chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Paraesthesia
Clinical narrative: Initial non-serious report received from the patient on 17 September 2007.  A 27-year-old male patient with no reported medical history had received a dose of Menactra (Lot number, route and site not reported) on 12 September 2007. Two days post vaccination, the patient developed a tingling sensation in his right foot. On 15 September 2007, the patient developed a tingling sensation throughout his body. It was reported that the patient also had erectile dysfunction. The patient was seen in the Emergency Room on 14 September 2007, was treated and released. Recovery status was reported as 'not recovered'. No additional information had been provided at the time of this report. Follow-up information received 25 October 2007. The patient received a first intramuscular left deltoid injection of Menactra (lot number U2327AA) on 12 September 2007 and 48 hours post vaccination, he developed tingling of the right foot and a feeling of coldness in the right foot. It was reported that a few hours later, the patient also described the same symptoms in his right arm. There was no weakness and the patient denied numbness. Within five hours of symptom onset, the patient had a completely normal neurologic exam. The patient reported that the symptoms completely resolved by 19 September 2007.
Age: 27.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Erectile dysfunction, Paraesthesia
Clinical narrative: Initial non-serious report received from the patient on 17 September 2007.  A 27-year-old male patient with no reported medical history had received a dose of Menactra (Lot number, route and site not reported) on 12 September 2007. Two days post vaccination, the patient developed a tingling sensation in his right foot. On 15 September 2007, the patient developed a tingling sensation throughout his body. It was reported that the patient also had erectile dysfunction. The patient was seen in the Emergency Room on 14 September 2007, was treated and released. Recovery status was reported as 'not recovered'. No additional information had been provided at the time of this report. Follow-up information received 25 October 2007. The patient received a first intramuscular left deltoid injection of Menactra (lot number U2327AA) on 12 September 2007 and 48 hours post vaccination, he developed tingling of the right foot and a feeling of coldness in the right foot. It was reported that a few hours later, the patient also described the same symptoms in his right arm. There was no weakness and the patient denied numbness. Within five hours of symptom onset, the patient had a completely normal neurologic exam. The patient reported that the symptoms completely resolved by 19 September 2007.
Age: 27.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Erectile dysfunction, Feeling cold, Neurological examination normal, Paraesthesia
Clinical narrative: Initial non-serious report received from the patient on 17 September 2007.  A 27-year-old male patient with no reported medical history had received a dose of Menactra (Lot number, route and site not reported) on 12 September 2007. Two days post vaccination, the patient developed a tingling sensation in his right foot. On 15 September 2007, the patient developed a tingling sensation throughout his body. It was reported that the patient also had erectile dysfunction. The patient was seen in the Emergency Room on 14 September 2007, was treated and released. Recovery status was reported as 'not recovered'. No additional information had been provided at the time of this report. Follow-up information received 25 October 2007. The patient received a first intramuscular left deltoid injection of Menactra (lot number U2327AA) on 12 September 2007 and 48 hours post vaccination, he developed tingling of the right foot and a feeling of coldness in the right foot. It was reported that a few hours later, the patient also described the same symptoms in his right arm. There was no weakness and the patient denied numbness. Within five hours of symptom onset, the patient had a completely normal neurologic exam. The patient reported that the symptoms completely resolved by 19 September 2007.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Rash vesicular, Tenderness
Clinical narrative: Information has been received from a physician concerning an 87 year old female with no allergies who on 01-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck). There was no concomitant medication. In October 2007, after vaccination the patient developed shingles and itching at the injection site. The patient did not report this rash to the office until 23-OCT-2007 when she came into the office for a flu vaccination. The chart notes by the physician stated that the patient had a 2 cm shingles like rash with vesicles, redness and mild tenderness. The patient was treated with famciclovir (FAMVIR). No diagnostic laboratory tests were undertaken. The patient's experiences were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site pruritus, Tenderness
Clinical narrative: Information has been received from a physician concerning an 87 year old female with no allergies who on 01-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck). There was no concomitant medication. In October 2007, after vaccination the patient developed shingles and itching at the injection site. The patient did not report this rash to the office until 23-OCT-2007 when she came into the office for a flu vaccination. The chart notes by the physician stated that the patient had a 2 cm shingles like rash with vesicles, redness and mild tenderness. The patient was treated with famciclovir (FAMVIR). No diagnostic laboratory tests were undertaken. The patient's experiences were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, UNK, HPV4, MEN
Symptoms: Ataxia, Azotaemia, Blood creatinine increased, Blood urea increased, Diplopia
Clinical narrative: Information has been received from a physician concerning a female, approximately 12 years old, who was vaccinated with the first dose of Gardasil. At that time, she was administered an unspecified meningitis vaccination in a different body location. Subsequently the patient was hospitalized for 2 weeks with swelling of the brain. The patient was discharged from the hospital and had residual double vision. She was scheduled to see an ophthalmologist. The patient was "recovering". Brain swelling with residual double vision were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, UNK, HPV4, MEN
Symptoms: Leukoencephalomyelitis, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from a physician concerning a female, approximately 12 years old, who was vaccinated with the first dose of Gardasil. At that time, she was administered an unspecified meningitis vaccination in a different body location. Subsequently the patient was hospitalized for 2 weeks with swelling of the brain. The patient was discharged from the hospital and had residual double vision. She was scheduled to see an ophthalmologist. The patient was "recovering". Brain swelling with residual double vision were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, UNK, HPV4, MEN
Symptoms: Brain oedema, Diplopia
Clinical narrative: Information has been received from a physician concerning a female, approximately 12 years old, who was vaccinated with the first dose of Gardasil. At that time, she was administered an unspecified meningitis vaccination in a different body location. Subsequently the patient was hospitalized for 2 weeks with swelling of the brain. The patient was discharged from the hospital and had residual double vision. She was scheduled to see an ophthalmologist. The patient was "recovering". Brain swelling with residual double vision were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, UNK, HPV4, MEN
Symptoms: Chest X-ray normal, Computerised tomogram normal, Diplopia, Encephalopathy, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a female, approximately 12 years old, who was vaccinated with the first dose of Gardasil. At that time, she was administered an unspecified meningitis vaccination in a different body location. Subsequently the patient was hospitalized for 2 weeks with swelling of the brain. The patient was discharged from the hospital and had residual double vision. She was scheduled to see an ophthalmologist. The patient was "recovering". Brain swelling with residual double vision were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, UNK, HPV4, MEN
Symptoms: Glioma, Meningitis, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a female, approximately 12 years old, who was vaccinated with the first dose of Gardasil. At that time, she was administered an unspecified meningitis vaccination in a different body location. Subsequently the patient was hospitalized for 2 weeks with swelling of the brain. The patient was discharged from the hospital and had residual double vision. She was scheduled to see an ophthalmologist. The patient was "recovering". Brain swelling with residual double vision were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood culture, Diarrhoea, Dizziness postural
Clinical narrative: Severe myalgias and arthralgias, fever (101.5) and diarrhea (brief and transient.  Myalgias and arthralgias were severe.  Orthostasis.  Onset of symptoms within a few hours of vaccine.  No local reaction at injection site.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Full blood count normal, Metabolic function test normal, Myalgia, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Severe myalgias and arthralgias, fever (101.5) and diarrhea (brief and transient.  Myalgias and arthralgias were severe.  Orthostasis.  Onset of symptoms within a few hours of vaccine.  No local reaction at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Pain in extremity
Clinical narrative: Five days after admin. of Flu Vaccine, I very suddenly developed extreme joint pain in my knee (was nearly unable to walk up stairs), which lasted 3 days, and then disappeared over-night.  Pain then developed in my shoulder joint.  It continues, though it seems to be very gradually improving.  My grandson has had a very similar event:  He is 3 years old and developed over-night(two days after the vaccine injection)such extreme pain in his leg/knee joint that he could/would not walk on his leg.  He also had arm pain, though not as extreme.  Because this had happened to me, my daughter waited to take him to the pediatritian.  However, it did not resolve, and after six days, he did see the MD.  She evaluated/drew labs, etc, and stated their practice had seen two other children with the same events.  One who actually was hospitalized.  Once again...overnight the pain disappeared, however it has now moved to his other leg, though it is less severe.  His pediatritian stated she felt it was probably a reaction to the thimerosol in the vaccine, and that he should never have another flu shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a female who on 11-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included unspecified antibiotics for an unspecified reason. Subsequently the patient experienced a shingles rash. The patient was seen by the physician. At the time of the report the patient was recovering. No further information was provided. There was no product quality complaint involved. Follow up information from the physician indicated that the patient who had allergies to sulfa, grass and dust, was vaccinated on 11-SEP-2007. On 12-SEP-2007 the patient saw podiatry for an unspecified reason and was treated with cephalexin (KEFLEX) x 10 days. Then on 24-SEP-2007 the patient was treated with levofloxacin (LEVAQUIN) x 7 days as well as a dose of fluconazole (DIFLUCAN) for an unspecified reason. The patient was also treated with famciclovir (FAMVIR) x 7 days. On 01-OCT-2007 the patient presented to the office with complaints of a painful rash in the right flank area (at approximately T10-T12 dermatome) consistent with herpes zoster that began on 29-SEP-2007. There were no lab studies performed. The patient recovered on 09-OCT-2007. Additional information is not expected. The reporter considered the patient's shingles to be an other important medical event.
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Infection, Surgery
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with drug reaction/allergy to amoxicillin/clavulanate potassium (AUGMENTIN) and codeine, and a history of tonsillectomy who on 23-OCT-2007 was vaccinated subcutaneously, "back of right arm" with the first 0.5 mL dose of Pneumovax 23, (Lot # 656233/0200U). Concomitantly, the patient was vaccinated into the opposite arm with influenza virus vaccine (unspecified). The nurse reported that the patient was hospitalized either late 24-OCT-2007 or early in the morning on 25-OCT-2007 because of cellulitis and infection on one of her arms. This was the patient's first dose of Pneumovax 23. The area was lanced and the patient was still in the hospital. The nurse did not know which arm was affected. The nurse requested a lot check for Pneumovax 23, (Lot # 656233/0200U). At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: C-reactive protein increased, Inflammation, Juvenile arthritis
Clinical narrative: Initial report received from a health care provider on 23 August 2007. A female adolescent patient received an injection of Menactra and experienced arthralgia for three weeks following vaccination. The reporter provided no additional information and the patient's recovery status had not been reported. Follow-up information received on 21 September 2007 from a health care professional. A 14-year-old female patient had received a first dose, intramuscular injection of Menactra, lot number U2331AA; and a first dose, intramuscular injection of Havrix 720, manufacturer GSK, lot number AHAVB184AA; on 26 July 2007. There was no illness at the time of vaccination. The onset of the adverse event was the following day. The patient was subsequently diagnosed with polyarticular inflammation and follow-up was by a pediatric rheumatologist. C-reactive protein was 8.17 to 31.7. Updated recovery status was not provided. Follow-up information was received from a health care professional on 25 October 2007. SERIOUSNESS CRITERIA OTHER - MEDICALLY SIGNIFICANT The reporting physician noted that "JRA not related to shot". Diagnosis was updated to juvenile rheumatoid arthritis (JRA) and the case was determined to be serious. No additional information was provided.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blindness, Nausea, Syncope
Clinical narrative: My daughter had never had a previous problem (2 of series of 3 shots). The shot was given when patient was sitting and as soon as the shot was given we were told where to check out. Within a minute of walking out of exam room patient went blind and fainted. I was close enough to catch her. The Dr and Nurse came to help and we layed patient on an exam table. Within a minute her color came back and I held a cold damp towel on her head for releif. She layed for about 10 minutes and felt good enough to leave.   I wish I had read the website and I would have insisted that she would have been laying down and monitored for 15 minutes after, as this could have been prevented. She was so anxious that this would happen again the day after that she had felt nausea again. I talked to Dr the next day and he still insist that he will not have all patients lay down while giving Gardasil injections.  Even though he knows there is a risk of fainting.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Blood glucose abnormal, Chills, Malaise, Myalgia
Clinical narrative: Shaking, trembling,chills, high (102.4 degree) fever, whole body muscle aches.  My husband called our family physician emergency line. Dr. was on call and recommended Tylenol and fluids to relieve symptoms. I took 500 mg Tylenol every 4-6 hours and water throughout the night. Symptoms abated by morning but I had no appetite for the next 24 hours, and aches continued throughout the next day and night, ending after about 48 hours.  I don't ever remember feeling this sick in my life.  My blood sugars still require extra humalog to bring them down 5 days after vaccinations. I called the Department of Health for the information about vaccines that are required in this form and reported my symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking, trembling,chills, high (102.4 degree) fever, whole body muscle aches.  My husband called our family physician emergency line. Dr. was on call and recommended Tylenol and fluids to relieve symptoms. I took 500 mg Tylenol every 4-6 hours and water throughout the night. Symptoms abated by morning but I had no appetite for the next 24 hours, and aches continued throughout the next day and night, ending after about 48 hours.  I don't ever remember feeling this sick in my life.  My blood sugars still require extra humalog to bring them down 5 days after vaccinations. I called the Department of Health for the information about vaccines that are required in this form and reported my symptoms.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Received Fluzone on 11/1/07.  That night started itching, and was scratching her skin.  On 11/2 she had hives and bumps all over.  On 11/3, her hands were swollen.  She saw here doctor who gave her a steroid injection, and placed her on steroids.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Induration, Oedema peripheral, Skin warm
Clinical narrative: bicep where admin. got swollen to twice the size and very hard and hot.   from the flu vaccine appt was monday morning did not see any reaction til wednes. morning  I don't know what manufactor .
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Heart rate increased, Pain
Clinical narrative: difficulty breathing/wheezy;fast heart beat;chills;achy body;headache
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: difficulty breathing/wheezy;fast heart beat;chills;achy body;headache
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Approx. 12 hours after injection, arm swollen, red and tender.  Extended below injection site, elbow and into forearm.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Oedema, Oedema peripheral, Pain in extremity
Clinical narrative: 10/17 Vaccine given in left deltoid.  Within hours the left arm from shoulder to fingertips were red and edemoutous.  Pt. c/o extreme itching and whelps visible.  Prednisone 20mg. PO given imediately.  Hydoxyzine 25mg. PO taken at bed time to relieve the itching.  10/18 Seen in the ER c/o increasing pain in arm and in joints from the hip to neck.  The left arm had increase in swelling.  Pt. took Tylenol, Ibuprofen and Excedrin to relieve pain with not results.  Medrol dose pack and Toradol given to pt. i
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: 10/17 Vaccine given in left deltoid.  Within hours the left arm from shoulder to fingertips were red and edemoutous.  Pt. c/o extreme itching and whelps visible.  Prednisone 20mg. PO given imediately.  Hydoxyzine 25mg. PO taken at bed time to relieve the itching.  10/18 Seen in the ER c/o increasing pain in arm and in joints from the hip to neck.  The left arm had increase in swelling.  Pt. took Tylenol, Ibuprofen and Excedrin to relieve pain with not results.  Medrol dose pack and Toradol given to pt. i
Age: 65.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy, Urticaria
Clinical narrative: Hives, very large on buttocks.  Took two benadryl tablets.  Next morning most were gone.  Also pain and redness at injection site (in the arm (left) where the pneumonia shot was given) lasting several days.  Swollen lymph node in left armpit.  I had two vaccines that day, the last (third) of the hepatitis B and Pneumococcal 23 valent.  Since I had no reactions to the previous 2 hepatitis shots and no pain in the arm in which it was given, I assume the reaction was to the Pneumomia shot.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Influenza, Malaise
Clinical narrative: flu SHOT GIVEN 10/25/07  General feelig of malaze on Saturday and Sunday following.  Little inpact on activities.  Monday AM head ache, chills, able to complete workday.  Tuesday severe head ache, chills able to complete workday.  Tuesday night diarreha, vomiting (dry heaves).  Wednesday home in bed.  Severe head ache, chills, no further diarreha or vomiting.  Thursday temp 101.1 @ 5am (first taken)  stayed home in bed same symptoms. temp 100.8 @ 1pm. Reported sickness to company Nurse.  Friday more of the same, Missed work. temp over 100 all day.  Seen by primary care provider at military clinic.  Diagnosis: flu symptoms. Saturday and Sunday home continued head ache, chills, fever.  Monday (Nov 5)returned to work with head ache and chills all day. Went from 205 pounds to 195 pounds over course of the period.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Retching, Vomiting, Weight decreased
Clinical narrative: flu SHOT GIVEN 10/25/07  General feelig of malaze on Saturday and Sunday following.  Little inpact on activities.  Monday AM head ache, chills, able to complete workday.  Tuesday severe head ache, chills able to complete workday.  Tuesday night diarreha, vomiting (dry heaves).  Wednesday home in bed.  Severe head ache, chills, no further diarreha or vomiting.  Thursday temp 101.1 @ 5am (first taken)  stayed home in bed same symptoms. temp 100.8 @ 1pm. Reported sickness to company Nurse.  Friday more of the same, Missed work. temp over 100 all day.  Seen by primary care provider at military clinic.  Diagnosis: flu symptoms. Saturday and Sunday home continued head ache, chills, fever.  Monday (Nov 5)returned to work with head ache and chills all day. Went from 205 pounds to 195 pounds over course of the period.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Pt stated that the AM after receiving the flu vac, her arm was "red, hot, swollen, and itching a little".  By the next AM, arm was "less swollen and not as bright red".  Pt stated that she "never had any discomfort" at the site.  Nurse recommended that she apply an ice pack and take some Tylenol or Advil to reduce the redness and swelling further.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt stated two hours after receiving the vaccine she had a sore arm and difficulty breathing. She went outside her home and administered her albuterol inhaler and felt better. Two hours later she again experienced the sore arm and the difficulty breathing she visited the drug store to get more albuterol which she took and again felt better. At approximately 7pm she experienced the same symtoms again and had a neighbor drive her to Hospital. At this time she was also experiencing a stiff neck. They administered a nebulizer treatment and kept her for observation until 11pm. She has not experienced any further difficulties. She reported the incident to our Agency on 11/5/07.  11/14/2007 MR received for ER visit 10/26/2007 with DX: Acute asthma exacerbation.  Pt presented to ER with moderate dyspnea.  Had 3 episodes of wheezing and sweating requiring albuterol. (+) muscle soreness at injection site. PE WNL. Given albuterol neb and d/c with epipen.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Chest discomfort, Cough, Erythema, Eye irritation
Clinical narrative: wheezing and tightness in chest, coughing (asthma-like symptoms) ~4 hours post-vax lasting 6 hours before sleep- no symptoms next AM; sore throat ~10hrs post-vax - no symptoms next AM; redness and irritation in both eyes ~6 hours post-vax lasting ~24hrs.  No treatment sought.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Pharyngolaryngeal pain, Wheezing
Clinical narrative: wheezing and tightness in chest, coughing (asthma-like symptoms) ~4 hours post-vax lasting 6 hours before sleep- no symptoms next AM; sore throat ~10hrs post-vax - no symptoms next AM; redness and irritation in both eyes ~6 hours post-vax lasting ~24hrs.  No treatment sought.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Adult flu vaccine (fluarix) given to my daughter instead of child's flu vaccine (fluzone).
Age: 0.3
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: NOT PROVIDER UNSURE
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Ear pain, Influenza like illness, Joint swelling, Lymphadenopathy
Clinical narrative: 11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT @  Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm vist to Med Ctr for burning rash on body; Mar 06 -Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 @ Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: Adult Onset Still Diease (intially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DOS 5/10-5/26/06-DC DX: Still disease. Temp 102.2, Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive mascular rash especially on tongue and chest.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia, Rash, Skin burning sensation
Clinical narrative: 11/05 - Influenza, live, intranasal vaccine (vaccine record date reflects 8 Nov 05) was administered while performing (weekend duty); 2-3 weeks later (week after Thanksgiving) developed sore throat; slight fever, stuffy head & other flu-like symptoms; 12/05- Sore throat continued, noticeable rash appeared on thighs & small lymph nodes on face; 1/06 - same symptoms continued intermittently, visited ENT @  Med Ctr for sore throat, ear pain & advised possible allergy; experienced joint pain in fingers, wrist, slight swelling in right knee & ankle; 02/06 - Emergency Rm vist to Med Ctr for burning rash on body; Mar 06 -Visit to Family Clinic for rash on body; Mid 4/06 - sore throat continued with high fever, body pain & swelling of fingers, wrists, knees, ankles & feet; Hospitalized: 4/17/06 @ Med Ctr; Diagnosis - Undetermined, Discharged 5/9/06; Hospitalized: 5/10/06 - Hospital, 2; Diagnosis 5/25/06: Adult Onset Still Diease (intially 60 mg of Prednisone, reduced to 3 mg; at present, regular visits have continued w/ treating physician since hospital discharge date - Dr. 11/9/07-records received from patient for hospital stay DOS 5/10-5/26/06-DC DX: Still disease. Temp 102.2, Bilateral axillary lymphadenopathy. Leukocytosis. Generalized body pains, weakness and extensive mascular rash especially on tongue and chest.
Age: 59.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Nausea, Red blood cell sedimentation rate normal
Clinical narrative: Patient vaccinated with BioThrax as documented, last 07/17/07.  On 10/10/07, patient reported joint stiffness & swelling in hands, wrists, knees and feet --- onset 2-3 days prior; no fever, chills,rash, shortness of breath, or chest pain.  No history of RA, SLE or other autoimmune disorders.  Patient examined; no fever or visible rash; mild swelling & tenderness over MCP, PIP & both knees.  No pedal edema, no redness or increased temperature over joints; remainder of exam WNL.  Advised by center MD to take Ibuprofen 400-800mg TID-QID; call center for increased swelling, pain, fever, rash or other symptoms.  On 10/18/07, patient contacted by center MD; patient reported she was not feeling well on 10/13/07 and went to emergency department of local hospital with c/o joint pain, nausea, vomiting; patient stated she had extended work-up in ED including labs/Xray/CT and that "every thing was normal: per ED physician and that she thought it was result of anthrax vaccine.  Patient requested by MD to come to center for evaluation and bring copies of tests performed in ED for review.  Patient seen by center MD 10/23/07; patient stated she feels much better, decreased pain & swellin in joints, no further nausea/vomiting, fever.  Labs from ED w/u reviewed (urinalysis, CBC with differential, sedimentation rate (Westergren), general chemistry); and all wnl except sedimentation rate of 24 mm/hr (normal 0-30 mm/hr). Patient back to baseline on physical exam.  Patient advised by ED on 10/14/07 (discharge from ED) to take Propoxyphene N-APAP 100/650 q 6hours prn pain, Promethazine 25mg q 6hours prn nausea/vomiting, Ibuprofen over-the-counter prn pain.  Center MD advised patient to follow up at center in 2 weeks and prn.  Patient again seen & evaluated by center physician 11/7/07; patient states she "feels much better", no pain, fever, jiont swelling or other symptoms.  she reports she takes ibuprofen prn infrequently.  Physical exam entirely wnl for age.  Current plan is to follow-up only if new symptoms develop.  Patient voiced understanding of plan and agrees.
Age: 59.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Patient vaccinated with BioThrax as documented, last 07/17/07.  On 10/10/07, patient reported joint stiffness & swelling in hands, wrists, knees and feet --- onset 2-3 days prior; no fever, chills,rash, shortness of breath, or chest pain.  No history of RA, SLE or other autoimmune disorders.  Patient examined; no fever or visible rash; mild swelling & tenderness over MCP, PIP & both knees.  No pedal edema, no redness or increased temperature over joints; remainder of exam WNL.  Advised by center MD to take Ibuprofen 400-800mg TID-QID; call center for increased swelling, pain, fever, rash or other symptoms.  On 10/18/07, patient contacted by center MD; patient reported she was not feeling well on 10/13/07 and went to emergency department of local hospital with c/o joint pain, nausea, vomiting; patient stated she had extended work-up in ED including labs/Xray/CT and that "every thing was normal: per ED physician and that she thought it was result of anthrax vaccine.  Patient requested by MD to come to center for evaluation and bring copies of tests performed in ED for review.  Patient seen by center MD 10/23/07; patient stated she feels much better, decreased pain & swellin in joints, no further nausea/vomiting, fever.  Labs from ED w/u reviewed (urinalysis, CBC with differential, sedimentation rate (Westergren), general chemistry); and all wnl except sedimentation rate of 24 mm/hr (normal 0-30 mm/hr). Patient back to baseline on physical exam.  Patient advised by ED on 10/14/07 (discharge from ED) to take Propoxyphene N-APAP 100/650 q 6hours prn pain, Promethazine 25mg q 6hours prn nausea/vomiting, Ibuprofen over-the-counter prn pain.  Center MD advised patient to follow up at center in 2 weeks and prn.  Patient again seen & evaluated by center physician 11/7/07; patient states she "feels much better", no pain, fever, jiont swelling or other symptoms.  she reports she takes ibuprofen prn infrequently.  Physical exam entirely wnl for age.  Current plan is to follow-up only if new symptoms develop.  Patient voiced understanding of plan and agrees.
Age: 40.0
Sex: M
Vaccine: FLUX, PNC
Symptoms: Chills, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Fever < 101F; Extreme body ache, Nausea, Shivering, head ache which advil or tylenol would not control taken at max levels. Both shots were given in same arm and that arm had stiff/cold fingers. Arm sore to touch and could not raise.  These happened the evening of the shot.  The next day:  fever <101F, shivering, body stiffness, stiff neck and joints, massive headaches, sore throat when swallowing, skin sensitivity to the point where hair/follicles hurt, red oval area around shot area. Next evening:  flu-like symptons, shivering then during sleep woke up completly wet with sweat.  11/7/07: Redness around shot area and tender to touch.
Age: 40.0
Sex: M
Vaccine: FLUX, PNC
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Fever < 101F; Extreme body ache, Nausea, Shivering, head ache which advil or tylenol would not control taken at max levels. Both shots were given in same arm and that arm had stiff/cold fingers. Arm sore to touch and could not raise.  These happened the evening of the shot.  The next day:  fever <101F, shivering, body stiffness, stiff neck and joints, massive headaches, sore throat when swallowing, skin sensitivity to the point where hair/follicles hurt, red oval area around shot area. Next evening:  flu-like symptons, shivering then during sleep woke up completly wet with sweat.  11/7/07: Redness around shot area and tender to touch.
Age: 40.0
Sex: M
Vaccine: FLUX, PNC
Symptoms: Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Fever < 101F; Extreme body ache, Nausea, Shivering, head ache which advil or tylenol would not control taken at max levels. Both shots were given in same arm and that arm had stiff/cold fingers. Arm sore to touch and could not raise.  These happened the evening of the shot.  The next day:  fever <101F, shivering, body stiffness, stiff neck and joints, massive headaches, sore throat when swallowing, skin sensitivity to the point where hair/follicles hurt, red oval area around shot area. Next evening:  flu-like symptons, shivering then during sleep woke up completly wet with sweat.  11/7/07: Redness around shot area and tender to touch.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Sensation of foreign body
Clinical narrative: Patient reported a "fuzzy tongue" feeling about shortly after injection.  She took oral benadryl 25mg.  Pt was observed for about 15-20 min., but symptoms were slowly increasing to the point of her feeling a "lump" in her throat.  At this point another 25mg of benadryl IM along with Epi 1:1000 SQ was given.  Pulse was noted, and within a few moments, patient reported lump was decreasing in throat and tingling of the tongue had stopped.
Age: 11.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given a HIB instead of a Meningitis. Nurse misread the front of the box and saw the word Meningitis in the descrioption and thought it was the correct vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Malaise, Vomiting
Clinical narrative: Patient report that at 3am 11/2/07 she experienced vomiting, diarrhea, chills and has 3-4 more bouts of vomiting and diarrhea into the day. She was not able to eat anything on 11/2 and did not go to work on 11/2 and 11/3. She reported these events to me today 11/7. She no long has vomiting or diarrhea but still does not feel well.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Aspartate aminotransferase increased, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated aspartate aminotransferase in a 41-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy and sulfa allergy. There were no concurrent medications. The subject had no adverse events following receipt of previous immunizations. The subject received no other vaccinations on 5 June 2007. On 5 June 2007 the subject received 1st dose of Havrix (1440 elisa unit, unknown, left arm). The healthcare professional reported that in late June 2007, less than one month after vaccination with Havrix, the subject had blood work performed that showed elevated aspartate aminotransferase by double the normal amount. The subject was retested approximately two weeks prior to 05 November 2007, on an unspecified date in October 2007, and aspartate aminotransferase remained elevated at double the normal range but not higher than the first test performed in late June 2007. At the time of reporting the even was unresolved. Comment: Elevated aspartate aminotransferase was assessed as medically serious by GSK.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lead, Dizziness, Migraine, Pallor
Clinical narrative: During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lead, Convulsion, Electroencephalogram, Laboratory test, Migraine
Clinical narrative: During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pallor
Clinical narrative: During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, CSF protein increased, Guillain-Barre syndrome, Muscular weakness, Neurological examination
Clinical narrative: Ascending lower extremity weakness, loss of reflexes consistent with Guillain Barre. Mild improvement of already mild symptoms.  11/27/07 Reviewed hospital medical records which reveal patient experienced sudden onset of bilateral lower extremity weakness beginning 4 days prior to admit.  Seen by several physicians prior to admit including neurologist who performed EMG/NCS & diagnosed w/GBS.  Admission to hospital 10/25-10/30/2007.  Exam on admit revealed areflexia.  LP revealed elevated protein & glucose. Tx w/IVIG x 5 days & improved.  D/C to home w/pcp & neuro f/u. FINAL DX: Guillian Barre syndrome.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre (alleged) 11/16/07-records received for DOS 10/13-11/7/07-DC DX: Guillain Barre syndrome (acute inflammatory demyelinating polyneuropathy), status post IVIG treatments with 10 day course. Exacerbation of chronic obstructive pulmonary disease. Hypertension. Pulmonary hypertension. Schizophrenia. Depression.  Admitted with weakness, shortness of breath and hyponatremia. Severe weakness and numbness of arms and legs. Onset uncertain. Bell's phenomenon is apparent when she blinks. Weakness of orbicularis oculus muscles bilaterally. Pin sens of extremities blunted. Loss of deep tendon relexes and proprioception as well as sensation to light touch and pain. Severe sensori-motor polyneuropathy. Per 60 day follow up: Minimal residual still recovering.
Age: 1.5
Sex: M
Vaccine: FLU3, IPV
Symptoms: Convulsion
Clinical narrative: Afebrile seizure activity 11/26/07-records received for DOS 11/6/07-DX: afebrile tonic clonic seizure and previously diagnosed with febrile seizures. Admitted for overnight observation. Temp in ED 98.7.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient came to pharmacy 11/6/07 complaining of arm pain thought was from Flu shot. Patient recovered Fluzone 10/23/07 + no problems saving injection or injection site problems. Pharmacist called patient 11/7/07 and patient said he had normal soreness from Flu shot baton 11/4/07 got noticeably worse said had shoulder/arm pain from shoulders to elbow) hurt enough to cause trouble sleeping on arm. Saw his physician and physician prescribed Methylprednisolone pak
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Skin disorder
Clinical narrative: Superficial Erythema & mild skin breakdown at injection site
Age: 50.0
Sex: F
Vaccine: FLU3, MNQ, PPV, TDAP
Symptoms: Blood culture, Headache, Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: Fever of 102 started 1 day after immunization. WBC 38.1 + neutrophils 88. Now with mild headache 2 weeks after immunizations.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Blood pressure decreased, Dizziness, Heart rate decreased, Pallor
Clinical narrative: Approximately 5 minutes after vaccine , patient "felt faint" and "could not walk" >fainted Blood Pressure - 74/44 pulse 47! Within 5 minutes patient BP increased to 102/68 pulse 74. Still pale. Complete recovery 15 minutes 115/72 pulse 85.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Approximately 5 minutes after vaccine , patient "felt faint" and "could not walk" >fainted Blood Pressure - 74/44 pulse 47! Within 5 minutes patient BP increased to 102/68 pulse 74. Still pale. Complete recovery 15 minutes 115/72 pulse 85.
Age: 1.7
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: 11/7/07 FluMist given to 20 month old - No adverse effects known at this time.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Trunk erythematous rash along elastic wait band and few scattered pink papules on the knees that blacken.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient arrived at clinic for influenza vaccine. O.5 ml dose administered. Followed up with Patient's father 48 hours later. Child had mild fever over weekend. Treated with Tylenol. To note, older sibling had pre-existing cold symptoms.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site swelling
Clinical narrative: Swelling in right thigh where shots were given
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash erythematous, Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: Rash developed approximately 24 hours after vaccine, multiple erythematous patches, raised. Located on neck, chest, abdomen, arms, upper legs. One brief episode of shortness of breath.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Pruritus, Swelling
Clinical narrative: Itching, redness, swelling started 10/25 unable to sleep night of 10/25 due to these symptoms - took Motrin
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Muscle soreness/cramping/pain ongoing with no improvement. Reported 10/30/07. No longer any redness or soreness directly at injection site. Pain radiates down arm. Began after shot. Treated with over the counter analgesics and now Tramadol 50mg. Also suggested ice/cold compresses.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Feeling hot, Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Shot given at 9AM. By 2:30PM patient was nauseated, weak and hot all over. Right upper arm was swollen red and painful. She felt she couldn't move her arm. Stayed in bed Saturday. Sunday she felt a little better. Today (Monday) there is minimal swelling in her right arm. Her arms is tender with patches of red on her upper arm and it is stiff.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Shot given at 9AM. By 2:30PM patient was nauseated, weak and hot all over. Right upper arm was swollen red and painful. She felt she couldn't move her arm. Stayed in bed Saturday. Sunday she felt a little better. Today (Monday) there is minimal swelling in her right arm. Her arms is tender with patches of red on her upper arm and it is stiff.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: States after getting immunization on 10/25/07, she had pain from her left shoulder up into neck lasting at least 8 days - taking Tylenol
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral
Clinical narrative: Patient cannot hear through right ear.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site swelling
Clinical narrative: large red swollen area - G " at injection site, dizzy.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Sensory disturbance, Urticaria
Clinical narrative: Shot given at 10:30a-on 11/3/07. Arm started feeling "funny" about 6p.m. Took Advil. Had red rash at site of bandaid. Woke up next morning with hives on torso. Had a "reverse sunburn" in bra area.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Fatigue, Immediate post-injection reaction, Migraine, Pain
Clinical narrative: Stinging when she got the shot - then she could taste vaccine. A migraine started immediately. She was then achy and fatigue for a few days. Issues are now resolved.