chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Computerised tomogram abnormal, Death, Headache, Malaise
Clinical narrative: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon 'appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination.  10/18/07 Patient name received from FDA.  10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis.  10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007.  VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm.  11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day.  Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus.  Intubated & IV antibiotics started & transferred to higher level of care.  Neurosurgery & ID consults done.  Pupils dilated & nonreactive.  Diffuse cerebral edema leading to brain herniation & death.  12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007.  Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia.  Temp in ER max 104.7  Became nonresponsive w/posturing in ER.  Intubated.  Started on IV antibiotics & transferred to higher level of care.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon 'appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination.  10/18/07 Patient name received from FDA.  10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis.  10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007.  VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm.  11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day.  Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus.  Intubated & IV antibiotics started & transferred to higher level of care.  Neurosurgery & ID consults done.  Pupils dilated & nonreactive.  Diffuse cerebral edema leading to brain herniation & death.  12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007.  Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia.  Temp in ER max 104.7  Became nonresponsive w/posturing in ER.  Intubated.  Started on IV antibiotics & transferred to higher level of care.
Sex: U
Vaccine: PNC
Symptoms: Child maltreatment syndrome, Expired drug administered
Clinical narrative: This case was considered medically important for the event of child maltreatment syndrome. Information regarding Prevnar was received from a consumer regarding a patient who received a dose of expired Prevnar on 25-Sep-2007 and experienced "shaking baby." On 25-Sep-2007, the patient received a dose of expired Prevnar. On 27-Sep-2007, the child experienced "shaking baby". As of 11-Oct-2007, the patient was still alive, but will "probably not make it." It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Fall, Hyperhidrosis, Leukocytosis, Mobility decreased
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with an aspirin allergy and a history of cutaneous candidiasis and depression who on 03-OCT-2007 was vaccinated with a dose of Pneumovax 23. Concomitant vaccination on the same day and in the same arm included Zostavax (MSD). Other concomitant therapy included fluconazole (DIFLUCAN), amphetamine aspartate/amphetamineSO4/dex (ADDERALL) and esomeprazole magnesium (NEXIUM). On 03-OCT-2007 the patient presented with pain in the arm and shoulder. The patient was unable to move his arm and became sweaty, dizzy, and fell down. The patient was hospitalized. A white blood cell count revealed Leukocytosis. At the time of the report the patient was recovering. This is one of several reports received from the same source. The pharmacist considered pain in the arm and shoulder, sweaty, dizzy, and falling down to be serious events due to hospitalization. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain, White blood cell disorder
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male with an aspirin allergy and a history of cutaneous candidiasis and depression who on 03-OCT-2007 was vaccinated with a dose of Pneumovax 23. Concomitant vaccination on the same day and in the same arm included Zostavax (MSD). Other concomitant therapy included fluconazole (DIFLUCAN), amphetamine aspartate/amphetamineSO4/dex (ADDERALL) and esomeprazole magnesium (NEXIUM). On 03-OCT-2007 the patient presented with pain in the arm and shoulder. The patient was unable to move his arm and became sweaty, dizzy, and fell down. The patient was hospitalized. A white blood cell count revealed Leukocytosis. At the time of the report the patient was recovering. This is one of several reports received from the same source. The pharmacist considered pain in the arm and shoulder, sweaty, dizzy, and falling down to be serious events due to hospitalization. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blindness, Cerebrovascular accident, Thrombotic thrombocytopenic purpura
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 29-AUG-2007, was vaccinated with MMR (lot #656428/0203U). Concomitant vaccines included Varivax (lot#655320/1009F) and HAVRIX (lot# AHAVB186AA). On 05-SEP-2007, the patient was hospitalized with a diagnosis of thrombotic thrombocytopenia purpura (TTP). During his hospitalization, he experienced a stroke affecting his left side, and blindness. He was hospitalized for one month, and on 09-OCT-2007, was to under go follow up in the office with his physician. No product complaint was reported. No further information was available. Thrombotic thrombocytopenic purpura (TTP) and stroke affecting his left side, and blindness were considered to be life threatening. Additional information has been requested. A lot check has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Electrolyte imbalance, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 10 weeks old female with no pertinent medical history and no drug reactions/allergies, who on 01-OCT-2007 was vaccinated po with a first dose of Rotateq. There was no concomitant medication. The physician is reporting that the patient was admitted in the hospital for dehydration. On approximately 03-OCT-2007 or 04-OCT-2007, two to three days after administration of the dose of Rotateq, the patient experienced fever, vomiting, and diarrhea. The patient tested positive for rotavirus antigens. Lab diagnostics studies performed included: electrolytes- abnormal (unknown date). The patient was treated with IV fluids for dehydration. The patient is currently in the hospital. The outcome is reported as recovering. No further information was available. The events were considered other medical event by the reporter. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 10 weeks old female with no pertinent medical history and no drug reactions/allergies, who on 01-OCT-2007 was vaccinated po with a first dose of Rotateq. There was no concomitant medication. The physician is reporting that the patient was admitted in the hospital for dehydration. On approximately 03-OCT-2007 or 04-OCT-2007, two to three days after administration of the dose of Rotateq, the patient experienced fever, vomiting, and diarrhea. The patient tested positive for rotavirus antigens. Lab diagnostics studies performed included: electrolytes- abnormal (unknown date). The patient was treated with IV fluids for dehydration. The patient is currently in the hospital. The outcome is reported as recovering. No further information was available. The events were considered other medical event by the reporter. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 week old female who on 19-JUL-2007 and 26-SEP-2007 was vaccinated with her first and second doses of Rotateq. On 27-SEP-2007 and on 05-OCT-2007 the patient developed mucus and blood in stools. On 06-OCT-2007 the patient was seen in the physicians office. Otherwise the patient was content and did not appear to have pain. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review blood in the stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Diarrhoea, Insomnia
Clinical narrative: Information has been received from a physician concerning a 50 day old female with no pertinent medical history who on 14-SEP-2007 was vaccinated PO with her first 2.0 ml dose of Rotateq (lot# 657515/0668U). Concomitant vaccinations administered that day included a dose of COMVAX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified) and a dose of PREVNAR. On that same day, the patient experienced severe diarrhea, insomnia and uncontrolled crying. Medical attention was sought by contacting the physician by phone. Also, on 17-SEP-2007 the patient was examined in the physician's office and was hospitalized for "a couple of days". On 02-OCT-2007 the patient was seen for a follow-up visit by the physician and was noted to be recovering. No other symptoms were reported and no other information was available. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion
Clinical narrative: Information has been received from an office manager in the physician's office concerning a female who was vaccinated with a dose of Zostavax (lot number not available). Subsequently the patient experienced a seizure 30 days after vaccination. Unspecified medical attention was sought. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram, Fall, Head injury
Clinical narrative: Information has been received from an office manager in the physician's office concerning a female who was vaccinated with a dose of Zostavax (lot number not available). Subsequently the patient experienced a seizure 30 days after vaccination. Unspecified medical attention was sought. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from an office manager in the physician's office concerning a female who was vaccinated with a dose of Zostavax (lot number not available). Subsequently the patient experienced a seizure 30 days after vaccination. Unspecified medical attention was sought. The patient's outcome was unknown at the time of this report. There was no product quality complaint. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 73 year old female with no medical history and penicillin allergy who on 16-APR-2007 was vaccinated SC on right arm with a single dose of Zostavax (Oka/Merck) (Lot 3 656412/1476F). Concomitant therapy included 10mg/20 mg once daily ezetimibe (+) simvastatin (MSD). On 05-OCT-2007 the patient developed shingles on her "bottom" which was described very painful to sit. The patient was prescribed valacyclovir hydrochloride (VALTREX), prednisone and hydrocodone for her symptoms. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. The patient's experience was considered to be disabling by the reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Granuloma, Hypoaesthesia, Injection site mass, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a dentist concerning his 19 year old daughter with penicillin allergy who on 28-Jun-2007 was vaccinated with her third dose of Gardasil. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA). On 12-Jul-2007 the patient experienced a large tender lump at the injection site in her left deltoid muscle. The area became progressively more painful with pain radiating up to the left shoulder and clavicle and down to the left ring finger. The patient was seen in the office and referred to an orthopedist. X-rays and an MRI of the left arm revealed fluid collection. Ultrasound guided aspiration revealed granulomatous reaction. The pain continued to worsen and on 10-Oct-2007 the patient experienced transient numbness of left hand lasting 15 minutes and hand tremor lasting 5 hours. The patient was scheduled to have a neurologic evaluation on 12-Oct-2007. It was reported that the patient's adverse events were disabling. The patient has not recovered at this time. No further details were provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Tremor, Ultrasound scan abnormal
Clinical narrative: Information has been received from a dentist concerning his 19 year old daughter with penicillin allergy who on 28-Jun-2007 was vaccinated with her third dose of Gardasil. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA). On 12-Jul-2007 the patient experienced a large tender lump at the injection site in her left deltoid muscle. The area became progressively more painful with pain radiating up to the left shoulder and clavicle and down to the left ring finger. The patient was seen in the office and referred to an orthopedist. X-rays and an MRI of the left arm revealed fluid collection. Ultrasound guided aspiration revealed granulomatous reaction. The pain continued to worsen and on 10-Oct-2007 the patient experienced transient numbness of left hand lasting 15 minutes and hand tremor lasting 5 hours. The patient was scheduled to have a neurologic evaluation on 12-Oct-2007. It was reported that the patient's adverse events were disabling. The patient has not recovered at this time. No further details were provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Somnolence, Syncope
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 15 year old female patient who was vaccinated IM with a second dose of Gardasil. The NP reported that the patient developed syncope and seizure type activity after receiving her second Gardasil. The patient was described as feeling "groggy" for 24 hours after the syncopal episode. The patient recovered fully. Upon internal review, "seizure type activity" was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Spinal fracture, X-ray abnormal
Clinical narrative: Information has been received from a physicians assistant concerning a 17 year old female who in approximately August 2007 was vaccinated with a first dose of Gardasil. Subsequently the patient had a lot of back pain. On approximately 23-SEP-2007 was vaccinated with a second dose of Gardasil. On approximately 24-SEP-2007 the patient ended up going in the hospital the next day for severe back pain. After seeing a Rheumatologist and having an x-ray it was discovered she had a lumbar fracture. At the time of the report the patient's outcome was unknown. It was determined that the mother and the patient seem to feel that the lumbar fracture was still due to Gardasil. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Ataxia, Dizziness, Headache, Multiple sclerosis, Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a female who on 05-JUL-2007 was vaccinated with Gardasil (Lot # not reported). Suspect secondary therapy included Varivax (Oka/Merck). On 03-SEP-2007 the patient came back into the office with headache, bodyache, and tingling in hands. She then came back in on 10-SEP-2007 and 11-SEP-2007 with more pronounced symptoms of dizziness and ataxia. She had an MRI and was diagnosed with multiple sclerosis with transverse myelitis. On 13-SEP-2007 the patient was hospitalized, length of hospitalization was not provided. The patient's multiple sclerosis persisted. Multiple sclerosis was considered to be disabling. Additional information has been requested.  8/14/2008 MR received for DOS 9/13-17/2007 with D/C DX:  Multiple Sclerosis (most likely dx, monophasic at present). Pt presented with 1 week hx of generalized weakness and numbness in the bilateral fingers, 1 episode of urinary retention requiring catheterization and ataxia beginning 9/10/07.   On exam, dysmetria, ataxia, R lower extremity weakness and nystagmus, pupillary defect (R>L) noted. Tx with solumedrol with improvement in dysthesias and strength. F/u as outpt.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who on 05-JUL-2007 was vaccinated with Gardasil (Lot # not reported). Suspect secondary therapy included Varivax (Oka/Merck). On 03-SEP-2007 the patient came back into the office with headache, bodyache, and tingling in hands. She then came back in on 10-SEP-2007 and 11-SEP-2007 with more pronounced symptoms of dizziness and ataxia. She had an MRI and was diagnosed with multiple sclerosis with transverse myelitis. On 13-SEP-2007 the patient was hospitalized, length of hospitalization was not provided. The patient's multiple sclerosis persisted. Multiple sclerosis was considered to be disabling. Additional information has been requested.  8/14/2008 MR received for DOS 9/13-17/2007 with D/C DX:  Multiple Sclerosis (most likely dx, monophasic at present). Pt presented with 1 week hx of generalized weakness and numbness in the bilateral fingers, 1 episode of urinary retention requiring catheterization and ataxia beginning 9/10/07.   On exam, dysmetria, ataxia, R lower extremity weakness and nystagmus, pupillary defect (R>L) noted. Tx with solumedrol with improvement in dysthesias and strength. F/u as outpt.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Pediarix (GlaxoSmithKline). In 2002 (5 years ago) the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. It was reported that the staff was squeezing the subjects arms before giving the Pediarix and that using this wrong technique was creating the cellulitis reaction because the vaccine was not going into the muscle completely. In the reporter's opinion, the event was probably related to treatment with Pediarix.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cellulitis in a 18-month-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included Havrix given in the right thigh on 22 September 2007. On 22 September 2007 the subject received 4th dose of Infanrix at 0.5 ml, intramuscularly, in the left thigh. Other vaccinations given the same day included Havrix given intramuscularly in the right thigh. On 23 September 2007, 1 day after vaccination with Infanrix, the subject experienced cellulitis. He was taken to the emergency room. The physician observed an area that was eight by eight centimeters, round and raised. This case was assessed as medically serious. The subject was treated with Rocephin. At the time of reporting the event was unresolved. The healthcare professional considered the event was probably related to vaccination with Infanrix. Follow-up information received on 16 October 2007 indicated that the subject was diagnosed with an allergic reaction which was resolved at the time of reporting. The outcome of the cellulitis was not specifically reported. In the reporter's opinion, the events were related to treatment with Infanrix. The reporter stated that in the future, Infanrix will be administered on a separate visit than other vaccines.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Death  11/27/07 Reviewed vax record which confirms dose & lot #s as reported. 4/15/08 Autopsy report states COD as anoxic/hypoxic encephalopathy & bronchopneumonia due to infantile reflux & aspiration while sleeping.
Age: 24.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Electrocardiogram, Myocarditis, Pericarditis
Clinical narrative: Pericarditis/Myocarditis. 12/26/07-records received-DX: myocarditis. Developed right sided chest pain and erythema at vaccination site about 10 days after receiving primary smallpox and anthrax #3. One day after chest pains started he developed a dry cough. Temp 102.3.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Atrioventricular block second degree, Electrocardiogram
Clinical narrative: 2nd Degree Heartblock 6/20/08-records received:10/2/07-C/O mid-sternal CP with lightheadedness, palpitations, mild SOB. DX: non-cardiac chest pain.
Age: 1.02
Sex: F
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: Large local Rx to shots. Admitted to hospital for observation given only Benadryl per mom. Per attending Doc Allergic Rx.  10/26/07 Reviewed hospital medical records which reveal patient admitted 10/6-10/7/2007 for observation.  Experienced vomiting, swelling, warmth, itching  & redness of left arm vax site.  Left arm swollen from forearm to above the elbow w/full ROM.  D/C to home FINAL DX: inflammatory reaction secondary to vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Oedema peripheral, Skin infection
Clinical narrative: Patient came in on 10/5/07 (3 days later) with red, raised area on left arm. She stated she felt nauseous and that the raised red place was growing bigger over the last 3 days. She was given Claritin 10 mg tablets once daily for 7 days and asked to report to doctor immediately. Contacted doctor on 10/9/07 - pt determined to have skin infection and was treated with Cephalexin for 7 days. Per pt arm is back to normal.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: Fever, slight chills, red skin 5-6 inches in diameter, 2" below vaccination site of RD (Pneumovax).
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysphagia, Inappropriate schedule of drug administration, Urticaria
Clinical narrative: 10/4/07 2 hives on chest, 2 hives (L) hand. Took Benadryl 25mg and at night took 25 mg. 10/7/07 To ER trouble swallowing, light headed took Benadryl, Rx Epi pen. More hives 10/8 (5) (L) leg. Still taking Benadryl.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Hypoaesthesia, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Transverse myelitis, etiology unknown. Had weakness and numbness rising to mid chest level. Admitted to hospital 9/7/07.  Discharged 9/12/07.  Attending physician MD. Treated with steroids.  Almost completely resolved at present.  10/19/07 Reviewed hospital medical records which reveal patient experienced progressive ascending paresthesias & weakness of lower extremities x approx 2 wks.    Neurosurgery & neurology consults done.  Admitted 9/7-9/12/2007.  Tx w/high dose IV steroids.  Improved on titrating oral steroids to pcp & neuro f/u. FINAL DX: Transverse myelitis; type 2 DM secondary to steroids; elevated WBC due to steroids.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: A large rash (about 8 inch by 7 inch) on the site of injection. Treated with Benadryl PRN and 1% hydrocortisone cream.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Skin warm
Clinical narrative: 24 hours post vaccination pt experienced erythema and heat that spread to elbow and up through chest and armpit. Painful to move extremity. She is treating with acetaminophen and ice. (This is regarding her Pneumovax vaccination)
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on (L) arm started after Gardasil injection 10/8/07. Numbness on top of arm - goes to fingers.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Swelling face
Clinical narrative: Vaccine was given on 10/3, late at night patient experience SOB, swollen face, HA. See MD the next day and was given Toradol and advise to take Benadryl.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Oedema peripheral, Paraesthesia, Tenderness
Clinical narrative: Imm. given early a.m. 9/21. Evening of 9/22 hard to hold up arm, tender, numb, tingling down back of arm to fingers (swollen). Rx: prednisone.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Pyrexia
Clinical narrative: 10/3 at 10 AM. Pat. called 10/3 and said she was on her way to the doctor. Felt ok until 10/2 at 3 PM. Noticed red raised bump. Currently has a fever of 102. Sx completely resolved by 10/5/07.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold compress therapy, Erythema, Swelling
Clinical narrative: Redness, swelling, near injection site. Tx: cold compress and Ibuprofen.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Redness at injection site - slight knot, slight warmness. Pt to apply ice, use ibuprofen and Benadryl cream and watch for other sx.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Syncope
Clinical narrative: Pt fainted. Per mom - seizure-like movement for a few seconds. Then became alert and awake. I saw pt immediately after the fainting episode - no post-ictal. No follow-up required.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Muscle swelling, Pain, Skin warm
Clinical narrative: Swelling like a large muscle (like men) Red fever to elbow - hurting (stinging).
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Pruritus, Skin warm
Clinical narrative: Pt describes reaction as very hot and itchy and site about 8 cm erythema with induration upon exam.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site streaking, Skin striae
Clinical narrative: Red "stripe" on back of arm, red "stripe" inch below injection site, R Deltoid only affected arm (Pneumovax). No treatment needed.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash developed two inches below injection site, about 5-6 inches in diameter. Pt given prescription for Keflex and Benadryl.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site streaking, Pain, Pyrexia
Clinical narrative: "Stripe" inch away from injection site of PNEUMOVAX  (RD). Developed fever. Pt took OTC TYLENOL, relieved pain and fever.
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Wheezing. Was given Depo Medrol IM and Benadryl IM and sent to ER. Pt improved by time seen in ER.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Pain
Clinical narrative: (L) arm local reaction initially itchy then painful. 10 cm erythema, induration, tenderness area VVX site.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: (L) arm local reaction initially itchy then painful. 10 cm erythema, induration, tenderness area VVX site.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Crying, Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: 9/29/07 fever of 103, Sunday rash started on nose and cheeks then moved to chest and stomach then 10/1/07 rash moved to legs - acted irritated - crying/fussy and decreased appetite.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing
Clinical narrative: Flushing and mild dizziness.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Excoriation, Injury, Syncope
Clinical narrative: Patient received Varivax, Tdap, and Menactra in office. Patient had syncope episode at check out area. Patient hit chin on counter - small abrasion. Patient was alert and oriented immediately.
Age: 11.0
Sex: F
Vaccine: MMRV, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness around site of injection from MMRV. Itching and slight swelling also present. Redness spread to 3x3 inch area. Started next morning after injection. Tried Benadryl for treatment. Was evaluated for reaction by doctor.
Age: 17.0
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red circle around site reported 9-7-07. It was the Menactra site. It lasted a week and went away without Rx. It appeared the day after the shot.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: started with a mild headache on 10/7/07 around noon and progressively getting worse toward the end of the day. At around 6:30 PM, headache is worse (splitting/throbbing) and had 2 episodes of vomiting. Have to get home early and not finish work that day. Took ZOFRAN ODT at 7PM vomiting / Took Advil migraine at 7:30 p.m - Headache better at around 12 p.m.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient states had sudden onset of severe pain, in bilateral legs - right shin and left foot and ankle pain. Lasted 15 minutes, then gradually went away. Fine this AM.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 5 x 5 cm induration and erythema left arm, 6 x 6 right arm.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives to body, vomiting.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Local reaction with redness (patchy) pain at site of vaccine and below (right upper arm).
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out shortly after shots given, given hard candy and rested, then was fine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received vaccine 11am on 9-29-07. On 9-30-07 around 630pm injection site became red, swollen, itchy and burning - symptoms subsided on their own then returned evening of 10-1-07. Patient called pharmacy. She was told to try Benadryl and to report reaction to her doctor. She may possibly be allergic to the to the preservative.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives: chest, back of thighs, feet - applied Caladryl lotion - symptoms gone in 12 hours. Dizziness
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Patient became faint, assisted from sitting position to lying RL on floor. Brief syncope but responded spontaneously wet wash clothes applied to forehead and neck - after 5 - 10 minutes assisted back to chair in good condition.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Pyrexia, Skin warm
Clinical narrative: Fever, myalgia, area of erythema, warmth, LUE 5 x 5 inches.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient felt like throat was closing in. She went to Nurse Practitioner and got an injection of Benadryl and was fine after that also went to urgent care and but was fine after couple hours.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Anorexia, Bone pain, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Bones ached - Skin very tender on entire body, tired, no appetite, sight of shot red, swollen + sore. Finally got warm 9-28 about 6 pm - shot sight sore + itchy until Monday 10-1
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Tenderness
Clinical narrative: Bones ached - Skin very tender on entire body, tired, no appetite, sight of shot red, swollen + sore. Finally got warm 9-28 about 6 pm - shot sight sore + itchy until Monday 10-1
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: September 6th, patient suffered stomach pain, with nausea, vomiting, diarrhea, headache; event lasted from 8 Am until next morning upon awakening. September 12th about 1:30 pm the same episode took place and lasted until awakening the next morning.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, soreness - 3 x 3" patch possible breathing constricted
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose abnormal, Blood glucose decreased, Depressed level of consciousness
Clinical narrative: Pt was found with a decreased level of consciousness in which his blood sugar was 33, on one touch.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Arthralgia, Immediate post-injection reaction, Pallor, Syncope, Vomiting
Clinical narrative: Immediately following administration of shots got up from exam table and had syncopal episode with collapse for seconds, developed pallor + emesis after. No airway compromise, vital signs normal. Follow-up Information 06-NOV-2007: 14 year old female presents with c/o pain for 3 weeks bilateral knee pain, achiness all the time worse with activity, Advil about one time per day for the last 1 week. Points to lateral aspect of both knees where tendon inserts. Denies: direct trauma, fall. Denies any redness, swelling or other joint pain. Had gardisil vaccine 10/16/07 and family concerned that the joint pain may be related. Also play club soccer with practices 2-3 times per week and games on the weekend. Discussed at length with patient and parents. History and exam c/w tendonitis likely from overuse. Rec advil 400 mg 3 times per day for one week, rest when possible, ice or heat prn. Does not have a break from soccer until the holidays. Also rec doing Jump exercises for adolescent girls they will talk to trainer at school and look on Internet. Could be related to vaccine with small percentage of girls in studies having arthralgias but would expect it to be getting better. Gave Parents phone number for Merck to call and further discuss vaccine with them. Doubt autoimmune with no family history and no other signs or symptoms but if no improvement over the next 1-2 months especially after 1-2 week rest from soccer would consider doing blood work. arthralgia
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Arthralgia, Syncope
Clinical narrative: Immediately following administration of shots got up from exam table and had syncopal episode with collapse for seconds, developed pallor + emesis after. No airway compromise, vital signs normal. Follow-up Information 06-NOV-2007: 14 year old female presents with c/o pain for 3 weeks bilateral knee pain, achiness all the time worse with activity, Advil about one time per day for the last 1 week. Points to lateral aspect of both knees where tendon inserts. Denies: direct trauma, fall. Denies any redness, swelling or other joint pain. Had gardisil vaccine 10/16/07 and family concerned that the joint pain may be related. Also play club soccer with practices 2-3 times per week and games on the weekend. Discussed at length with patient and parents. History and exam c/w tendonitis likely from overuse. Rec advil 400 mg 3 times per day for one week, rest when possible, ice or heat prn. Does not have a break from soccer until the holidays. Also rec doing Jump exercises for adolescent girls they will talk to trainer at school and look on Internet. Could be related to vaccine with small percentage of girls in studies having arthralgias but would expect it to be getting better. Gave Parents phone number for Merck to call and further discuss vaccine with them. Doubt autoimmune with no family history and no other signs or symptoms but if no improvement over the next 1-2 months especially after 1-2 week rest from soccer would consider doing blood work. arthralgia
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Radioallergosorbent test, Urticaria
Clinical narrative: hives all over body within 1 hour of vaccines. NO wheezing or shortness of breath. Benadryl given.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Seizure occurred on same day as immunizations. Lasted 2 min, temp 102.7. No prior history of seizures.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Vaccines administered around 10:15 am; Mom went next door to WIC and returned at 10:30 AM. Child noted to have rash and hives to entire front of neck and chin. Rash to cheeks and chest. Child in no visible resp distress, awake and alert but fuzzy. Benadryl 0.25 PO given. EMS called.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt received Flu shot on 10/15/07. Had seizure 10/16/07. Seen in ER for new onset seizure. Started on Dilantin.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at the site of injection, warm to touch but no pain. Pt says it does not hurt.
Age: 71.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Wrong drug administered
Clinical narrative: Was possibly given diphth-tetanus booster instead of a flu shot 10-08-07.
Age: 65.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Wrong drug administered
Clinical narrative: Accidently gave dipth/tetanus instead of flu vaccine on 10-8-07. (possibly)
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pruritus, Urticaria
Clinical narrative: Lightheadedness, nausea, hives, and itching.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Pain
Clinical narrative: Immunization given 9/27 afternoon. Awoke 9/28 AM with T = 104 and red, sore (L) deltoid. Tylenol. Fever resolved 9/28 and saw her 9/29 afternoon - arm red and painful, but not hot or tender. No evidence infection.
Age: 33.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Disorientation
Clinical narrative: Pt reported being very disoriented as a side note pt had take 1mg Ativan 2 hours before vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in having rash and swelling in left upper arm after Flu shot on 10/15/07. The rash extended up to her neck across her left shoulder and down under her arm. It is hot and painful. Used cold packs. Take antihistamine PRN, cold packs, Zithromax.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Pruritus, Unevaluable event
Clinical narrative: Allergic reaction red, swollen. Patient states site was itchy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pallor, Rash erythematous
Clinical narrative: rash on thighs, chest abdomen blanch regular erythematous
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Day after vaccine pt developed some swelling to arm at injection site. 2 Days after administration Redness and Swelling to arm 10 cm x 17 cm. c/o painful to touch
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling noted to left upper arm. Pt recovered.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Condition aggravated, Hypertension, Vomiting projectile
Clinical narrative: Vaccine given 10/5 at 0700; temp increased 102 and projectile vomiting (multiple) - all on 10/6/07. Hypertensive.  02/18/2008 MR received for DOS 10/6-7/2007 with D/C DX: Self-limiting Acute Gastroenteritis.  Pt had RBBB on EKG. Pt presented to ER with c/o sudden onset severe abdominal cramping and projectile vomiting (8-9 episodes). Temp 101.9 in ER.  PE (+) for dry mucous membranes, otherwise WNL. TXd with IVF, Zofran, Compazine and Ativan with sx resolving by 10/7/07
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: 10-3-07 resident received Pneumonia and Flu vaccine in the same injection. On 10-05-07 erythema noted at the site.
Age: 94.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incorrect dose administered
Clinical narrative: On 10-3-07 resident received pneumonia and flu vaccine through the same injection. No adverse reaction.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Incorrect dose administered, Induration
Clinical narrative: 10-3-07 resident received pneumonia and flu vaccine. There was erythema, induration and elevated temp. 1:20 AM resident sent to ER. Pneumonia and flu vaccine combined in same injection.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Incorrect dose administered, Oedema
Clinical narrative: On 10-3-07 received pneumonia and flu vaccine thru the same injection. Patient observed with slight edema and slight temperature elevation.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Induration, Wrong technique in drug usage process
Clinical narrative: 10-3-07 resident received pneumonia and flu vaccine thru the same injection. Reaction was erythema, induration and elevated temperature.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Wrong technique in drug usage process
Clinical narrative: On 10-3-07 resident received Pneumonia and flu vaccine thru the same injection. No adverse reaction
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Ocular hyperaemia, Palpitations, Wheezing
Clinical narrative: Flu vaccine given 3:00 PM - 8:00 PM went to ER. Dry cough, red eyes - lungs clear, patient may have allergic rx - gave Tamiflu (Patient didn't fill) and hydrocodone cough syrup. Called patient's physician and explained event. Called patient; said she was ok but had wheezing, cough, flu symptoms, racing heart.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: On 10-12-07 Fri. red around mouth about 5:30 pm, spread within hour hives on arms, legs, trunk after Friday evening. Started improving. Better Sat morning. Gave antihistamine, generic Zyrtec. Couple hives chin Sat. By Sunday much improved. Clear today, Monday 10-15-07.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: 10-1-07 - Pneumonia shot right arm. By PM 10-1-07 - upper arm hard, swollen, hot, painful itching. 10-2-07 called my doctor. Was put on medication advised to cell doctor- I notified pharmacy
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: 10-1-07 - Pneumonia shot right arm. By PM 10-1-07 - upper arm hard, swollen, hot, painful itching. 10-2-07 called my doctor. Was put on medication advised to cell doctor- I notified pharmacy
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC, RV5
Symptoms: Mass
Clinical narrative: Knot on Rt leg.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives for about three days but not in full days only mostly night. But I did sleep. But on Sept 25th 4 days before Flu shot I received for the first time an im injection called Epogen 40000/ml
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Muscular weakness, Nausea
Clinical narrative: Received three vaccines.  Left Arm - HPV #2 and Right Arm - Fluzone and Hepatitis A.  Immediately after receiving vaccines, patient c/o feeling faint, nauseated and weakness in the legs.  Patient remained coherrent and blood pressures remained stable.  After 15 minutes, patient was released c/o of very mild weakness but reports that it was improving as she stood longer in one place.