chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP, HEP
Symptoms: Anaphylactic reaction, Circulatory collapse, Death, Dyspnoea, Hyperhidrosis
Clinical narrative: Information has been received from the author of a literature article concerning an adult male patient with obesity, asthma, dermatitis, coronary artery disease, rhinitis allergic and dapsone allergy who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). This case was received from a review from the Agency from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that the "the Agency's administrative database was queried for all cases submitted to the Agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases all met the Collaboration case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DPT, DTAP, TD, HIB, hepatitis A virus , hepatitis B virus, HPV, influenza, MMR, meningococcal, IPV, pneumococcal conjugate and varicella-zoster virus". This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: HEP, HEP
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: Information has been received from the author of a literature article concerning an adult male patient with obesity, asthma, dermatitis, coronary artery disease, rhinitis allergic and dapsone allergy who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). This case was received from a review from the Agency from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient experienced a case of anaphylaxis; the patient developed diaphoresis, shortness of breath (SOB), loss of consciousness (LOC), respiratory arrest and cardiovascular collapse. The case could have been an acute coronary event. The anaphylaxis case occurred 15 minutes after vaccination. The patient was treated with epinephrine and atropine. On an unspecified date, the patient died. The author of the article considered that the anaphylactic reaction was related to therapy with RECOMBIVAX HB. It was reported that the "the Agency's administrative database was queried for all cases submitted to the Agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases all met the Collaboration case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DPT, DTAP, TD, HIB, hepatitis A virus , hepatitis B virus, HPV, influenza, MMR, meningococcal, IPV, pneumococcal conjugate and varicella-zoster virus". This is one of several reports received from the same source. No further information is available.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Lymphadenopathy, Pain in jaw, Paraesthesia
Clinical narrative: Pt has severe headaches, swollen glands in the neck - numbness, tingling in arms & legs. Jaw pain, twitching legs, tremors in hands, vomiting, fever.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt has severe headaches, swollen glands in the neck - numbness, tingling in arms & legs. Jaw pain, twitching legs, tremors in hands, vomiting, fever.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Muscle twitching, Pain in jaw
Clinical narrative: Pt has severe headaches, swollen glands in the neck - numbness, tingling in arms & legs. Jaw pain, twitching legs, tremors in hands, vomiting, fever.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Pyrexia, Tremor, Vomiting
Clinical narrative: Pt has severe headaches, swollen glands in the neck - numbness, tingling in arms & legs. Jaw pain, twitching legs, tremors in hands, vomiting, fever.
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Abdominal pain, Anaphylactic reaction, Depressed level of consciousness, Hypotension, Urticaria
Clinical narrative: Information has been received from the author of a literature article concerning a pediatric female patient with no drug allergies or pertinent medical history who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of MMR II. Secondary suspect vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot number not provided) and a dose of poliovirus vaccine inactivated (unspecified) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. It was reported that the patient presented with a case of anaphylaxis; the patient experienced abdominal pain, hives, decreased consciousness and hypotension. The patient developed the anaphylactic reaction minutes to hour after vaccination. The patient was treated with diphenhydramine and epinephrine. The patient presented a recovery to preimmunization status (PIS). The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 2 certain). The author of the article considered that the anaphylactic reaction was related to vaccination with MMR II (manufacturer unknown), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified) (lot number not provided). Upon internal review anaphylactic reaction treated with epinephrine was considered to be an other important medical event. It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Oropharyngeal pain, Urticaria
Clinical narrative: Information has been received from the author of a literature article concerning a pediatric male patient 30 weeks premature with cataracts, latex allergy, IgE positive to gelatin and lens replacement who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of MMR II and a dose of VAQTA (manufacturer unknown) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the patient presented a case of anaphylaxis; the patient experienced cough, sore throat, welts, shortness of breath (SOB), wheezing and urticaria. The patient presented the anaphylactic reaction two hours after vaccination. The patient was treated with diphenhydramine and oral steroids. It was reported that the elevated IgE levels to gelatin was a known risk factor for vaccine-associated anaphylaxis. The patient presented a recovery to preimmunization status (PIS). The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with MMR II and VAQTA (manufacturer unknown). It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." Upon internal review anaphylactic reaction was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Wheezing
Clinical narrative: Information has been received from the author of a literature article concerning a pediatric male patient 30 weeks premature with cataracts, latex allergy, IgE positive to gelatin and lens replacement who between 01-JAN-2000 and 31-DEC-2009 was vaccinated with a dose of MMR II and a dose of VAQTA (manufacturer unknown) (lot number not provided). This case was received from a review from "The National Vaccine Injury Compensation Program (VICP)" from 01-JAN-2000 through 31-DEC-2009. Concomitant vaccination included a dose of poliovirus vaccine inactivated (unspecified) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the patient presented a case of anaphylaxis; the patient experienced cough, sore throat, welts, shortness of breath (SOB), wheezing and urticaria. The patient presented the anaphylactic reaction two hours after vaccination. The patient was treated with diphenhydramine and oral steroids. It was reported that the elevated IgE levels to gelatin was a known risk factor for vaccine-associated anaphylaxis. The patient presented a recovery to preimmunization status (PIS). The anaphylaxis case met the Brighton Collaboration (BC) case definition. The causality was level 1 (certain). It was unspecified if the patient sought medical attention. The author of the article considered that the anaphylactic reaction was related to vaccination with MMR II and VAQTA (manufacturer unknown). It was reported that "The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from 01-JAN-2000 through 31-DEC-2009. The anaphylaxis cases met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria with level 1 being the greatest level of certainty. It was reported that a petition was filed without medical records in 4 cases. The alleged vaccines for the anaphylactic and possibly allergic-not anaphylactic cases were DTP, DTaP, Td, Haemophilus influenzae type B, HAV, HBV, HPV, influenza, MMR, meningococcal, IPV and varicella-zoster virus." Upon internal review anaphylactic reaction was considered to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Aldolase normal, Arthralgia, Asthenia, Ataxia, Blood creatine phosphokinase normal
Clinical narrative: Parents report sudden onset of Rt knee pain 8 hrs after injections. Pain & weakness, mild ataxia progressed for several days involving hips, knees & feet. Sx resolved on 6-18-11. Pt saw MDx2, ERx1 & had labs.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Full blood count normal, Metabolic function test, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Parents report sudden onset of Rt knee pain 8 hrs after injections. Pain & weakness, mild ataxia progressed for several days involving hips, knees & feet. Sx resolved on 6-18-11. Pt saw MDx2, ERx1 & had labs.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Abasia, Abdominal pain upper, Cough, Ear pain, Nasal congestion
Clinical narrative: Vaccine given 5/6. Mother states on 5/7 child couldn't walk. Next day could walk but had dry cough and nasal congestion. 5/9 stomach pain & earache. 5/11 child felt well.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: SM describes a large local reaction following his 4th and 5th anthrax shots. Both shots given SQ. Developed pain and swelling at injection site within 24 hrs. Resolved after 3 days with use of cold packs. No residual symptoms. Did not affect work or PT.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Ocular hyperaemia, Rash maculo-papular
Clinical narrative: Vaccine given 6/16/11. On 6/17/11 pt got a rash on (R) forehead, upper cheek & (R) scalp. Macular, papular red & swollen around (R) eye.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site pain, Pyrexia
Clinical narrative: Fever 102 pain at leg pain, patient refused to walk
Age: 0.19
Sex: F
Vaccine: PNC13
Symptoms: Apnoeic attack, Aspiration tracheal, Blood culture, Bradycardia, Endotracheal intubation
Clinical narrative: Infant had 9 apneic/bradycardic episodes with desats and most requiring stimulation and bagging. Infant was on high flow nasal cannula and had to be intubated at 0215 on 6/21/2011. Labs drawn, antibiotics started.
Age: 0.19
Sex: F
Vaccine: PNC13
Symptoms: Full blood count, Oxygen saturation decreased
Clinical narrative: Infant had 9 apneic/bradycardic episodes with desats and most requiring stimulation and bagging. Infant was on high flow nasal cannula and had to be intubated at 0215 on 6/21/2011. Labs drawn, antibiotics started.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Rash to upper body with hives, redness of skin, itching, anxiety. Recieved Benadryl and possible steroid dose.
Age: 44.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Patient c/o "flu-like" symptoms. Aches, fatigue, sore throat, headache. Additionally erythema at the injection site of the left arm that radiates downward toward axilla.
Age: 44.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Patient c/o "flu-like" symptoms. Aches, fatigue, sore throat, headache. Additionally erythema at the injection site of the left arm that radiates downward toward axilla.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Sinusitis, Vaccine positive rechallenge
Clinical narrative: With each successive immunization of GARDASIL, father reports that patient developed cold sores on her lips and inside the mouth 2-3 days post injections. Dates of GARDASIL. (see below) * #1 9-11-2009, #2 4/22/2010 #3 6/9/2011. Incident was not reported by father until after GARDASIL #3 was given, but father reports that cold sores on lips & inside of mouth occurred after each GARDASIL dose was given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Injection site urticaria
Clinical narrative: Left arm swelling with erythema & urticarial papules 6cm x 3 1/2cm at deltoid area. Pt given 1 bt BENADRYL.
Age: 43.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Abdominal pain, Chills, Migraine, Pyrexia
Clinical narrative: Migraine H.A., fever, chills, severe abdominal pain.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Irritability, Oedema peripheral
Clinical narrative: 8 wk old infant received vaccines on 6/17/11 at clinic - on 6/17/11 afternoon brought in clinic with fussiness, crying - cried several hours - unconsolable, (R) leg swollen from thigh to mid calf.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Hyperhidrosis, Hypopnoea, Loss of consciousness, Respiratory rate decreased
Clinical narrative: Positive LOC after administration, gradual return within 2 min. Positive bradycardia resps slow, slightly shallow: pt. enc. to take slow deep breaths, heart rate 76, skin slightly damp. Pt moved to supine position and symptoms resolved. Pt drinking fluids prior to ambulation.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site swelling, Skin reaction
Clinical narrative: Vaccine #2 of Hep B series given 6/16/11 positive cutaneous reaction began 6/20/11 positive hard, swollen area in site of injection, no fever, no rash.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Gastrointestinal obstruction, Surgery
Clinical narrative: Surgical resection.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the editor of an interactive online portal supported by foreign Vaccine Manufacturers concerning a daughter who on an unspecified date was vaccinated at the hospital with a dose of RECOMBIVAX HB (route, dose and lot # not provided) when she was hours old.
Age: 14.0
Sex: F
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: Hives all over body and in mouth-contacted M.D./mother. Unable to reach by phone-mutiple messages left. Mother left message that hives had resolved and child had no other problems.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Approximately 10 minutes after pt received the flu shot he had a "sunburn" type facial look, swelling of feet but no throat or tongue swelling or difficulty breathing.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Throat tightness
Clinical narrative: Redness of face and neck, states he thinks his throat is closing, shortness of breath.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Rash, Rash pruritic
Clinical narrative: Patient states she got the flu shot 2 days prior to presenting to ED and developed itchy rash on her face and mild abdominal cramps.  No SOB, trouble breathing.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Borrelia test positive, Cardiac enzymes, Chest X-ray, Chest pain, Computerised tomogram
Clinical narrative: VARIVAX (Merck 1613Z exp date 11/18/12) administered 6/2/2011. Seen 6/7/11 with "bulls eye "rash on (R) arm & diagnosis of Lyme Disease confirmed by serology 2-3 days later; anterior chest pain -> diagnosis of myocarditis prob secondary to Lyme Disease.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Echocardiogram, Electrocardiogram, Full blood count, Lyme disease, Myocarditis
Clinical narrative: VARIVAX (Merck 1613Z exp date 11/18/12) administered 6/2/2011. Seen 6/7/11 with "bulls eye "rash on (R) arm & diagnosis of Lyme Disease confirmed by serology 2-3 days later; anterior chest pain -> diagnosis of myocarditis prob secondary to Lyme Disease.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging, Rash, Scan with contrast, Troponin
Clinical narrative: VARIVAX (Merck 1613Z exp date 11/18/12) administered 6/2/2011. Seen 6/7/11 with "bulls eye "rash on (R) arm & diagnosis of Lyme Disease confirmed by serology 2-3 days later; anterior chest pain -> diagnosis of myocarditis prob secondary to Lyme Disease.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Tremor, Urticaria
Clinical narrative: Hives and muscle pain, aches, an tremors
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: About 5 minutes after recieving HPV vaccine #1 patient reported feeling dizzy, mildly diaphoretic and pale.  Put patient's head between knees, applied cool washcloth to back of neck and forhead.  Took BP and Pulse x 5.  Gave pt. apple juice to drink.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Pt called RN at clinic on 6/20 stating that he had fever, chills, body aches, "not feeling well all weekend". Was treating symptoms with Advil several times daily.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPVX
Symptoms: Movement disorder, Muscle tightness, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no known drug allergies who on 14-JUN-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 666987/1016Z, expiration: November 2012) in her right arm. Secondary suspect therapy included a dose of VARIVAX (lot # 669098/1567Z, expiration: November 2012) (route and dose not reported) on 14-JUN-2011. Concomitant therapy included DTAP and MENACTRA. There were no concomitant pharmaceutical therapies. The certified medical assistant reported that on 14-JUN-2011 post vaccination the patient had seizure type activity with the muscles of her arms tightening and clenching of the fists. There was no incontinence or other symptoms usually associated with a seizure. The patient might have fainted for a few seconds. The patient was seated at time of vaccination. The patient was observed and monitored and her vital signs were checked but no treatment was needed. At the time of reporting, the patient had recovered. Upon internal review, seizure type activity with the muscles of her arms tightening and clenching of the fists was determined to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPVX
Symptoms: Laboratory test normal, Musculoskeletal stiffness, Tremor, Unresponsive to stimuli
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no known drug allergies who on 14-JUN-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 666987/1016Z, expiration: November 2012) in her right arm. Secondary suspect therapy included a dose of VARIVAX (lot # 669098/1567Z, expiration: November 2012) (route and dose not reported) on 14-JUN-2011. Concomitant therapy included DTAP and MENACTRA. There were no concomitant pharmaceutical therapies. The certified medical assistant reported that on 14-JUN-2011 post vaccination the patient had seizure type activity with the muscles of her arms tightening and clenching of the fists. There was no incontinence or other symptoms usually associated with a seizure. The patient might have fainted for a few seconds. The patient was seated at time of vaccination. The patient was observed and monitored and her vital signs were checked but no treatment was needed. At the time of reporting, the patient had recovered. Upon internal review, seizure type activity with the muscles of her arms tightening and clenching of the fists was determined to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Condition aggravated, Confusional state, Full blood count, Headache
Clinical narrative: Information has been received from a registered nurse, a physician and the patient's mother concerning a 13 year old female patient with attention deficit/hyperactivity disorder (ADHD) and a history of headaches in the past and no known drug allergies (NKDA) who on 29-MAR-2007, 27-JUN-2007 and 13-JUN-2011 ("yesterday") was vaccinated with the first, second and third dose of GARDASIL (lot#: 656049/0187U, 657868/0523U and 668554/0306AA respectively) (dose and route not reported) respectively. Concomitant therapy included TENEX and FOCALIN for the treatment of attention deficit/hyperactivity disorder (ADHD). No other vaccines were given concomitantly with the third dose of GARDASIL. The physician reported that on 13-JUN-2011 ("yesterday") the patient experienced severe headache, fever of 103 degrees, nausea, vomiting, and tingling of toes and hands just a few hours after the injection. The mother also reported that her daughter experienced vision problems and confusion. The patient did not have a reaction after dose 1 or dose 2. The registered nurse reported that in early hours on 14-JUN-2011 the patient went to the emergency room where she was given IV hydration, IV TORADOL, FORADIL and IV ZOFRAN and neurological examination and blood work were normal. The patient remarkably improved and released. The patient was not admitted to the hospital. The emergency room physician believed this was a care of meningitis and offered a lumbar test. However the patient's mother declined to have the test done. After leaving the emergency room, symptoms returned and a call was made to the physicians' office. The patient was seen later in the day on 14-JUN-2011. By the time of visit, the patient had recovered again. No lumbar puncture was performed as there was no longer suspicion of meningitis. Other lab diagnostics studies included complete blood cell count, a urine test at the office and they took blood samples at the hospital, but the tests were not specified. The outcome of the vision problems and confusion were not reported. The reporting physician considered the severe headache, nausea, vomiting, fever of 103 degrees and tingling of toes and hands to be other important medical events because the patient required "hydration". No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Neurological examination normal, Paraesthesia, Pyrexia, Urine analysis
Clinical narrative: Information has been received from a registered nurse, a physician and the patient's mother concerning a 13 year old female patient with attention deficit/hyperactivity disorder (ADHD) and a history of headaches in the past and no known drug allergies (NKDA) who on 29-MAR-2007, 27-JUN-2007 and 13-JUN-2011 ("yesterday") was vaccinated with the first, second and third dose of GARDASIL (lot#: 656049/0187U, 657868/0523U and 668554/0306AA respectively) (dose and route not reported) respectively. Concomitant therapy included TENEX and FOCALIN for the treatment of attention deficit/hyperactivity disorder (ADHD). No other vaccines were given concomitantly with the third dose of GARDASIL. The physician reported that on 13-JUN-2011 ("yesterday") the patient experienced severe headache, fever of 103 degrees, nausea, vomiting, and tingling of toes and hands just a few hours after the injection. The mother also reported that her daughter experienced vision problems and confusion. The patient did not have a reaction after dose 1 or dose 2. The registered nurse reported that in early hours on 14-JUN-2011 the patient went to the emergency room where she was given IV hydration, IV TORADOL, FORADIL and IV ZOFRAN and neurological examination and blood work were normal. The patient remarkably improved and released. The patient was not admitted to the hospital. The emergency room physician believed this was a care of meningitis and offered a lumbar test. However the patient's mother declined to have the test done. After leaving the emergency room, symptoms returned and a call was made to the physicians' office. The patient was seen later in the day on 14-JUN-2011. By the time of visit, the patient had recovered again. No lumbar puncture was performed as there was no longer suspicion of meningitis. Other lab diagnostics studies included complete blood cell count, a urine test at the office and they took blood samples at the hospital, but the tests were not specified. The outcome of the vision problems and confusion were not reported. The reporting physician considered the severe headache, nausea, vomiting, fever of 103 degrees and tingling of toes and hands to be other important medical events because the patient required "hydration". No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment, Vomiting
Clinical narrative: Information has been received from a registered nurse, a physician and the patient's mother concerning a 13 year old female patient with attention deficit/hyperactivity disorder (ADHD) and a history of headaches in the past and no known drug allergies (NKDA) who on 29-MAR-2007, 27-JUN-2007 and 13-JUN-2011 ("yesterday") was vaccinated with the first, second and third dose of GARDASIL (lot#: 656049/0187U, 657868/0523U and 668554/0306AA respectively) (dose and route not reported) respectively. Concomitant therapy included TENEX and FOCALIN for the treatment of attention deficit/hyperactivity disorder (ADHD). No other vaccines were given concomitantly with the third dose of GARDASIL. The physician reported that on 13-JUN-2011 ("yesterday") the patient experienced severe headache, fever of 103 degrees, nausea, vomiting, and tingling of toes and hands just a few hours after the injection. The mother also reported that her daughter experienced vision problems and confusion. The patient did not have a reaction after dose 1 or dose 2. The registered nurse reported that in early hours on 14-JUN-2011 the patient went to the emergency room where she was given IV hydration, IV TORADOL, FORADIL and IV ZOFRAN and neurological examination and blood work were normal. The patient remarkably improved and released. The patient was not admitted to the hospital. The emergency room physician believed this was a care of meningitis and offered a lumbar test. However the patient's mother declined to have the test done. After leaving the emergency room, symptoms returned and a call was made to the physicians' office. The patient was seen later in the day on 14-JUN-2011. By the time of visit, the patient had recovered again. No lumbar puncture was performed as there was no longer suspicion of meningitis. Other lab diagnostics studies included complete blood cell count, a urine test at the office and they took blood samples at the hospital, but the tests were not specified. The outcome of the vision problems and confusion were not reported. The reporting physician considered the severe headache, nausea, vomiting, fever of 103 degrees and tingling of toes and hands to be other important medical events because the patient required "hydration". No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Appendicectomy, Vomiting
Clinical narrative: Information has been received from a consumer via the internet concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and route not reported). Two hours after vaccination, the patient experienced vomiting and abdominal pain, which subsequently worsened. Subsequently, the patient was hospitalized and had an appendectomy. At the time of the report, the status of the patient was not reported. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Abdominal symptom, Abnormal behaviour, Autism, Emotional disorder, Speech disorder
Clinical narrative: Information has been received from a grandmother who reported that there was "too much evidence that side effects did occur with" MMR II. The reporter stated the vaccine had the side effects that she believed to be attached to autism. The reporter spoke with different parents that after the vaccination of MMR II the child was different "in a bad way". The reporter stated the children were different in the speech, no emotion, difficult behavior, abdominal problems. The outcome of the patients was not reported. Upon internal overview, autism was determined to be an other important medical event. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: 6/6/11 acute vomiting.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Hyperhidrosis, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Swelling and redness with warmth to areas of right upper arm and left upper arm at injection site. BENADRYL Allergy 12.5mg/5ml 1/2 tsp po Q 6 hr prn, ORAPRED 15mg/5ml 3ml bid x 3 day, KEFLEX 250mg/5ml 1 tsp po tid x 7 to 10 day.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Developed rash within 24 hrs of vaccine administration. Started on neck, then chest, arms & torso & thighs. Pruritus. Took OTC BENADRYL & cortisone cream.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Fall
Clinical narrative: Patient was administered 3 vaccines. She left exam room with her dad. After cleaning exam room I came out & saw dad picking pt up - she was awake & alert at this point. She sat down as she did wanted to lie down. BP was 96/58 pulse 68. Then retrieved provider. Patient stayed for an additional 15 minutes drank water & did lie down. Pt stable when left.
Age: 36.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Erythema, Lymphadenopathy, Pain, Swelling
Clinical narrative: Redness, swelling, pain, lymph node enlargement, tenderness, elevated temp. KEFLEX 500mg 1 TID x 7 days.
Age: 36.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Tenderness
Clinical narrative: Redness, swelling, pain, lymph node enlargement, tenderness, elevated temp. KEFLEX 500mg 1 TID x 7 days.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: 4/13/2011 pt presents to clinic stating that she is pregnant. She was previously told by her MD that her estrogen levels were low and she would probably not get pregnant. RN referred pt to prenatal clinic. On 5/9/11 pt reported to RN that she had a spontaneous abortion. Fetus was approximately 6-7 weeks old.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red raised circle around vaccine site-over 2-4 days it became swollen-hot- and skin hard to the touch. It both itched and hurt.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Red raised circle around vaccine site-over 2-4 days it became swollen-hot- and skin hard to the touch. It both itched and hurt.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test, Antinuclear antibody, Bacterial test, Blood thyroid stimulating hormone, Borrelia test
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Brucella test, Complement factor C3 increased, Complement factor C4, Complement factor normal, Differential white blood cell count normal
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Double stranded DNA antibody, Echocardiogram, Ehrlichia test, Epstein-Barr virus antibody, Epstein-Barr virus antibody negative
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Full blood count normal, HLA marker study, Laboratory test, Nuclear magnetic resonance imaging, Platelet count increased
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Psoriatic arthropathy, Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor, Serum ferritin
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Streptococcus test, Thyroxine, Toxoplasma serology, Urine analysis
Clinical narrative: Fever 102-103, max 104, lasting ~3 weeks; onset of psoriatic arthritis.
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Rash erythematous, Rash generalised
Clinical narrative: Around 3AM noticed his lips were swelling so he went to ER. While in ER he broke out in a red rash all over body. Given "three antibiotics" (actually prednisone 60 mg for 7 days, Pepcid 20 mg for 14 days, and Benadryl 25mg x1. States rash and swelling went down as soon as he received the medications. No further problems after he received treatment. No labs drawn.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 6/22/11 1:45pm.  T.C. rec'd from pt's father, stating that daughter had swelling at the site of one of the shots she had rec'd on 6/20/11.  States that the swollen area is slightly red and warm and "only covers the area of the shot".  I asked the father to tell me which arm and he stated "the one that only had one shot", but he couldn't tell me right or left.  When I prodded and said it was a very important piece of information for documentation he stated that he wasn't sure because he wasn't with his daughter right now to see but he thought the right arm.  He also stated that his wife was putting ice to the site.  I instructed him to give comfort measures including cold compress to site and Tylenol or Motrin as directed on bottle and to monitor the site and take daughter to Pedi or ER if condition worsenes.  Also informed him that I would be completing VAERS for CDC and for him to contact me if the information on site was incorrect.  He verbalized understanding.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash morbilliform, Somnolence
Clinical narrative: Patient at first seemed sleepy and quiet.  He developed a fever of 101-103 which lasted for four days.  On day two of the fever he also developed a measles rash on the roof of his mouth.  This rash lasted for 2-3 days.  The fever and rash have resolved but he is still very irritable and has poor appetite.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Patient at first seemed sleepy and quiet.  He developed a fever of 101-103 which lasted for four days.  On day two of the fever he also developed a measles rash on the roof of his mouth.  This rash lasted for 2-3 days.  The fever and rash have resolved but he is still very irritable and has poor appetite.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Hypotonia, Hypotonic-hyporesponsive episode
Clinical narrative: On 6/17/11 Pt rec'd DTaP, HIB, PCV13. On 6/18/11 Pt had hyporesponsive-hypotonic reaction = temp 105 degrees, limp, no tonic-clonic movements. To ER via ambulance.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Migraine
Clinical narrative: After receiving Hep B shot, developed migraine headache, and diarrhea 1 hour after administration.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain in upper posterior arm, started shortly after injection. Persisted for over 1 month & associated with weakness of arm. Pain persisting. Referred to neurology and P.T.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 101, myalgias.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Pallor, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: A few seconds after HPV vaccine was given in right deltoid pt slumped over on left side and was unresponsive - her body was shaking, she came around after about 30 seconds - she was very pale, complained of a headache that lasted a few minutes. She was placed in supine position, given water & monitored for 30-60 minutes.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Blood count, Chills, Headache, Mononucleosis heterophile test, Paraesthesia
Clinical narrative: Tingling/loss of feeling in legs, fever of 105 and chills, bad headache.  Gave 1 Tylenol and 2 Motrin, fluids and popsicles to lower temp.  In Dr office during this time.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia, Sensory loss, Streptococcus test
Clinical narrative: Tingling/loss of feeling in legs, fever of 105 and chills, bad headache.  Gave 1 Tylenol and 2 Motrin, fluids and popsicles to lower temp.  In Dr office during this time.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Auricular swelling, Diarrhoea, Erythema, Fatigue, Headache
Clinical narrative: On Monday 4/11/11, patient called to report symptoms at 7:32 pm.  Message was received the next morning, and called the patient at 11:40 am 4/12/11.  Patient returned call at about 5:45 pm on the same day.  He reported having received HPV Vaccine #2 on 4/7/11, felt fine that day.  About 24-30 hours later, developed muscle pain in the bilateral lower trapezius and gluteal area, Left-sided joint stiffness.  The next day he got up and felt fine x two hours, then developed extreme fatigue.  Complained of ear swelling and redness.  Finally developed palpitations, so went to a walk-in clinic (not identified).  Per clinic doc, reported that the patient was physically stable, but stated that in a "recent study on vaccines for women" several women came in with similar complaints, and recommended that he report this to the study staff.  The next day, he developed one loose bowel movement.  Denied nausea or vomiting or fever.  Slight headache was present. Slowly all of his symptoms have dissipated, and he feels almost normal on the day of the call.  Of note, the patient reported that he felt presyncopal during the injection of the 1st dose, however, felt fine at the time of the 2nd dose. I attempted to call participant on 4/18/11 around 10 am-message left on voice mail. No treatment was given.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Joint stiffness, Myalgia, Palpitations, Presyncope
Clinical narrative: On Monday 4/11/11, patient called to report symptoms at 7:32 pm.  Message was received the next morning, and called the patient at 11:40 am 4/12/11.  Patient returned call at about 5:45 pm on the same day.  He reported having received HPV Vaccine #2 on 4/7/11, felt fine that day.  About 24-30 hours later, developed muscle pain in the bilateral lower trapezius and gluteal area, Left-sided joint stiffness.  The next day he got up and felt fine x two hours, then developed extreme fatigue.  Complained of ear swelling and redness.  Finally developed palpitations, so went to a walk-in clinic (not identified).  Per clinic doc, reported that the patient was physically stable, but stated that in a "recent study on vaccines for women" several women came in with similar complaints, and recommended that he report this to the study staff.  The next day, he developed one loose bowel movement.  Denied nausea or vomiting or fever.  Slight headache was present. Slowly all of his symptoms have dissipated, and he feels almost normal on the day of the call.  Of note, the patient reported that he felt presyncopal during the injection of the 1st dose, however, felt fine at the time of the 2nd dose. I attempted to call participant on 4/18/11 around 10 am-message left on voice mail. No treatment was given.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Nervousness, Syncope
Clinical narrative: Faint after receiving shots - very nervous dizzy & nauseous. Gave her candy, water, cold compress - check vital signs after stabilizing client B/P 100/60 - Pulse 72 - Client mother verbalize no breakfast.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on both knees. Still present at this time. Undiagnosed rash, saw the dermatologist.
Age: 16.0
Sex: F
Vaccine: MMR, MNQ, TDAP
Symptoms: Blindness, Deafness, Feeling cold, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Pt. immediately complained of vision and hearing loss lasting 2-3 seconds, excessive sweating, skin cool to touch, B/P 90/70. 06/15/2011 8:50 AM spoke with patients, states she is doing fine with no problems.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Pharyngeal oedema
Clinical narrative: Throat swelled, unable to breathe, dizzy, passed out.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: Had painful, indurated red spot.  Today, 6/22/11, she only has a 25-cent size area of nonpalpable faded erythema.  No longer painful.
Age: 1.77
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Screaming, Sleep disorder
Clinical narrative: Woke in the middle of the night every hour screaming for two nights. No problems during the day.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Chest discomfort, Fatigue
Clinical narrative: First event was a headache that occurred 12 hours after injection.  Next was a complaint of pressure inside of the neck, chest and stomach along with extreme swelling in the cheek and jaw on the side of the injection. Extreme fatigue, ankle joint pain. Returned to the doctor 24 hours after injection and was re-examined.  Stomach and neck pain was experienced when doctor pressed on these parts.  Extreme arm swelling and hot red rash the size of a large grapefruit occurred at 32 hours after injection.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Feeling hot, Headache, Neck pain, Oedema peripheral, Rash erythematous
Clinical narrative: First event was a headache that occurred 12 hours after injection.  Next was a complaint of pressure inside of the neck, chest and stomach along with extreme swelling in the cheek and jaw on the side of the injection. Extreme fatigue, ankle joint pain. Returned to the doctor 24 hours after injection and was re-examined.  Stomach and neck pain was experienced when doctor pressed on these parts.  Extreme arm swelling and hot red rash the size of a large grapefruit occurred at 32 hours after injection.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Sensation of pressure, Swelling face
Clinical narrative: First event was a headache that occurred 12 hours after injection.  Next was a complaint of pressure inside of the neck, chest and stomach along with extreme swelling in the cheek and jaw on the side of the injection. Extreme fatigue, ankle joint pain. Returned to the doctor 24 hours after injection and was re-examined.  Stomach and neck pain was experienced when doctor pressed on these parts.  Extreme arm swelling and hot red rash the size of a large grapefruit occurred at 32 hours after injection.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Nausea, dizziness, sharp pains to shoulder and neck, pain, redness, swelling at sight (right tricep area).
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Nausea, Neck pain
Clinical narrative: Nausea, dizziness, sharp pains to shoulder and neck, pain, redness, swelling at sight (right tricep area).
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Skin reaction
Clinical narrative: NO ADVERSE EVENTS MOM STATES" HE HAS HAD NO FEVER NO VOMITING NO SHORTNESS OF BREATH. SITE IS ERYTHEMATOUS ABOUT 2 INCHES, WARM TO TOUCH WITH SLIGHT EDEMA.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Pt got a local reaction to shots including spreading erythema & tenderness & warmness around the injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local erythema, tenderness after getting shots as below (these two event happened within couple of wks).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Redness and induration following vaccine administration. Seen 6/21/2011 and induration improved, fading redness.