chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: red 4 by 5 inches on deltoid
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blood culture, Headache, Musculoskeletal stiffness, Myalgia, Rash
Clinical narrative: Headache, muscle stiffness/pain starting in neck and going throughout body, rash on arm.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope
Age: 34.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Fatigue
Clinical narrative: Extreme fatigue, tiredness. Don't feel as tired but extremely fatigued since onset when walking for commute and exercising. I am extremely healthy and have been in great shape.
Age: 32.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Antibody test negative, Injection site pain, Injection site rash, Pruritus, Rash
Clinical narrative: Seen on 4/11 for Varicella Vaccine given on 3/29/11. Last week noticed pain at site; local rash at site & also sev. spots on face. Noticed "itchy" areas other places as well. Afebrile. ? dev. chickenpox.
Age: 0.31
Sex: M
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None at this time - symptoms 4 month old infant accidentally administered varicella vaccine instead of Rota vaccine at 4 month well child check.
Age: 44.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Given MMR immunization (L) upper arm SQ 3-9-11. Developed "lump" in area w/in 2-3 days. Two weeks later area became more erythematous with pain/itching developing over the next week. Was seen in occupational health 3-31-11 and diagnosed with delayed hypersensitivity reaction localized. Treated with cold packs & topical hydrocortisone cream.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: (DTAP-IPV-HIB) administered in Rt arm on 4/5/11. On 4/8/11 pt presented in office with cellulitis vs allergy.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Conjunctival hyperaemia, Periorbital oedema
Clinical narrative: Patient received Tdap, HPV and Meningococcal immunizations - 15 minutes after, had erythema, edema (periorbital) & conjunctival infection. Fading & resolving within 10 minutes and resolved after 30 minutes.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Erythema, Flushing, Headache, Nausea
Clinical narrative: About 14 hr post vaccination fever, nausea, generalized body aches. Fever continues, dehydration, nausea, redness of face (flushing) and severe headache seeing visual spots/blurry. Treated urgent care 4/10/11.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Vision blurred, Visual impairment
Clinical narrative: About 14 hr post vaccination fever, nausea, generalized body aches. Fever continues, dehydration, nausea, redness of face (flushing) and severe headache seeing visual spots/blurry. Treated urgent care 4/10/11.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Dermatitis allergic, Pruritus, Urticaria
Clinical narrative: Approx. 5 min. after vaccines given, pt. developed severe hives on arms & neck. Says they are itchy but denies difficulty swallowing or breathing or any other symptoms. Per interpreter, nurse says child put on a new coat immediately after vaccines. She feels the rash is due to coat. Patient received same vaccines at last visit here without reactions. Dr. ordered BENADRYL 25 mg po which was given at 3:35pm. 20 min. post BENADRYL -> no.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Tender at touch, (L) arm hot painful 10/10, not cellulitis, allergic reaction per MD.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Cold sweat, Dizziness, Fatigue
Clinical narrative: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Headache, Myalgia, Rash
Clinical narrative: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Arthralgia, Blood aluminium increased, Blood test normal, Dyspepsia, Dysuria
Clinical narrative: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Eye disorder, Fatigue, Feeling abnormal, Migraine, Myalgia
Clinical narrative: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Rash, Weight decreased
Clinical narrative: Headache, dizziness, stomach pain, joint pain, muscle pain. Cold sweats. Fatigue. Rash.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Oedema peripheral, Skin warm
Clinical narrative: (L) arm swollen, hot at touch. No cellulitis. Allergic reaction to whooping cough.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site macule, Injection site pain
Clinical narrative: Pt's mother reported reaction on 4/7/11 & pt. evaluated at clinic on same day. S/S: rash/hives: (L) upper arm w/erythematous raised macules covering approximately 50% of lateral side; (R) upper arm w/ sml single erythematous raised macule (2x3cm). (L) knee w/warm, swollen red rash (5x5cm); some abd. pain, itchiness & burning at site; headache.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Joint swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Pt's mother reported reaction on 4/7/11 & pt. evaluated at clinic on same day. S/S: rash/hives: (L) upper arm w/erythematous raised macules covering approximately 50% of lateral side; (R) upper arm w/ sml single erythematous raised macule (2x3cm). (L) knee w/warm, swollen red rash (5x5cm); some abd. pain, itchiness & burning at site; headache.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt's mother reported reaction on 4/7/11 & pt. evaluated at clinic on same day. S/S: rash/hives: (L) upper arm w/erythematous raised macules covering approximately 50% of lateral side; (R) upper arm w/ sml single erythematous raised macule (2x3cm). (L) knee w/warm, swollen red rash (5x5cm); some abd. pain, itchiness & burning at site; headache.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Non-consummation
Clinical narrative: Amenorrhea (no period) x 3 1/2 + months (ongoing) in non sexually active pt given GARDASIL vaccine.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Diplopia, Eye operation, Headache, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Headaches one week after 6-18-10 vacation & double vision 2 weeks after. Eye surgery on 8-30-10. Double vision remains. MRI of brain was normal.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Hypertension, Hypoaesthesia, Loss of consciousness, Pain
Clinical narrative: This report from a claims management service (initial receipt 30-MAR-2011) concerns a female patient. On an unspecified date, the patient was given a flu shot. A few hours later, the patient was paralyzed. She remained paralyzed for approximately 3-4 days before regaining movement. The date of loss was reported as 09-JAN-2011.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paralysis, Posture abnormal
Clinical narrative: This report from a claims management service (initial receipt 30-MAR-2011) concerns a female patient. On an unspecified date, the patient was given a flu shot. A few hours later, the patient was paralyzed. She remained paralyzed for approximately 3-4 days before regaining movement. The date of loss was reported as 09-JAN-2011.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paralysis
Clinical narrative: This report from a claims management service (initial receipt 30-MAR-2011) concerns a female patient. On an unspecified date, the patient was given a flu shot. A few hours later, the patient was paralyzed. She remained paralyzed for approximately 3-4 days before regaining movement. The date of loss was reported as 09-JAN-2011.
Age: 7.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Anaphylactic reaction, Throat tightness, Urticaria
Clinical narrative: Per MD: "Anaphylactic Response to MMR - hives & throat tightness - Rx EPIPEN//BENADRYL//SOLUMEDROL".
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Cardiac electrophysiologic study, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: This case was received on 07 April 2011 from a health care professional who also reported the event to VAERS (Temporary VAERS E-Report Number E-52802). A 55-year-old male patient (date of birth not reported) received the following vaccination on 04 February 2011: ACAM2000 (lot number not reported). On 23 February 2011, 19 days post vaccination, the patient developed palpitations and SOB (shortness of breath). The event required an emergency room / doctor's visit. Relevant diagnostic testing included electrocardiogram, echocardiogram, MRI with gad, Indium scan of the heart, CT angiogram and EP study. Results of diagnostic testing were not reported. According to the reporter, further details of the patient's diagnosis and condition were limited at the time of the report. The patient's recovery status was not reported. Documents held by sender: None. This report is NOT part of the H-406-003 Myopericarditis Registry.
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nuclear magnetic resonance imaging, Palpitations, White blood cell scan
Clinical narrative: This case was received on 07 April 2011 from a health care professional who also reported the event to VAERS (Temporary VAERS E-Report Number E-52802). A 55-year-old male patient (date of birth not reported) received the following vaccination on 04 February 2011: ACAM2000 (lot number not reported). On 23 February 2011, 19 days post vaccination, the patient developed palpitations and SOB (shortness of breath). The event required an emergency room / doctor's visit. Relevant diagnostic testing included electrocardiogram, echocardiogram, MRI with gad, Indium scan of the heart, CT angiogram and EP study. Results of diagnostic testing were not reported. According to the reporter, further details of the patient's diagnosis and condition were limited at the time of the report. The patient's recovery status was not reported. Documents held by sender: None. This report is NOT part of the H-406-003 Myopericarditis Registry.
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram, Cardiac electrophysiologic study, Diagnostic procedure, Dyspnoea, Echocardiogram
Clinical narrative: This case was received on 07 April 2011 from a health care professional who also reported the event to VAERS (Temporary VAERS E-Report Number E-52802). A 55-year-old male patient (date of birth not reported) received the following vaccination on 04 February 2011: ACAM2000 (lot number not reported). On 23 February 2011, 19 days post vaccination, the patient developed palpitations and SOB (shortness of breath). The event required an emergency room / doctor's visit. Relevant diagnostic testing included electrocardiogram, echocardiogram, MRI with gad, Indium scan of the heart, CT angiogram and EP study. Results of diagnostic testing were not reported. According to the reporter, further details of the patient's diagnosis and condition were limited at the time of the report. The patient's recovery status was not reported. Documents held by sender: None. This report is NOT part of the H-406-003 Myopericarditis Registry.
Age: 55.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram, Nuclear magnetic resonance imaging, Palpitations
Clinical narrative: This case was received on 07 April 2011 from a health care professional who also reported the event to VAERS (Temporary VAERS E-Report Number E-52802). A 55-year-old male patient (date of birth not reported) received the following vaccination on 04 February 2011: ACAM2000 (lot number not reported). On 23 February 2011, 19 days post vaccination, the patient developed palpitations and SOB (shortness of breath). The event required an emergency room / doctor's visit. Relevant diagnostic testing included electrocardiogram, echocardiogram, MRI with gad, Indium scan of the heart, CT angiogram and EP study. Results of diagnostic testing were not reported. According to the reporter, further details of the patient's diagnosis and condition were limited at the time of the report. The patient's recovery status was not reported. Documents held by sender: None. This report is NOT part of the H-406-003 Myopericarditis Registry.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram normal, Convulsion
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Depressed mood, Dysstasia, Eye pain, Fatigue, Headache
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Neurological examination, Nuclear magnetic resonance imaging normal, Photophobia, Tremor
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site pain, Injection site reaction, Mononucleosis heterophile test positive, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Photophobia, Tremor
Clinical narrative: Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Fatigue, Headache, Malaise, Pruritus
Clinical narrative: She describes feeling itchy on her arms and legs, but without a rash. Malaise symptoms with headache, chest pressure and fatigue. She went to sleep after dinner and her symptoms were gone by the next morning. Reported this many days after administration as an afterthought when we were scheduling her 3rd and final vaccine.
Age: 0.09
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Immunizations given prior to recommended age (12 days early).
Age: 0.3
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Cough, Inflammation
Clinical narrative: This is an initial spontaneous report from a contactable consumer (case was not medically confirmed). The consumer reported that a 3-month-old, female, daughter, received a dose of PREVNAR 13, solution for injection in pre-filled syringe on an unspecified date in 2010 as immunization. No relevant medical history or concomitant medications were reported. The patient experienced  bronchitis infection on an unspecified day in Dec2010. The patient also experienced coughing and inflammation on an unspecified date post-vaccination. Relevant laboratory data was unknown. Treatment included SINGULAIR for inflammation, BENADRYL for allergy, albuterol for bronchitis infection and also she was on a nebulizer as a therapeutic measure for the bronchitis infection. The patient recovered from the bronchitis infection but the coughing and inflammation were not recovered at the time of report.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Grandmthr. states pt received vax. on Monday. Thursday pt developed low grade temp and full body rash; was sent home from school. Went to ED however didn't stay = wait too long. Referred to Peds - Peds instruction was if rash not better by Monday to go in to be seen; does not feel related to vax.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia, Anxiety, Arthralgia, Asthenia, Bedridden
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with a family history of neurological conditions of unknown origin who "in summer 2009", in approximately June 2009, completed three dose series of GARDASIL (lot number, dose and site of administration not reported). In 2009 "right after" receiving the third dose, the patient had a "slow downward path" and developed nausea, weakness, fatigue, hair loss, lost control of her bowels, sore joints, anxiety, a movement disorder and seizure like activity. It was also reported that "currently", she could not walk with out assistance and was bedbound and she was currently in the hospital since she took a "turn for the worst last week". Also, the physician reported that the patient was a straight a student two years ago. Unspecified treatment was given for the adverse event. At the time of the report, the patient had not recovered. The sister's experience has been captured in WAES # 1104USA00837. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Faecal incontinence, Fatigue, Gait disturbance, Immediate post-injection reaction, Movement disorder
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with a family history of neurological conditions of unknown origin who "in summer 2009", in approximately June 2009, completed three dose series of GARDASIL (lot number, dose and site of administration not reported). In 2009 "right after" receiving the third dose, the patient had a "slow downward path" and developed nausea, weakness, fatigue, hair loss, lost control of her bowels, sore joints, anxiety, a movement disorder and seizure like activity. It was also reported that "currently", she could not walk with out assistance and was bedbound and she was currently in the hospital since she took a "turn for the worst last week". Also, the physician reported that the patient was a straight a student two years ago. Unspecified treatment was given for the adverse event. At the time of the report, the patient had not recovered. The sister's experience has been captured in WAES # 1104USA00837. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with a family history of neurological conditions of unknown origin who "in summer 2009", in approximately June 2009, completed three dose series of GARDASIL (lot number, dose and site of administration not reported). In 2009 "right after" receiving the third dose, the patient had a "slow downward path" and developed nausea, weakness, fatigue, hair loss, lost control of her bowels, sore joints, anxiety, a movement disorder and seizure like activity. It was also reported that "currently", she could not walk with out assistance and was bedbound and she was currently in the hospital since she took a "turn for the worst last week". Also, the physician reported that the patient was a straight a student two years ago. Unspecified treatment was given for the adverse event. At the time of the report, the patient had not recovered. The sister's experience has been captured in WAES # 1104USA00837. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Emotional disorder, Laboratory test normal, Mental disorder
Clinical narrative: Information has been received from a registered nurse and Cancer Administrator and the patient's mother who works in Nuclear Medicine concerning a 13 year old female patient with a medical history of dermographism and grass or tree allergies and allergic to cephalosporins who in August 2008 and in October 2008 (also reported as in approximately 2009 ("about two years ago") ) was vaccinated with the first and second dose of GARDASIL (dose, route and lot # were not reported) respectively. The registered nurse reported that in approximately 2009 ("about two years ago") the patient experienced severe mental, emotional side effects from the vaccine. The patient had to go to see a psychiatrist. The registered nurse learned of this event while in conversation with the patient's mother. The patient's mother mentioned that in approximately October 2008 ("within a week or two of receiving the second dose") the patient experienced the severe mental, emotional side effects. The patient was referred to many specialists and performed much diagnostic testing. All physical workups were okay. The patient currently was on psychiatry medications and in a special learning program at school. It was unknown if there was any relationship to GARDASIL, but the third dose would not be given (a younger sister would also not be receiving the GARDASIL series). At the time of reporting, the patient's status was unknown. The severe mental, emotional side effects were considered to be disabling for a number of reasons including missed school. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autism, Condition aggravated
Clinical narrative: Information has been received from a physician concerning a female patient with autism who on unspecified date, was vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). On unspecified date, the patient worsened after receiving vaccine. Upon internal review, autism was determined to be an other important medical event. The sister's experience has been captured in WAES1104USA00214. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cyanosis, Dyskinesia, Electroencephalogram normal, Fall, Movement disorder
Clinical narrative: 3/31/11 child had 4-5 episodes of seizure-like activity: mouth open/head shaking/unresponsive to voice/falling to ground/rigid body with interspersed periods of motor hyperactivity. Some perioral cyanosis. All over 15-20 minutes. Parents called 911.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle rigidity, Psychomotor hyperactivity, Tremor, Unresponsive to stimuli
Clinical narrative: 3/31/11 child had 4-5 episodes of seizure-like activity: mouth open/head shaking/unresponsive to voice/falling to ground/rigid body with interspersed periods of motor hyperactivity. Some perioral cyanosis. All over 15-20 minutes. Parents called 911.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Clumsiness, Decreased appetite, Diarrhoea, Dyspnoea, Fall
Clinical narrative: Fever spiked on and off for a week (highest got to 104.7 degrees) rash covering entire body day 4 after shot. Inside of mouth swelled. Clumsiness - falling down. Labored breathing. Diarrhea. Loss of appetite.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Oedema mouth, Pyrexia, Rash generalised, Vaccination complication, Viral infection
Clinical narrative: Fever spiked on and off for a week (highest got to 104.7 degrees) rash covering entire body day 4 after shot. Inside of mouth swelled. Clumsiness - falling down. Labored breathing. Diarrhea. Loss of appetite.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive, Intensive care, Mechanical ventilation, Pneumonia
Clinical narrative: A serious spontaneous report of pneumonia and H1N1 has been received from a healthcare professional concerning 40 adults, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for these patients. The patient received FLUMIST immunization at various dates at the beginning of their recruitment. Approximately twelve weeks after receiving FLUMIST, the patients developed respiratory symptoms and contracted influenza. 17 of these patients were confirmed to have H1N1 via laboratory tests. Approximately twenty patients were eventually hospitalized with an initial diagnosis of pneumonia, with six patients needing ICU care and two to three patients needing ventilator support. The outcome for all these events are unknown. An investigation is underway for these patients, and additional information will be available once the investigation is completed.
Sex: U
Vaccine: FLUN3
Symptoms: Respiratory disorder
Clinical narrative: A serious spontaneous report of pneumonia and H1N1 has been received from a healthcare professional concerning 40 adults, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for these patients. The patient received FLUMIST immunization at various dates at the beginning of their recruitment. Approximately twelve weeks after receiving FLUMIST, the patients developed respiratory symptoms and contracted influenza. 17 of these patients were confirmed to have H1N1 via laboratory tests. Approximately twenty patients were eventually hospitalized with an initial diagnosis of pneumonia, with six patients needing ICU care and two to three patients needing ventilator support. The outcome for all these events are unknown. An investigation is underway for these patients, and additional information will be available once the investigation is completed.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Apnoea, Condition aggravated
Clinical narrative: Apneic event requiring hospital stay.
Age: 1.37
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Temperature of 102. 5, vomiting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 5th dose of DTAP given and pt. acquired red round area to injection site on Lt. deltoid. NP aware instructed to do cooling measures and children's MOTRIN/childrens TYLENOL PRN. Verbalized understanding.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Axonal neuropathy, Musculoskeletal pain, Neck pain, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: 1. Neck & Rt shoulder pain 9/30 -> pain increased. Went to doctor. Trigger point inj. of lidocaine did not help pain. 2. MRI ordered. No nerve compression. 3. Neurologist consulted because fingers had partial paralysis. 4. Medical center performed nerve conduction electro diagnostic studies and found severe Rt sided axonal post interosseous neuropathy. Neurologist who performed tests asked patient if she had a recent (within last 2 weeks) vaccine & determined this to be the cause of the neuropathy as other causes had been R/O.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paralysis
Clinical narrative: 1. Neck & Rt shoulder pain 9/30 -> pain increased. Went to doctor. Trigger point inj. of lidocaine did not help pain. 2. MRI ordered. No nerve compression. 3. Neurologist consulted because fingers had partial paralysis. 4. Medical center performed nerve conduction electro diagnostic studies and found severe Rt sided axonal post interosseous neuropathy. Neurologist who performed tests asked patient if she had a recent (within last 2 weeks) vaccine & determined this to be the cause of the neuropathy as other causes had been R/O.
Age: 1.37
Sex: U
Vaccine: DTAP, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right thigh.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: 3-9-11 About 4 hours of the injection, I started feeling pain between my shoulder and elbow...severe aching which increased as the evening went on. No fever. So about 7 p.m. I took a 1000 mg TYLENOL to ease the pain. (No pinkness at the injection site). It did not help, so I called the hospital for advice and they said to apply ice. Which did not do much. I just hung in there till 11 p.m. so I could take more TYLENOL safely in hopes of taking off the edge so that I could sleep. I was able to sleep through the night after more TYLENOL. During the above time I could not move my arm behind me, I lost range of motion as far as trying to undress myself for bed. (The pain level reminded me of when I had blood poisoning in a finger many many years ago from a rose thorn stick). 3-10-11.. So by morning, the pain level had eased a little bit, but I still could not move my arm enough to independently put on clothes with my left arm, or move it behind my back. 3-11-11 Big improvement with range of motion of my arm, and by then there was a large pink area (very slight swelling) the size of my hand--about 4 inches below the injection point. By the 5th day, all symptoms had subsided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis at site of injection. Vaccine administered on 4/7/11, redness at site on 4/8/11 & only slight improvement by visit at Provider office on 4/11/11, red warm to touch throughout shoulder & midway down bicep of arm.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Swelling
Clinical narrative: Redness, swelling, redness going all around arm, not feeling right.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccines given 3/30/11. Mother removed band aid 3/31/11 evening & noticed large red raised area. Painful to touch. Took to MD for eval. was told that was allergic reaction. (Area was on (R) arm) was given antibiotic, lidocaine cream, & told to apply tea bags. Brought here 4/1/11. Area red, raised, & approx 4 cm x 5cm in size.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Immediately following vaccine, child developed lacy red rash over face, arms, trunk. No SOB. Child had Fifths disease approximately 1 month ago and does break out in rash when overheated. Observed x 30 mins. Rash began to fade. Sent to MD as precaution. MD diagnosed as allergic reaction. Parent stated (L) arm was red & swollen when got to MD office.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash, Rash erythematous
Clinical narrative: Immediately following vaccine, child developed lacy red rash over face, arms, trunk. No SOB. Child had Fifths disease approximately 1 month ago and does break out in rash when overheated. Observed x 30 mins. Rash began to fade. Sent to MD as precaution. MD diagnosed as allergic reaction. Parent stated (L) arm was red & swollen when got to MD office.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented in clinic with erythema, swelling and minor bruising at injection site in the upper left arm. Area warm to the touch. Dr. was notified, he examined the patient and informed patient it is an allergic reaction to injection Tdap advised patient to apply heating pad and ice compress. Patient verbalized understanding.
Age: 1.51
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Nystagmus, Pyrexia, Rash
Clinical narrative: 3-9 "fever" (tactile) - lasting for 2 days. 3-10 rash on back of neck. 3-11 lateral nystagmus. 3-12 office exam - lateral nystagmus seen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Fever up 105 + stomach cramps treated with Tyenol and Ibuprofen
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm around injection site is red, warm, tender and swollen
Age: 1.38
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site swelling, Oedema peripheral, Swelling face, Urticaria
Clinical narrative: Swollen feet Hand and face 2 hours after shots. Broke out in Hives. Mom gave Atarax. No breathing difficulties noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Allergy to vaccine, Dermatitis allergic, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Mother stated patient started with itching to the right deltoid in the evening of 04/04/11. Later the itching developed into a swollen, red and warm to the touch rash measuring 3 inches by 2 inches. Patient was seen by FNP on 04/06/11 in the AM and diagnosed with Allergic dermatitis due to an allergic reaction to the vaccines. Patient was treated with an injection of Diphenhydramine 12.5 IM left deltoid and a prescription for Hydrocortisone cream to apply daily as needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother stated patient started with itching to the right deltoid in the evening of 04/04/11. Later the itching developed into a swollen, red and warm to the touch rash measuring 3 inches by 2 inches. Patient was seen by FNP on 04/06/11 in the AM and diagnosed with Allergic dermatitis due to an allergic reaction to the vaccines. Patient was treated with an injection of Diphenhydramine 12.5 IM left deltoid and a prescription for Hydrocortisone cream to apply daily as needed.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Full blood count normal, Hypoaesthesia, Metabolic function test
Clinical narrative: 16 days after receiving ADACEL, complains of feeling pins and needles in her feet and numb sensation on both legs. MD notes state decreased sensation to light touch on both feet below the ankles.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: 16 days after receiving ADACEL, complains of feeling pins and needles in her feet and numb sensation on both legs. MD notes state decreased sensation to light touch on both feet below the ankles.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Varicella vaccine given on 3/9/11 to an immune suppressed child who has underlying JRA per request of Rheumatologist. Phone call received on 3/31/11 from parent stating child awoke with blisters on neck and belly. Came in for office visit and admitted to hospital from doctor's office same day.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC
Symptoms: Irritability, Lacrimation increased, Rash, Rash maculo-papular, Rhinorrhoea
Clinical narrative: 2 weeks after MMR/Varicella vaccines received patient developed diffuse maculopapular rash over trunk & arm, runny eyes, runny nose, crankiness.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Muscle tightness, Neck pain, Pain in jaw, Skin tightness
Clinical narrative: Pt. rec. immunizations on afternoon of 3-9-11. Later that evening - c/o pain in neck, jaw, headache and tightness in face and jaw. Began to feel better, no further s/s of above after 3-14-11 - F/u call on 4-12-11.
Age: 30.0
Sex: U
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: VARIVAX #2 administered subcutaneously at 100 PM on 4/6/11 within a couple hours 1/2" diameter red & raised area developed at injection site. Hours later site began to itch. On 4/7/11 at 330 pm affected area enlarged to 14 cm x 10 1/2 cm with 3 1/2 cm x 3 1/2 cm center of induration & pallor. On 4/8/11 redness & heat increased to 16 cm x 15 cm with center induration 2 cm x 2 1/2 cm redness & heat much decreased from 4/7/11.
Age: 30.0
Sex: U
Vaccine: VARCEL
Symptoms: Pallor, Pruritus
Clinical narrative: VARIVAX #2 administered subcutaneously at 100 PM on 4/6/11 within a couple hours 1/2" diameter red & raised area developed at injection site. Hours later site began to itch. On 4/7/11 at 330 pm affected area enlarged to 14 cm x 10 1/2 cm with 3 1/2 cm x 3 1/2 cm center of induration & pallor. On 4/8/11 redness & heat increased to 16 cm x 15 cm with center induration 2 cm x 2 1/2 cm redness & heat much decreased from 4/7/11.
Age: 1.44
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: None stated.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: We have a record that shows patient had VARIVAX in 2002. Came to our office 3 days w/a rash & dx with Ch Pox.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Skin lesion
Clinical narrative: "5 inch diameter area of erythema and warmth on right thigh, some induration of lesion, palpable throughout and edges of lesion" per PA.
Age: 0.12
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypophagia, Hypotonia, Hypotonic-hyporesponsive episode, Staring, Unresponsive to stimuli
Clinical narrative: 24 hours of hypotonia; limp, staring blankly or sleeping, not crying, not reacting, nursing very little (sxs c/w HHE).
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Seen in clinic 3-31-11. Left thigh was red, swollen and non tender to touch at vaccination site. Vaccine was administered 3-30-11. Redness and swelling began the following day.
Age: 1.36
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling
Clinical narrative: Swelling of (R) leg (DTaP) side extending from thigh to upper calf. 3 days after imm. still w/ mild swelling of right thigh, knee and calf. Walking well, no erythema.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Rt anterior thigh with erythema & induration measuring 12cm x 13cm in diameter. Very warm & tender to touch. Discussed using ice 2-3 x a day, Ibuprofen 3 x a day & BENADRYL.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Pt is c/o severe pain in her (R) arm, especially at the shoulder. She needs a pillow under her arm in order to sleep. She needs to use her left arm to move her right arm. She cannot use her right arm much at all now. She is still having severe pain after a month. There is no redness or heat at the site.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Started with a mild cough that got progressively more severe.  Sore throat after cough worsened.  Runny nose.  Had fever that lasted 3 days and reached as high as 101 degrees.  Aches and pains.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: SOME REDNESS AND FIRMNESS ON THE L LOWER THIGH
Age: 5.0
Sex: F
Vaccine: 6VAX-F, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: thick hives developed at injection sites on both arms, and began to spread all over her body
Age: 1.41
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Discomfort, Vomiting
Clinical narrative: BABY VOMITED X 2. DID NOT ACT SICK. NO TEMPERATURE. BABY SLEPT WELL THE NIGHT BEFORE AND ATE MEAL IN EVENING.  MOTHER GAVE MOTRIN FOR DISCOMFORT THE PREVIOUS NIGHT.  NO FURTHER TREATMENT.  MOM ASKED IF SHE WOULD LIKE THIS REPORTED AND SHE SAID YES.
Age: 7.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: IZ given 1 month past licensing date age 4-6 years.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Cough, Dysphemia, Fatigue, Otitis media, Rhinorrhoea
Clinical narrative: 4-5 days after Hepatitis A & Influenza vaccines pt developed nasal DC, cough, fatigue and unusual speech. Stuttering and prolonged duration of sounds of speech. Improving symptoms after 2-3 days. Dx with URI and otitis media on 4/11/11.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Speech disorder, Upper respiratory tract infection
Clinical narrative: 4-5 days after Hepatitis A & Influenza vaccines pt developed nasal DC, cough, fatigue and unusual speech. Stuttering and prolonged duration of sounds of speech. Improving symptoms after 2-3 days. Dx with URI and otitis media on 4/11/11.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Chills, Dysphagia, Lip swelling, Pyrexia
Clinical narrative: Difficulty swallowing, lip swelling. Fever & chills.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Bradycardia, Convulsion, Dizziness, Loss of consciousness, Tremor
Clinical narrative: 1445 - administered Hep A vaccine administered Varicella vaccine. 1446 - pt states "I feel like I am going to faint". Pt passes out - shakes hands as passing out. 1447 - called Dr into room. 1449 - pt seen, noted to have seizure activity lasting about 10 seconds and bradycardia to 40.
Age: 16.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site swelling, Swelling
Clinical narrative: Swelling in (L) upper extremity. Red swollen - vaccine given 3/25/11.
Age: 4.0
Sex: F
Vaccine: DT
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: On the night the vaccine was given, pt had small brown spots down her arms. The next day I noticed similar spots on her legs. They were slowly fading away.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abscess drainage, Injection site abscess
Clinical narrative: Left ,shot injection site, thigh abscess - 1cm, drained and given BACTROBAN TID x 7.
Age: 25.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Eye pruritus, Urticaria
Clinical narrative: WHEALS ON FACE AND EYES ITCHING. URTICARIA ON FACE.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Heart rate increased, Nausea
Clinical narrative: 15 minutes after injection dizziness and rapid heartrate and nausea occurred