chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Haematology test normal, High density lipoprotein increased, Hot flush, Immunology test normal, Infectious mononucleosis
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Joint swelling, Laboratory test normal, Memory impairment, Metabolic function test
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Metabolic function test normal, Musculoskeletal pain, Nervous system disorder, Pain, Plantar fasciitis
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Platelet count normal, Sinus disorder, Thyroid function test normal, Weight increased, X-ray abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced arthralgia, fatigue, pain, swollen joint, walking difficulty, decrease hand grasp, back pain, sinus problems, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information in the form of medical records was received on 22 September 2008. Medical history noted by the subject included recurring flu, asthma, frequent pneumonia, anaphylactic shock to penicillin and vomiting with codeine. Also mentioned was a small lump in the left breast (cyst-date no specified). An x-ray of the right hip and pelvis due to chronic pain performed on 07 February 2005 was unremarkable. An x-ray of the right knee performed on the same date showed narrowing of the medial compartment of the knee joint and was otherwise unremarkable. It was documented that the subject uses NASOCORT for sinus problems. In the course of review of medical records, it was noted that the subject was at some point diagnosed with reflux and was given PRILOSEC as treatment. This was not indicated as an adverse event at this time. The PRILOSEC seemed to improve the subjects symptoms. Also in the course of review, it was noted that the subjects hearing was tested on 26 February 2008 and found to be at normal thresholds. An exam dated 11 February 2008 for nasal problems noted hearing loss, chronic otitis externa, allergic rhinitis and rhinitis medicamentosa, but did not indicate these specifically as events or related symptoms to claimed events. Follow up information was received on 07 November 2008 via an interview between lawyers and the subject. The subject received the first and second doses of LYMERIX on 16 May 2001 and 13 June 2001. In May 2001, she developed joint pain. In June 2001, she developed fatigue and flu-like symptoms. In 2001 she experienced forgetfulness and hot flashes. In 2005 she developed bursitis, dyslexia, and mononucleosis. In 2006/2007, she was diagnosed with plantar fasciitis. On unspecified dates she experienced depression and weight gain. Treatment included glucosamine chondroitin, ALEVE, cortisone, clonazepam, and CELEXA. Dyslexia was assessed by GSK to be medically significant. With the exception of flu-like symptoms and mononucleosis, the events were unresolved at the time of reporting.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Blood culture, Culture urine, Full blood count, Laboratory test, Pyrexia
Clinical narrative: 1 year shots administered approx 1 PM 11/18/07. URI symptoms, weak prior, resolved. Parents brought child back to clinic 11/19/08 with fever 104.5. Onset of fever approx 5-6 PM on 11/18/08. Non-focal exam on presentation with exception of fever. Tachycardia 190-200 BPM. Tachycardia resolved with fever reduction. 11/20/08-records received for DOS 11/19/08-presented to acute care clinic with fever x1 day. Received vaccines around 2pm and at 6-7 pm developed high fevers max of 104 at home. Decreased PO intake since last night. Three episodes of emesis. Fussiness, tachycardia, drenching sweats, increased sleepiness and nasal drip, rhinorrhea, constipation. An incident like this has never happened before with other vaccinations. URI.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Tachycardia
Clinical narrative: 1 year shots administered approx 1 PM 11/18/07. URI symptoms, weak prior, resolved. Parents brought child back to clinic 11/19/08 with fever 104.5. Onset of fever approx 5-6 PM on 11/18/08. Non-focal exam on presentation with exception of fever. Tachycardia 190-200 BPM. Tachycardia resolved with fever reduction. 11/20/08-records received for DOS 11/19/08-presented to acute care clinic with fever x1 day. Received vaccines around 2pm and at 6-7 pm developed high fevers max of 104 at home. Decreased PO intake since last night. Three episodes of emesis. Fussiness, tachycardia, drenching sweats, increased sleepiness and nasal drip, rhinorrhea, constipation. An incident like this has never happened before with other vaccinations. URI.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: From 10/30/2008 to 11/18/2008 - severe joint pain- head to toe.  No fever hurt to walk. Resolved 11/18/2008 on own- No missed work.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: From 10/30/2008 to 11/18/2008- severe joint pain- head to toe.  No fever- painful to even walk.  Resolved on own 11/18/2008 AM.  No missed work.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: After receiving the full vaccine the patient experienced increased pain, swelling and numbness to right arm. Pt was seen through the ER-given IM-Benadryl and PO-Vicodin. Pt did have a fever at the time of ER visit.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain
Clinical narrative: Patient came in with complaints of a pain under right armpit, began at 10:00AM. Pain is a 3-4 on a 1-10 pain scale. No swelling, redness or lymphadema noted. Patient instructed to take either Tylenol or Ibuprofen if needed. Call with any problems.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Rt thigh 5.5 x 3.5 cm erythema- mild tenderness increased warmer. Lt thigh -1 circle.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia, Somnolence, Tremor
Clinical narrative: After about 15-20 min of getting a flu shot, she felt dizzy & light headed.  She sat down on the chair and experienced tingling sensation all over her body.  Tremor in her hands & drowsiness.  I called 911 and have medics check her out as precautionary measure.  Later, they took her to the hospital for further tests.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect drug dosage form administered, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site. The event was reported by the provider because the MA giving the vaccines mixed the MENACTRA and the DTaP in the same syringe. She was "re-educated". so it will not happen again. The practice has arranged fpr the child to be revaccianted with both vaccines, at no cost to the patient. They advised BENADRYL and ice for the swelling.
Age: 36.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood creatinine normal, Blood urea normal, Liver function test abnormal
Clinical narrative: Hives, hand swelling, myalgias, joint pain.
Age: 36.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Myalgia, Oedema peripheral, Urticaria
Clinical narrative: Hives, hand swelling, myalgias, joint pain.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Chills, Fatigue, Headache
Clinical narrative: TC from patient 4:45 pm, 11/18/2008. States received AFLURIA on 11/17/2008 off site clinic. Complains of headache, chills, fatigue, and loss of appetite. Recommended patient go to physician, patient refuses.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Reported: "Half-dollar" raised, felt like areas of erythema at both injection sites.  "Extremely sore arms", "unable to touch" - entire arm sore.  "Sick" for 1 week after injection - low grade fever.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Chest discomfort, Dizziness, Dyspnoea, Nausea
Clinical narrative: Began to note shortness of breath and chest tightness, some dizziness.  No treatment sought.  Rested.  Some nausea, lack of appetite.  Symptoms gradually resolved today.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Ct. given BOOSTRIX (Tdap) instead of ADACEL Tdap). BOOSTRIX is approved for use thru 18yrs old. No adverse effects reported. Medication errors.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pyrexia
Clinical narrative: Patient in today with left upper arm deltoid swelling approximately 80 mm's.  Painful to touch.  Reports temp 101 last pm.  Today 11:00 am 98.9.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Patient passed out and had two seizure like episodes about 1 minute and 3 minutes after immunizations.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Lacrimation increased, Lip swelling, Pain, Rhinorrhoea
Clinical narrative: Received flu vaccine for 1st time ever on 10/18/08 at 10am. By afternoon had runny nose, eyes watering, difficulty swallowing, aches and lip swelling. Seen in our ER at 17:38 for allergic prescription. Given BENADRYL, SOLU MEDROL and PEPCID and discharged. Better by 10/19/08.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Presyncope
Clinical narrative: The patient felt faint and reported almost passing out. EMS was called and evaluated the patient. EMS after monitoring the patient and consulting with an ER physician allowed the patient to go home.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Intolerable pain (R) arm since 9PM of day of vaccine. Unable to move arm for 3-4days. Physical Therapy stated 8 days after injection. Pain continues today.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Local swelling, Pain, Pyrexia
Clinical narrative: Fever up to 103 deg F started about 48 hrs after shot given. (Flu shot). Swollen and achy neck body aches and chills. Lasted 3 days. Fever 103 deg. for on whole day. Then 101 deg for 2 days.
Age: 28.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, soreness in arms and legs.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Ear discomfort, Eye discharge, Ocular hyperaemia, Paraesthesia oral
Clinical narrative: Runny nose, burning ears, reddened eyes, mattery eyes, throbbing lips, hives, angioedema.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Runny nose, burning ears, reddened eyes, mattery eyes, throbbing lips, hives, angioedema.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test, Blood immunoglobulin G, Blood immunoglobulin M, Pyrexia, Rash generalised
Clinical narrative: Patient received MMR and Varivax 11-7-08.  Developed body rash 11-15-08 pm and became generalized maculopapular and developed fever 11-17-08.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Patient received MMR and Varivax 11-7-08.  Developed body rash 11-15-08 pm and became generalized maculopapular and developed fever 11-17-08.
Age: 23.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, No reaction on previous exposure to drug, Urine human chorionic gonadotropin negative
Clinical narrative: SM unaware that she was pregnant at the time she received her MMR inoculation. This is not a follow-up to the previously submitted VAERS report 332837. This is actually a second, repeat episode of inadvertent receipt of MMr on 03/05/2010, early in her second pregnancy. Once again, the SM states she did not know she was pregnant when she received a second dose of MMR on (03/05/10). Her current pregnancy was confirmed by a positive serum HCG test on 03/25/2010. The SM denies any sequelae or adverse event following the first episode of inadvertent receipt of the MMR (08/18/2008), during her 1st pregnancy. She delivered a normal, healthy infant at 38 weeks gestation in April of 2009. Her labor was induced due to low amniotic fluid. She currently denies any spotting, bleeding, pelvic pain or contractions with her second pregnancy. She is currently at 7 weeks gestatio. Her LMP was 01/29/2010 and her estimated date of delivery (EDD) is 11/05/2010. Her primary care manager is aware of the SM's second episode of inadvertent MMR immunization during early gestation.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Joint stiffness, Malaise, Pyrexia, Rash pustular
Clinical narrative: 1 week post vaccination pustule formation across chest, malaise, joint pain/ stiffness. (101F)
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Approximately 7mm on left arm.  Left arm swollen, warm to touch and area is red and itching.  Advised to apply ice pack and take Ibuprofen as needed, follow up with private MD if no change by 11-21-08.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Dehydration, Hypertension, Vertigo
Clinical narrative: Had Shingles vaccine at my doctor's office - two days later (Aug 15) started feeling ill and dehydrated. Admitted to hospital on Aug 24th with runaway high blood pressure and extreme vertigo. Hospitalized for 2 days.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dehydration, Hypertension, Malaise, Vertigo
Clinical narrative: Had Shingles vaccine at my doctor's office - two days later (Aug 15) started feeling ill and dehydrated. Admitted to hospital on Aug 24th with runaway high blood pressure and extreme vertigo. Hospitalized for 2 days.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Facial pain, Facial palsy, Hypoaesthesia facial, Neurological examination, Similar reaction on previous exposure to drug
Clinical narrative: 11/7/08 pt complained of tingling of her tongue over the past week, Woke up this AM, cannot smile, taste or completely close (L) eye. Pt's mother concerned because HPV and HEP A given 11/16/08. Doctor documented pt with cold sores (L) corner of her mouth. Pt was diagnosed Bell's Palsy with and placed on PREDNISONE 40mg for 7 days, ACYELAVIR 20mg for 7 days and pt was to return to clinic in 1 week for a follow-up.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Oral herpes, Paraesthesia oral
Clinical narrative: 11/7/08 pt complained of tingling of her tongue over the past week, Woke up this AM, cannot smile, taste or completely close (L) eye. Pt's mother concerned because HPV and HEP A given 11/16/08. Doctor documented pt with cold sores (L) corner of her mouth. Pt was diagnosed Bell's Palsy with and placed on PREDNISONE 40mg for 7 days, ACYELAVIR 20mg for 7 days and pt was to return to clinic in 1 week for a follow-up.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Facial paresis, Oral herpes, Paraesthesia
Clinical narrative: 11/7/08 pt complained of tingling of her tongue over the past week, Woke up this AM, cannot smile, taste or completely close (L) eye. Pt's mother concerned because HPV and HEP A given 11/16/08. Doctor documented pt with cold sores (L) corner of her mouth. Pt was diagnosed Bell's Palsy with and placed on PREDNISONE 40mg for 7 days, ACYELAVIR 20mg for 7 days and pt was to return to clinic in 1 week for a follow-up.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Paraesthesia oral
Clinical narrative: 11/7/08 pt complained of tingling of her tongue over the past week, Woke up this AM, cannot smile, taste or completely close (L) eye. Pt's mother concerned because HPV and HEP A given 11/16/08. Doctor documented pt with cold sores (L) corner of her mouth. Pt was diagnosed Bell's Palsy with and placed on PREDNISONE 40mg for 7 days, ACYELAVIR 20mg for 7 days and pt was to return to clinic in 1 week for a follow-up.
Age: 36.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Musculoskeletal pain, Neck pain, Urticaria
Clinical narrative: Initial report was received from a health care professional on 07 November 2008. A 36-year-old male patient with an unknown medical history, had received an intramuscular left deltoid injection of TYPHIM VI, lot number B0347-2, and a subcutaneous left upper arm injection of YF VAX, lot number UF305AA, and a first dose right deltoid intramuscular injection of Hepatitis A (manufactured by GSK), lot number AHAVB251BA on 23 October 2008 and eight days later, he developed widespread hives and severe pain in his neck and shoulders. The patient was evaluated in the emergency room and prescribed PREDNISONE. Concomitant medications included LAMISIL. The reporter followed-up with the patient (date not specified), at which time, the patient indicated the pain was still present to a lesser degree, however hives were still occurring. The patient's recovery status was reported as unknown at the time of the report. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Ultrasound scan abnormal
Clinical narrative: Information has been received from a health professional, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who in September 2008, was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient was pregnant.  The LMP was 22-AUG-2008.  On 13-NOV-2008, at the 12 weeks of pregnancy, ultrasound showed fetal demise.  The outcome of the patient's experience was unknown.  Upon internal review, fetal demise was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyskinesia, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of GARDASIL 0.5 mL on unspecified date. "Recently" the patient experienced faint and had a "jerky moment" that was "seizure like". On the same day the patient recovered. The patient sought unspecified medical attention. The doctor said that the vaccine was given by her OB doctor. Upon internal review, the seizure-like was determined to be an Other Important Medical Event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Full blood count, Pain in extremity, Platelet count increased
Clinical narrative: Information has been received from a medical assistant concerning a female patient with penicillin and sulfonamide allergy, ACE-I, HYTRIN and CATAPRESS patches allergy and a history of chronic obstructive pulmonary disease, hypertension, arthritis and CVA (stroke). The medical assistant reported that on 07-NOV-2008, the patient was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, intramuscularly. Concomitant therapy included verapamil, vitamins (unspecified), COVERA-HS, lorazepam and FLONASE. On the weekend of 08-NOV-2008, the patient developed cellulitis of the whole arm with warm, redness and pain. The patient went to the emergency room on 08-NOV-2008 and was treated with IV ROCEPHIN and DARVOCET. Subsequently, the patient was sent home with a prescription for KEFLEX and followed-up on 10-NOV-2008 and she still had symptoms, including pain, warmth and itching on the affected arm. It was also reported that the patient had elevated platelets. The patient sought medical attention and was seen by the physician. At the time of this report, the patient is recovering. This is one of several reports from the same source. A lot check has been requested by the medical assistant's office. The medical assistant considered the patient's events to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a female patient with penicillin and sulfonamide allergy, ACE-I, HYTRIN and CATAPRESS patches allergy and a history of chronic obstructive pulmonary disease, hypertension, arthritis and CVA (stroke). The medical assistant reported that on 07-NOV-2008, the patient was vaccinated with PNEUMOVAX 23 (Lot #662100/0742X), 0.5ml, intramuscularly. Concomitant therapy included verapamil, vitamins (unspecified), COVERA-HS, lorazepam and FLONASE. On the weekend of 08-NOV-2008, the patient developed cellulitis of the whole arm with warm, redness and pain. The patient went to the emergency room on 08-NOV-2008 and was treated with IV ROCEPHIN and DARVOCET. Subsequently, the patient was sent home with a prescription for KEFLEX and followed-up on 10-NOV-2008 and she still had symptoms, including pain, warmth and itching on the affected arm. It was also reported that the patient had elevated platelets. The patient sought medical attention and was seen by the physician. At the time of this report, the patient is recovering. This is one of several reports from the same source. A lot check has been requested by the medical assistant's office. The medical assistant considered the patient's events to be other important medical events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (Lot # 660717/0224X, exp. date: 11-SEP-2009) and developed injection site reactions. The pharmacist stated that the reactions included joint pain and immobility and were "over and beyond soreness". The pharmacist reported that he was not sure if it was the first or the second dose for the patient. The registered nurse reported that the reactions that the patient experienced were severe and the patient was hospitalized due to the reaction. A lot check has been requested by the registered nurse. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: Information has been received from a 69 year old female patient concerning herself. The patient has sulfonamide allergy and was still hospitalized for an unspecified reason when on 03-NOV-2008 was vaccinated with PNEUMOVAX 23 (Lot#), 0.5ml (unspecified route). Concomitant therapy included analgesic (unspecified names and manufacturers) and omega-3 marine triglycerides. The consumer reported that about three or four hours after receiving the vaccine, she could not lift, move, put weight on her arm and was in a lot of pain. The consumer also reported that she had a fever and it felt like she had paralysis. The patient reported that this experience lasted for two days, but she is still experiencing pain in her shoulder and some pain in her fingers. The patient sought unspecified medical attention. Upon internal review paralysis was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Enema administration, Haematochezia, Intussusception
Clinical narrative: Information has been received from a health professional concerning an 8 week old male who was entered in a study. In approximately 2007, the patient was vaccinated PO with the first dose of ROTATEQ. It was reported that 21 days post-vaccination, the patient presented with dark bloody stools and crampy abdominal pain. The patient was hospitalized and referred for a surgical evaluation to rule out intussusception. An air enema revealed an ileocolic intussusception which was reduced. The patient was discharged "well" on "day 2". The reporting investigator considered intussusception to be an other important medical event. No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male with a latex allergy to "latex"  who on 05-NOV-2008 was vaccinated with ZOSTAVAX (lot #663198/1419X), 0.65ml, subcutaneously into the left arm.  3-4 days after vaccination the patient developed pain in his left leg and difficulty walking.  The patient's pain in left leg and difficulty walking persisted.  Unspecified medical attention was sought.  Pain in left leg and difficulty walking were considered by the reporter to be disabling.  Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Exercise electrocardiogram
Clinical narrative: Elevated ST's on EKG.  Mild chest pain 4 wks post immunization, worried, but had personalized level for next 3 conceal months.  Recurrent pain NDV/CE when he tired to run.  11/25/08 Reviewed hospital medical records of 11/11-11/12/2008. FINAL DX:probable post-vaccinal smallpox immunization myopericarditis; atypical chest pain secondary to #1; possible GERD. Records reveal patient experienced retrosternal chest pain while running w/radiation to left shoulder & slight dizziness.  Pain resolved w/rest.  Reported he had similar chest pain in past.  Became fatigued w/insomnia, generally weak, dyspneic, increased thirst, nasal stuffiness, anorexia, heartburn.  Admitted to ICU for monitoring.  Tx w/NSAIDS & antacids.  Responded well & d/c to be medevaced stateside for recovery.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: Severe pain and limitation in movement in upper right arm and shoulder. Pain has slowly decreased over a period of 2 weeks and range of motion is improving. Patient sought care at a hospital and was given pain medication and recommended for physical therapy.  10/24/08 ER record dated 10/31/08 received with DX: Calcific Tendonitis. Pt presnted with 9 day hx of shoulder pain since receiving flu shot.  PE (+) for tenderness, limited ROM, and weak arm abduction past 90'.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: Severe pain and limitation in movement in upper right arm and shoulder. Pain has slowly decreased over a period of 2 weeks and range of motion is improving. Patient sought care at a hospital and was given pain medication and recommended for physical therapy.  10/24/08 ER record dated 10/31/08 received with DX: Calcific Tendonitis. Pt presnted with 9 day hx of shoulder pain since receiving flu shot.  PE (+) for tenderness, limited ROM, and weak arm abduction past 90'.
Age: 1.3
Sex: F
Vaccine: FLU3, MMR
Symptoms: CSF culture negative, Convulsion, Culture urine positive, Endotracheal intubation, Full blood count normal
Clinical narrative: Approx 24 hrs after immunization had prolonged (15 min) afebrile, generalized seizure required meds, intabatin, ICU admission. 12/8/08-records received for DOS 11/13/08-presented to ED with C/O multiple seizures. Tonice-clonic seizure and multipe seizure per EMS. Unarousable. Intubated. DX: Status epilepticus. UTI. transferred.  1/23/09-records received for DOS 11/13-11/14/08-DC DX:New onset afebrile seizure. Post-ictal and intubated due to deteriorating mental status and poor airway protection. Agitated, vomited. Subsequently extubated. Sleepier day of vaccination.
Age: 1.3
Sex: F
Vaccine: FLU3, MMR
Symptoms: Metabolic function test normal
Clinical narrative: Approx 24 hrs after immunization had prolonged (15 min) afebrile, generalized seizure required meds, intabatin, ICU admission. 12/8/08-records received for DOS 11/13/08-presented to ED with C/O multiple seizures. Tonice-clonic seizure and multipe seizure per EMS. Unarousable. Intubated. DX: Status epilepticus. UTI. transferred.  1/23/09-records received for DOS 11/13-11/14/08-DC DX:New onset afebrile seizure. Post-ictal and intubated due to deteriorating mental status and poor airway protection. Agitated, vomited. Subsequently extubated. Sleepier day of vaccination.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Itchy rash beginning on 10/28/08 progressively getting worse + face, upper ext. trunk and small amount right thigh 11/3/08 in clinic.  Rash red, slightly raised.  Reports itches.  Plans to see private MD today.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Loss of consciousness
Clinical narrative: After receiving the vaccine, patient left the clinic room, walked to the reception area and passed out onto the floor.  He was "out" for only about 1 minute.
Age: 0.4
Sex: U
Vaccine: VARCEL
Symptoms: Blood immunoglobulin M, Drug exposure during pregnancy, Rash, Skin lesion
Clinical narrative: Mother received VARIVAX on 9-27-2008 around birth of child. Mom broke out with 2-3 lesions1 week later. Child broke out chicken pox rash 3 weeks later. child's mother at 5 weeks of age. Mom had rash, left wrist and center back.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Had immunizations on 11-18-08.  Came into office on 11-19-08 with rash that "looked" like insect bites all over body.  No fever.  Treated with Zyrtec.  Dx: Urticaria vs.
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: Mom went to ER because daycare called mom on 11-19-08 because child c/o hives and wheezing.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever105 ~ 24 degrees after immunizations.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Haematochezia
Clinical narrative: 2 episodes of streaks of blood in stool on 10/08/08.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Hard lump approx 1 1/4" diameter noted under site of injection next day. Over next several days developed 4 1/4" x 3 1/4" Dark red vesicular area R upper arm. Area is very warm, itchy and tender.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Hard lump approx 1 1/4" diameter noted under site of injection next day. Over next several days developed 4 1/4" x 3 1/4" Dark red vesicular area R upper arm. Area is very warm, itchy and tender.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Fall, Head injury, Skeletal injury, Syncope
Clinical narrative: Syncope, resulting in fall, blow to head with contusion: blow to ribs with contusion. ER visit.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope vasovagal
Clinical narrative: Syncope, resulting in fall, blow to head with contusion: blow to ribs with contusion. ER visit.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1005-Flu vaccine given. 1330-hives noted 1400-Benadryl given Benadryl repeated at 2000 and 0800, 1400, and 2000 on 10/29/2008
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Allergy to vaccine, Drug hypersensitivity, Food allergy, Irritability
Clinical narrative: 1115-FLUZONE given; 1130 child developed hives and fussiness;1140-epinephrine given, MD notified; 1152-prednisolone 10 mg given, continued twice daily for 3days.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1115-FLUZONE given; 1130 child developed hives and fussiness;1140-epinephrine given, MD notified; 1152-prednisolone 10 mg given, continued twice daily for 3days.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: Pt's wife mentioned that her husband was hospitalized 1 month after receiving flu shot and that the neurologist thought that it might be Guillain-Barre Syndrome and that it may be from the flu shot. We have not spoken to the doctor. Wife has come in a few times afterwards but has not mentioned anything else. 1/29/2010 Patient had found out later he had had a stroke in his spinal cord. They ruled out the flu shot as being the course of paralysis. He has since passed away due to complications from sepsis.  3/9/09 Received hospital medical records of 11/13/2008-11/25/2008 FINAL DX: No d/c summary available.  Recent onset paraplegia; spinal vascular malformation, unlikely GBS. Records reveal patient experienced s/s as noted above including progressive parapesis, sensory loss & bowel/bladder dysfuntion, paraplegia T8 & had been transferred from outlying hospital.  Admitted to ICU & continued on steroids.  Neuro, Neurosurg, Medicine, Heme, Nephro & Uro consults done.  12/11/08 Reviewed hospital medical records of 10/29-11/7/08. FINAL DX: Guillain Barre syndrome; paraplegia; atrial fib; ileus; urinary retention. Records reveal patient experienced Gi symptoms & URI approx 1 wk prior to admit.  On admit had LE numbness & weakness, areflexia. Neuro & cardio consults done. Tx w/plasmapheresis.  Transferred to inpatient rehab.  Worsened & returned to acute care 11/10 for further treatment & evaluation.  1/23/09 Reviewed hospital medical records of 11/9-11/12/2008. FINAL DX: paraplegia perhaps secondary to some spinal cord hemorrhage Records reveal patient experienced initial leg weakness that rapidly progressed to complete paralysis which had been dx as GBS.  Pt had been transferred to rehab where neurologists felt presentation atypical for GBS & repeated MRI which revealed possible bony metatases & spinal cord abnormality.  Readmitted to acute care where exam revealed complete paralyisis & anesthesis from waist down w/loss of bowel & bladder control.  Transferred to higher level of care.
Age: 62.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Tetnus on 11/13/08.  By 11/15/08 had baseball size red warm, puffy site reaction plus a trunk rash (which he gets every time he's sick).  On 11/16/08 inject site normal but 3'' cellulitus fluid area noted above anticubitul everything normal by 11-19-08.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Bright red rash over injection site, itching x 1 wk. Benadryl.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Given MENACTRA 11/12/08 Left upper arm swelling redness itchy and painful 11/13/08 worsening. Took BENADRYL and MOTRIN, induration 12 x 11 cm. 11/14/08 return with induration 22 x 20 cm.
Age: 13.0
Sex: F
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Blood glucose normal, Contusion, Gait disturbance, Head injury, Oxygen saturation normal
Clinical narrative: 13 year old received vaccines above. Initially seemed well, patient then stood up while stumbling. Vaccinated. Nursing stopped the report hearing that patient on the ground. Patient hit head. Contusion.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Diarrhoea, Dizziness, Injected limb mobility decreased, Injection site pain
Clinical narrative: Received flu vaccine in left arm and TDAP in right arm. Developed increasing Rt upper arm, Rt upper back and neck pain over subsequent couple days. Developed fever to 102 degrees F, diarrhea and nausea, dizziness. Eventually had trouble abducting rt arm and moving neck. Fever, diarrhea, nausea, and dizziness resolved.
Age: 20.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: Received flu vaccine in left arm and TDAP in right arm. Developed increasing Rt upper arm, Rt upper back and neck pain over subsequent couple days. Developed fever to 102 degrees F, diarrhea and nausea, dizziness. Eventually had trouble abducting rt arm and moving neck. Fever, diarrhea, nausea, and dizziness resolved.
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Autoimmune disorder, Blindness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included iritis, macular edema and visual disorder. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). This case was reported via medical records forwarded by a lawyer and described the occurrence of unspecified adverse event(s) in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received unspeciifed dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced unspecified adverse event (s). At the time of reporting the outcome of the event (s) was unspecified. Follow up information was received on 13 November 2008 via a statement of injuries. At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, vision loss, hearing loss, eye pain, headache, fatigue, possibly memory loss, and decreased activities of daily life impaired. He also experienced rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX, including but not limited to those set forth above. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Cognitive disorder, Deafness, Eye pain, Fatigue, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included iritis, macular edema and visual disorder. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). This case was reported via medical records forwarded by a lawyer and described the occurrence of unspecified adverse event(s) in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received unspeciifed dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced unspecified adverse event (s). At the time of reporting the outcome of the event (s) was unspecified. Follow up information was received on 13 November 2008 via a statement of injuries. At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, vision loss, hearing loss, eye pain, headache, fatigue, possibly memory loss, and decreased activities of daily life impaired. He also experienced rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX, including but not limited to those set forth above. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.