chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody, C-reactive protein, Juvenile arthritis, Musculoskeletal pain
Clinical narrative: Initial and additional information has been received from a nurse practitioner concerning a 14 year old female who on 17-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #: 653735/0688) into the left shoulder. Concomitant therapy included ZYRTEC. In February 2007, the patient developed neck and right shoulder pain, later the patient was diagnosed with juvenile rheumatoid arthritis. The patient was seen by a rheumatologist. On 18-APR-2007, the patient's laboratory test revealed homogeneous antinuclear antibody (ANA) pattern 1 per 80. On 24-APR-2007, the patient's laboratory revealed rheumatoid factor 24.7 and C-reactive protein (CRP) 2.7. On 25-SEP-2007 the patient was seen by another rheumatologist. The patient also saw another physician and a homeopathic physician. On 21-APR-2008, the patient was seen by an orthopedist. On 09-APR-2009, the patient was seen by the physician in the reporter's office. The reporter stated that while the patient was waiting to see the physician, she was seated in a cross-legged position. It was reported the patient's mother request the patient to receive a whole body MRI. The physician was unable to examine the patient due to the patient's pain. The whole body was not ordered by the physician. The reporter stated that she thought the patient's mother was relating the patient's condition to the GARDASIL. Follow-up information was received from a medical assistant in a rheumatologist's office. The medical assistant stated that the patient was first seen the rheumatologist on 18-APR-2007. The patient's laboratory tests revealed a positive rheumatoid factor and a positive anti-CCP (anti-cyclic citrullinated peptide) test. The patient was diagnosed with juvenile rheumatoid arthritis. The medical assistant stated that there was no mention of the patient receiving the GARDASIL vaccine in the physician's notes. The patient was no longer a patient of the rheumatologist. Juvenile rheumatoid arthritis was considered to be disabling. Additional information has been requested.  6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. Assessment: Inflammatory arthritis, rheumatoid arthritis, anemia. Patient presents with neck and right shoulder pain. Numbness of R hand. 'Tightness', pain, erythema, effusion of R knee. Loss of color left hip. Limping. Back, hip, hand and wrist aches. Sore legs and ankles. Rash on legs, knees. Tired, nauseated, headaches. Jaw pain and swelling. Wrist nodules. Soreness of gums.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Rheumatoid factor positive
Clinical narrative: Initial and additional information has been received from a nurse practitioner concerning a 14 year old female who on 17-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #: 653735/0688) into the left shoulder. Concomitant therapy included ZYRTEC. In February 2007, the patient developed neck and right shoulder pain, later the patient was diagnosed with juvenile rheumatoid arthritis. The patient was seen by a rheumatologist. On 18-APR-2007, the patient's laboratory test revealed homogeneous antinuclear antibody (ANA) pattern 1 per 80. On 24-APR-2007, the patient's laboratory revealed rheumatoid factor 24.7 and C-reactive protein (CRP) 2.7. On 25-SEP-2007 the patient was seen by another rheumatologist. The patient also saw another physician and a homeopathic physician. On 21-APR-2008, the patient was seen by an orthopedist. On 09-APR-2009, the patient was seen by the physician in the reporter's office. The reporter stated that while the patient was waiting to see the physician, she was seated in a cross-legged position. It was reported the patient's mother request the patient to receive a whole body MRI. The physician was unable to examine the patient due to the patient's pain. The whole body was not ordered by the physician. The reporter stated that she thought the patient's mother was relating the patient's condition to the GARDASIL. Follow-up information was received from a medical assistant in a rheumatologist's office. The medical assistant stated that the patient was first seen the rheumatologist on 18-APR-2007. The patient's laboratory tests revealed a positive rheumatoid factor and a positive anti-CCP (anti-cyclic citrullinated peptide) test. The patient was diagnosed with juvenile rheumatoid arthritis. The medical assistant stated that there was no mention of the patient receiving the GARDASIL vaccine in the physician's notes. The patient was no longer a patient of the rheumatologist. Juvenile rheumatoid arthritis was considered to be disabling. Additional information has been requested.  6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. Assessment: Inflammatory arthritis, rheumatoid arthritis, anemia. Patient presents with neck and right shoulder pain. Numbness of R hand. 'Tightness', pain, erythema, effusion of R knee. Loss of color left hip. Limping. Back, hip, hand and wrist aches. Sore legs and ankles. Rash on legs, knees. Tired, nauseated, headaches. Jaw pain and swelling. Wrist nodules. Soreness of gums.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician assistant and a licensed practical nurse concerning a female who was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml. The patient experienced seizure like symptoms after receiving her first dose. Series was discontinued and the patient did not receive any further doses of GARDASIL. The patient sought unspecified medical attention. Upon internal review, seizure like symptoms was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypothyroidism, Rheumatoid arthritis
Clinical narrative: Information has been received from a physician assistant concerning a 20 year old female with migraine, penicillin allergy and VICODIN allergy and a history of pneumonia (in November 2006) who on 15-AUG-2007 was intramuscularly vaccinated with the 3rd 0.5 ml dose of GARDASIL (lot #658556/1060U) into the left arm deltoid. The dates of the first two doses of GARDASIL were not available. Concomitant therapy included multivitamins (unspecified), ascorbic acid, vitamin E and unspecified over the counter medication for migraines. In August 2008, the patient experienced hypothyroidism and rheumatoid arthritis. The patient initially treated with prednisone. At the time of reporting, the patient did not recover. The patient had an office visit for medical attention. Hypothyroidism and rheumatoid arthritis were considered to be disabling. Additional information has been requested.  5/19/09 medical records received 4/9/07 to 4/16/09. FINAL DIAGNOSIS: Rheumatoid arthritis, hypothyroidism Post vaccination: Rheumatoid arthritis, hypothyroidism diagnosed. Candida.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Headache, Hypersensitivity, Lymphadenopathy, Malaise, Mononucleosis heterophile test negative
Clinical narrative: Mother reports child woke up "Sunday night at 1:30" (April 12) with c/o not feeling well, sore throat and swollen glands on side of neck.  Reports c/o headache and aching "all over".  Reports child was seen by Dr 4/13/09 and diagnosed with "allergies".  On 4/14/09 was seen at ED with diagnosis of "virus".
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Mumps antibody test negative, Oropharyngeal pain, Pain, Streptococcal identification test negative, Viral infection
Clinical narrative: Mother reports child woke up "Sunday night at 1:30" (April 12) with c/o not feeling well, sore throat and swollen glands on side of neck.  Reports c/o headache and aching "all over".  Reports child was seen by Dr 4/13/09 and diagnosed with "allergies".  On 4/14/09 was seen at ED with diagnosis of "virus".
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Discomfort, Injection site infection, Pyrexia, Skin infection
Clinical narrative: Patient developed a skin infection at the site of the MMR vaccination.  She had low grade fevers for days and was in discomfort.  10 days on antibiotic Cephalexin 125MG/5ML susp 200ML, 1 tsp by mouth three times daily.
Age: 16.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: PT RECEIVED DTAP INSTEAD OF TDAP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site oedema, Injection site warmth
Clinical narrative: Left upper arm from just above elbow to shoulder joint. Had 4+ edema.  Hot to touch, with deeper reddish black skin discoloration below where Kinrix inj. was given.  This swelling started around 8 to 12 hours after injection was given.  It was at it's peak in about 24 hours.  Saw his PCP who prescribed antibiotics and Benadryl.  Started this treatment 48 hours after injection. At the 72 hour mark swelling started to subside.  This was after 2 doses of antibiotic and Benadryl. The patient never complained of pain.  Nor did the reaction interfear with his daily routine.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
Clinical narrative: Patient had loss of consciousness after vaccination, associated with tonic clonic motions of extremities.  Complete recovery.  No prior history of seizures or adverse reactions to vaccine.  No loss of bowel or bladder control, no tongue biting
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Child received 2 month vaccines as Pentacel, Prevnar and Rotateq.  Vaccines given at 10:30 AM, Infant had inconsolable crying and mild fever (not recorded) for a period of 5-6 hrs with a small nap in between.  Child was seen in my office later in the evening at 4.30 PM, tylenol was given and ice pack applied on the thighs.  Child gradually settled in 1.5 hrs after Tylenol and Ice, fed BF and remained OK since, temp in ofice was 99.1.  Called mom today and said to be doing fine.  Mom did give a total of 4 doses of Tylenol
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Patient received vaccinations and about 5.5 - 6 hours later experienced weakness, fatigue and fever of 102.5 axillary.  No other symptoms other than muscle weakness in all 4 extremities
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: THIRD VARICELLA VACCINE RECEIVED.  PREVIOUS DOSES ON CHILD GIVEN ON THESE DATES: 4/21/03, 04/18/2007
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Hyperhidrosis, Immediate post-injection reaction, Nervousness, Pallor
Clinical narrative: Patient turned pale and diphoretic after administration of first Gardasil vaccine. Patient complained of feeling like she was going to pass out. Patient was told to lie down, feet were put up, patient was fanned. Recovered with in 1 to 2 minutes, did not pass out. Patient stated that she has passed out before with injections and when her umbilicus was pierced. Was very nervous prior to injection and started crying. Blood pressure after recovery was 90/68. Patient stated that she had not eaten yet today, time was around 1030am.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Patient turned pale and diphoretic after administration of first Gardasil vaccine. Patient complained of feeling like she was going to pass out. Patient was told to lie down, feet were put up, patient was fanned. Recovered with in 1 to 2 minutes, did not pass out. Patient stated that she has passed out before with injections and when her umbilicus was pierced. Was very nervous prior to injection and started crying. Blood pressure after recovery was 90/68. Patient stated that she had not eaten yet today, time was around 1030am.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red and indurated at injection site. Heat and prednisolone.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity, Skin induration
Clinical narrative: Large local reaction from left elbow to over left shoulder including underside of arm. Red, hot to touch, skin hard and swollen, painful, no enlarged axillary nodes, no fever. Per physician, parent to continue with Tylenol, ice pack, Benadryl if desired, return to clinic if increasing redness or fever. Line drawn on child's arm to mark redness and swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Skin warm
Clinical narrative: Large local reaction from left elbow to over left shoulder including underside of arm. Red, hot to touch, skin hard and swollen, painful, no enlarged axillary nodes, no fever. Per physician, parent to continue with Tylenol, ice pack, Benadryl if desired, return to clinic if increasing redness or fever. Line drawn on child's arm to mark redness and swelling.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood test, Convulsion, Electroencephalogram
Clinical narrative: 3 days after receiving his 4 month booster vaccines patient started having seizures which have resulted in several hospitalizations, numerous medications and he is still currently having 1-3 seizures a week which have been very difficult to control  05/8/09 ED records received for DOS 10/1/07-10//2/07 FINAL DIGANOSIS: Seizure Lip smacking, staring, unaware of surroundings. Later head turned to right, eyes deviated to right, pale, lip smacking. Later head deviated to left, eyes to left, stiffened.  PE - Irritable but easy to console, Ant fontanel opened but slightly small, slightly unsteady on sitting.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: WITHIN 24 HR OF VACCINES, PT GOT RAISED RASH ON BOTH ARMS. RX KEFLEX 250MG TID FOR 1 WK. CLARITIN RX, BENADRYL HS PRN.RETURN IF NOT IMPROVED.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site macule, Injection site swelling, Injection site warmth
Clinical narrative: LT DELTOID MACULAR RASH,MILD SWELLING, WARM TO TOUCH. CLARITIN RX/BENADRYL RX. RETURN IF NOT IMPROVED.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site reaction
Clinical narrative: developed large local reaction at site of vaqricella vaccine
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Fatigue, Heart rate decreased, Hyperhidrosis
Clinical narrative: Patient became dizzy, pale, clammy & sweaty lethargic stated his very tired.  Pulse droped into the 50's - oxygen @ 3 liters had patient lie down checked vitals 97/51.  68 pulse ox 99% 911 called and was further assessed.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Lethargy, Pallor
Clinical narrative: Patient became dizzy, pale, clammy & sweaty lethargic stated his very tired.  Pulse droped into the 50's - oxygen @ 3 liters had patient lie down checked vitals 97/51.  68 pulse ox 99% 911 called and was further assessed.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Lymphadenopathy, Nausea, Pyrexia, Swelling
Clinical narrative: Received telephone call from patient on 4-16-09 stating the she had slight nausea and slight swollen  lymph node in (L) clavicle area. No fever. 4-21-09 Pt presented for injection #2 of -Pre-exposure series, still c/o grape sized lymph node- swelling in left clavicle area. mild nausea, T 98 degrees. No other sx. Private MD notified; permission to continue with vaccine, may be other infection . on 4-22-09 still c/o nausea, some light headiness, fever, lymph node (L) clavicle 'larger, swelling area. MD notified.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Pyrexia, Rhinorrhoea, Swelling face
Clinical narrative: 34 y/o ADSM referred from aid station for left facial swelling in temporal association with the receipt of AVA and Typhoid vaccines.  Symptoms:  Swelling, Fever, Chills, Nasal Drainage.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Non stated.
Age: 60.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Pt given injection 02/13/2009 @ 4:00pm 36 later Pt states fever of 100, chills body ache L arm, headache.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Rash
Clinical narrative: MMR given on 4/8/2009. Pt noted symptoms. Flu like achy onset 4/18/09. Stopped 4/21/09. Rash onset 4/21/09 - ongoing. Rash on side of face, neck & trunk.
Age: 21.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Syncope
Clinical narrative: Patient vaccinated with Hepatitis A and Hepatitis B vaccines 15-20 seconds after vaccines administered patient fainted. Per guardian "patient  has always fainted after injections, I thought after his last shots in 2005 he'd be better". Patient observed and monitored, no injury occurred. Advised to go to nearest ER if any complications occur.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh large area redness/heat denies itching mildly painful area raised warm area breadth of thigh with central clearing around vaccine site.  Benadryl & ice prn.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Cyanosis, Oxygen saturation, Wrong drug administered
Clinical narrative: After leaving office, parents report baby turned blue, when strapped in her car seat lasted few seconds -> pinked up on her own. Brought her right back in.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Cyanosis, Oxygen saturation normal, Wrong drug administered
Clinical narrative: After leaving office, parents report baby turned blue, when strapped in her car seat lasted few seconds -> pinked up on her own. Brought her right back in.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood cholesterol, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vax given on 4/17 - Sore, red and itchy, and a little swollen. Saturday swollen and warm.- little fever. Monday 4/20, still sore and warm. Dr. prescribed NEOSPORIN and wash the shot site.  ZOSTAVAX vaccine was administered on Friday 4/17. Same day developed itchiness redness and soreness on the site of the shot. On Saturday 4/18 still swollen, warm, and a little fever. Did not take temperature. On Monday 4/20, still sore & warm. Her Dr. recommended to wash the shot's site and prescribed NEOSPORIN.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Vax given on 4/17 - Sore, red and itchy, and a little swollen. Saturday swollen and warm.- little fever. Monday 4/20, still sore and warm. Dr. prescribed NEOSPORIN and wash the shot site.  ZOSTAVAX vaccine was administered on Friday 4/17. Same day developed itchiness redness and soreness on the site of the shot. On Saturday 4/18 still swollen, warm, and a little fever. Did not take temperature. On Monday 4/20, still sore & warm. Her Dr. recommended to wash the shot's site and prescribed NEOSPORIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swollen left thigh around on a or injection and fever of 100.2
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: Patient had hives 3 days after getting HPV vaccine for the 1st time.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Drug exposure during pregnancy, Dyspepsia, Onychomycosis
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a 23 year old female with a history of 2 previous pregnancies and 2 elective terminations, who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660553/0070X) and is pregnant. On 22-JUL-2008, the patient was seen in the office and was 8 weeks 6 days gestation. On an unknown date, an unspecified blood test was performed (results not provided). The patient sought medical attention at the physician's office. On 22-JUL-2008, an ultrasound was performed for confirm dates and was found within normal limits. The date of the last menstrual period was 21-MAY-2008 and the estimated date of delivery is 25-FEB-2008. Follow-up information has been received from a questionnaire completed by a health professional. It was reported that she was a patient with asthma and with a history of 2 pregnancies and 0 live births, terminations of pregnancy - elective; who 17-JUN-2008, was vaccinated with the second dose of GARDASIL (previously reported as the first dose). On 01-AUG-2008, the patient presented sinus infection and was treated with ZITHROMAX (2 tabs a day/1 tab x 3 days). In November 2008, the patient presented a toe nail infection and was treated with clotrimazole. Subsequently, the patient developed anemia and was prescribed with SLOW FE. In January 2009, the patient developed heartburn and was treated with ranitidine, TUMS (Q4-6H) (most often used), MYLANTA (before or after meals) and ZANTAC 75. During pregnancy, a MSAFP test was performed and results were within normal limits. On 14-FEB-2009, the patient delivered a normal, healthy female baby weighing 7 pounds 7 ounces and 19 inches in height. Apgar score was 8/9. On approximately 14-FEB-2009, the patient experienced pre eclampsia post partum. Outcome not reported. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pre-eclampsia, Sinusitis, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL, concerning a 23 year old female with a history of 2 previous pregnancies and 2 elective terminations, who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660553/0070X) and is pregnant. On 22-JUL-2008, the patient was seen in the office and was 8 weeks 6 days gestation. On an unknown date, an unspecified blood test was performed (results not provided). The patient sought medical attention at the physician's office. On 22-JUL-2008, an ultrasound was performed for confirm dates and was found within normal limits. The date of the last menstrual period was 21-MAY-2008 and the estimated date of delivery is 25-FEB-2008. Follow-up information has been received from a questionnaire completed by a health professional. It was reported that she was a patient with asthma and with a history of 2 pregnancies and 0 live births, terminations of pregnancy - elective; who 17-JUN-2008, was vaccinated with the second dose of GARDASIL (previously reported as the first dose). On 01-AUG-2008, the patient presented sinus infection and was treated with ZITHROMAX (2 tabs a day/1 tab x 3 days). In November 2008, the patient presented a toe nail infection and was treated with clotrimazole. Subsequently, the patient developed anemia and was prescribed with SLOW FE. In January 2009, the patient developed heartburn and was treated with ranitidine, TUMS (Q4-6H) (most often used), MYLANTA (before or after meals) and ZANTAC 75. During pregnancy, a MSAFP test was performed and results were within normal limits. On 14-FEB-2009, the patient delivered a normal, healthy female baby weighing 7 pounds 7 ounces and 19 inches in height. Apgar score was 8/9. On approximately 14-FEB-2009, the patient experienced pre eclampsia post partum. Outcome not reported. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Information has been received from a 22 year old medical assistant who was given the second dose of GARDASIL "subcutaneously instead of intramuscularly" by a worker in their office. The medical assistant reported she had a "plump" area under her skin after it was given since it was given wrong. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Device leakage, Underdose
Clinical narrative: Information has been received from a Nurse Practitioner concerning a patient who on 13-FEB-2009 was vaccinated with an inadequate dose of GARDASIL, which was partially lost during vaccination. The patient has not experienced any known symptoms. Follow-up information was received from the Nurse Practitioner concerning the 25 year old patient who on 13-FEB-2009 received her second dose of GARDASIL (lot # 661951/1129X) in her right arm. The patient only received partial dose due to needle separating from syringe. The patient was unharmed. No diagnostic test were preformed. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site urticaria, Rash
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 12-JAN-2009 was vaccinated with the second dose of GARDASIL (Lot # not reported). After receiving the second dose of GARDASIL, the patient broke out in a rash and hives on her legs, and she also had swelling and hives at the injection site. The outcome of adverse event was unknown. It was reported that the patient sought medical attention: called the physician. Additional information has been received from the medical assistant who was inquiring if the patient should received her third dose of GARDASIL. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Nausea, Pharyngitis streptococcal, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female with a history of pharyngitis streptococcal who on 26-FEB-2009 was vaccinated with her first and only dose of GARDASIL (lot # 661952/1129X) IM. On 26-FEB-2009, "2 to 3 hours after the vaccination" the patient experienced abdominal pain, nausea and vomiting. The patient was diagnosed with "strep throat". The patient was prescribed AMOXIL. The patient's mother called the physician for medical attention. On an unspecified date the patient recovered from abdominal pain, nausea, vomiting and strep throat. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash macular
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female who was vaccinated intramuscularly with her third dose of GARDASIL. Subsequently the patient developed a rash on her arm and a blotchy rash on her nose shortly after receiving the vaccine. Lot numbers not available. The patient sought unspecified medial attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 19-FEB-2009 was vaccinated IM into the left arm with a first 0.5 ml dose of GARDASIL (661046/0546X). Concomitant therapy included hormonal contraceptives (unspecified). On 19-FEB-2009 the patient experienced pain and numbness in left arm and forearm. The patient sought medical attention at physician's office on 26-FEB-2009. No lab test were performed. The patient was told to take ADVIL and to call the office if her symptoms did not improve within a week. The physician has not heard from the patient. As of 2-MAR-2009, the patient's outcome was unknown. It was reported that the patient did not want to continue the series. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female who on 27-FEB-2009 was vaccinated with a first dose of GARDASIL 0.5 ml IM. That same day, 6 hours later the patient experienced fever, chest pains, nausea and dizziness. The patient sought unspecified medical attention. No further information is available. Additional information is available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspepsia, Pain in extremity, Pregnancy test negative
Clinical narrative: Information has been received from a 25 year old female who on 18-FEB-2009 was vaccinated with her first dose of GARDASIL and the patient had not had her period although she was due on 27-FEB-2009. A pregnancy test was negative. She also experienced on 18-FEB-2009, heartburn since vaccination and stated her arm was sore after vaccination. The patient's symptoms still persisted. The patient sought unspecified medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 26-AUG-2008 was vaccinated with her first dose of GARDASIL 0.5 ml, IM. The patient received her second dose of GARDASIL 0.5 ml, IM on 2-NOV-2008 and her third dose of GARDASIL 0.5 ml, IM on 3-MAR-2009. She mentioned she had not had a menstrual period "since my last dose of vaccine". Her last menstrual period was "at the end of November 2008". A urine pregnancy test performed in the office on 3-MAR-2009 was negative. A serum pregnancy test had been ordered but the results were pending. The patient's absence of period persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no known drug allergies, who on 12-FEB-2009 was vaccinated with the first dose of GARDASIL (lot # 661046/0546X) 0.5ml  intramuscularly. There was no concomitant medication. On approximately 17-FEB-2009, "within the last week or two, the patient developed generalized joint pain that was migratory, and pain at the unspecified arm and was not able to lift that arm, which has improved. Patient also developed generalized body pain and leg pain.; Patient sought medical attention by calling the office. No lab diagnostic studies were performed. At the time of this report the patient had not yet recovered. Additional information has been requested
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lichen nitidus, No reaction on previous exposure to drug, Rash generalised
Clinical narrative: Information has been received from a physician assistant concerning a female under 18 year old who on unspecified date was vaccinated with her third dose of GARDASIL (lot number, route and site not reported) About 6 weeks after the third dose of GARDASIL the patient broke out in a rash all over her body. The patient had gone to a dermatologist who diagnosed the patient with lichen nitidus. The physician assistant was not sure if it was from the GARDASIL since the patient had no reaction with the first and second dose of GARDASIL, but the dermatologist believed it was from GARDASIL. Subsequently, the patient recovered from lichen nitidus. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Medical device complication, Mobility decreased, Pain in extremity, Underdose
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old with no pertinent medical history and no drug reactions/allergies who on 29-DEC-2008 was vaccinated with the second dose of GARDASIL. No concomitant medications. On 29-DEC-2008, during the injection, the needle broke apart. It was reported that the patient only received part of the vaccine. On 20-MAR-2009 the patient has been a little tired and her arm was sore and she was having trouble lifting her arm. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning her daughter (approximately 17 year old) with codeine allergy who had been experiencing headaches 6 month ago (approximately September 2008) after receiving a dose of GARDASIL. The patient received the third dose last month. She had been receiving the vaccine at a Healthcare Center. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning her 14 year old daughter with frequently injection site reaction after unspecified vaccination who was vaccinated with GARDASIL (Lot # not reported). After vaccination with GARDASIL, the patient experienced injection site reaction, she experienced redness, irritation and soreness that lasted 1 day after her second vaccination and maybe her first vaccination. Subsequently, the patient recovered from the adverse events. It was not reported whether the patient sought medical attention. This is one of several reports received from the same resource. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test, Ultrasound abdomen, Wrong drug administered
Clinical narrative: Information has been received from a 41 year old female patient with an allergy to "cloricidin" and a history of bleeding during pregnancy who on 2-MAR-2009 was accidentally vaccinated with a first dose of GARDASIL (lot number and route not reported) in the arm while she was 10 weeks pregnant. She was supposed to be receiving globulin, RHOGAM. Concomitant therapy included levothyroxine Na. Pregnancy test and ultrasound were performed on an unspecified date (no results reported). The patient saw the physician. It was reported that the patient was 10 1/2 weeks pregnant at the time of this report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Infertility
Clinical narrative: Information has been received from a female who was vaccinated with a first and second doses of GARDASIL on an unspecified date, respectively. The patient and her husband had been trying to get pregnant since November but no luck. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of GARDASIL. On 2-MAR-2009 the patient developed a reaction similar to hives. The patient was fine within 24 hours. It is unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female who in approximately February 2009, about 1 month ago, was vaccinated IM with the first 0.5 ml dose of GARDASIL into the arm. On an unspecified date, following vaccination, the patient developed a headache that lasted 3 days. At the time of this report, the patient was in the office to receive her second dose. The physician was considering whether to continue the series. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no pertinent medical history or drug reaction/allergies who on 23-MAR-2007 was vaccinated  IM with the first 0.5ml dose of GARDASIL, on 23-MAY-2007 was vaccinated IM with the second 0.5ml dose of GARDASIL and on 25-SEP-2007 was vaccinated IM with the third dose of GARDASIL. There was no concomitant medication. It was reported the patient had a positive DNA test for high risk Human Papilloma Virus (HPV) on 24-FEB-2009. The patient was seen by physician. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who 25-FEB-20009 was vaccinated with a dose of GARDASIL (lot # not reported). 1-2 days post vaccination, on approximately 26-FEB-2009 the patient experienced prolonged dizziness. The patient received an ear exam to check for inner ear problems and a neurological exam (results unknown). Unspecified medical attention was sought. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal rigidity
Clinical narrative: Information has been received from a radiologist concerning her niece (a 14 year old female) who on 08-FEB-2008 was vaccinated with her first dose of GARDASIL and then shortly after receiving the vaccine (approximately 08-FEB-2009) the patient experienced horrible stomach spasms. There was no concomitant medication. The radiologist reported that since the patient's stomach spasms were so bad the patient was taken to emergency room (name and address unspecified), but the radiologist did not know if the patient was admitted to the hospital. Then after three days of stomach spasms (approximately 11-FEB-2009) the pain went away. The patient sought medical attention and saw a gastroenterologist who told the patient the stomach spasms were from GARDASIL. At an unspecified date the patient was recovered on therapy. This is one of several reports from the same source. Additional information has been requested.  6/4/09 Consultant records received DOS 2/12/09. FINAL DIAGNOSIS: Abdominal pain  Patient presented with LUQ abdominal discomfort radiating to back and then to right side, then to lower abdomen. Vomiting. Hip myalgia. R/O post-infectious enteritis, irritable bowel syndrome, colonic spasms after "vaccine for herpes", constipation vs bacterial overgrowth, idiopathic pancreatitis.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a female who was vaccinated with 0.5 ml dose of GARDASIL. The patient experienced shortness of breath after getting the vaccine and had got worse. Lot # was not provided. At the time of reporting (05-MAR-2009) the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metal poisoning
Clinical narrative: Information has been received from a registered nurse (R. N.) concerning a female patient at one of the local schools who had an aluminum poisoning. The patient received a dose of GARDASIL at an unspecified date. The patient sought medical attention and was seen by a doctor. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated intramuscularly with 0.5 ml dose of GARDASIL. Concomitant therapy included HAVRIX. The patient developed a fever 2 days after she received the vaccine. The fever lasted 2 days. After the fever went back down, she had "swelling in her legs". The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with all the three doses of GARDASIL (lot number, route and site not reported). On an unspecified date, the patient developed HPV. The outcome of the event was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female teenager who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number, site and route not reported). the patient developed a very large swollen area around injection site after receiving GARDASIL. Subsequently, the patient recovered from the event. Unspecified medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site papule, Tinnitus
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 28-FEB-2009 was vaccinated with the first dose of GARDASIL (lot number and route not reported) in her arm. After receiving the vaccination, the patient felt dizzy and had ringing in her ears. So the office had the patient lay down for 10 minutes with an ice pack on her head and then she was "ok" to leave the office. The nurse stated that on 5-MAR-2009 the patient called the office and stated that she woke up with a red bump on her arm near the injection site. The patient was told to put ice on the bump and if the bump would not go away or get worse by the weekend then she should call the office back. The red bump on her arm persisted at the time of this report. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 22-DEC-2008 was vaccinated with her first dose of GARDASIL (lot number, route and site not reported). On 22-DEC-2008 the patient was vaccinated with her second dose of GARDASIL (lot number 661766/0652X, route and site not reported) 0.5 ml. There was no concomitant medication. On 23-FEB-2009 after receiving the second dose, the patient fainted. On 23-FEB-2009 the patient recovered from fainting. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Headache, Lethargy
Clinical narrative: Information has been received from a physician concerning a 15 or 16 year old female who was vaccinated with the second dose of GARDASIL. On an unspecified date, 2 months after receiving the second dose of GARDASIL, the patient had a terrible headache, severe lack of energy and was very lethargic. The patient sought unspecified medical attention from physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Back pain, C-reactive protein normal, Chest X-ray normal, Chest pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with an allergy to naproxen who on 23-APR-2008 was vaccinated with a second dose of GARDASIL. The patient was vaccinated with a third dose of GARDASIL at college so exact date was unknown. Concomitant therapy included NUVARING. After the 3rd dose of vaccination, in early November 2008 the patient developed intermittent chest pain. She had been having "sharp left-sided chest pain that radiated up the chest". It was typically moderate but sometimes severe. On occasion it had radiated to the right side and one time it went down her back. It happened with rest and activity. It happened randomly without an identified precipitating factor. Typically the pain lasted 2 minutes and happened 4 to 5 times daily. Her longest episode happened only one time and lasted 45 minutes. She had a hard time catching her breath when the pain occurred but otherwise normal breathing. She denied palpitations, crushing chest pain and no sweating. The patient sought medical attention via phone and on an unspecified date the patient went to the ER and was not admitted to the hospital. Tests were normal. She had a negative magnetic resonance imaging, chest X-ray and electrocardiogram. A complete metabolic panel, complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, antinuclear antibodies choice screen and thyroid tests were conducted in the city where the patient attended college and all the results were normal. Her internist tried a "prednisone burst" with no improvement, then tried PRILOSEC for acid reflux with no improvement. She was being followed by an internal medicine specialist who believed the problem was musculoskeletal and her mom felt it was a "muscle spasm". She was given  FLEXERIL, ibuprofen and heat. The patient refused physical therapy. She was waiting additional lab work (results unknown). The patient missed her last appointment so her current condition was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Full blood count normal, Gastrooesophageal reflux disease, Metabolic function test normal, Muscle spasms
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with an allergy to naproxen who on 23-APR-2008 was vaccinated with a second dose of GARDASIL. The patient was vaccinated with a third dose of GARDASIL at college so exact date was unknown. Concomitant therapy included NUVARING. After the 3rd dose of vaccination, in early November 2008 the patient developed intermittent chest pain. She had been having "sharp left-sided chest pain that radiated up the chest". It was typically moderate but sometimes severe. On occasion it had radiated to the right side and one time it went down her back. It happened with rest and activity. It happened randomly without an identified precipitating factor. Typically the pain lasted 2 minutes and happened 4 to 5 times daily. Her longest episode happened only one time and lasted 45 minutes. She had a hard time catching her breath when the pain occurred but otherwise normal breathing. She denied palpitations, crushing chest pain and no sweating. The patient sought medical attention via phone and on an unspecified date the patient went to the ER and was not admitted to the hospital. Tests were normal. She had a negative magnetic resonance imaging, chest X-ray and electrocardiogram. A complete metabolic panel, complete blood cell count, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, antinuclear antibodies choice screen and thyroid tests were conducted in the city where the patient attended college and all the results were normal. Her internist tried a "prednisone burst" with no improvement, then tried PRILOSEC for acid reflux with no improvement. She was being followed by an internal medicine specialist who believed the problem was musculoskeletal and her mom felt it was a "muscle spasm". She was given  FLEXERIL, ibuprofen and heat. The patient refused physical therapy. She was waiting additional lab work (results unknown). The patient missed her last appointment so her current condition was unknown. Additional information has been requested.