chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Fever 99-100 for 48 hours following vaccine administration, along with shaking chills and fatigue. Tylenol taken Q4H and Naproxin Q12H. Severe muscle soreness at injection site limiting use.  Erythema at site began on 12/13 at 8 cm.  Muscle soreness is less, but reddness contines to date.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology negative, Rash pruritic, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Patient developed vesicular clusters with about 10 vesicles over about a 3 centimeter diameter on the inside of her right arch and then has a similar cluster up on the outside of her right thigh. No other rash is noted around her right leg. Has no apparent pain in her back or buttock.  This began on 12/5/08, just 14 days after receiving Zostravax.  Patient stated that this rash itches but no significant pain associated with it. Patient was started on Prednisone 20 mg. 2 tabs (40 mg.) x 4 days, then 1 tab for 4 days.  Valacyclovir 1 G tabs, 1 tab 3 times a day x 7 days.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Rash generalised
Clinical narrative: Develope headache with in 5 hours of receiving vaccine, Within 18 hours developed generalized rash of the upper torso and face. Self treated with over the counter benadryl capsules and cortaid creme about three days after symptoms appeared. Symptoms cleared in one week (7 days) after appearance. Did not seek professional medical care.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: "Did not go to the Dr."; swelling of the cheek and neck glands; strawberry, rash-like areas that were itchy over chest, arms, stomach and behind her ears(pt. kept calling the areas hives, though having 0 open areas); fever, body aches and pains; site reaction stated of the size of an orange, red, hot, slightly raised; missed work 11/12/08 due to c/o reaction; felt body aches for up to 1 week; no treatment was sought by pt.; nurse reviewed VIS information with pt. again;
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Swelling face
Clinical narrative: "Did not go to the Dr."; swelling of the cheek and neck glands; strawberry, rash-like areas that were itchy over chest, arms, stomach and behind her ears(pt. kept calling the areas hives, though having 0 open areas); fever, body aches and pains; site reaction stated of the size of an orange, red, hot, slightly raised; missed work 11/12/08 due to c/o reaction; felt body aches for up to 1 week; no treatment was sought by pt.; nurse reviewed VIS information with pt. again;
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Infection, Inflammation, Oedema, Pain in extremity
Clinical narrative: Vaccine given on 07 Dec @0910 Local time. (EST)Monday- Pt felt extremely discomfort and Soreness to Left deltoid and rest of extremity. Took Tylenol for pain.Tue- Bicep inflammation, edema and itcy skin. Sought help from local M.D. in her office and was told to take Ibuprofen. Wen- Pt went to personal Physcian whom dx with infection and cellulitis and prescribed Keflex 500mg qid and Motrin 400mg three time daily. Pt. took Keflex qid till three days and is currently taking the dose three time a day. Still some cellulitis and edema but has almost resolved.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Vaccine given on 07 Dec @0910 Local time. (EST)Monday- Pt felt extremely discomfort and Soreness to Left deltoid and rest of extremity. Took Tylenol for pain.Tue- Bicep inflammation, edema and itcy skin. Sought help from local M.D. in her office and was told to take Ibuprofen. Wen- Pt went to personal Physcian whom dx with infection and cellulitis and prescribed Keflex 500mg qid and Motrin 400mg three time daily. Pt. took Keflex qid till three days and is currently taking the dose three time a day. Still some cellulitis and edema but has almost resolved.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Abdominal pain upper, Anorexia, Arthralgia, Asthenia, Chest pain
Clinical narrative: fever, weakness, joint pain, chest and stomach pain, loss of appetite
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Pyrexia
Clinical narrative: fever, weakness, joint pain, chest and stomach pain, loss of appetite
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Glossodynia, Increased upper airway secretion, Injection site pain, Oral herpes
Clinical narrative: I received Zostavax,shingles vaccine, on 11/12/2008. The sight of the injection was very sore for about two weeks. Since that time the tissue of the lining of my mouth and the surface of my tongue have been very sore and I have had some fever like blisters. I have also developed symptoms of soreness and excess phlegm from my esophagus. I recently developed a feeling soreness in my left lung. The pain increased and I went to the ERl on Sat. morning 12/13/08; they checked my heart and found nothing and I was discharged. I intend to visit my physician this week and I would like to know if these symptoms might be side effects of the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral pain
Clinical narrative: I received Zostavax,shingles vaccine, on 11/12/2008. The sight of the injection was very sore for about two weeks. Since that time the tissue of the lining of my mouth and the surface of my tongue have been very sore and I have had some fever like blisters. I have also developed symptoms of soreness and excess phlegm from my esophagus. I recently developed a feeling soreness in my left lung. The pain increased and I went to the ERl on Sat. morning 12/13/08; they checked my heart and found nothing and I was discharged. I intend to visit my physician this week and I would like to know if these symptoms might be side effects of the vaccine.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Anorexia, Arthralgia, Diarrhoea, Dizziness
Clinical narrative: Two hours after vaccination, patient felt nauseaus. Symptoms worsened by that afternoon to include, headache, light-headedness, stomach ache, aching joints (knuckles), aching teeth, loss of appetite, fever, shakes, and diarrhea. Resolved with OTC medication (Immodium and Tylenol PRN) after 5 days.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Two hours after vaccination, patient felt nauseaus. Symptoms worsened by that afternoon to include, headache, light-headedness, stomach ache, aching joints (knuckles), aching teeth, loss of appetite, fever, shakes, and diarrhea. Resolved with OTC medication (Immodium and Tylenol PRN) after 5 days.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy lymph gland abnormal, Chemotherapy, Computerised tomogram abnormal, Lymphadenopathy, Mediastinal mass
Clinical narrative: Patient recieved 2 doses of gardasil, july 15th 2008 and sept 15th 2008. She was diagnosed with non-hodgkins lymphoma on 11-20-08. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. I read articles about recepients of HPV vaccine developing lymphadenopathy.  1/23/09 Reviewed hospital medical records of 11/17-11/20/2008; 12/4-12/5; and 12/12-12/15/2008; same day stays on 12/10 & 12/17.   FINAL DX: primary mediastinal large B-cell lymphoma, Murphy stage III. Records reveal patient experienced left supraclavicular lymphadenopathy x 10 days beginning 11/7 along w/intermittent diarrhea & abdominal pain x 1 mo.   Surgery & cardio consult done.   Returned to hospital 12/4 to have port placed for chemotherapy & diagnostic LP & also intrathecal methotrexate & steroids. Returned to hospital for chemo & f/u CT scan 12/10.  Returned to hospital 12/12-15 for chemo.  Returned to hospital 12/17 for LP w/intrathecal chemotherapy.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: LARGE LUMP IN LEFT DELTOID 60MM WIDE: tdap, ADMINISTERED AT THIS SITE.  NO PAIN, NO REDNESS OR BRUISIN.  HAS HAD NO FEVER OR DISCOMFORT. APETITE GOOD RESTING WELL. PATIENT FIRST NOTICED LUMP ON 12-04-208, RECEIVED IMMUNIZATION ON 12-0-2008.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood test normal, Computerised tomogram normal, Electroencephalogram abnormal, Grand mal convulsion
Clinical narrative: On 12/10/08, pt was given gardasil dose #3 and menactra.  on 12/11/08, while sitting in school, pt had a tonic-clonic seizure and was taken to hospital, admitted, observed 24 hours.  CT scan and blood tests were normal.  EEG abnormal.  MRI and repeat EEG to be done.  Patient has no history of seizure or syncope. 1/29/09-records received for DOS 12/11/08-presented to ED with questionable seizure, tonic-clonic seizure witnessed along with eyes rolling back. Unable to recall event and was disoriented to place and time. PE: slight dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash erythematous, Skin warm
Clinical narrative: Rough, raised, red skin, warm to the touch, similar to hives, below the injection site, as large as my hand.  Gradually faded.  Gone in a week.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt experienced syncope. Upon recovering Pt's blood pressure was 92/62 pulse 64. Pt was out approxiamately 1-2 seconds.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The day after injection the patient noticed a swollen, tender, red strip at site of injection.  The strip was approximately 5 inches long and 2 inches wide.  Patient also had a headache.  Headache has resolved.  Redness, tenderness, swelling improving but not completely resolved on day 5.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: It is unlikely that the adverse effect is from the vaccine but from damage to the tendon from the placement of the shot in the tendon. Have experienced pain for getting close to two months. Pain in right arm especially in shoulder but also elbow lower arm and some in hand and fingers.  Pain has continued since the shot was administered.  Started physical therapy December 8.  Would have started sooner but was out of the country.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: "Left shoulder/arm pain started after flu shot 2 weeks ago.  I have been icing it and taking ibuprofen."  C/O weakness in left arm.  Then, as of 11/19/08, 14 days after vaccination, her pain had continued.  She then disclosed that she had left shoulder pain 2-3 days prior to the vaccine.  She was referred to her PCP for f/u evaluation and treatment
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Eye swelling, Fatigue, Lacrimation increased, Odynophagia
Clinical narrative: Client called my home phone four days after receiving his flu vaccination. Client stated that when he got to thinking about it, he decided he better report the reaction he had. Client stated that after receiving vaccine he went home and was feeling tired. He had been dealing with some type of cold so he took a nap around noon. When he woke up his eyes were burning, watering and swollen, his throat was sore and it hurt to swallow. Client states he took some Benadryl and lay back down and when he soke a couple of hours later he felt fine.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Client called my home phone four days after receiving his flu vaccination. Client stated that when he got to thinking about it, he decided he better report the reaction he had. Client stated that after receiving vaccine he went home and was feeling tired. He had been dealing with some type of cold so he took a nap around noon. When he woke up his eyes were burning, watering and swollen, his throat was sore and it hurt to swallow. Client states he took some Benadryl and lay back down and when he soke a couple of hours later he felt fine.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Approximately 24 hours after administration of vaccine, patient's Right Deltoid began to swell and began running low grade fever.  At 48 hours, patient was running a fever of 102 degrees that lasted for 24 hours. Right Deltoid eventually swelled to golf-ball size with erythematous and warm & tender to touch.  No signs of streaking to suggest lymphangitis. The reaction is believed to be to the Pertussis.  Patient has received DT in the past with no incidents.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Heart rate increased, Salivary hypersecretion, Throat tightness
Clinical narrative: began coughing, noticed throat felt tight, increased thick saliva, chills, pulse rapid at 100 bpm.  Used 4 puffs of albuterol inhaler before feeling relief
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Hypoaesthesia, Induration, Musculoskeletal pain, Pain in extremity
Clinical narrative: States he is not able to go to work due to pain and inability to lift arm.  Clarified with pt that he is able to physically move his arm but is not moving  it secondary to pain from his left shoulder to his elbow. c/o warmth, numbness  and induration within a 3-4 inch radius of the injection site .  Pain 8/10
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: States he is not able to go to work due to pain and inability to lift arm.  Clarified with pt that he is able to physically move his arm but is not moving  it secondary to pain from his left shoulder to his elbow. c/o warmth, numbness  and induration within a 3-4 inch radius of the injection site .  Pain 8/10
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Painful, red, itching and burning in right arm 1 1/2 days after receiving Zostavax.  Swelling and redness measured 5 1/2 inches.  Did not seek medical attention.  Resolving.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Keloid scar
Clinical narrative: Keloid formation devoloped at site of smallpox vaccination given on 17 Aug 2007.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMR, VARCEL
Symptoms: Body temperature increased, Dyskinesia, Heart rate increased, Irritability, Muscle twitching
Clinical narrative: 7:pm on day of vaccination parents noticed child having a high heart rate. Around midnight child's arms/legs were "twitching and jerking," fussy, temp 101.7. Tylenol given at home. At 4:00 am child was taken to the emergency room, heart rate 220, tx: an EKG was attempted but it was not completed, Motrin administered, heart rate decreased to wnl, temp 99.7, twitching was noted at ER; parents were told child was not having seizures. child was discharged at 8:00 am. Mother stated child's twitching gradually fully resolved after about 36 hours from onset. Low grade temp <100 degrees on 12/15/08.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PPV, RVX
Symptoms: Crying, Immediate post-injection reaction, Screaming
Clinical narrative: Immediately after injection, baby cried, and then had uncontrollable screeming for 4 hours.
Age: 1.42
Sex: F
Vaccine: RUB
Symptoms: Abnormal behaviour, Autism, Eye disorder, Feeling abnormal, Pyrexia
Clinical narrative: Fever two days after.  Melt downs.  Acting as if in a fog.  Blinky eyes in strange manner.  Running in circles.  Stopped babbling and saying words she did have.  Lack of eye contact.  Lack of any kind of connection to parents and others.
Age: 1.42
Sex: F
Vaccine: RUB
Symptoms: Social problem, Speech disorder
Clinical narrative: Fever two days after.  Melt downs.  Acting as if in a fog.  Blinky eyes in strange manner.  Running in circles.  Stopped babbling and saying words she did have.  Lack of eye contact.  Lack of any kind of connection to parents and others.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, no treatment
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Cyanosis, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Immediately after vaccine baby became cyanotic, stiff, arched back and eyes rolled back. Immediately got Dr and O2 sat monitor. O2 sat in 80's while cryying. Go O2 mask which brough sat up to high 80's low 90's. When calm increased too 95%. Called EMS. Baby brought to ER. 2/11/09-records received for DOS 12/15-12/26/08-DC DX:TAPVR with surgical repair on 12/22/08. C/O turning blue after receiving vaccines. Cyanotic spell. Cardiology referral revealed TAPVR. Follow-up: Pt admitted to hospital. And was found to have an underlying condition -Total Anomalous Pulmonary Venous Return, which had not been identified previously.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Opisthotonus, Oxygen saturation decreased
Clinical narrative: Immediately after vaccine baby became cyanotic, stiff, arched back and eyes rolled back. Immediately got Dr and O2 sat monitor. O2 sat in 80's while cryying. Go O2 mask which brough sat up to high 80's low 90's. When calm increased too 95%. Called EMS. Baby brought to ER. 2/11/09-records received for DOS 12/15-12/26/08-DC DX:TAPVR with surgical repair on 12/22/08. C/O turning blue after receiving vaccines. Cyanotic spell. Cardiology referral revealed TAPVR. Follow-up: Pt admitted to hospital. And was found to have an underlying condition -Total Anomalous Pulmonary Venous Return, which had not been identified previously.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Oligohydramnios
Clinical narrative: Patient likely conceived with pregnancy day of vaccine administration. Her pregnancy has been complicated by oligohydramnios at early as 16 weeks, and eminent concern for loss of pregnancy. 1/16/2009 ER record received for 12/7/08 with DX: Vaginal bleeding at 18 wks pregnant, anhydramnios, mid trimester ROM, 2 vessel umbilical cord, possible TGA in fetus.  Prognosis poor. Pt presented with large amount of vaginal bleeding.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash
Clinical narrative: The patient received the below vaccination at 12:42. About 25 minutes after the vaccine, he developed a mild rash all over his chest and stomach. The M.D. was called. BENADRYL was ordered, 1.5 ml, 4 x day, for 2 days; and to call PMD on Monday. Baby still has slight rash on abdomen and chest 12/15/08.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: After ZOSTAVAX, left arm became red, swollen, painful itching.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: After flu shot - pain down to fingertips for 2 days after injection.  Noticed difficulty lifting arm higher than shoulder.  Per MD - tendonitis - 6 days Methyl prednisone per patient.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling, itching, redness. Tx ice, BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Pigmentation disorder
Clinical narrative: Information has been received from a consumer via an office concerning patient who was vaccinated with GARDASIL (route and site not reported).  The consumer reported that the office had a  "similar but not as serious case" of loss of pigmentation in the skin as his daughter had experienced.  The office said it was caused by GARDASIL.  The office also said it was not an allergic reaction.  Attempts are being made to verify the existence of an identifiable patient and reporter.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient with diabetes and hypothyroidism who on 05-AUG-2008 was vaccinated with the first dose of GARDASIL, lot # 660620/0571X, 0.5 mL, intramuscularly; and on 31-OCT-2008 was vaccinated with the second dose of GARDASIL, lot # 661044/054f8X, 0.5 mL, intramuscularly. Concomitant therapy included insulin Novolog and insulin Levemir. It was reported that the patient on 31-OCT-2008 experienced pain and redness at the injection site of the left upper arm after receiving her second dose of HPV vaccine. The pain was increased and the area formed a large, firm lump surrounded by a red ring. The patient had difficulty lifting the left arm. Patient not recovered. She was scheduled for an office evaluation on 28-NOV-2008. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow-up information from her physician indicated that the patient was a female student (152 pounds, 67.5 inches) with diabetes, hypothyroidism and celiac disorder who reported redness, swelling and decrease of mobility in arm after being vaccinated. The patient was seen on 29-NOV-2008 with erythema (2 cm thick) at site of injection, mobility within normal limits. Therapy with nonsteroidal anti-inflammatory drug (unspecified) was prescribed. Patient recovered on 19-JAN-2009. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 44 year old female who was supposed to receive ADACEL on 25-NOV-2008 was accidentally vaccinated with a dose of GARDASIL (lot # 659184/0843X).  The patient was also outside the recommended age for the vaccine.  Unspecified medical attention was sought.  Additional information has been requested. This is in following to report previously submitted on 12/12/2008 : 1/7/2009. Information has been received from a nurcse practioner (N.P.) concerning a 44 year old female who was supposed to receive ADACEL on 25-NOV-2008 was accidentally vaccinated with a dose GARDASIL (lot# 659184/063X). The patient was also outside the recommended age for the vaccine. Unspecified medical attention was sought. Follow up information was received from a person at the the providers center who reported that she was the one who inadvertently administered the wrong vaccine to the patient. She reported that it was a case of human error) she simpley grabbed the wrong vaccine. She said that the patient had no side effects to report. Follow-up information has been received from a nurse practioner concerning a 44 year old female in sales who on the morning of 25-NOV-2008 was accidentally vaccinated in the right arm with the first dose of GARDASIL (lot# 659164/0643X). As of the report date, there was still no adverse event. No further information is avaliable.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a news source concerning a 20 year old female who on an unspecified date was vaccinated with GARDASIL. The reporter indicated that the patient believed that she had an adverse effect after receiving GARDASIL. The patient complained of nausea and dizzy spells after vaccination. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a news source concerning a 14 year old female who on an unspecified date was vaccinated with GARDASIL.  The reporter indicated that the patient believed that she had an adverse effect after receiving GARDASIL.  The patient now suffers from chronic fatigue.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning an unknown numbers of patients who were vaccinated with GARDASIL.  The patients complained of injection site reactions including pain.  The reporter did not have any detailed information.  The outcome of adverse event was not reported.  It was not reported whether the patients sought medical attention.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Eye rolling, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning a 10 year old female who on 25-NOV-2008 was vaccinated with GARDASIL (lot # not provided) for her first dose.  ON 25-NOV-2008, after receiving GARDASIL, the patient fainted.  The patient sought medical attention and recovered on 25-NOV-2008.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008.  Follow up information was received from the nurse practitioner.  It was reported the patient was vaccinated with GARDASIL intramuscularly in the left deltoid.  Concomitant therapy also given on 25-NOV-2008 included FLUZONE (lot # U2772AA) which was was vaccinated with intramuscularly in the right deltoid on the same day.  Right after GARDASIL was given the patient fainted.  Her eyes rolled back and had some shakiness.  No further information was available.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 9 year old female with penicillin allergy and Rocephin hypersensitivity and a history of gastroesophageal reflux and stomach ache who on 19-JUN-2008 was vaccinated intramuscularly with first dose of GARDASIL (lot # 659655/14486U) 0.5 mL, on 20-AUG-2008 was vaccinated with a second dose of GARDASIL (lot # 660389/1968U) and on 20-NOV-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). There was no concomitant medication. On 20-NOV-2008 the patient developed a swollen and red area about the size of a golf ball at the site of injection after the third dose of complained of pain when pressure was applied to the area and during movement of her arm. The patient visited the office. Ice was applied to the area and improvement occurred within 20 to 30 minutes. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning a 24 year old female with hypersensitivity to AMOXICILLIN (+) AUGMENTIN who on 20-NOV-2008 was vaccinated with the first dose of GARDASIL, lot 660620/0571X, 0.5 ml, intramuscularly.  There was no concomitant medication.  On 20-NOV-2008 the patient experienced persistent arm pain since she received her first dose of GARDASIL.  Patient not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/12/2008.  Follow up information has been received from a registered nurse concerning the waitress (weight 202 pounds, height 67 inches) with AUGMENTIN allergy (hives) who on 20-NOV-2008 was vaccinated with the first dose of GARDASIL, lot 660620/0571X, 0.5 mL, intramuscularly, in her right deltoid.  The nurse indicated that on 25-NOV-2008 the patient called with complaint of right deltoid sore (onset 20-NOV-2008) and stated that the injection site swelled.  She had the patient stop by the physician's office, the physician didn't find swelling, erythema or skin induration at the injection site.  On 22-Jan-2009 the patient received her second dose of GARDASIL (lot # not reported), no complaints of or problems, just soreness for 1 day.  Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 10 year old female who was vaccinated with a first dose of GARDASIL. The patient had spotting for two days and then experience resolved. There was no laboratory studies performed. The patient sought medical attention through a call to the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy, Ovarian cyst
Clinical narrative: Information has been received from a female concerning herself, with no medical history of allergies, who on 15-OCT-2008 was vaccinated with GARDASIL, 0.5ml, intramuscularly. There was no concomitant medication. Caller stated that she was pregnant at the time she received the vaccine. The last menstrual period was approximately on 01-AUG-2008 and the estimated delivery date is 08-MAY-2008. No AE related to the pregnancy reported. Caller stated that she experienced "severe pain" in her abdominal muscle and she no longer had that pain. Caller also stated that she developed a cyst on her right ovary after she got the vaccine. The patient did not indicated if the cyst has improved. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site rash, Limb discomfort
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with AMOXICILLIN allergy who on 21-JUN-2008 was vaccinated  intramuscularly with a 0.5 ml first dose GARDASIL and experienced mild tenderness at the injection site for one day.  On 01-AUG-2008 she received the second dose of GARDASIL (LOT # 660557/0072X).  Following the second dose, the patient experienced an itchy hive-like rash at the injection site that lasted for 4 months, and fatigue and leg symptoms.  The reporter stated that the patient was not seen by a physician for the symptoms.  Additional information has been requested. This is in follow-up to reports previously submitted on 12/12/2008. Information has been received from a registered nurse concerning a 19 year old stundent female patient with amoxicillin allergy who on 2-JUN-2008 was vaccinated intramusculary in her left deltoid with a 0.5 ml first dose of GARDASIL (LOT #659183/1757U) and experienced mild tenderness at the injection site for one day. On 01-AUG-2008 she received intramusculary in her right deltoid the second dose of GARDASIL (LOT # 660557/0072X). Following the second dose, the patient experienced an itchy hive-like rash at the injection site that lasted for 4 months, and fatigue and leg symptoms. The reporter stated that the patient was not seen by a physician for the symptoms. Follow-up information has been received from a registered nurse concerning the patient who complained of experiencing rash and itch at the injection site for four weeks (previously reported as four months) after receiving the second dose of GARDASIL vaccine given on 01-AUG-2008. It was reported that the patient did not seek medical attention during that time and on 21-NOV-2008 she reported the event when she went back to receive the third dose of GARDASIL vaccine. The vaccination was deferred and on 12-DEC-2008 the patient received intramusculary in her left deltoid the third dose of GARDASIL (LOT #660616/0570X) along with Benadryl 50 mg. orally given 30 minutes prior vaccination as per patient's physician. The nurse stated that the patient's mom denied any itch or rash after the third vaccination with HPV vaccine. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from office manager concerning a patient who on an unspecified date was vaccinated with GARDASIL. On unspecified date the patient experienced a rash at the injection site for 2 weeks. The patient contacted office. On unknown date, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site abscess, Injection site infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of GARDASIL.  Subsequently the patient experienced an abscess or an infection at the injection site.  The physician reported that this is not a patient of hers and she heard about the experience from a third party.  Attempts to verify the existence of an identifiable patient has been unsuccessful.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry of GARDASIL vaccine, concerning an 18 year old female with migraines who was intramuscularly vaccinated with the first , second and third 0.5 ml doses of GARDASIL vaccine on 27-SEP-2007, 17-JAN-2008 and 10-NOV-2008 respectively (lot number: dose 1: 658563/1063U, dose 2:  658558/1061U, dose 3:  659184/0843X).  Concomitant therapy included IMITREX (Sumatriptan).  The patient was pregnant and her LMP was 06-OCT-2008.  On 23-NOV-2008 the patient performed urine pregnant test but no result provided.  No symptoms reported.  The patient went to the office for medical attention on 24-NOV-2008.  It was reported that the patient began albuterol and augmentin for an unspecified illness.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter without medical history or drug allergies who around 25-SEP-2008 was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided).  There was no concomitant medication.  Around 11-NOV-2008 the patient had PAP and urine analysis done and it was discovered that she had HPV (the patient developed HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68).  No further information was provided.  The outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Menstruation irregular, Metrorrhagia
Clinical narrative: Information has been received from a consumer who is the mother of the 18 year old female patient.  The patient at the beginning of October 2008, was vaccinated with a first dose of GARDASIL.  When the patient received the first dose of GARDASIL, she was supposed to get her menstrual period that next week, but she ended up being two weeks later and when she did get her period it was very light and then it stopped.  Then a few days later she had  gotten her period again which it was light again and then it stopped.  Then a few weeks later the patient got her period again which the bleeding was heavier than it ever has been before.  Last week the patient was spotting again.  As of 24-NOV-2008, the patient had not started her period again.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Information has been received from a physician concerning a female adolescent patient who was vaccinated on an unspecified date with a dose of GARDASIL, and stood up right away and got dizzy, light headed and fell down. The patient did not loose consciousness. Subsequently, the patient recovered. The did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning an unspecified number of patients who were vaccinated with a dose of GARDASIL (route, site of administration and batch number not reported). The patient have had pain from GARDASIL. The outcome is unknown. This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Menstruation delayed, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient, with no pertinent medical history and no allergies/drug reactions, who on 28-OCT-2008 was vaccinated with GARDASIL (lot # 661530/0575X).  There was no concomitant medication.  On 29-OCT-2008 the patient experienced fatigue, achiness and menstrual period was late.  The patient sought medical attention via telephone.  The patient had not recovered as of 21-NOV-2008.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008.  On follow up the patient's mother reported that menstruation finally came almost two weeks late.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling cold, Hot flush, Malaise, Menstruation irregular
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 14 year old female with a history of migraines who was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient developed a red rash and swelling. The patient was experiencing dizziness, muscle weakness, malaise, hot and cold flashes, vomiting, irregular menstrual periods and an increase in severity of migraines. The patient was more prone to illness. The patient's red rash and swelling and dizziness and muscle weakness and malaise and hot and cold flashes and vomiting and irregular menstrual periods and increase in severity of migraines and more prone to illness persisted. Medical attention was sought in the physician's office. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Muscular weakness, Rash erythematous, Swelling, Vomiting
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 14 year old female with a history of migraines who was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient developed a red rash and swelling. The patient was experiencing dizziness, muscle weakness, malaise, hot and cold flashes, vomiting, irregular menstrual periods and an increase in severity of migraines. The patient was more prone to illness. The patient's red rash and swelling and dizziness and muscle weakness and malaise and hot and cold flashes and vomiting and irregular menstrual periods and increase in severity of migraines and more prone to illness persisted. Medical attention was sought in the physician's office. No further information is available.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter who on 16-OCT-2008 was vaccinated with her first dose of GARDASIL (route and site not reported). Concomitant therapy included flu vaccine in the same day. On 16-OCT-2008, later that evening the patient experienced vomiting and nausea and was hospitalized for at least 4 days. Patient was vomiting almost every half an hour for those days. When the patient was brought home, she started vomiting again and was hospitalized the second time for 2 days. The patient was recovering. The patient was tested for computed axial tomography (cat scan), magnetic resonance imaging (MRI) and blood test with no result. Follow-up information was received from a registered nurse. The nurse stated that the patient received dose 1 of GARDASIL 0.5 ml IM on 16-OCT-2008. The patient was treated with Phenergan and her symptoms were almost completely resolved. Additional information has been requested. Follow up information was received from the patient's mother concerning her 11 year old daughter. The patient had symptoms of respiratory abnormality at the time of vaccination. On 16-OCT-2008 the patient was vaccinated with GARDASIL (lot number 659657/1487U) IM into her left arm. Concomitant therapy included FLUZONE (lot number U2761AA) IM into her left arm. On 17-OCT-2008 the patient experienced vomiting and was hospitalized. The patient had stayed in the hospital for 4 days. Complete blood count. Streptococcus. basic metabolic panel, urinalysis, chest poster-anterior/laterial and gastric occult blood were performed with no result reported. The patient recovered at the time of reporting. Additional information is not expected.   1/22/09 Received PCP medical records of 10/16-10/25/2008.  Records reveal pt in state of usual health on day of vaccination.  Later same day, parent had to pick up from school due to SOB, weakness & dizziness.  Seen same day by PCP & dx w/allergic rhinitis.  Tx w/antihistamines.  Developed vomiting.  RTC 10/20 for same & sent to hospital.  RTC 10/24 s/p hospitalzation.  Concerns for PVCs noted in hospital & continued lightheadedness, otherwise feels well.  Referred for Holter monitor.  Recurrent vomiting 10/25 & was readmitted to hospital.  1/22/09 PCP records included hospital medical records of 10/20-10/23/2008. FINAL DX: vomiting w/dehydration & viral exanthem Records reveal patient experienced bilious vomiting x 5 days, poor appetite, lack of sleep, fatigue.  Had been seen in PCP office previous week for viral infection w/SOB & dizziness. In hospital had nausea & diarrhea.  On 3rd day in hospital developed facial flushing & rash.  1/30/09 Received additional hospital medical records of 10/25-10/26/2008. FINAL DX: dehydration, bilious vomiting & sinusitis Tx w/IVF & oral antibiotics.  Improved overnight & d/c to home on continued oral antibiotics w/PCP f/u.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Eye swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female who on 19-SEP-2008 was vaccinated with a first dose of GARDASIL vaccine  (lot # 661044/0548X) intramuscularly.  On 20-NOV-2008, the patient was vaccinated with a second dose of GARDASIL vaccine (lot # 661764/0650X) intramuscularly.  Secondary suspected therapy included varicella virus vaccine live on 20-NOV-2008.  The patient developed swelling to her eyes after receiving her second dose of GARDASIL vaccine.  The patient had office visit to treat the event.  The patient may have experienced eye swelling after her first dose of GARDASIL vaccine, but was not certain.  At the time of reporting, the patient was recovering from the event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mass
Clinical narrative: Information has been received from a physician concerning a female who on 21-NOV-2008 was vaccinated with a second dose of GARDASIL.  The patient experienced a lump in right arm after second dose of GARDASIL.  The patient sought unspecified medical attention.  At the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with the second dose of GARDASIL (route, site of administration and batch number not reported) early on 02-OCT-2008. Subsequently the patient experienced pain from GARDASIL. The outcome is unknown. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information received from a nurse practitioner providing the name and date of birth of a patient who experienced pain after her second dose of GARDASIL vaccine (yeast). Follow up information was received from a nurse practitioner concerning the 11 year old female patient with no pre-existing allergies, birth defects, or medical conditions who was vaccinated intramuscularly in the left arm with the second dose of GARDASIL vaccine (lot#659962/1740U) on 02-OCT-2008. On 02-OCT-2008 the patient experienced pain from GARDASIL vaccine. There was no illness at the time of vaccination. No relevant diagnostic tests or laboratory tests were performed. The patient recovered on 02-OCT-2008. This is one of several reports from the same source. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 19 year old female who on 18-NOV-2008 was vaccinated with a dose of GARDASIL.  The patient reported that on 20-NOV-2008, "my arm is hurting me at the injection site".  The outcome of the patient was not reported.  She did not seek medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old patient with allergies who on 28-AUG-2008 was vaccinated with a first dose of GARDASIL vaccine into her left arm, in the afternoon approximately at 3:00 pm.  Concomitant medication included ZYRTEC, vitamins (unspecified), ZANTAC and NASONEX.  The only that she had been taking every evening was apparently mometasone furoate.  The patient complained of numbness and pain in the arm that the dose was given the whole night.  There was no swelling or redness in the area of injection.  It was also reported a little redness.  Pain eased up somewhat next day (not a persistent), numbness lasted approximately three days.  No medical interventions or treatment for the adverse events.  No other signs and symptoms reported besides the above mentioned which lasted approximately three days after injection.  The patient came for the second dose of GARDASIL vaccine on 30-OCT-2008 but she did not receive it.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL and no reaction was noted.  On an unspecified date the patient received  a second dose of GARDASIL and developed hives, "4 hours after the second dose was given".  The patient did not seek medical attention.  Additional information has been requested.