chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL
Symptoms: Rash pustular, Reading disorder, Retching, Sinusitis, Skin discolouration
Clinical narrative: See attached side effects which have been checked.   Abdomen cramps; ache: joints; aches: whole body; bowels: irritable, cellulitis; chills, chills fever; mood: Anxiety; concentration: difficulty; concentration: loss of, concentration: trouble; neurological: Confusion; constipation; coordination: problems; Cramps leg; balance: dizziness; balance: vertigo; balance: problems; bladder problems; cyst: right ovary cysts painful; blood pressure: high; Depression; dermatitis; diarrhea; diarrhea: constant; gagging (means nausea); gastric ulcer; indigestion: nausea; constant; Balance: Dizziness; Dry mouth; Dyspnea; energy loss; exhaustion; eyes: loss of ability to produce tears (aka sicca syndrome or Sjogren's syndrome, autoimmune); fatigue; fatigue: muscle; fibromyalgia; Flu syndrome; Gastritis; hair: turned white, then brown; hair: loss of facial; hair: falling out; head: shakes; headache: uncontrollable thump on left side; headaches: migraines; headache; hearing: ringing in ears; hearing: poor tolerance for loud noises; heart: murmur; heart: rapid pulse rate; heart: palpitations; Hypertonia; Hypokinesia; Hypotension; memory: difficult, loss, bad, loss with dizziness, trouble remembering recent information, short-term memory loss, increase in forgetfulness; Infection: fungal, pockets of infection in throat and mouth, staphylococcal, chronic to include ear and sinus; Menstrual abnormalities, loss; neurological; reading comprehension difficulty, slowed responses, unable to perform multiple tasks simulatenously, slowness, disorientation, depression, confusion, staring spells (likely minor seizures), migraine, mood swings, anxious, angry, irritable; Myalgia; sleep: Insomnia; joint: stiffness, ache; nasal: nose bleeds; lesion: brain; Nervousness; libido: loss; numbness and tingling: fingers, arms and down one side of body, leg, neck down; pain: stomach, bone and joint, muscle and joint, arthritic, ear, abdo, back, chest, in feet, like electrical shocks, charlie horse (I do not think the pain location is of great interest); Photophobia; Rash pustular, burn-type on entire body; respiratory: shortness of breath; shaking; skin: cysts developed, eczema, discoloration, sensitivity, rashes, pain; verbal skills: unable to comprehend words, stuttering, trouble finding words, struggle for words; Sleep: feel not refreshed upon waking up, unable to sleep flat without medication; Speech disorder; Voice alteration; weakness; weight gain; suicide attempt; sweating; swelling: joints, feet and ankles; Tachycardia; Taste loss of; Thinking abnormality; Tinnitus; Twitching or jerking
Age: 32.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL
Symptoms: Speech disorder, Staphylococcal infection, Suicide attempt, Thinking abnormal, Tinnitus
Clinical narrative: See attached side effects which have been checked.   Abdomen cramps; ache: joints; aches: whole body; bowels: irritable, cellulitis; chills, chills fever; mood: Anxiety; concentration: difficulty; concentration: loss of, concentration: trouble; neurological: Confusion; constipation; coordination: problems; Cramps leg; balance: dizziness; balance: vertigo; balance: problems; bladder problems; cyst: right ovary cysts painful; blood pressure: high; Depression; dermatitis; diarrhea; diarrhea: constant; gagging (means nausea); gastric ulcer; indigestion: nausea; constant; Balance: Dizziness; Dry mouth; Dyspnea; energy loss; exhaustion; eyes: loss of ability to produce tears (aka sicca syndrome or Sjogren's syndrome, autoimmune); fatigue; fatigue: muscle; fibromyalgia; Flu syndrome; Gastritis; hair: turned white, then brown; hair: loss of facial; hair: falling out; head: shakes; headache: uncontrollable thump on left side; headaches: migraines; headache; hearing: ringing in ears; hearing: poor tolerance for loud noises; heart: murmur; heart: rapid pulse rate; heart: palpitations; Hypertonia; Hypokinesia; Hypotension; memory: difficult, loss, bad, loss with dizziness, trouble remembering recent information, short-term memory loss, increase in forgetfulness; Infection: fungal, pockets of infection in throat and mouth, staphylococcal, chronic to include ear and sinus; Menstrual abnormalities, loss; neurological; reading comprehension difficulty, slowed responses, unable to perform multiple tasks simulatenously, slowness, disorientation, depression, confusion, staring spells (likely minor seizures), migraine, mood swings, anxious, angry, irritable; Myalgia; sleep: Insomnia; joint: stiffness, ache; nasal: nose bleeds; lesion: brain; Nervousness; libido: loss; numbness and tingling: fingers, arms and down one side of body, leg, neck down; pain: stomach, bone and joint, muscle and joint, arthritic, ear, abdo, back, chest, in feet, like electrical shocks, charlie horse (I do not think the pain location is of great interest); Photophobia; Rash pustular, burn-type on entire body; respiratory: shortness of breath; shaking; skin: cysts developed, eczema, discoloration, sensitivity, rashes, pain; verbal skills: unable to comprehend words, stuttering, trouble finding words, struggle for words; Sleep: feel not refreshed upon waking up, unable to sleep flat without medication; Speech disorder; Voice alteration; weakness; weight gain; suicide attempt; sweating; swelling: joints, feet and ankles; Tachycardia; Taste loss of; Thinking abnormality; Tinnitus; Twitching or jerking
Age: 32.0
Sex: F
Vaccine: ANTH, HEPAB, SMALL
Symptoms: Tremor, Vertigo, Weight increased
Clinical narrative: See attached side effects which have been checked.   Abdomen cramps; ache: joints; aches: whole body; bowels: irritable, cellulitis; chills, chills fever; mood: Anxiety; concentration: difficulty; concentration: loss of, concentration: trouble; neurological: Confusion; constipation; coordination: problems; Cramps leg; balance: dizziness; balance: vertigo; balance: problems; bladder problems; cyst: right ovary cysts painful; blood pressure: high; Depression; dermatitis; diarrhea; diarrhea: constant; gagging (means nausea); gastric ulcer; indigestion: nausea; constant; Balance: Dizziness; Dry mouth; Dyspnea; energy loss; exhaustion; eyes: loss of ability to produce tears (aka sicca syndrome or Sjogren's syndrome, autoimmune); fatigue; fatigue: muscle; fibromyalgia; Flu syndrome; Gastritis; hair: turned white, then brown; hair: loss of facial; hair: falling out; head: shakes; headache: uncontrollable thump on left side; headaches: migraines; headache; hearing: ringing in ears; hearing: poor tolerance for loud noises; heart: murmur; heart: rapid pulse rate; heart: palpitations; Hypertonia; Hypokinesia; Hypotension; memory: difficult, loss, bad, loss with dizziness, trouble remembering recent information, short-term memory loss, increase in forgetfulness; Infection: fungal, pockets of infection in throat and mouth, staphylococcal, chronic to include ear and sinus; Menstrual abnormalities, loss; neurological; reading comprehension difficulty, slowed responses, unable to perform multiple tasks simulatenously, slowness, disorientation, depression, confusion, staring spells (likely minor seizures), migraine, mood swings, anxious, angry, irritable; Myalgia; sleep: Insomnia; joint: stiffness, ache; nasal: nose bleeds; lesion: brain; Nervousness; libido: loss; numbness and tingling: fingers, arms and down one side of body, leg, neck down; pain: stomach, bone and joint, muscle and joint, arthritic, ear, abdo, back, chest, in feet, like electrical shocks, charlie horse (I do not think the pain location is of great interest); Photophobia; Rash pustular, burn-type on entire body; respiratory: shortness of breath; shaking; skin: cysts developed, eczema, discoloration, sensitivity, rashes, pain; verbal skills: unable to comprehend words, stuttering, trouble finding words, struggle for words; Sleep: feel not refreshed upon waking up, unable to sleep flat without medication; Speech disorder; Voice alteration; weakness; weight gain; suicide attempt; sweating; swelling: joints, feet and ankles; Tachycardia; Taste loss of; Thinking abnormality; Tinnitus; Twitching or jerking
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23 vaccine in her left deltoid muscle at her place of employment on 04/09/2007. She experienced swelling and pain in the few hours following the injection. The next day she awakened to find her left arm between her shoulder and elbow with the following: erythema, swelling, induration, warmth, and pain. The patient phoned the office of her internist and was advised to taken an antihistamine and apply over-the-counter hydrocortisone cream. The symptoms gradually subsided over a several day period.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt came in the clinic on 5/20. Mom states that on 5/19/09 pt had fever 105 and rash. Today rash is worst but no fever. Red bump raised pink on abdomen, back, chest and extremities.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Local reaction with marked erythema, warmth, and pain at injection site within 12hrs of administration. Size of affected area 12cm X 10 cm Treated with Benadryl + pain meds.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: Had rash on neck after 1st shot (4-5 days later) thought it was from something else, itching also. After 2nd shot rash widespread on trunk, neck, arms and itching. A lot worse. Took a couple of weeks to go away. (Also 4-5 days later). Instructed to tell physician.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Feeling hot, Immediate post-injection reaction, Nausea
Clinical narrative: About 2min after injection (s/s) Pt got hot, very moist feeling, felt nauseated, dizzy. After she sat for about 5-10 min and had drank of H20 she felt better. I've talked to with Pt and she is fine. She was ok after about 15min.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling from shoulder to elbow - MOTRIN - rest- elevation
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Contusion, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right arm red, swollen, bruised, warm to touch.
Age: 4.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient given ADACEL instead of DAPTACEL at age 4 yrs 10 mths. No adverse reaction. All other vaccines given in another state.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Forceful vomiting 24 hours after vaccines. Advised pedialyte (Sm. am'ts) Then gradually increase to formula. Same symptoms after 1st series of vaccines.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Swollen, itchy, warm, sore, rash 6" long x 4" wide went to my doctor, prescribed KEFLEX generic cephalexin 500 mg twice daily for 7 days.
Age: 26.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Antinuclear antibody increased, Arthralgia, Autoimmune disorder
Clinical narrative: This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Age: 26.0
Sex: M
Vaccine: LYME
Symptoms: Blindness, Borrelia burgdorferi serology, Cognitive disorder, Decreased activity, Erythema
Clinical narrative: This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Age: 26.0
Sex: M
Vaccine: LYME
Symptoms: Fall, Fatigue, Gait disturbance, Immunology test, Joint swelling
Clinical narrative: This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Age: 26.0
Sex: M
Vaccine: LYME
Symptoms: Lyme disease, Lymphadenopathy, Musculoskeletal stiffness, Nervous system disorder, Nodule
Clinical narrative: This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Age: 26.0
Sex: M
Vaccine: LYME
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Rash, Tremor, Visual impairment
Clinical narrative: This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Pt received Tdap vaccine in the ED. The vaccine is to be given to patients between 11-64 years of age.Pt reported to our office on 6/8/09 that 6 days following the injection (which was given on 5/27/09), she noticed her arm at the injection site was red, warm to the touch and full of hives.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: From physician note:  "her right arm shows an inflammation, some redness and mild induration at the site of her recent injection when she got her pneumonia shot at discharge last time".  Mild reaction to the right arm.  Patient currently receiving antibiotic therapy due to possible diverticulitis, recovering pneumonia.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Erythema, Inflammation, Lymphadenopathy, Nausea
Clinical narrative: 3day fever to 101F responded to NSAID's, nausea, sattelite lesions, marked inflammation of shoulder with bilateral swelling of axillary and cervical lyph nodes and red streaking around shoulder.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Skin striae
Clinical narrative: 3day fever to 101F responded to NSAID's, nausea, sattelite lesions, marked inflammation of shoulder with bilateral swelling of axillary and cervical lyph nodes and red streaking around shoulder.
Age: 28.0
Sex: F
Vaccine: HEP, MM
Symptoms: Glossitis
Clinical narrative: client received vaccines MMR, and Hep. B. on Monday 06/08/2009. Called today.Stated on Tues night tongue became sore and swollen. Still sore and swollen today. Took Benadryl yesterday. Advised client to take more Benadryl if needed and if tongue swells any more or if client experiences any difficulty breathing to go to ER immediately.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: C/O pain, erythema, swelling 3-4" in diameter 24 hours after receiving shot.  Warm compresses and Benedryl advised.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Diffuse drug reaction of head chest back arms and legs.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after vaccine was given, the patient developed pallor and was dizzy.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anorexia, Blood thyroid stimulating hormone, Dizziness, Full blood count
Clinical narrative: HEADACHE, DIZZINESS, PROBLEMS WITH SPEECH, NAUSEA, STOMACH ACHE, SLEEPINESS, NO APPETITE.  6/12/09 Medical records received DOS 9/14/2006 to 6/4/09. Medical progress notes are illegible.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Somnolence, Speech disorder
Clinical narrative: HEADACHE, DIZZINESS, PROBLEMS WITH SPEECH, NAUSEA, STOMACH ACHE, SLEEPINESS, NO APPETITE.  6/12/09 Medical records received DOS 9/14/2006 to 6/4/09. Medical progress notes are illegible.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pallor, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: maculopapular, red in color, blanching, generalized in arrangement
Age: 11.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: rash on trunk and forearms presented after second pill administered.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash
Clinical narrative: Rash to trunk and back with some itching.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC
Symptoms: Culture urine negative, Febrile convulsion, White blood cells urine positive
Clinical narrative: 2-3 minute long seizure associated with fever 2 hours after administration of Dtap and Prevnar
Age: 1.75
Sex: F
Vaccine: MMR
Symptoms: Photophobia, Rash, Rhinorrhoea
Clinical narrative: Rash: onset 6/7/09, duration of 3 days; Eye sensitivity to light: onset 6/8/09, duration 1 day; Runny Nose: onset 6/7, duration still ongoing as of 6/11/09.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: patient experienced yesterday (6/10/09)  on the body from face to upper thigh, fever. Mom gave Tylenol- steaspoonsful and applied Calamine lotion. Temp at visit today was 102.4- Tylenol  2&1/2 teaspoonsful was given to patient. Orders were to continue Tylenol 2&1/2 teapspoonsful q 6 hours, Calamin elotion if tiching and Benadryl 1 teaspoonful q 6 hours for itching.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 55 X 60 mm area of induration, warm to touch, erythematous
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, induration, pain, itching, warmth, 14cm x 11.5 cm area surrounding injection site. Local cellulitis.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Second dose of Hepatitis A given by error too early from first dose.CDC called and verified that this dose would not be valid and should be repeated in 6 months from today's dose. Adverse reactions would be the same as any other dose of Hepatitis A.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Concussion, Contusion, Convulsion, Dizziness, Headache
Clinical narrative: Approx 90 seconds after the first injection my daughter became faint and passed out, she then began having a seizure, the entire episode lasted approx 2 minutes. After being treated and stabilized at the clinic, we saw our family DR approx one hour later. She had multiple xrays due to the injuries when she fainted, she has a mild concussion with slight dilation of the left pupil. She has a lingering headache, (we are sure this is at least in part due to the facial injuries from the fall to the tile floor). There is significant pain at the injection site which is being treated with ice packs and extra strength Tylenol (no Motrin allowed due to the high level of bruising) after seeing our family DR she has referred us to a Neurologist to rule out any underlying factors leading to the fainting and seizures that our daughter experienced today.  7/29/09 Consultant records received DOS 6/11/09. Assessment "faint" vasovagal Patient felt dizzy, passed out, loss of consciousness, posturing, incontinence, hit (R) face, (R) hip, (R) knee, some jerking.  Presents with erythema (R) cheek / skin / (R) Hip and knee. Contusion (R) hip (R) knee (R) face. Face and knee feel sore. (L) pupil > (R) properly responding. Auditory canal blocked with wax.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Injury, Loss of consciousness, Mydriasis, X-ray
Clinical narrative: Approx 90 seconds after the first injection my daughter became faint and passed out, she then began having a seizure, the entire episode lasted approx 2 minutes. After being treated and stabilized at the clinic, we saw our family DR approx one hour later. She had multiple xrays due to the injuries when she fainted, she has a mild concussion with slight dilation of the left pupil. She has a lingering headache, (we are sure this is at least in part due to the facial injuries from the fall to the tile floor). There is significant pain at the injection site which is being treated with ice packs and extra strength Tylenol (no Motrin allowed due to the high level of bruising) after seeing our family DR she has referred us to a Neurologist to rule out any underlying factors leading to the fainting and seizures that our daughter experienced today.  7/29/09 Consultant records received DOS 6/11/09. Assessment "faint" vasovagal Patient felt dizzy, passed out, loss of consciousness, posturing, incontinence, hit (R) face, (R) hip, (R) knee, some jerking.  Presents with erythema (R) cheek / skin / (R) Hip and knee. Contusion (R) hip (R) knee (R) face. Face and knee feel sore. (L) pupil > (R) properly responding. Auditory canal blocked with wax.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Face and mouth X-ray, Syncope
Clinical narrative: Approx 90 seconds after the first injection my daughter became faint and passed out, she then began having a seizure, the entire episode lasted approx 2 minutes. After being treated and stabilized at the clinic, we saw our family DR approx one hour later. She had multiple xrays due to the injuries when she fainted, she has a mild concussion with slight dilation of the left pupil. She has a lingering headache, (we are sure this is at least in part due to the facial injuries from the fall to the tile floor). There is significant pain at the injection site which is being treated with ice packs and extra strength Tylenol (no Motrin allowed due to the high level of bruising) after seeing our family DR she has referred us to a Neurologist to rule out any underlying factors leading to the fainting and seizures that our daughter experienced today.  7/29/09 Consultant records received DOS 6/11/09. Assessment "faint" vasovagal Patient felt dizzy, passed out, loss of consciousness, posturing, incontinence, hit (R) face, (R) hip, (R) knee, some jerking.  Presents with erythema (R) cheek / skin / (R) Hip and knee. Contusion (R) hip (R) knee (R) face. Face and knee feel sore. (L) pupil > (R) properly responding. Auditory canal blocked with wax.
Age: 47.0
Sex: U
Vaccine: FLUX
Symptoms: Headache, Vaccine positive rechallenge, Visual impairment
Clinical narrative: Not recently, but want to report now. 3 Influenza vac, with identical reactions each time of visual change (marked) & headache. Recovered all 3 times within 6-8 hours.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Molluscum contagiosum, Varicella
Clinical narrative: Varicella Molluscum after previous dose of PROQUAD.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Woke up from a nap around 5pm on 6/9/09 and noticed (L) arm was red, swollen, and warm to touch. Gave TYLENOL d/t LG fever of 99 per mother, and applied ice. Contacted Doctor on 6/10/09 after hrs. He advised her to take BENADRYL and bring her to the office the following morning.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt presents with red, raised area on outer Lt thigh + tender to touch, about size of a baseball -SX began this a.m. 6/11/09- Area is site of KINRIX inj. given 06/10/09. Saw Doctors + orders for Benadryl + warm compresses given.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Fainted after Tdap, Menactra , Varicella vaccines administered - Vital taken rest, fluids, EKG.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram normal, Immediate post-injection reaction, Syncope
Clinical narrative: Fainted after Tdap, Menactra , Varicella vaccines administered - Vital taken rest, fluids, EKG.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticarial rash within 6 H of administration of PREVENAR Lt  - MMR, VARIVAX, HAV
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Localize reaction. Injection site, swelling, red and hot Fever treated with Motrin and Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: (L) arm 2x2 cm red, cellulitic area were INFANRIX given - x2 days - warm compresses-PO AUGMENTIN, 400 POBID
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles - dx 5/5/09.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pyrexia
Clinical narrative: Red arm syndrome, headache + fever treated with  Keflex 500mg - PO TID X 10 days.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Oropharyngeal blistering
Clinical narrative: Broke out with blisters on mouth.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Eyelid oedema, Headache, Malaise
Clinical narrative: Thickness of the eyelids, dizziness, feel sick. top center of head tender to touch, hurts. "This feeling" will not go away! I called the Doctors Office the next day nothing can be done. She informed the shot will last 10 years, Office mgr told me, her boss told her, my symptoms were not caused by the "TDAP" made by:"Sanofi Pasteur" I have not taken any other meds for 5-weeks, just so I could make sure there wasn't any other reason for the way I've been feeling. I've informed the Doctor every visit. This is no way to live.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Pt fainted immediately following vaccination of Tdap, Menactra, & Varicella vaccines. Vital signs taken, pt lying down to rest, and given fluids, EKG done--normal
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram normal, Immediate post-injection reaction, Syncope
Clinical narrative: Pt fainted immediately following vaccination of Tdap, Menactra, & Varicella vaccines. Vital signs taken, pt lying down to rest, and given fluids, EKG done--normal
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Febrile (101) 24 hours after immunizations - red rash on trunk 10 days after immunization
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema, Nodule, Rash
Clinical narrative: Bilateral finger rash, erythematous nodules well demarcated.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: 1 1/2" diameter redness no induration or tenderness -  no cellulitis - no treatment necessary
Age: 8.0
Sex: M
Vaccine: TYP, YF
Symptoms: Abdominal pain, Anorexia, Asthenia, Diarrhoea, Fatigue
Clinical narrative: 6/9/09 Mother of the client reported the following events occurred after vaccination of client for Yellow Fever and Typhoid VI at clinic on 5/27/09. 5/28/09 Client had a low grade fever, nausea, loss of appetite, and low energy. 5/29/09 Client c/o same symptoms as previous day and also abd. cramping. Mother took client to Urgent Care Dr. A strep culture was done and client emesed in office. Also emesed later in P.M. at home. The strep test was neg. and when told that the client had received vaccines on 5/27/09 the Dr. felt his symptoms were vaccine related - T 99 degree. 5/30/09 Client no appetite, cramping and diarrhea - 6-7 stools that day. Mother kept client hydrated. 5/30/09 Client c/o nausea and was weak, had a low fever - no diarrhea or vomiting. 6/1/09 Client was taken to school, he c/o cramping and emesed at school. 6/2/09 Client had diarrhea with emesic.  6/3/09 Client woke with c/o cramping. Mother took client to Dr. again.. Dr. indicated that client was likely reacting to Yellow Fever vaccine. Mother was instructed to give client IMODIUM and hydrate. Client had lost 3 lbs. 6/4/09 Client left with relative to another state - had diarrhea stool x 1 and tool IMODIUM. 6/5/09 Client had no vomiting or diarrhea, was in better mood and still had no appetite. 6/6/09 Client flew with relative to another city. Cont. to c/o cramping, low fever. 6/7/09 Client reached destination in a Foreign country. Client c/o being tired with no appetite but had no vomiting or diarrhea. Mother related these events to me 6/8/09 at clinic.
Age: 8.0
Sex: M
Vaccine: TYP, YF
Symptoms: Foreign travel, Nausea, Pyrexia, Streptococcal identification test negative, Vomiting
Clinical narrative: 6/9/09 Mother of the client reported the following events occurred after vaccination of client for Yellow Fever and Typhoid VI at clinic on 5/27/09. 5/28/09 Client had a low grade fever, nausea, loss of appetite, and low energy. 5/29/09 Client c/o same symptoms as previous day and also abd. cramping. Mother took client to Urgent Care Dr. A strep culture was done and client emesed in office. Also emesed later in P.M. at home. The strep test was neg. and when told that the client had received vaccines on 5/27/09 the Dr. felt his symptoms were vaccine related - T 99 degree. 5/30/09 Client no appetite, cramping and diarrhea - 6-7 stools that day. Mother kept client hydrated. 5/30/09 Client c/o nausea and was weak, had a low fever - no diarrhea or vomiting. 6/1/09 Client was taken to school, he c/o cramping and emesed at school. 6/2/09 Client had diarrhea with emesic.  6/3/09 Client woke with c/o cramping. Mother took client to Dr. again.. Dr. indicated that client was likely reacting to Yellow Fever vaccine. Mother was instructed to give client IMODIUM and hydrate. Client had lost 3 lbs. 6/4/09 Client left with relative to another state - had diarrhea stool x 1 and tool IMODIUM. 6/5/09 Client had no vomiting or diarrhea, was in better mood and still had no appetite. 6/6/09 Client flew with relative to another city. Cont. to c/o cramping, low fever. 6/7/09 Client reached destination in a Foreign country. Client c/o being tired with no appetite but had no vomiting or diarrhea. Mother related these events to me 6/8/09 at clinic.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Marked by swollen upper left arm shoulder to elbow.  No fever good movement in shoulder, elbow, and wrist prescribed Keflex for cellulitis.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Child broke out in hives within 24 hrs.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed rash about 1 1/2" in diameter at injection site. White in center.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Electrocardiogram normal, Heart rate irregular, Pallor, Presyncope, Syncope
Clinical narrative: Shortly after vaccine administration, approximately 15-25 minutes child had syncopal episode that was prolonged with noticeable pallor, and fluctuant heart rate = 80 bpm with 100% saturation. No rashes, no wheezing noticed. Patient then fell asleep with heart rate remaining in  80's. After about 20-30 minutes Pt. awakened in no distress - heart rate returned back to 110-115 bpm and no distress noticed, presumed vasovagal response (prolonged) - EKG ordered to r/o cardiac arrhythmia
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt developed redness, swelling & induration of R thigh approximately 48 hrs after receiving vaccines.  Minimally tender, no fever or other systemic symptoms. Placed on Augmentin 400mg BID x10d.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Received MMR, varicella, PREVNAR with Hep A 6/8/09. Began with erythematous rash that night that became a generalized urticarial RXN the next day. No SOB wheezing or difficulty swallowing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Developed spots located on her scalp, forehead and face Lt is bilaterally. Spots itchy. no blistering -Treatment - acyclovir X 7 days
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Difuse varicellaform rash on chest, back, abdomen, buttocks, upper thighs. Treated with diflorasone diacetate ointment for itching.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability
Clinical narrative: very fussy
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: After administration of GARDASIL patient got dizzy + started perspiring.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Aborted pregnancy, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with no medical history and no drug allergies, who on 26-NOV-2007 was vaccinated intramuscularly in the left arm with a 0.5mL first dose of GARDASIL (Lot# 658563/1063U). On 28-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 658563/1063U). There was no concomitant medication. Subsequently, the patient was pregnant. The patient believed her last menstrual period to be 20-NOV-2007 and her estimated delivery date was 26-AUG-2008. The patient was seen in the office. A urine pregnancy test was taken. No symptoms were reported. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow up information was received from the physician who reported that the patient's EDD was 11-AUG-2008. On an unspecified date the patient aborted her pregnancy as it was unwanted pregnancy. Upon internal review, pregnancy aborted was considered to be an other important medical event. Additional information is not expected.