chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Diarrhoea, Gastrointestinal disorder, Irritability, Vaccine positive rechallenge
Clinical narrative: Infant experienced gastrointestinal distress and diarrhea within the first 24 hours of initial administration of Rotateq vaccine at 2 months of age.  I felt it was not necessary to not administer the second vaccine at 4 months of age; however after the second vaccine the infant again experienced gastrointestinal distress with a bloated stomach and diarrhea which lasted 48 hours.  In both instances the infant was fussy but no fever was noticed.  In the next section I have listed the vaccines administered at the 2 month visit but the same adverse event occurred with the 4 month immunizations.  Also, I am not really sure of the manufacturer other than Sanofi Pasteur and Wyeth
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Autoimmune disorder, Borrelia burgdorferi serology
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Sex: M
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology positive, Chest pain, Cognitive disorder, Fatigue, Hypertension
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Sex: M
Vaccine: LYME
Symptoms: Immune system disorder, Immunology test, Joint swelling, Laboratory test normal, Mycoplasma serology
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Neurological symptom, Paraesthesia, Polymerase chain reaction, Psoriatic arthropathy
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Sex: M
Vaccine: LYME
Symptoms: Sleep apnoea syndrome, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Blood test normal, Developmental delay, Endotracheal intubation, Epilepsy
Clinical narrative: Atypical febrile seizure, intubated, ICU stay.  Now epilepsy, behavioral problems, developmental delay.  10/20/2008 MR received for numerous ER visits and one admission beginning 3/14/2007 with DX: Status epilepticus, possibly 2' to meningitis.  Respiratory Failure. Fever. Pt presented after having a seizure at daycare.  EMS found infant unresponsive with decreased respirations.  Responding only to pain, lethargic with poor gag reflex, tachycardic and with mottled skin. Temp 102.5"F. Tonic-clonic activity bilaterally of upper and lower extremities. R TM erythematous. Pt intubated and transfered to higher level of care, txd with abx and d/c Returned 3/22/03 with repeat febrile seizure.  Numerous ER visits for Febrile seizure 3/2003-2008.  10/30/2008 MR received from transfer hospital DOS 3/14-16/2003 with D/C Dx:  Anticonvulsant induced apnea.  Immunization Fever. Seizure with fever.  URI/apnea. Intubation < 24 hrs.  Sepsis w/u.  Antibiotics x 48hrs. DOS 6/18/03 D/C Dx:  Complex Febrile seizure.   PCP records also received from 2003-2008. Speech delay noted 12/15/04. Behavior problems and repetitive behaviors, developmental delay and Autism like tendencies noted 12/7/05. Behavior problems worsening after seizure 3/2008. 1/27/2010 Has ongoing epilepsy and developmental delays.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Intensive care, Lumbar puncture normal, Viral test negative
Clinical narrative: Atypical febrile seizure, intubated, ICU stay.  Now epilepsy, behavioral problems, developmental delay.  10/20/2008 MR received for numerous ER visits and one admission beginning 3/14/2007 with DX: Status epilepticus, possibly 2' to meningitis.  Respiratory Failure. Fever. Pt presented after having a seizure at daycare.  EMS found infant unresponsive with decreased respirations.  Responding only to pain, lethargic with poor gag reflex, tachycardic and with mottled skin. Temp 102.5"F. Tonic-clonic activity bilaterally of upper and lower extremities. R TM erythematous. Pt intubated and transfered to higher level of care, txd with abx and d/c Returned 3/22/03 with repeat febrile seizure.  Numerous ER visits for Febrile seizure 3/2003-2008.  10/30/2008 MR received from transfer hospital DOS 3/14-16/2003 with D/C Dx:  Anticonvulsant induced apnea.  Immunization Fever. Seizure with fever.  URI/apnea. Intubation < 24 hrs.  Sepsis w/u.  Antibiotics x 48hrs. DOS 6/18/03 D/C Dx:  Complex Febrile seizure.   PCP records also received from 2003-2008. Speech delay noted 12/15/04. Behavior problems and repetitive behaviors, developmental delay and Autism like tendencies noted 12/7/05. Behavior problems worsening after seizure 3/2008. 1/27/2010 Has ongoing epilepsy and developmental delays.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypertension, Hypoaesthesia, Lip swelling, Local swelling, Oedema peripheral
Clinical narrative: Severe swelling over olecranon quite distal to area of injection on deltoid.  Swelling of lips, numbness in feet.  Acceleration of hypertension.  11/14/08 Reviewed hospital medical records of 10/3-10/4/2008. FINAL DX:allergic inflammatory reaction to pneumo vaccine; cellulitis; paresthesia; & left arm swelling Records reveal patient experienced LUE warmth, erythema, pain & swelling at pneumo injection site which worsened progressively restricting LUE movement.  Temp on admit 99.  Tx w/IV antibiotic & steroids.  Progressed well & d/c to home on continued oral antibiotics & tapering steroids.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of arm hurting - was not able to lift above head the morning after receiving PNE shot.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complained of arm hurting - very sore and not able to lift very high the morning after injection.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Cough, Dyspnoea
Clinical narrative: Pt's mother denied asthma prior to receiving Flu Meds on 10/208. Mom reported he had cough on Saturday but worsened yesterday; severe cough v SOB. She gave multiple albuterol neb treatments, which helped Per pt's chart, he has asthma attacks wever winter season.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Drooling, Gaze palsy, Heart rate normal, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Pt received Tdap then HPV #2 as soon as MD finished with HPV 2, pt eyes rolled back and pt started to twitch and drool x 5 seconds. Recovered vital signs taken, water given, observed pt x 30 min. Pt states "I feel fine" and Dad feels comfortable taking pt home.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Drooling, Gaze palsy, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Pt received Tdap then HPV #2 as soon as MD finished with HPV 2, pt eyes rolled back and pt started to twitch and drool x 5 seconds. Recovered vital signs taken, water given, observed pt x 30 min. Pt states "I feel fine" and Dad feels comfortable taking pt home.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Biopsy skin abnormal, Culture negative, Culture wound negative, Inflammation, Pain
Clinical narrative: Evaluation of painful itchy rash on her face, elbows, hands, knees, feet, and palms 16 days post immunization with SPV and AVA #3. Upon speaking with SM on 23 Sep she reported that she stopped taking her steroids approx 10 days ago and has had a few outbreaks of the lesions, however she stated they are not as bad as they were initially.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Perivascular dermatitis, Rash pruritic, Skin lesion, Virus culture negative
Clinical narrative: Evaluation of painful itchy rash on her face, elbows, hands, knees, feet, and palms 16 days post immunization with SPV and AVA #3. Upon speaking with SM on 23 Sep she reported that she stopped taking her steroids approx 10 days ago and has had a few outbreaks of the lesions, however she stated they are not as bad as they were initially.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm, Sleep disorder
Clinical narrative: Fri to Sat (Oct 3rd to 4th) - Pt couldn't sleep on left side, sore and little warm and red. Then 4th to 5th, still warm, red decreased now a little more swollen.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm, numbness, tingling
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Blood test normal, CSF test normal, Febrile convulsion, Lumbar puncture
Clinical narrative: Child had febrile seizure on 10/02/08.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ADACEL given 10-1-08. Pt. was previously vaccinated on 3-8-07
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.  Rx for Keflex.
Age: 4.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Headache, Inappropriate schedule of drug administration, Injection site erythema, Injection site pruritus
Clinical narrative: Received on MMR II and Tdap on 10/1/08. Pt is a nurse and saw a PA at the hospital where she works. The pt. c/o aching all over, headache, soreness in the arms and joints. The MMR II shot was raised with redness more than a 50c piece, hurt to touch, hot to touch and red. Is having some itching at the site now.
Age: 4.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Received on MMR II and Tdap on 10/1/08. Pt is a nurse and saw a PA at the hospital where she works. The pt. c/o aching all over, headache, soreness in the arms and joints. The MMR II shot was raised with redness more than a 50c piece, hurt to touch, hot to touch and red. Is having some itching at the site now.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Nausea, Pharyngeal oedema
Clinical narrative: Throat felt swollen; chest tight, hard to breathe. Then hours after felt weak, nauseous, fever
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Throat felt swollen; chest tight, hard to breathe. Then hours after felt weak, nauseous, fever
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: Employee felt achey and was feverish, dizzy and nauseated. Also tingling in her face and hands.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Migraine, Myalgia, Nausea, Pain
Clinical narrative: Shot Tues 10/23, headache and muscle ache began Wed 10/4. Severe migraine, pain scale 9 at night. Thurs 10/25 nausea, headache and achiness continuously through the Sunday 10/38. Began to feel better after that.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Employee received a Tdap in (L) deltoid on 7-24-07. She states her arm became red and swollen at the site and painful.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: Had Tetanus shot on 6/29/07- soreness in shoulder resulting in swelling and soreness in soft tissue around clavicle.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: have had constant ache at injection site since received-at times certain movements would increase pain. No pain is significantly worse without movement.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass
Clinical narrative: C/O swelling in area in arm pit that appeared the day after a Tdap injection. Injection site no redness or swelling.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pt came back with c/o a painful deltoid muscle where she received the flu vaccine 1 month ago. Ice/warm packs to arm alternating. Return for recheck.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Anorexia, Asthenia, Blood creatine phosphokinase normal, Chills, Fatigue
Clinical narrative: Severe body aches, generalized weakness, fatigue, chills, fluid flushing, looking sick, sleepiness, poor appetite (could not eat) drank for (24 h), + redness, swelling at the injection site.  Treated with Tylenol, Motrin, fluids after 48-72 hours.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Flushing, Full blood count, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Severe body aches, generalized weakness, fatigue, chills, fluid flushing, looking sick, sleepiness, poor appetite (could not eat) drank for (24 h), + redness, swelling at the injection site.  Treated with Tylenol, Motrin, fluids after 48-72 hours.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Pain, Somnolence, White blood cell count decreased
Clinical narrative: Severe body aches, generalized weakness, fatigue, chills, fluid flushing, looking sick, sleepiness, poor appetite (could not eat) drank for (24 h), + redness, swelling at the injection site.  Treated with Tylenol, Motrin, fluids after 48-72 hours.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Severe pain and increased temperature (mild) around injection site. Pain radiated to axilla with small adenopathy 0.5x0.5cm. TC: Pain control, Ibuprofen/Tylenol 4 Codeine, local measures.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Bloody discharge, Body temperature increased, Flushing, Irritability
Clinical narrative: Body Temperature increased, Bloody discharge, Irritable Flushing. Initial information was received from a health care professional in the USA on 25 July 2008.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Headache, Intensive care, Laboratory test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 22-FEB-2008 a 21 year old female with seasonal allergies was vaccinated with her third dose of GARDASIL (lot # 658560/1062U) IM.  Concomitant therapy included oral contraceptive.  Approximately four months post the vaccination, she experienced headache, seizures, fever, dizziness and lupus-like syndrome. She was hospitalized several times and placed in intensive care unit.  Computed axial tomography (CT) scan and lab work were performed.  The original reporting source was not provided.  The VAERS ID # is 324169.  A lot check has been requested.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lupus-like syndrome, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 22-FEB-2008 a 21 year old female with seasonal allergies was vaccinated with her third dose of GARDASIL (lot # 658560/1062U) IM.  Concomitant therapy included oral contraceptive.  Approximately four months post the vaccination, she experienced headache, seizures, fever, dizziness and lupus-like syndrome. She was hospitalized several times and placed in intensive care unit.  Computed axial tomography (CT) scan and lab work were performed.  The original reporting source was not provided.  The VAERS ID # is 324169.  A lot check has been requested.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Dizziness, Headache, Laboratory test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  On 22-FEB-2008 a 21 year old female with seasonal allergies was vaccinated with her third dose of GARDASIL (lot # 658560/1062U) IM.  Concomitant therapy included oral contraceptive.  Approximately four months post the vaccination, she experienced headache, seizures, fever, dizziness and lupus-like syndrome. She was hospitalized several times and placed in intensive care unit.  Computed axial tomography (CT) scan and lab work were performed.  The original reporting source was not provided.  The VAERS ID # is 324169.  A lot check has been requested.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No additional information is expected.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Back pain, Cough, Gait disturbance, Neck pain, Pain in extremity
Clinical narrative: 1st symptoms leg pains, fevers, vomiting, boils.  Coughs, fever, leg pain when walking triggered breathing problems.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Pyrexia, Skin irritation
Clinical narrative: 1st symptoms leg pains, fevers, vomiting, boils.  Coughs, fever, leg pain when walking triggered breathing problems.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Condition aggravated, Cough, Dyspnoea, Furuncle, Gait disturbance
Clinical narrative: 1st symptoms leg pains, fevers, vomiting, boils.  Coughs, fever, leg pain when walking triggered breathing problems.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: 1st symptoms leg pains, fevers, vomiting, boils.  Coughs, fever, leg pain when walking triggered breathing problems.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Convulsion, Disturbance in attention, Extrasystoles, Fatigue
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter with no pertinent medical history or allergies who in July 2007 and on an unspecified date was vaccinated intramuscularly with a 0.5 ml first and second doses of GARDASIL (lot #658094/0524U, 658563/1063U), respectively. There was no concomitant medication. The patient experienced bigeminy after receiving GARDASIL. "Two months after the second dose", the patient developed severe migraines, dizziness and seizures. The patient had been hospitalized twice because of the migraines. The patient stayed in the hospital for 1 and 1/2 days for the first stay and 2 days for the second stay. During the hospital stay, the patient received "intravenous dihydroergotamine mesylate". "Spinal tap, MRI, CT scan" were performed but no results provided. The patient had also been seen by a neurologist. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Migraine, Palpitations
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter with no pertinent medical history or allergies who in July 2007 and on an unspecified date was vaccinated intramuscularly with a 0.5 ml first and second doses of GARDASIL (lot #658094/0524U, 658563/1063U), respectively. There was no concomitant medication. The patient experienced bigeminy after receiving GARDASIL. "Two months after the second dose", the patient developed severe migraines, dizziness and seizures. The patient had been hospitalized twice because of the migraines. The patient stayed in the hospital for 1 and 1/2 days for the first stay and 2 days for the second stay. During the hospital stay, the patient received "intravenous dihydroergotamine mesylate". "Spinal tap, MRI, CT scan" were performed but no results provided. The patient had also been seen by a neurologist. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Dizziness, Extrasystoles, Lumbar puncture
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter with no pertinent medical history or allergies who in July 2007 and on an unspecified date was vaccinated intramuscularly with a 0.5 ml first and second doses of GARDASIL (lot #658094/0524U, 658563/1063U), respectively. There was no concomitant medication. The patient experienced bigeminy after receiving GARDASIL. "Two months after the second dose", the patient developed severe migraines, dizziness and seizures. The patient had been hospitalized twice because of the migraines. The patient stayed in the hospital for 1 and 1/2 days for the first stay and 2 days for the second stay. During the hospital stay, the patient received "intravenous dihydroergotamine mesylate". "Spinal tap, MRI, CT scan" were performed but no results provided. The patient had also been seen by a neurologist. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning his 15 year old daughter with no pertinent medical history or allergies who in July 2007 and on an unspecified date was vaccinated intramuscularly with a 0.5 ml first and second doses of GARDASIL (lot #658094/0524U, 658563/1063U), respectively. There was no concomitant medication. The patient experienced bigeminy after receiving GARDASIL. "Two months after the second dose", the patient developed severe migraines, dizziness and seizures. The patient had been hospitalized twice because of the migraines. The patient stayed in the hospital for 1 and 1/2 days for the first stay and 2 days for the second stay. During the hospital stay, the patient received "intravenous dihydroergotamine mesylate". "Spinal tap, MRI, CT scan" were performed but no results provided. The patient had also been seen by a neurologist. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3
Symptoms: Activities of daily living impaired, Vaccinia
Clinical narrative: Patient has generalized vaccinia onset 11 days after vaccination.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3
Symptoms: Vaccinia
Clinical narrative: Patient has generalized vaccinia onset 11 days after vaccination.
Age: 39.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Fever, chills, severe body ache/muscle fatigue, extreme redness, swelling, blistering and heat at injection site and an approx. 3 inch diameter surrounding site.
Age: 39.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Muscle fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, severe body ache/muscle fatigue, extreme redness, swelling, blistering and heat at injection site and an approx. 3 inch diameter surrounding site.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Drooling, Gaze palsy, Heart rate normal, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Pt received Tdap then HPV #2 as soon as MA finished w/HPV #2- pt's eyes rolled back and pt started to twitch and drool x 5 seconds. Recovered vital signs taken, water given, observed pt x 30 minutes. Pt staes "I feel fine"; Dad feels comfortable taking pt home. BP 110/84, P 64, R 12. Spoke with Dr. on 10/06/08 at 0945. Physician stated to have parents call to schedule an appointment for this week. 0950 called family and spoke with Mom. She stated that pt is fine. Told Mom that the physician would like to see the patient this week and that Mom should call to make an appointment.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Drooling, Gaze palsy, Immediate post-injection reaction, Muscle twitching
Clinical narrative: Pt received Tdap then HPV #2 as soon as MA finished w/HPV #2- pt's eyes rolled back and pt started to twitch and drool x 5 seconds. Recovered vital signs taken, water given, observed pt x 30 minutes. Pt staes "I feel fine"; Dad feels comfortable taking pt home. BP 110/84, P 64, R 12. Spoke with Dr. on 10/06/08 at 0945. Physician stated to have parents call to schedule an appointment for this week. 0950 called family and spoke with Mom. She stated that pt is fine. Told Mom that the physician would like to see the patient this week and that Mom should call to make an appointment.
Sex: F
Vaccine: HPV4
Symptoms: Renal failure
Clinical narrative: Information has been received from physician, via the patient's mother, who reported that her daughter was vaccinated with a dose of GARDASIL. Subsequently the patient experienced renal failure and was hospitalized. The physician thought renal failure was possibly related to GARDASIL. No outcome was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest discomfort, Hyperhidrosis, Pyrexia, Renal pain
Clinical narrative: Case received from a healthcare professional through MIS on 23 September 2008 under the local reference number 08-0440. This case was reported as not-serious. However, upon internal review, it has been upgraded to serious (important medical condition). A 29-year-old female patient, with a medical history of allergies to PC (penicillin) and latex, had received her intramuscular dose of FLUZONE (batch number U2474AA) in the left deltoid, on 19 September 2008. Four hours post-vaccination, the patient's throat started feeling like congestion. As evening progressed, the patient's throat felt tight and under ribs felt constricted. Ten and a half hours post-vaccination, belly button felt knot like, the patient developed fever and lower back pain. Kidneys felt achy and the patient developed amber colored urine. The patient got sweaty and had to change. She went back to sleep after taking MOTRIN. The patient recovered on 20 September 2008.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Upper respiratory tract congestion, Urine colour abnormal
Clinical narrative: Case received from a healthcare professional through MIS on 23 September 2008 under the local reference number 08-0440. This case was reported as not-serious. However, upon internal review, it has been upgraded to serious (important medical condition). A 29-year-old female patient, with a medical history of allergies to PC (penicillin) and latex, had received her intramuscular dose of FLUZONE (batch number U2474AA) in the left deltoid, on 19 September 2008. Four hours post-vaccination, the patient's throat started feeling like congestion. As evening progressed, the patient's throat felt tight and under ribs felt constricted. Ten and a half hours post-vaccination, belly button felt knot like, the patient developed fever and lower back pain. Kidneys felt achy and the patient developed amber colored urine. The patient got sweaty and had to change. She went back to sleep after taking MOTRIN. The patient recovered on 20 September 2008.
Age: 51.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dyspnoea, Erythema, Hemiparesis, Injection site pain, Neck pain
Clinical narrative: Initial information was received from a health care professional on 25 September 2008.  A 51 year old female patient with a history of hypertension, diabetes, and an allergy to penicillin developed symptoms two days after she received the YF VAX (lot number UF305AA) subcutaneously in the left arm and a second dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400) on 25 September 2008.  The patient received a first dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400).  The date was not reported.  On 25 September 2008 the patient presented to the doctor's office with pain at the injection site in the left arm, quarter size redness, swelling, left neck and jaw pain, left sided weakness, and shortness of breath.  She was being evaluated at the time by a physician.  The patient was not recovered at the time of the report. 12/15/08-records received-presented 9/25/08-C/O SOB, left sided weakness, left sided numbness, left side of neck and jaw hurts. Small localized red area at injection site, warm to touch. Sudden onset of pain at injection site travels to back of arm and associated with numbness and burning sensation, neck stiffness on left. Assessment: possible reaction to vaccine, possible infection at injection site with lymphatic response.
Age: 51.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pain in jaw, Swelling
Clinical narrative: Initial information was received from a health care professional on 25 September 2008.  A 51 year old female patient with a history of hypertension, diabetes, and an allergy to penicillin developed symptoms two days after she received the YF VAX (lot number UF305AA) subcutaneously in the left arm and a second dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400) on 25 September 2008.  The patient received a first dose of oral TYPHOID vaccine (manufacturer Berna, lot number 3001400).  The date was not reported.  On 25 September 2008 the patient presented to the doctor's office with pain at the injection site in the left arm, quarter size redness, swelling, left neck and jaw pain, left sided weakness, and shortness of breath.  She was being evaluated at the time by a physician.  The patient was not recovered at the time of the report. 12/15/08-records received-presented 9/25/08-C/O SOB, left sided weakness, left sided numbness, left side of neck and jaw hurts. Small localized red area at injection site, warm to touch. Sudden onset of pain at injection site travels to back of arm and associated with numbness and burning sensation, neck stiffness on left. Assessment: possible reaction to vaccine, possible infection at injection site with lymphatic response.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bone pain, Fatigue, Inappropriate schedule of drug administration, Muscular weakness
Clinical narrative: Initial report was received 19 June 2008 from a consumer, who is also the patient.  A 42-year-old female patient with a history of diabetes, had received an injection of ADACEL (lot number, route/site not reported) on 30 May 2008 and on "approximately" 06 June 2008, she complained of muscle weakness, sore bones, sore joints, and tiredness.  She was seen by her physician on 12 June 2008 at which time laboratory tests for iron and B12 were performed (results pending).  The patient had no concurrent illness at the time of vaccination and had received ADACEL because she sustained a cut while at work.  At the time of vaccination, the patient had been taking concomitant medications which included ZYRTEC, metformin, PROTONIX and YASMIN.  No other vaccinations had been received during the four weeks prior to ADACEL.  At the time of the report, the patient had not recovered from the event.  Follow-up information was received 12 August 2008 from a health care professional.  The reporter verified that the patient had received a first booster dose of ADACEL in June 2007 with no adverse events experienced.  The dose of ADACEL administered on 30 May 2008 had been a second dose (lot number, route and site of administration not reported).  Per the reporter, the results from the B12 and Iron laboratory tests would be forwarded.  No further information was provided.  Follow-up information was received 18 August 2008 from a health care professional.  The reporter stated that "the patient had an overload of pertussis so the doctor put her on antibiotics because she was symptomatic without a cough.  The patient is better now".  Laboratory results included Vitamin B12 (406) and Ferritin (12.8).  Additional information was provided for both ADACEL doses received by the patient.  The patient had received a second dose right deltoid intramuscular injection of ADACEL, lot number C2888AA on 30 May 2008 at 13:05.  The reporter also confirmed the patient had received a first dose right deltoid intramuscular injection of ADACEL, lot number C2688AA on 29 June 2007 approximately one year prior.  The patient recovered from the event (date not reported) and no further information was provided.  Follow-up information was received 26 September 2008 and 30 September 2008 from a health care professional.  On 26 September 2008, the reporter stated that "the patient was treated for pertussis because she had the symptoms of pertussis without the cough".  The reporter indicated that additional follow-up information would be forwarded.  From information received on 30 September 2008, the reporter confirmed the lot number for dose two of ADACEL administered on 30 May 2008 had been C2888AA.  The date for dose one of ADACEL was confirmed to have been 29 June 2007 with no adverse events experienced.  Based upon this new information received, this case has been upgraded to serious.