chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Menorrhagia, Menstrual disorder, Menstruation irregular, Muscle spasms
Clinical narrative: Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Death, Epistaxis, Feeling cold
Clinical narrative: Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Movement disorder
Clinical narrative: Possible seizures (repetitive head turning and possible salaam seizure) occuring Jan 14, 2009 over a 10-15 minute time span. No fever at that time, otherwise not ill at that time. No treatment. Evaluation still in progress (EEG, Peds Neurologic consultation)
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt c/o pain, swelling, redness to right deltoid. No exudate.  Dx: cellulitis
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Full blood count, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Fever developed; Right arm red, swollen, hot from upper deltoid to mid humerus- started KEFLUX & ROCEPLIN 2gm 1mx 3 days -> improvement is WBC, SXS, arm redness & fever
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Fever developed; Right arm red, swollen, hot from upper deltoid to mid humerus- started KEFLUX & ROCEPLIN 2gm 1mx 3 days -> improvement is WBC, SXS, arm redness & fever
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Hypokinesia, Paraesthesia
Clinical narrative: Jan 16 received vaccine (Anthrax) in L arm.  No pain or erythema.  Pt woke up Jan 18 with  inability to left arm and paresthesia over the lateral aspect of the arm. No pain.
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pain in extremity, Sleep disorder
Clinical narrative: Patient reported a lot of pain in left arm and couldn't even sleep on it. The next morning he thought he was blacking out. Left message on patient's answering machine to see how he was doing.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: Within a few hours of shots pt developed low grade fever.  Subsequently the next day got  profuse watery diarrhea (only 1 episode of blood in stool).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Induration, Injection site vesicles, Rash erythematous, Skin warm, Swelling
Clinical narrative: Left upper arm 6 inch by 9 inch erythemous plaque, firm,warm to touch with discrete? clusters of vesicles in center medial, lateral area of left deltoid area. Start AUGMENTIN 40015 6ml BID x 10 day, BENADRYL 12.5mg/5ml 2 tsp of 6hr for swelling.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Site never got swollen or red. Just very painful. Continues to throb, hurts to raise arm up above head after few seconds gets a shooting pain from the injection site to her finger tips.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, No reaction on previous exposure to drug, Pain, Pain in extremity
Clinical narrative: Site never got swollen or red. Just very painful. Continues to throb, hurts to raise arm up above head after few seconds gets a shooting pain from the injection site to her finger tips.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave pediatric dose of HEP A was supposed to give adult dose.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, H5N1, HEP, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Child received PENTACEL, HEP B, PREVNAR, ROTAVIRUS & flu vaccines, instead of PEDIARIX, HIB, PREVNAR, ROTAVIRUS & flu vaccines.  No adverse reaction or treatment necessary.
Age: 0.32
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash
Clinical narrative: Developed red rash around injection site on thigh within hours of vaccines (8 cm X 8 cm in doctors office) man reported prior to arriving @ doctors office left leg was purple from injection site to toes
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, slightly warm to touch, swelling right upper arm approx 8in x5in. Patient applied "anti-itch" cream.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Laboratory test abnormal, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with penicillin and amoxicillin allergy who on 19-JUN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660555/0279X) while she was pregnant. Concomitant therapy included ADDERALL TABLETS and oral hormonal contraceptives (unspecified). Her last menstrual period was 15-MAY-2008 and the expected delivery date was 19-JUN-2008. On 31-JUL-2008 the patient had a fetal ultrasound that showed a 10 week and 5 days gestational age fetus with positive cardiac activity. A pregnancy Ultra-screening test was performed with abnormal results. It showed an increased risk, 1 in 10, of having a baby with Down's syndrome. On an unspecified date, the patient elected to terminate this pregnancy. After the pregnancy was terminated, on 25-NOV-2008 the patient received the second dose of GARDASIL (Lot 661764/0650X). Upon internal review, the elected termination of pregnancy was determined to be another important medical event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner and a certified nurse midwife, for the pregnancy registry for GARDASIL, concerning a 21 year old female with no medical history, no known drug allergies and with no history of previous pregnancies who on 15-FEB-2008 was vaccinated IM with the first 0.5 ml IM dose of GARDASIL (lot # 659962/1740U).  The patient received the second 0.5 ml IM dose on 15-Apr-2008 (lot# 659962/1740U).  There was no concomitant medication.  On 15-APR-2008 the patient had a positive pregnancy test result.  The patient's LMP was 03-Mar-2008 and an estimated delivery date is 08-Dec-2008.  No other symptoms were noted.  Patient sought medical attention via an office visit.  Follow up information has been received from a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient.  In May 2008, the patient was seen due to a miscarriage.  It is not known if the patient had received any prenatal care prior to the miscarriage.  Upon internal review, miscarriage was determined to be an other important medical event.  No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood sodium normal, Blood urea normal, Chest pain, Chills, Cough
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Culture stool negative, Diarrhoea, Dizziness, Eosinophil count normal, Haematocrit normal
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Headache, Lymphadenopathy, Lymphocyte count normal, Malaise
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Neutrophil count, Neutrophil count normal, Oropharyngeal pain, Pallor
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X).  There was no concomitant medication.  "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain.  "One month later", the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia.  The patient had office visits.  "White blood cell differential count and white blood cell count" were normal.  "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC.  At the time of the report, 09-JAN-2009, the patient had not recovered.  Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up.  It was reported that the patient had a sore throat and abdominal pain which persisted one month.  The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week".  There was no blood.  The patient was treated with omeprazole, 2-3 times daily for 3 weeks.  At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough.  Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive.  It was reported that the patient's mother was suspecting that her daughter's "recent medical troubles may be a side effect of GARDASIL".  Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache.  The reporter considered the patient's adverse events to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.  2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam.  ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given.   OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment:  H/A.  Abd pain.  Hyperemesis. ? GER.  ? (unreadable) ? AGE.  Sent for labs.  Letter from parent  1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Frequent bowel movements, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 9 weeks old male who on 10-NOV-2008 was vaccinated oral with the first dose of ROTATEQ (LOT# 661031/0467X). Concomitant therapy included PENTACEL and PREVNAR. Two or three days after receiving ROTATEQ, the patient had a small amount of blood in the stool. The physician reported that the parents contacted him once on 17-NOV-2008 and stated that the patient had about ten bowel movements, but did not state if every bowel movement had blood. The physician reported that the patient was not going to receive the second dose of ROTATEQ. Vaccination with ROTATEQ was discontinued. Subsequently, the patient recovered from adverse events on therapy. It was reported that the patient sought medical attention: contacted the physician. Upon internal review blood in the stool was considered an other important medical event. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Autism, Somnolence
Clinical narrative: Information has been received from a consumer concerning his daughter, a 6 year old female with no medical history who "at 18 months of age" was vaccinated with MMR II, "one dose only". There was no concomitant medication. Subsequently the patient had a bad reaction to it. The patient seemed groggy and sleepy. The patient was also diagnosed with autism. At time of the report the patient was not recovered. The patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Age: 1.7
Sex: M
Vaccine: MMR, PPV
Symptoms: Abnormal behaviour, Autism
Clinical narrative: Information has been received from a consumer concerning her 20 month old son who was vaccinated with MMR II. Secondary suspected vaccine included PNEUMOVAX 23 (manufacturer not reported). After receiving MMR II, the patient became quieter. After receiving PNEUMOVAX 23 (manufacturer unknown), the patient developed full blown autism. Upon internal review, autism was considered to be an other important medical event. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Patient developed erythematous papules on his low back (#12) and his face (#3) following the administration of VARICELLA vaccine
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Patient developed erythematous papules on his low back (#12) and his face (#3) following the administration of VARICELLA vaccine
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lip swelling
Clinical narrative: Patient lips were swelling. Patient was going to call primary doctor. Patient called me on Sunday 1/18/2009 in the afternoon. Patient did receive other vaccines a few days after getting here.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Quarter- sized erythema around injection site slightly warm no discharge.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Erythema and pruritis on forehead & neck some blistering
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Grip strength decreased, Laboratory test abnormal, Muscular weakness
Clinical narrative: Information has been received from a 61 year old female patient with no pertinent medical history and no known drug allergies who on 09-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not provided) 0.65ml subcutaneously. There was no concomitant medication at the time of vaccination. Reporter stated that right after getting the vaccination she "just didn't feel right". She developed weakness in her legs and hands. She "shuffled" when she walked and "had trouble holding things". Her fever goes up to 102 degrees "3 times every day" and went up to 103 "yesterday". Patient sought unspecified medical attention. She was admitted to the hospital for 4 days and had all kinds of laboratory work done, as stated "you name it, they did it". A test done there showed a small blood clot. She now has "about 75% of my strength back". She is now taking COUMADIN and Ceruroxime (unspecified) 500mg. At the time of this report, the patient was recovering. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Thrombosis
Clinical narrative: Information has been received from a 61 year old female patient with no pertinent medical history and no known drug allergies who on 09-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not provided) 0.65ml subcutaneously. There was no concomitant medication at the time of vaccination. Reporter stated that right after getting the vaccination she "just didn't feel right". She developed weakness in her legs and hands. She "shuffled" when she walked and "had trouble holding things". Her fever goes up to 102 degrees "3 times every day" and went up to 103 "yesterday". Patient sought unspecified medical attention. She was admitted to the hospital for 4 days and had all kinds of laboratory work done, as stated "you name it, they did it". A test done there showed a small blood clot. She now has "about 75% of my strength back". She is now taking COUMADIN and Ceruroxime (unspecified) 500mg. At the time of this report, the patient was recovering. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: 1. Legs pain.  2.  Some time weaken of lower limbs.  3.  Some time numbness of lower limbs.  4.  Shoulder  pain once in a while.  5.  Body ache-  3 weeks after #2 gardasil.  2/10/09 Received PCP medical records of 2/6/09. FINAL DX: none provided Records reveal patient experienced body aches, weakness & leg pain with intermittent leg numbness since 6/08 w/20# wt gain.  Exam WNL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate
Clinical narrative: 1. Legs pain.  2.  Some time weaken of lower limbs.  3.  Some time numbness of lower limbs.  4.  Shoulder  pain once in a while.  5.  Body ache-  3 weeks after #2 gardasil.  2/10/09 Received PCP medical records of 2/6/09. FINAL DX: none provided Records reveal patient experienced body aches, weakness & leg pain with intermittent leg numbness since 6/08 w/20# wt gain.  Exam WNL.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient had vaccination- shortly after the site became red  and inflamed. The size increased following day and became warm to touch. Size approx 4"x3". Patient was advised to come in. Patient treated with BENADRYL, patient's inflammation was resolved after one dose.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Convulsion, Febrile convulsion, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: 1 yr old boy (WM) seen 1/9/2009 for 1 yr old health steps exam. Mild rhinorrhea reported and nose congested. Exam otherwise normal. Afebrile. 1x 10 immunizations given. Evening on 1/19/2009 seemed ok at bedtime. mother heard noise child with fever and tonic seizure. Taken to local ER 103 degrees positive. Nose congested. Said to ? OM. Rechecked 1/20/09 in office- ?, ?. Rhinorrhea. No ear infection.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Tonic convulsion
Clinical narrative: 1 yr old boy (WM) seen 1/9/2009 for 1 yr old health steps exam. Mild rhinorrhea reported and nose congested. Exam otherwise normal. Afebrile. 1x 10 immunizations given. Evening on 1/19/2009 seemed ok at bedtime. mother heard noise child with fever and tonic seizure. Taken to local ER 103 degrees positive. Nose congested. Said to ? OM. Rechecked 1/20/09 in office- ?, ?. Rhinorrhea. No ear infection.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction to VARIVAX given SC to Left upper arm 12/15/08- 2x3 cm area arm sl, red, sl warm and swollen. Treatment: warm compress, OTC analgesics pm.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient received 2nd dose of Rotateq on 10/27/08.  Pt has diarrhea x 10 days, watery stool 3-4x/days.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: 7x6cm area erythema, warm, tender, slightly hard, Left deltoid. 2 days s/p immunization with DTap, flu IM and polio SC in left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Information has been received from a pharmacy technician concerning a patient who on 14-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (no lot# provided). On 14-JAN-2009 the patient experienced difficulty moving the arm where vaccination was given. The pharmacy technician considered "not being able to move the arm" to be disabling. At the time of this report the patient had not yet recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 76 year old female patient who on 05-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 662969/1206X). On 09-JAN-2009 the patient developed shingles of the right face and scalp. The patient was experiencing significant discomfort in the area of the vesicular lesions. The patient was examined in the office on 09-JAN-2009 and was prescribed VALTREX and PREDNISONE. The patient had been referred to an unspecified ophthalmologist for evaluation. The patient had visited office for medical attention. The patient had not recovered from the adverse effect. The physician felt that the events were disabling. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Fatigue, Hypokinesia, Oedema, Pain in extremity
Clinical narrative: Left upper arm & shoulder; edema & warm with pain 6/10 with movement; itching; T 98.8 degree; tiredness; tender on palpation to underarm; motion was abnormal seen at TMC by medical provider 16 Jan 09- Rx BENADRYL & Ibuprofen
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Skin warm
Clinical narrative: Left upper arm & shoulder; edema & warm with pain 6/10 with movement; itching; T 98.8 degree; tiredness; tender on palpation to underarm; motion was abnormal seen at TMC by medical provider 16 Jan 09- Rx BENADRYL & Ibuprofen
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Vaccination small pox, left shoulder, excess redness est. 70 x 55mm; gauze dressing placed recommend air dry 30min at hs; TYLENOL. Seen 16 JAN 09, less red states less itching.
Age: 51.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Pain in extremity, X-ray normal
Clinical narrative: Deep aching pain in upper arm, and shoulder left side. Onset 1 week after Tdap. Pain duration approx. 3 mo. Weakness of arm occurred approx. 2 weeks after onset of symptoms. Numbness of thumb also occurred in left hand at same time. Numbness and weakness of arm continues. Mostly some weakness continues.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a 26 year old female who on 13-DEC-2008 was vaccinated with a dose of VARIVAX (Oka/Merck). The reporter stated that her last menstrual period was 01-DEC-2008 and that 3 recent at home pregnancy tests were positive. The estimated delivery date is 07-SEP-2009. No adverse effect reported. Follow-up information has been received from the patient who stated that she is going to terminate her pregnancy due to getting VARIVAX (Oka/Merck). Upon internal review elective termination of pregnancy was considered to be another medical important event. No further information is available.
Age: 28.0
Sex: U
Vaccine: IPV
Symptoms: Dizziness, Hypoaesthesia, Hypoventilation, Mydriasis, Paraesthesia
Clinical narrative: W/in 30 seconds: tingling & numbness down arm to fingers.  Then, blurred vision, dilated pupils, wain skin, light headedness, shallowed breathing.  After 15-20 min, symptoms dissipated treatment. laid down, called 911(arrived)
Age: 28.0
Sex: U
Vaccine: IPV
Symptoms: Vision blurred
Clinical narrative: W/in 30 seconds: tingling & numbness down arm to fingers.  Then, blurred vision, dilated pupils, wain skin, light headedness, shallowed breathing.  After 15-20 min, symptoms dissipated treatment. laid down, called 911(arrived)
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MEN, PNC, RV5
Symptoms: Bronchiolitis, Cough, Dehydration, Otitis media, Pyrexia
Clinical narrative: This male subject was enrolled in the study 110870 (MenACWY-TT-057). On 27 August 2008, 22 October 2008 and 23 December 2008, he received the 1st, 2nd and 3rd dose of combined (Hib-MenCY-TT, IM L thigh) and (PEDIARIX, IM right thigh). On 22 December 2008, 61 days after the 2nd dose of PEDIARIX, 61 days after the 2nd dose of Hib-MenCY-TT, this six-month-old subject developed broncholitis. On 08 January 2009, 16 days after the 3rd dose of PEDIARIX and Hib-MenCY-TT, he developed dehydration. The subject was hospitalised. The events were unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the bronchiolitis may have been caused by PEDIARIX and Hib-MenCY-TT and that the events were possibly due to viral infection. The investigator considered that there was no reasonable possibility that the dehydration may have been caused by PEDIARIX and Hib-MenCY-TT. Relevant risk factors: sibling with asthma. Investigator comments: On 1/5/09 subject presented with 2 week history of cough, diagnosed with bronchiolitis and treated with ALBUTEROL. The subject returned on 1/7/09 with worsening symptoms and fever and was diagnosed with OM, brronchiolitis and treated with OMNICEF antibiotic and ORAPRED. Returned to clinic on 1/9/09, unable to keep his meds down and became dehydrated. Hospitalized for  for management of bronchiolitis and dehydration.
Age: 41.0
Sex: F
Vaccine: SMALL
Symptoms: Axillary pain, Injection site rash, Lymphadenitis, Rash
Clinical narrative: T 98.0 degree rash on left arm surrounding smallpox vaccination site. Started 2 days ago 14 JAN 09, spread to axilla area, swelling in axilla area, tenderness to touch, no meds used ; states rash much improved. No fever, no chills, seen at 16 JAN 09. Sick call.  Prescription for BENADRYL and IBUPROFEN.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Blood culture, Crying, Full blood count normal, Lethargy, Metabolic function test normal
Clinical narrative: Fever to 103.5, lethargy with crying off and on. Tx - IV fluids and fever control with TYLENOL, MOTRIN. 1/29//09-records received for DOS 1/20/09-presented to ED with C/O cough and fever and fussy, lethargic. Impression:acute febrile reaction to immunizations.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC, RV5
Symptoms: Abdominal X-ray, Blood count, Blood culture, Intussusception
Clinical narrative: Patient was admitted to medical center.  Abdominal CT was performed.  Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Barium enema, Blood culture, Computerised tomogram abnormal
Clinical narrative: Patient was admitted to medical center.  Abdominal CT was performed.  Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC, RV5
Symptoms: Dehydration, Depressed level of consciousness, Enema administration, Full blood count, Haematochezia
Clinical narrative: Patient was admitted to medical center.  Abdominal CT was performed.  Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAP, PNC, RV5
Symptoms: Hypothermia, Intussusception, Lethargy, Rectal haemorrhage, Thrombosis
Clinical narrative: Patient was admitted to medical center.  Abdominal CT was performed.  Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Apnoea, Cyanosis, Eye disorder, Gaze palsy, Respiratory arrest
Clinical narrative: On 12/17 and 12/18 4-5 episodes where lips turned blue and eyes seemed unfocused; lasted 5-10 sec. on 12/19 11:30 am turned blue, stopped breathing, eyes rolled back, taken in ambulance to ER. Pt was admitted to hospital for 4 days - discharged on 12/23/2009. Test came back normal. Since 12/20 has been taking KEPPRA/phenobarbitol twice a day to prevent seizures, no seizures since then. Was seen by neurologist who sent samples to state lab and an adenovirus was found. Clarification episodes did not involve convulsion more limping of body. 2/5/09-records received for DOS 12/19-12/23/08-admitted for apparent life threatening event (ALTE) episode of eyes rolle4d upward, lips purple, pale neck limp, unresponsive, one day status post vaccination. While in hospital presented with significant apnea/bradycardia and seizure.   He had multiple seizures in the hospital but once they got him on PHENOBARNITOL and it took effect, the seizures stopped. He took PHENPBARNITOL for 6 month after that but is now off the medication. He never had more seizures. We have stopped most vaccinations, although we did give him the polio vaccine after stopping the medication in July or August 2009, since that vaccine (we were told) has a low incidence of reactions, and nobody has died from it. We would like to vaccinate him in the future, but there are too many unknown for the moment. Thank you for inquiring.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Pain, Pyrexia
Clinical narrative: Initial report received on 12 March 2008 from the patient's parent.  A 17-year-old male patient, with no illness at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of Menomune, lot number UP157AB, on 10 March 2008.  Approximately 24 hours post-vaccination, the patient developed a fever of 100 degrees Fahrenheit and body aches.  At the time of this report, the patient had not recovered.  Follow-up information received on 26 September 2008 from a health care provider.  Per the reporter, there is no complete description of the event as the patient was not seen by their facility or physicians, and no tests or treatments were provided.  The patient has not been evaluated by this physician's office since 10 September 2007.  Per the reporter, there is no additional information, and the reporter requested the case be closed.  No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Chest pain, Feeling hot, Malaise
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 14-JAN-2009 was vaccinated with a first and only dose of GARDASIL intramuscularly 0.5 mL. There was no concomitant medication. On the same day the patient experienced anaphylactic reaction. She experienced severe vomiting, abdominal pain within the hour of vaccination. She also had hard time breathing and sensation of the throat closing. She went to an emergency room and was given oxygen and intravenous steroids. The patient was discharged after the recovery (The outcome also reported as "recovering"). Anaphylactic reaction, abdominal pain and abdominal pain were reported to be immediately life-threatening. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Paraesthesia, Pruritus generalised, Throat irritation, Wheezing
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 14-JAN-2009 was vaccinated with a first and only dose of GARDASIL intramuscularly 0.5 mL. There was no concomitant medication. On the same day the patient experienced anaphylactic reaction. She experienced severe vomiting, abdominal pain within the hour of vaccination. She also had hard time breathing and sensation of the throat closing. She went to an emergency room and was given oxygen and intravenous steroids. The patient was discharged after the recovery (The outcome also reported as "recovering"). Anaphylactic reaction, abdominal pain and abdominal pain were reported to be immediately life-threatening. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Anaphylactic reaction, Dyspnoea, Throat tightness, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who on 14-JAN-2009 was vaccinated with a first and only dose of GARDASIL intramuscularly 0.5 mL. There was no concomitant medication. On the same day the patient experienced anaphylactic reaction. She experienced severe vomiting, abdominal pain within the hour of vaccination. She also had hard time breathing and sensation of the throat closing. She went to an emergency room and was given oxygen and intravenous steroids. The patient was discharged after the recovery (The outcome also reported as "recovering"). Anaphylactic reaction, abdominal pain and abdominal pain were reported to be immediately life-threatening. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin decreased, Transfusion
Clinical narrative: Information has been received from a representative as reported by a colleague concerning a 13 year old female who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. It was reported that the patient developed low hemoglobin levels after receiving GARDASIL. She was taken to hospital where she received blood infusions. The outcome of the patient was not reported. The reporter considered "low hemoglobin levels" to be an other important medical event because the patient received blood infusion. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with her first 0.5 ml dose of GARDASIL towards the latter part of last year. The patient had a seizure "a couple days" after getting GARDASIL and had "several" seizures since then. The doctor's nurse said that the patient's father checked with a neurologist who said that the seizures were linked to GARDASIL. The outcome is unknown. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.