T=103'F), respiratory distress and irritability at 4 hrs of age.  Txd with Acyclovir for presumed viral infection, viral cultures (-).  Pt later developed macular rash which resolved. Pt developed fever and increasing respiratory distress ultimately requiring intubation on 7/8/07. Infant became edematous and developed thrombocytopenia and seizures. Transfered to higher level of care. Upon admission pt exibited temperature elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted after admission.  6 wk hospital course was dominated by diffuse edema, respiratory distress, thrombocytopenia and renal failure.  ID consult suspect Neonatal Onset Multisystem Inflammatory Disease (NOMID).   Autopsy revealed anasarca, Pseudomonas pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow, cholestatic hepatopathy, and marked thymic involution.  Presumed COD:  Overwhemling sepsis.  Contributing COD: Pancytopenia.