chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Mononucleosis heterophile test negative, Platelet count normal, Protein total normal, White blood cell count
Clinical narrative: 29 y/o male w/ no significant past medical history received smallpox vaccination by scarification on 10MAR09. Pt then deployed. On 20MAR09, pt presented to my clinic c/o a tender, enlarged left submandibular lymph node. He had no other symptoms.  He informed me of his recent immunization, and I treated him w/ a course of Motrin. On 23MAR09, pt f/u, and his lymphadenopathy had largely resolved. He noted new symptoms of chills and fatigue lasting one hour daily for the past two days, occuring 2-3hrs postprandially. Pt was asymptomatic during the visit, so no therapy was prescribed. On 24MAR09, pt presented c/o worsening chills and fatigue. Basic labs were obtained (CBC, chemistry, liver function panel) which were w/in normal limits. A monospot test was also negative. Five hours later, pt presented w/ rigors and new onset belly pain in the RLQ. Oral temp was 101.1F, and abdominal exam revealed an acute abdomen w/ RLQ rebound pain. Pt was immediately transported to the hospital. CT revealed a 3 cm cystic lesion at the base of the appendix. The pt was taken to the operating room, and a R hemicolectomy was performed to remove the suspicious mass found on the lumen side of the bowel wall just distal to the ileocecal junction. The specimen was sent for evaluation. The pt tolerated the operation well and was sent to recover. He arrived on 25MAR09 and was in stable condition. 4/1/09-records received-office visit 3/28/09- s/p R hemicolectomy 3/24/09.  3/10/09-presented to clinic with C/O L sided sumandible lymph node that was resolving per 3/23/09 note.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Abdominal pain, Abdominal pain lower, Abdominal wall cyst, Appendix disorder, Blood amylase
Clinical narrative: 29 y/o male w/ no significant past medical history received smallpox vaccination by scarification on 10MAR09. Pt then deployed. On 20MAR09, pt presented to my clinic c/o a tender, enlarged left submandibular lymph node. He had no other symptoms.  He informed me of his recent immunization, and I treated him w/ a course of Motrin. On 23MAR09, pt f/u, and his lymphadenopathy had largely resolved. He noted new symptoms of chills and fatigue lasting one hour daily for the past two days, occuring 2-3hrs postprandially. Pt was asymptomatic during the visit, so no therapy was prescribed. On 24MAR09, pt presented c/o worsening chills and fatigue. Basic labs were obtained (CBC, chemistry, liver function panel) which were w/in normal limits. A monospot test was also negative. Five hours later, pt presented w/ rigors and new onset belly pain in the RLQ. Oral temp was 101.1F, and abdominal exam revealed an acute abdomen w/ RLQ rebound pain. Pt was immediately transported to the hospital. CT revealed a 3 cm cystic lesion at the base of the appendix. The pt was taken to the operating room, and a R hemicolectomy was performed to remove the suspicious mass found on the lumen side of the bowel wall just distal to the ileocecal junction. The specimen was sent for evaluation. The pt tolerated the operation well and was sent to recover. He arrived on 25MAR09 and was in stable condition. 4/1/09-records received-office visit 3/28/09- s/p R hemicolectomy 3/24/09.  3/10/09-presented to clinic with C/O L sided sumandible lymph node that was resolving per 3/23/09 note.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Body temperature increased, Chills, Colectomy, Computerised tomogram abnormal, Condition aggravated
Clinical narrative: 29 y/o male w/ no significant past medical history received smallpox vaccination by scarification on 10MAR09. Pt then deployed. On 20MAR09, pt presented to my clinic c/o a tender, enlarged left submandibular lymph node. He had no other symptoms.  He informed me of his recent immunization, and I treated him w/ a course of Motrin. On 23MAR09, pt f/u, and his lymphadenopathy had largely resolved. He noted new symptoms of chills and fatigue lasting one hour daily for the past two days, occuring 2-3hrs postprandially. Pt was asymptomatic during the visit, so no therapy was prescribed. On 24MAR09, pt presented c/o worsening chills and fatigue. Basic labs were obtained (CBC, chemistry, liver function panel) which were w/in normal limits. A monospot test was also negative. Five hours later, pt presented w/ rigors and new onset belly pain in the RLQ. Oral temp was 101.1F, and abdominal exam revealed an acute abdomen w/ RLQ rebound pain. Pt was immediately transported to the hospital. CT revealed a 3 cm cystic lesion at the base of the appendix. The pt was taken to the operating room, and a R hemicolectomy was performed to remove the suspicious mass found on the lumen side of the bowel wall just distal to the ileocecal junction. The specimen was sent for evaluation. The pt tolerated the operation well and was sent to recover. He arrived on 25MAR09 and was in stable condition. 4/1/09-records received-office visit 3/28/09- s/p R hemicolectomy 3/24/09.  3/10/09-presented to clinic with C/O L sided sumandible lymph node that was resolving per 3/23/09 note.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Full blood count normal, Laboratory test normal, Liver function test normal, Lymph node pain
Clinical narrative: 29 y/o male w/ no significant past medical history received smallpox vaccination by scarification on 10MAR09. Pt then deployed. On 20MAR09, pt presented to my clinic c/o a tender, enlarged left submandibular lymph node. He had no other symptoms.  He informed me of his recent immunization, and I treated him w/ a course of Motrin. On 23MAR09, pt f/u, and his lymphadenopathy had largely resolved. He noted new symptoms of chills and fatigue lasting one hour daily for the past two days, occuring 2-3hrs postprandially. Pt was asymptomatic during the visit, so no therapy was prescribed. On 24MAR09, pt presented c/o worsening chills and fatigue. Basic labs were obtained (CBC, chemistry, liver function panel) which were w/in normal limits. A monospot test was also negative. Five hours later, pt presented w/ rigors and new onset belly pain in the RLQ. Oral temp was 101.1F, and abdominal exam revealed an acute abdomen w/ RLQ rebound pain. Pt was immediately transported to the hospital. CT revealed a 3 cm cystic lesion at the base of the appendix. The pt was taken to the operating room, and a R hemicolectomy was performed to remove the suspicious mass found on the lumen side of the bowel wall just distal to the ileocecal junction. The specimen was sent for evaluation. The pt tolerated the operation well and was sent to recover. He arrived on 25MAR09 and was in stable condition. 4/1/09-records received-office visit 3/28/09- s/p R hemicolectomy 3/24/09.  3/10/09-presented to clinic with C/O L sided sumandible lymph node that was resolving per 3/23/09 note.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Mass, Mononucleosis heterophile test negative, Tenderness
Clinical narrative: 29 y/o male w/ no significant past medical history received smallpox vaccination by scarification on 10MAR09. Pt then deployed. On 20MAR09, pt presented to my clinic c/o a tender, enlarged left submandibular lymph node. He had no other symptoms.  He informed me of his recent immunization, and I treated him w/ a course of Motrin. On 23MAR09, pt f/u, and his lymphadenopathy had largely resolved. He noted new symptoms of chills and fatigue lasting one hour daily for the past two days, occuring 2-3hrs postprandially. Pt was asymptomatic during the visit, so no therapy was prescribed. On 24MAR09, pt presented c/o worsening chills and fatigue. Basic labs were obtained (CBC, chemistry, liver function panel) which were w/in normal limits. A monospot test was also negative. Five hours later, pt presented w/ rigors and new onset belly pain in the RLQ. Oral temp was 101.1F, and abdominal exam revealed an acute abdomen w/ RLQ rebound pain. Pt was immediately transported to the hospital. CT revealed a 3 cm cystic lesion at the base of the appendix. The pt was taken to the operating room, and a R hemicolectomy was performed to remove the suspicious mass found on the lumen side of the bowel wall just distal to the ileocecal junction. The specimen was sent for evaluation. The pt tolerated the operation well and was sent to recover. He arrived on 25MAR09 and was in stable condition. 4/1/09-records received-office visit 3/28/09- s/p R hemicolectomy 3/24/09.  3/10/09-presented to clinic with C/O L sided sumandible lymph node that was resolving per 3/23/09 note.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN3, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Mother noted a red, hot raised area on the child's left upper arm 2 days after receiving the vaccines. It was 3 in in diameter and had a white area in the center. The mother gave the child one dose of Benadryl and the area went away.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Swelling
Clinical narrative: Reported by Mother of client on 3/25/09 @ 08:30 a.m.):  "Left leg is sore by her knee with swelling, redness (in a big red circle where vaccine given) and it hurt her to walk on that leg.  The swelling is moving down her leg. I have been marking it to see if it's moving. This started after she had the immunizations on Monday (3/23/09) of this week."  I advised mother of which vaccinations the client received in the left leg, that I was reporting this as a VAERS (teaching to mother on what a VAERS is) to the CDC and the State, and encouraged her to follow up with the client's physician today.  Mother stated she would call and try to get patient into the Dr.s office.  Further advised her that she may receive a call or contact from the agency regarding the reaction.  She advised that would be okay.  Notified the agency of the event by phone.  Notified Nurse Supervisor and Manager of the event by email.  Will cc the Vaers and Incident report to both parties for distribution as needed and a cc to agency with a hard cc sent in the mail.  Contacted mother @ 11:30 a.m. and she advised had just returned from patient seeing Dr. Dr. had said it was a major reaction involving an immunization and likely the Pertussis in the DTAP.  He has Rx her Prenisolone 5 mgl/ml orally 1 1/2 teaspoons BID.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Amnesia, Asthenia, Feeling abnormal, Pain
Clinical narrative: Zostavax administered Jan 27th, 2009. Fever developed within 2-3 days of vaccine administration, pt felt bad, experienced body aches and weakness within 1 week.  At 1 week post administration pt unable to ambulate.  Daughter called 911, pt admitted to hospital for 10 days, diagnosis fever of unknown origin. Pt subsequently transferred to rehab facility. 1 week later pt developed chickenpox-like rash, fever of 104-105 degrees F, and body weakness persisted. Pt remained in rehab facility an additional 37 days. Released to daughter's care March 18th. Pt has no recollection of events post-vaccination. Daughter reports pt rxn on March 19th, pt remaining extremely weak. 4/13/09-reocrds received-for DOS 2/3-2/14/09DC DX: fever of unknown origian, etiology not clear. Probably reaction to shingles vaccine, encephalopathy due to fever, generalized weakness/deconditioning. Presented to ED with fever and C/O weakness. Symptoms began 3 days after receiving vaccine. Presented to ED with fever, confusion and lethargy ongoing for 2-3 days. Developed diarrhea/
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Zostavax administered Jan 27th, 2009. Fever developed within 2-3 days of vaccine administration, pt felt bad, experienced body aches and weakness within 1 week.  At 1 week post administration pt unable to ambulate.  Daughter called 911, pt admitted to hospital for 10 days, diagnosis fever of unknown origin. Pt subsequently transferred to rehab facility. 1 week later pt developed chickenpox-like rash, fever of 104-105 degrees F, and body weakness persisted. Pt remained in rehab facility an additional 37 days. Released to daughter's care March 18th. Pt has no recollection of events post-vaccination. Daughter reports pt rxn on March 19th, pt remaining extremely weak. 4/13/09-reocrds received-for DOS 2/3-2/14/09DC DX: fever of unknown origian, etiology not clear. Probably reaction to shingles vaccine, encephalopathy due to fever, generalized weakness/deconditioning. Presented to ED with fever and C/O weakness. Symptoms began 3 days after receiving vaccine. Presented to ED with fever, confusion and lethargy ongoing for 2-3 days. Developed diarrhea/
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood pressure increased, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: Elevated Blood pressure, Face and eye swelling, shortness of breath and chest pain went to the emergency department and is currently admited at Medical Center. Now experienceing new onset atrial fibrillation which is still occurring. Patient still in hospital presently. 4/29/09-records received for DOS 3/24-3/28/09-new onset atrial fibrillation and anaphylactoid reaction to vaccine. Became reddened and itchy with some chest pressure
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Swelling face
Clinical narrative: Elevated Blood pressure, Face and eye swelling, shortness of breath and chest pain went to the emergency department and is currently admited at Medical Center. Now experienceing new onset atrial fibrillation which is still occurring. Patient still in hospital presently. 4/29/09-records received for DOS 3/24-3/28/09-new onset atrial fibrillation and anaphylactoid reaction to vaccine. Became reddened and itchy with some chest pressure
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Blood pressure increased, Chest pain, Dyspnoea, Eye swelling
Clinical narrative: Elevated Blood pressure, Face and eye swelling, shortness of breath and chest pain went to the emergency department and is currently admited at Medical Center. Now experienceing new onset atrial fibrillation which is still occurring. Patient still in hospital presently. 4/29/09-records received for DOS 3/24-3/28/09-new onset atrial fibrillation and anaphylactoid reaction to vaccine. Became reddened and itchy with some chest pressure
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Elevated Blood pressure, Face and eye swelling, shortness of breath and chest pain went to the emergency department and is currently admited at Medical Center. Now experienceing new onset atrial fibrillation which is still occurring. Patient still in hospital presently. 4/29/09-records received for DOS 3/24-3/28/09-new onset atrial fibrillation and anaphylactoid reaction to vaccine. Became reddened and itchy with some chest pressure
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Left hand red, swelling and itching, mom administered childrens benadryl
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Erythema
Clinical narrative: Arm redness, tightness in chest. S/s started 10 days after vaccination.  Pt was given naproxen 500mg twice daily and Zantac 150mg twice daily.  Consults pending for pulmonary clinic and 4 week follow-up with cardiology.  6/18/09 Hospital and outpatient records received DOS 3/23/09 to 5/4/09. FINAL DIAGNOSIS: Acute Myopericarditis after Smallpox Vaccination. Patient presented with chest tightness, substernal pain, painful knees, rash on shoulder, red papules around vaccination site.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, IPV, PNC, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: no adverse reactions/symptoms. patient given extra dose of IPV (Polio) vaccine, FOC upset.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Mass, Swelling
Clinical narrative: Had 2 swollen lump area. One lump to left deltoid 8.5x5.5mm. One lump to left arm sub-q 5 x 5mm. Lumps occurred one day after injection.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site vesicles, Pain
Clinical narrative: erythematous vessicles at injection site, pain and burning
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Nurse gave first dose of Rotateq after 15 weeks of age on 3/20/09. Infant has had no untoward affects when nurse checked with the parent the next day and none by 3/25/09.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody positive, Arthralgia, Cellulitis, Erythema, Injection site reaction
Clinical narrative: I am submitting this report per patient's primary care physician's request. Patient was hospitalized and was given Pneumovax prior to discharge on 3/16/09.  She had local reaction at injection site (L Deltoid) and was seen at the ER on 3/20 and 3/22 - prescribed Cephalexin and Septra for cellulitis. Seen by her primary care physician 3/23/09 for diffuse arthritis type symptoms; especially swelling and redness in both hands. Labs show positive ANA (profile and titer pending). MD now has her on course of Prednisone.  Primary care physician feels this is an adverse reaction to Pneumovax.  Patient has received this before and did not have any side effects.  She states she did not remember that she had received the vaccine previously.  Do not know manufacturer or lot # as this was not administered here at the clinic.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: I am submitting this report per patient's primary care physician's request. Patient was hospitalized and was given Pneumovax prior to discharge on 3/16/09.  She had local reaction at injection site (L Deltoid) and was seen at the ER on 3/20 and 3/22 - prescribed Cephalexin and Septra for cellulitis. Seen by her primary care physician 3/23/09 for diffuse arthritis type symptoms; especially swelling and redness in both hands. Labs show positive ANA (profile and titer pending). MD now has her on course of Prednisone.  Primary care physician feels this is an adverse reaction to Pneumovax.  Patient has received this before and did not have any side effects.  She states she did not remember that she had received the vaccine previously.  Do not know manufacturer or lot # as this was not administered here at the clinic.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood test, Borrelia burgdorferi serology, Full blood count, Hyperhidrosis
Clinical narrative: Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscle twitching, Musculoskeletal pain, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw, Paraesthesia, Pruritus, Rash, Thyroid function test
Clinical narrative: Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Vitamin D deficiency
Clinical narrative: Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin lesion, Tenderness
Clinical narrative: Localized erythema, plaque lesion; mild tenderness; no fevers, no chills, no airway compromise; treated with ALTABAX; no other problems reported.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: DV made by pt to show nurse reaction. Pt told nurse that 8:30 A.M. 3/18/2009 - area became hot to touch & itchy. 1:30 P.M. - Pt went to see school nurse- pt was given ice pack. 3:30 P.M. - Pt was given 25 mg of BENADRYL po. Site of injection red raised 4 1/2 hr pt was given ice pack on dismissal.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Injection site pruritus, Oedema peripheral
Clinical narrative: L arm red and swollen all around back of arm approximately 5 1/2 inches long.  Pt. states site itches.
Age: 25.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Asthenia, Dysphagia, Erythema, Oedema peripheral, Pharyngeal oedema
Clinical narrative: Swelling of throat with difficulty swallowing, fever, weakness, red and swollen arms
Age: 25.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Swelling of throat with difficulty swallowing, fever, weakness, red and swollen arms
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Full blood count, Injected limb mobility decreased, Lymphadenopathy, Pain in extremity
Clinical narrative: 3-20-09: Tdap left deltoid, 3-22-09: arm sore, fatigue, 3-23-09: pain in arm with movement swollen left axillary lymph node, tender to touch, 3-24-09: pain worse, swelling worse, 3-25-09: pain worse, swelling worse, CBC test results pending
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: 3-20-09: Tdap left deltoid, 3-22-09: arm sore, fatigue, 3-23-09: pain in arm with movement swollen left axillary lymph node, tender to touch, 3-24-09: pain worse, swelling worse, 3-25-09: pain worse, swelling worse, CBC test results pending
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Pt was waiting in line about 15 minutes after receiving iz and fainted, hitting head on wall and floor. Received immediate medical attention. VSS. nl neuro exam after incident. Pt fully recovered within an hour.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No reaction reported yet.  Misadministration 2 hrs ago.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Developed Acute L arm swelling + redness. Was seen on 3/18/09 + started on Keflex. Was seen again on 3/20/09 redness + swelling had improved.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Dizziness, Full blood count, Headache, Red blood cell sedimentation rate increased
Clinical narrative: Vomiting Thurs. night Temp 105 Friday with HA dizziness Temp lasting till seen Tuesday - 100.1 in clinic.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting Thurs. night Temp 105 Friday with HA dizziness Temp lasting till seen Tuesday - 100.1 in clinic.
Age: 33.0
Sex: U
Vaccine: HEP, HEPA, IPV, MNQ, YF
Symptoms: Abdominal discomfort, Back pain, Pyrexia, Vomiting
Clinical narrative: Pt reported a fever 103-104 F on Sat 3/21/09. He also C/O abdomen discomfort X vomited x1 and backache.
Age: 11.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Chills, Headache, Injection site pain, Pyrexia, Vomiting
Clinical narrative: My son right after getting vaccines started with chills, low grade fever and headaches. I called doctors office told it was normal. Today 3/25/2009 Son had fever, vomiting, headache pain at vaccines sites (missed school).
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Demyelination, Guillain-Barre syndrome, Laboratory test, Neuropathy peripheral
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Saliva analysis
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Convulsion, Demyelination, Dyspnoea, Gait disturbance
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gastrointestinal disorder, Guillain-Barre syndrome, Hair metal test abnormal, Hypophagia, Irritability
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Migraine, Neuropathy peripheral, Pain in extremity, Rash
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling face, Urine aluminium increased, Weight decreased, Wheelchair user
Clinical narrative: Information has been received from a consumer concerning her daughter a 22 year old patient with asthma who on 26-JUN-2007 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot not reported). Concomitant therapy included TOPAMAX. On approximately 29-JUN-2007 the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. After receiving her second dose of GARDASIL (Lot not reported) on 24-AUG-2007, all of her symptoms progressed extremely. She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She was experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. The doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an ER for a few hours but she was not admitted. Patient only received two doses of GARDASIL and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting 18-MAR-2009 the patient had not recovered from symptoms. Additional information has been requested. 5/11/10 Follow up: Loss of sensation in legs; complex/complicated migraine; Epileptic seizures, mini strokes (TIAs); Brain Fog; Chronic Fatigue; Malaisse; Blurred vision and sensitivity to light; GI tract issues. Uses a wheelchair and/or cuff crutches to get around. Patient has no quality of life-Needs assistance with menial tasks. Wears dark glasses.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: Didn't feel well - Nausea. Headache. Fatigue.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood culture negative, Differential white blood cell count abnormal, Haematocrit normal, Haemoglobin normal, Injection site cellulitis
Clinical narrative: (R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased, X-ray limb abnormal
Clinical narrative: (R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Dysstasia, Erythema, Full blood count normal, Injection site nodule
Clinical narrative: (R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Pain in extremity, Pyrexia, Red blood cell abnormality, Skin warm
Clinical narrative: (R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.
Age: 2.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: (R) thigh cellulitis (with question of osteomyelitis/deep abscess on x ray => referred to Pediatric Ortho at hospital to R/O above); fever.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Blood test, Choking, Dehydration, Dyskinesia
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and eye redness who on 04-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659437/1266U) intramuscularly. On 20-MAR-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U) intramuscularly and on 24-JUL-2008 the patient received the third dose of GARDASIL (Lot # 660620/0571X) intramuscularly. It was reported that approximately two months after receiving the third dose of GARDASIL the patient experienced a delayed anaphylactic allergic reaction. The reaction was described as being severe but there were no specific symptoms provided. It was reported that the anaphylactic reaction has been concurrent. The number of recurrent anaphylactic episodes was unspecified. The patient was seen at the emergency room following each episode and received intravenous fluids and epinephrine. The reporting physician considered the delayed anaphylactic allergic reaction to be other important medical event, life threatening and significantly disabling. A standard lot check investigation was performed for the Lot # 660387/1967U. 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 Biologics Evaluation and Research and was released. A standard lot check investigation was performed for the Lot # 660620/0571X. 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 Biologics Evaluation and Research and was released. A standard lot check investigation was performed for the Lot # 659437/1266U. 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 Biologics Evaluation and Research and was released. Follow-up information was received from the licensed practical nurse via phone call indicating that the patient's mother had called the office on 25-FEB-2009. The patient's mother reported that approximately two months after her daughter's last GARDASIL injection; she began having seizures and had an anaphylactic reaction. The mother told the office that the patient was being seen by an allergist. The licensed practical nurse had no other information to provide as they had not been following/treating the patient. It was also believed that the patient may have moved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Hypersensitivity, Oedema peripheral, Rash, Tremor
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and eye redness who on 04-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot # 659437/1266U) intramuscularly. On 20-MAR-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U) intramuscularly and on 24-JUL-2008 the patient received the third dose of GARDASIL (Lot # 660620/0571X) intramuscularly. It was reported that approximately two months after receiving the third dose of GARDASIL the patient experienced a delayed anaphylactic allergic reaction. The reaction was described as being severe but there were no specific symptoms provided. It was reported that the anaphylactic reaction has been concurrent. The number of recurrent anaphylactic episodes was unspecified. The patient was seen at the emergency room following each episode and received intravenous fluids and epinephrine. The reporting physician considered the delayed anaphylactic allergic reaction to be other important medical event, life threatening and significantly disabling. A standard lot check investigation was performed for the Lot # 660387/1967U. 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 Biologics Evaluation and Research and was released. A standard lot check investigation was performed for the Lot # 660620/0571X. 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 Biologics Evaluation and Research and was released. A standard lot check investigation was performed for the Lot # 659437/1266U. 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 Biologics Evaluation and Research and was released. Follow-up information was received from the licensed practical nurse via phone call indicating that the patient's mother had called the office on 25-FEB-2009. The patient's mother reported that approximately two months after her daughter's last GARDASIL injection; she began having seizures and had an anaphylactic reaction. The mother told the office that the patient was being seen by an allergist. The licensed practical nurse had no other information to provide as they had not been following/treating the patient. It was also believed that the patient may have moved. Additional information has been requested.