chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Myalgia, Nausea, Pain, Palmar erythema, Pruritus
Clinical narrative: Description: 28 y/o Asian male who received primary SPV (left arm), Typhoid IM (left arm) and first dose AVA(right arm) on 10/24/2007. 48 hours later he experienced 'flu-like' symptoms - mild nausea without vomiting, diarrhea, malaise and fatigue. On 11/1/2007 (8 days after vaccination), he developed itching at the back of his lower legs, followed by the appearance of a few itchy non-tender red eruptions covering his legs, back and chest. By 11/2/2007 both the itching and skin eruptions worsened to involve his face, neck, scalp and arms. On 11/3/2007, he had increased itching with swelling of his eyes, lips and ears with non-tender palmar lesions as well. There were no blisters, oral lesions, fever/chills, or cardio-pulmonary symptoms. He was seen at Hospital ER 11/1/2007 and 11/3/2007, diagnosed with dermatitis and treated with antihistamines. On 11/5/2007, he was seen at Medical Center, by Allergy and Infectious Disease (12 days post vaccination), and diagnosed with allergic urticaria vs EM. On 11/6/2007, he was seen by MC Dermatology for a skin punch biopsy - results below. SM was started on Zyrtec with gradual improvement in symptoms. Symptom: Nausea w/o vomiting Start: 10/26/2007 End: 10/28/2007; Symptom: Diarrhea Start: 10/26/2007 End: 10/28/2007; Symptom: Fatigue, Malaise <60 Days Start: 10/26/2007 End: 10/28/2007; Symptom: Muscle Pain Start: 10/26/2007 End: 10/28/2007 Comment: generalized aches; Symptom: Pruritis Start: 11/01/2007 Comment: starting posterior legs, later generalized; Symptom: Lesions, wheal Start: 11/03/2007 Comment: ID: maculopapular rash; A/I: lesions, raised; Derm: papules
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus generalised, Rash, Rash generalised, Rash maculo-papular, Urticaria
Clinical narrative: Description: 28 y/o Asian male who received primary SPV (left arm), Typhoid IM (left arm) and first dose AVA(right arm) on 10/24/2007. 48 hours later he experienced 'flu-like' symptoms - mild nausea without vomiting, diarrhea, malaise and fatigue. On 11/1/2007 (8 days after vaccination), he developed itching at the back of his lower legs, followed by the appearance of a few itchy non-tender red eruptions covering his legs, back and chest. By 11/2/2007 both the itching and skin eruptions worsened to involve his face, neck, scalp and arms. On 11/3/2007, he had increased itching with swelling of his eyes, lips and ears with non-tender palmar lesions as well. There were no blisters, oral lesions, fever/chills, or cardio-pulmonary symptoms. He was seen at Hospital ER 11/1/2007 and 11/3/2007, diagnosed with dermatitis and treated with antihistamines. On 11/5/2007, he was seen at Medical Center, by Allergy and Infectious Disease (12 days post vaccination), and diagnosed with allergic urticaria vs EM. On 11/6/2007, he was seen by MC Dermatology for a skin punch biopsy - results below. SM was started on Zyrtec with gradual improvement in symptoms. Symptom: Nausea w/o vomiting Start: 10/26/2007 End: 10/28/2007; Symptom: Diarrhea Start: 10/26/2007 End: 10/28/2007; Symptom: Fatigue, Malaise <60 Days Start: 10/26/2007 End: 10/28/2007; Symptom: Muscle Pain Start: 10/26/2007 End: 10/28/2007 Comment: generalized aches; Symptom: Pruritis Start: 11/01/2007 Comment: starting posterior legs, later generalized; Symptom: Lesions, wheal Start: 11/03/2007 Comment: ID: maculopapular rash; A/I: lesions, raised; Derm: papules
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Blood glucose, Pallor, Syncope
Clinical narrative: After receiving flu and varicella vaccines pt. stood up and stiffened and fainted and fell to floor. She around almost immediately, color pale. Blood sugar done, p.o. fluids given, rested briefly, discharged home.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Skin exfoliation
Clinical narrative: R deltoid w/ exfoliated area 4x6cm, no tenderness/swelling.  Advised to keep clean & observe.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash - belly, back, legs.  Dec. 7th - doctor office.  Hydrocortisone.  Rash and hives on whole body.  Dec. 9th, called doctor.  Doctor called in Zyrtec.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Wheezing
Clinical narrative: Fluvirin vaccine 10/31/07. Several hours later began to have itch, rash to legs, abd, back. Also noted some wheezing. Began to use Benadryl. Was seen by Employee physician who prescribed Allegra and was off work until 11-6-07.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus generalised, Rash
Clinical narrative: Received Fluvirin vaccine on 10/30/07. Began to experience over entire body itchiness. This was on 11/1/07. On 11/2/07 a raised hive-like rash developed with blisters on (L) arm. Took own Diprolene ointment and advised employee health who advised OTC Benadryl.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate decreased
Clinical narrative: about 6 hours after getting a flu shot I experienced a rapid heart beat for about 5 min. I take metoprolol but it didn't help this episode to quit
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Cold sweat, Cough, Dizziness, Dyspepsia
Clinical narrative: Started 12/4/07 tired & achy, sleepy, "weird dizziness", cold sweats, some nausea, no vomiting, some heartburn & LLQ pain, mild cough, occipital HA, lots of gas.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flatulence, Headache, Nausea, Pain
Clinical narrative: Started 12/4/07 tired & achy, sleepy, "weird dizziness", cold sweats, some nausea, no vomiting, some heartburn & LLQ pain, mild cough, occipital HA, lots of gas.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Started 12/4/07 tired & achy, sleepy, "weird dizziness", cold sweats, some nausea, no vomiting, some heartburn & LLQ pain, mild cough, occipital HA, lots of gas.
Age: 0.2
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: None. Pt was given a DTaP and Pediarix in error; should have received only Pediarix.
Age: 0.8
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Body temperature increased, Crying, Pallor, Tremor, Vomiting
Clinical narrative: Pt mother called.  Stated pt. was crying, vomiting, had an episode of shakes and was pale.  Advised mother to call MD.  Mom took child to the dr.  Dr. told mother she thought it was a reaction to the vaccine.  Sent her home, later in the evening child had increased vomiting & temp of 103.5.  Went to ER, had IV fluids & suppository to stop vomiting.  Sent home, was doing well on 12/07/07.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Pt had hives at injection site.  Pt complained of itching.  Reported adverse effects to health dept.  Pt parents & teacher notified.  If hives worsen pt to report to teacher.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis, Dermatitis atopic, Pruritus, Rash
Clinical narrative: Developed atopic eczema after AVA #3.  Symptom: Dermatitis, diffuse, generalized. Follow-up: It took me so long to report this because I was not aware the reason I was having problems was adverse effect from the Anthrax Vaccine. I had a chemical test in 2006, and my results stated that I am allergic to a chemical in the Vaccine, which may have given me this skin disease. My symptoms are rashes, which I later found out was eczema. My first episode of eczema was when I was deployed in 2001. I started breaking out after the third Anthrax Vaccine was administered. I came back to the states, and saw my primary doctor numerous times and he told me I had a "desert funk". The rash was so bad that I was bleeding on my arms, legs and stomach. My face had numerous rashes, which caused my left eye to swell shut. After numerous doctor visits, they finally referred me to an off base dermatologist. He took one glance at me and told me it was eczema. After numerous steroid shots and pills, I finally got it somewhat under control. To this day, I still have to see a dermatologist on a regular basis. I use numerous steroid creams to keep the eczema somewhat under control. I always have lesions on my hands and rashes on my legs and arms. My skin itches to the point that it sometimes feels like it is crawling. No one in the history of my family has ever had any skin problems. I truly believe my eczema is an adverse effect of the Anthrax Vaccine.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Headache, Joint swelling
Clinical narrative: 12/11/07 315p.m. Patient given Pneumovax (L) upper arm s.q. Developed pain and swelling (L) elbow. increased 12/12/07. Swelling, redness for 5 days, intense headache first 2 days; continued soreness.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Vomiting
Clinical narrative: Pt presented to clinic with red raised area on left thigh, approx 18mm, which began 6-7 days after injection of vaccines. Rec'd HIB and Varicella injections in LT. Both nurse and mother believe it is the Varicella inj site. Pt has had 2 previous HIB inj, this was first Varicella. Also had episode of vomiting 2 days after shot lasted 2 days. No fever.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Rash generalised
Clinical narrative: Pt had imm on 12/4/07.  On 12/6/07 R knee swelled, parent said R leg was red and very tender to the touch.  He was taken to ER, they were told be ER dr. to give him Motrin.  The child had not had Motrin before.  The following day child had broken out in whelps all over his body.  Had a temperature of approx 100 degrees.  Took back to ER, given steroid pack.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Facial palsy
Clinical narrative: Developed Bells Palsy 36 hours after vaccines were administered.
Age: 0.1
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Feeling hot, Wrong drug administered
Clinical narrative: 48 hours after mistakenly received Hepatitis A instead of Hepatitis B vaccination at one month visit, baby had low appetite, seemed uncomfortable, felt warm (no temperature taken).  Did fine by the next day.  Discovered mistaken Hepatitis A for B at next visit.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea, Urticaria, Vomiting
Clinical narrative: Broke out in small Whelts on arms and legs the day the vaccines were given. Low-grade fever - 99 deg-100 deg Diarrhea 2-3 times day Vomiting x2
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Chest pain, Chills, Headache, Malaise, Pyrexia
Clinical narrative: This case was received from a health professional on 17 July 2007.  A 20-year-old male patient with no reported medical history received an intramuscular left deltoid injection of Menactra (lot number U2370AA).  Approximately 12 hours later, he experienced chest pain, headache, malaise, chills, and a fever of 102 degrees Fahrenheit.  He was seen in his physician's office on 17 July 2007, and was treated with Advil.  At the time of the report, the event was resolving.  Follow-up information received on 27 August 2007 from a health care professional.  The patient has medical history of allergy to "PCN" (penicillin) and  Cephalosporins.  He had no illnesses at the time of the Menactra vaccination on 16 July 2007.  The patient had no relevant diagnostic tests or laboratory data performed for the reported events in this case.  It was reported the patient recovered from the events, however a recovery date was not provided.  No further information is expected.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Headache
Clinical narrative: This case was received from a health professional on 18 July 2007. An 11-year-old patient with no reported medical history received an injection of Menactra (U2338AA) on 17 July 2007. That same day, the patient experienced a headache and stomach ache. Outcome was not reported. Follow-up information received on 20 August 2007 from a health care professional. Menactra was a first dose administered in the "arm." The patient had no illness at the time of vaccination and had no pre-existing medical conditions. Relevant diagnostic testing was none. The patient recovered from the event.
Age: 12.0
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Chills, Malaise, Neck pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: This case was received from a health professional on 25 July 2007.  A 12-year-old patient with no known medical history received an intramuscular right deltoid injection of Menactra (lot number U2327AA) and an intramuscular left deltoid injection of Varivax (Merck, lot number 0674U) on 11 July 2007.  On 13 July 2007, two days after vaccination, the patient developed a temperature of 101 degrees Fahrenheit, chills, sore throat, malaise, vomiting, and neck pain.  The patient was seen in the doctor's office on 16 July 2007, at which time a strep test was negative.  Treatment included fluids and rest, and the events resolved after 48 hours.  Follow-up information received on 20 August 2007 from a health care professional.  The case was reviewed, and there was no additional information at this time. The reporter in this case is the same as in case 2007-02626.
Age: 12.0
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Streptococcal identification test negative, Vomiting
Clinical narrative: This case was received from a health professional on 25 July 2007.  A 12-year-old patient with no known medical history received an intramuscular right deltoid injection of Menactra (lot number U2327AA) and an intramuscular left deltoid injection of Varivax (Merck, lot number 0674U) on 11 July 2007.  On 13 July 2007, two days after vaccination, the patient developed a temperature of 101 degrees Fahrenheit, chills, sore throat, malaise, vomiting, and neck pain.  The patient was seen in the doctor's office on 16 July 2007, at which time a strep test was negative.  Treatment included fluids and rest, and the events resolved after 48 hours.  Follow-up information received on 20 August 2007 from a health care professional.  The case was reviewed, and there was no additional information at this time. The reporter in this case is the same as in case 2007-02626.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Bacterial culture negative, Candidiasis, Culture positive, HIV test negative, Throat irritation
Clinical narrative: Initial report received from the patient's parent on 01 August 2007.  A 14-year-old female with a history of seasonal allergies had received vaccinations with Menactra (Lot number U2227AA), varicella (manufactured by Merck, Lot number 0606U), and Gardasil (manufactured by Merck, Lot number not provided) on 12 July 2007 and two days later developed white spots on her throat.  The patient had no illness at the time of vaccination and the only reported concomitant medication was Zyrtec, taken daily.  The patient was seen in the hospital emergency room and was given Nystatin and unspecified antibiotics.  Blood work, throat cultures and an HIV test were performed.  Diagnosis was "thrush".  Patient outcome was not reported.  No additional information had been provided at the time of this report.  Follow-up information received on 21 September 2007 from a health care professional, the patient's treating physician; Menactra was given intramuscular, into the left arm.  Varicella was given subcutaneous into the left arm and Gardasil (lot #0525U) was given intramuscular into the right arm.  The final diagnosis was candidal pharyngitis (thrush).  Extensive work-up performed in the emergency room (ER) (on 17 July 2007) with multiple cultures.  The patient was given 1 dose of IM Ceftriaxone.  Then results of bacterial cultures came back all negative.  The only positive culture was fungal culture positive for candida.  Further evaluation for immunodeficiency performed as out patient.  All labs were okay, including negative HIV.  No etiology determined for candidal pharyngitis, which, per reporter was unusual in immunocompetent adolescents.  As of last contact with the parent, the patient was still using Nystatin, which was the final treatment.  Concomitant medications (per patient's records) included also Flonase.  Current status was unknown.  Documents held by the sender: ER and office visits and labs.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Body temperature increased, Injection site erythema, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 03 August 2007. A 37-year-old female patient with non relevant medical history, had received an intramuscular left deltoid injection of Menactra, lot number U2377BA on 01 August 2007 and one day later, she developed minimal redness at the injection site, pain in her left upper extremity and left axilla. The reporter noted the patient's temperature was 99.3 degrees Fahrenheit. The patient had no illness at the time of vaccination. At the time of the report, the patient had not recovered. No additional information had been provided.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Headache, Streptococcal identification test negative
Clinical narrative: Follow up information received from a health care provider on 11 September 2007.  A 16-year-old female patient with a medical history of depression and attention deficit disorder, had received a left arm injection of Menactra (route not reported), lot number U2233C, and a right arm injection of Gardasil (route not reported), lot number U2233CA (lot number reported is consistent with Menactra) on 30 July 2007, and five days later, she complained of a headache and stomach ache.  A strep test was performed (date not provided) and the results were negative.  The patient had been taking Zoloft and Concerta at the time of vaccination.  Corrective treatment for the event consisted of Tylenol and ibuprofen.  The patient was not ill at the time of vaccination and they had not received any vaccines during the four weeks prior to receipt of Menactra.  The duration for the event was not indicated and the patient had been listed as recovered at the time of the report.  No further information was provided.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Back pain, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial report received on 28 August 2007 from a physician. A 15-year-old female patient, with no concurrent illnesses, and who has a past medical history of "ADHD" (attention deficit hyperactivity disorder) being treated with Adderall, had received a right deltoid dose of Menactra, lot number U8534, on 27 August 2007. The evening after vaccination the patient experienced sight pain at the right deltoid area and the following day, the pain got progressively worse to include pain and stiffness in the right shoulder. Her right arm was very tender but had no redness. She also experienced back pain and a temperature of 99.4 degrees Fahrenheit. No diagnostic testing was performed. The patient was "prescribed" Motrin. At the time of this report, the patient had not recovered.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Tenderness
Clinical narrative: Initial report received on 28 August 2007 from a physician. A 15-year-old female patient, with no concurrent illnesses, and who has a past medical history of "ADHD" (attention deficit hyperactivity disorder) being treated with Adderall, had received a right deltoid dose of Menactra, lot number U8534, on 27 August 2007. The evening after vaccination the patient experienced sight pain at the right deltoid area and the following day, the pain got progressively worse to include pain and stiffness in the right shoulder. Her right arm was very tender but had no redness. She also experienced back pain and a temperature of 99.4 degrees Fahrenheit. No diagnostic testing was performed. The patient was "prescribed" Motrin. At the time of this report, the patient had not recovered.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Bacterial disease carrier, Culture positive, Meningitis meningococcal
Clinical narrative: Initial information received on 10 September 2007 from a health care professional.  A 15-year-old male patient, who had nasal congestion at the time of vaccination and a history of sinus infections, had received a first dose injection of Menactra, lot number U2375BA, 09 August 2007.  Route and site of administration were not provided.  The subject had been treated with Cefzil on 23 July 2007 for ten days and was started on Augmentin on the day of vaccination.  In the "first week of September", a nasal culture was completed secondary to a history of sinus infections, which showed an unknown strain of Neisseria meningitidis.  "No other symptoms reported."  The subject was treated with Levaquin.  Other medical intervention was noted as "none".  Recovery status was not reported.
Age: 38.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a health care professional on 24 September 2007. A 38 year old, female patient (with no medical history) complained of pain in her left arm and neck, and fever, 2 days after she received Menactra (lot number U2379BA) intramuscularly in the left deltoid on 20 September 2007. She did not have any illness at the time of vaccination. The fever has resolved, however it was reported the other symptoms were still resolving.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Back pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a health professional on 12 October 2007.  A 17-year-old female patient, with a history of chondromalacia of the knee and allergies to morphine and aspirin, received an intramuscular right deltoid injection of Menactra (lot number U2428AA) and an intramuscular left deltoid injection of Gardasil (Merck, lot number 1265U) on 11 October 2007.  Approximately eight hours later, she developed a low grade fever and pain at the back of the neck, which traveled down her spine.  Her mother took her to the emergency room, where she was seen and sent home.  Per the reporter, no tests were performed, and the symptoms recovered completely by noon on 12 October 2007.  Concomitant medication included Wellbutrin daily.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Initial non-serious report received from the patient's parent on 01 August 2007. A twelve-year old male with history of migraines had received an intramuscular injection of Menactra (Lot number not reported) to his left arm on 31 July 2007. On 01 August 2007, approximately 16 hours following vaccination, the patient experienced redness at injection site, fever of 100.9 degrees Fahrenheit and headache. The patient had no illness at the time of vaccination and no concomitant medications were reported. Recovery status was reported as "resolving". On 02 August 2007, the patient's mother called to report an additional symptom of left axillary lymph node swelling (the size of a lemon). The patient went to the Emergency Room and was placed on "steroids". It was reported that Infectious Disease specialist was being consulted. No additional information had been provided at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Ataxia, Crying, Vomiting
Clinical narrative: The day after vaccination, he developed vomiting 1-2 episodes daily, inability to stand, screaming intermittently, cessation of talking, diminished appetite, and 2 pustules on back of right leg.  These all gradually resolved over the following two weeks.  No treatment was given.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Decreased appetite, Screaming, Speech disorder, Vomiting
Clinical narrative: The day after vaccination, he developed vomiting 1-2 episodes daily, inability to stand, screaming intermittently, cessation of talking, diminished appetite, and 2 pustules on back of right leg.  These all gradually resolved over the following two weeks.  No treatment was given.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Arthralgia, Immediate post-injection reaction, Pallor, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 mL dose of Gardasil.  Suspect vaccination included Menactra and influenza virus vaccine (unspecified) given on the same date as Gardasil.  On 16-Oct-2007 the patient fainted.  On approximately 18-Oct-2007 "couple days later" the patient's mother reported that her daughter experienced "bilateral knee pain."  The patient's outcome was not reported.  There was no product quality complaint.  Additional information has been requested. Follow up information received on 23-JAN-2008. It was reported that on 16-OCT-2007 at 11:30, immediately following administeration of GARDASIL (lot # 658490/0802U, via IM) the patient a white female weighing 124 pounds and height of 63 inches, stood up and had syncope episode with collapse for seconds. She developed pallor and emesis after. No airway compromise. On 16-OCT-2007 at 11:30 the patient was also vaccinated via IM with a dose of )MENACTRA, lot # U2419AA) and influenza virus vaccine (Sanofi, lot # U2441AA). At the time of vaccination the patient had a mild sore throat and no fever. The patient had a "craniosynastosis" treated with surgery at 11 month old of age. Laboratory diagnostic test performed included: VS 98.8, blood pressure of 120/64, HR 75, orthostatic P laying 100/62, sitting 100/40 and standing 102/60. The patient was vaccinated at a private doctor's office/hospital and the vaccines were purchsed with private funds. ON an unspecified date, the patient recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Arthralgia, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a 0.5 mL dose of Gardasil.  Suspect vaccination included Menactra and influenza virus vaccine (unspecified) given on the same date as Gardasil.  On 16-Oct-2007 the patient fainted.  On approximately 18-Oct-2007 "couple days later" the patient's mother reported that her daughter experienced "bilateral knee pain."  The patient's outcome was not reported.  There was no product quality complaint.  Additional information has been requested. Follow up information received on 23-JAN-2008. It was reported that on 16-OCT-2007 at 11:30, immediately following administeration of GARDASIL (lot # 658490/0802U, via IM) the patient a white female weighing 124 pounds and height of 63 inches, stood up and had syncope episode with collapse for seconds. She developed pallor and emesis after. No airway compromise. On 16-OCT-2007 at 11:30 the patient was also vaccinated via IM with a dose of )MENACTRA, lot # U2419AA) and influenza virus vaccine (Sanofi, lot # U2441AA). At the time of vaccination the patient had a mild sore throat and no fever. The patient had a "craniosynastosis" treated with surgery at 11 month old of age. Laboratory diagnostic test performed included: VS 98.8, blood pressure of 120/64, HR 75, orthostatic P laying 100/62, sitting 100/40 and standing 102/60. The patient was vaccinated at a private doctor's office/hospital and the vaccines were purchsed with private funds. ON an unspecified date, the patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Chest pain, Full blood count, Haemoglobin decreased, Pain
Clinical narrative: Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with Gardasil (Lot # 658490/0802U). Concomitant therapy included levonorgestrel (Plan B) that was administered on the same day as Gardasil. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting arm). On 30-OCT-2007 she sought medical attention. She had a complete blood count done which found RDW out of range and hemoglobin at 11.8. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The patient had a complete blood count with normal hemoglobin, hematocrit and white blood cell count, some levels such as MCV were a bit off (specifics unknown). The HCP reported that it did not appear the patient had an infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tired and weak. The outcome of the pain at the injection site was not reported. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with her first dose GARDASIL (Lot #658490/0802U) intramuscularly in the right deltoid. Concomitant therapy included levonorgestrel (PLAN B) that was administered on the same day as GARDASIL. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting her arm) and heaviness in her legs. On 30-OCT-2007 she sought medical attention. She had a complete blood count done on 30-OCT-2007 which found RDW 15.5%, MCV 75.32 and hemoglobin at 13.2, WBC 9.2, hematocrit19.9. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The HCF reported that it did not appear the patient had no infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tiredd and weak. On 02-NOV-2007 the patient had recovered.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine negative
Clinical narrative: Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with Gardasil (Lot # 658490/0802U). Concomitant therapy included levonorgestrel (Plan B) that was administered on the same day as Gardasil. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting arm). On 30-OCT-2007 she sought medical attention. She had a complete blood count done which found RDW out of range and hemoglobin at 11.8. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The patient had a complete blood count with normal hemoglobin, hematocrit and white blood cell count, some levels such as MCV were a bit off (specifics unknown). The HCP reported that it did not appear the patient had an infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tired and weak. The outcome of the pain at the injection site was not reported. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with her first dose GARDASIL (Lot #658490/0802U) intramuscularly in the right deltoid. Concomitant therapy included levonorgestrel (PLAN B) that was administered on the same day as GARDASIL. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting her arm) and heaviness in her legs. On 30-OCT-2007 she sought medical attention. She had a complete blood count done on 30-OCT-2007 which found RDW 15.5%, MCV 75.32 and hemoglobin at 13.2, WBC 9.2, hematocrit19.9. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The HCF reported that it did not appear the patient had no infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tiredd and weak. On 02-NOV-2007 the patient had recovered.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Chest pain, Fatigue, Haematocrit decreased, Injected limb mobility decreased
Clinical narrative: Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with Gardasil (Lot # 658490/0802U). Concomitant therapy included levonorgestrel (Plan B) that was administered on the same day as Gardasil. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting arm). On 30-OCT-2007 she sought medical attention. She had a complete blood count done which found RDW out of range and hemoglobin at 11.8. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The patient had a complete blood count with normal hemoglobin, hematocrit and white blood cell count, some levels such as MCV were a bit off (specifics unknown). The HCP reported that it did not appear the patient had an infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tired and weak. The outcome of the pain at the injection site was not reported. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with her first dose GARDASIL (Lot #658490/0802U) intramuscularly in the right deltoid. Concomitant therapy included levonorgestrel (PLAN B) that was administered on the same day as GARDASIL. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting her arm) and heaviness in her legs. On 30-OCT-2007 she sought medical attention. She had a complete blood count done on 30-OCT-2007 which found RDW 15.5%, MCV 75.32 and hemoglobin at 13.2, WBC 9.2, hematocrit19.9. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The HCF reported that it did not appear the patient had no infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tiredd and weak. On 02-NOV-2007 the patient had recovered.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Mean cell volume abnormal, Pain, Red cell distribution width increased
Clinical narrative: Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with Gardasil (Lot # 658490/0802U). Concomitant therapy included levonorgestrel (Plan B) that was administered on the same day as Gardasil. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting arm). On 30-OCT-2007 she sought medical attention. She had a complete blood count done which found RDW out of range and hemoglobin at 11.8. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The patient had a complete blood count with normal hemoglobin, hematocrit and white blood cell count, some levels such as MCV were a bit off (specifics unknown). The HCP reported that it did not appear the patient had an infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tired and weak. The outcome of the pain at the injection site was not reported. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a female nurse practitioner concerning a 15 year old female with no known allergies, who is in recovery from substance abuse. On 29-OCT-2007 the patient was vaccinated with her first dose GARDASIL (Lot #658490/0802U) intramuscularly in the right deltoid. Concomitant therapy included levonorgestrel (PLAN B) that was administered on the same day as GARDASIL. On 29-OCT-2007, 12 hours after receiving the vaccine, the patient developed body aches, diffuse chest pain, pain at the injection site, and experienced weakness (was not able to or had difficulty lifting her arm) and heaviness in her legs. On 30-OCT-2007 she sought medical attention. She had a complete blood count done on 30-OCT-2007 which found RDW 15.5%, MCV 75.32 and hemoglobin at 13.2, WBC 9.2, hematocrit19.9. Additional information was received from the nurse practitioner on 08-NOV-2007. The nurse practitioner reported that the patient also experienced pain at the injection site. The HCF reported that it did not appear the patient had no infection. She was able to attend school on 30-OCT-2007 and 31-OCT-2007 but missed school on 01-NOV-2007. She had gotten better but as of 2-NOV-2007 still felt tiredd and weak. On 02-NOV-2007 the patient had recovered.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with a history of chronic abdominal issues, polycystic ovaries and drug hypersensitivity to penicillin who on 30-OCT-2007 was vaccinated intramuscularly in the left deltoid with her second (previously reported as third dose) dose of Gardasil (lot #657006/0188U). There was no concomitant medication. On 31-OCT-2007 the patient experienced tingling and numbness in all 4 extremities (hands and feet) (previously reported as numbness in legs and arms) within 12 hours of receiving her second dose. The patient's tingling and numbness in hands and feet persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a registered nurse concerning a 17 year old white female with a penicillin allergy who was vaccinated with her second dose of GARDASIL on 10-OCT-2007, intramuscularly in the left deltoid. During the early morning of 11-OCT-2007 the patient experienced numbness in her arms and legs. On 01-NOV-2007 the patient sought medical attention in the physican's office and was improving. On 2-NOV-2007 the patient reported that she was much improved.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with a history of chronic abdominal issues, polycystic ovaries and drug hypersensitivity to penicillin who on 30-OCT-2007 was vaccinated intramuscularly in the left deltoid with her second (previously reported as third dose) dose of Gardasil (lot #657006/0188U). There was no concomitant medication. On 31-OCT-2007 the patient experienced tingling and numbness in all 4 extremities (hands and feet) (previously reported as numbness in legs and arms) within 12 hours of receiving her second dose. The patient's tingling and numbness in hands and feet persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a registered nurse concerning a 17 year old white female with a penicillin allergy who was vaccinated with her second dose of GARDASIL on 10-OCT-2007, intramuscularly in the left deltoid. During the early morning of 11-OCT-2007 the patient experienced numbness in her arms and legs. On 01-NOV-2007 the patient sought medical attention in the physican's office and was improving. On 2-NOV-2007 the patient reported that she was much improved.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Blood glucose abnormal, Blood potassium decreased, Blood urea decreased, Dizziness, Electrocardiogram QT prolonged
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 07-Aug-2007 was vaccinated with her first dose of Gardasil (lot #658094/0524U), 0.5mL injection.  On 07-Aug-2007 the patient experienced syncope right after receiving the first dose of Gardasil.  The patient also received hepatitis A vaccine (inactive) (MSD) the same day.  On 17-Oct-2007 the patient received her second dose of Gardasil and again experienced syncope.  The patient also received influenza virus vaccine (unspecified) (lot #02505AA) the same day.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Lymphocyte count decreased, Nausea, Neutrophil count decreased
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 07-Aug-2007 was vaccinated with her first dose of Gardasil (lot #658094/0524U), 0.5mL injection.  On 07-Aug-2007 the patient experienced syncope right after receiving the first dose of Gardasil.  The patient also received hepatitis A vaccine (inactive) (MSD) the same day.  On 17-Oct-2007 the patient received her second dose of Gardasil and again experienced syncope.  The patient also received influenza virus vaccine (unspecified) (lot #02505AA) the same day.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Orthostatic hypotension, Pallor, Presyncope, Tinnitus, Tunnel vision
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 07-Aug-2007 was vaccinated with her first dose of Gardasil (lot #658094/0524U), 0.5mL injection.  On 07-Aug-2007 the patient experienced syncope right after receiving the first dose of Gardasil.  The patient also received hepatitis A vaccine (inactive) (MSD) the same day.  On 17-Oct-2007 the patient received her second dose of Gardasil and again experienced syncope.  The patient also received influenza virus vaccine (unspecified) (lot #02505AA) the same day.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 07-Aug-2007 was vaccinated with her first dose of Gardasil (lot #658094/0524U), 0.5mL injection.  On 07-Aug-2007 the patient experienced syncope right after receiving the first dose of Gardasil.  The patient also received hepatitis A vaccine (inactive) (MSD) the same day.  On 17-Oct-2007 the patient received her second dose of Gardasil and again experienced syncope.  The patient also received influenza virus vaccine (unspecified) (lot #02505AA) the same day.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 07-Aug-2007 was vaccinated with her first dose of Gardasil (lot #658094/0524U), 0.5mL injection.  On 07-Aug-2007 the patient experienced syncope right after receiving the first dose of Gardasil.  The patient also received hepatitis A vaccine (inactive) (MSD) the same day.  On 17-Oct-2007 the patient received her second dose of Gardasil and again experienced syncope.  The patient also received influenza virus vaccine (unspecified) (lot #02505AA) the same day.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abasia, Asthenia, Blood product transfusion, Electromyogram abnormal, Gait disturbance
Clinical narrative: Initial and follow up information has been received from a physician, via a company representative, concerning a 15 year old female patient with no known drug allergies or birth anomalies, who on  an unknown date was vaccinated with a dose of Gardasil (lot # not provided). The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to Guillain Barre syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have Guillain Barre, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with Gardasil, the patient received a concomitant vaccination of a does of VAQTA. The patient, contrary to the above information, was actually diagnosed with Guillain Barre Syndrome. At the time of this report, the outcome of the event was unknown. No further details were available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Malaise, Myalgia, Polyneuropathy, Tremor
Clinical narrative: Initial and follow up information has been received from a physician, via a company representative, concerning a 15 year old female patient with no known drug allergies or birth anomalies, who on  an unknown date was vaccinated with a dose of Gardasil (lot # not provided). The physician reported that 48 hours after the vaccination, the patient presented with "symptoms similar to Guillain Barre syndrome," and went into the hospital. Diagnostic testing was done, and a specialist determined that she did not have Guillain Barre, but rather a severe case of muscle myalgia. Follow up information from the physician, via the company representative, indicated that on the same day of vaccination with Gardasil, the patient received a concomitant vaccination of a does of VAQTA. The patient, contrary to the above information, was actually diagnosed with Guillain Barre Syndrome. At the time of this report, the outcome of the event was unknown. No further details were available. Additional information has been requested.