chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: Information has been received from a physician concerning a female with "some health troubles" who on 30-NOV-2007 was vaccinated with Zostavax single dose of the series. The patient had a heart attack and died. The physician mention that she does not think it was due to Zostavax as the patient had "some health trouble before." Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase normal, Dizziness, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physical therapist concerning her daughter with a history of meningitis at the age of 2 and seasonal allergies who on unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). On 26-NOV-2007 the patient was vaccinated with a second 0.5 mL dose of Gardasil (lot # not reported). Concomitant therapy included WELLBUTRIN and other "unnamed medications." On 28-NOV-2007 the patient developed hives over her entire body (also reported as 26-NOV_2007). The patient contacted her gynecologist, who advised her to call her internist. The patient took 4 Benadryl 25 mg as directed. She was slightly better the following morning and called her physician who then started her on Medrol DosePack. On approximately 29-NOV-2007 the patient experienced horrific muscle pain, she blacked out for a short period, vomitted green bile, was dizzy and had a fever. The doctor discontinued the Medrol DosePack. Hives returned and she went to the ER on 01-DEC-2007. The patient was given intravenous fluids and was treated with Motrin and Benadryl which were ineffective. Blood test for Creatine Phosphokinase was normal. The patient then started on another unnamed medication for hives which was later discontinued. A few hours later, the patient was started on Prednisone. The patient was later released from the emergency room and is completing therapy with prednisone. The patient was reported as recovering. Hives over her entire body, horrific muscle pain, blacked out for a short period, vomitted green bile, dizziness and fever were considered to be other important medical events. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vomiting
Clinical narrative: Information has been received from a physical therapist concerning her daughter with a history of meningitis at the age of 2 and seasonal allergies who on unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). On 26-NOV-2007 the patient was vaccinated with a second 0.5 mL dose of Gardasil (lot # not reported). Concomitant therapy included WELLBUTRIN and other "unnamed medications." On 28-NOV-2007 the patient developed hives over her entire body (also reported as 26-NOV_2007). The patient contacted her gynecologist, who advised her to call her internist. The patient took 4 Benadryl 25 mg as directed. She was slightly better the following morning and called her physician who then started her on Medrol DosePack. On approximately 29-NOV-2007 the patient experienced horrific muscle pain, she blacked out for a short period, vomitted green bile, was dizzy and had a fever. The doctor discontinued the Medrol DosePack. Hives returned and she went to the ER on 01-DEC-2007. The patient was given intravenous fluids and was treated with Motrin and Benadryl which were ineffective. Blood test for Creatine Phosphokinase was normal. The patient then started on another unnamed medication for hives which was later discontinued. A few hours later, the patient was started on Prednisone. The patient was later released from the emergency room and is completing therapy with prednisone. The patient was reported as recovering. Hives over her entire body, horrific muscle pain, blacked out for a short period, vomitted green bile, dizziness and fever were considered to be other important medical events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Aspartate aminotransferase decreased, Blood creatine phosphokinase increased, C-reactive protein normal, Complement factor C3
Clinical narrative: Information has been received from a physician concerning a 17 year old female with coeliac disease and no drug allergies and a history of headaches, who, on 08-NOV-2007 was vaccinated with a first dose of (previously reported as a second dose) on Gardasil. Concomitant suspect therapy included cyproheptadine hydrochloride (MSD), tablet for the treatment of headache (duration and dose not reported). On 09-NOV-2007 (previously reported as 08-NOV-2007 later in the day) the patient experienced bilateral calf pain. It was reported that the patient "couldn't walk." On 12-NOV-2007 (also reported as 4 days later) the patient was seen in the office with bilateral calf pain, marked calf tenderness, and difficulty getting out of bed. There was no treatment prescribed. Laboratory diagnostics were performed with the following results: complete blood count was normal, sedimentation rate was 3, c-reactive protein was normal, antinuclear antibodies were less than 80, chemistry profile was normal except serum aspartate aminotransferase which was 75, and creatine phosphokinase was 2739. A component C3 test was performed with no results provided. On 14-NOV-2007 the patient recovered. No product quality complaint was involved. The physician considered the bilateral calf pain and difficulty getting out of bed/couldn't walk to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Gait disturbance, Hypokinesia, Laboratory test normal, Myalgia
Clinical narrative: Information has been received from a physician concerning a 17 year old female with coeliac disease and no drug allergies and a history of headaches, who, on 08-NOV-2007 was vaccinated with a first dose of (previously reported as a second dose) on Gardasil. Concomitant suspect therapy included cyproheptadine hydrochloride (MSD), tablet for the treatment of headache (duration and dose not reported). On 09-NOV-2007 (previously reported as 08-NOV-2007 later in the day) the patient experienced bilateral calf pain. It was reported that the patient "couldn't walk." On 12-NOV-2007 (also reported as 4 days later) the patient was seen in the office with bilateral calf pain, marked calf tenderness, and difficulty getting out of bed. There was no treatment prescribed. Laboratory diagnostics were performed with the following results: complete blood count was normal, sedimentation rate was 3, c-reactive protein was normal, antinuclear antibodies were less than 80, chemistry profile was normal except serum aspartate aminotransferase which was 75, and creatine phosphokinase was 2739. A component C3 test was performed with no results provided. On 14-NOV-2007 the patient recovered. No product quality complaint was involved. The physician considered the bilateral calf pain and difficulty getting out of bed/couldn't walk to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female with coeliac disease and no drug allergies and a history of headaches, who, on 08-NOV-2007 was vaccinated with a first dose of (previously reported as a second dose) on Gardasil. Concomitant suspect therapy included cyproheptadine hydrochloride (MSD), tablet for the treatment of headache (duration and dose not reported). On 09-NOV-2007 (previously reported as 08-NOV-2007 later in the day) the patient experienced bilateral calf pain. It was reported that the patient "couldn't walk." On 12-NOV-2007 (also reported as 4 days later) the patient was seen in the office with bilateral calf pain, marked calf tenderness, and difficulty getting out of bed. There was no treatment prescribed. Laboratory diagnostics were performed with the following results: complete blood count was normal, sedimentation rate was 3, c-reactive protein was normal, antinuclear antibodies were less than 80, chemistry profile was normal except serum aspartate aminotransferase which was 75, and creatine phosphokinase was 2739. A component C3 test was performed with no results provided. On 14-NOV-2007 the patient recovered. No product quality complaint was involved. The physician considered the bilateral calf pain and difficulty getting out of bed/couldn't walk to be disabling. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Metrorrhagia, Muscle spasms
Clinical narrative: This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound abdomen, Vaginal haemorrhage
Clinical narrative: This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Blood immunoglobulin E increased, Headache
Clinical narrative: We received from a nurse via the Medical Communication the following information on 03 DEC 2007: A 58-year-old man was vaccinated with Fluvirin, batch-no. 80435, i.m. on 16 OCT 2007. Severe headache was reported on 18 OCT 2007 and the patient was admitted to hospital. Laboratory result: elevated IGE of 993. The patient is receiving Prednisone and still has daily mild headaches at the time of report (03 DEC 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated due to the long duration and intensity of the symptom. Expectedness assessment according to manufacturer label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No meaure necessary. NA07-006827
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt found expired no breathing - non responsive next AM after getting shots.  12/18/07 Reviewed provider medical records including vax records which confirm vax dose & lot #s as reported. Family found patient not breathing in crib.  07/04/2008 Reviewed the pathology report received via fax from CDC: FINAL DX: mild focal tracheitis & vascular congestion of multiple organs.  No immunohistochemical or PCR based evidence of influenza A or B, mycoplasma pneumoniae or bacillus cereus.  No infectious etiology identified.  9/11/09 Autopsy report received. DOD 11/30/07 - Sudden Infant Death Syndrome.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5
Symptoms: Death
Clinical narrative: Pt found expired no breathing - non responsive next AM after getting shots.  12/18/07 Reviewed provider medical records including vax records which confirm vax dose & lot #s as reported. Family found patient not breathing in crib.  07/04/2008 Reviewed the pathology report received via fax from CDC: FINAL DX: mild focal tracheitis & vascular congestion of multiple organs.  No immunohistochemical or PCR based evidence of influenza A or B, mycoplasma pneumoniae or bacillus cereus.  No infectious etiology identified.  9/11/09 Autopsy report received. DOD 11/30/07 - Sudden Infant Death Syndrome.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Barium double contrast, Enema administration, Haematochezia, Intussusception, Vomiting
Clinical narrative: Intussusception, reduced by diagnostic enema. Presented with vomiting and bloody stools on 12/7/07. 1/7/08-records received for DOS 12/7-12/8/07-DC DX: Intussusception status post reduction. HX of emesis, not tolerating foods and bloody diarrhea. Vomiting. Air contrast enema with successful and uncomplicated reduction of ileocolic intussusception which had originally progressed nearly to the splenic flexture.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, CSF white blood cell count increased, Change of bowel habit, Computerised tomogram
Clinical narrative: Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, "endurance lower extr.". Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Culture urine, Faecal incontinence, Gait disturbance, Gastrointestinal disorder, Lumbar puncture
Clinical narrative: Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, "endurance lower extr.". Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Motor dysfunction, Muscle fatigue, Myalgia, Myelitis transverse
Clinical narrative: Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, "endurance lower extr.". Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nasal congestion, Nervous system disorder, Neuropathy peripheral, Sexual dysfunction, Upper respiratory tract infection
Clinical narrative: Transverse myelitis - spinal cord T1-T4 sensory and motor loss from nipple line down. Loss of GU and GI total control. Loss of motor gait, stability, muscle strength, "endurance lower extr.". Sensory changes hands. 1/18/08-records received for DOS 11/8-11/16/07 and 11/28-12/1/07-DC DX: Transverse myelitis. C/O increasing paresthesias, felt well in 8/07, developed upper respiratory infection symtpoms and improved. Began to feel ill 2 weeks after receiving flu vaccine. C/O sore throat, rhinorrhea, nasal congestion, postnasal drip, productive cough, chills and nausea. On 10/24/07 developed progressive neuropathy to ankles, felt numbness of feet progressing superiorly to knees, thighs and upper abdomen. Watery stool. Discharged and readmitted with paresthesias in ascending fashion up to the previous level (umbilicus), 2-3 days after steroid taper.  Follow-up: Residual bowel and GU problems. Paraesthesia of legs - minor gait and stability problems. Have me advised by neurology and infectious disease physicians never to get flu shots, hepatitis, PNEUMOVAX or tetanus shots again. I submitted an event report and responded to a subsequent request. I am responding to this subsequent request but in return, I have a request. Do I get any responses or conclusions from either you, the CDC? It seems to be a one-way street of information in and nothing but stonewalling out from three federal taxpayer funded agencies who should be responding on the subject matter. A response from your agency is requested. 02/02/2010 Senso-neurological changes in feet, legs, groin, back, abdomen and chest. Motor function loss of the lower extremities right greater than left with weakness muscle fatigue, pain and contractility. Pain back awith increased motor activity. Neurological changes affecting the normalcy of bowel, bladder and sexuality functions. Mental stresses associated with pain, disability and recovery; avoidance of depression and demoralization from debilitating disorder and length of recovery time.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dehydration, Hepatic enzyme increased, Pyrexia, Rash, Skin exfoliation
Clinical narrative: 10 days after MMR, pt had fever to 102 with facial and truncal rash x 7 days. The desquamation on 8th day. Liver enzymes elevated. Hospitalized for dehydration. 1/7/08-ED notes received for DOS 12/3/07-no hospital admission. C/O rash and temperature starting night before. Rash has gone from neck to trunk, arms, legs, macular becoming confluent. Nausea and vomiting. Body aches. PE: rash appears to be clearing. Confluent erythmatous viral exanthem across trunk and extremities.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: 10 days after MMR, pt had fever to 102 with facial and truncal rash x 7 days. The desquamation on 8th day. Liver enzymes elevated. Hospitalized for dehydration. 1/7/08-ED notes received for DOS 12/3/07-no hospital admission. C/O rash and temperature starting night before. Rash has gone from neck to trunk, arms, legs, macular becoming confluent. Nausea and vomiting. Body aches. PE: rash appears to be clearing. Confluent erythmatous viral exanthem across trunk and extremities.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Kawasaki's disease, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Patient developed fever 24 hours after 2 month immunizations which persisted. Septic work up was negative and on day 4 of fever patient developed sx of Kawasaki disease. Patient was treated for Kawasaki disease with IVIG on day 5 of fever and dx improved. 12/26/07-incomplete record received for DOS 11/23-11/27/07-4/28/08-record received for DOS 11/22/07-DX: febrile illness. 6/3/08-records received from PCP-note for 11/23/07 seen for conjunctivitis and fever persists up to 101. Not eating well, irritable. PE-scleral injection. DX: Kawasaki Disease.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Soreness in left shoulder- and down arm. Pain is not constant but occurs with arm movement especially when dressing. Also pain when patient sleeps on that arm. Pt's trying gentle arm exercise.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Throat irritation, Throat tightness
Clinical narrative: Employee developed itching in throat, itching all over body, throat closing within 15 minutes after receiving influenza vaccine.  Was taken to hospital - received Zantac 50mg iv, Benadryl 50mg iv, Solu-Medrol 125mg iv.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure diastolic increased, Blood pressure increased, Chills, Pyrexia
Clinical narrative: Approximately 8 hours after administration of vaccine, patient developed weakness, chills, fever, arms felt heavy.  Slept for several hours.  Wife took blood pressure of patient which was up to 150/132.  Patient returned to clinic.  Blood pressure read to be 146/88 and patient was feeling better.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of heaviness
Clinical narrative: Approximately 8 hours after administration of vaccine, patient developed weakness, chills, fever, arms felt heavy.  Slept for several hours.  Wife took blood pressure of patient which was up to 150/132.  Patient returned to clinic.  Blood pressure read to be 146/88 and patient was feeling better.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever - 101, swelling and redness at injection site (L) thigh. No treatment was required.
Age: 1.6
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Erythema multiforme, Rash
Clinical narrative: Patient developed a rash consistent with erythema multiform (minor form) 1 day after 2nd flu vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pain, numbness tingling in lower left arm; keeping arm bent as forearm and wrist hurt. Pt guarding arm distal to injection site. No site reaction.
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Similar reaction on previous exposure to drug
Clinical narrative: Light-headedness, central cyanosis, no loss of consciousness, no local reaction. Same event on previous dose 2 months ago.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient complained of pruritis around eyes, face.  No rash on face trunk appeared.  Vitals within normal limits.  Quick dissolve strip (19 mg).  No reactions 25 mg after 15 minutes.  Called at 12:30 pm.  Mom said patient slept when came home.  Is fine and is not itchy anymore.  Mom aware when to call 911/MD.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth at injection site.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash papular
Clinical narrative: 12/12/07 Patient present to clinic with a papular erythematous rash, afebrile, good appetite. 12/11/07 Influenza vaccine administered.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Asthenia, Back pain, Blood test, Body temperature increased, Diplegia
Clinical narrative: 6/7/07 vaccinated; 6/8/07 late or early 6/9/07 temp 105 degrees, to EOR, treated & discharged; 6/18/07 noticed lower back pain, he thought it was related to his job-landscaping; 6/27/07 went on trip to amusement park, noticed back ache; 6/28/07 late noted he had not urinated on 6/27 or 28; 6/29/07 in EOR catheterized, blood work & sent home; 6/30/07 home & OK; 7/1/07 woke up, no feeling in legs & unable to move them, admitted to hospital; 7/6/07 able to walk with walker and help; 7/9-Present able to walk independently, very weak; 7/6/07 self catheterized himself prn until today could urinate on his own; 7/12/07 to start out pt physical therapy.  Diagnosis - told he had viral infection, caused swelling of spinal cord.  7/10/07 this report was initiated because the health dept. received a fax from the medical center regarding person who was a patient of theirs.  I called and spoke with the patient and he gave me this verbal history.  I asked if he would sign a release of information form so I could obtain a complete report from the hospital to include with this report, he agreed.  I sent form with SASE.  No response received, I called & left message on phone to please call, no response.  12/5/07 I called home again, younger sister answered & gave me patient's cell phone number for at college.  I sent release again.  12/10/07 I received a call from patient's mom saying they weren't going to sign any release & were considered a law suit against the vaccine because patient continues to have problems.  I am not including the hospital report that initiated this because of privacy rules. 12/21/07-records received for DOS 7/1-7/10/07-DC DX: Acute myelitis. Bladder and bowel dysfunction (neurogenic). Gait and balance dysfunction. Presented with C/O back pain, weakness of legs and difficulty passing urine and moving his bowels. Two days after vaccination temperature of 104 degrees. Five days prior to admission seen by chiropractor for lower back pain. Subsequently experienced shooting pain from umbilicus to both lower extremties with numbness in both legs and tingling in knees and thigs. Unable to walk. Unable to void. Weight lifting daily. Visited an amusement park and developed back pain.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Hypoaesthesia, Viral infection
Clinical narrative: 6/7/07 vaccinated; 6/8/07 late or early 6/9/07 temp 105 degrees, to EOR, treated & discharged; 6/18/07 noticed lower back pain, he thought it was related to his job-landscaping; 6/27/07 went on trip to amusement park, noticed back ache; 6/28/07 late noted he had not urinated on 6/27 or 28; 6/29/07 in EOR catheterized, blood work & sent home; 6/30/07 home & OK; 7/1/07 woke up, no feeling in legs & unable to move them, admitted to hospital; 7/6/07 able to walk with walker and help; 7/9-Present able to walk independently, very weak; 7/6/07 self catheterized himself prn until today could urinate on his own; 7/12/07 to start out pt physical therapy.  Diagnosis - told he had viral infection, caused swelling of spinal cord.  7/10/07 this report was initiated because the health dept. received a fax from the medical center regarding person who was a patient of theirs.  I called and spoke with the patient and he gave me this verbal history.  I asked if he would sign a release of information form so I could obtain a complete report from the hospital to include with this report, he agreed.  I sent form with SASE.  No response received, I called & left message on phone to please call, no response.  12/5/07 I called home again, younger sister answered & gave me patient's cell phone number for at college.  I sent release again.  12/10/07 I received a call from patient's mom saying they weren't going to sign any release & were considered a law suit against the vaccine because patient continues to have problems.  I am not including the hospital report that initiated this because of privacy rules. 12/21/07-records received for DOS 7/1-7/10/07-DC DX: Acute myelitis. Bladder and bowel dysfunction (neurogenic). Gait and balance dysfunction. Presented with C/O back pain, weakness of legs and difficulty passing urine and moving his bowels. Two days after vaccination temperature of 104 degrees. Five days prior to admission seen by chiropractor for lower back pain. Subsequently experienced shooting pain from umbilicus to both lower extremties with numbness in both legs and tingling in knees and thigs. Unable to walk. Unable to void. Weight lifting daily. Visited an amusement park and developed back pain.
Age: 1.9
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema multiforme, Malaise, Vomiting
Clinical narrative: Developed erythema multiforme 2 days after vaccination. Then developed vomiting, diarrhea, malaise.
Age: 22.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt received Anthrax and Flumist vaccine 26 Oct 07 does not known if she is/was pregnant. LMP 19 Oct 07. But is somewhat unsure of LMP dates. EDC based on LMP 19Oct07 is 2Nov07.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: erythema at site (L) deltoid edema at site pain/tenderness all symptom in 9cm x 5 cm area on deltoid
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Blister, Erythema, Pruritus
Clinical narrative: Red, itchy blisters and lower left and right legs. Clobetasol Propionate cream .05 twice a day for 2 weeks. Neosporin antibiotic ointment twice a day for 2 weeks. Scar therapy band-aids applied for 12 hrs. To biopsy sites for next three months.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin burning sensation
Clinical narrative: Shingles vaccine injected Monday 11/23/07. On Saturday 11/26 My hands up to the elbow and both ankles developed extreme redness and some burning and itching. The rash then developed on the back. I used hydrocortisone cream for the itching and the burning. Today 12/6/07 I still have rash but itching has sub-sided. Started with rash on upper hand from finger to wrist then it went to both ankles down to toes. Also on back doctor recommended Benedryl which I took it 4-6 hours. Rash dissappeared in about about a week.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Mydriasis, Nausea, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Gardasil given 11:45 L.A. Patient instructed to wait 15 minutes to be observed. 1210 Pt slumped over in chair, not responsive to voice. Lowered to floor-eyes open, pupils dilated, began clonic-tonic movements lasting approximately 10 seconds. Pt awoke immediately; dizziness, nausea, vomiting continued until transported to ER.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Gardasil given 11:45 L.A. Patient instructed to wait 15 minutes to be observed. 1210 Pt slumped over in chair, not responsive to voice. Lowered to floor-eyes open, pupils dilated, began clonic-tonic movements lasting approximately 10 seconds. Pt awoke immediately; dizziness, nausea, vomiting continued until transported to ER.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy, Influenza
Clinical narrative: -Bell's Palsy-facial paralysis (partial), ongoing. Prednisone prescribed. -Developed flu for 48 hours following shot.  1/15/08 Reviewed pcp office note which reveals tongue started feeling numb then right side of face & right ear "clogged" x 1 day.  Currently pregnant.  Tx only w/tapering steroids & eye gtts. FINAL DX: Bell's palsy.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 24 hours after injection of Adacel patients arm became painful, swollen, red. Used ice on area numerous times with little relief. Took Ibuprofen 800 mg, periodically area involved approx 40-50 min.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Crying, Hypokinesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Within Hours of the Pneumonia shot my arm was hurting. By 10:00 pm I was in such pain I was crying, I could not raise my arm. On 10/25 I went back to the doctor. He gave me Prednisone for 10 days which did not help. He then sent me to an Orthopedic Dr. he put a shot of cortisone in my shoulder and by the next day I could move my arm, still had pain. Was out of work for 3 weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Induration, Injection site discharge, Injection site vesicles, Oedema peripheral
Clinical narrative: Vaccine given IM In (L) arm. (L) arm red, swollen with 4 draining blisters. Clear fluid noted from blisters. Most of upper arm red/indurated but not tender. Vesicles clustered around site of Hep A injection.
Age: 11.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Medication error, Rash generalised, Scab, Wrong drug administered
Clinical narrative: Patient started with spots in school and sent home by school nurse to be evaluated.  Went to hospital and rash continued to develop on belly, back and inner thighs.  Patient took Benadryl to assist with itching.  Scabbing on 12/13/07 per mom.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, swelling Rt arm required Prednisone and ATB.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Gaze palsy, Hypotonia, Unresponsive to stimuli, Vomiting
Clinical narrative: In clinic 10/30/07 for 4 mo. immunizations. Mother related that baby "went limp, eyes rolled back in his head and wouldn't respond to them" on 9/8/07. Has started vomiting earlier in the evening. Took baby to ER where they told her that they thought baby was allergic to soy milk. States that baby did not have any fever or other symptoms after immunizations on 8/30/07. Copy of ER notes were requested and received by HD. Neuro exam was normal in ER stated that "initially" baby looked chilled and cyanotic" with physicians notation. "Child may have choked with vomiting". Child has not had any further episodes.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperaemia, Induration
Clinical narrative: Localized swelling and hyperemia around injection site approx 8cm x 6cm induration of left thigh. 5x3cm hyperemia.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: pediatric DTaP was administered when Tdap was indicated
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction, Skin warm, Tenderness
Clinical narrative: Local reaction (R) arm 6x7 cm, erythema, heat, tenderness, 15mm induration. No systemic sx.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Client reported feeling diaphoretic, nauseous, and lightheaded 2-3 hours after receiving vaccine. She did not seek medical treatment. She reported the event on 12-10-07
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site swelling, Pain in extremity, Rash, Sleep disorder
Clinical narrative: 11-27-07 7 PM Pain in (R) upper arm. 11-28-07 Pain continued. 11-29-07 Swollen, "knots" below injection site 7x6 cm and swollen area Tricep 1cmx2cm and rash. No fever. 11-30-07 Above swelling increased in size and coverage, pain intense - unable to sleep.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Nausea, Swelling face
Clinical narrative: Patient called office on 12/10/07 to cancel 2nd Gardasil vaccine.  Complained of nausea after 1st injection on 10/18/07, on 10/19/07 noted left side of face red and swollen.  No other symptoms, resolved without any further symptoms.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient complained of pain at injection site, traveled down arm.  Patient states it hurts like past rotator cuff injury.  Patient has seen orthopedist, had corticosteroid injection.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, TD
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Medication drawn up for WCC by MA, LPN administered vaccine, after doing vaccine count found that patient was given Td instead of PCV - vials are similar.  Patient's parent informed of mistake.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Baby developed an unusual rash after 2nd set of shots. Rash developed in the 24 hrs after immunizations. A red raised rash was noted locally on 9-19-07. Baby put on an antibiotic. The rash worsened on 12-3-07.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness at the site of injection about 1 inch in diameter, hard, tender & hyperemic on the right thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Red swollen L thigh, itching.  Ice, Benadryl, elevate.
Age: 12.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site rash, Oedema peripheral
Clinical narrative: ? Received chicken pox vaccine in L upper arm on 12/05/07, seen 2d later for swollen & redness of upper arm, 7cm diameter, mildly erythem circular raised area surrounding injection site.  No Rx.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC, VARCEL
Symptoms: Convulsion, Full blood count, Pyrexia
Clinical narrative: Patient was transported via ambulance to emergency room after having a seizure per mother.  She had a fever of 103.8 after motrin.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Crying, Erythema, Feeling cold, Injection site mass
Clinical narrative: 12/11/07 - Patient reports pain, warmth, and a knot "goose egg" at injection site.  Pain brought crying to patient.  12/12/07 - patient reports cold chills, fever 100.2 - swelling, warmth, redness to right arm to elbow.  Ibuprophen 400mg morning and night.  12/13/07 - patient reports to public health - right arm swollen, warm red from shoulder to fingertips.  Patient reports pain less but pain continues.  400mg Ibuprophen.  12/13/07 - measurement upper arm 11'14".
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Oedema peripheral, Pyrexia
Clinical narrative: 12/11/07 - Patient reports pain, warmth, and a knot "goose egg" at injection site.  Pain brought crying to patient.  12/12/07 - patient reports cold chills, fever 100.2 - swelling, warmth, redness to right arm to elbow.  Ibuprophen 400mg morning and night.  12/13/07 - patient reports to public health - right arm swollen, warm red from shoulder to fingertips.  Patient reports pain less but pain continues.  400mg Ibuprophen.  12/13/07 - measurement upper arm 11'14".
Age: 0.14
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, Wheezing, Wrong drug administered
Clinical narrative: An non serious event of vaccination administration error occurred in a fourteen-month-old female.  The report was received from a registered nurse in the USA.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The reporter indicated the infant has had wheezing issues.  The infant received a one-time dose of Flumist intranasally on 02-Nov-2007.  On 02-Nov-2007 the reporter indicated a infant was inadvertently administered Flumist, the mistake was discovered 30 minutes after dosing.  The administering nurse thought Flumist was indicated for children over 1 year of age; the infant was also reported to have wheezing issues.  The reporter called to check on the infant the day after dosing and no problems had been observed and the family has not contacted the health department to report any adverse effects.  Outcome: the infant had no ill effects.  Further dosing with Flumist is not indicated.  Causality assessment was not reported for this medication error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Bronchitis, Pneumonia
Clinical narrative: A non-serious spontaneous report of bronchitis and pneumonia was received from a parent concerning a four-year-old male.  The child's medical history included cold, seasonal allergy, postnasal drip, atopic, and peanut allergy.  No concomitant medication was reported.  The patient received FluMist on 03Nov2007.  On 07Nov2007, a parent reported that her son was diagnosed with "bronchitis/early pneumonia" four days following Flumist vaccination.  The child had sniffles the day of vaccination.  The mother states that it was difficult to tease apart her son's colds from his seasonal allergies and postnasal drips.  The child was started on a Z-pack.  The patient was recovering.  The causality was not reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 0.9
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: A medical assistant reported a non-serious event of FluMist vaccine intentionally given to a ten-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical or drug history information has been reported for this patient. The patient received Flumist on 09-Nov-2007. The reporter stated the physician ordered that FluMist be given at the insistence of the infant's mother. The vaccine is indicated for patients two years to 49 years of age. No adverse events were reported in the patient. Further dosing with Flumist is not reported. The reporter did not provide a causality assessment for this. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 0.7
Sex: U
Vaccine: FLUN3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: A non-serious report of medication error has been received from a physician concerning a nine-month-old infant. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical history nor concomitant medications were provided. The patient received Flumist on an unknown date. The physician realized that FluMist had been inadvertently administered to a nine-month-old infant. No other events were reported. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Rhinorrhoea, Upper respiratory tract congestion, Viral infection
Clinical narrative: A non-serious report of viral infection with wheezing, fever, runny nose and congestion was received from a consumer in the USA concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history was reported.  However, the child received four other vaccines at the time of Flumist administration.  The patient received FluMist on 22Oct2007.  Four days after receiving FluMist and four other vaccines, the child experienced runny nose, congestion, cough, and wheezing with fever.  Per the parent, the pediatrician believes her daughter has a viral infection and is treating the child with nebulizers and steroids.  The symptoms improved but the child still had intermittent episodes of wheezing with fever.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.