chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tilt table test, Vision blurred
Clinical narrative: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon 6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse.  DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia. DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Accidental exposure, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon 6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse.  DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia. DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Fatigue, Head injury, Incorrect dose administered, Loss of consciousness
Clinical narrative: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon 6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse.  DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia. DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Medication error, Palpitations, Periorbital haematoma, Syncope, Tilt table test
Clinical narrative: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon 6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse.  DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia. DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray limb
Clinical narrative: Dizziness, syncope, headaches, blurred vision, constipation, insomnia, racing heart, chest pain 12/06 to present. Treatment: Florinef, Midrodone, Mestinon 6/7/07-records received from facility for DOS 5/10-5/15/07-Impression:orthostatic intolerance. EEG, somewhat disorganized occipital dominant rhythm. CT head unremarkable. CBC WNL. Echocardiogram normal. Tilt table test with electrophysiologic study no orthostatic hypotension with head-up tile but a prominent tachycardia. Apparent stimulation of A-V nodal pathway showed no evidence of an A-V nodal re-entrant tachycarida. HX of recurrent syncope. Onset of occasional chest pain and a fleeting sensation of palpitations. Without any other symptoms until January of this year. C/O being dizzy a lot. PE WNL except for some palmar hyperhidrosis. 6/20/07-record received fro DOS 1/9-5/29/07. One year history of significant recurrent arrhythmia with heart pounding especially when laying flat or bending forward. No syncope during exercise. Possible mitral valve prolapse.  DC DX: from 1/9-1/11/07-Orthostatic paroxysmal tachycardia. DC DX for DOS 3/15-3/20/07-Postural orthostatic tachycardia syndrome. Recurrent syncope. Orthostatic hypotension.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cough, Rash, Wheezing
Clinical narrative: After receiving DTaP, IPV and HAV, developed a cough, wheezing and facial rash. Responded to epinephrine albuterol aerosol, Zyrtec, Singulair and Prednisone without sequelae has transported to ER (after treatment in office) for reevaluation.  06/14/2007 MR received for ERvisit for c/o coughing and wheezing after immunizations in ped office.  AS they were leaving ped office child began a very hard coughing spell and then began wheezing.  RTO and was given Epi, Zyrtec, Singulair and nebs.  Transported via EMTs to ER. No sx noted by the time they reacher ER. D/C DX:  Reactive Airway Disease/Wheezing.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Chromosome analysis normal, Cognitive disorder, Convulsion, Diarrhoea, Drug level below therapeutic
Clinical narrative: Pediarix given 5/27/04 running high fever first 24 hours after shot. Seizure 5/28/04 temp 101.7 to 102.3 ER diagnosed with febrile seizure. June 9 2004 seizure #2 temp 100 - 101 taken to ER. Seizure #3 July 22 and taken to ER. Seen by Neuro MRI. EEG recommended no further pertussis vaccine started on Phenobarbital.  6/5/07 Received records from PCP which reveal patient seen 7/22/04 s/p seizure & visit to ER that day.  Being w/u for seizure disorder.  Seen again on 7/24 for diarrhea.  Vax records included do not include Lot numbers. Next note is from neuro clnic on 11/15/05.  Noted to have had last seizure on 11/9/05 & was febrile at that time, 103.  Seen in ER that day & d/c on same anticonvulsants but labs revealed subtherapeutic & dosages changed. FINAL DX: symptomatic seizure disorder secondary to pertussis vaccine; s/p febrile seizure status epilepticus; expressive speech delay. 9/28/07 Reviewed hospital medical records of 5/17/2005-8/22/2007 which are outpatient medical records and reveal patient experienced developmental delays esp language delay since 5/2004.  Hx states was in good health on day of vax 5/2004 & developed fever that evening & had seizure.  Had multiple subsequent episodes of status epilepticus usually associated w/fever.  Speech very limited, able to follow commands & drools excessively.  No psychosocial isolation.  Mildly hyperactive.  Multiple dietary concerns, weight below 3rd percentile.  On multiple antiseizure meds.  Motor skills were near age appropriate level.  Below age level on language both auditory & expressive.  Referred for early intervention services. FINAL DX: seizure disorder s/p AE to DTaP; cognitive delay, expressive & receptive language delay; mild adaptive delay; motor skills age appropriate. Epilepsy - Currently on orti-epileptic Tegretol.  Also has developmental delays.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Febrile convulsion, Nuclear magnetic resonance imaging, Personality disorder, Pyrexia, Pyrexia
Clinical narrative: Pediarix given 5/27/04 running high fever first 24 hours after shot. Seizure 5/28/04 temp 101.7 to 102.3 ER diagnosed with febrile seizure. June 9 2004 seizure #2 temp 100 - 101 taken to ER. Seizure #3 July 22 and taken to ER. Seen by Neuro MRI. EEG recommended no further pertussis vaccine started on Phenobarbital.  6/5/07 Received records from PCP which reveal patient seen 7/22/04 s/p seizure & visit to ER that day.  Being w/u for seizure disorder.  Seen again on 7/24 for diarrhea.  Vax records included do not include Lot numbers. Next note is from neuro clnic on 11/15/05.  Noted to have had last seizure on 11/9/05 & was febrile at that time, 103.  Seen in ER that day & d/c on same anticonvulsants but labs revealed subtherapeutic & dosages changed. FINAL DX: symptomatic seizure disorder secondary to pertussis vaccine; s/p febrile seizure status epilepticus; expressive speech delay. 9/28/07 Reviewed hospital medical records of 5/17/2005-8/22/2007 which are outpatient medical records and reveal patient experienced developmental delays esp language delay since 5/2004.  Hx states was in good health on day of vax 5/2004 & developed fever that evening & had seizure.  Had multiple subsequent episodes of status epilepticus usually associated w/fever.  Speech very limited, able to follow commands & drools excessively.  No psychosocial isolation.  Mildly hyperactive.  Multiple dietary concerns, weight below 3rd percentile.  On multiple antiseizure meds.  Motor skills were near age appropriate level.  Below age level on language both auditory & expressive.  Referred for early intervention services. FINAL DX: seizure disorder s/p AE to DTaP; cognitive delay, expressive & receptive language delay; mild adaptive delay; motor skills age appropriate. Epilepsy - Currently on orti-epileptic Tegretol.  Also has developmental delays.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Speech disorder developmental, Thyroid function test normal
Clinical narrative: Pediarix given 5/27/04 running high fever first 24 hours after shot. Seizure 5/28/04 temp 101.7 to 102.3 ER diagnosed with febrile seizure. June 9 2004 seizure #2 temp 100 - 101 taken to ER. Seizure #3 July 22 and taken to ER. Seen by Neuro MRI. EEG recommended no further pertussis vaccine started on Phenobarbital.  6/5/07 Received records from PCP which reveal patient seen 7/22/04 s/p seizure & visit to ER that day.  Being w/u for seizure disorder.  Seen again on 7/24 for diarrhea.  Vax records included do not include Lot numbers. Next note is from neuro clnic on 11/15/05.  Noted to have had last seizure on 11/9/05 & was febrile at that time, 103.  Seen in ER that day & d/c on same anticonvulsants but labs revealed subtherapeutic & dosages changed. FINAL DX: symptomatic seizure disorder secondary to pertussis vaccine; s/p febrile seizure status epilepticus; expressive speech delay. 9/28/07 Reviewed hospital medical records of 5/17/2005-8/22/2007 which are outpatient medical records and reveal patient experienced developmental delays esp language delay since 5/2004.  Hx states was in good health on day of vax 5/2004 & developed fever that evening & had seizure.  Had multiple subsequent episodes of status epilepticus usually associated w/fever.  Speech very limited, able to follow commands & drools excessively.  No psychosocial isolation.  Mildly hyperactive.  Multiple dietary concerns, weight below 3rd percentile.  On multiple antiseizure meds.  Motor skills were near age appropriate level.  Below age level on language both auditory & expressive.  Referred for early intervention services. FINAL DX: seizure disorder s/p AE to DTaP; cognitive delay, expressive & receptive language delay; mild adaptive delay; motor skills age appropriate. Epilepsy - Currently on orti-epileptic Tegretol.  Also has developmental delays.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Full blood count, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Occult blood positive
Clinical narrative: Blood in Stools-Pt was seen in ER to R/O Intussusception.  5/22/07 Received hospital medical records which reveal patient experienced blood in stool & was seen in ER on 5/7/07.  Based on CBC, given 1 dose IV antibiotics after cultures & d/c to home.  Admitted to hospital 5/12-5/15/07 for  + cultures.  Remained afebrile & playful but w/sporadic bloody stools for approx 1 wk.  Started on IV antibiotics.  GI consult obtained which revealed dx: cow's milk protein sensitivity. FINAL DX: Bacteremia, melena, anemia, sickle cell trait. 5/25/07 Received medical records from PCP but no vax records included.  T/C to PCP to request same.  No new info in PCP records, patient had mild nasal congestion & GERD otherwise healthy & developing well.  6/19/07 Received vax record from PCP which provided RO lot & dose #.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Blood lead, Haematocrit, Haemoglobin, Rash generalised
Clinical narrative: 2 hours after giving MMRV patient broke out in rash entire body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Urticaria
Clinical narrative: Patient developed a site of injection inflammation which is red, hot to touch and welt approx 2 inches in diameter she reported initiate SX on 5/16/07, and still has SZ even after 7 days.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Injection site reaction, Rash vesicular
Clinical narrative: Rash at injection site - chickpox like bumps at injections site two weeks after vaccinated.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin burning sensation, Swelling
Clinical narrative: Red and swollen 3-4 in in diameter itching burning. Applying ice.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Dehydration, Diarrhoea, Ultrasound abdomen normal, Vomiting
Clinical narrative: Vomiting, diarrhea, dehydration requiring IV fluids and follow up Doctor visits.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccines 5/16/07. Received Pediarix LT deltoid on 5/16/07. Client returned to clinic 5/18/07 - Had swollen left upper arm, Warmth to touch, intact skin, had induration irregular oval 4 3/8" x 3 24". Circumference L upper arm 7 3/4". Slightly pinker then rest of skin. Child active and alert.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Started 5/9/07 redness and hot to touch to LT arm. Swelling and redness from shoulder to 1" above elbow hurts to lift arm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Otitis media
Clinical narrative: Left arm redness (about 7cm diameter) and itching at site of injection, no induration, swelling, or warmth. Child taking amox since 4/30/07 for B/L otitis media.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 5/8/07 17:17 6CM x 6CM induration at L inferior deltoid injection site. No fever, Benadryl 1tsp PO Q6 hrs PRN swelling. Ice Q20 min on/off PRN pain and swelling
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Erythema, Headache, Induration, Musculoskeletal discomfort
Clinical narrative: 3CM induration with erythema and warm to touch. Also c/o headache, chest and neck discomfort
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: 3CM induration with erythema and warm to touch. Also c/o headache, chest and neck discomfort
Age: 1.2
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 103 5/10 - 5/11
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Child received Gardasil - within 3-4 minutes stated "I don't feel good" - within 7-8 minutes after injection, child fainted to the floor. Child woke right away.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Pharyngitis
Clinical narrative: Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Inappropriate schedule of drug administration, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: RN received call from school nurse, stating that client was in her office with a rash on the outer aspect of her B/L arms. Rash raised sl, not fluid filled, and itchy. RN called clients mother. Rash was noted 4/27/07 in arm, itchy and raised only located on B/L arms. Child did not see MD. Rash is now subsiding. Mother instructed to take child to MD if rash worsens.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Pt received Gardasil HPV vaccine #1 on 4/4/07. On 4/6/07 pt awoke with raised welts (hives) on arms, Right leg, and had swelling of the toes (bilateral). This lasted for 1 week.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Irritability
Clinical narrative: Extreme irritability and Injs and refused to eat mom instructed to give Tylenol 9.5hrs, ice bags to injection sites, To go to ER in 3hrs if not resolved.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Swollen R arm from shoulder to elbow, mildly pink, not warm or tender given Advil and Benadryl
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Weight decreased
Clinical narrative: fogginess of head, dizziness weight loss
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Pt felt dizzy and faint. She laid down and was given soda.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Rotator cuff syndrome
Clinical narrative: Injection was given a little high - diagnosis - poked rotator cuff
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema, Hypersensitivity, Irritability, Respiration abnormal, Urticaria
Clinical narrative: Mom states approximately 2 hours after receiving vaccines infant experienced "Allergic Reaction" including welts over entire body, no fever, respirations noted as being "off" for approx 1 min about 3-4 times PMD called - infant given Benadryl with relief of symptoms "a little cranky" today. Slight redness on body no welts eating well.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Brief febrile seizure with temp of 102 about 12 min after shots
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Medication error
Clinical narrative: Rotavirus series started after 12 weeks of age. Child received 2 doses of Polio vaccine. One in Pediarix and one as a single dose of Ipol. Mother reports child had no ill effects or adverse reaction to immunizations.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient noticed red bumps around injection site on 5/13/07. The patient is not sure how long the bumps had been there. She received the injection on 5/10/07. Had injection Left deltoid.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient noticed red bumps around injection site on 5/13/07. The patient is not sure how long the bumps had been there. She received the injection on 5/10/07. Had injection Left deltoid.
Age: 31.0
Sex: F
Vaccine: MEN, TDAP, TYP
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Injection site pain, Pericarditis
Clinical narrative: Left pleuritic chest pain starting 48 hours after immunizations with peak pain approx 60-72 hours after immunizations. EKG normal. CXR normal. Suspected pericorditis vs pleurisy. Treatment w/NSAIDS. Also significant muscle pain at injection site left deltoid 2-60 minutes after injection. No fever. No muscle swelling.
Age: 31.0
Sex: F
Vaccine: MEN, TDAP, TYP
Symptoms: Pleurisy, Pleuritic pain
Clinical narrative: Left pleuritic chest pain starting 48 hours after immunizations with peak pain approx 60-72 hours after immunizations. EKG normal. CXR normal. Suspected pericorditis vs pleurisy. Treatment w/NSAIDS. Also significant muscle pain at injection site left deltoid 2-60 minutes after injection. No fever. No muscle swelling.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Lymph node pain, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Patient received vaccine on 5-8-07. 5-09-07 normal slight of sore arm muscle. 5/10/07 gland in Left armpit and left neck swelled and became painful. Glands continue to be swollen and painful-armpit>neck. Patient reports very painful to lift left arm above head. No fever. Advised to see primary provider, today.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Induration, Myalgia, Oedema peripheral
Clinical narrative: erythema, induration, myalgias, edema of extremities
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: 5-3-07 - Received Adacel vaccine. 5-4-07 - pm right arm swollen, sore, tender to touch. 5-5-07 Right side of neck and right arm very sore with limited ROM.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Skin warm, Swelling, Tenderness
Clinical narrative: Arm became very tender and Swollen and warm to touch x 6 days muscle strength reduced x 2-3 days
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling, Ultrasound scan normal
Clinical narrative: 1-24-07 arm pain 3-15-07 c/o pain an swelling, hot, red, swelling
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: 1-24-07 arm pain 3-15-07 c/o pain an swelling, hot, red, swelling
Age: 1.1
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC
Symptoms: Scar
Clinical narrative: 5mm diameter scar on R mid - thigh
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Cellulitis, Erythema, Induration, Pyrexia, Skin warm
Clinical narrative: 12 hours after immunization swelling 24 hours after swelling redness, fever and hot to touch. 5/11/07 1000 AM 4.5 x 5 inches induration no D/C. Suspect cellulitis - Antibiotics begun.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Swelling
Clinical narrative: 12 hours after immunization swelling 24 hours after swelling redness, fever and hot to touch. 5/11/07 1000 AM 4.5 x 5 inches induration no D/C. Suspect cellulitis - Antibiotics begun.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Vaccines admin in an office at 945Am. FOC took child to school at 1035 school called pt B eyes were red and swollen - Benadryl was given to pt and swelling was subsided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pruritus, Swelling
Clinical narrative: Redness, extreme swelling, over back of upper arm, itching, malaise started 24 hours after vaccination lasting four days.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count, Myalgia, Rheumatoid factor negative
Clinical narrative: Myalgia, diffuse arthralgia
Age: 14.0
Sex: U
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 5/11/07 Received Varivax booster RA. On 5/12/07 woke up with small red, tender area at shot site. On 5/13/07 area 7-8 inches in diameter, very tender, raised red, areas. 5/14/07 area of redness decreased. Now erythema 2 inch diameter. Ice and Benadryl advised.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling right deltoid region after 1 day.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Right arm swollen - black and blue
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Nausea, Pyrexia, Rash macular
Clinical narrative: Tdap - local red area right deltoid and blotchy also nausea, fever.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Soreness at injection site 4 x 6cm erythema, fever, headache, nausea.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Rash
Clinical narrative: After patient received injection she began feeling dizzy sat for approximately 10 minutes felt fine and went home. Later developed rash on knees and legs. Mom gave her Benadryl and resolved. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a nurse practioner, concerning a 17 year old white female who on 10-May-2007 was vaccinated IM, with the first dose GARDASIL. Following the vaccination, the patient felt dirty while still in the physician's office, she sat down for 10 minutes and was fine. Later that day, 10-May-2007, she developed a rash on her legs; treament with BENADRYL brought relief of the rash "off and on" at different locations. At the time of this report, the outcome of the rash was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: After patient received injection she began feeling dizzy sat for approximately 10 minutes felt fine and went home. Later developed rash on knees and legs. Mom gave her Benadryl and resolved. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a nurse practioner, concerning a 17 year old white female who on 10-May-2007 was vaccinated IM, with the first dose GARDASIL. Following the vaccination, the patient felt dirty while still in the physician's office, she sat down for 10 minutes and was fine. Later that day, 10-May-2007, she developed a rash on her legs; treament with BENADRYL brought relief of the rash "off and on" at different locations. At the time of this report, the outcome of the rash was unknown. Additional information is not expected.
Sex: U
Vaccine: HEPA, HIBV, MMRV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever to 103.2, vomiting, loose stool
Age: 37.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia
Clinical narrative: Joint pain
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Noticed within 24 hours of injection itchy rash - joints - armpit - elbows - knees - ankles - stomach.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Patellofemoral pain syndrome
Clinical narrative: Pain in both knees was minor with the first dose and got worse with the second dose. Patient given 500mg Naproxen BOD, ice bilateral. Dx: Patellofemoral pain syndrome.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Full blood count, Headache, Malaise, Myalgia
Clinical narrative: Malaise, Myalgia, fever, fatigue, headache, nausea
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Pyrexia
Clinical narrative: Malaise, Myalgia, fever, fatigue, headache, nausea
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 4 x 5 cm hot red tender area on left thigh 3 days post vaccine
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Sinus congestion, Sinus operation, Skin warm
Clinical narrative: Reddened area approx 6" x 5", slightly warm. Sinus congestion, drainage approx 32 hours after injection Tylenol/Advil as needed Augmentin 250mg (Tid x 10D)
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site oedema, Pruritus, Respiratory disorder
Clinical narrative: + Edema, erythema to LD (site of injection) post 24 hours after vaccination with Resp sx. 5/19/07 + purplish hue to site with increased edema extending pass L elbow, mom worried, seen at ER. Tx with Benadryl PO Q PM increasing itching.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Gastrointestinal haemorrhage, Haematochezia, Occult blood negative, Parasite stool test negative
Clinical narrative: One episode of hematochezia 3 days after receiving 4 month-old immunizations, including 2nd Rotateq. 2nd Pediarix, 2nd Prevnar, and 2nd Hib vaccine. Stool culture and parasites negative. No recurrence of GI bleeding. Stool guaiac neg on exam
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Haematochezia, Rectal examination
Clinical narrative: One episode of hematochezia 3 days after receiving 4 month-old immunizations, including 2nd Rotateq. 2nd Pediarix, 2nd Prevnar, and 2nd Hib vaccine. Stool culture and parasites negative. No recurrence of GI bleeding. Stool guaiac neg on exam
Age: 58.0
Sex: F
Vaccine: JEV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Paraesthesia oral
Clinical narrative: 5/16 Red swollen at injection site and tingling lips, pain and warmth at injection site.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Mild chickenpox illness <50 spots. No fever. Resolved in 3-4 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count, Oedema peripheral
Clinical narrative: Swollen R upper arm with in 24 hrs.
Age: 2.42
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Swelling, Urticaria
Clinical narrative: Hives and swelling migrating/reoccurring at different body sites over 2 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Skin nodule
Clinical narrative: Here for Synagis injection mother called my attention to lumps in both legs about 2 mm knot in each leg palpated. No redness or tenderness. No fever, consoles easily.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Pain in extremity
Clinical narrative: 05/08 evening pt complained of pain L arm with small area of erythema. 05/09 evening L upper arm more painful, larger area of redness, continued to increase in size and pain level increase 5/10. Pt has been afebrile, no signs of anaphylaxis. L upper arm in clinic with 20cm x 20cm area of erythema, induration, encompassing approx 2/3 circumference of upper arm. 1cm x 1cm well demarcated patch of increased erythema at injection site. Treated to cover both allergy and infection. Received Benadryl and IgM IV Ancef in clinic.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Blepharospasm, Ear pain, Headache, Muscle spasms, Myalgia
Clinical narrative: (R) eye twitch, blurring of vision (b); (L) headache; (L) ear ache. (L) leg muscle ache. (B) calf cramps; feeling of lump in Throat
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Sensation of foreign body, Vision blurred
Clinical narrative: (R) eye twitch, blurring of vision (b); (L) headache; (L) ear ache. (L) leg muscle ache. (B) calf cramps; feeling of lump in Throat
Age: 58.0
Sex: U
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella
Clinical narrative: Pt reports she has never had chicken Pox - titer - neg. Pt given vaccine 3/29/07. Pt broke out with 15-20 chicken pox lesion 4-15-07. Lesions on 4/27/07 scabbed over
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: Patient received Hep A vaccination on 5-11-07, not red swelling starting 5-12-07 gradually increased swelling to 6 cm Diameter-injection site below Deltoid (L) upper Arm
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: L arm slightly red, warm to the touch, measured 25 mm x 20 mm. Returned 5-11-07 for recheck very little redness, no swelling no warm to touch.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Lip swelling, Wheezing
Clinical narrative: Lip swelling, cough, wheezing
Age: 70.0
Sex: U
Vaccine: DTOX, HEPA, TTOX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Approximately 4 days after the Hepatitis A shot my left arm started to itch where th shot was given. I started rubbing it and it became very itchy and red. Inj doctor said to use ice on it 24 hrs, and take an Ibuprofen it was cleared up.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: GM brought pt to HB Pt R arm is swollen and firm about 1 1/2 inch around shot site, Area is red. GM said pt said it itches. First her to cont Tylenol or Motrin every 4-6 HR today and tomorrow and apply cool cloth to area.
Age: 0.42
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: 2 weeks after 2nd dose of Rotateq administered-2 episodes of bloody stools.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Pt received Dtap vaccine (R) arm 5/11/07 should have been given tdap. Pt seen in clinic today 0930 with localized redness and swelling (65cm x 70cm) at injection site. No anaphylaxis reported or noted. Pt instructed to take Ibuprofen Q 4 hours x 24 hours 2x day. and alternate ice packs with warm packs until redness/swelling subside.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Full blood count, Injection site rash, Pain
Clinical narrative: 3 days after receiving Td arm rash from deltoid area to antecubical area. Painful red area, warm to touch. Treated for cellulitis with Levaquin, and Prednisone no fever.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Skin warm
Clinical narrative: 3 days after receiving Td arm rash from deltoid area to antecubical area. Painful red area, warm to touch. Treated for cellulitis with Levaquin, and Prednisone no fever.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Dry eye, Erythema, Ocular hyperaemia, Pain, Pain in extremity
Clinical narrative: Sunday Day 3 - Complain of severe pain - 1:00 pm shoulder to elbow bright red, hot to touch, very hard + swollen. 4:30p worse- now eyes are red - very frigitty. Called then patients doctor 10:30pm was told to give him Benadryl every 4 hours and Zyrtec  every 4 hours if any worse take to ER. Had clusters of red rash all over his back. Day 4 - 6:30am bright red slightly less - continued with Benadryl and Zyrtec stayed same. Day 5 - Redness fading - swelling not eyes still Red and dry. Day 6 - severe itching arm and eyes, leg pains, runny nose. Day 7 - just starting to sleep all night again. Shoulder has red streaks - nut hardness and hot to touch starting to lessen and yes still itch - but not red. Day 8 and Day 9 Benadryl and Zyrtec stopped to see if reaction would come back or still subside. Day 10 - much better layed around most of weekend.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Pruritus, Rash, Rhinorrhoea, Skin warm, Swelling
Clinical narrative: Sunday Day 3 - Complain of severe pain - 1:00 pm shoulder to elbow bright red, hot to touch, very hard + swollen. 4:30p worse- now eyes are red - very frigitty. Called then patients doctor 10:30pm was told to give him Benadryl every 4 hours and Zyrtec  every 4 hours if any worse take to ER. Had clusters of red rash all over his back. Day 4 - 6:30am bright red slightly less - continued with Benadryl and Zyrtec stayed same. Day 5 - Redness fading - swelling not eyes still Red and dry. Day 6 - severe itching arm and eyes, leg pains, runny nose. Day 7 - just starting to sleep all night again. Shoulder has red streaks - nut hardness and hot to touch starting to lessen and yes still itch - but not red. Day 8 and Day 9 Benadryl and Zyrtec stopped to see if reaction would come back or still subside. Day 10 - much better layed around most of weekend.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: One day after receiving tetanus/diphtheria adult booster, developed fever and flu like symptoms.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Rec'd Varivax and Prevnar 4/2/07 in R thigh woke up week later with red, swelling. Seen in office 4/12/07 and diagnosed with cellulitis 20 immunizations.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash papular, Rash pruritic, Varicella
Clinical narrative: Pt was exposed to chicken Pox and had a mild, papular, pruritic rash.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased activity, Decreased appetite, Erythema, Eye swelling, Flushing
Clinical narrative: Mother calls to report child with 4/28/07 onset of flushed (red/ hot/ face/ neck, facial eye swelling ("like when you get up in the morning with eyes narrowed secondary to swelling). No fever (T= 97.6), gagged/emesis with H2O today only. No respiratory/breathing problems, decrease appetite (sl), sl decrease activity level. Has appointment to see PCP (Doctor got pet turtle4/18/07 today).
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pharyngitis streptococcal, Retching, Scarlet fever, Skin warm, Swelling face
Clinical narrative: Mother calls to report child with 4/28/07 onset of flushed (red/ hot/ face/ neck, facial eye swelling ("like when you get up in the morning with eyes narrowed secondary to swelling). No fever (T= 97.6), gagged/emesis with H2O today only. No respiratory/breathing problems, decrease appetite (sl), sl decrease activity level. Has appointment to see PCP (Doctor got pet turtle4/18/07 today).
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: Mother calls to report child with 4/28/07 onset of flushed (red/ hot/ face/ neck, facial eye swelling ("like when you get up in the morning with eyes narrowed secondary to swelling). No fever (T= 97.6), gagged/emesis with H2O today only. No respiratory/breathing problems, decrease appetite (sl), sl decrease activity level. Has appointment to see PCP (Doctor got pet turtle4/18/07 today).
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Lymphadenopathy
Clinical narrative: Erythematous indurated reaction 13 X 12cm with adjacent lymphadenopathy.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, White blood cell count normal
Clinical narrative: Redness, swelling pain at injection site which extended down to elbow. Seen in ER 5/13 and then admitted 5/15/07 with diagnosis of cellulitis. Discharged 5/10/07 to home.  05/31/2007 MR received for a 1 day admission for cellulitis of the L upper arm at the site of her Pneumovax which was increasing, despite po abx.  Pt/ c/o redness pain, and swellingx 2 days. Placed on po Zithromax, but redness and swelling were increasing.  Txd with IV abx. Discharge DX: Cellulits after recent Pneumovax in the L arm.  Hypertension. Anxiety.  Gastroenteritis-now resolved.  Hx. of Helicobactor pylori (+) antibody.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blood culture, Cellulitis, Erythema, Full blood count, Oedema peripheral
Clinical narrative: Right upper arm swollen with skin redness at immunization site - cellulitis tx with Keflex 250mg/5ml suspension. 1 Tsp PO q hours.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Mother brought pt in for PPD read with complaints of redness, swelling and fever at site of left deltoid. Pt has full ROM without complaint of joint stiffness. Pt evaluated by RN. Doctor appt sch  for 5/18/07.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injection site irritation, Injection site pain, Nausea
Clinical narrative: C/O Burning and soreness at injection site. Also, nausea since the day of the shot.
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a third dose of Rotateq. Subsequently the patient developed intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Blood potassium decreased, Blood potassium normal, Blood sodium decreased
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a third dose of Rotateq. Subsequently the patient developed intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Carbon dioxide decreased, Culture stool negative, Culture urine negative, Dehydration, Intussusception
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a third dose of Rotateq. Subsequently the patient developed intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Lethargy, Occult blood positive, Oral intake reduced, Otitis media, Urinary system X-ray
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a third dose of Rotateq. Subsequently the patient developed intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a third dose of Rotateq. Subsequently the patient developed intussusception and was hospitalized. Subsequently, the patient recovered from intussusception. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Child received Menactra Hep A in right deltoid on 5/20.07. The next day developed a rash and swelling at the injection site. No temp.
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Head injury, Loss of consciousness
Clinical narrative: Information has been received from the physician's office manager concerning a female who in January 2007, was vaccinated with her first dose of Gardasil. In January 2007, after the patient was vaccinated, she walked to the front of the office and "passed out and hit her head on the floor". The patient was taken by ambulance to the hospital where she was admitted with a possible concussion. The patient outcome was not reported. The reporting office manager considered the event to be an other important medical event. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who had a biopsy on 08-MAY-2007 (reason not reported) and was also vaccinated with Gardasil at 8:00 pm. Concomitant therapy included ethinyl estradiol (+) norethindrone acetate (LOESTRIN). On 09-MAY-2007 the patient became paralyzed from the neck down while at school and was taken to the emergency room by ambulance. Upon internal review, paralyzed from the neck down was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: Information has been received from a health professional concerning a 23 year old black/white female receptionist with asthma (diagnosed at the age of 5 year old) and outdoor allergies who on 19-APR-2007 at 01:15 (AM or PM not reported) was vaccinated IM in left arm deltoid with a first dose of Gardasil lot #655849/0263U. Concomitant therapy included montelukast sodium (MSD) loratadine (+) pseudoephedrine sulfate (LORATIDINE D) and albuterol sulfate (VENTOLINE (albuterol sulfate)). On 20-APR-2007, Friday night at 11:00 PM patient woke up with short of breath. Her rescue inhaler did not help so she used her nebulizer. On 21-APR-2007 she used her nebulizer again around 6:30 AM and through out that day 4 to 6x. On 22-APR-2007, Sunday she did 6 nebulizer treatment within one-two hours before being admitted at the hospital. In the hospital she had additional nebulizer treatment (10+) times and steroid injections. Patient stated that this was her worst asthma attack since being diagnosed. Patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Ultrasound abdomen
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for Gardasil, concerning a 26 year old female with a drug reaction/allergy to Wellbutrin, factor v laiden mutation/clotting disorder, prothrombin mutation, bipolar disorder, seizure disorder and Mthfr and a history of pulmonary embolism and multiple deep vein thrombosis and herpes virus infection who on 13-SEP-2006 was vaccinated with her first Gardasil 0.5 ml IM (lot # 653735/0688F). Concomitant therapy included Coumadin, Topamax and clonazepam. The nurse stated that the patient was very non-complaint and never returned for the second or third dose of the vaccine. On 16-APR-2007, the patient was found to be pregnant which was confirmed by ultrasound and a pregnancy test. The patient's last menstrual period, gestational age or due date were not reported. On 11-MAY-2007 the patient experienced spontaneous miscarriage which was confirmed by ultrasound. The patient sought unspecified medical attention. The patient was not hospitalized. Upon internal review, spontaneous miscarriage was determined to be an other important medical event. Additional information has been requested.