chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose fluctuation, Burning sensation, Chest discomfort, Diarrhoea, Disorientation
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Insomnia, Migraine, Myalgia, Nausea
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats, Road traffic accident, Syncope
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Alopecia, Anxiety, Appetite disorder, Asthenia
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Blood glucose fluctuation, Blood iron, Blood test, Burning sensation
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest discomfort, Constipation, Convulsion, Depression, Dizziness
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Echocardiogram, Food allergy, Human papilloma virus test, Insomnia, Loss of consciousness
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mononucleosis heterophile test, Muscle atrophy, Neurological examination, Night sweats, Pain
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Protein total, Psoriasis, Smear cervix, Thyroxine
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tri-iodothyronine, Vitamin B12, Vulvovaginal pruritus
Clinical narrative: Information has been received from a consumer concerning her approximately 16 year old daughter with penicillin allergy and sulfonamide allergy who on 30-JUL-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The first adverse experiences were nausea, diarrhea and headache which started on 31-JUL-2008, the day after she received the vaccine. The patient then began to experience insomnia, night sweats, heaviness in her chest, burning and aching in her muscle, extreme fatigue and migraines. The patient then began to experience unexplained fluctuations in her blood sugar levels and she was disoriented. It was noted that the patient fainted approximately two weeks after she received the vaccine. It was also noted that the patient was in a car accident on an unspecified date after she received GARDASIL. Medical attention was sought. At the time of the report, the patient had not recovered. The patient experience was reported as disabling. Additional information has been requested.  9/19/08 Reviewed PCP medical records of 7/30/08-9/4/08. FINAL DX: none provided Records reveal patient experienced malaise, extreme fatigue, insomnia, HA on 8/13.  Had prior episodes of same w/extensive testing.  Had near syncope on 8/13 & seen in ER.  Neuro consult done 9/4 & WNL.   1/19/09 Reviewed PCP medical records of 10/6-10/28/2008. FINAL DX: vaginal irritation, acne, dermatitis around nose & eyes, food allergies Records reveal patient experienced vulvar itch/burn, skin breakouts on face.  Missed several days of school.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Antibody test positive, Arthralgia, Fibula fracture, Laboratory test abnormal, Peripheral coldness
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Raynaud's phenomenon, Systemic lupus erythematosus
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Hypoaesthesia, Peripheral coldness, Raynaud's phenomenon
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Bone pain, Fatigue, Hypoaesthesia, Raynaud's phenomenon, Rheumatoid arthritis
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Skin discolouration, Systemic lupus erythematosus
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U).  Concomitant therapy included MENACTRA.  In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists.  The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud's lupus.  Smith antigen antibodies test indicated positive. SM/RNP antibody was positive.  The patient's Raynaud's lupus persisted.  No product quality complaint was involved.  Raynaud's lupus was considered to be disabling due to numbness and joint pain.  Additional information has been requested.  10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP.  Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement.   9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination.  RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before.  Also complaining of numbness of hands.  Exam revealed tender lymph nodes, reddened throat.  Dx w/viral illness.  RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA.  Boyfriend had mono.  RTC 12/21 for final HPV.  C/O spotting few days prior to menses for past several cycles.  RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms.  Dx w/probably Raynaud's.  RTC 2/25 for hands turning purple when cold then white & painful.  When warm, hands get red, sweaty & swollen.  Also c/o facial acne.  RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose.  Dx w/pharyngitis, probably viral.  RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive.  Dx w/probable connective tissue/autoimmune disorder.  Encouraged to d/c oral contraceptiives & switch to IUD.  Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.
Age: 20.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Erythema, Pruritus, Rash generalised, Rash papular, Urticaria
Clinical narrative: Onset of rash on trunk; gradually spreading to full body (including face); red, raised, whelpy with complaint of itching, generalized.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Convulsion, Fatigue, Feeling hot, Hypotonia
Clinical narrative: Information has been received from a physician and a medical assistant, concerning a 12 year old female who on 30-NOV-2006 was vaccinated with the first dose of GARDASIL (lot # 653735/0688F). On 10-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (657736/0389U). On 19-AUG-2008, the patient was vaccinated with the third dose of GARDASIL (lot # 660612/0229X) and had a seizure. The patient went to the car with her mother after the vaccination and complained of feeling hot and tired. The patient slumped over and had a generalized shaking that lasted 5 seconds. The patient was being monitored in the office at the time of the call. the patient did not have any problems with the first and second dose of GARDASIL. Laboratory data included glucose test reading 81. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a physician and a medical assistant, concerning a 12 year old female who on 30-NOV-2006 was vaccinated with the first dose of GARDASIL (lot # 653735/0688F). On 10-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (657736/0389U). On 19-AUG-2008, the patient was vaccinated with the third dose of GARDASIL (lot # 660612/0229X) and had a seizure. The patient went to the car with her mother after the vaccination and complained of feeling hot and tired. The patient slumped over and had a generalized shaking that lasted 5 seconds. The patient was being monitored in the office at the time of the call. the patient did not have any problems with the first and second dose of GARDASIL. Laboratory data included glucose test reading 81. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Epstein-Barr virus infection, Facial palsy, Headache, Pyrexia, VIIth nerve paralysis
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 13-MAR-2008 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included MENACTRA.  On 09-APR-2008, the patient experienced back pain, fever and headache.  The patient was given Z-PAK.  On 14-APR-2008, the patient presented at the office with complete facial paralysis and was admitted to the hospital.  On 18-APR-2008, the patient was discharged.  A neurologist in the hospital diagnosed her with possible Guillain-Barre and bilateral 7th cranial nerve palsy.  On 24-APR-2008, the patient was seen by a physician and her adverse events were resolving but not complete.  On 15-MAY-2008, the neurologist felt her symptoms were resolving and possibly not related to Guillain-Barre or GARDASIL.  The neurologist diagnosed her as having Epstein-Barr meningitis.  Back pain, fever, headache, facial paralysis and Epstein-Barr meningitis were considered to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  10/3/08 Reviewed neuro medical records of 5/15/2008. FINAL DX: Epstein Barr viral meningitis with montherapy multiplex Records reveal patient experienced HA x 2 weeks in 4/2008.  Developed shoulder pain, LBP, sleep disturbance & fever.  Seen in ER, dx w/throat lesion & tx w/antibiotics.  No response to antibiotic therapy although throat lesion did improve.  Developed severe pain, facial weakness, tingling in fingertips.  Hospitalized & brain MRI revealed inflammation of VII crainal nerve bilaterally.  LP showed WBC (H), protein (H) & marginal glucose indicating viral meningitis.  EBV IgM (H).  Neuro exam on 5/15/08 revealed right facial weakness w/depressed UE reflexes.  10/31/08 Reviewed hospital medical records of 4/14-4/18/2008. FINAL DX: bilateral 7th cranial nerve palsy, possible variant of GBS triggered by acute Epstein-Barr infection. Records reveal patient experienced HA, muscle aches, fevers, strep throat, mono x approx 2 wks.  Developed facial paralysis 3 days prior to admit.  Exam revealed cervical & submandibular lymphadenopathy w/peritonsillar erythema.  Unable to close eyes completely, could not wrinkle forehead, smile or frown.  Right patella areflexia.  Neuro consult done.  Tx w/IVIG.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a consumer concerning her daughter who on a date not reported was vaccinated with GARDASIL.  Subsequently the patient was temporarily paralyzed.  Upon internal review paralysis was consider to be an other important medical event.  It was unknown if the patient sought medical attention.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from an office manager concerning an 18 year old female who on 05-AUG-2008 was vaccinated with a second dose of GARDASIL (route and administration site not reported).  Immediately post the vaccination the patient fainted and had convulsions and seizures which lasted for approximately 1 minute.  Subsequently, the patient recovered from seizures and faint.  The adverse events happened in the office.  Upon internal review the seizure was considered to be an other important medical event.  Additional information has been requested.  This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse events.  HPV #3 given to early.  No event/misadministration.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Cold sweat, Nausea
Clinical narrative: Patient here for TDAP, after injection patient began to have decreasing B/P, clammy skin, and complained of nausea. Continued to have decreasing B/P while sitting or standing only. EMS called patient transported to ER.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Client here for immunization to "catch up" series for immigration purposes. Nurse gave client a second TDaP instead of the needed "TD". 1 misadministration (No event)
Age: 23.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose given to an adult - Hepatitis A; No event misadministration
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of hepatitis A given to an adult. No event-misadministration. No adverse event.  Misadministration of vaccine.  Pediatric vaccine given to adult.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: TDAP given IM LD and VZV SQ LA 6-30-08. 7-2-08 child returned to clinic with large, red, swollen area noted on LD and LA at injection site. Complained of "burning and itching." Mom states onset started 7-1-08. Instructed mom to con't Ibuprofen and Benadryl - po if no allergies and to apply cool compress. Instructed to see  MD.
Age: 21.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No adverse event problem occurred. Nurse administered pediatric dose to adult patient. Explained to patient, consulted with immunization coordinator & nurse manager. District permission received to immunize patient with adult dose. Nurse administered adult dose to patient with no symptoms of adverse event.
Age: 9.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pruritus
Clinical narrative: At 4:15pm, right deltoid used for DTAP injection, severe itching after administration, down to just past elbow.  No rash, no sob, no whelping.  Red/pink quarter-sized area at injection site.  Benadryl 25mg PO liquid given, itching stopped per client.
Sex: U
Vaccine: HEP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Information has been received from a physician via another physician concerning a patient (age and gender not reported) with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medications were not reported. Subsequently on an unspecified date, the patient experienced Henoch-Schonlein purpura. No other details about this patient or the event were available. No product quality complaint was involved. Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. No further information is available.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Injection site reaction, Nausea, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female who on 15-AUG-2008 was vaccinated with a dose of PNEUMOVAX, 0.5 milliliters, intramuscularly in the right arm (lot # 659150/1348U or 658673/0990U), the office had two lots of PNEUMOVAX 23, but did not known what lot was administered. On 15-AUG-2008, the night of vaccination, the patient developed an injection site reaction with severe pain in the right arm, "shaking and chilling", dizziness and nausea. There was no swelling or redness at the injection site. The patient called the office on 19-AUG-2008 and reported that the arm was still sore. The reporter considered the events of severe pain in the right arm, "shaking and chilling", dizziness and nausea to be a significant disability of incapacity. At the time of reporting, the patient was recovering. This is one of 7 reported from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female who on 15-AUG-2008 was vaccinated with a dose of PNEUMOVAX, 0.5 milliliters, intramuscularly in the right arm (lot # 659150/1348U or 658673/0990U), the office had two lots of PNEUMOVAX 23, but did not known what lot was administered. On 15-AUG-2008, the night of vaccination, the patient developed an injection site reaction with severe pain in the right arm, "shaking and chilling", dizziness and nausea. There was no swelling or redness at the injection site. The patient called the office on 19-AUG-2008 and reported that the arm was still sore. The reporter considered the events of severe pain in the right arm, "shaking and chilling", dizziness and nausea to be a significant disability of incapacity. At the time of reporting, the patient was recovering. This is one of 7 reported from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of hepatitis A given to an adult. No event-misadministration.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of Hepatitis A given to an adult.  No event misadministration.
Age: 28.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of hepatitis A given to an adult. No event-misadministration
Age: 20.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of Hepatitis A given to an adult.  No event misadministration.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose given TD an adult
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of hepatitis A given to an adult. No event-misadministration
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose given to an adult.  No event misadministration.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose given to an adult; No event; Misadministration
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of hepatitis A given to an adult.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child's dose of Hepatitis A given to an adult; No event
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child dosage given to an adult.  No event-misadministration
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: States his arm is still tender where he received the pneumonia shot on 08/14. States within 24 hours his arm swelled up the size of a grapefruit, turned red, warm to touch, and then started to bruise. States he did not see a doctor, but applied ice and if finally was better by the third day. Symptoms: 1. Arm swelling see notes from chart