chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: ANTH, FLUX, SMALL
Symptoms: Muscular weakness, Nausea, Rash pruritic, Red blood cell sedimentation rate normal, Rheumatoid factor
Clinical narrative: The pt was in her normal state of good health when she received Smallpox, Anthrax and Influenza vaccinations on 4/30/11. Approximately 24 hrs later while flying, she c/o "feeling hot, mild dyspnea (felt like she was not taking a full breath), generalized malaise/fatigue, weakness in her fingers bilaterally, and mild 'queasiness'." She denied chest pain, palpitations, headache, abdominal pain, V/D, rash, wheeze, cough, myalgia, or arthralgia. There was no local reaction at the AVA or Influenza vaccination sites. The pustule formed at her SPV site after a few days and within a week or two she had a robust take with axillary adenopathy. She described her SOB as a constant sense of not getting enough oxygen. She had no sense of restricted chest wall motion, chest wall pain, or laryngeal obstruction. She had no cough or wheeze. Her SOB was better with lying flat, noted with walking, and most noted with climbing stairs. She was able to run her usual 3-5 miles without difficulty. Her joint symptoms are described as a "feeling as if fluid in her joints had been replaced with glue". The small joints of her fingers were most obviously involved, but also involved were her metatarsals and her neck. To a much lesser degree she feels all joints were involved. Her joint involvement was most pronounced in the morning, improving with activity. There was no joint pain or swelling, nor was there any myalgia or rheumatism. TYLENOL taken intermittently for headaches also improved her joint symptoms. Her post vaccination symptoms peaked at about 5/10 and slowly improved over the next 8+ weeks. The beginning of June the pt noted a mildly pruritic rash on the nape of her neck. She first noted the onset of the above symptoms (hot, dizzy, SOB, finger weakness, as well as new-onset hypertension) after a head-to-head contact injury playing soccer in 2008. Prior to entry into the Academy she was totally symptom free. These symptoms persisted for weeks until she underwent chiropractic cervical adjustment for "a disk problem". Intermittently over the next year she would have waves of feeling hot, air hunger, and hand weakness. Then these symptoms became constant, but never enough to interfere with her daily activities. She eventually went to a naturopath who after hair and stool analysis informed her that her symptoms were the result of toxic levels of titanium, copper, and 'something else', an unknown parasite, and an allergy to gluten. She underwent oral chelation (and antiparasite?) therapy, and began gluten avoidance. Following this therapy, she associated her only recurrences of these symptoms with accidentally ingested suspected gluten containing foods. With her suspected accidental ingestions, her symptoms would last about 2-3 days. Her vaccine-associated symptoms, while identical, lasted over 2 months. All of the pt's symptoms totally abated around mid July.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUX, SMALL
Symptoms: Thyroxine, Tri-iodothyronine
Clinical narrative: The pt was in her normal state of good health when she received Smallpox, Anthrax and Influenza vaccinations on 4/30/11. Approximately 24 hrs later while flying, she c/o "feeling hot, mild dyspnea (felt like she was not taking a full breath), generalized malaise/fatigue, weakness in her fingers bilaterally, and mild 'queasiness'." She denied chest pain, palpitations, headache, abdominal pain, V/D, rash, wheeze, cough, myalgia, or arthralgia. There was no local reaction at the AVA or Influenza vaccination sites. The pustule formed at her SPV site after a few days and within a week or two she had a robust take with axillary adenopathy. She described her SOB as a constant sense of not getting enough oxygen. She had no sense of restricted chest wall motion, chest wall pain, or laryngeal obstruction. She had no cough or wheeze. Her SOB was better with lying flat, noted with walking, and most noted with climbing stairs. She was able to run her usual 3-5 miles without difficulty. Her joint symptoms are described as a "feeling as if fluid in her joints had been replaced with glue". The small joints of her fingers were most obviously involved, but also involved were her metatarsals and her neck. To a much lesser degree she feels all joints were involved. Her joint involvement was most pronounced in the morning, improving with activity. There was no joint pain or swelling, nor was there any myalgia or rheumatism. TYLENOL taken intermittently for headaches also improved her joint symptoms. Her post vaccination symptoms peaked at about 5/10 and slowly improved over the next 8+ weeks. The beginning of June the pt noted a mildly pruritic rash on the nape of her neck. She first noted the onset of the above symptoms (hot, dizzy, SOB, finger weakness, as well as new-onset hypertension) after a head-to-head contact injury playing soccer in 2008. Prior to entry into the Academy she was totally symptom free. These symptoms persisted for weeks until she underwent chiropractic cervical adjustment for "a disk problem". Intermittently over the next year she would have waves of feeling hot, air hunger, and hand weakness. Then these symptoms became constant, but never enough to interfere with her daily activities. She eventually went to a naturopath who after hair and stool analysis informed her that her symptoms were the result of toxic levels of titanium, copper, and 'something else', an unknown parasite, and an allergy to gluten. She underwent oral chelation (and antiparasite?) therapy, and began gluten avoidance. Following this therapy, she associated her only recurrences of these symptoms with accidentally ingested suspected gluten containing foods. With her suspected accidental ingestions, her symptoms would last about 2-3 days. Her vaccine-associated symptoms, while identical, lasted over 2 months. All of the pt's symptoms totally abated around mid July.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received an adult dose of HAVRIX Hep A vaccine 1.0ml. No reaction occurred.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Headache, Myalgia
Clinical narrative: Headache, myalgia & erythema multiforme.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states swelling, redness, and tenderness began in area of injection about five days after she received shot. Seen in office on 8/3/11 and treated with oral antibiotics.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash on body after smallpox vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain, Skin induration
Clinical narrative: Redness, swelling, hardness (R) posterior arm - noted approx 18 hrs after injection; redness spreading, no fever, no pain noted. Dx cellulitis, tx: BACTRIM, compresses.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: 3in x 3in hive with erythema and multiple small pin pointed vesicles and induration, swelling to (L) upper arm where the immunization was given 2 days ago. Pt. denies fever, denies SOB, denies, N, V, D. C/o some tenderness. Plan: hydroxyzine 10/5 for itching, TYLENOL for pain.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Tenderness, Urticaria
Clinical narrative: 3in x 3in hive with erythema and multiple small pin pointed vesicles and induration, swelling to (L) upper arm where the immunization was given 2 days ago. Pt. denies fever, denies SOB, denies, N, V, D. C/o some tenderness. Plan: hydroxyzine 10/5 for itching, TYLENOL for pain.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Infant developed a rash & a fever approximately a week after receiving her MMR.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Parent (father) reported that child of parent reported awaken on 8-2-11 with s/s noted swelling at right arm site. C/o soreness and noticeable tender to touch. Denies fever, respiratory problems, or other problems. Advised post care & immobilization, ice pack, pain reducer acetaminophen or ibuprofen as directed.
Age: 1.03
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Insomnia, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever 101, runny nose, decreased appetite, rash, up at night.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain, Tenderness
Clinical narrative: Tdap 8/2/11 - that day developed redness swelling of arm & pain. Seen 8/8/11 - 8x6" area of swelling & redness & tenderness.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration
Clinical narrative: 2.5-3cm redness with bruising. 1 cm induration palpable (L) anterior thigh.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Vaccination site swelling
Clinical narrative: Vaccination site turned red & large. Patient experienced rash 2-3 days after but not itchy or blistery, no crusting. Still visible 8/2/11 but doesn't require treatment. Still has rash under skin.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, TD, VARCEL
Symptoms: Body temperature increased, Headache
Clinical narrative: Dx: Headache x 10 hrs s/p vaccinations. Temp: 99.1 degrees F, NL PE. Treatment: Analgesics/MOTRIN PRN.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: 2 days after immunization child's arm had localized reaction with area measuring 4 3/4" in diameter with darker center of 1 1/4" of redness. Area warm to touch and he c/o itching. His father gave him PO BENADRYL night before and instructed him to give him some more. The following morning redness had subsided.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Bone pain, Muscle tightness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt received 4 vaccines 3 days ago on 8-5-11 on 8-7-11 pt started having neck pain and stiffness - c/o pain on palpating around base of skull - tightness of (R) sternocleidomastoid.
Age: 17.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Sepsis
Clinical narrative: Case number PHHY2011US68639 is an initial spontaneous report received from a nurse on 27 Jul 2011. This report refers to an adult female patient. She was sick for a year and her medical history included tonsillitis which occurred before the administration of RABAVERT vaccine. She was vaccinated with the first dose of pre exposure series of RABAVERT vaccine (batch number: 454100G) intramuscularly on 05 Jul 2011 and then received the day seven dose (batch number: 454100G) intramuscularly on 12 Jul 2011. After vaccination, she developed fever on 18 Jul 2011. She was reported to be septic and therefore, she was hospitalized. No event onset date for sepsis was reported. She had not yet received the third dose of RABAVERT vaccine. She was still in hospital and her condition remained unchanged. The nurse assessed this event as not related to the vaccine.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Tremor
Clinical narrative: Pt stated with 1st GARDASIL vaccine she passed out. Immediately after giving pt IM inj of GARDASIL. Pt leaned forward. Had pt sit up as she sat up. Pt started to have like tremor and straighten stiff administered ammonia inhalant to nasal passage and pt regained in matter of 1 minute sweating profusely.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration
Clinical narrative: 6.5 x 7.0cm induration at injection site, beginning approx 24 hrs. after injection. No systemic complaints.
Age: 0.82
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever 104 x 48 hours followed by maculopapular rash.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Anovulatory cycle, Dehydration, Diarrhoea, Dizziness
Clinical narrative: Information has been received from a mother concerning her daughter with pyruvate kinase deficiencies who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). The patient received GARDASIL and was recently diagnosed as post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent to the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with a vitamin B complex, vitamin C, vitamin D3 and NIACIN (after being on a very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related to therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event on an internet, concerning her 17 year old daughter who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # 654389/0961F) together with hepatitis A virus vaccine (manufacturer unspecified) and MENACTRA. The patient received a single dose (the second dose) of GARDASIL (Lot # 657617/0384U) on 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot # 658094/0524U) took place on 25-JUL-2007 which she had along with a shot of hepatitis A virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit, and pneumonia was so severe that the patient was on oxygen at an ER and at home. The patient's mother had to continuously pound on her back to help break up the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause at age 19 - getting a heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints of dyslexia) and severe PMS (premenstrual syndrome) symptoms. By November 2007, the patient was experiencing changes in her menstrual cycle. In December 2008, the patient had to be admitted to ER, OH with diarrhea and vomiting, and that re-occurred again in August 2009 and the patient had to go back to the ER to be treated. After hours upon hours of research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed my daughter of her best years in college". The patient would often call her mother in tears because the fatigue was so overwhelming. The patient was now doing much better after getting help from a doctor. Additional information has been requested. The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit to Hospital. In December 2008 and in August 2009, the patient had to be admitted to ER to be treated for diarrhea and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyslexia, Fatigue, Feeling abnormal, Increased upper airway secretion, Medical diet
Clinical narrative: Information has been received from a mother concerning her daughter with pyruvate kinase deficiencies who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). The patient received GARDASIL and was recently diagnosed as post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent to the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with a vitamin B complex, vitamin C, vitamin D3 and NIACIN (after being on a very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related to therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event on an internet, concerning her 17 year old daughter who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # 654389/0961F) together with hepatitis A virus vaccine (manufacturer unspecified) and MENACTRA. The patient received a single dose (the second dose) of GARDASIL (Lot # 657617/0384U) on 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot # 658094/0524U) took place on 25-JUL-2007 which she had along with a shot of hepatitis A virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit, and pneumonia was so severe that the patient was on oxygen at an ER and at home. The patient's mother had to continuously pound on her back to help break up the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause at age 19 - getting a heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints of dyslexia) and severe PMS (premenstrual syndrome) symptoms. By November 2007, the patient was experiencing changes in her menstrual cycle. In December 2008, the patient had to be admitted to ER, OH with diarrhea and vomiting, and that re-occurred again in August 2009 and the patient had to go back to the ER to be treated. After hours upon hours of research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed my daughter of her best years in college". The patient would often call her mother in tears because the fatigue was so overwhelming. The patient was now doing much better after getting help from a doctor. Additional information has been requested. The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit to Hospital. In December 2008 and in August 2009, the patient had to be admitted to ER to be treated for diarrhea and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstrual disorder, Migraine, Pneumonia, Polymenorrhoea
Clinical narrative: Information has been received from a mother concerning her daughter with pyruvate kinase deficiencies who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). The patient received GARDASIL and was recently diagnosed as post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent to the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with a vitamin B complex, vitamin C, vitamin D3 and NIACIN (after being on a very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related to therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event on an internet, concerning her 17 year old daughter who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # 654389/0961F) together with hepatitis A virus vaccine (manufacturer unspecified) and MENACTRA. The patient received a single dose (the second dose) of GARDASIL (Lot # 657617/0384U) on 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot # 658094/0524U) took place on 25-JUL-2007 which she had along with a shot of hepatitis A virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit, and pneumonia was so severe that the patient was on oxygen at an ER and at home. The patient's mother had to continuously pound on her back to help break up the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause at age 19 - getting a heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints of dyslexia) and severe PMS (premenstrual syndrome) symptoms. By November 2007, the patient was experiencing changes in her menstrual cycle. In December 2008, the patient had to be admitted to ER, OH with diarrhea and vomiting, and that re-occurred again in August 2009 and the patient had to go back to the ER to be treated. After hours upon hours of research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed my daughter of her best years in college". The patient would often call her mother in tears because the fatigue was so overwhelming. The patient was now doing much better after getting help from a doctor. Additional information has been requested. The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit to Hospital. In December 2008 and in August 2009, the patient had to be admitted to ER to be treated for diarrhea and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Postmenopause, Premature menopause, Premenstrual syndrome, Sinusitis, Vomiting
Clinical narrative: Information has been received from a mother concerning her daughter with pyruvate kinase deficiencies who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). The patient received GARDASIL and was recently diagnosed as post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent to the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with a vitamin B complex, vitamin C, vitamin D3 and NIACIN (after being on a very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related to therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event on an internet, concerning her 17 year old daughter who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # 654389/0961F) together with hepatitis A virus vaccine (manufacturer unspecified) and MENACTRA. The patient received a single dose (the second dose) of GARDASIL (Lot # 657617/0384U) on 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot # 658094/0524U) took place on 25-JUL-2007 which she had along with a shot of hepatitis A virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit, and pneumonia was so severe that the patient was on oxygen at an ER and at home. The patient's mother had to continuously pound on her back to help break up the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause at age 19 - getting a heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints of dyslexia) and severe PMS (premenstrual syndrome) symptoms. By November 2007, the patient was experiencing changes in her menstrual cycle. In December 2008, the patient had to be admitted to ER, OH with diarrhea and vomiting, and that re-occurred again in August 2009 and the patient had to go back to the ER to be treated. After hours upon hours of research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed my daughter of her best years in college". The patient would often call her mother in tears because the fatigue was so overwhelming. The patient was now doing much better after getting help from a doctor. Additional information has been requested. The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit to Hospital. In December 2008 and in August 2009, the patient had to be admitted to ER to be treated for diarrhea and vomiting.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a mother concerning her daughter with pyruvate kinase deficiencies who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). The patient received GARDASIL and was recently diagnosed as post-menopausal. This was after she lost hair, had severe pneumonia, dehydration (which she was sent to the hospital twice for), migraines, etc. Currently, the patient was not ovulating, although she still had regular menses. The patient was being treated with a vitamin B complex, vitamin C, vitamin D3 and NIACIN (after being on a very specific diet for several months). The patient's outcome was not reported. The reporter felt that these events were related to therapy with GARDASIL. Additional information has been received from the mother who posted her daughter's event on an internet, concerning her 17 year old daughter who on 23-JAN-2007 was vaccinated with the first dose of GARDASIL (Lot # 654389/0961F) together with hepatitis A virus vaccine (manufacturer unspecified) and MENACTRA. The patient received a single dose (the second dose) of GARDASIL (Lot # 657617/0384U) on 25-JUL-2007, and her final vaccination (the third dose) with GARDASIL (Lot # 658094/0524U) took place on 25-JUL-2007 which she had along with a shot of hepatitis A virus vaccine (manufacturer unspecified). The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit, and pneumonia was so severe that the patient was on oxygen at an ER and at home. The patient's mother had to continuously pound on her back to help break up the mucous. Several months later (in 2007), the patient was continuously ill with migraines, sinus infections, and menstrual changes (she was starting menopause at age 19 - getting a heavy period every two weeks). The patient's symptoms included hair loss, chronic sinus infections, migraines, weight gain, dizziness and brain fog (complaints of dyslexia) and severe PMS (premenstrual syndrome) symptoms. By November 2007, the patient was experiencing changes in her menstrual cycle. In December 2008, the patient had to be admitted to ER, OH with diarrhea and vomiting, and that re-occurred again in August 2009 and the patient had to go back to the ER to be treated. After hours upon hours of research, the mother realized that GARDASIL was the culprit. The mother stated that "This vaccine has robbed my daughter of her best years in college". The patient would often call her mother in tears because the fatigue was so overwhelming. The patient was now doing much better after getting help from a doctor. Additional information has been requested. The patient was first diagnosed with pneumonia in July 2007 which resulted in an ER visit to Hospital. In December 2008 and in August 2009, the patient had to be admitted to ER to be treated for diarrhea and vomiting.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: Information has been received from a consumer via internet concerning her daughter. The patient was vaccinated with a dose of GARDASIL on 23-APR-2009. She was told the side effects were; pain and redness at the injection site and possible fainting so she would need to stay in the office for 15 minutes following the injection. The next day, on 24-APR-2009 she began having symptoms of dizziness, nausea and abdominal pain. On the 5th day of symptoms, the parents called the pediatrician and she said that it could not be due to the vaccine because it was too long past the injection and she felt it was viral. So they waited. The longer the vaccine was in her system, the sicker she became. They called the doctor again in June because the symptoms had progressed to include: numbness and tingling to feet, joint pain, muscle weakness so severe that she needed her parent to support her to walk, stabbing pain to her back, headaches, stabbing pain to her feet, skin sensitivity, brain fog, chest pain, shortness of breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician on 03-JUN-2009 and she referred them to a neurologist. On 08-JUN-2010 they saw him and he diagnosed her extreme foot pain as peripheral neuropathy which was a result of GARDASIL. She was started on Prednisone to treat the extreme inflammatory process going on in her body and the neuropathy. She was seen in th ER on 16-JUN-2009 due to severe chest pain, shortness of breath and nerve pain to feet and arms. EKG's, CXR, blood drawn. After 4 hours in ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about 10 good days. The symptoms slowly returned. They sought the help from several different doctors who had little else to offer because they did not know how to deal with GARDASIL side effects. They consulted a chiropractor on 30-JUL-2009 and treatment was begun. Once again, the patient has had about 10 good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue
Clinical narrative: Information has been received from a consumer via internet concerning her daughter. The patient was vaccinated with a dose of GARDASIL on 23-APR-2009. She was told the side effects were; pain and redness at the injection site and possible fainting so she would need to stay in the office for 15 minutes following the injection. The next day, on 24-APR-2009 she began having symptoms of dizziness, nausea and abdominal pain. On the 5th day of symptoms, the parents called the pediatrician and she said that it could not be due to the vaccine because it was too long past the injection and she felt it was viral. So they waited. The longer the vaccine was in her system, the sicker she became. They called the doctor again in June because the symptoms had progressed to include: numbness and tingling to feet, joint pain, muscle weakness so severe that she needed her parent to support her to walk, stabbing pain to her back, headaches, stabbing pain to her feet, skin sensitivity, brain fog, chest pain, shortness of breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician on 03-JUN-2009 and she referred them to a neurologist. On 08-JUN-2010 they saw him and he diagnosed her extreme foot pain as peripheral neuropathy which was a result of GARDASIL. She was started on Prednisone to treat the extreme inflammatory process going on in her body and the neuropathy. She was seen in th ER on 16-JUN-2009 due to severe chest pain, shortness of breath and nerve pain to feet and arms. EKG's, CXR, blood drawn. After 4 hours in ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about 10 good days. The symptoms slowly returned. They sought the help from several different doctors who had little else to offer because they did not know how to deal with GARDASIL side effects. They consulted a chiropractor on 30-JUL-2009 and treatment was begun. Once again, the patient has had about 10 good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Gait disturbance, Headache, Heart rate increased, Hyperaesthesia
Clinical narrative: Information has been received from a consumer via internet concerning her daughter. The patient was vaccinated with a dose of GARDASIL on 23-APR-2009. She was told the side effects were; pain and redness at the injection site and possible fainting so she would need to stay in the office for 15 minutes following the injection. The next day, on 24-APR-2009 she began having symptoms of dizziness, nausea and abdominal pain. On the 5th day of symptoms, the parents called the pediatrician and she said that it could not be due to the vaccine because it was too long past the injection and she felt it was viral. So they waited. The longer the vaccine was in her system, the sicker she became. They called the doctor again in June because the symptoms had progressed to include: numbness and tingling to feet, joint pain, muscle weakness so severe that she needed her parent to support her to walk, stabbing pain to her back, headaches, stabbing pain to her feet, skin sensitivity, brain fog, chest pain, shortness of breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician on 03-JUN-2009 and she referred them to a neurologist. On 08-JUN-2010 they saw him and he diagnosed her extreme foot pain as peripheral neuropathy which was a result of GARDASIL. She was started on Prednisone to treat the extreme inflammatory process going on in her body and the neuropathy. She was seen in th ER on 16-JUN-2009 due to severe chest pain, shortness of breath and nerve pain to feet and arms. EKG's, CXR, blood drawn. After 4 hours in ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about 10 good days. The symptoms slowly returned. They sought the help from several different doctors who had little else to offer because they did not know how to deal with GARDASIL side effects. They consulted a chiropractor on 30-JUL-2009 and treatment was begun. Once again, the patient has had about 10 good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Nausea, Neuralgia, Neuropathy peripheral
Clinical narrative: Information has been received from a consumer via internet concerning her daughter. The patient was vaccinated with a dose of GARDASIL on 23-APR-2009. She was told the side effects were; pain and redness at the injection site and possible fainting so she would need to stay in the office for 15 minutes following the injection. The next day, on 24-APR-2009 she began having symptoms of dizziness, nausea and abdominal pain. On the 5th day of symptoms, the parents called the pediatrician and she said that it could not be due to the vaccine because it was too long past the injection and she felt it was viral. So they waited. The longer the vaccine was in her system, the sicker she became. They called the doctor again in June because the symptoms had progressed to include: numbness and tingling to feet, joint pain, muscle weakness so severe that she needed her parent to support her to walk, stabbing pain to her back, headaches, stabbing pain to her feet, skin sensitivity, brain fog, chest pain, shortness of breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician on 03-JUN-2009 and she referred them to a neurologist. On 08-JUN-2010 they saw him and he diagnosed her extreme foot pain as peripheral neuropathy which was a result of GARDASIL. She was started on Prednisone to treat the extreme inflammatory process going on in her body and the neuropathy. She was seen in th ER on 16-JUN-2009 due to severe chest pain, shortness of breath and nerve pain to feet and arms. EKG's, CXR, blood drawn. After 4 hours in ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about 10 good days. The symptoms slowly returned. They sought the help from several different doctors who had little else to offer because they did not know how to deal with GARDASIL side effects. They consulted a chiropractor on 30-JUL-2009 and treatment was begun. Once again, the patient has had about 10 good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Paraesthesia, Visual impairment
Clinical narrative: Information has been received from a consumer via internet concerning her daughter. The patient was vaccinated with a dose of GARDASIL on 23-APR-2009. She was told the side effects were; pain and redness at the injection site and possible fainting so she would need to stay in the office for 15 minutes following the injection. The next day, on 24-APR-2009 she began having symptoms of dizziness, nausea and abdominal pain. On the 5th day of symptoms, the parents called the pediatrician and she said that it could not be due to the vaccine because it was too long past the injection and she felt it was viral. So they waited. The longer the vaccine was in her system, the sicker she became. They called the doctor again in June because the symptoms had progressed to include: numbness and tingling to feet, joint pain, muscle weakness so severe that she needed her parent to support her to walk, stabbing pain to her back, headaches, stabbing pain to her feet, skin sensitivity, brain fog, chest pain, shortness of breath, racing pulse, extreme fatigue, visual disturbances and severe pain with movement. They saw the pediatrician on 03-JUN-2009 and she referred them to a neurologist. On 08-JUN-2010 they saw him and he diagnosed her extreme foot pain as peripheral neuropathy which was a result of GARDASIL. She was started on Prednisone to treat the extreme inflammatory process going on in her body and the neuropathy. She was seen in th ER on 16-JUN-2009 due to severe chest pain, shortness of breath and nerve pain to feet and arms. EKG's, CXR, blood drawn. After 4 hours in ER, she was given acetaminophen (TYLENOL) and sent home. They did not know what was causing the problems because tests came back normal. Symptoms continued daily until 10-JUL-2009 when she had about 10 good days. The symptoms slowly returned. They sought the help from several different doctors who had little else to offer because they did not know how to deal with GARDASIL side effects. They consulted a chiropractor on 30-JUL-2009 and treatment was begun. Once again, the patient has had about 10 good days but slowly the symptoms were re-occurring. She was suffering from dizziness, foot pain and extreme fatigue. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Condition aggravated, Depression, Endoscopy normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a history of arthralgia and no allergies who in 2008, "2 years ago", was vaccinated with the first, second and third doses of GARDASIL (lot number, injection site and route not reported). Concomitant therapy included unspecified birth control pill. Subsequently the patient experienced arthralgia, chronic abdominal pain, depression, myalgia and headaches. The patient had been referred for evaluation to an unspecified psychiatrist, gastroenterologist and rheumatologist. Laboratory diagnostic test included endoscopy by gastroenterologist which was normal. The patient had been diagnosed with fibromyalgia and was prescribed, by psychiatrist, medication for depression. The physician added that the patient had experienced arthralgia in the past prior to receiving GARDASIL. The patient's arthralgia and chronic abdominal pain and depression and headache and fibromyalgia persisted. Additional information has been received from a female receptionist reported that two of the GARDASIL was vaccinated on 30-JAN-2008 (Lot# 658560/1062U and on 30-MAY-2008 (lot# 659439/1267U). She was not able to provide any other information. The health care professional contacted during telephone follow up could not supply the following information: date of event. Additional information has been received from the physician indicated that the patient's joint pain pre-existed the first dose of GARDASIL. It was thought that the joint pain was sports related. The physician confirmed there were only two doses of GARDASIL given and there were no concomitant vaccines. The physician gave the AE onset date as 05-MAY-2008 and stated the fibromyalgia diagnosis was not made by the rheumatologist until 24-OCT-2009. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Headache, Myalgia
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a history of arthralgia and no allergies who in 2008, "2 years ago", was vaccinated with the first, second and third doses of GARDASIL (lot number, injection site and route not reported). Concomitant therapy included unspecified birth control pill. Subsequently the patient experienced arthralgia, chronic abdominal pain, depression, myalgia and headaches. The patient had been referred for evaluation to an unspecified psychiatrist, gastroenterologist and rheumatologist. Laboratory diagnostic test included endoscopy by gastroenterologist which was normal. The patient had been diagnosed with fibromyalgia and was prescribed, by psychiatrist, medication for depression. The physician added that the patient had experienced arthralgia in the past prior to receiving GARDASIL. The patient's arthralgia and chronic abdominal pain and depression and headache and fibromyalgia persisted. Additional information has been received from a female receptionist reported that two of the GARDASIL was vaccinated on 30-JAN-2008 (Lot# 658560/1062U and on 30-MAY-2008 (lot# 659439/1267U). She was not able to provide any other information. The health care professional contacted during telephone follow up could not supply the following information: date of event. Additional information has been received from the physician indicated that the patient's joint pain pre-existed the first dose of GARDASIL. It was thought that the joint pain was sports related. The physician confirmed there were only two doses of GARDASIL given and there were no concomitant vaccines. The physician gave the AE onset date as 05-MAY-2008 and stated the fibromyalgia diagnosis was not made by the rheumatologist until 24-OCT-2009. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 12-MAR-2010 was vaccinated with a dose (the nurse was not sure what dose in the series this was) of GARDASIL (Lot#663453/0249Y) and ended up being diagnosed with Guillain-Barre. On 13-MAR-2010 the patient went to the emergency room and was hospitalized with symptoms (nurse did not know what symptoms the patient had). At the time of reporting, the patient recovered from Guillain-Barre. The nurse stated this case was already from the neurologist in the hospital. A lot check has been initiated. Guillain-Barre was considered to be immediately life-threatening by the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient with no pertinent medical history, no drug reactions and no known drug allergies, who on 07-JUN-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # and route not reported). There were no concomitant medications. The nurse reported that the patient experienced blurry vision then minutes after receiving the first dose. Nurse stated that the patient was at the office at this time. The blurry vision resolved 25 minutes after the onset, while the patient was still at the office. Follow-up information has been received from a certified medical assistant indicating the 12 year old female with no illness at time of vaccination and a history of thyromegaly, who on 07-JUN-2010 at 09:10 a.m. was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 666768/1377Y) intramuscularly into her left deltoid. On 07-JUN-2010 at about 09:15 a.m. the patient complained of blurred vision about 10 minutes after injection of GARDASIL. The blurry vision improved and then resolved by 25-40 minutes after injection. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tonic clonic movements
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no drug reactions/allergies who on 27-JUL-2010 was vaccinated IM with 0.5 ml first dose GARDASIL (lot number: 665547/1318Y). There was no concomitant medication. On 27-JUL-2010, five minutes "after getting GARDASIL", the patient was on her way out and she experienced tonic clonic movement from about 3 seconds without loss of consciousness. The physician did not think the patient would be back to receive any other doses. At the time of the report the outcome of the patient was recovered on the same day (on 27-JUL-2010). The patient sought unspecified medical attention. No lab diagnostic studies were performed. The physician considered the events non serious. Telephone followed up on 03-AUG-2010 from the medical assistant confirmed the lot as 1318Y and the patient had no pertinent medical history and received a TB test concomitantly with the GARDASIL vaccine. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin negative, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with the second dose of GARDASIL (lot # 0644X) 2 days ago on 26-JUL-2010 and had been experiencing vomiting since then. The physician stated the vomiting started 30 minutes after the dose was given. Per the physician, a pregnancy test was conducted 2 days ago and it was negative. The patient had no symptoms after the first dose of GARDASIL was given. The outcome was not reported. Follow-up information received from the physician stating that the patient experienced vomiting within 30 minutes of the dose, the physician had followed-up with patient on day 3 and vomiting was letting up. The physician stated that no medications reported to be used by patient for vomiting, caregivers just tried to keep patient hydrated. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a medical assistant concerning a current 12 year old female patient who on 13-AUG-2009 at the age of 11 year old was vaccinated IM with a 0.5 ml dose of GARDASIL (dose unspecified and lot number: 661953/1130X, expiration date: 13-MAR-2011). The Medical assistant reported that the patient had been experiencing numbness in arms and legs after vaccination. The patient did not seek medical attention until 28-JUL-2010. At the time of the report the patient has not recovered. Follow up information was received from the medical assistant concerning the female patient with no illness at time of vaccination and no pertinent medical history, drug reactions or allergies who on 13-AUG-2009, was vaccinated with a first dose of GARDASIL (Lot# 661953/1130X). Concomitant therapy included MENACTRA and Tdap (manufacturer unknown). The medical assistant reported that on 13-AUG-2010, "fairly night after the patient had received the first dose of GARDASIL, MENACTRA and Tdap (manufacturer unknown)", the patient started to feel numbness at the upper extremity which through one year went to her legs and other arm. No test was done because patient's parent did not notify them until one year later when the patient went in to another exam. The patient did not come in for the second dose of GARDASIL then info was disclosed. The outcome of the patient was not reported. Additional information has been requested.