chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Full blood count normal, Intestinal anastomosis, Intestinal gangrene, Intestinal resection, Intussusception
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. 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 Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Laparotomy, Large intestinal obstruction reduction, Lethargy, Rectal haemorrhage, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. 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 Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Urine output decreased, Vomiting, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 2 month old female with no medical history who on 11-FEB-2008 was vaccinated po with the first dose of ROTATEQ (lot # reported as 657667/1392U). Concomitant suspect vaccine includes the first dose of COMVAX (lot # reported as 653783/0012F) in the right leg. Other concomitant vaccines included are the first doses of poliovirus vaccine (unspecified) (Sanofi Pasteur) (lot # reported as A0474PK) in the left leg, PREVNAR (Wyeth Pharmaceuticals) (lot # reported as C49271) in the right leg and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown)  (lot # reported as C2607AB) in the left leg. Records revealed on 15-FEZB-2008 a patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output and rectal bleeding times one day. Patient was seen at outlying ER where ultrasound of abdomen confirmed intussusception. Hydrostatic reduction was unsuccessful and taken to the operating room. Surgical findings included compound ileocolic colocolic intussusception involving entire large bowel to level of sigmoid colon. Unable to manually reduce and terminal ileum and ascending colon were resected. Patient was admitted to the pediatric intensive care unit post operatively. Progressed well and discharged to home with surgery clinic follow-up. Final diagnosis gangrenous ileocolic, colocolic compound intussusception, laparotomy; right hemicolectomy with ileocolic anastomosis. It was reported that abdominal mass, abdominal pain, crying, diet refusal, intestinal gangrene, intussusception, lethargy, rectal hemorrhage, urine output decreased and vomiting was considered life threatening and serious. The original reporting source was not reported The VAERS ID $# is 305057. Other related VAERS reports include 305057-2 and 305057-3. A standard lot check investigations were performed. 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 Center for Biologic Evaluation and Research and was released. No further information is available.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cough, Drooling, Erythema, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Information has been received from a physician concerning an otherwise healthy female, who on 09-JUN-2008 was vaccinated with MMR II (Lot #660202/0451X). Suspect therapy included VARIVAX (Lot # 660033/1852U). On 09-JUN-2008 the patient experienced anaphylactic reaction and was hospitalized. The patient was treated in the pediatrician's office with ephinephrine and dexamethasone. The patient was taken to the hospital where she was admitted and observed overnight. The physician is requesting gelatin and neomycin for hypersensitivity testing for this patient. Anaphylactic reaction was also considered to be another important medical event. It was reported that the patient recovered from anaphylactic reaction. No product quality complaint. A lot check has been requested. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Retching
Clinical narrative: Information has been received from a physician concerning an otherwise healthy female, who on 09-JUN-2008 was vaccinated with MMR II (Lot #660202/0451X). Suspect therapy included VARIVAX (Lot # 660033/1852U). On 09-JUN-2008 the patient experienced anaphylactic reaction and was hospitalized. The patient was treated in the pediatrician's office with ephinephrine and dexamethasone. The patient was taken to the hospital where she was admitted and observed overnight. The physician is requesting gelatin and neomycin for hypersensitivity testing for this patient. Anaphylactic reaction was also considered to be another important medical event. It was reported that the patient recovered from anaphylactic reaction. No product quality complaint. A lot check has been requested. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning an otherwise healthy female, who on 09-JUN-2008 was vaccinated with MMR II (Lot #660202/0451X). Suspect therapy included VARIVAX (Lot # 660033/1852U). On 09-JUN-2008 the patient experienced anaphylactic reaction and was hospitalized. The patient was treated in the pediatrician's office with ephinephrine and dexamethasone. The patient was taken to the hospital where she was admitted and observed overnight. The physician is requesting gelatin and neomycin for hypersensitivity testing for this patient. Anaphylactic reaction was also considered to be another important medical event. It was reported that the patient recovered from anaphylactic reaction. No product quality complaint. A lot check has been requested. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TD, TD
Symptoms: Chills, Erythema, Migraine, Nausea, Pain in extremity
Clinical narrative: Vaccine given left deltoid 7/14/08. Pt. developed pain, swelling (L) deltoid, no fever, chills x 48 hrs. Seen 7/17/08 -> Given KEFLEX. Re-examined 7/1808. Stable. MOTRIN recommended.
Age: 27.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia, Swelling
Clinical narrative: Vaccine given left deltoid 7/14/08. Pt. developed pain, swelling (L) deltoid, no fever, chills x 48 hrs. Seen 7/17/08 -> Given KEFLEX. Re-examined 7/1808. Stable. MOTRIN recommended.
Age: 27.0
Sex: F
Vaccine: TD, TD
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Vaccine given left deltoid 7/14/08. Pt. developed pain, swelling (L) deltoid, no fever, chills x 48 hrs. Seen 7/17/08 -> Given KEFLEX. Re-examined 7/1808. Stable. MOTRIN recommended.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Convulsion, Immediate post-injection reaction, Syncope
Clinical narrative: This case was received from a physician via another manufacturer on 18 July 2008, under reference number WAES0807USA02253. SERIOUSNESS CRITERIA-OTHER: MEDICALLY SIGNIFICANT. The following is verbatim from the other manufacturer's report: "Information has been received from a physician concerning a 12-14 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Concomitant vaccinations received on the same day included: MENACTRA and DTaP (manufacturer unknown)." "The physician reported that a patient fainted postvaccination with GARADASIL. The patient was vaccinated with her first dose of GARDASIL, on an unknown date, and also with MENACTRA and another vaccine DTaP (manufacturer unknown) on the same day. Immediately post vaccination the patient fainted and had "seizure like activity". The patient sought for medical attention: in the office." "At the time of the report, the patient outcome was unknown." "There was no product quality complaint." "Upon internal review "seizure like activity" was considered to be other important medical event." "Additional information has been requested."
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: This case was received from a physician via another manufacturer on 18 July 2008, under reference number WAES0807USA02253. SERIOUSNESS CRITERIA-OTHER: MEDICALLY SIGNIFICANT. The following is verbatim from the other manufacturer's report: "Information has been received from a physician concerning a 12-14 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Concomitant vaccinations received on the same day included: MENACTRA and DTaP (manufacturer unknown)." "The physician reported that a patient fainted postvaccination with GARADASIL. The patient was vaccinated with her first dose of GARDASIL, on an unknown date, and also with MENACTRA and another vaccine DTaP (manufacturer unknown) on the same day. Immediately post vaccination the patient fainted and had "seizure like activity". The patient sought for medical attention: in the office." "At the time of the report, the patient outcome was unknown." "There was no product quality complaint." "Upon internal review "seizure like activity" was considered to be other important medical event." "Additional information has been requested."
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Lymphadenopathy, Pain
Clinical narrative: I felt achy all over and my joints hurt.  Also, felt as if the lymph nodes in both arms were swollen.  I had to go and lay down because I felt so bad.  I took Ibuprofen 200 mg and it helped until it wore off.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injected limb mobility decreased, Musculoskeletal pain, Neurological examination normal, Paraesthesia
Clinical narrative: Onset morning after vaccine rec'd. Could not lift left arm for 24 hours. Continued difficulty lifting arm, but shoulder area above bicep has constant ache and is very weak.  Most noticable at night when sleeping and interferes w/ sleep.  Especially difficult to move arm at night.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Onset morning after vaccine rec'd. Could not lift left arm for 24 hours. Continued difficulty lifting arm, but shoulder area above bicep has constant ache and is very weak.  Most noticable at night when sleeping and interferes w/ sleep.  Especially difficult to move arm at night.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Meningitis meningococcal
Clinical narrative: This case was received from a physician on 21 July 2008.  A 20-year-old female patient with a history of aplastic anemia received an injection of MENACTRA in 2005 (lot number, route/site, and date of administration not reported).  According to the reporter, the patient was "recently" diagnosed with meningitis, serogroup Y.  The patient was taking cyclosporines at the time of the event.  Outcome was reported as recovered.  No other information was provided. 10/27/08-records received for DOS 6/9-6/9/08-DC DX: Meningococcemia with presumptive Neisseria meningitis. Presented to ER after a 1 day history of fatigue fever and chills. Felt dizzy and was febrile. C/O severe and generalized body aches, headache. Began menses that morning. Sepsis with tachycardia, elevated temperature subsequently became hypotensive, hemolysis with hemoglobin dropping to 7.5 from 10.7. On 8th day C/O pleuritic type chest pain and hypoxic. Syncope likely secondary to antibiotic reaction to Amoxicillin. No lumbar puncture performed.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness unilateral, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from an 87 year old male with blood pressure high and no drug reactions or allergies who on 29-NOV-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included other unspecified medications. On 20-JUN-2008 the patient experienced complete hearing loss in his right ear. Audiology tests and magnetic resonance imaging (MRI) were performed (results not provided). At the time of the report, the patient's complete hearing loss in his right ear persisted and he wore a hearing aid on his left. The patient stated that he felt the adverse experience he has was from receiving ZOSTAVAX. Unspecified medical attention was sought. Upon internal review, "complete hearing loss" was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 16 year old female with no medical history, and no drug reactions/allergies, who on 09-APR-2008 was vaccinated intramuscularly with her first 0.5ml dose of GARDASIL (lot# 659964/1978U) while pregnant.  It was reported that the patient was "9 weeks pregnant on 22-May-2008" (estimated LMP = 19-Mar-2008).  The patient has no symptoms.  Unspecified medical attention was sought by calling the office.  No further information available.  In follow-up information it was reported that date of last menstrual period was 19-MAR-2008 and the estimated delivery date was 24-DEC-2008.  On 16-JUN-2008 the patient had an elective termination of pregnancy.  It was reported that LMP was 19-MAR-2008, so the patient was approximately 13 weeks.  It was unknown if the products of conception were examined and it was unknown if the fetus is normal.  Upon internal review elective termination was determined to be an other important medical event.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain upper, Anaphylactic reaction, Cough, Dyspnoea, Eye swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old female who was vaccinated with the second dose of MMR II. Suspect therapy included VARIVAX. On 21-JUL-2008 the patient experienced anaphylactic reaction after her second vaccination with MMR II and VARIVAX. Immediately after vaccination the patient started to cough excessively. She was sent to the ER, treated and later released. The patient's mother reported that she developed a severe allergic reaction. She reported that her daughter's face and eyes were swollen, she had trouble breathing, a rash on her arms and feet, coughing and sneezing and severe belly pain. The mother also reported that her daughter was given steroids, "BENADRYL" (manufacturer unspecified), and "epinephrine" (manufacturer unspecified). It was reported that the patient received the first vaccination for MMR II and VARIVAX at 12-15 months. Patient is going to see her allergist. No product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Rash, Sneezing, Swelling face
Clinical narrative: Information has been received from a physician concerning a 4 year old female who was vaccinated with the second dose of MMR II. Suspect therapy included VARIVAX. On 21-JUL-2008 the patient experienced anaphylactic reaction after her second vaccination with MMR II and VARIVAX. Immediately after vaccination the patient started to cough excessively. She was sent to the ER, treated and later released. The patient's mother reported that she developed a severe allergic reaction. She reported that her daughter's face and eyes were swollen, she had trouble breathing, a rash on her arms and feet, coughing and sneezing and severe belly pain. The mother also reported that her daughter was given steroids, "BENADRYL" (manufacturer unspecified), and "epinephrine" (manufacturer unspecified). It was reported that the patient received the first vaccination for MMR II and VARIVAX at 12-15 months. Patient is going to see her allergist. No product quality complaint. Additional information has been requested.
Sex: F
Vaccine: RUB
Symptoms: Abortion induced, Drug exposure during pregnancy, Injury
Clinical narrative: Information has been received regarding a case in litigation from a lawyer concerning a female who on or about 29-SEP-2005 was vaccinated with a dose of MERUVAX II.  On an unspecified date the patient sustained "grave, serious and permanent personal injuries" and "was caused to terminate her pregnancy".  "Grave, serious and permanent personal injuries" was considered to be disabling.  Upon internal review, "was caused to terminate her pregnancy" was considered an other medically important event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Labour complication
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with allergy to codeine and no pertinent medical history who on 17-SEP-2007 was vaccinated with GARDASIL (lot#: 658558/1061U) 0.5ml IM.  Concomitant therapy included ALDOMET.  Subsequently, she became pregnant.  Her LMP was 10-SEP-2007.  The estimated due date was 16-JUN-2008.  The patient delivered a baby on 20-JUN-2008.  She had a cesarean section because of "failure to descend".  The delivery was successful.  A cervical smear (PAP smear) was performed (results not reported).  The patient was seen by a physician.  Upon internal review, failure to descend, the indication for cesarean section, was considered to be an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no past history of seizures and no history of drug reactions or allergies who on approximately 07-JUL-2008 was vaccinated with the first dose of GARDASIL. Right after the vaccination the patient experienced convulsions. The patient "improved" the same day. subsequently, the patient recovered from convulsion. The patient sought unspecified medical attention. Upon internal review, convulsion was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician who received an e-mail that was addressed to all physicians from another physician, a pediatric neurologist. He stated in e-mail that one of his patients experienced seizures after GARDASIL. The patient outcome was not reported. Upon internal review, seizures were considered to be an other important event. Additional information has been requested. This is one of several reports received from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Morphoea
Clinical narrative: Information has been received from a physician concerning her niece, a 16 year old female who on unspecified dates was vaccinated with the first and second doses of GARDASIL, 0.5 ml.  In February 2008, the patient experienced cellulitis type skin condition.  She was seen by a dermatologist and she was hospitalized a few times with diagnosis of Morphea, an autoimmune disease.  In March 2008, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml, with no additional reaction or exacerbation of symptoms noted.  At the time of report, the patient had not recovered.  No additional information at this time.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Gingival swelling, Gingivitis ulcerative
Clinical narrative: Information has been received from a nurse concerning a her daughter 19 year old with "allergic sulfa" and no pertinent medical history who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant therapy included TRI-CYCLEN and montelukast sodium (MSD). The nurse reported that her daughter developed swelling of the gums and cankers sores in the mouth following vaccination with GARDASIL. The daughter's gums swelled and she developed cankers sores 4 days after the first vaccination with GARDASIL. The daughter was treated by a dentist for the gum swelling and cankers sores. The gum swelling was characterized as necrotizing gingivitis. The canker sores developed over a period of 5 days and totaled 7. The gum swelling and canker sores made it hard to eat and the daughter did not eat any solid food for one week. Swelling of the gums and cankers sores in the mouth and necrotizing gingivitis was considered to be disabling. No lab diagnostics were performed. On 06-JUL-2008 the patient recovered. There was no product quality complaint. Additional information has been requested. 8/11/08-records received for DOS 6/28/08 college physical exam normal no complaints.
Age: 15.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a physician concerning a 12 year old female with family history of seizure who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The patient did not have any problems after the first and second dose of GARDASIL. The patient had a seizure 30 days after receiving the third dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered. The physician did not feel the seizure was related to GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. 8/8/08-records received- ED report 1/4/08-presented to ED first seizure 12/26/07-C/O feeling tired. Seizure generalized tonic-clonic lasting 5 minutes. Postictal. Abrasion to tongue. Headache after seizure. Confusion lasting half hour. Neurology consult 1/10/08-the two seizures occurred while playing karaoke.   Subsequent seizure with forced eye closure while on the computer. Impression-cryptogenic generalized seizure disorder with multifocal and generalized discharges on EEG. Indeterminate staring spells probably atypical absence seizures. Depression.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician who received an e-mail that was addressed to all physicians from another physician, a pediatric neurologist. The e-mail stated that the NVIC reported that 82 patients developed syncope and seizures after injection of GARDASIL. The patients sought medical attention. The patients' outcomes were not reported. The reporting physician who was not the physician of any of these patients expressed concern that GARDASIL was not safe. Upon internal review, seizures were considered to be an other important event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 21-MAY-2007, was vaccinated with the first dose of GARDASIL (Lot # and Batch # not provided). Date of second dose not reported. On 03-APR-2008, was vaccinated with the third dose of GARDASIL (Lot # and Batch # not provided). On 02-JUN-2008, about two months after completion of the GARDASIL series, the patient experienced seizure. The patient sought for medical attention at physician's office. On unspecified date, the patient recovered from seizure. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested.  8/26/08 Reviewed ER medical records of 5/31/2008. FINAL DX: new onset seizures Records reveal patient experienced an initial seizure w/LOC, dizziness, nausea, weakness, blurry vision while in restaurant.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Arthropathy, Costochondritis
Clinical narrative: Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Erythema, Fatigue, Full blood count normal, Gait disturbance
Clinical narrative: Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Labyrinthitis, Musculoskeletal pain
Clinical narrative: Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal stiffness, Neck pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Urine analysis normal
Clinical narrative: Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Fatigue, Gait disturbance
Clinical narrative: Gradual progression of symptoms since receiving the third booster of the GARDASIL vaccine in January of 2008. Initial Labrynthitis diagnosed by student health center and costochrondritis in late March. Followed by extreme exhaustion and a diagnosis of depression. Fatigue increased. Tempromandibular Joint problems, severe headaches, and neck pain began in Spring. Hip and knee pain followed in April and has worsened to limping and sharp pain. Shoulder pain. Redness and stiffness of the hands followed in early May, followed by ankles. Also, in May, I started experiencing numbness intermittently in my hands. I am seeing a rheumatologist who is treating the symptoms and has made no diagnosis at this time. I am no longer able to work a full day and have spent most of my summer on the sofa. 8/18/08-records received for DOS 6/25/08-presented with C/O arthralgias and myalgias that began in March 2008 noted pain over right trochanteric bursa and pain when walking or standing for periods of time. Participating in spinning class. Stiff and achy in morning. Some numbness and tingling. Color changes in fingertips when exposed to cold. Heat rash on chest. Costochondritis. Pain in chest, headaches.   DOS 7/16/08-follow up visit. Improvement in symptoms after Medrol dospak. Assessment:potential inflammatory arthritis.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Shingle shot-No ad mentioned patients would get shingles. I wrote Merck president. He did not reply-got form letter unsigned!-saying their tests showed no one got shingles. My doctor said all who got shot got shingles-live cultures-I was not told. I did own tests and discovered (from friends) that all got shingles!!! Please have them (Merck) publish this fact!!. At @240.00 a shot (I had to pay). I have Medicare A + B + D and an AARP supplement. So far, all refuse to reimburse me even a fraction. Dr is my primary care. The unsigned forms from Merck hide the person responsible!!!. I am now breaking out for 2nd time since shot.8/5/08-records received-office visit 2/18/08 vaccine administered. 5/13/08-Blood surgars elevated. Left sciatica. Rash on wrist and finger resolving. Left neck pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Sciatica
Clinical narrative: After receiving third injection of GARDASIL there was an acute pain in lower back. Persistent to this date. Sibling-sister-has same acute symptom. Diagnosed as sciatica but not convinced due to the events for two sisters with same symptoms. 7/31/08-records received for DOS 6/25/07-emotional problems, lower back leg pain, sciatica. HPV#1 received 4/9/07, HPV#2 6/4/07, vaccine administration GYN office. Office visit 7/9/07-still C/O back pain getting worse. 12/28/07-hives and itching for 2 months, urticaria. 3/21/08-C/O back pain on and off last seen for this complaint was 7/9/07.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5
Symptoms: Clostridium difficile toxin test, Coagulation test normal, Culture stool negative, Diarrhoea, Eosinophil percentage increased
Clinical narrative: Pt is a 3-1/2-month-old male who presented for evaluation of recurrent mucousy blood in the stool. He was asymptomatic until 06/04/08. He received a rotavirus vaccine. Two days later, his mom noticed mucousy blood in the stool, small in amount, gradually with every bowel movement mom noticed mucousy blood in the stool, loose in consistency, continued and the patient was seen in emergency room. He was admitted overnight. Workup was done, which include normal CBC except 13% eosinophils, which is high. PT, PTT, and INR were normal. Stool studies negative for C. diff toxins A and B, and culture for bacterial pathogens. Barium enema was also unremarkable. Mom stopped taking any protein in her diet because mom is exclusively breast feeding. Within 72 hours, no more visible blood in the stool seen. Baby has been gaining weight very well, feeding well. No history of any respiratory, urinary, or neurologic symptoms or rash. No weight loss. No vomiting. 7/29/08-records received with report for DOS 6/7-6/9/08-DC DX: Hematochezia,  Presented to ED after having blood in stools with every bowel movement for past day. Breast fed. PE: WNL. Note from GI consultant for DOS 6/20/08-impression:allergic colitis.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5
Symptoms: Haematochezia, Haemoglobin normal, Lymphocyte percentage increased, Monocyte percentage increased, Mucous stools
Clinical narrative: Pt is a 3-1/2-month-old male who presented for evaluation of recurrent mucousy blood in the stool. He was asymptomatic until 06/04/08. He received a rotavirus vaccine. Two days later, his mom noticed mucousy blood in the stool, small in amount, gradually with every bowel movement mom noticed mucousy blood in the stool, loose in consistency, continued and the patient was seen in emergency room. He was admitted overnight. Workup was done, which include normal CBC except 13% eosinophils, which is high. PT, PTT, and INR were normal. Stool studies negative for C. diff toxins A and B, and culture for bacterial pathogens. Barium enema was also unremarkable. Mom stopped taking any protein in her diet because mom is exclusively breast feeding. Within 72 hours, no more visible blood in the stool seen. Baby has been gaining weight very well, feeding well. No history of any respiratory, urinary, or neurologic symptoms or rash. No weight loss. No vomiting. 7/29/08-records received with report for DOS 6/7-6/9/08-DC DX: Hematochezia,  Presented to ED after having blood in stools with every bowel movement for past day. Breast fed. PE: WNL. Note from GI consultant for DOS 6/20/08-impression:allergic colitis.
Age: 0.2
Sex: M
Vaccine: DTAP, RV5
Symptoms: Neutrophil percentage decreased, Occult blood positive, White blood cells stool negative
Clinical narrative: Pt is a 3-1/2-month-old male who presented for evaluation of recurrent mucousy blood in the stool. He was asymptomatic until 06/04/08. He received a rotavirus vaccine. Two days later, his mom noticed mucousy blood in the stool, small in amount, gradually with every bowel movement mom noticed mucousy blood in the stool, loose in consistency, continued and the patient was seen in emergency room. He was admitted overnight. Workup was done, which include normal CBC except 13% eosinophils, which is high. PT, PTT, and INR were normal. Stool studies negative for C. diff toxins A and B, and culture for bacterial pathogens. Barium enema was also unremarkable. Mom stopped taking any protein in her diet because mom is exclusively breast feeding. Within 72 hours, no more visible blood in the stool seen. Baby has been gaining weight very well, feeding well. No history of any respiratory, urinary, or neurologic symptoms or rash. No weight loss. No vomiting. 7/29/08-records received with report for DOS 6/7-6/9/08-DC DX: Hematochezia,  Presented to ED after having blood in stools with every bowel movement for past day. Breast fed. PE: WNL. Note from GI consultant for DOS 6/20/08-impression:allergic colitis.
Age: 70.0
Sex: F
Vaccine: PPV, TTOX, PPV, PPV, TD
Symptoms: Autopsy, Death
Clinical narrative: Unknown adverse event. Patient received vaccines and passed away within 24 hrs. Autopsy scheduled 7/24/08. 10/14/08 MR and Death Cert received from PCP. Pt seen 7/21/08 with Assessment: Healthy 70 year old. PE WNL. Pt expired at unknown time 7/22/08 of unknown causes. Autopsy deferred by ME. COD:  Unknown causes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Back pain, CSF glucose normal, CSF protein normal, Demyelination, Endotracheal intubation
Clinical narrative: On 6-12-08, pt developed back pain, fever, and acute onset of weakness. He was initially admitted to floor but developed resp. distress and was transferred to Ped ICU and intubated. He was subsequently diagnosed with transverse myelitis.9/18/08-records received for DOS 6/13-7/22/08-DC/Transfer Summary DX: Acute transverse myelitis. Respiratory failure. Presented to ED on 6/11/08 with acute onset of upper back pain and weakness in upper extremities and lower extremities with upper worse than lower. Developed problems with balance. Unable to squeeze parent's finger, and developed upper body twitching and shaking. Fever 103. In ED unable to raise arms. Developed respiratory distress and was intubated and placed on mechanical ventilation. Hyperglycemia due to high-dose Solu-Medrol. Aspiration pneumonia. Nasograstric tube feedings.  Continued with low grade fevers. Transferred to rehabilitation facility. 2/27/09-records received-rehabiliation facility with subsequent decannulation after venitaltor dependency. Neurogenic bladder. Postvoid residual. 1/25/2010 Follow-up: patient had an active transverse myelitis and continues to have physical limitation he continues to received physical therapy services.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Grip strength decreased, Intensive care, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: On 6-12-08, pt developed back pain, fever, and acute onset of weakness. He was initially admitted to floor but developed resp. distress and was transferred to Ped ICU and intubated. He was subsequently diagnosed with transverse myelitis.9/18/08-records received for DOS 6/13-7/22/08-DC/Transfer Summary DX: Acute transverse myelitis. Respiratory failure. Presented to ED on 6/11/08 with acute onset of upper back pain and weakness in upper extremities and lower extremities with upper worse than lower. Developed problems with balance. Unable to squeeze parent's finger, and developed upper body twitching and shaking. Fever 103. In ED unable to raise arms. Developed respiratory distress and was intubated and placed on mechanical ventilation. Hyperglycemia due to high-dose Solu-Medrol. Aspiration pneumonia. Nasograstric tube feedings.  Continued with low grade fevers. Transferred to rehabilitation facility. 2/27/09-records received-rehabiliation facility with subsequent decannulation after venitaltor dependency. Neurogenic bladder. Postvoid residual. 1/25/2010 Follow-up: patient had an active transverse myelitis and continues to have physical limitation he continues to received physical therapy services.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Physiotherapy, Pyrexia, Rehabilitation therapy, Respiratory distress, Terminal dribbling
Clinical narrative: On 6-12-08, pt developed back pain, fever, and acute onset of weakness. He was initially admitted to floor but developed resp. distress and was transferred to Ped ICU and intubated. He was subsequently diagnosed with transverse myelitis.9/18/08-records received for DOS 6/13-7/22/08-DC/Transfer Summary DX: Acute transverse myelitis. Respiratory failure. Presented to ED on 6/11/08 with acute onset of upper back pain and weakness in upper extremities and lower extremities with upper worse than lower. Developed problems with balance. Unable to squeeze parent's finger, and developed upper body twitching and shaking. Fever 103. In ED unable to raise arms. Developed respiratory distress and was intubated and placed on mechanical ventilation. Hyperglycemia due to high-dose Solu-Medrol. Aspiration pneumonia. Nasograstric tube feedings.  Continued with low grade fevers. Transferred to rehabilitation facility. 2/27/09-records received-rehabiliation facility with subsequent decannulation after venitaltor dependency. Neurogenic bladder. Postvoid residual. 1/25/2010 Follow-up: patient had an active transverse myelitis and continues to have physical limitation he continues to received physical therapy services.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Erythema, Oedema, Skin plaque
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old male with a history of shingles (twice in the past) and no drug reactions/allergies, who on 28-SEP-2007 was vaccinated in the left upper with first dose of ZOSTAVAX (lot number: 657766/0620U).  Concomitant therapy included aspirin (manufacturer unknown), LISINOPRIL COMP and TEVETEN.  On 22-OCT-2007 the patient went into the office with what looked like a typical chicken pox rash that had a blister-like appearance.  The physician's notes stated that the patient had edematous, pink plaques.  No description of location of plaques.  The patient was prescribed six days post vaccination, VALTREX, hydroxyzine hcl and triamcinolone cream.  The patient was also told to sit in a tub of water for 20 minutes, not dry off and then put on the triamcinolone cream.  Lab diagnostics studies performed included: viral culture (negative) and skin biopsy pathology report (negative for chicken pox, but revealed blisters).  Unspecified medical attention was sought.  The patient was seen in the office.  It was noted that the patient (about 90% of the rash) significantly improved within 72 hours of treatment with VALTREX "and may have already recovered".  No other details.  There was no product quality complaint.  Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella, Virus culture negative
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old male with a history of shingles (twice in the past) and no drug reactions/allergies, who on 28-SEP-2007 was vaccinated in the left upper with first dose of ZOSTAVAX (lot number: 657766/0620U).  Concomitant therapy included aspirin (manufacturer unknown), LISINOPRIL COMP and TEVETEN.  On 22-OCT-2007 the patient went into the office with what looked like a typical chicken pox rash that had a blister-like appearance.  The physician's notes stated that the patient had edematous, pink plaques.  No description of location of plaques.  The patient was prescribed six days post vaccination, VALTREX, hydroxyzine hcl and triamcinolone cream.  The patient was also told to sit in a tub of water for 20 minutes, not dry off and then put on the triamcinolone cream.  Lab diagnostics studies performed included: viral culture (negative) and skin biopsy pathology report (negative for chicken pox, but revealed blisters).  Unspecified medical attention was sought.  The patient was seen in the office.  It was noted that the patient (about 90% of the rash) significantly improved within 72 hours of treatment with VALTREX "and may have already recovered".  No other details.  There was no product quality complaint.  Additional information has been requested.