chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: Had seizure - grand mal - 11 days after GARDASIL.  Diagnosed idiopathic generalized epilepsy, CT scan - NL. 11/10/08-EEG report received for DOS 1/10/08-first seizure 1/8/08-with fall to floor and generalized tonic clonic seizure.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Lethargy, Pyrexia, Screaming
Clinical narrative: Lethargic.  Yelled unless he was held "clingy".  No appetite.  High fever x2 days.  All reactions occurred for about 2 days.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Contusion, Differential white blood cell count normal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Increased and very large bruises noted by patient - worse than her usual "easy bruising" around 1 1/2 week after shots.  CBC showed ITP.  Platelets = 22 on 7/21/08.  Immunizations given 7/7/08. 9/15/08-records received-Outpatient infusion documentation received-treated with WINRho.9/22/08-records received for DOS 7/7/08-received vaccination. Regular periods. Begin BCP ortho-tri-cyclen.. Period 5-7 days heavy with clots. 7/28/08-Increased bruising and very large ones from minor trauma today. Symptoms began about 1 1/2 week ago with larger and more bruises. Feels fine. After vaccination on 7/7/08 felt little under the weather for 2 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Local reaction
Clinical narrative: Location reaction as well as behavioral changes.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Oral herpes, Pain, Skin warm
Clinical narrative: A mass developed the size of a grapefruit that was warm to the touch.  I was also very painful.  I also developed a cold sore.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Palmar erythema
Clinical narrative: Redness on palm of hands and bottom of feet.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Facial palsy, Headache, Migraine, Pyrexia
Clinical narrative: Pt developed high fever for 48 hours of 104 degrees F. With high fever, pt had headache that then developed to migraine 3-4 days after HAV and HPV given. Symptoms continued despite high dose Motrin and Fioricet therapy until 7/30/08. Headache resolved but pt developed new onset of Bell's Palsy - sent to ED. 8/18/08-records received for DOS 7/31/08-DX: Bell's palsy. Presented to ED with C/O right sided facial droop.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Hypersensitivity, Injection site reaction, Irritability, Oedema peripheral, Pain
Clinical narrative: On 7/29/08 mother of patient called and stated that her child was in extreme pain and arm was very swollen.  She was very upset and stated that it had never happened before and had said that it was administered incorrectly.  Appointment was set 7/30/08 and was seen by doctor and was determined to be an allergic reaction to the Varicella.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blister, Pruritus, Rash, Rash vesicular
Clinical narrative: Recurrent blistery spot on anterior chest wall that itches/postvaccination, noninjection site zoster-like rash, anterior chest wall. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician's office member concerning a 60 year old female consumer with osteoporosis and allergic to penicillin and erythromycin (rash), who on 23-MAY-2008 at 8-9 am was vaccinated with 0.65 mL of the first dose of ZOSTAVAX (Merck) IM in the left arm. Concomitant therapy included alendronate sodium (+) cholecalciferol. The patient did not have any illness at time of vaccination. On 27-MAY-2008, the patient developed blood blister on her chest. The office member reported that the patient had a recurrent blister spot in anterior chest wall that itched. Post vaccination, the patient had a non injection site zoster like rash on her anterior chest wall. The patient has seen the dermatologist, he performed biopsies. The patient now had blisters in the mouth. At the time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood blister
Clinical narrative: Recurrent blistery spot on anterior chest wall that itches/postvaccination, noninjection site zoster-like rash, anterior chest wall. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician's office member concerning a 60 year old female consumer with osteoporosis and allergic to penicillin and erythromycin (rash), who on 23-MAY-2008 at 8-9 am was vaccinated with 0.65 mL of the first dose of ZOSTAVAX (Merck) IM in the left arm. Concomitant therapy included alendronate sodium (+) cholecalciferol. The patient did not have any illness at time of vaccination. On 27-MAY-2008, the patient developed blood blister on her chest. The office member reported that the patient had a recurrent blister spot in anterior chest wall that itched. Post vaccination, the patient had a non injection site zoster like rash on her anterior chest wall. The patient has seen the dermatologist, he performed biopsies. The patient now had blisters in the mouth. At the time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Pt noticed local erythema <40mm along with heat in affected area.  No SOB.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 7/2/08, injection site swollen, red, hot.  2 weeks later, 7/16/08, ran a fever of 104 for two days then broke out with bumps/blisters on upper and lower extremities.  7/23/08, client healing.  7/31/08, client doing fine per mother.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash papular
Clinical narrative: Diffuse rash including palms & soles.  Fine red rash (papular).  Low grade fever.
Age: 1.9
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported to clinic 2 days post vaccine complaining of redness and swelling at injection site.  10cm area of redness with a 3 cm pale center on right thigh.  Area painful to touch.  Evaluated by doctor.  Patient started on Keflex 250mg/5cc 3/4 tsp tid x 10 days, OTC Benadryl 12.5mg/5cc 1/2 tsp q 4 hours.  Patient advised to return to clinic 8/4/08.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Movement disorder, Oedema peripheral, Pain in extremity, Rash macular
Clinical narrative: R thigh swelling red blotchy area hot to touch.  C/O pain with movement.  Dr did assess suggested to continue with BENADRYL.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse events
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received a chickenpox vaccine VARIVAX (Merck) on her right thigh, after having the pt. wait for 15 minutes mom notified us that pt. was developing a reaction.  The area around the injection site was red and felt hot to the touch.  I notified Dr.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 7-21-08 received #2 varicella, then had redness, swelling pain RA by AM on 7/22/08.  Started compresses BENADRYL & ibuprofen by mom on 7-22-08.  Checked arm site on arm 7/23/08 & 7/25/08 - still red but improving.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male with a history of upper respiratory tract infection who on 20-DEC-2007 was vaccinated orally with his second dose of ROTATEQ (Lot # reported as 657985/1244U). Suspect therapy included his second dose of HIB conj vaccine (Lot # reported as 654680/0072U), IM in the right leg. Concomitant therapy included his second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GSK lot # AC21B12SCB) IM in the left leg and his second dose of pneumococcal vaccine (Wyeth Lot # B54015D) IM in the right leg. On 01-MAR-2008 the patient experienced abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception,m irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting and was hospitalized. Intussusception requiring surgical reduction occurred 01-MAR-2008. MR received for DOS 01-04-MAR-2008 with D/C DX: S/P exploratory laparotomy. Reduction of Intussusception. Appendectomy. Infant presented to local hospital with abdominal pain, vomiting and bloody stools. Recent URI. Intussusception noted on abdominal CT and pt transferred to current facility for tx. Air enema unsuccessful at reduction and pt to OR for Ex Lap and reduction of IS. Pt experienced post op fevers. Taking PO ON POD #2 and D/C home on POD #3. Seen again in ER 05-MAR-2008 after no BM and fussiness. Glycerine supp given for constipation. Labs and diagnostics: Air contrast enema (+) for ileocecal IS in the transverse colon. CT (+) for IS. Abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception, irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 306670. Lot check has been requested. Lot check results as follows: A  standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Appendicectomy, Barium double contrast, Computerised tomogram abnormal, Constipation
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male with a history of upper respiratory tract infection who on 20-DEC-2007 was vaccinated orally with his second dose of ROTATEQ (Lot # reported as 657985/1244U). Suspect therapy included his second dose of HIB conj vaccine (Lot # reported as 654680/0072U), IM in the right leg. Concomitant therapy included his second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GSK lot # AC21B12SCB) IM in the left leg and his second dose of pneumococcal vaccine (Wyeth Lot # B54015D) IM in the right leg. On 01-MAR-2008 the patient experienced abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception,m irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting and was hospitalized. Intussusception requiring surgical reduction occurred 01-MAR-2008. MR received for DOS 01-04-MAR-2008 with D/C DX: S/P exploratory laparotomy. Reduction of Intussusception. Appendectomy. Infant presented to local hospital with abdominal pain, vomiting and bloody stools. Recent URI. Intussusception noted on abdominal CT and pt transferred to current facility for tx. Air enema unsuccessful at reduction and pt to OR for Ex Lap and reduction of IS. Pt experienced post op fevers. Taking PO ON POD #2 and D/C home on POD #3. Seen again in ER 05-MAR-2008 after no BM and fussiness. Glycerine supp given for constipation. Labs and diagnostics: Air contrast enema (+) for ileocecal IS in the transverse colon. CT (+) for IS. Abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception, irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 306670. Lot check has been requested. Lot check results as follows: A  standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Enema administration, Explorative laparotomy, Haematochezia, Intussusception, Irritability
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male with a history of upper respiratory tract infection who on 20-DEC-2007 was vaccinated orally with his second dose of ROTATEQ (Lot # reported as 657985/1244U). Suspect therapy included his second dose of HIB conj vaccine (Lot # reported as 654680/0072U), IM in the right leg. Concomitant therapy included his second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GSK lot # AC21B12SCB) IM in the left leg and his second dose of pneumococcal vaccine (Wyeth Lot # B54015D) IM in the right leg. On 01-MAR-2008 the patient experienced abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception,m irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting and was hospitalized. Intussusception requiring surgical reduction occurred 01-MAR-2008. MR received for DOS 01-04-MAR-2008 with D/C DX: S/P exploratory laparotomy. Reduction of Intussusception. Appendectomy. Infant presented to local hospital with abdominal pain, vomiting and bloody stools. Recent URI. Intussusception noted on abdominal CT and pt transferred to current facility for tx. Air enema unsuccessful at reduction and pt to OR for Ex Lap and reduction of IS. Pt experienced post op fevers. Taking PO ON POD #2 and D/C home on POD #3. Seen again in ER 05-MAR-2008 after no BM and fussiness. Glycerine supp given for constipation. Labs and diagnostics: Air contrast enema (+) for ileocecal IS in the transverse colon. CT (+) for IS. Abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception, irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 306670. Lot check has been requested. Lot check results as follows: A  standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Large intestinal obstruction reduction, Pyrexia, Surgery, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old male with a history of upper respiratory tract infection who on 20-DEC-2007 was vaccinated orally with his second dose of ROTATEQ (Lot # reported as 657985/1244U). Suspect therapy included his second dose of HIB conj vaccine (Lot # reported as 654680/0072U), IM in the right leg. Concomitant therapy included his second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GSK lot # AC21B12SCB) IM in the left leg and his second dose of pneumococcal vaccine (Wyeth Lot # B54015D) IM in the right leg. On 01-MAR-2008 the patient experienced abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception,m irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting and was hospitalized. Intussusception requiring surgical reduction occurred 01-MAR-2008. MR received for DOS 01-04-MAR-2008 with D/C DX: S/P exploratory laparotomy. Reduction of Intussusception. Appendectomy. Infant presented to local hospital with abdominal pain, vomiting and bloody stools. Recent URI. Intussusception noted on abdominal CT and pt transferred to current facility for tx. Air enema unsuccessful at reduction and pt to OR for Ex Lap and reduction of IS. Pt experienced post op fevers. Taking PO ON POD #2 and D/C home on POD #3. Seen again in ER 05-MAR-2008 after no BM and fussiness. Glycerine supp given for constipation. Labs and diagnostics: Air contrast enema (+) for ileocecal IS in the transverse colon. CT (+) for IS. Abdominal pain, appendicectomy, constipation, enema administration, explorative laparotomy, haematochezia, intussusception, irritability, large intestinal obstruction reduction, pyrexia, surgery and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 306670. Lot check has been requested. Lot check results as follows: A  standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Impaired driving ability, Muscle disorder
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Limb discomfort
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Band neutrophil percentage, Basophil count normal, Blood creatine phosphokinase, Eosinophil count normal
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell volume normal
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mean platelet volume normal, Monocyte count normal, Muscular weakness, Myalgia, Neurological examination
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neutrophil count normal, Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: White blood cell count normal
Clinical narrative: Joint pain.  "Sore muscles", weakness of large, lower muscle groups - pain hips, knees.  Saw by neurologist and I.D.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Pain, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old white female with clotting disorder diagnosed in 2002 (Factor V leiden) and no history of drug reactions or allergies who at 13:10 on 10-JUN-2008 was vaccinated with one dose of ZOSTAVAX (lot#: 658844/0204X) 0.68 ml subcutaneously in the right upper arm.  Concomitant therapy included hydrochlorothiazide and nadolol.  On the morning of 14-JUN-2008 the patient noticed that with walking she developed pain in the calf that worked its way up to her thigh.  The patient treated the pain with aspirin, ALEVE and ice over the weekend.  The patient also reported a low grade fever over the weekend, but no redness at the injection site.  On 16-JUN-2008 the patient went to the physician and then went to the emergency room.  The patient was not hospitalized.  On 16-JUN-2008 the patient had an ultrasound and was found to have clots in the left calf and no where else.  The patient was diagnosed with deep vein thrombosis.  The patient was treated with LOVENOX and COUMADIN.  As of 26-JUN-2008, the patient was recovering from deep vein thrombosis.  The reporting pharmacist considered low grade fever and deep vein thrombosis to be other important medical events.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Pain in extremity, Pyrexia, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old white female with clotting disorder diagnosed in 2002 (Factor V leiden) and no history of drug reactions or allergies who at 13:10 on 10-JUN-2008 was vaccinated with one dose of ZOSTAVAX (lot#: 658844/0204X) 0.68 ml subcutaneously in the right upper arm.  Concomitant therapy included hydrochlorothiazide and nadolol.  On the morning of 14-JUN-2008 the patient noticed that with walking she developed pain in the calf that worked its way up to her thigh.  The patient treated the pain with aspirin, ALEVE and ice over the weekend.  The patient also reported a low grade fever over the weekend, but no redness at the injection site.  On 16-JUN-2008 the patient went to the physician and then went to the emergency room.  The patient was not hospitalized.  On 16-JUN-2008 the patient had an ultrasound and was found to have clots in the left calf and no where else.  The patient was diagnosed with deep vein thrombosis.  The patient was treated with LOVENOX and COUMADIN.  As of 26-JUN-2008, the patient was recovering from deep vein thrombosis.  The reporting pharmacist considered low grade fever and deep vein thrombosis to be other important medical events.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activated partial thromboplastin time, C-reactive protein normal, CSF cell count normal, Full blood count abnormal, Gait disturbance
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypoaesthesia, International normalised ratio normal, Laboratory test abnormal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Prothrombin time normal, Red blood cell sedimentation rate normal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urine analysis abnormal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Activated partial thromboplastin time normal, Blood product transfusion, C-reactive protein normal, CSF cell count normal, Chest X-ray normal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Full blood count abnormal, Gait disturbance, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypoaesthesia
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: International normalised ratio normal, Laboratory test abnormal, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 51.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nuclear magnetic resonance imaging normal, Prothrombin time normal, Red blood cell sedimentation rate normal, Urine analysis abnormal
Clinical narrative: Initial report was received from a health care professional on 22 July 2008 in reference to VAERS temporary ID# E-23638.  A 51-year-old male patient with a medical history of hypertension, hyperlipidemia and L2-L4 Lumbar Laminectomy performed in 1992, complained of bilateral numbness in his legs 11 days after he had received an intramuscular left arm injection of MENACTRA, lot number U2566AA.  The patient had received concomitant medications which consisted of TOPROL, aspirin, ZETIA and BENICAR.  On 07 July 2008, 11 days after he had received the vaccine, the patient developed bilateral leg numbness.  He began having difficulty walking on 08 July 2008 and was hospitalized the following day on 09 July 2008.  The patient remained hospitalized at the time of the report.  The patient had numerous laboratory and diagnostic tests performed in which a chem 12, CBC, spinal tap, MSP, and an MRI of l-spine wo/w contrast were all shown to have abnormal results.  A urinalysis with culture and sensitivity had been slightly abnormal. Normal laboratory results were obtained from Sed rate, CRPQ, PT, INR, PTT, hepatitis B Sur Antigen, Hep C AB, SFC, and Cryptococcal Antigen.  Normal findings were also found in an MRI-C spine w/o contrast and an MRI-T spine w/o contrast (unremarkable).  A chest x-ray had been negative and an MRI of the brain was also normal.  Testing performed also included plasma exchange (results not provided).  The course of the event, corrective treatments received and the patient's outcome were not reported.  No further information was provided at the time of the report.
Age: 54.0
Sex: F
Vaccine: TD, TD
Symptoms: Chest pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Initial report was received 21 July 2008 from a consumer.  A 54-year-old female patient had received a booster dose injection of TD absorbed (manufacturer, route/site and lot number not reported) on 10 July 2008 and that same day, she developed a burning and paralysis type pain in the shoulder compartment that radiated down her arm and into the left clavicle and left pectoral muscle.  According to the reporter, she felt that the vaccine had not been administered into the deltoid muscle, and may have been administered into the shoulder bursa.  No further information was provided at the time of the report.
Age: 54.0
Sex: F
Vaccine: TD, TD
Symptoms: Burning sensation, Mobility decreased, Pain
Clinical narrative: Initial report was received 21 July 2008 from a consumer.  A 54-year-old female patient had received a booster dose injection of TD absorbed (manufacturer, route/site and lot number not reported) on 10 July 2008 and that same day, she developed a burning and paralysis type pain in the shoulder compartment that radiated down her arm and into the left clavicle and left pectoral muscle.  According to the reporter, she felt that the vaccine had not been administered into the deltoid muscle, and may have been administered into the shoulder bursa.  No further information was provided at the time of the report.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Culture negative, Erythema, Hypotension, Inflammation
Clinical narrative: Pt received the injection on 7/5/08 documented and signed by the nurse. On 7/7/08 was seen by Dr per consult report. Symptoms began on 7/6/08 and MD on 7/7/08 and surgery was recommended for necrotizing fasciitis/myositis.  He had surgical debridement of (L) upper arm 7/7/08.  Currently on vac. dsg for wound
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Pyrexia, Skin warm, Tenderness, White blood cell count increased
Clinical narrative: Pt received the injection on 7/5/08 documented and signed by the nurse. On 7/7/08 was seen by Dr per consult report. Symptoms began on 7/6/08 and MD on 7/7/08 and surgery was recommended for necrotizing fasciitis/myositis.  He had surgical debridement of (L) upper arm 7/7/08.  Currently on vac. dsg for wound
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Debridement, Drug screen, Laboratory test, Myositis, Necrotising fasciitis
Clinical narrative: Pt received the injection on 7/5/08 documented and signed by the nurse. On 7/7/08 was seen by Dr per consult report. Symptoms began on 7/6/08 and MD on 7/7/08 and surgery was recommended for necrotizing fasciitis/myositis.  He had surgical debridement of (L) upper arm 7/7/08.  Currently on vac. dsg for wound
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Pt received the injection on 7/5/08 documented and signed by the nurse. On 7/7/08 was seen by Dr per consult report. Symptoms began on 7/6/08 and MD on 7/7/08 and surgery was recommended for necrotizing fasciitis/myositis.  He had surgical debridement of (L) upper arm 7/7/08.  Currently on vac. dsg for wound
Age: 0.7
Sex: F
Vaccine: RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with a second 2 mL oral dose of ROTATEQ on an unknown date and experienced intussusception (date not specified). The patient went to the emergency room for 24 hours for observation. The patient was not hospitalized. Subsequently, the patient recovered from intussusception (date not reported). No product quality complaint was involved. Upon internal review, intussusception was considered to be another important medical event. Additional information has been requested. 12/24/08-records received for DOS 7/20/08-DX Intussusception-presented with one day history of abdominal pain and decrease oral intake, lethargic.   9/22/09 ED records received DOS 7/20/08. Assessment: Intussusception. Mother states child was having abdominal pain with intermittent crying. 12/2/09 Hospital records received for date 7/20/08. DX: intussusception. Observation nurse records. ER visit 9/30/08 DX: fever. Presented w/ fever, exposure to sibling w/ URI.
Age: 0.7
Sex: F
Vaccine: RV5, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with a second 2 mL oral dose of ROTATEQ on an unknown date and experienced intussusception (date not specified). The patient went to the emergency room for 24 hours for observation. The patient was not hospitalized. Subsequently, the patient recovered from intussusception (date not reported). No product quality complaint was involved. Upon internal review, intussusception was considered to be another important medical event. Additional information has been requested. 12/24/08-records received for DOS 7/20/08-DX Intussusception-presented with one day history of abdominal pain and decrease oral intake, lethargic.   9/22/09 ED records received DOS 7/20/08. Assessment: Intussusception. Mother states child was having abdominal pain with intermittent crying. 12/2/09 Hospital records received for date 7/20/08. DX: intussusception. Observation nurse records. ER visit 9/30/08 DX: fever. Presented w/ fever, exposure to sibling w/ URI.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 5 month old patient with a history of gastrooesophageal reflux who was vaccinated with the second dose of ROTATEQ, 1 ml. Concomitant therapy included PREVACID (TAP), routine vaccines and REGLAN (Unspecified). The patient experienced "intussusception" after receiving the second dose of ROTATEQ and had to be hospitalized overnight. It was reported that "patient is fine now." Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.  8/22/08 Reviewed PCP office records of 6/23/2008 FINAL DX: ileocecal intussusception. Records reveal patient experienced vomiting & constipation on day of vaccination.  Slept in bassinet w/bottle on side.  Next vs of 7/24 was s/p overnight hospitalization for enema reduced IS.  Patient had projectile vomiting & reduced oral intake.    9/5/08 Reviewed hospital medical records of 7/9-7/11/2008. FINAL DX: Intussusception Records reveal patient experienced projectile vomiting, severe abdominal pain, irritability, crying.  Pt admitted for observation s/p enema reduction of IS.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 25-JUL-2008 was vaccinated with GARDASIL, (Lot # 660553/0070X), 0.5 ml, IM.  Concomitant therapy included "Sulodine".  On 25-JUL-2008, within minutes after being vaccinated, the patient fainted and then had a seizure.  She was revived and almost immediately fainted again.  The physician states that the patient has recovered.  No other information was available.  Upon internal review, seizure was considered as other important medical event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Coagulation factor V level
Clinical narrative: Information has been received from a consumer concerning a 17 year old female with sulfur allergy and asthma who on 11-JUL-2007 was vaccinated with the first GARDASIL (lot # 657868/0523U), on 05-SEP-2007 with the second dose of GARDASIL (lot # 658490/0802U) and on 20-FEB-2008 with the third dose of GARDASIL (lot # 657868/0523U). Concomitant therapy included montelukast sodium. On 18-MAY-2008, the patient experienced blood clot at the injection site after getting the third shot of GARDASIL vaccine and was hospitalized for one day. On an unspecified date the patient recovered from blood clot at the injection site. The laboratory diagnostics study performed was blood work, factor 5 test (results not reported). The patient sought medical attention. Additional information has been requested. 10/16/08-records received for DOS 5/15-5/16/08-DC DX: Right axillary venous thrombosis. Etiology may be a hypercoagulable state from the NuvaRing versus a hypercoagulable syndrome or thrombophilia. Presented with 1 week history of pain in right arm and mild discoloration to right arm with subsequent swelling.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been received from a consumer concerning a 17 year old female with sulfur allergy and asthma who on 11-JUL-2007 was vaccinated with the first GARDASIL (lot # 657868/0523U), on 05-SEP-2007 with the second dose of GARDASIL (lot # 658490/0802U) and on 20-FEB-2008 with the third dose of GARDASIL (lot # 657868/0523U). Concomitant therapy included montelukast sodium. On 18-MAY-2008, the patient experienced blood clot at the injection site after getting the third shot of GARDASIL vaccine and was hospitalized for one day. On an unspecified date the patient recovered from blood clot at the injection site. The laboratory diagnostics study performed was blood work, factor 5 test (results not reported). The patient sought medical attention. Additional information has been requested. 10/16/08-records received for DOS 5/15-5/16/08-DC DX: Right axillary venous thrombosis. Etiology may be a hypercoagulable state from the NuvaRing versus a hypercoagulable syndrome or thrombophilia. Presented with 1 week history of pain in right arm and mild discoloration to right arm with subsequent swelling.
Age: 13.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 13 year old female patient who was vaccinated with a dose of GARDASIL.  Following vaccination the patient experienced numbness and tingling in the throat.  The patient received other vaccinations at the same visit.  The nurse practitioner administered epinephrine and the patient recovered.  It was unknown if the patient sought medical attention.  Upon internal review numbness and tingling in the throat treated with epinephrine was determined to be an other important medical event.  No further information is available.