chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Hypersensitivity, Mass, Rash, Rash erythematous
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report was received 10 September 2008 from a health care professional.  A 12-year-old male patient with a history of allergies to CEFTIN and FORTAZ, had received a first dose intramuscular right deltoid injection of ADACEL, lot number C2998BA on 20 August 2008 and three days later, he developed a lump on his arm (site not reported).  On 24 August 2008, four days post vaccination, he developed a generalized red flat rash from "head to toe", which had also been present orally.  The rash progressed to blisters.  The patient was seen at the emergency room and was administered steroids for an allergic reaction.  The patient was subsequently evaluated by his physician that same day (on 24 August 2008) who diagnosed the patient with Stevens Johnson Syndrome.  The patient recovered from the event.  No additional information was provided at the time of the report.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash macular, Stevens-Johnson syndrome
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report was received 10 September 2008 from a health care professional.  A 12-year-old male patient with a history of allergies to CEFTIN and FORTAZ, had received a first dose intramuscular right deltoid injection of ADACEL, lot number C2998BA on 20 August 2008 and three days later, he developed a lump on his arm (site not reported).  On 24 August 2008, four days post vaccination, he developed a generalized red flat rash from "head to toe", which had also been present orally.  The rash progressed to blisters.  The patient was seen at the emergency room and was administered steroids for an allergic reaction.  The patient was subsequently evaluated by his physician that same day (on 24 August 2008) who diagnosed the patient with Stevens Johnson Syndrome.  The patient recovered from the event.  No additional information was provided at the time of the report.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Anaphylactic reaction, Erythema, Hypersensitivity, Throat tightness, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  The following information was obtained from the above-referenced literature article received on 11 September 2008.  The article included background information on vaccine hypersensitivity and a detailed algorithm that provided a rational and organized approach for the evaluation and treatment of patients with suspected hypersensitivity.  Also included were cases of suspected allergic reactions to vaccines to demonstrate the practical application of the algorithm.  Information in this case pertains to a patient who experienced an allergic reaction, described as follows: "A 12-year-old boy received Tdap and MCV vaccines and within 30 minutes developed hives and redness of his face and chest, wheezing, and throat tightness.  He was given albuterol by inhaler by his mother and returned to the clinic, where he was treated with oral diphenhydramine and intramuscular epinephrine.  His symptoms completely resolved over the next 2 hours.  He had no history of food or drug allergy or previous adverse events after vaccinations.  He did have a history of asthma and most recently had an acute exacerbation 3 months earlier.  This presentation, including both the timing and the specific symptoms, is very consistent with an immediate-type, IgE-mediated hypersensitivity reaction."  The article did not report vaccine trade names, manufacturers, lot numbers, route/site of administration and date of administration.  Application of the algorithm to this case was then described: "Referral to an allergist for additional evaluation was recommended.  Skin testing would be indicated to elucidate the cause of this reaction before the administration of future doses.  Because this was an anaphylactic reaction, skin-prick skin testing would be initiated at a 1:10 dilution, followed by prick test to the full-strength vaccines and then intradermal tests at 1:100 and 1:10 dilutions.  An additional dose of Td is indicated in 10 years, or after 5 if he has a penetrating injury that is considered to be a high risk for tetanus.  Additional doses of MCV are not currently recommended; therefore, testing in the time frame immediately after the vaccine would be an option but was not absolutely needed, but skin testing should be performed before administration of future doses of Td (or Tdap or MCV if additional doses are ever recommended)."  This case is reported in the same literature article as case 2008-02852.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Wheezing
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  The following information was obtained from the above-referenced literature article received on 11 September 2008.  The article included background information on vaccine hypersensitivity and a detailed algorithm that provided a rational and organized approach for the evaluation and treatment of patients with suspected hypersensitivity.  Also included were cases of suspected allergic reactions to vaccines to demonstrate the practical application of the algorithm.  Information in this case pertains to a patient who experienced an allergic reaction, described as follows: "A 12-year-old boy received Tdap and MCV vaccines and within 30 minutes developed hives and redness of his face and chest, wheezing, and throat tightness.  He was given albuterol by inhaler by his mother and returned to the clinic, where he was treated with oral diphenhydramine and intramuscular epinephrine.  His symptoms completely resolved over the next 2 hours.  He had no history of food or drug allergy or previous adverse events after vaccinations.  He did have a history of asthma and most recently had an acute exacerbation 3 months earlier.  This presentation, including both the timing and the specific symptoms, is very consistent with an immediate-type, IgE-mediated hypersensitivity reaction."  The article did not report vaccine trade names, manufacturers, lot numbers, route/site of administration and date of administration.  Application of the algorithm to this case was then described: "Referral to an allergist for additional evaluation was recommended.  Skin testing would be indicated to elucidate the cause of this reaction before the administration of future doses.  Because this was an anaphylactic reaction, skin-prick skin testing would be initiated at a 1:10 dilution, followed by prick test to the full-strength vaccines and then intradermal tests at 1:100 and 1:10 dilutions.  An additional dose of Td is indicated in 10 years, or after 5 if he has a penetrating injury that is considered to be a high risk for tetanus.  Additional doses of MCV are not currently recommended; therefore, testing in the time frame immediately after the vaccine would be an option but was not absolutely needed, but skin testing should be performed before administration of future doses of Td (or Tdap or MCV if additional doses are ever recommended)."  This case is reported in the same literature article as case 2008-02852.
Sex: U
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received 12 September 2008 from another manufacturer who received the report from a health care professional. An unidentified patient had received an injection of Tetanus Toxoid (lot number, date, route/site of administration not reported) and an unspecified amount of time later, experienced an anaphylactic reaction. The manufacturer of the Tetanus Toxoid vaccine was unknown. No additional information was provided.
Sex: U
Vaccine: TDAP
Symptoms: Autism
Clinical narrative: Initial report received from another manufacturer on 12 September 2008 who received the report from a physician.  A child (gender and age not reported) developed autism after receiving TDaP (trade name, manufacturer, lot number, date of administration, route/site of administration not reported).  The reporting physician had no information concerning the patient's physician, symptoms, or treatment.  It was indicated that no additional information was available.
Sex: F
Vaccine: PER
Symptoms: Convulsion
Clinical narrative: SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT. Initial report was received 12 September 2008 from another manufacturer who received the report from a health care professional. A female infant experienced a seizure an unspecified amount of time after she had received a pertussis vaccine (lot number, date, route/site of administration not reported). The event occurred approximately 13 years ago and the manufacturer of the vaccine was unknown. The reporter had no other information available at the time of the report.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Blindness, Constipation, Erectile dysfunction, Gait disturbance
Clinical narrative: Developed tingling in the hands and feet in Jul 07. By Sept 07 had decreased rt leg strength and control. Had a limp and toe drag. Rt arm strength also diminished and started dropping things. Now has dark vision on it, bladder emptying problems, erectile dysfunction and constipation. Diagnosed with probable progressive multiple sclerosis. Condition worsening. Had Hep B vaccine 21Apr98, 20May03, and 19 Jan 05. Symptoms: Gait abnormality, Numbness, Weakness, Erectile dysfunction, Constipation, Loss of vision (CN II). 9/24/08-records received-office visit 9/9/08-seen for current demyelinating condition. Tingling in bilateral hands and feet began in June-July 2007 but with stress and activity of returning stateside, ignored symptoms. September 2007 developed decreased right arm strength and loss of control of right leg, began as a limp. Decreased right arm strength.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of control of legs, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Urinary retention
Clinical narrative: Developed tingling in the hands and feet in Jul 07. By Sept 07 had decreased rt leg strength and control. Had a limp and toe drag. Rt arm strength also diminished and started dropping things. Now has dark vision on it, bladder emptying problems, erectile dysfunction and constipation. Diagnosed with probable progressive multiple sclerosis. Condition worsening. Had Hep B vaccine 21Apr98, 20May03, and 19 Jan 05. Symptoms: Gait abnormality, Numbness, Weakness, Erectile dysfunction, Constipation, Loss of vision (CN II). 9/24/08-records received-office visit 9/9/08-seen for current demyelinating condition. Tingling in bilateral hands and feet began in June-July 2007 but with stress and activity of returning stateside, ignored symptoms. September 2007 developed decreased right arm strength and loss of control of right leg, began as a limp. Decreased right arm strength.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Balance disorder, Dysphagia, Dysstasia, Electromyogram normal, Foot deformity
Clinical narrative: In late 2003 or early 2004 the patient began to notice balance problems, difficulty running and foot pain. He is unsure of the exact date of onset of symptoms but they became significant enough that he sought evaluation by a podiatrist in Apr 04. Severe pes cavus and brisk reflexes were noted prompting neurologic referral. One year later he was seen by neurology. At that time symptoms included awkward running, feelings of "falling over", difficulty standing on 1 foot, myoclonic jerks, intermittent tremor, occasional dysphagia, and difficulty holding items. A brain MRI, EMG/NCS and LP were normal. A diagnosis of SCA was made when Athena diagnostic tests were sent for analysis as well as SCA panel which returned positive for SCA 8 repeat expansion.  Symptoms: Gait abnormality, Weakness, Hyper-reflexia. 10/13/08-records received for DOS 8/13/08-follow-up visit after development of spinocerebellar ataxia first presenting in 2003. Balance problems in late 2003. Anthrax vaccine 11/12/03, 12/1/07 and 3/9/08, began to have foot pain with abnormal reflexes and tremors in feet. April 2005 seen by neurologist, genetic testing performed found to have SCA8. Currently condition has worsened in that now has difficulty typing and writing, gait is abnormal, tremors in hands, muscle wasting in legs, balance problems, falls, chronic fatigue.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Gait disturbance, Grip strength decreased, Hyperreflexia, Laboratory test abnormal, Lumbar puncture normal
Clinical narrative: In late 2003 or early 2004 the patient began to notice balance problems, difficulty running and foot pain. He is unsure of the exact date of onset of symptoms but they became significant enough that he sought evaluation by a podiatrist in Apr 04. Severe pes cavus and brisk reflexes were noted prompting neurologic referral. One year later he was seen by neurology. At that time symptoms included awkward running, feelings of "falling over", difficulty standing on 1 foot, myoclonic jerks, intermittent tremor, occasional dysphagia, and difficulty holding items. A brain MRI, EMG/NCS and LP were normal. A diagnosis of SCA was made when Athena diagnostic tests were sent for analysis as well as SCA panel which returned positive for SCA 8 repeat expansion.  Symptoms: Gait abnormality, Weakness, Hyper-reflexia. 10/13/08-records received for DOS 8/13/08-follow-up visit after development of spinocerebellar ataxia first presenting in 2003. Balance problems in late 2003. Anthrax vaccine 11/12/03, 12/1/07 and 3/9/08, began to have foot pain with abnormal reflexes and tremors in feet. April 2005 seen by neurologist, genetic testing performed found to have SCA8. Currently condition has worsened in that now has difficulty typing and writing, gait is abnormal, tremors in hands, muscle wasting in legs, balance problems, falls, chronic fatigue.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Myoclonus, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Spinocerebellar ataxia
Clinical narrative: In late 2003 or early 2004 the patient began to notice balance problems, difficulty running and foot pain. He is unsure of the exact date of onset of symptoms but they became significant enough that he sought evaluation by a podiatrist in Apr 04. Severe pes cavus and brisk reflexes were noted prompting neurologic referral. One year later he was seen by neurology. At that time symptoms included awkward running, feelings of "falling over", difficulty standing on 1 foot, myoclonic jerks, intermittent tremor, occasional dysphagia, and difficulty holding items. A brain MRI, EMG/NCS and LP were normal. A diagnosis of SCA was made when Athena diagnostic tests were sent for analysis as well as SCA panel which returned positive for SCA 8 repeat expansion.  Symptoms: Gait abnormality, Weakness, Hyper-reflexia. 10/13/08-records received for DOS 8/13/08-follow-up visit after development of spinocerebellar ataxia first presenting in 2003. Balance problems in late 2003. Anthrax vaccine 11/12/03, 12/1/07 and 3/9/08, began to have foot pain with abnormal reflexes and tremors in feet. April 2005 seen by neurologist, genetic testing performed found to have SCA8. Currently condition has worsened in that now has difficulty typing and writing, gait is abnormal, tremors in hands, muscle wasting in legs, balance problems, falls, chronic fatigue.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Tremor
Clinical narrative: In late 2003 or early 2004 the patient began to notice balance problems, difficulty running and foot pain. He is unsure of the exact date of onset of symptoms but they became significant enough that he sought evaluation by a podiatrist in Apr 04. Severe pes cavus and brisk reflexes were noted prompting neurologic referral. One year later he was seen by neurology. At that time symptoms included awkward running, feelings of "falling over", difficulty standing on 1 foot, myoclonic jerks, intermittent tremor, occasional dysphagia, and difficulty holding items. A brain MRI, EMG/NCS and LP were normal. A diagnosis of SCA was made when Athena diagnostic tests were sent for analysis as well as SCA panel which returned positive for SCA 8 repeat expansion.  Symptoms: Gait abnormality, Weakness, Hyper-reflexia. 10/13/08-records received for DOS 8/13/08-follow-up visit after development of spinocerebellar ataxia first presenting in 2003. Balance problems in late 2003. Anthrax vaccine 11/12/03, 12/1/07 and 3/9/08, began to have foot pain with abnormal reflexes and tremors in feet. April 2005 seen by neurologist, genetic testing performed found to have SCA8. Currently condition has worsened in that now has difficulty typing and writing, gait is abnormal, tremors in hands, muscle wasting in legs, balance problems, falls, chronic fatigue.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Abasia, Asthenia, Gait disturbance, Hyperreflexia, Neurological symptom
Clinical narrative: This service member received Anthrax #1 on 10 Dec 02, #2 on 8 Jan 03, #3 on 21 Jan, and the smallpox vaccine on 6 Feb 03. He was in his usual state of good health when he deployed in Apr 2003. While deployed his neurologic symptoms started so gradually that he is unable to state when they first appeared. It was other men in his unit who pointed out to him that there was "something wrong". They noticed a change in his speech, that he stumbled, walked with a limp and had lost a lot of weight (from 200 lbs to 140 lbs). He does recall that his limp started about Oct 03. He returned home in Apr 04 and by his 22nd birthday on 7 May he was confined to a wheelchair unable to walk. Eight months later he was diagnosed with SCA spinocerebella ataxia type 8 by a doctor. Symptoms: Gait abnormality, Hyper-reflexia, Weakness, Weight loss, unexpected.   10/14/08 Reviewed medical records of 9/12/2008. FINAL DX: spinocerebellar ataxia Records reveal patient experienced usual state of good health when vaccinated w/anthrax & smallpox vaccines 2003.  While deployed, developed gradual onset of neurologic symptoms: speech changes, stumbling gait, limping, weight loss of 60# until became unable to walk by 5/2004.  10/24/08 Reviewed neuro clinic medical records of 8/12-8/16/2004. FINAL DX: none provided Records reveal patient experienced ataxia since approx 1/2004 w/difficulty walking, ascending/descending stairs, excessive fatigability, 80# weight loss, speech difficulty, balance difficulty, frequent falls.  Had been hospitalized x 3 wks after deployment, became w/c bound by 5/2004 & had numbness/tingling in all extremities w/profound loss of position sense in LEs.  Exam revealed spastic LEs w/clonus, marked incoordination, truncal titubation, difficulty standing.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Speech disorder, Spinocerebellar ataxia, Weight decreased
Clinical narrative: This service member received Anthrax #1 on 10 Dec 02, #2 on 8 Jan 03, #3 on 21 Jan, and the smallpox vaccine on 6 Feb 03. He was in his usual state of good health when he deployed in Apr 2003. While deployed his neurologic symptoms started so gradually that he is unable to state when they first appeared. It was other men in his unit who pointed out to him that there was "something wrong". They noticed a change in his speech, that he stumbled, walked with a limp and had lost a lot of weight (from 200 lbs to 140 lbs). He does recall that his limp started about Oct 03. He returned home in Apr 04 and by his 22nd birthday on 7 May he was confined to a wheelchair unable to walk. Eight months later he was diagnosed with SCA spinocerebella ataxia type 8 by a doctor. Symptoms: Gait abnormality, Hyper-reflexia, Weakness, Weight loss, unexpected.   10/14/08 Reviewed medical records of 9/12/2008. FINAL DX: spinocerebellar ataxia Records reveal patient experienced usual state of good health when vaccinated w/anthrax & smallpox vaccines 2003.  While deployed, developed gradual onset of neurologic symptoms: speech changes, stumbling gait, limping, weight loss of 60# until became unable to walk by 5/2004.  10/24/08 Reviewed neuro clinic medical records of 8/12-8/16/2004. FINAL DX: none provided Records reveal patient experienced ataxia since approx 1/2004 w/difficulty walking, ascending/descending stairs, excessive fatigability, 80# weight loss, speech difficulty, balance difficulty, frequent falls.  Had been hospitalized x 3 wks after deployment, became w/c bound by 5/2004 & had numbness/tingling in all extremities w/profound loss of position sense in LEs.  Exam revealed spastic LEs w/clonus, marked incoordination, truncal titubation, difficulty standing.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Admitted at medical center x 1 day then transferred to hospital for bilious vomiting. Dx-Intussusception of Intestine (560.0) 10/6/08-records received for DOS 7/23-7/24/08-DC DX:Instussusception. Successful reduction of ileocecal intussusception by air enema. Presented with 2 day history of vomiting bilious in last 24 hours, abdominal pain and lethargy. Unable to tolerate feedings. Irregular bowel movement with constipation, no blood.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Oedema peripheral
Clinical narrative: Child began to c/o (L) arm pain (back of arm) prior to going to bed last night. This a.m. Mom states child cont to c/o discomfort and mom notes that the area is reddened approx. SL of a "coffee cup" area is also "hard" to touch and she c/o itching. Mom advised re apply ice, Give TYLENOL or ibuprofen and option of topical or oral BENADRYL. TC to mom 09/0508. Mom states she applied ice intermittently and gave TYLENOL and BENADRYL PO. As well as applied topical BENADRYL for c/o itching "through Sunday" erythema was a 3" area with swelling to elbow. The swelling resolved Sun eve but she cont. to have firmness at the inj site.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Pain in extremity
Clinical narrative: Child began to c/o (L) arm pain (back of arm) prior to going to bed last night. This a.m. Mom states child cont to c/o discomfort and mom notes that the area is reddened approx. SL of a "coffee cup" area is also "hard" to touch and she c/o itching. Mom advised re apply ice, Give TYLENOL or ibuprofen and option of topical or oral BENADRYL. TC to mom 09/0508. Mom states she applied ice intermittently and gave TYLENOL and BENADRYL PO. As well as applied topical BENADRYL for c/o itching "through Sunday" erythema was a 3" area with swelling to elbow. The swelling resolved Sun eve but she cont. to have firmness at the inj site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity
Clinical narrative: Employee received TDAP - 2 weeks, severe arm pain.  Unable to raise arm above head.  Dresses with great difficulty getting arm in sleeve.  After 2 weeks, she called primary HCP for Rx.  Given hydrocodone.  Pain persisted for > 1 month.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Feeling hot
Clinical narrative: 4:00 pm mom gave TYLENOL 0.4 ml and stated infant felt warm. 8:00 pm gave more TYLENOL 101 deg. 2:00 a.m 104 Temp; Denies any redness, rash or swelling.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Eye rolling, Muscle twitching, Pruritus, Tremor
Clinical narrative: Pt's mom reported itching 1 hr after vaccines. Gave Benadryl. Pt's boyfriend states she started twitching/shaking head & neck & eyes rolled back in her head. 9/22/08-records received-9/9/08-Seen in office day after C/O itching, twitching and shaking head and neck. Eyes rolled. PE grossly WNL.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Occult blood, White blood cell count
Clinical narrative: Diarrhea - started same evening after vaccinations; numerous times/day, on-going each at day 18.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Breath sounds abnormal, Loss of consciousness, Nausea, Syncope vasovagal
Clinical narrative: None stated
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold compress therapy, Culture throat negative, Full blood count, Injection site bruising, Injection site erythema
Clinical narrative: Received vaccine 7/6/07- (R) thigh. Over subsequent 72 hr developed increasing redness, tenderness, warmth at injection site. Return of office visit 7/9/07. Site indurated, red and warm but without drainage. Impression-local tissue reaction without infection sent home on BENADRYL, cold compress. Return 7/18/07 with maculopapular rash over torso ext. vaccine site bruised, indurated.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Local reaction, Platelet count normal
Clinical narrative: Received vaccine 7/6/07- (R) thigh. Over subsequent 72 hr developed increasing redness, tenderness, warmth at injection site. Return of office visit 7/9/07. Site indurated, red and warm but without drainage. Impression-local tissue reaction without infection sent home on BENADRYL, cold compress. Return 7/18/07 with maculopapular rash over torso ext. vaccine site bruised, indurated.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, White blood cell count
Clinical narrative: Received vaccine 7/6/07- (R) thigh. Over subsequent 72 hr developed increasing redness, tenderness, warmth at injection site. Return of office visit 7/9/07. Site indurated, red and warm but without drainage. Impression-local tissue reaction without infection sent home on BENADRYL, cold compress. Return 7/18/07 with maculopapular rash over torso ext. vaccine site bruised, indurated.
Age: 24.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None - no adverse events.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Wrong technique in drug usage process
Clinical narrative: No side effects.  The HIB was mixed with sterile diluent instead of the diluent for Haemophilus 'b' conjugate.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: approx 8-10 days s/p Tdap developed a truncal rash H/O no previous exposure to Pertussis vaccine. Rash with mild itch. No other significant exposure except steroid injection to plantar fascia. Rash diffuse truncal and UE mac-pap rash constant with exanthem
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site pain, Joint stiffness, Malaise
Clinical narrative: Developed soreness at injection site the day of vaccination. The next day developed pain in back of head and neck, fever and chills, and joint stiffness. Two days later still had low grade fever, soreness of arm and general malaise. Symptoms persisted for 4 days.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia
Clinical narrative: Developed soreness at injection site the day of vaccination. The next day developed pain in back of head and neck, fever and chills, and joint stiffness. Two days later still had low grade fever, soreness of arm and general malaise. Symptoms persisted for 4 days.
Age: 1.4
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Seen 9/8 for well check, red, papular pruritic rash developed with 24 hr at time of visit 9/10 50-75 papular rash non vesicular, no crust. (+) pruritus
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: rash characteristic of varicella rxn
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt. with no adverse symptoms or reaction. Pt. received adult dose 1 ml of Hep A instead of pediatric dose 5 ml of Hep A. Telephone cell made to mother to advise signs and sxs advised. Mother to call if concerns arise.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea, Oral intake reduced, Pain
Clinical narrative: Pt. c/o no chills all night, less than AM. (2) nausea. still this am-unable to eat. (3) body aches-all night. (4) Fever-still this AM and all last night. (5) Headache more last night.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt. c/o no chills all night, less than AM. (2) nausea. still this am-unable to eat. (3) body aches-all night. (4) Fever-still this AM and all last night. (5) Headache more last night.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Inappropriate schedule of drug administration, Smear cervix normal
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female, with no drug reaction/allergies, and with normal PAP smear, who on 10-JAN-2007 was vaccinated with the first dose of GARDASIL (lot number unknown) IM 0.5 mL, and late on 21-MAY-2007 was vaccinated with the second dose of GARDASIL (Lot number 655324/0088U) IM 0.5 mL. Concomitant therapy included unspecified birth control pills. In the morning of 18-JUL-2008, the patient was in the office and mentioned to the physician she had genital warts. The patient had a PAP smear done (results unknown). The physician treated her for condyloma and will be back to the office later on 18-JUL-2008, possibly to receive the third dose of GARDASIL. At the time of the report the patient had not recovered. The patient sought medical attention, phone office and visited office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash
Clinical narrative: Information has been received from a physician who heard that a female who was vaccinated with the first dose of GARDASIL for prevention of HPV, at her physician's office experienced swelling of the lips and rash. The patient's symptoms resolved. The patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling, Pharyngolaryngeal pain
Clinical narrative: Approx 18 hours after recieving vaccine, parents noted a red swollen area at the injection site. Patient complained of itching at area.He also complained of sore throat. Temperature was 100.4 (oral) when examined in the office.He was given oral diphenhydramine and a topical steroid to apply to the area, instructed to apply cool compresses and return within 24 hours for follow-up.
Age: 16.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: GIVEN STATE SUPPLIED DOSE OF TWINRIX INSTEAD OF PEDIATRIC DOSE OF HEPATITIS A AND HEPATITIS B.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Aggression, Asperger's disorder, Condition aggravated, Sensory disturbance
Clinical narrative: Child has Aspergers.  Shot resulted in ongoing over sensory issues, sensory meltdowns and extreme violence. 10/2/08-records received for DOS 6/3-6/11/08-admitted for behavioral issues and on 6/20-6/26-08 for starting a fire and 8/11/08- for blasting out a window. Developed tremors in hands in May 2008. Diagnosed with Asperger's. Diffuse abdominal pain. Staff feels it is attention getting behavior.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Muscular weakness, Musculoskeletal stiffness, Sensory loss
Clinical narrative: Pt. complained of left arm weakness 3 days after HPV vaccine injected.  Had initial stiffness for 2 days after vaccine.  No local reaction, no fever. Patient reported one episode of complete loss of sensation and motor function after sleeping on left arm which resolved with reintroduction of circulation.  Patient states that episode occured during first week following vaccine, patient not able to give exact date.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT FIRST NOTICE REDNESS AND WARM TO THE TOCH ON THE VACCINE SITE (RIGHT ARM, SC) WITHING 24 HOURS. PATIENT THEN PRECIDED TO TAKE MOTRIN 200MG AS DIRECTED IN THE BOTTLE. THEN 9 DAYS LATER PT EXPERIENCED SWEELING AND REDNES ALONG WITH ITCHINES ON HIS RIGHT INNER ELBOW. PATIENT WAS THEN ADVISE TO GO TO THE E.R. WHERE HE WAS TREATED FOR CELLULITIS. PATIENT RECIEVED KEFLEX AND BENADRYL. PATIENT SYMPTOMS THEN GOT RESOLVED SHORTLY AFTER.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Rash erythematous
Clinical narrative: 102F temp for 2 days 9/6-9/8 in AM small red bumps on 9/8 on belly/back now on rest of body
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: Headaches: Patient has a history of migraine headaches(first seen 2005 for recurrent HA), mother feels that intensity and frequency of headaches have increased since gardisil vaccine was given. Severe headache within 24 hours of 3rd dose.Patient was assymptomatic at time of visit.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pustular
Clinical narrative: 24 hours after administration of the varicella vaccine, pt began developing small red pustual type bumps on buttocks.  Continued to spread to face and hands.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pruritus generalised, Rash macular, Sensation of foreign body
Clinical narrative: One hour after DTAP and IPV, and no known oral or contact exposures, developed diffuse extremety itching whole body rash and "lump in throat". ER visit-not hives but diffuse macules on skin all else fine. Given 25 mg Benadryl po, epi pen jr and oral prednisone X 5 days
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: No adverse effects at the time of injection.  But patient died of Sudden infant death syndrome at a later date 07/29/2008 9/22/08-autopsy report received;COD-Asphyxia due to overlay due to co-sleeping with older sibling and parents in same bed. Petechiae of eyes.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Erythema, Eyelid oedema, Mass, Rash macular
Clinical narrative: Pt returned to clinic apx 5 minutes after imms given with swelling of eyelids and pink, blotchy, macular rash over forehead, cheeks, few on upper chest. No peri-oral edema. No respiratory distress or wheezing. Pt examined by M.D., placed on oximeter (sats 97% RA), given 8mg diphenhydramine. Observed x 40minutes w/ 90% resolution of erythema and edema, no resp sx at any time. d/c to home; follow-up call to mom this am = PT remains well, no recurrence of rash or swelling.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest X-ray normal, Epistaxis, Headache, Nasopharyngitis, Pain
Clinical narrative: Extremely severe nasal discharge for 5 days following Flumist.  Bloody nose on and off for 2 days.  Cold progressively worse until 9/12/08.  Body aches, head aches. Dr. office visit - recieved chest x-ray due to severe congestion (negative for pnuemonia). Starting to clear up as of 9/17/08.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: Extremely severe nasal discharge for 5 days following Flumist.  Bloody nose on and off for 2 days.  Cold progressively worse until 9/12/08.  Body aches, head aches. Dr. office visit - recieved chest x-ray due to severe congestion (negative for pnuemonia). Starting to clear up as of 9/17/08.
Age: 7.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: PATIENT HAD VARICELLA VACCINE ON 09/16/2008, MOM CALLED OFFICE ON 09/17/2008 AND DESCRIBE CHILD'S INJECTION SITE TO HAVE SEVERAL SMALL VESICLES AND RED RASH.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased
Clinical narrative: Within 24 hours of vaccine administration pt's mother measured temperature of 103.0 F aurally.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Local reaction
Clinical narrative: patient received pneumvax on 9/16/08 at 12:05 pm.she called arround 7 pm,and said that she was experiencing redness,and discomforin area of shot.she was told by the rph to ice are,and if worsens to see a phycisian.i called her at 9 am on 9/17/08. she saw her primary physician,and received a prescription for triamcinolon 0.1 % cream
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Muscle twitching, Pallor, Syncope
Clinical narrative: Approx 3-4 minutes after receiving a HPV #2 and Tdap she fainted and twitching of facial muscles and extention of arms and legs for less than 5 seconds.  After episode was over and she set up she was oriented x 4, pale, Vital Signs within Normal limits.  Observed for 30 minutes with V.S. done every 10 minutes. V.S. remained WNL.  Mom was presented and escorted daughter home with instructions to take to ER if condition changed.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Activities of daily living impaired, Chills, Condition aggravated, Nasal congestion, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of arm soreness in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  The subject's medical history included hay fever.   Concurrent medications included Homeopathic medications (unspecified).  On 02 September 2008, the subject received 1st dose of ENGERIX B (1 ml, unknown, left arm) at an employee health clinic.  On 02 September 2008, less than one day after vaccination with ENGERIX B, the subject experienced arm soreness.  On 05 September, three days after vaccination with ENGERIX B, the subject experienced sneezing.  On 09 September 2008, seven days after vaccination with ENGERIX B, the subject experienced fever.  At an unspecified time after vaccination with ENGERIX B, the subject experienced chills and hay fever-like symptoms of sneezing and congestion.  As of 12 September 2008, the subject continued to have a low-grade fever and was seen in the physician's office.  At the time of reporting, the events were unresolved.  The physician considered the events to be disabling and to have jeopardized the subject requiring intervention, because the subject was not able to work.  The physician considered the events to be probably related to vaccination with ENGERIX B.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Seasonal allergy, Sneezing
Clinical narrative: This case was reported by a physician and described the occurrence of arm soreness in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  The subject's medical history included hay fever.   Concurrent medications included Homeopathic medications (unspecified).  On 02 September 2008, the subject received 1st dose of ENGERIX B (1 ml, unknown, left arm) at an employee health clinic.  On 02 September 2008, less than one day after vaccination with ENGERIX B, the subject experienced arm soreness.  On 05 September, three days after vaccination with ENGERIX B, the subject experienced sneezing.  On 09 September 2008, seven days after vaccination with ENGERIX B, the subject experienced fever.  At an unspecified time after vaccination with ENGERIX B, the subject experienced chills and hay fever-like symptoms of sneezing and congestion.  As of 12 September 2008, the subject continued to have a low-grade fever and was seen in the physician's office.  At the time of reporting, the events were unresolved.  The physician considered the events to be disabling and to have jeopardized the subject requiring intervention, because the subject was not able to work.  The physician considered the events to be probably related to vaccination with ENGERIX B.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Crying
Clinical narrative: Cried inconsolably for 3 hrs after shots.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Rash
Clinical narrative: Vaccinated in 9-10-2008. Developed bruise and redness at sight of injection. Few days later developed about 10 dots all over body (mild case of chicken pox) ? I called Merck directly- as well.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site haematoma, Rash erythematous
Clinical narrative: Vaccinated in 9-10-2008. Developed bruise and redness at sight of injection. Few days later developed about 10 dots all over body (mild case of chicken pox) ? I called Merck directly- as well.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Skin lesion
Clinical narrative: Vaccinated in 9-10-2008. Developed bruise and redness at sight of injection. Few days later developed about 10 dots all over body (mild case of chicken pox) ? I called Merck directly- as well.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Eosinophil count increased, Full blood count, Platelet count increased, Urticaria
Clinical narrative: Urticaria on both legs 12 - 48 hours after Prevnar administration.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Head injury, Joint injury, Syncope
Clinical narrative: Within 5min. of HPV vaccine the patient became dizzy and had syncope. She fell down and hit her head and right elbow on a table and chair respectively. We give her milk and she rested for 10 more minutes.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Woke up with hives Sunday 9/14/08, covering most of body. immunized 9/8/08
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Headaches, vomiting, fever to 101.9 F beginning few hours post vaccination.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Erythematous reaction 6cm deep red, surrounding pink halo of 2cm. and total induration of 15cm at site of varicella booster within 36 hours of receiving shot. Treated with cool compresses and Benadryl to itching.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Site redness, warm to touch, and swelling noted the size of two silver dollars on 9/16/08 - Parent advised to give patient Motrin, apply ice or warm washcloth to site and call MD's office in morning if continues with symptoms or worsens. Patient seen in MD office 9/17/08 with fever, swelling size of baseball, and blisters noted at site of injection given.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Angioedema, Erythema, Injection site reaction, Swelling, Tenderness
Clinical narrative: One hour S/P HIB given, had angioedema of extremity that vaccine was given on right thigh to ankle.  Swelling, redness, tender lasting 1/2 hour, then resolving on own.
Age: 1.01
Sex: M
Vaccine: HEP, HIBV, MMR, PPV, VARCEL
Symptoms: Expired drug administered
Clinical narrative: HIB vaccine outdated.  Exp 6/2008. Follow-up Information 15-OCT-2008: None/Vaccine was outdated/will repeat
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: DTAP given 9/11/08 left thigh; 9/16/08 patient presented with urticaria type rash, conc at injection site of DTAP left thigh, trunk and face areas itchy.  Benadryl 12.5 q 6.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: No adverse events
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash maculo-papular, Vasculitic rash
Clinical narrative: Rash 1-2 days after receiving MMR (1) and Varicella (1).  Patient had been on day 5 of Zithromax when received vaccines (9/2/08).  Mac pap and vasculitic rash (latter on extremity).
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Asthenia, Bundle branch block right, Dizziness, Electrocardiogram abnormal, Malaise
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient who was vaccinated with 0.5 mL of the first dose of GARDASIL vaccine (yeast) (Lot #659184/0843X). The patient fainted after vaccination. An ambulance was called and the patient was brought to the emergency room where it was determined by electrocardiogram that the patient had a blockage in her right branch. The patient sought medical attention at the office. There was no product quality complaint. Additional information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Bundle branch block right, Electrocardiogram abnormal, Syncope
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient who was vaccinated with 0.5 mL of the first dose of GARDASIL vaccine (yeast) (Lot #659184/0843X). The patient fainted after vaccination. An ambulance was called and the patient was brought to the emergency room where it was determined by electrocardiogram that the patient had a blockage in her right branch. The patient sought medical attention at the office. There was no product quality complaint. Additional information is expected.
Age: 0.17
Sex: F
Vaccine: RV5, UNK
Symptoms: Blood glucose abnormal, Body temperature normal, Culture stool positive, Decreased appetite, Diarrhoea
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/15/2008. Information Has been received from a nurse concerning a female who on 30-JUL-2008 was vaccinated live with orally ROTATEQ. Concomitant therapy included all "two month old vaccines" on 30-JUL-2008. The patient was seen in the office on 14-AUG-2008 with decreased appetite, low grade fever 99*F and loose stools. The patient was diagnosed with upper respiratory infection and diarrhea. The patient was seen in the emergency room on 16-AUG-2008 since the infant had vomiting and diarrhea. The patient was given IV fluids in the emergency room and discharged to home. On 18-AUG-2008, the patient was seen in the office for Rotavirus. On 19-AUG-2008, stool came back from hospital positive for rotavirus. It was reported that the patient recovered from the events (date unknown). No product quality complaint involved. Additional information has been received from a physician concerning a 10 week old female with NKDA, no birth defects and no medical history, who on 24-JUL-2008, was vaccinated with the first dose of oral ROTATEQ. Illness at time of vaccination included GERD. Concomitant therapy ZANTAC. On 16-AUG-2008, the patient was brought to the ER with complaints of diarrhea and vomiting. She had diarrhea for the last week, only had 1-2 loose stools a day and she had been vomiting. She was diagnosed with reflux and she had been spitting up. She was seen by her primary care physician earlier in the week and was instructed to continue feeding and to give her Pedialyte as needed. They increased her ZANTAC and switched her to Entamil gentle ease. It was reported that over the last 24 hours she has had about 10-11 watery stools but no fever. She has had a mild runny nose. She had still been waiting diapers, but was eating less. She was not  vomiting but just was not eating as well as her usual. The patient had IV initiated in the ER and was given a fluid bolus. Blood work was obtained. Her white count was 18,00 which is mildly elevated, predominant lymphocyte count rather. Catherized urine sample was negative for any signs of infection, bicarbonate 15 and glucose 117. She was hydrated for several hours. She tolerated a ounces of fluid and did not spit up. She had two small seedy stools one was sent for rotazyme and culture. In the evening of 16-AUG-2008, the stool culture came back positive for rotavirus. The patient's condition improved. She was active and discharged to home. Finial impression was acute vomiting with diarrhea. The pateint's formula was switched to Isomil soy formula to help with the diarrhea. The pateint was to continue with pedialyte and ordered to follow up with pediatrician for reevaluation on Monday. The patient was reported as recovered on 23-AUG-2008. Additional information is not expected.