chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Teacher was given the vaccine on Friday 3/7/08 at 3:00pm by late Friday night to early Saturday morning teacher awoke not feeling well had a very itchy throat.  By late Saturday early Sunday the right side of her face was red puffy and itchy.  On Monday morning I saw the teacher she told be about the the symptoms/ reaction she had over the weekend.  I observed a red splotch in my opinion a hive on her face under her right eye.  She stated that the splotch itched.  I spoke with her at the end of the day she stated that the swelling was getting better, but she was still very itchy.  I advised her to take some Benadryl once she got home.  I spoke with the teacher again on Tuesday she stated that the Benadryl had helped and the red spot was gone.  I spoke with the health dept. about the possible reaction and they advised against future inoculation.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Malaise, Oedema peripheral
Clinical narrative: VACCINE GIVEN ON 17 MARCH.  ON THE 19 MARCH PT HAD EDEMA AND ERYTHEMA TO ENTIRE LEFT ARM ALONG WITH SYSTEMIC SX OF MALAISE AND FATIGUE.  RESOLVING BY THE 20TH AFTER TX WITH BENADRYL.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient had her first varicella vaccine on 1/11/08. She had her second vaccine 2/20/08. She has a positive pregnancy test 3/14/08.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Agitation, Insomnia, Irritability
Clinical narrative: MOTHER REPORTS CALLED DR. ON HOLIDAY WEEKEND TO REPORT ADVERSE REACTION OF AGITATION, INABILTITY TO SLEEP AND FUSSY
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Aggression, Headache, Influenza serology negative, Nausea, Pyrexia
Clinical narrative: Patient woke on Saturday, 03/15/08 @ 8:00am with headache, nausea, fever of 99.  c/o numbness in toes and began hallucinating "talking to pink bunnies".  Numbness, hallucinations and "violent outbursts" continue.  Went to ER on Sunday, 03/16/08 with above symptoms.  4/4/08 Spoke w/parent who states patient never admitted.  Seen in ER x 2 & seen by PCP x 2.  No diagnosis other than new onset migraine HAs.  Missed 7 days of school due to pain & violet outbursts.  4/11/08 Reviewed ER medical records of 3/16 & 3/22/2008. 3/16/08 FINAL DX: Malaise, dehydration Records reveal patient feeling unwell x 1 day.  Aching pain in arms, neck & jaw, chills, malaise, nausea, HA, visual hallucinations & numbness/tingling.  Tx w/IVF & antinausea med.  Improved & d/c to home.  3/22/08 FINAL DX: fever, HA & nausea Records reveal patient returned to ER.  Tx w/antinausea med & d/c to home w/additional oral antinausea med.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Patient woke on Saturday, 03/15/08 @ 8:00am with headache, nausea, fever of 99.  c/o numbness in toes and began hallucinating "talking to pink bunnies".  Numbness, hallucinations and "violent outbursts" continue.  Went to ER on Sunday, 03/16/08 with above symptoms.  4/4/08 Spoke w/parent who states patient never admitted.  Seen in ER x 2 & seen by PCP x 2.  No diagnosis other than new onset migraine HAs.  Missed 7 days of school due to pain & violet outbursts.  4/11/08 Reviewed ER medical records of 3/16 & 3/22/2008. 3/16/08 FINAL DX: Malaise, dehydration Records reveal patient feeling unwell x 1 day.  Aching pain in arms, neck & jaw, chills, malaise, nausea, HA, visual hallucinations & numbness/tingling.  Tx w/IVF & antinausea med.  Improved & d/c to home.  3/22/08 FINAL DX: fever, HA & nausea Records reveal patient returned to ER.  Tx w/antinausea med & d/c to home w/additional oral antinausea med.
Age: 33.0
Sex: M
Vaccine: DT, IPV
Symptoms: Injected limb mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Pt. experienced continued soreness. To date he is experiencing muscle weakness and pain. Limited ability to lift weights using this arm.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood pressure increased, Headache, Hyperacusis, Loss of consciousness, Malaise
Clinical narrative: Nov 13, 2007 Flumist vaccination. He stated no problems with past IM flu vaccinations.  Following the Flumist, he remembers "not feeling well" for the next 12 hours as corpsmen advised. Within 1 days post vaccination he noted increasing "blurry vision" with elevation of BP >150 systolic. He described the blurry vision while reading and having difficulty focusing having to move his eyes about to refocus. Approximately 2 1/2 days post vaccination while working as correctional officer at a brig he passed out.  He was transferred to Hospital where he was monitored for 4-5 hours and sent home.  There he complained of a severe headache but cannot remember details. He does remember eyes were sensitive to light as was his hearing. He experienced intermittent episodes of headaches and visual blurry over the next two months before symptoms resolved. He stated eating "lots of garlic" which made these symptoms resolve.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Photophobia, Vision blurred
Clinical narrative: Nov 13, 2007 Flumist vaccination. He stated no problems with past IM flu vaccinations.  Following the Flumist, he remembers "not feeling well" for the next 12 hours as corpsmen advised. Within 1 days post vaccination he noted increasing "blurry vision" with elevation of BP >150 systolic. He described the blurry vision while reading and having difficulty focusing having to move his eyes about to refocus. Approximately 2 1/2 days post vaccination while working as correctional officer at a brig he passed out.  He was transferred to Hospital where he was monitored for 4-5 hours and sent home.  There he complained of a severe headache but cannot remember details. He does remember eyes were sensitive to light as was his hearing. He experienced intermittent episodes of headaches and visual blurry over the next two months before symptoms resolved. He stated eating "lots of garlic" which made these symptoms resolve.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Chest X-ray, Cough, Differential white blood cell count, Dizziness
Clinical narrative: General arthralgia/myalgia, fever up to 103, dizziness, sinus & chest congestion/drainage w/ dry cough, dfficulty focusing, general malaise.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Full blood count, Laboratory test, Malaise, Myalgia, Paranasal sinus hypersecretion
Clinical narrative: General arthralgia/myalgia, fever up to 103, dizziness, sinus & chest congestion/drainage w/ dry cough, dfficulty focusing, general malaise.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Respiratory tract congestion, Sinus congestion, Vision blurred
Clinical narrative: General arthralgia/myalgia, fever up to 103, dizziness, sinus & chest congestion/drainage w/ dry cough, dfficulty focusing, general malaise.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site induration
Clinical narrative: Administered HEP-A RAT-IM.  Upon withdrawal of syringe, noted bleeding.  Applied direct pressure until bleeding stopped which was less than one (1) minute.  Instructed mother to expect bruising at site and to apply ice for 10 min on then 10 min off for one (1) hour.  Called out to mother within 48 hours to f/u on patient.  No answer.  Left detailed message requesting a call back from parent - no response.  Parent brought patient and other children to clinic on 3/12/2008 and was seen by Nurse Practioner.  Parent stated there was bruising at the site but the patient was "ok".  Parent placed a call to the clinic on 3/20/2008 c/o "hard area" at injection site.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt. recently moved here from another country.  C/O fever 102-104, with vomiting.  No rash reported.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Induration, Night sweats, Pain
Clinical narrative: 7 days after admin of Adacel Tdap, developed 4X6 cm area induration and redness. c/o of severe headache, body aches. No documented fever but did report night sweats 2 nights previous.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: PT RECEIVED A CHICKEN POX INJECTION ON HIS LT ARM SUBCUT. ON 3-18-08. PT CAME IN ON 3-19-08 BECAUSE OF A RASH ON HIS LT ARM.  PT HAS A 3CM X 4CM ELEVATED, ERYTHEMATOUS EXANTHEM ON LEFT ARM ON THE OUTER ASPECT, SITE OF THE VARICELLA INJECTION.  RECOMMEND BENADRYL OTC, HYDROCORTISONE 1% CREAM FOR ITCHING.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Grip strength decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: C/O Soreness & Swelling around injection site and pain radiating down to Left hand. Starting 3 days after immunization. Also C/O inability to hold objects in Left Hand.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient called several days following administration stating she had experienced redness, swelling the size of her palm, and a knot developing where the immunization was given. She stated the pain was radiating down her arm.  This lasted 2 days, the redness lasted 3 or 4 days.  She consulted with her physician who advised her to wait another day.  She applied no ice pack nor took any pain reliever.  When I talked to her later in the week, she stated it was much better, and did not require a doctor's visit.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Parent paged me after hours, 8 hours after vaccine administered, because her son had severe headache and body aches and sore throat, tactile fevers, with acute onset.
Age: 1.08
Sex: M
Vaccine: FLU3
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Fever 105.2 irritability unconsolable. Hospital referral.
Age: 1.54
Sex: M
Vaccine: DTPHIB
Symptoms: Convulsion, Ear infection, Lethargy, Pyrexia, Unresponsive to stimuli
Clinical narrative: Fever started within 48 hours. 5:30 pm March baby acting lethargic and went into seizure which lasted approx 6 minutes. 911 called and responded. Rescue breathing and oxygen given. Rushed to hospital. HIgh dose of Motrin given to reduce fever.  They noticed ear infection which was not present at well visit two days prior when he recieved the shot.  Baby was unresponsive for approx two hours.  Starting coming around when fever broke.  Was administered antibotic for ear infection.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling, Tenderness
Clinical narrative: Swelling, redness began 24 hrs after vaccine and more marked 48 hrs with 13x15 cm.  Tender with slight itching moderate pain.  Although not clear this was bacterial cellulitis, is rxed on 3/20/08 with cephalexin.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site swelling, Oedema peripheral
Clinical narrative: Left arm looked normal until a couple of days after vaccination, became swollen, slight raised, red, goose bumps with white dots on left deltoid where shot was given. No shortness of breath, arm itching. Applied Benadryl cream to arm, it helped with the itching, used for three to four days. Raise bumps is still there according to Mother on 3/20/2007 Watch for shortness of breath, see MD is arm becomes worse or bump does not go away. Warm packs and Benadryl cream to left deltoid arm. PHN RN
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Left arm looked normal until a couple of days after vaccination, became swollen, slight raised, red, goose bumps with white dots on left deltoid where shot was given. No shortness of breath, arm itching. Applied Benadryl cream to arm, it helped with the itching, used for three to four days. Raise bumps is still there according to Mother on 3/20/2007 Watch for shortness of breath, see MD is arm becomes worse or bump does not go away. Warm packs and Benadryl cream to left deltoid arm. PHN RN
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: MA misread orders and gave Tdap along with other vaccines. Tdap, Lot: AC52B018AB, Site: Right leg
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Felt dizzy and passed out, skin turned pale.  Was given juice and was told to lay down.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch Augmentin XR one tablet p.o. BID x 7 days
Age: 22.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: "Patient" noticed site tenderness, posterior left upper arm region (where sq yellow fever was administered) on 3/16/08 and then visualized redness about 1 1/2 "diameter, warmth. On 3/20 still w/erythema. No induration, fever. Will see again if not improved or resolved by 3/25.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received Zostavax on 3-3-08. She called on 3-7-08, and states she noticed on 3-6-08 that she had a tender, red area about 3 inches oblong where shot was given. Was bright red yesterday, lighter today. Will observe, call if doesn't resolve.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash papular
Clinical narrative: Patient with rash, papule.  Non specific rash over head, neck and trunk.  Diagnosis: modified measles vs rubella.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Animal scratch, Cellulitis, Erythema, Induration, Oedema peripheral
Clinical narrative: (L) upper arm red/swollen. Seen 3/19/08 11x8 cm area of erythema/induration. Treated with Augmentin for cellulitis (Cat Scratch abrasion on left anterior cerb fossa).
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Stridor, Urticaria, Wheezing
Clinical narrative: mild self resolved wheezing for 30-45 min then diffuse urticaria, treated with Benadryl. Normal perfusion, nl exam without wheezing, stridor
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema (2 x 2 1/2 in diameter) at Varivax injection site.  Observe - improving by 3/14/08.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, PNC, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: 3/20/08 - Mother brought child to Health Dept. today. 12 month old received Varicella in right thigh on 3/10/08. Mother noticed redness/blistering/swelling at site on 3/17/08. Irregular shaped erythema 25mm x 45mm with 6 small blisters on right thigh. Mother denies child had any fever. States child keeps trying to scratch site. Light gauze dry covering.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Rash, Urticaria
Clinical narrative: Experienced rash/hives starting at mid neck line - then continued to jawline and then ears and towards eyes - did not itch or feel painful.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10cm x 11cm warm red area to (L) upper thigh
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Muscular weakness
Clinical narrative: Initial report received on 21 November 2007 from a nurse.  A 46-year-old female patient, who had no concurrent illnesses, but had past medical history of hypertension, had received a first, left deltoid, intramuscular dose of ADACEL (Lot number C2769AA) on 19 October 2007 at 18:00 pm.  The following day, around 11:00 am, the patient developed left arm weakness that lasted four weeks.  There was "no redness or edema" associated.  The patient did not seek medical attention; and no diagnostic testing was performed.  Treatment received was not reported.  At the time of this report, the patient had recovered.  Follow-up information was received from a health professional on 22 January 2008.  The patient had no history of injury or trauma, and had not sought treatment for the event.  The reporter did not know if the weakness was neurological or muscular, and final diagnosis was unknown.  At the time of the follow-up report, the patient still had persistent weakness (outcome previously reported as "recovered").  Per the reporter, she was not able to rake leaves or lift heavy boxes, and was awakened at night with discomfort when rolling onto her left side.  The reporter for this case is the same as for cases 200703938, 200703940, 200703941, and 200703942.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: Initial report received on 12 February 2008 from a health care professional. A 40-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2862AA, on 30 October 2007. Twenty-two days post-vaccination, the patient complained of an inability to use her arm appropriately and had pain and weakness in the arm. The patient could not exercise secondary to the discomfort. She was examined by a physician, and the left deltoid muscle seemed a little irregular at the injection site. A MRI was negative. The patient was treated with deep muscle massage. At the time of this report, the patient had not recovered.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Discomfort, Injected limb mobility decreased, Injection site reaction, Mobility decreased
Clinical narrative: Initial report received on 12 February 2008 from a health care professional. A 40-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2862AA, on 30 October 2007. Twenty-two days post-vaccination, the patient complained of an inability to use her arm appropriately and had pain and weakness in the arm. The patient could not exercise secondary to the discomfort. She was examined by a physician, and the left deltoid muscle seemed a little irregular at the injection site. A MRI was negative. The patient was treated with deep muscle massage. At the time of this report, the patient had not recovered.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Initial report received on 12 February 2008 from a health care professional. A 40-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2862AA, on 30 October 2007. Twenty-two days post-vaccination, the patient complained of an inability to use her arm appropriately and had pain and weakness in the arm. The patient could not exercise secondary to the discomfort. She was examined by a physician, and the left deltoid muscle seemed a little irregular at the injection site. A MRI was negative. The patient was treated with deep muscle massage. At the time of this report, the patient had not recovered.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Amyotrophic lateral sclerosis, Electromyogram abnormal, Lumbar puncture, Muscular weakness
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient with an allergy to strawberries and no pertinent medical history, who in the spring of 2007 was vaccinated with the third dose of GARDASIL (lot # not reported). Several weeks after the third vaccination, she developed progressive bilateral upper and lower extremity muscle weakness, further described as asymmetric weakness of the limbs, first the left leg, then the right arm, then the right leg, followed by the left arm. She had no antecedent viral illness. She has no sensory symptoms, no cranial involvement or obvious respiratory compromise (pulmonary function tests are pending). The working diagnosis is "some kind of peripheral motor neuropathy." The patient has been hospitalized 3 times, and was "being admitted" to yet another hospital. She was seen by 3 top neurologists, and they could not identify the cause of the symptoms. Nerve conduction studies were abnormal. Treatment included steroids (unspecified) and plasmapheresis, but she is now wheelchair bound. The physician stated complex medical information would be provided on follow up correspondence. At the time of this report, the patient had not recovered. The physician considered the events to be serious as disabling and as an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nerve conduction studies abnormal, Neuropathy, Nuclear magnetic resonance imaging, Paralysis flaccid, Respiratory failure
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient with an allergy to strawberries and no pertinent medical history, who in the spring of 2007 was vaccinated with the third dose of GARDASIL (lot # not reported). Several weeks after the third vaccination, she developed progressive bilateral upper and lower extremity muscle weakness, further described as asymmetric weakness of the limbs, first the left leg, then the right arm, then the right leg, followed by the left arm. She had no antecedent viral illness. She has no sensory symptoms, no cranial involvement or obvious respiratory compromise (pulmonary function tests are pending). The working diagnosis is "some kind of peripheral motor neuropathy." The patient has been hospitalized 3 times, and was "being admitted" to yet another hospital. She was seen by 3 top neurologists, and they could not identify the cause of the symptoms. Nerve conduction studies were abnormal. Treatment included steroids (unspecified) and plasmapheresis, but she is now wheelchair bound. The physician stated complex medical information would be provided on follow up correspondence. At the time of this report, the patient had not recovered. The physician considered the events to be serious as disabling and as an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sleep study abnormal, Swelling, Urinary incontinence, Vomiting
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient with an allergy to strawberries and no pertinent medical history, who in the spring of 2007 was vaccinated with the third dose of GARDASIL (lot # not reported). Several weeks after the third vaccination, she developed progressive bilateral upper and lower extremity muscle weakness, further described as asymmetric weakness of the limbs, first the left leg, then the right arm, then the right leg, followed by the left arm. She had no antecedent viral illness. She has no sensory symptoms, no cranial involvement or obvious respiratory compromise (pulmonary function tests are pending). The working diagnosis is "some kind of peripheral motor neuropathy." The patient has been hospitalized 3 times, and was "being admitted" to yet another hospital. She was seen by 3 top neurologists, and they could not identify the cause of the symptoms. Nerve conduction studies were abnormal. Treatment included steroids (unspecified) and plasmapheresis, but she is now wheelchair bound. The physician stated complex medical information would be provided on follow up correspondence. At the time of this report, the patient had not recovered. The physician considered the events to be serious as disabling and as an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amyotrophic lateral sclerosis, Muscular weakness, Nerve conduction studies abnormal, Peripheral motor neuropathy, Pulmonary function test
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient with an allergy to strawberries and no pertinent medical history, who in the spring of 2007 was vaccinated with the third dose of GARDASIL (lot # not reported). Several weeks after the third vaccination, she developed progressive bilateral upper and lower extremity muscle weakness, further described as asymmetric weakness of the limbs, first the left leg, then the right arm, then the right leg, followed by the left arm. She had no antecedent viral illness. She has no sensory symptoms, no cranial involvement or obvious respiratory compromise (pulmonary function tests are pending). The working diagnosis is "some kind of peripheral motor neuropathy." The patient has been hospitalized 3 times, and was "being admitted" to yet another hospital. She was seen by 3 top neurologists, and they could not identify the cause of the symptoms. Nerve conduction studies were abnormal. Treatment included steroids (unspecified) and plasmapheresis, but she is now wheelchair bound. The physician stated complex medical information would be provided on follow up correspondence. At the time of this report, the patient had not recovered. The physician considered the events to be serious as disabling and as an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Wheelchair user
Clinical narrative: Information has been received from a physician, concerning a 13 year old female patient with an allergy to strawberries and no pertinent medical history, who in the spring of 2007 was vaccinated with the third dose of GARDASIL (lot # not reported). Several weeks after the third vaccination, she developed progressive bilateral upper and lower extremity muscle weakness, further described as asymmetric weakness of the limbs, first the left leg, then the right arm, then the right leg, followed by the left arm. She had no antecedent viral illness. She has no sensory symptoms, no cranial involvement or obvious respiratory compromise (pulmonary function tests are pending). The working diagnosis is "some kind of peripheral motor neuropathy." The patient has been hospitalized 3 times, and was "being admitted" to yet another hospital. She was seen by 3 top neurologists, and they could not identify the cause of the symptoms. Nerve conduction studies were abnormal. Treatment included steroids (unspecified) and plasmapheresis, but she is now wheelchair bound. The physician stated complex medical information would be provided on follow up correspondence. At the time of this report, the patient had not recovered. The physician considered the events to be serious as disabling and as an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Fatigue, Vomiting
Clinical narrative: Information has been received from a 21 year old female medical assistant who in October 2007, was vaccinated with a first dose of Gardasil.  Concomitant therapy included MENACTRA.  In October 2007, the patient experienced vomiting, tiredness and stomach cramps shortly after receiving the first dose of Gardasil.  Medical attention was sought.  On an unspecified date the patient recovered from the events with unspecified therapy.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Epstein-Barr virus antibody negative, Fatigue, Hyperhidrosis
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 05-FEB-2008 was vaccinated with Gardasil (lot number not provided). On 03-MAR-2008 the patient experienced extreme fatigue, severe stomach pains and breaking out in sweat. The patient also stated "the pain is so extreme, she can not go to school." The patient's extreme fatigue and severe stomach pains and breaking out in sweat persisted. On an unspecified date, the patient had a mononucleosis test performed-result was negative. On an unspecified date an ultrasound was also performed, results indicated that the patients spleen was slightly enlarged. Extreme fatigue, severe stomach pains and breaking out in sweat were considered to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Splenomegaly, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 05-FEB-2008 was vaccinated with Gardasil (lot number not provided). On 03-MAR-2008 the patient experienced extreme fatigue, severe stomach pains and breaking out in sweat. The patient also stated "the pain is so extreme, she can not go to school." The patient's extreme fatigue and severe stomach pains and breaking out in sweat persisted. On an unspecified date, the patient had a mononucleosis test performed-result was negative. On an unspecified date an ultrasound was also performed, results indicated that the patients spleen was slightly enlarged. Extreme fatigue, severe stomach pains and breaking out in sweat were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Gaze palsy
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with the first dose of Gardasil (lot # not reported). The NP stated that "before she could remove the needle from the patient's arm her eyes rolled into the back of her head and she began having seizure-like convulsions." The episode lasted for less than 1 minute, and the patient fully recovered. The patient's mother did not want her daughter to finish the vaccination series. The patient sought unspecified medical attention. Upon internal review, the event was considered to be serious as an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a certified nurse midwife concerning a 20 year old female with a history of syncope after unspecified vaccinations and anaesthesia who on 07-MAR-2008 was vaccinated IM with a first dose of GARDASIL (lot # 659665/1486U). Concomitant therapy included ORTHO TRI-CYCLEN. On 07-MAR-2008, right after vaccination, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure." The nurse brought in smelling salt and the patient "came back." The nurse did not let the patient leave the office for 2 hours. Later that day, the patient's mother took her to the emergency department to check for any neurological problems and everything came back normal. The patient was not admitted. At the time of the report, the patient had improved. Upon internal review, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure" was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently, one month post vaccination the patient experienced idiopathic thrombocytopenic purpura. The patient sought medical attention. The patient's mother stated that her daughter will not receive the rest of the vaccine series. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, idiopathic thrombocytopenic purpura was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first 0.5 ml dose of Gardasil. Subsequently, the patient fainted and experienced seizures. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, seizures was considered to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Groin pain, Incorrect route of drug administration, Lymphadenitis, Mononucleosis heterophile test
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 11-JAN-2008 was vaccinated with a first dose of GARDASIL (lot# 659653/1448U) injection in her left hip. On approximately 15-JAN-2008 "4 days post vaccination" the patient developed "lymphadenitis" along with tenderness in her left groin and fatigue. The patient returned to the physician's office on 21-JAN-2008 and again on 24-JAN-2008 and was referred to a general surgeon for the enlarged lymphnode. On an unspecified date the patient had surgery to remove the lymph node. On an unspecified date blood work and a mononucleosis test was performed. The results were unknown. It was unknown as to whether or not the patient will receive the second and third doses of the vaccine. Further information was not provided regarding this adverse experience. The physician felt that the enlarged lymphnode, tenderness in her left groin area and fatigue were other medical events (OME). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Surgery, Tenderness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 11-JAN-2008 was vaccinated with a first dose of GARDASIL (lot# 659653/1448U) injection in her left hip. On approximately 15-JAN-2008 "4 days post vaccination" the patient developed "lymphadenitis" along with tenderness in her left groin and fatigue. The patient returned to the physician's office on 21-JAN-2008 and again on 24-JAN-2008 and was referred to a general surgeon for the enlarged lymphnode. On an unspecified date the patient had surgery to remove the lymph node. On an unspecified date blood work and a mononucleosis test was performed. The results were unknown. It was unknown as to whether or not the patient will receive the second and third doses of the vaccine. Further information was not provided regarding this adverse experience. The physician felt that the enlarged lymphnode, tenderness in her left groin area and fatigue were other medical events (OME). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a nurse concerning a 9 month old male with no pertinent medical history or drug allergies who on 26-JUN-2007, 04-SEP-2007 and 02-NOV-2007 was vaccinated PO with his first, second and third doses of Rotateq (lot# 656099/0433U, 657660/0972U, 657657/1151U). There was no concomitant medication. On 23-FEB-2008 the patient experienced diarrhea and was dehydrated. The patient was brought to the emergency room and was placed on intravenous fluids and was subsequently admitted to the hospital for observation. A stool culture was performed which was positive for rotavirus and was diagnosed with rotavirus. The patient was discharged after one night in the hospital. The patient was seen in the office on 10-MAR-2008. The patient was noted to be hydrated and fully recovered at this time. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Cold sweat, Convulsion, Dizziness, Inappropriate schedule of drug administration, Pallor
Clinical narrative: Information has been received from a medical assistant, via a company representative, concerning a 14 year old female patient, who on 14-MAR-2008 was vaccinated with first dose, IM in the arm, of GARDASIL (lot # not reported). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). On 14-MAR-2008 the patient became pale, dizzy, and clammy after receiving her first dose, she fainted and had a mild seizure. The patient stated that she had not eaten yet that day. The patient recovered after an unknown duration of time. The patient sought unspecified medical attention. Upon internal review, a mild seizure was considered to be serious as an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant, via a company representative, concerning a 14 year old female patient, who on 14-MAR-2008 was vaccinated with first dose, IM in the arm, of GARDASIL (lot # not reported). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). On 14-MAR-2008 the patient became pale, dizzy, and clammy after receiving her first dose, she fainted and had a mild seizure. The patient stated that she had not eaten yet that day. The patient recovered after an unknown duration of time. The patient sought unspecified medical attention. Upon internal review, a mild seizure was considered to be serious as an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a patient's sister who was vaccinated with a dose of Gardasil.  It was reported that the patient's sister had "seizures and convulsions" post vaccination at another facility.  No other information was available.  It was unknown if patient sought medical attention.  The outcome was unknown.  Upon internal review "seizures and convulsions" was determined to be an other important medical event.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with a dose of Gardasil.  One month after the dose, the patient developed a grand mal seizure.  The patient sought unspecified medical attention.  The reporter was unsure if this was the patient's first or second dose of the vaccine.  At the time of the report the patient's outcome was unknown.  No product quality complaint was involved.  Upon internal review, grand mal seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium enema abnormal, Intussusception, X-ray gastrointestinal tract normal
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on 09-NOV-2007 and 10-JAN-2008 was vaccinated with her first and second doses of Rotateq (lot# 656841/1168U, 657673/0904U). In March 2008 (date unknown) the patient experienced intussusception and was hospitalized (length of stay unknown). Therapy with Rotateq was discontinued. There was no product quality complaint. Follow-up information from the reporting physician indicated that the 6 month old female with no current conditions or medical history who on 10-JAN-2008 was vaccinated with her second dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Comvax (OMPC) (MSD), a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On 03-MAR-2008 the patient started with symptoms of vomiting which was the only symptom. There was no diarrhea. The patient was hospitalized for three or four days and had no stool in the hospital. An upper GI was performed questioning reflux but no reflux was noted. A barium enema was performed and the patient was diagnosed with intussusception. The event was not life-threatening. The patient was due back in the office this month and the physician was unsure if she was going to give the third dose of Rotateq. Subsequently, the patient recovered. The physician stated that there was no way she'll know if Rotateq caused the intussusception. Additional information has been requested.  4/28/08-records received-for DOS 3/3-3/5/08-DX DC: Intussusception. Presented with 5 episodes vomiting bilious. Decreased urine output. No diarrhea. Mildly dehydrated.
Age: 0.4
Sex: M
Vaccine: RV5, UNK
Symptoms: Dehydration, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 5 month old male who was vaccinated PO with the second 2.0 ml dose of Rotateq.  Concomitant vaccinations administered that same day were "other vaccines" (names unknown).  In 2008 "10-12 days" after vaccination, the patient experienced "full-blown" rotavirus and dehydration and was hospitalized (length of hospitalization unspecified).  Lab diagnostic studies included a positive test for rotavirus.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 03-MAR-2008 was vaccinated PO with his third dose of Rotateq. On 05-MAR-2008 2 days after vaccination, the patient experienced blood in his stools. the physician was called for medical attention. Subsequently, the patient recovered. It was noted that the patient had no symptoms after the first and second doses of Rotateq. There was no product quality complaint. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Autism, Blood mercury abnormal, Candidiasis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Information has been received from a registered nurse concerning her son with no known allergies or past medical history who on 28-JUN-2000 was vaccinated with a first dose of Recombivax HB (lot # 636274/0641K).  On unspecified dates the patient was vaccinated with second (lot # 636477/0812K) and third (lot # "0411C") doses of Recombivax HB.  There was no concomitant therapy.  Approximately one week after the first injection, the patient developed an upper respiratory infection that led to thrush and fever.  The patient was reported to be sick with continuous upper respiratory infections for a year and a half.  It was also noted that the patient developed autism on an unspecified date.  Labs performed included "brain mercury levels", reported to be high.  The patient's autism was being treated by an unspecified specialist and he was "making progress in therapy".  The patient was reported to be recovering.  No further information is expected.  Upon internal review the patient's autism was determined to be an other important medical event.
Age: 27.0
Sex: M
Vaccine: DT
Symptoms: Eye rolling, Pallor, Syncope
Clinical narrative: Eyes rolled back in head, pt became pale, syncopal episode. Solu Medrol, Benadryl, Epinephrine  3/25/08 Reviewed ER medical records of 3/15/08. FINAL DX: dog bite leg; anaphylactic shock Records reveal patient seen s/p unprovoked attack & dog bite left leg by stray dog.  Visible bite marks on anterior left leg were cleansed & tx w/topical antibiotics & oral antibiotics x 10 days.  Also had Td, (Decavac, lot #1275). Rabies prophylaxis: infiltration of 1650 IU of human rabies immunoglobulin (HRIG) in & around wound approx 1 hour after Td.  During infiltration, became diaphoretic, pale, pupils dilated, seizure like activity for approx 30 sec.  Tx w/steroids, benadryl, epi & IV antibiotics.  Oriented immediately after reaction & VSS. No reaction at wound site.  Kept overnight for continued observation & d/c to home.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Skin warm
Clinical narrative: 1 day after injection developed erythema and edema at site, redness extended 2 cm at site. 2 days post injection redness, warmth extended distally to 2 or 3 cm above elbow. 6/17/08-DC Summary received for DOS 3/14-3/16/08-DC DX: left upper arm cellulitis. 6/9/08-records received for DOS 3/15/08-H&P admitted with cellulitis of left upper arm, received vaccinations on 3/12/08, and 8 hours after erythema of left upper arm extending to elbows with swelling and warm to touch was noted. Temperature 100. PE: erythema diffusely macular in nature, no drainage. Nausea.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: 1 day after injection developed erythema and edema at site, redness extended 2 cm at site. 2 days post injection redness, warmth extended distally to 2 or 3 cm above elbow. 6/17/08-DC Summary received for DOS 3/14-3/16/08-DC DX: left upper arm cellulitis. 6/9/08-records received for DOS 3/15/08-H&P admitted with cellulitis of left upper arm, received vaccinations on 3/12/08, and 8 hours after erythema of left upper arm extending to elbows with swelling and warm to touch was noted. Temperature 100. PE: erythema diffusely macular in nature, no drainage. Nausea.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPAB, TD
Symptoms: Malaise, Pallor, Unresponsive to stimuli
Clinical narrative: Immediately after vaccines given pt c/o not feeling well and pale, non-responsive, placed on floor O2 via mask 10L administered and pulse ox 99, glucose 82, BP 130/80, P 92. Pt responsive. Epipen 0.3mg IM LT, Benadryl 50mg IM RT, BP 116/70. Ambulance transported and pt to respond for evaluation.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain in extremity, Sleep disorder
Clinical narrative: Head hurt around 3:00 am, arm hurt. Couldn't go back to sleep.
Age: 0.6
Sex: M
Vaccine: FLU3
Symptoms: Allergy test negative, Lethargy, Pallor, Vomiting
Clinical narrative: About 5 min after Flu vaccine after vomited x2 and looked very pale - after 15 min vomited more and looked pale and lethargic. No stridor, wheeze, rash. Given epinephrine to 2 in office EMTS took to hospital, he received fluids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Hypotension, Syncope
Clinical narrative: - Fainting; - Hypotension
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Pt noticed about a 3" round/red inflammation at injection site with no pain.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: 4cm x 6cm, red hot area on left upper deltoid; Zyrtec 10 mg qd, NSAIDS
Age: 21.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Erythema, Myalgia, Pruritus, Rash macular
Clinical narrative: - Tenderness deltoid muscle - Erythematous pruritic macular lineal rash encircling deltoid areas - Patient had Td without problem. This one is Tdap
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Antinuclear antibody negative, Arrhythmia supraventricular, Arthralgia, Arthralgia, Aspartate aminotransferase normal
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Autoimmune disorder, Blood bilirubin normal, Body temperature normal, C-reactive protein normal, Drug hypersensitivity
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Fatigue, Full blood count normal, Glucose tolerance impaired, Insomnia, Lymphocyte percentage increased
Clinical narrative: Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions