chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Swelling face, Tremor
Clinical narrative: THURSDAY, JUNE 4TH, RIGHT SIDE OF FACE STARTED SWELLING. PARENT TOOK HER INTO EMERGENCY ROOM. BY THE TIME THE M.D. GOT THERE SHE WAS ALERT AND ACTIVE. E.R. STAFF SAID SHE SEEMED LIKE A NORMAL BABY AND THEY COULDN'T NOTICE THE SWELLING BUT PARENT COULD. THEY DISCHARGED HER TO HOME THURSDAY NIGHT. FRIDAY, JUNE 5TH, SHE WENT TO HER REGULAR DR. FOR HER ROUTINE 4 MO. CHECK UP AND WAS FINE THERE. THEN AT 3:00 P.M. SHE STARTED HAVING SEIZURES, RIGHT EYE WAS DROOPING AND SHE WAS SHAKING. PROBABLY HAD 15 SEIZURES AT HOME PER MOM, AND HAD ABOUT 5 SEIZURES ON WAY TO HOSPITAL. ER STAFF TOOK HER INTO TRAUMA ROOM AND CHECK-IN NURSE SAW A SEIZURE. THEY DREW BLOOD AND DID A SPINAL TAP AND ADMITTED HER. SHE KEPT ON HAVING SEIZURES THROUGH OUT NIGHT. DID EEG ON SAT JUNE 6TH AND THEY CAUGHT A SEIZURE AND PUT HER ON PHENOBARBITAL. SUNDAY JUNE 7TH SHE HAD THREE MORE SEIZURES. THEY KEPT HER ON EEG MACHINE UNTIL MONDAY MORNING JUNE 8TH. THEN MONDAY MORNING SHE GOT AN MRI DONE. NO MORE SEIZURES SINCE SUNDAY JUNE 7TH. MRI CAME BACK NORMAL. TUESDAY DID ANOTHER SPINAL TAP, FIRST CULTURE HAD BACTERIA IN IT BUT THOUGHT IT WAS CONTAMINATION BECAUSE IT WAS JUST A LITTLE BIT. 2ND SPINAL CAME BACK NORMAL. WEDNESDAY JUNE 10TH SHE WAS RELEASED HOME AND NOTHING HAS HAPPENED SINCE WITH SEIZURE ACTIVITY. SHE IS ON PHENOBARBITAL 20 MG. AMT: 1 AND 1/2 TSP. QD PO. THE NEUROLOGIST SAID IF NO MORE SEIZURE ACTIVITY FOR 6 MONTHS, WILL TRY TO WEAN HER OFF MED.  7/1/09 Hospital records received DOS 6/6/09 to 6/10/09. Assessment: New onset seizures. Patient presented with multi episodes of eye blinking, unresponsiveness, drooling. Twitching, eyes rolling back. Tachycardic. Stares to right. Rash lower extremities. Hyperreflexia, clonus.  7/16/09 ICD-9 Codes: 780.39, 987.8
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: syncope and briefly passed out a few minutes after vaccines administered.  Client laid on exam table and given juice.
Age: 29.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP, TYP
Symptoms: Auricular swelling, Urticaria
Clinical narrative: CLIENT RECEIVED ALL THE VACCINES LISTED IN ITEM NUMBER 13 ON 06/10/2009 SHE STATED HAD AN OUTBREAK OF HIVES THE FOLLOWING DAY WITH EARS VERY SWOLLEN. HAD TO GO SEE HER PHYSICIAN AND WAS GIVEN STEROID INJECTION TREATMENTS. STILL CONTINUING WITH TREATMENT DUE TO THE FACT THAT IT WILL CLEAR UP TEMPORARILY. DENIES ANY FEVER, SWELLING OR REDNESS AT THE VACCINE INJECTION SITES.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Pain, Pain in extremity, Urticaria
Clinical narrative: Day of injection patient complained of left arm pain rest of day.  Next day had headache, chills, body aches, and hives to arms and torso.  2 days later all symptoms resolved other than hives to left arm and face.  3 days later feeling well, but hives to legs.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: 3010/29 Itching under armpits 10/30 red and itchy under arms, down side of breasts, on stomach and down to the pelvic area. 10/31 went to stat care saw 2 Dr.s sent her to Dr. Advised prob. reaction to flu shot. Gave predisone and "itch" med. Had Hx. of hives from boiled eggs when 2yrs eats eggs now and has had flu shot for 10 years without problems.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Menorrhagia
Clinical narrative: Following anthrax vaccination, member states she had 5 menstration flows in a 6 week period.  This reaction has never happened to her prior to vaccination or since.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Herpes zoster
Clinical narrative: Pt developed zoster rash within 24hrs of receiving vaccine. Pt was seen in office 6/15/09 and started on Famciclovir and Prednisone.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Fatigue, Vomiting
Clinical narrative: Vaccination given at 9:20 a.m. Patient showed signs of excessive tiredness at 7:45 p.m. Vomiting occured beginning at 4:00 a.m.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: 4 days after receiving DTaP #4 and Hepatitis A #1, patient presented to ER with c/o redness and swelling at injection site. Today (6/15/09)mom reports that redness is gone, but that lump is still present and patient is limping on that leg. Patient has appointment for evaluation in our office tomorrow.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shots were given on 5/20/09. Shot site got swollen, hot and erythematous.  Was adv to try ice and Benadryl initially.  Came into offc on 5/22/09 & was diagnosed with Cellulitis of thigh and Immunization Reaction. Was started on Omnicef x 10 days.
Age: 56.0
Sex: F
Vaccine: TD, TYP, YF
Symptoms: Erythema, Malaise, Rash macular
Clinical narrative: HAD yellow fever INJECTION ON 6/10/09 DEVELOPED A 4 INCH RED BLOTCH ( NO FILLED) ON LEFT BACK OF ARM AND FELT MALAISE x 1 DAY.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed zoster pain 48 hours after administration and classic rash 6 days after vaccine.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/extreme swelling to injection site per mom. Witnessed by Dr. at home visit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Injection site erythema, Injection site pain, Vomiting
Clinical narrative: Pt received vaccinations on 6/9/09. He was up most of the night after vaccine with pain in his left thight. On 6/10/09, thigh was red & still painful. Also had emesis and may have had the chills.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Asthenia, Dizziness
Clinical narrative: Fainting spells started in January 2009. They occurred multiple times per day and continued for over 2 months. She also experienced nausea, dizziness and was lightheaded. She also suffered from fatigue, weakness, stomach aches and muscle and joint pain. She was unable to attend school for an extended period of time.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Myalgia, Nausea, Syncope
Clinical narrative: Fainting spells started in January 2009. They occurred multiple times per day and continued for over 2 months. She also experienced nausea, dizziness and was lightheaded. She also suffered from fatigue, weakness, stomach aches and muscle and joint pain. She was unable to attend school for an extended period of time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site vesicles
Clinical narrative: 4x4 Swelling, redness, irritation at injection site with little blister bubbles at site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Varicella-like rash developed 3 days after given Zostavax
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Red swollen dots around injection site. Hives on upper deltoid to elbow. Pt to take BENADRYL q 6 hours prn call if worse. 15cm hive around injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: At injection site approximately equal to 2 X 2" red swollen, hot to the touch, raised area.  The next day injection has gotten approximately 1 " bigger than before.  Pt has been taken MOTRIN 94-6 hours BENADRYL 98 hours.  No improvement.   Injection site left thigh will give ORAPREDOCT today with BENADRYL to see if any improvement.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall
Clinical narrative: Patient suddenly fell to the floor about 1 minute after.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Gait disturbance, Malaise, Oedema, Pain
Clinical narrative: Severe bilateral lower extremity edema. Assoc with pain that makes walking difficult. Also assoc with malaise and fatigue. Occurred both times she was given Hep A vaccines but did not realize relation to vaccine after 1st injection. Sx lasted 10 days each time.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Ultrasound Doppler
Clinical narrative: Severe bilateral lower extremity edema. Assoc with pain that makes walking difficult. Also assoc with malaise and fatigue. Occurred both times she was given Hep A vaccines but did not realize relation to vaccine after 1st injection. Sx lasted 10 days each time.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Erythema multiforme
Clinical narrative: Developed erythema multiforme w/in 96' of DTaP, Hep A, PREVNAR and MOTRIN.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Cellulitis, Genital swelling, Potassium hydroxide preparation negative, Similar reaction on previous exposure to drug, Vaginal swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of labial swelling in a 16-Year-old female subject who was vaccinated with HEPATITIS A vaccine (unspecified manufacturer). Concurrent medical conditions included acne and heavy period. Concurrent medications included ZIANA, ORTHO TRI-CYCLEN LO, TYLENOL NO. 3, unspecified Antibiotic, Lignocaine gel and Duraplast spray. On an unspecified date in February 2009, the subject received 1st dose of HEP A vaccine (unspecified manufacturer, unknown). On an unspecified date, the subject received the 2nd dose of HEP A vaccine (unspecified manufacturer, unknown). At an unspecified time after vaccination with the first dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. Outcome of the events was unspecified. Causality was not specified. At an unspecified time after vaccination with the second dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. The events were unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with HEP A vaccine. The subject's next follow-up was on 27 April 2009. Follow-up was received from the reporting healthcare professional on 8 June 2009: The HEP A vaccine was confirmed as HAVRIX (GlaxoSmithKline). Concurrent medical conditions included dysmenorrhea. The subject denied history of sexual activity ever. Concurrent vaccination included MENACTRA, non-GSK manufacturer, intramuscular, left deltoid given on 22 January 2009. On 22 January 2009 the subject received 1st dose of HAVRIX (intramuscular, left deltoid). On 23 January 2009, 1 day after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. The events resolved on an unspecified date. On 16 April 2009 the subject received 2nd dose of HAVRIX (intramuscular, left deltoid). On 20 April 2009, 4 days after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. It was reported that the symptoms were milder after the 1st dose of HAVRIX. The subject also experienced cellulitis. This case was assessed as medically serious by GSK. The subject had been treated with an unknown medication without relief by her primary care provider. She was seen by a gynecologist on 20 April 2009 and potassium hydroxide slide was negative for yeast, the subject was noted to have mild cellulitis. The subject was treated with KEFLEX and an unknown medication. At the time of reporting the events were resolved; the follow-up scheduled for 27 April 2009 was cancelled.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of labial swelling in a 16-Year-old female subject who was vaccinated with HEPATITIS A vaccine (unspecified manufacturer). Concurrent medical conditions included acne and heavy period. Concurrent medications included ZIANA, ORTHO TRI-CYCLEN LO, TYLENOL NO. 3, unspecified Antibiotic, Lignocaine gel and Duraplast spray. On an unspecified date in February 2009, the subject received 1st dose of HEP A vaccine (unspecified manufacturer, unknown). On an unspecified date, the subject received the 2nd dose of HEP A vaccine (unspecified manufacturer, unknown). At an unspecified time after vaccination with the first dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. Outcome of the events was unspecified. Causality was not specified. At an unspecified time after vaccination with the second dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. The events were unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with HEP A vaccine. The subject's next follow-up was on 27 April 2009. Follow-up was received from the reporting healthcare professional on 8 June 2009: The HEP A vaccine was confirmed as HAVRIX (GlaxoSmithKline). Concurrent medical conditions included dysmenorrhea. The subject denied history of sexual activity ever. Concurrent vaccination included MENACTRA, non-GSK manufacturer, intramuscular, left deltoid given on 22 January 2009. On 22 January 2009 the subject received 1st dose of HAVRIX (intramuscular, left deltoid). On 23 January 2009, 1 day after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. The events resolved on an unspecified date. On 16 April 2009 the subject received 2nd dose of HAVRIX (intramuscular, left deltoid). On 20 April 2009, 4 days after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. It was reported that the symptoms were milder after the 1st dose of HAVRIX. The subject also experienced cellulitis. This case was assessed as medically serious by GSK. The subject had been treated with an unknown medication without relief by her primary care provider. She was seen by a gynecologist on 20 April 2009 and potassium hydroxide slide was negative for yeast, the subject was noted to have mild cellulitis. The subject was treated with KEFLEX and an unknown medication. At the time of reporting the events were resolved; the follow-up scheduled for 27 April 2009 was cancelled.
Age: 0.7
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Mom reports she noticed hives on baby's back; Buttocks at 8 PM on 5/27/09 - approximately 4 hours after injection - and a fever of 99.9 gone by noon next day.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dizziness
Clinical narrative: Pt. was seen on 6/9/09 for pap smear - during course of visit she advised provider that she refused any further GARDASIL. Stated that apx 3 hours after 1st GARDASIL, she felt disoriented - family members claim she was "in and out of reality" - dizzy, disoriented lasted for 24 hours.
Age: 10.4
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Syncope
Clinical narrative: Pt fainted in waiting area.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Vaginal lesion, Varicella zoster virus serology positive
Clinical narrative: (No pain) 11/11/08 - 1st sore on outer vaginal area/left side. 11/12/08 - fever 101. 11/14-18/08 - more sores-outer left vaginal area. 11/20/08 DR. takes blood tests and prescribes Famciclovir. 12/11 - 2nd blood test. 12/4/08 - per DR - clearing up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Patient has red rash, left side of forehead and surrounding Lt eye, consistent with shingles.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, CSF protein increased, Computerised tomogram normal, Gait disturbance, Headache
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Borrelia burgdorferi serology, Computerised tomogram, Dehydration, Dyskinesia
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Gait disturbance, Gastroenteritis viral, Intensive care, Miller Fisher syndrome
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Sinusitis, Speech disorder
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, Blood test, Borrelia burgdorferi serology, CSF test abnormal, Computerised tomogram head
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dehydration, Facial paresis, Fatigue, Gait disturbance, Gastroenteritis viral
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Head deformity, Headache, Intensive care, Miller Fisher syndrome, Motor dysfunction
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging normal, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Sinusitis, Speech disorder, Viral infection, Vomiting
Clinical narrative: 5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry.  7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome?  ICD-9 Codes: 781.3  357.0  112.0  578.0  783.0  787.20  461.0  477.9  784.7
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, erythema in (whole upper right) arm of injections. Symptoms started within 24hrs. At 4 days starting to improve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At bedtime on 6/5/09 mother noticed left arm was red and swollen from shoulder to elbow. Afebrile. Cold compress applied.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Facial palsy
Clinical narrative: Rt facial nerve palsy "Bell's palsy"
Age: 1.4
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Urine analysis normal
Clinical narrative: Given vaccines 6/3/09, started with fevers to 104-105 on 6/4/09, seen in clinic 6/5/09 with fever to 104.4, no S/S URI, UA dip (-). F/U call 6/6/09 fever resolved, now 99: today started with congested cough.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Chest X-ray normal, Dehydration, Diarrhoea, Pyrexia
Clinical narrative: On 5-29-09-4AM started vomiting/diarrhea, 11:00AM Fever 100.7. By 7:00 PM fever 102.8. Continued to vomit, went to emergency room. Received IV fluids with ZOFRAN IV for vomiting. Blood work was normal. UA normal, CXR normal. After hydrated (3 hours) was discharged with oral PHENERGAN. 5-30-09 Temp 100.1; 6-1 Temp 99.6. 6-2 temp normal.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: On 5-29-09-4AM started vomiting/diarrhea, 11:00AM Fever 100.7. By 7:00 PM fever 102.8. Continued to vomit, went to emergency room. Received IV fluids with ZOFRAN IV for vomiting. Blood work was normal. UA normal, CXR normal. After hydrated (3 hours) was discharged with oral PHENERGAN. 5-30-09 Temp 100.1; 6-1 Temp 99.6. 6-2 temp normal.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction
Clinical narrative: Numbness in wrist, elbow and shoulder of arm ADACEL was administered, began within a few minutes of injection. Numbness was in (R) arm. Full range of motion of hand, elbow, and shoulder, equal strength, intraradial and ulnar pulse, good capillary refill, sharp and light touch diminished. No hives or respiratory distress. To ice and use MOTRIN for 6 hrs as needed. Sent to neurology since numbness continued. Seen on 6/10/09 by neurology. Neurology note attached.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Pain, Urine analysis normal
Clinical narrative: Pt developed body aches, myalgias on 5/29/09. The next day, she was much better.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling R Deltoid
Age: 18.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Rash erythematous
Clinical narrative: Red raised rash on hands, chin 6/12 taken to Medical Center Rx for Prednisone 20 mg Qd II tabs 6/15 spoke with mother, patient is doing well today.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Syncope in waiting room. Fell and hit her head on chair in waiting room ~ 5 min after receiving vaccines. Possibly hit head on seat cushion or possibly on chair arm. Was tx with rest, juice, + crackers. No c/o head pain, no contusion or bruising noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Lt thigh with large area of erythema, warm to touch
Age: 22.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Feeling hot, Induration, Oedema, Tenderness
Clinical narrative: R interior deltoid ~ 3 cm oval shaped area erythema, edema + warmth + induration 0 fluctuation + tender to palpation. given Bactrim DS #14, T by mouth RID x 1 wk.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site papule, Pain, Pruritus
Clinical narrative: Varicella vaccine adm. on 6/10/09. Mother noted "small red bump" at site yesterday. Larger red round spot today. (Left triceps area) (6cm diameter) Slight itching and soreness; no other Sx.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Ophthalmological examination normal, Screaming, X-ray normal
Clinical narrative: Patient received her vaccine on 4/20/09 am and began screaming at 4/23/09. She was seen in the ER after 2018 on 4/25/09, when abdominal x ray, un, and fluorescein eye eval were negative. I also examined her there. She fell asleep @ 0200 4/26, slept 9hr, and was much better. She'd been happier in the 48 hr immediately after vaccine then she'd ever been.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Back pain, Chest pain, Headache, Oedema peripheral
Clinical narrative: (1) Severe headache and swelling RT arm - Aspirin TYLENOL. Ice pack initially. (2) Repetition of above q 2 weeks with shooting pains RT side body to left side of body. Pain in chest and up L back. Headaches with vision changes and low grade fever.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Visual impairment
Clinical narrative: (1) Severe headache and swelling RT arm - Aspirin TYLENOL. Ice pack initially. (2) Repetition of above q 2 weeks with shooting pains RT side body to left side of body. Pain in chest and up L back. Headaches with vision changes and low grade fever.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt states he had swelling and pain at injection site.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: On 5/21/09 Pt saw Doctor reports received Td Booster at Hospital on 5/19/09. Left arm erythema induration 2 degrees. DX: Local allergic reaction to Tetanus. Rx: Benadryl, Medrol dose pack + warm compresses.
Age: 30.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Body temperature increased, Cellulitis
Clinical narrative: T to > 102 within 4 hours, cellulitis picture 48 hours later.
Age: 30.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Body temperature increased, Cellulitis, Fatigue, Nausea, No reaction on previous exposure to drug
Clinical narrative: T to > 102 within 4 hours, cellulitis picture 48 hours later.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fatigue, Headache, Hypersomnia, Oropharyngeal pain
Clinical narrative: (Hep A and MENACTRA) Tdap 8/407. Head ache /st over time developed fatigue (sleep up to whole day) and headache (1st concerning Reaction). (2nd reaction) After Hep A on 10/29/08 HA started that he did not have at time of apt and vaccine for pain and HA. Seen 10/31/08.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Abdominal pain, Headache
Clinical narrative: After HepA on 10/29/08 HA started that he did not have at time of apt & vaccine. Seen 10/31/08 for abd pain & HA.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Administered 5/22/09; on Sunday, 5/24/09 Pt developed papular rash on upper back and chest, with itching. Both itch and rash diminished over next few days still mildly present 5/29/09.
Sex: U
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of GARDASIL (LOT# not reported). The reporter said the patient experienced an AE involving GUILLAIN-BARRE Syndrome-like symptoms. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Tremor, Vomiting
Clinical narrative: Information has been received from a nurse concerning a female with no allergies who on 20-JUL-2007 and on 24-SEP-2007 was vaccinated IM 0.5 mL with the first and second doses of GARDASIL (lot# Not reported) respectively. It was unspecified if the patient had any adverse events after the first or second doses. On an unknown date, the patient received the third dose of GARDASIL (lot# not reported) IM 0.5mL. After the third shot, on 25-JAN-2008, the patient started "shaking" and vomiting. The patient went to the Emergency Room of a hospital and had "an anaphylactic reaction" while there. The patient was not admitted to that hospital but was "transferred" and admitted to another hospital for the "anaphylactic reaction". Subsequently, the patient recovered from the anaphylactic reaction while she was in hospital. In follow-up, it was reported the events happened in 2008 and patient's name and details could not be recalled. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a nurse practitioner concerning 3 children who was vaccinated with GARDASIL. The nurse practitioner reported that a mother of her patient informed her that 3 children in her patient's high school developed guillain-barre syndrome after receiving GARDASIL. The patient refused and did not get the GARDASIL for this reason. Upon internal review, Guillain-Barre syndrome was considered to be an Other Important Medical Event. Attempts are being made to verify the existence of an identifiable patient and reporter. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a teenage female who within the last two years (approximately 2007) was vaccinated IM with a dose of GARDASIL (route in the series and lot number unspecified).  The physician reported that the patient "fainted" after getting the vaccine.  The outcome of the patient was recovered.  The patient sought unspecified medical attention.  This is one of two reports from the same source.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received for the Merck pregnancy registry, from a nurse concerning a female patient, who was vaccinated with two doses of GARDASIL on 28-Sep-2006 and 27-Nov-2006 respectively. The patient is currently pregnant and her LMP was 15-Dec-2006. The patient's outcome was unknown. Follow-up information was received via the registered nurse from pregnancy questionnaire. The 17 year old patient with a history of 1 previous pregnancies and 1 full and a history of gestational diabetes mellitus was vaccinated with three doses of GARDASIL on 28-sep-2005 (lot # 653735/0688F), 27-Nov-2006 (lot # 653978/0955F) and 05-Oct-2007 (lot # 658282/0929U) respectively. Other medication use during pregnancy included prenatal VITAMIN. On 04-APR-2007, serum alpha-fetoprotein test was performed with negative delivered a male normal baby weighting 7 pounds 5.5 ounces with apgar score 9/9 at 36 weeks. The length of the baby is 19 inches. There were no congenital anomalies, other complication or abnormalities. There was no complication during pregnancy and labor/delivery. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning a 21 year old female with a history of laparoscopic cholecystectomy (27-JUL-2007) and cesarean section who on 16-JAN-2008 was vaccinated intramuscularly in the right deltoid with a dose of GARDASIL (lot#659439/1267U). There was no concomitant medication. The patient sought unspecified medical attention during an office visit on 16-JAN-2008 and 04-FEB-2008. The nurse reported that the patient was pregnant. Last menstrual period was 23-DEC-2007 and estimated date of delivery is 28-SEP-2008. The patient had a negative urine pregnancy test on 16-JAN-2008 and a positive pregnancy test on 04-FEB-2008. No symptoms have been reported. Follow up information received on 04-MAY-2009 from the registered nurse stated that the patient transferred her prenatal care to another physician. The reporter said that she does know that the patient did deliver her baby and had no complications. Follow information received from a physician indicated that the patient gave birth to a normal live born female, who weighted 6 lbs and 6 ounces on 13-SEP-2008 at 37 weeks and 3 days from LMP. The baby's length was 19" and her apgar score was 9/9. There were no congenital abnormalities. It was also reported that the baby experienced decreased fetal movements and decreased heart beat to beat variability. There were no complications during pregnancy and during labor. The patient had routine prenatal blood work within normal limits. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no known allergies and a history of depression, iron deficiency anemia and gastroesophageal reflux who on 27-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 659435/1265U). On 25-FEB-2008 the patient was vaccinated intramuscularly in the "right upper arm" with a 0.5 mL second dose of GARDASIL (lot # 659962/1740U). The physician reported that on an unspecified date the patient called her OB/GYN and reported that she was approximately 8 weeks gestation. Actual LMP and method of pregnancy confirmed were not reported. In follow-up it was reported that concomitant medication included BENTYL, 10 mg as needed for the treatment of GERD; ORTHO TRI-CYCLEN, 0.025 mg daily for "prevention"; and ZOLOFT, 25 mg daily for the treatment of "Post Partum". It was also reported that the patient's estimated delivery date is 20-NOV-2008 (estimated LMP 12-FEB-2008). Follow-up information has been received that the patient made a preterm delivery on an unknown date, the infant was normal. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Chlamydia identification test positive, Chlamydial infection, Drug exposure during pregnancy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Information has been received from a Nurse Practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with thrombocytopenia who on 09-MAY-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included tetanus toxoid, administered "on the same day, 09-MAY-2008") and vitamins (unspecified). On an unspecified date the patient had a positive urine pregnancy test. The patient's LMP was reported as 08-APR-2008. The patient sought unspecified medical attention. Patient outcome was not reported. Follow up information has been received from a completed questionnaire by a certified nurse midwife (previously reported as nurse practitioner). It was reported on the questionnaire that the patient with no concurrent medical conditions, on an unspecified date experienced Chlamydia infection (2 episodes) and thrombocytopenia (previously reported as concurrent condition) during pregnancy (diagnostic tests performed on unspecified dates). Other medications used during this pregnancy included prenatal vitamins (unspecified) and azithromycin. On 22-AUG-2008, the patient had a screening ultrasound. On 10-JAN-2009 at 39 weeks from LMP, the patient delivered a male liveborn infant. He weighed 8 lbs and 03 oz, apgar score was 8/9. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Nurse Practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with thrombocytopenia who on 09-MAY-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included tetanus toxoid, administered "on the same day, 09-MAY-2008") and vitamins (unspecified). On an unspecified date the patient had a positive urine pregnancy test. The patient's LMP was reported as 08-APR-2008. The patient sought unspecified medical attention. Patient outcome was not reported. Follow up information has been received from a completed questionnaire by a certified nurse midwife (previously reported as nurse practitioner). It was reported on the questionnaire that the patient with no concurrent medical conditions, on an unspecified date experienced Chlamydia infection (2 episodes) and thrombocytopenia (previously reported as concurrent condition) during pregnancy (diagnostic tests performed on unspecified dates). Other medications used during this pregnancy included prenatal vitamins (unspecified) and azithromycin. On 22-AUG-2008, the patient had a screening ultrasound. On 10-JAN-2009 at 39 weeks from LMP, the patient delivered a male liveborn infant. He weighed 8 lbs and 03 oz, apgar score was 8/9. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Condition aggravated, Drug exposure during pregnancy, Pyelonephritis, Ultrasound scan normal
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with no pertinent medical history and no history of drug reactions or allergies who on 03-APR-2008 was vaccinated with the first dose of GARDASIL (lot#: 659964/1978U) 0.5 ml IV, and on 05-JUN-2008 was vaccinated with the second dose of GARDASIL (lot#:658556/1060U). Concomitant therapy included BENADRYL and ADVIL. After vaccination on 05-JUN-2008, the patient mentioned that she may be pregnant. On 05-JUN-2008, a urine pregnancy test confirmed the patient was pregnant. The patient's last menstrual period was 20-APR-2008, the estimated delivery date is 25-JAN-2009. The patient sought medical attention with a physician office visit. Follow up information received on 28-MAY-2009 from a registered nurse stated that the coach with seasonal allergies and a history of pyelonephritis and one previous pregnancy that resulted in spontaneous abortion on 05-JUN-2008 at 11:15 a.m. received the second dose of GARDASIL intramuscularly into the left deltoid. Concomitant therapy included BENARYL, vitamins unspecified, and MACROBID given for history of pyelonephritis. The patient was prescribed ADVIL for pain. The patient had a ultrasound on 25-JUN-2008 which confirmed the EDC on 02-FEB-2009 and a MSAFP on 21-AUG-2008, which was normal. On 04-SEP-2008 the patient developed pyelonephritis. Her outcome was not reported. On 06-FEB-2009 the patient gave birth to a normal female at 40 4/7 weeks from LMP, who weighted 7 lbs; her apgar score was 8/9. It was reported that there were no complications, during pregnancy and labor/delivery. There were no congenital anomalies. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with no pertinent medical history and no history of drug reactions or allergies who on 03-APR-2008 was vaccinated with the first dose of GARDASIL (lot#: 659964/1978U) 0.5 ml IV, and on 05-JUN-2008 was vaccinated with the second dose of GARDASIL (lot#:658556/1060U). Concomitant therapy included BENADRYL and ADVIL. After vaccination on 05-JUN-2008, the patient mentioned that she may be pregnant. On 05-JUN-2008, a urine pregnancy test confirmed the patient was pregnant. The patient's last menstrual period was 20-APR-2008, the estimated delivery date is 25-JAN-2009. The patient sought medical attention with a physician office visit. Follow up information received on 28-MAY-2009 from a registered nurse stated that the coach with seasonal allergies and a history of pyelonephritis and one previous pregnancy that resulted in spontaneous abortion on 05-JUN-2008 at 11:15 a.m. received the second dose of GARDASIL intramuscularly into the left deltoid. Concomitant therapy included BENARYL, vitamins unspecified, and MACROBID given for history of pyelonephritis. The patient was prescribed ADVIL for pain. The patient had a ultrasound on 25-JUN-2008 which confirmed the EDC on 02-FEB-2009 and a MSAFP on 21-AUG-2008, which was normal. On 04-SEP-2008 the patient developed pyelonephritis. Her outcome was not reported. On 06-FEB-2009 the patient gave birth to a normal female at 40 4/7 weeks from LMP, who weighted 7 lbs; her apgar score was 8/9. It was reported that there were no complications, during pregnancy and labor/delivery. There were no congenital anomalies. No further information is available.