chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Patient presented to Hospital on 2/18/2010. Pt was found to have symptoms consistent with Guillain-Barre syndrome including bilateral weakness, decreased deep tendon reflexes and an acute onset.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal
Clinical narrative: Patient presented to Hospital on 2/18/2010. Pt was found to have symptoms consistent with Guillain-Barre syndrome including bilateral weakness, decreased deep tendon reflexes and an acute onset.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Bacterial test, HIV test, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt. reports that she awake yesterday AM with upper rt. arm sore, slightly swollen and tight with knot @ injection site and hot to touch. Denies any difficulty breathing N/V or diarrhea. No MD or ER visit. Pt. states doing much better today.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site warmth, Skin tightness, Treponema test
Clinical narrative: Pt. reports that she awake yesterday AM with upper rt. arm sore, slightly swollen and tight with knot @ injection site and hot to touch. Denies any difficulty breathing N/V or diarrhea. No MD or ER visit. Pt. states doing much better today.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Leg began to swell, large uneven edged rash appeared and itching began.  Swelling, rash and itching continued. The swelling became softball size and remained for 1 week and then began to go down.  Rash is still apparent and larger than a golf ball and it has been 2 weeks since the injection.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Movement disorder, Muscular weakness, Urinary incontinence
Clinical narrative: weakness in legs, unable to walk or get up into bed, urinary incontinence
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: The day after taking the 3rd (of 4) doses of the vaccine, patient woke up with swollen lips.  Next day patient had itchy hives on face and lips and still swollen.  Went to Clinic and was told to take Claritin and Pepcid.  On third day swelling and hives were worse and had not responded to above treatment or Benadryl.  Went to ER and was given steroid shot and prescription.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Hypoaesthesia, Hypoaesthesia oral, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia oral
Clinical narrative: Pt stated that the right side of his tongue went numb and tingly.  On 8/15/2010 the right side of his jaw line went numb and momentarily his right eye had double vision.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Impaired work ability, Injection site rash, Injection site swelling
Clinical narrative: 08/22/2010 awoke with occipital headache, stiff neck, right side of neck large swollen lymph node, some discomfort of neck.  Took pain/anti-inflamitory med. Did not help head ache. Area of injection was right deltoid, c/o swelling entirely around right upper arm. 8/24 eve. noted a rash 2 inches x 4 inches on right deltoid. Took Benadryl. Symptom disappeared by next morning. 08/26/2010 was seen by primary physician. Dx: reaction from pertussis, Rx Darvon for headache.  08/27/2010 went home from work ill; c/o headache, dizzy, blurred vision, uncoordination of movement. Rested at home. 08/28/2010 felt better and improved the next day as well. Heacache continued until 09/03/2010. Today, 09/08/2010 is feeling good--no symptoms.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Movement disorder, Musculoskeletal discomfort, Musculoskeletal stiffness, Vaccination complication
Clinical narrative: 08/22/2010 awoke with occipital headache, stiff neck, right side of neck large swollen lymph node, some discomfort of neck.  Took pain/anti-inflamitory med. Did not help head ache. Area of injection was right deltoid, c/o swelling entirely around right upper arm. 8/24 eve. noted a rash 2 inches x 4 inches on right deltoid. Took Benadryl. Symptom disappeared by next morning. 08/26/2010 was seen by primary physician. Dx: reaction from pertussis, Rx Darvon for headache.  08/27/2010 went home from work ill; c/o headache, dizzy, blurred vision, uncoordination of movement. Rested at home. 08/28/2010 felt better and improved the next day as well. Heacache continued until 09/03/2010. Today, 09/08/2010 is feeling good--no symptoms.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: 08/22/2010 awoke with occipital headache, stiff neck, right side of neck large swollen lymph node, some discomfort of neck.  Took pain/anti-inflamitory med. Did not help head ache. Area of injection was right deltoid, c/o swelling entirely around right upper arm. 8/24 eve. noted a rash 2 inches x 4 inches on right deltoid. Took Benadryl. Symptom disappeared by next morning. 08/26/2010 was seen by primary physician. Dx: reaction from pertussis, Rx Darvon for headache.  08/27/2010 went home from work ill; c/o headache, dizzy, blurred vision, uncoordination of movement. Rested at home. 08/28/2010 felt better and improved the next day as well. Heacache continued until 09/03/2010. Today, 09/08/2010 is feeling good--no symptoms.
Age: 15.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever to 102F, chills, nausea, headache, muscle aches
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Myalgia, Weight bearing difficulty
Clinical narrative: Following day, Patient returned to my office not wanting to bear weight on the leg that had the shot given in.  Muscle very sore to palpation.  Within the next couple of days was walking just fine.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Day following administration of Prevnar 13, parents called me when I was on call because patient did not want to bear weight on leg, shot was given in
Age: 36.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: 9/1 - I had pertussis and chicken pox vaccines since I'm a new mom with no immunity to those.  9/2 - I had low grade fever and fatigue.  9/3 - I noticed a sore, half dollar size red circular blotch around one of the shots (not sure which). 9/5 - the red blotch doubled in size and was somewhat itchy. 9/8 - it is fading and much less sore or itchy.
Age: 36.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash macular
Clinical narrative: 9/1 - I had pertussis and chicken pox vaccines since I'm a new mom with no immunity to those.  9/2 - I had low grade fever and fatigue.  9/3 - I noticed a sore, half dollar size red circular blotch around one of the shots (not sure which). 9/5 - the red blotch doubled in size and was somewhat itchy. 9/8 - it is fading and much less sore or itchy.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Vomiting
Clinical narrative: Vomiting, right side chest pain worse with deep inspiration and without radiation.
Age: 79.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Asthenia, Chills, Dyspnoea, Heart rate increased, Incorrect dose administered
Clinical narrative: difficulty breathing, paleness, fast heart beat, wheezing, Chills, weakness
Age: 79.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Pallor, Wheezing
Clinical narrative: difficulty breathing, paleness, fast heart beat, wheezing, Chills, weakness
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Breakout of hives throughout the body.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia, Eye pruritus, Fatigue, Lacrimation increased, Malaise
Clinical narrative: First I had strong metallic taste on tongue which lasted about an hour. Then I got a very runny and raw nose. Today 9/8/10 Very runny nose, itchy runny eyes, tired and about 2:00PM started to get a sore throat my teeth also hurt. Just feel sick like a bad cold or allergies with a sore throat.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal discomfort, Nasal disorder, Oropharyngeal pain, Rhinorrhoea, Toothache
Clinical narrative: First I had strong metallic taste on tongue which lasted about an hour. Then I got a very runny and raw nose. Today 9/8/10 Very runny nose, itchy runny eyes, tired and about 2:00PM started to get a sore throat my teeth also hurt. Just feel sick like a bad cold or allergies with a sore throat.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: PT FAINTED AT COUNTER WHEN LEAVING CLINIC. ASSESSED BY MD. BROUGHT TO EXAM ROOM AND WATCHED FOR 30 MIN, VS TAKEN FREQ. WATER GIVEN.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling, pain which is almost resolved as of 9/8.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Pain, swelling which is resolving now. Patient did not feel it was necessary to see MD.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC10
Symptoms: Body temperature increased, Diarrhoea haemorrhagic, Occult blood positive
Clinical narrative: 103 temperature with bloody diarrhea
Age: 3.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Crying, Dyskinesia, Ear infection, Ear pain, Facial pain
Clinical narrative: Patient was complaining at 7:00 PM (just 4.5 hours after vaccination) that his mouth and cheeks hurt and couldn't open his mouth well, but didn't have a fever. I went ahead and gave him some Motrin. He went to bed around 8:00 PM. He woke up at 11:00 PM that night crying and saying his mouth was hurting and this time had a fever. So I gave him more Motrin. He then woke up at 3:00 crying saying again that his mouth, ears, and neck hurt. I gave him more Motrin. He was probably awake for almost an hour because he was in so much pain. He finally fell back asleep and woke up at 7:00 AM. He said his mouth still hurt and I gave him more Motrin. I called the doctor and left a message that I needed an appointment. So I saw the doctor today, September 8, 2010 at 2:30 PM, just 24 hours after he received the vaccination and she checked him out. He had a double ear infection. She said it was bad. One side much worse than the other. She said that he looked perfect the day before and that his ears were completely clear the day before when she checked them.
Age: 3.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Neck pain, Oral pain, Pyrexia
Clinical narrative: Patient was complaining at 7:00 PM (just 4.5 hours after vaccination) that his mouth and cheeks hurt and couldn't open his mouth well, but didn't have a fever. I went ahead and gave him some Motrin. He went to bed around 8:00 PM. He woke up at 11:00 PM that night crying and saying his mouth was hurting and this time had a fever. So I gave him more Motrin. He then woke up at 3:00 crying saying again that his mouth, ears, and neck hurt. I gave him more Motrin. He was probably awake for almost an hour because he was in so much pain. He finally fell back asleep and woke up at 7:00 AM. He said his mouth still hurt and I gave him more Motrin. I called the doctor and left a message that I needed an appointment. So I saw the doctor today, September 8, 2010 at 2:30 PM, just 24 hours after he received the vaccination and she checked him out. He had a double ear infection. She said it was bad. One side much worse than the other. She said that he looked perfect the day before and that his ears were completely clear the day before when she checked them.
Age: 37.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Orchitis
Clinical narrative: Orchitis
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Lethargy, Malaise, Pallor, Peripheral coldness
Clinical narrative: Patient received 5 immunization shots and later found weak and complaining of not feeling well. Noted by MA pale and cold. Code blue called. Pt awake & alert but noted to be lethargic told to lie down. Presently a little color and VS as recorded. C/L = clear. Heart regular rhythm. Neuro = no ? except lethargy.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Oropharyngeal pain, Throat tightness
Clinical narrative: Progressively over next few hours, not immediately, patient developed very sore throat. Went to Emergency Dept. Found to have throat constriction thought to be from anaphylactic reaction.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, No reaction on previous exposure to drug, Oropharyngeal pain, Throat tightness
Clinical narrative: Progressively over next few hours, not immediately, patient developed very sore throat. Went to Emergency Dept. Found to have throat constriction thought to be from anaphylactic reaction.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dysgeusia, Nausea
Clinical narrative: After vaccination, patient developed symptoms, not immediately, but within a few hours, nausea, chest tightening, altered taste, went to Emergency Dept. Determined to have anaphylactic reaction.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Pain, Pericarditis
Clinical narrative: Pain in chest and down left side. (ER physician said symptoms are not likely related to the flu shot.)
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Lethargy, Pain, Surgery
Clinical narrative: Child received ROTATEQ Aug. 9, 2010. On 15th - pain - lethargy - vomiting, bloody stool - intussusception - needed open reduction.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Child received ROTATEQ Aug. 9, 2010. On 15th - pain - lethargy - vomiting, bloody stool - intussusception - needed open reduction.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came to pharmacy at 10:15 AM today to show her arm. About 3" below injection site there is a raised (about 1/4") circular area about size of baseball that is red. She said she just noticed it in shower this A.M. She took Fexofenadine as usual.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Varicella vaccine given on 9/7/10. Patient returns to clinic with complaint of (R)ight arm pain, itching at the site and a rash. -> Treated with antibiotic (KEFLEX) TYLENOL/MOTRIN.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Large - golf ball sized welt at site of injection post injecting. Cold pack applied to site to minimize reaction/swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Pain, Rash, Swelling
Clinical narrative: Pt received PNEUMOVAX 23 at 1115AM, reported the symptoms on 9/8/10 as swollen, rash, hot red around the area of about 1 inch, hurts when move, no fever, no body ache, looks like fluid inside, pt's sister called by phone to pharmacy.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception 9/6/10. - 9/7/10.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Fever of 103.8, red, hot, swollen area of the injection site malaise and fatigue. Injection site was right deltoid.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever of 103.8, red, hot, swollen area of the injection site malaise and fatigue. Injection site was right deltoid.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Rash, red, warm to touch, dark red center and larger pink circle surrounding it.
Age: 38.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Body temperature increased, Fatigue
Clinical narrative: 2 1/2 hours post vaccination temp 99.2 with fatigue. Patient given TYLENOL 500mg, rested and repeat vital signs. Discharged with temp 98.8 B/P decreased to 128/88 from 140/94. Patient discharged home.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately lightheaded, briefly passed out (on table). Observed for > 1 hr. Given juice & food but continued to c/o lightheaded until just became cleared to go home. BP 110/68 P 68.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying. Started 2 hours after vaccines. Lasted for 8 hours.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm red, swollen, tender, hot to touch x 2days. Started to decrease on 3day post vaccination.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever x 2 days, rash x 3-4 days, vomiting x 1 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Condition aggravated, Eczema, Fatigue
Clinical narrative: Information has been received from a pharmacist concerning a 15 year old female with eczema who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL. On 15-JUL-2009 the patient experienced extreme fatigue and an exacerbation of pre existing eczema after her first dose. The patient sought medical attention. Severe fatigue was considered to cause a disability because the patient could not get out of bed. At the report time the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Appendicectomy, Appendicitis, Drug exposure before pregnancy, Pain
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female with no pertinent medical history or allergies who was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The vaccine was given at a different facility so the physician did not have the specific date for dose 1, however she believes the patient received dose 1 two weeks before she found out she was pregnant. Her LMP was 28-FEB-2009. Unspecified medical attention was sought. Prenatal labs were performed with no results reported. No symptoms reported. Her estimated delivery date is 05-DEC-2009. Information has been received from the physician concerning the 25 year old female with a history of 1 pregnancy and 1 live birth and no birth defect in previous pregnancy. On 30-Jul-2009, ultrasound was performed for organ survey, with normal result. On approximately 1-NOV-2009, the patient underwent abdominal ultrasound, result not provided. On approximately 01-NOV-2009, at 35 weeks gestation, the patient experienced appendicitis and underwent appendectomy. From 01-NOV-2009 to 03-NOV-2009, VICODIN was given, as needed, for post appendectomy treatment. On 25-NOV-2009, at 38 weeks and 4 days gestation, the patient delivered a normal male baby, weighing 3579 grams with no complication during labor. The baby's length 51 cm, head circumference 13.5", apgar score 9/9. Follow-up information has been received from a registered nurse in the physician's office who was able to access the patient's chart. It was reported that the patient was diagnosed with appendicitis and admitted to the hospital and underwent an open appendectomy on 01-NOV-2009. The patient was discharged home on 04-NOV-2009. She was seen for follow-up appointment on 10-NOV-2009, when it was noted that she was still having some pain, but was feeling much better. Her assessment was within normal limits. On 25-NOV-2009, the patient delivered a male neonate via a spontaneous vaginal delivery. The health professional contacted during telephone follow-up could not supply the following information: date of vaccination or lot number. Follow-up information was received from a physician via medical records indication that on 30-NOV-2009 the baby was seen for a newborn check. The baby had breast feeding, using similac formula with iron. The physician's assessment was healthy newborn and continued the current feeding regimen. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female with no pertinent medical history or allergies who was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The vaccine was given at a different facility so the physician did not have the specific date for dose 1, however she believes the patient received dose 1 two weeks before she found out she was pregnant. Her LMP was 28-FEB-2009. Unspecified medical attention was sought. Prenatal labs were performed with no results reported. No symptoms reported. Her estimated delivery date is 05-DEC-2009. Information has been received from the physician concerning the 25 year old female with a history of 1 pregnancy and 1 live birth and no birth defect in previous pregnancy. On 30-Jul-2009, ultrasound was performed for organ survey, with normal result. On approximately 1-NOV-2009, the patient underwent abdominal ultrasound, result not provided. On approximately 01-NOV-2009, at 35 weeks gestation, the patient experienced appendicitis and underwent appendectomy. From 01-NOV-2009 to 03-NOV-2009, VICODIN was given, as needed, for post appendectomy treatment. On 25-NOV-2009, at 38 weeks and 4 days gestation, the patient delivered a normal male baby, weighing 3579 grams with no complication during labor. The baby's length 51 cm, head circumference 13.5", apgar score 9/9. Follow-up information has been received from a registered nurse in the physician's office who was able to access the patient's chart. It was reported that the patient was diagnosed with appendicitis and admitted to the hospital and underwent an open appendectomy on 01-NOV-2009. The patient was discharged home on 04-NOV-2009. She was seen for follow-up appointment on 10-NOV-2009, when it was noted that she was still having some pain, but was feeling much better. Her assessment was within normal limits. On 25-NOV-2009, the patient delivered a male neonate via a spontaneous vaginal delivery. The health professional contacted during telephone follow-up could not supply the following information: date of vaccination or lot number. Follow-up information was received from a physician via medical records indication that on 30-NOV-2009 the baby was seen for a newborn check. The baby had breast feeding, using similac formula with iron. The physician's assessment was healthy newborn and continued the current feeding regimen. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal, Vaginitis bacterial
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 18 year old female with asthma and no drug allergy who on 14-NOV-2007 was intramuscularly vaccinated with her first dose of GARDASIL 0.5 ml. (site of administration not reported; Lot number 658282/0929U). On 29-MAY-2008, the patient was intramuscularly vaccinated with her second dose of GARDASIL 0.5 ml. (site of administration not reported; Lot number 659441/1446U). Concomitant therapy included FLOVENT, ZYRTEC, ADVAIR and albuterol. The physician reported that the patient was pregnant. She was 9 weeks gestation on 05-AUG-2008. The patient sought medical attention and was seen. Her last menstrual period was 25-MAY-2008 and her estimated due date was 01-MAR-2009. The pregnancy test was performed and the result was positive. The outcome of the patient was unknown. Follow up information has been received from the pediatrician reported that she did not have any additional information on this patient. She last saw the patient in August 2008. At that time the patient was planning to go for obstetrical care at  hospital. Follow up information has been received from a physician concerning the 18 year old female with asthma, oesophageal acid reflux, anaemia, migraine, juvenile rheumatoid arthritis, hypersensitivity, gastrooesophageal reflux disease and iron deficiency anaemia and a history of papilloedema and pseudotumor cerebri who on 14-NOV-2007 and 29-MAY-2008 was vaccinated with the first and second doses of GARDASIL. Concomitant therapy included FLOVENT, ZYRTEC, ADVAIR, albuterol, PEPCID AC, influenza virus vaccine (unspecified), iron (unspecified), TYLENOL and vitamins (unspecified). On an unspecified date the patient developed bacterial vaginitis and was treated with FLAGYL. On 23-JUL-2008 ultrasound was performed with the result of intrauterine pregnancy. On an unspecified date serum alpha-fetoprotein test was performed with the result of negative. On 08-OCT-2008 the other ultrasound was performed with the result of 20 weeks intrauterine pregnancy. On 18-FEB-2009 the patient delivered a normal, healthy male baby weighing 7 pounds 4 ounces with no congenital anomalies. Apgar score is 8. There was not complication during pregnancy and labor/delivery, and not diagnostic test, infections. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Postpartum depression, Shoulder dystocia, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 20 year old female with no medical history or drug allergies who was vaccinated with a dose of GARDASIL. There was no concomitant medication. The patient was pregnant 15 weeks and 6 days. No problems reported. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information was received concerning a female was vaccinated with the first dose of GARDASIL in May 2008. On 09-SEP-2008, ultrasound was performed and it was normal. Follow-up information on 01-JUL-2009 was received from a certified nurse-midwife who reported that on 21-JAN-2009, the patient delivered a female infant who weighed 6Lbs 14 Oz and had Apgar of 7 & 8 at 1 and 5 minutes respectively. The patient delivered vaginally and had a shoulder dystocia during delivery. The baby was fine and doing wonderfully. The patient developed a postpartum depression, but  was currently in treatment and her depression was resolving. As of 01-JUL-2009, the outcome of shoulder dystocia was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure before pregnancy, Headache, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with a history of migraine and anaemia and no known drug allergies/reactions reported who on 12-MAY-2008 was vaccinated with the first dose GARDSIL (lot # 657006/0188U), 0.5 mL, IM. On 23-JUL-2008, the patient was vaccinated with a second dose of GARDASIL (lot # 657737/0522U), 0.5 mL, IM. A urine pregnancy test on 13-AUG-2008 was negative and on 11-SEP-2008 a urine pregnancy test was positive (LMP: 04-AUG-2008, estimated delivery date: 12-MAY-2009). The patient sought medical attention in the office. Follow-up information has been received from a nurse who reported that the patient experienced "severe" headaches during the pregnancy but she did not know the status of those headaches at the time of reporting. It was unknown if the patient sought medical attention. On an unspecified date, the patient delivered her baby. The baby was healthy and normal. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Kidney infection, Pregnancy test positive
Clinical narrative: Information has been received from a licensed practical nurse for the pregnancy registry for HPV vaccine, concerning a 17 year old female with petit mal seizures and bipolar disorder who in August 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included GEODON and TOPAMAX. The nurse reported that on 24-SEP-2008, the patient did a home pregnancy test which was positive. The patient's LMP was 18-JUN-2008, and her EDD was 25-MAR-2009. The patient did not seek medical attention; her first obstetrics appointment would be on 08-OCT-2008. Follow-up information has been received from the licensed practical nurse concerning her now 19 year old neighbor who delivered a fine baby on 16-APR-2009 (she's not sure that's exact date). As far as the nurse knew, the baby had no anomalies and was doing well. The patient had a "bad kidney infection" prenatally, but she was "OK" now. The nurse didn't think there were any other prenatal complications. The patient had another infant after the one born in April 2009. The information has been captured in WAES #1004USA00607. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Conjunctival haemorrhage, Constipation, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner, for the pregnancy registry for GARDASIL concerning a 6 day old female. Her 22 year old mother was vaccinated with the first 0.5 ml dose of GARDASIL (lot# 660555/0279X) on 07-JUL-2008. On 10-OCT-2008 the patient received the second 0.5 ml dose of GARDASIL (lot# 660620/0571X). LMP was 17-SEP-2008. Estimated delivery date was 24-Jun-2009. On 26-JUN-2009 (40.4 gestation weeks), the mother delivered a normal female baby (6 pounds and 4.8 ounce, 20.5 length, head circumference 12, apgar score 9/9, no congenital anomalies and no other complications or abnormalities). On 01-JUL-2009, 6 day after birth, the baby was found have bilateral small subconjunctive hemorrhage. Routine newborn care handout was given. On 04-JUL-2009, the mother called doctor on call that the baby experienced constipation. She was instructed to add light karo syrup to bottle. If not stool again, add dark karo to bottle. One top was 2 ounce. One bottle was on 06-JUL-2009 and one on 07-JUL-2009. The mother could call back if the baby was not stooling well 7 to 8 days later. Small wet gerps was described by now. The mother's experience has been captured in WAES 0810USA03940. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a physician concerning a newborn male patient who's mother was vaccinated on an unspecified date with a first dose of GARDASIL. 09-SEP-2008 the patient's mother was vaccinated with a second dose of GARDASIL. On 21-MAY-2009, the patient experienced fetal tachycardia during labor and delivery. The patient's outcome was unknown. The mother's experience has been captured in WAES # 0810USA04882. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a physician concerning a male infant who was born from a 17 year old female with history of anger issues, who on 03-DEC-2008 was vaccinated with the second dose of GARDASIL (Lot 660553/0070X). It was reported that the patient's mother received her first dose over a year ago. Concomitant therapy included HAVRIX and hormonal contraceptives (unspecified). It was reported that the patient's mother (G2P1) got 2 doses of GARDASIL prior to delivery (WAES0812USA00560). On 24-JUN-2009, the patient's mother delivered the infant weighing 3308g with an Apgar score of 9/9 via C-section due to decreased fetal heart rate. His newborn metabolic screen was normal and his newborn hearing screen was normal. He received his first immunization of HBV on 26-JUN-2009. At his first well child visit on 01-JUL-2009, his physical examination was within normal limits including his heart and pulses. No murmurs were heard. The patient was considered a well "FI" newborn. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Alpha 1 foetoprotein normal, Amniocentesis normal, Dizziness, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse for the pregnancy registry for GARDASIL, concerning an 18 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who on an unspecified date was vaccinated with the first dose of GARDASIL. On 27-MAY-2008, the patient was vaccinated with the second dose of GARDASIL. On 26-NOV-2008, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included YAZ. It was reported that the patient was subsequently determined to be pregnant. Last menstrual period was the end of October 2008 and estimated date of delivery was 07-AUG-2009. At the time of the report the patient had a urine pregnancy test done. No problems reported. The patient sought medical attention. Follow up information was received on 13-FEB-2009 from a Licensed Practical Nurse concerning a female patient who on 27-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot # 660389/1968U). On 29-JUL-2008 was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and on 26-NOV-2008 received the third dose of GARDASIL (Lot # 660618/0572X). It was reported that the patient had no previous pregnancies. Last menstrual period was on 15-OCT-2008, estimated date of conception was 31-OCT-2008, and estimated date of delivery was 23-JUL-2009. On 31-DEC-2008 an ultrasound was performed (normal results). Follow up information was received from a Licensed Practical Nurse (L.P.N) concerning an 18 year old female patient with no previous pregnancies or concurrent conditions reported who on 27-MAY-2008, 29-JUL-2008 and on 26-NOV-2008 was vaccinated with the first, second and third doses of GARDASIL (Lot # 660389/1968U), (Lot # 660620/0571X) and (Lot # 660618/0572X) respectively. Concomitant therapy used during the pregnancy included doxycycline and MACROBID 100 mg twice a day for vaginal infection, YAZ for birth control and ZOFRAN for nausea and vomiting. It was reported that an ultrasound was performed on 31-DEC-2008 and it showed that was within normal limits. On 10-FEB-2009 a Maternal Serum Alpha-Fetoprotein test (MSAFP) was performed and it was within normal limits. On 01-JUL-2009 another ultrasound was performed and it was determined that the baby was slightly small for gestational age. On the same date, 01-JUL-2009, it was determined that the Amniotic Fluid Factor (14) was within normal limits. On an unspecified date a Maternal Serum Screen 4 test was performed and showed that it was within normal limits. The patient experienced episodes of dizziness during pregnancy but there were no complications during labor. It was reported that on 15-JUL-2009, at 39 weeks of gestation, the patient delivered a normal female baby (weight 5 Lb and 11 ounces, apgar score were 8 at the first minute and 9 at the 5 minute). It was reported that there were no congenital anomalies. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Small for dates baby, Ultrasound antenatal screen abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse for the pregnancy registry for GARDASIL, concerning an 18 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who on an unspecified date was vaccinated with the first dose of GARDASIL. On 27-MAY-2008, the patient was vaccinated with the second dose of GARDASIL. On 26-NOV-2008, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included YAZ. It was reported that the patient was subsequently determined to be pregnant. Last menstrual period was the end of October 2008 and estimated date of delivery was 07-AUG-2009. At the time of the report the patient had a urine pregnancy test done. No problems reported. The patient sought medical attention. Follow up information was received on 13-FEB-2009 from a Licensed Practical Nurse concerning a female patient who on 27-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot # 660389/1968U). On 29-JUL-2008 was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and on 26-NOV-2008 received the third dose of GARDASIL (Lot # 660618/0572X). It was reported that the patient had no previous pregnancies. Last menstrual period was on 15-OCT-2008, estimated date of conception was 31-OCT-2008, and estimated date of delivery was 23-JUL-2009. On 31-DEC-2008 an ultrasound was performed (normal results). Follow up information was received from a Licensed Practical Nurse (L.P.N) concerning an 18 year old female patient with no previous pregnancies or concurrent conditions reported who on 27-MAY-2008, 29-JUL-2008 and on 26-NOV-2008 was vaccinated with the first, second and third doses of GARDASIL (Lot # 660389/1968U), (Lot # 660620/0571X) and (Lot # 660618/0572X) respectively. Concomitant therapy used during the pregnancy included doxycycline and MACROBID 100 mg twice a day for vaginal infection, YAZ for birth control and ZOFRAN for nausea and vomiting. It was reported that an ultrasound was performed on 31-DEC-2008 and it showed that was within normal limits. On 10-FEB-2009 a Maternal Serum Alpha-Fetoprotein test (MSAFP) was performed and it was within normal limits. On 01-JUL-2009 another ultrasound was performed and it was determined that the baby was slightly small for gestational age. On the same date, 01-JUL-2009, it was determined that the Amniotic Fluid Factor (14) was within normal limits. On an unspecified date a Maternal Serum Screen 4 test was performed and showed that it was within normal limits. The patient experienced episodes of dizziness during pregnancy but there were no complications during labor. It was reported that on 15-JUL-2009, at 39 weeks of gestation, the patient delivered a normal female baby (weight 5 Lb and 11 ounces, apgar score were 8 at the first minute and 9 at the 5 minute). It was reported that there were no congenital anomalies. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a pharmacist concerning a male baby who was born from a 23 year old female with penicillin allergy and obesity with a history of 1 pregnancy and 1 full term live birth with no birth defects or infant complications in previous pregnancies and a history of postpartum depression after first pregnancy, who on 04-DEC-2008 was vaccinated into the left deltoid with first dose of GARDASIL (dose and route not provided) (lot number 661044/0548X). Concomitant therapy included prenatal vitamins (unspecified) for supplement. It was reported that the patient's mother gave birth to a normal male infant with no congenital anomalies, weighing 9 pounds and 13.9 ounces (length 22 inches; head circumference 36.3cm) on 17-JUL-2009, at 40 5/7 weeks from LMP. The baby experience fetal macrosomia and reduced fetal movement but was a normal newborn. Medications the mother used during pregnancy included cyclobenzaprine (started on 04-FEB-2009) for the treatment of muscle spasm/shoulder strain, metronidazole (From 09-MAR-2009 to 16-MAR-2009, dose 500mg BID) for the treatment of bacterial vaginosis and sulfamethoxazole (+) trimethoprim (from 05-JUN-2009 to 09-JUN-2009, dose 800/160mg BID) for presumed UTI, culture negative. Follow up information was received from a pharmacist. It was reported that the intended vaccine for the mother was influenza virus vaccine (unspecified). The patient's mother delivered a live born infant on 17-JUL-2009 without problems. It was noted that the patient's mother received prenatal vitamins, sulfamethoxazole (+) trimethoprim, cyclobenzaprine and metronidazole during her pregnancy. The mother's experience during pregnancy is reported in WAES 0812USA02810. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia of pregnancy, Blood test, Delivery, Diagnostic procedure, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient, for the pregnancy registry of GARDASIL, with a history of papanicolaou smear abnormal in 2006 and no known drug allergies/drug reactions, who on 14-MAY-2008 was vaccinated with the first dose of GARDASIL. On an unspecified date she was vaccinated with the second dose of GARDASIL and on 26-NOV-2008 was vaccinated with the third dose of GARDASIL. Subsequently it was determined to be pregnant by home pregnancy test. Last menstrual period was 19-OCT-2008 and estimated date of delivery was 26-JUL-2009. At the time of the report the patient had a prenatal blood work done (results were pending). The patient sought medical attention. Follow up information was received which reported that the patient had a vaginal delivery on 30-JUL-2009. Follow up information was received from a Physician's Assistant (P.A.) who reported that the patient had a spontaneous vaginal birth and delivered a healthy female on 30-JUL-2009, at 40 weeks (Estimated Gestational Age). It was reported that at the patient's postpartum visit it was noted that the baby was "thriving". The physician assistant stated there were no complications for the baby, and the mother only had mild anemia in her pregnancy, nothing more. It was unknown if the patient recovered from mild anemia. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient, for the pregnancy registry of GARDASIL, with a history of papanicolaou smear abnormal in 2006 and no known drug allergies/drug reactions, who on 14-MAY-2008 was vaccinated with the first dose of GARDASIL. On an unspecified date she was vaccinated with the second dose of GARDASIL and on 26-NOV-2008 was vaccinated with the third dose of GARDASIL. Subsequently it was determined to be pregnant by home pregnancy test. Last menstrual period was 19-OCT-2008 and estimated date of delivery was 26-JUL-2009. At the time of the report the patient had a prenatal blood work done (results were pending). The patient sought medical attention. Follow up information was received which reported that the patient had a vaginal delivery on 30-JUL-2009. Follow up information was received from a Physician's Assistant (P.A.) who reported that the patient had a spontaneous vaginal birth and delivered a healthy female on 30-JUL-2009, at 40 weeks (Estimated Gestational Age). It was reported that at the patient's postpartum visit it was noted that the baby was "thriving". The physician assistant stated there were no complications for the baby, and the mother only had mild anemia in her pregnancy, nothing more. It was unknown if the patient recovered from mild anemia. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fungal infection, Placental disorder, Ultrasound scan abnormal, Vacuum extractor delivery
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.), for the Pregnancy Registry for GARDASIL, concerning an approximately 18 year old female patient who on an unknown dates received all 3 doses of GARDASIL and was pregnant. This is one of several reports received from the same source. Follow up information was received from a physician concerning the 18 year old female with a history of 1 previous pregnancy and one spontaneous abortion, no significant past medical history and no known drug allergies. The physician did not have information regarding the dates of vaccination because the patient was transferred at 28 weeks of gestation. The patient's LMP was 10-OCT-2008. Ultrasounds performed on 30-MAR-2009 and 11-APR-2009 showed a low lying placenta. The Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was not done at the previous doctor's office. On 17-JUN-2009, the patient gave birth to a normal female baby via vacuum assisted delivery, with no congenital anomalies and no other complication or abnormalities, weighing 8 pounds and 10 ounces, length 20.5, apgar score 8/9, head circumference 13.4 inches. The normal prenatal tests were performed during pregnancy (all were within normal limits). During the pregnancy the patient used TERAZON cream for a yeast infection (start date 14-MAY-2009). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who was expose to GARDASIL (Lot not reported) on 02-JUN-2009 in utero. Concomitant therapy included WELLBUTRIN. It was reported that on 04-JAN-2010 at 34 weeks and 2 days of gestation, the patient born with an Apgar score of 9/9. The mother of the patient had a premature rupture of membrane and this forced a premature labor (WAES 0906USA01485). An ultrasound performed during pregnancy revealed a possible benign heart echogenic focus. No infections or illnesses were reported during pregnancy. No other medications were used during pregnancy. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy Registry for GARDASIL, concerning a female patient with no known drug allergies or pertinent medical history, who on 09-MAY-2008 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot: 659964/1978U). On 21-JUL-2008 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot: 660553/0070X) and on 03-JUN-2009 the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. There was no concomitant medication. In March 2009, the patient had her last menstrual period (LMP), her estimated delivery date (EDD): December 2009. No adverse effect was reported. On 05-JUN-2009, the patient underwent a comprehensive metabolic panel, complete blood count, lipids, insulin level, TSH and hCG quantitative (lab results not reported). At the time of this report, this patient's outcome was unknown.  Follow up information was received from a nurse practitioner indicated that the patient was a 17 year old female. The patient received a third dose of GARDASIL (Lot: 661441/0631X valid for varicella virus vaccine live (Merck) (MSD)), while she was pregnant. The patient had an ultrasound on 24-JUN-2009: which reported "19 6/7 e 14 2/7" with an estimated date of delivery of 12-NOV-2009. There were no previous pregnancies or births. Follow up information received from a nurse practitioner indicated that on 23-NOV-2009 at 41 2/7 weeks from her last menstrual period, the patient gave birth to a normal female, who weighed 7 pounds and 6 ounces. The baby's length was 19 3/4. It was reported that the baby experienced nuchal cord and fetal bradycardia (WAES # 0906USA03366B1). Concomitant medication used during this pregnancy included prenatal vitamins. On an unspecified date, the patient developed anemia and reflux. She was prescribed ferrous sulfate for the anemia and ranitidine for the reflux. The patient had a seasonal influenza virus vaccine (unspecified) shot on 09-SEP-2009 and a H1N1 shot on 26-OCT-2009.  The patient's outcome was unknown. Attempts to obtain additional information regarding the infant have been unsuccessful. No further information is available.