chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Borrelia burgdorferi serology, Facial palsy, Muscular weakness
Clinical narrative: Pt recieved FluMist on 11/18/08 next day mom noticed weak facial muscle on left. On Friday 11/21 to ER dx with Left Facial Palsy, started on Prednisone. No antecedant illness. Patient in usual stae of health. Follow up today, PE just for left facial palsy.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nasal congestion, No reaction on previous exposure to drug
Clinical narrative: Red arms and stuffy nose appeared approximately 3 hours after administration of flu shot.Was seen at MD office. DX:   ? Adverse Reaction Flu Shot. RX: Claritin 10 mg 1 po q day x 4. After administration of Claritin symptoms resolved.  Patient has had influenza  vaccine before without any adverse reaction.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Psoriasis, Rash
Clinical narrative: Recurring rash on left wrist and palm on right hand.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Large red welt around where vaccine was administered in Right deltoid. Warm to the touch, itchy. Treatment- Benedryl every 4-6 hrs as needed for itchiness, swelling.
Age: 45.0
Sex: F
Vaccine: FLU3, HEP, MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: swollen glands-behind right ear, scalp, neck, throat area, left cheek
Age: 0.92
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal blistering
Clinical narrative: Blisters in mouth over night after getting flu vaccine
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Dull, aching, chronic pain in right shoulder where flu shot was administered.  Pain has lasted since flu shot was first administered on October 23, 2008.  Was seen by a medical doctor who recommended physical therapy to strengthen arm back to normal.  Treatment begins next week.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Disorientation, Encephalitis, Intensive care
Clinical narrative: Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis.  Presently in an intensive care unit at Medical Center.  1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated.  Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week.  Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs.  Fever 101.5 in ER.  ID, Neuro, Uro,  Nephro, Pulmo, Heme consults done.  Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress.  Admitted ICU & intubated.  LP done.  Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis.  Continued downhill course & transferred to hospice on 12/20/08.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Delirium, Dementia, Encephalitis, Intensive care
Clinical narrative: Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis.  Presently in an intensive care unit at Medical Center.  1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated.  Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week.  Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs.  Fever 101.5 in ER.  ID, Neuro, Uro,  Nephro, Pulmo, Heme consults done.  Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress.  Admitted ICU & intubated.  LP done.  Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis.  Continued downhill course & transferred to hospice on 12/20/08.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Received vaccine 11/19/08 @ noon approximately 12 hours later reported vomiting and diarrhea.  Saw her private MD and Dr. told her she had a reaction to the flu vaccine.  Patient returned to work 3 days later.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac flutter, Chest discomfort, Wheezing
Clinical narrative: chest fluttering, tightness and wheezing within one hour after vaccination. Used Maxair inhaler/Singular from 11-11-08 to 11-16-08
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: My daughter had the LAIV (nasal spray) and had a severe reaction - hives from her head to her toes.  She needed to be on steroids to bring relief.  Not sure if doctor reported this reaction.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oral pruritus, Swollen tongue
Clinical narrative: Client had never received flu shot in past. Administered at flu clinic at 11:00am. Client noticed itching tongue at 4:00pm. It then became swollen and she went to the Emergency room at 5:00. She was given Benadryl and a shot?? Client unsure what the shot was. She states symptoms were gone within 1 hour and she was discharged. She took 3 more doses of Benadryl throughout the evening/night. No further problems.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: itchy rash on upper arms, thighs, & bra line; new areas appearing right elbow 7 days after injection; calamine lotion was applied by pt.
Age: 49.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Fever up to 101, achy, headache, dizzy   Patient received injection on Thursday 11/20/08 and symptoms started Saturday 11/22/08. Patient feels some better today 11/25/08. He will update prn.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Angioedema, Dyspnoea, Hypersensitivity
Clinical narrative: After Administering a series of vaccination, the child had an allergic reaction. The Physician Assistant on duty, evaluated the patient and gave him treatmant. the child was Complaining of Shortness of breath, difficulty breathing, and Angioedema.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site of vaccine was 2 inches in diameter, red, warm to touch , painful. Client was instructed to apply cold compress and use analgesic as needed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of vaccine was 2 inches in diameter, red, warm to touch , painful. Client was instructed to apply cold compress and use analgesic as needed.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Oedema peripheral, Skin warm
Clinical narrative: On 10/30/08 pt stated arm swollen, extremely hot and sore at elbow which lasted until Friday.  On Saturday symptoms improved and he returned to work on Monday.  On 10/30/08 he also went to Dr. and they gave him penicillin QID.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Had headache, body aches, high fever lasted 12 hours
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site rash, Injection site vesicles, Rash pruritic, Rash vesicular
Clinical narrative: DEVELOPED A RASH SURROUNDING INJECTION SITE. APPROXIMATELY 3" IN DIAMETER. RASH HAS MULTIPLE LESIONS VESICULAR IN NATURE. MEMBER STATES RASH ITCHES. NO FEVER OR OTHER C/O AT THIS TIME BUT MEMBER IS RECOVERING FROM ANOTHER RASH ON HIS LEG THAT DEVELOPED PRIOR TO HAVING ANY ANTHRAX VACCINATIONS.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash macular, Rash pruritic
Clinical narrative: No fever.  Mom stated it started with blotchy bumps on arm and rash on neck noted at bedtime.  Pinpoint rash on right side of back and stomach.  Rash area itchy.  She gave him benadryl last night.  He slept well.  This AM child has "football shaped" reddened area on upper arm of injection site that is about 3.5 in long.  She described knees and feet as sunburned red.  I advised seeing childs doctor.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Patient had a seizure 3 minutes after having the Flu -mist. We were still in the doctors office.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood test, Crying, Cytomegalovirus test negative, Immunisation reaction, Intensive care
Clinical narrative: Patient developed unconsolable crying at 11:00 pm on 11/19/2008. This was approximately 14 hours after the immunizations were given. Patient's mother attempted to calm infant through the night but did take infant to Hospital at 9:00 am on 11/20/2008. At admission to ER patient was still crying and was running a fever of 101.6. Patient was admitted to ICU. Rule out diagnosis included: MRSA, menningitis, and CMV. All tests for these were negative. Patient was treated palitatively while hospitalized. Patient was discharged home on 11/22/2008 with the diagnosis of a pertusis reaction.  12/1/08 MR received for DOS 11/20-22/2008 with DX: Inconsolability associated with fever.  Inconsolability 2' to DTaP.  Thrush.  Leukocytosis. Pt presented with abrupt onset of fever and inconsolability. Seen by PCP and dx with otitis media and concern for meningitis due to a far off stare.  Recent foul smelling diarrhea. PE (+) for screaming when moved, fussiness, dry mucous membranes, tachycardia, nuchal rigidity and injection site swelling on the R.  Improved in IVF and abx.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lumbar puncture, Methicillin-resistant staphylococcal aureus test negative, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Patient developed unconsolable crying at 11:00 pm on 11/19/2008. This was approximately 14 hours after the immunizations were given. Patient's mother attempted to calm infant through the night but did take infant to Hospital at 9:00 am on 11/20/2008. At admission to ER patient was still crying and was running a fever of 101.6. Patient was admitted to ICU. Rule out diagnosis included: MRSA, menningitis, and CMV. All tests for these were negative. Patient was treated palitatively while hospitalized. Patient was discharged home on 11/22/2008 with the diagnosis of a pertusis reaction.  12/1/08 MR received for DOS 11/20-22/2008 with DX: Inconsolability associated with fever.  Inconsolability 2' to DTaP.  Thrush.  Leukocytosis. Pt presented with abrupt onset of fever and inconsolability. Seen by PCP and dx with otitis media and concern for meningitis due to a far off stare.  Recent foul smelling diarrhea. PE (+) for screaming when moved, fussiness, dry mucous membranes, tachycardia, nuchal rigidity and injection site swelling on the R.  Improved in IVF and abx.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Deafness unilateral, Ear congestion, Hypoaesthesia, Nerve injury
Clinical narrative: Given Zostavax vaccine 1500 10/23/08, onset of vertigo 0800 10/24/08, onset of vomiting and tinnitus 1300 10/24/08, also noted ear congestion feeling, numbness of ear internal canal and external pinna.  No recent or concurrent cold or flu symptoms, no fever or sore throat.  Symptoms continued 3 days despite meclizine and sudafed, and I was seen by Dr. on 10/28/08.  Exam confirmed central nerve damage (vertical nystagmus, audiogram with 80% hearing loss on R - affected ear). He started me on high dose steroids with 3 week taper, which improved vertigo and hearing (to 60% loss)4 weeks later.  I am a physician but also a musician, and he has no hope that I will return to normal hearing on that side.  He has seen this with flu shots (I've taken them for 20 years without incident, and had one 10/14/08), but never with the zostavax.  12/2/08 Reviewed ENT medical records of 10/28-11/13/2008. FINAL DX: vestibular neuronitis, likely viral etiology.  Right sensorineural hearing loss. Records reveal patient experienced sudden hearing loss. dizziness, fullness & pressure in right ear, tinnitus, slow wide-based gait.  Exam revealed vertical nystagmus.  Tx w/high dose steroids.  Improved w/steroids 1/29/2010 Follow-up: Persistent tinnetus, 30% hearing loss right ear.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: No reaction on previous exposure to drug, Nystagmus, Tinnitus, Vertigo, Vomiting
Clinical narrative: Given Zostavax vaccine 1500 10/23/08, onset of vertigo 0800 10/24/08, onset of vomiting and tinnitus 1300 10/24/08, also noted ear congestion feeling, numbness of ear internal canal and external pinna.  No recent or concurrent cold or flu symptoms, no fever or sore throat.  Symptoms continued 3 days despite meclizine and sudafed, and I was seen by Dr. on 10/28/08.  Exam confirmed central nerve damage (vertical nystagmus, audiogram with 80% hearing loss on R - affected ear). He started me on high dose steroids with 3 week taper, which improved vertigo and hearing (to 60% loss)4 weeks later.  I am a physician but also a musician, and he has no hope that I will return to normal hearing on that side.  He has seen this with flu shots (I've taken them for 20 years without incident, and had one 10/14/08), but never with the zostavax.  12/2/08 Reviewed ENT medical records of 10/28-11/13/2008. FINAL DX: vestibular neuronitis, likely viral etiology.  Right sensorineural hearing loss. Records reveal patient experienced sudden hearing loss. dizziness, fullness & pressure in right ear, tinnitus, slow wide-based gait.  Exam revealed vertical nystagmus.  Tx w/high dose steroids.  Improved w/steroids 1/29/2010 Follow-up: Persistent tinnetus, 30% hearing loss right ear.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: 11 November 2008 I got the flu shot in my left arm. About 6 to 8 hours following the shot I started getting muscle ache in my left shoulder. I took ibuprofen to try to releive the pain. After almost a week with the pain I went to a chiropractor who said that he could no cause for the pain except possibly the flu shot. He gave me a treatment but it had no effect. Today I went back to the doctors office where I got the flu shot and they are prescribing a pain medication and a muscle relaxant which I have not yet picked up from the drugest. The person who gave me the shot said that I should call the CDC and they told me to fill out this form. If others have reported this same side effect please let me know.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site swelling, Urticaria
Clinical narrative: URTICARIA, SWOLLEN LEFT THIGH 5 DAYS AFTER GETIING MMR & VARICELLA VACCINATION IN HIS LEFT THIGH
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Hypersensitivity, Oropharyngeal pain, Pruritus, Urticaria
Clinical narrative: Recieved shot on Monday Nov 10, 2008, Woke up Tuesday with a sore throat, Wednesday arms started itching by Thursday red Welts started showing up and covered both arms and a few red itchy welts showed up on the Abdomen. I was diagnosed with Hives due to an alergic reaction to something..........
Age: 1.3
Sex: M
Vaccine: UNK
Symptoms: Cough, Respiratory distress, Stridor
Clinical narrative: Developed stridor, cough with resp distress. Received epinephrine in ER, admitted overnight.  12/2/08 Reviewed hospital medical records of 11/21-11/22/2008. FINAL DX: croup Records reveal patient experienced sore throat, fever & barky cough x 1 day on the day he received the vaccination.  Symptoms worsened that evening to include stridor.  Tx w/nebs in ER w/o improvement & admitted for observation & management.   Tx w/steroids & d/c to home on continued steroids.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary embolism, Respiratory disorder
Clinical narrative: 20 y.o. female with no prior past medical history, presents to the Emergency room after 3 weeks of worsening respiratory symptoms.  Medical work-up on admission reveals an acute pulmonary embolism patient reports completing GARDASIL vaccine series in August 2008.  2/2/09 Received multiple medical records for 11/4/2008-1/6/2009. 11/4/2008 ER records. FINAL DX: pneumonia Only records were CXR which was WNL.  11/14/2008 Hospital medical records for 11/14-11/22/2008. FINAL DX: hypercoagulable state; venous thrombosis embolic disease w/bilateral LE DVTs & pulmonary embolus w/lung infarct & pleural effusion; s/p IVC filter; sinus tachycardia; anemia; hemorrhagic ovarian cyst for outpatient w/u; possible mood disorder Records reveal patient experienced cough, chills, fever, yellow sputum & worsening difficulty breathing x 3 weeks.  Had been on oral antibiotics for pneumonia w/worsening s/s.  Heme, Pulmo, GYN & surgery consults.  Improved slowly & d/c to home on continued anticoagulants w/outpatient f/u.  12/11/2008 ER records Only records were CXR which revealed bibasilar subsegmental atelectasis; lung VQ scan which revealed large perfusions defects bilateral lung bases, unchanged; and duplex scan of bilateral LEs which revealed resolved thrombus of right common femoral vein.  2/12/09 Received PCP vaccine records & office notes of vaccine visit dates.  2/21/08 #1 was well except for dry hands/feet & allergic conjunctivitis.  4/24/08 pt dx w/chronic sinusitis & recurrent abdominal pain.  9/16/08 #3 pt dx w/URI.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: 11/20/08 fever up to 101.7; seizures.  12/26/08 MR received for DOS 11/20-21/2008 with DX: Febrile illness, possible seizure. Recent vaccination. Pt presented fever, decreased po intake and an episode of jerking of the whole body lasting ~ 5 min. On arrival T=100.0"F.  Some diarrhea x 1 week. No further episodes during o/n observation.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 104; seen in ER and given MOTRIN and TYLENOL.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Urticaria
Clinical narrative: 11-18-08 5:30pm lower lip swollen, then both lips swollen, hives on (R) wrist and (L) fingers. On call Dr advised Benadryl and ER. At ER pt given Prednisone x6 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: T.C. from Pt. at 2:50pm 11/25/08; reports swelling of (R) arm when PNEUMOVAX was administered. Stated symptoms began approximately 2 hrs post vaccination. Advised to apply ice, take ibuprofen every 4-6 hrs; call physician  if symptoms persists.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: T.C. from Pt. at 2:50pm 11/25/08; reports swelling of (R) arm when PNEUMOVAX was administered. Stated symptoms began approximately 2 hrs post vaccination. Advised to apply ice, take ibuprofen every 4-6 hrs; call physician  if symptoms persists.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyspnoea, Eye rolling, Wheezing
Clinical narrative: 9-28-08 8pm- while changing diaper experienced difficulty breathing with wheezing, eyes rolled back into head-mom picked her up and symptoms redin within 10 seconds. 10-05-08 same symptoms occurred as on 9-28-08 with same recovery.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Palpitations
Clinical narrative: Patient complained of having weakness, heart palpitations, and soreness all  over body the evening of FLUZONE vaccination was administered. No fever noted. Doctor suggested taking Tylenol and resting.
Age: 11.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Vomiting
Clinical narrative: 11-31-08, PC learns client's older sister states client began vomiting about 5 AM, today. No increase temp reported. Referred to PMD. DC to home about 2pm. Client feeling better. Did not see doctor.
Age: 13.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Vomiting
Clinical narrative: 11/21/08- PC from clients adult sister. She states client began vomiting about 5pm on 11-20-08 until about, AM (4x) no high temp reported. PC from aunt 2pm on 11-21-08- client improving no more vomiting had not seen doctor.
Age: 86.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Neuralgia
Clinical narrative: Nerve like pain in arm over 2 month period
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 11/24 - reported pain/hurt through out arm since shot given on 10-22-08. Has not taken anything as of yet. Saw doctor within last few days - MD said it could take up to 3 months to get better.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient received 2 vaccine injections to left deltoid muscle 1 1/2-2" apart on 11/23/2008 12:30PM; 10hrs later pain and swelling of left arm and left breast area. Described as burning; arm immobilized with pain. On 11/24/08 patient returned to pharmacy and was instructed to go to Dr's office for treatment; at Dr's office she received a steroid shot and on 11/25/08 patient awoke with symptoms diminished and had no complaints.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling
Clinical narrative: Left thigh swelling from mid thigh to knee 4-5 hours after vaccine administered.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Localized swelling 6cm right deltoid area warm to touch slight redness surrounding swollen area. PNEUMOVAX given. Pharmacist suggested cold compress to area and Benadryl 50mg at 4-6 hours. If becomes worse to go to ER.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient C/O muscle aches, body aches, flu like S/S, on 11/22/08. Redness, warmth, tenderness to touch at injection site 11/23. Muscle aches/body aches d/c on 11/24. Redness spread 11/26. Seen by health services 11/24 & 11/25. No fever, no N/V, no SOB/wheezing.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Pain
Clinical narrative: Patient C/O muscle aches, body aches, flu like S/S, on 11/22/08. Redness, warmth, tenderness to touch at injection site 11/23. Muscle aches/body aches d/c on 11/24. Redness spread 11/26. Seen by health services 11/24 & 11/25. No fever, no N/V, no SOB/wheezing.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Blood glucose, Fatigue, Headache
Clinical narrative: My 16 year old daughter was given GARDASIL injection #1 on 9/24/08 along with MENACTRA and TdaP.  Immediately she was nauseated. One week later she developed a headache that would not go away for seven weeks. We went to a doctor after hours and received a shot of TORADOL which did not stop the pain, they began orders for MRI of the head. Two days later she almost passed out in the shower and was so weak she could not walk up the stairs at home. I took her to the ER where they did blood tests ruling out diabetes, mono, infection, virus etc. 11/5/08. They did a head CT which showed nothing. They gave IMITREX which made the headache worse. We were referred to a neurologist and would need an MRI which we could not get done because of insurance problems, but ultimately the neurologist eluded to problems with the HPV virus and that this should go away and did not need to get MRI. She spent seven weeks straight with a headache and weakness that is unparalleled. She missed a minimum of six days of school due to exhaustion and headache. During those seven weeks she had constant headache, weakness, severe lethargy, nausea and vomiting. She almost missed making her basketball team that she had been working out for every day of the months because she could not even function on the lowest level.  12/2/08 Reviewed ER medical records of 11/05/2008. FINAL DX: chronic HA & fatigue. Records reveal patient experienced HA x 6 weeks & had developed chills, nasal drainage, nausea, decreased appetite.  Had completed antibiotic course recently for sinusitis.  Had been seen in urgent care & referred to ER for MRI of brain.  Phone consult w/neuro who recommended CT scan instead & outpatient f/u.  12/5/08 Reviewed PCP & neuro medical records. FINAL DX: protracted HA related to immunizations or URI.   Records reveal patient experienced usual state of good health on day of vaccination.  Neuro consult done 11/18/08 for protracted HA.  Had HA, fatigue, intermittent weakness & nausea day starting day after vaccination.  Also experienced URI & rhinorrhea.  Neuro exam was WNL.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Lethargy, Loss of consciousness, Mononucleosis heterophile test, Nausea
Clinical narrative: My 16 year old daughter was given GARDASIL injection #1 on 9/24/08 along with MENACTRA and TdaP.  Immediately she was nauseated. One week later she developed a headache that would not go away for seven weeks. We went to a doctor after hours and received a shot of TORADOL which did not stop the pain, they began orders for MRI of the head. Two days later she almost passed out in the shower and was so weak she could not walk up the stairs at home. I took her to the ER where they did blood tests ruling out diabetes, mono, infection, virus etc. 11/5/08. They did a head CT which showed nothing. They gave IMITREX which made the headache worse. We were referred to a neurologist and would need an MRI which we could not get done because of insurance problems, but ultimately the neurologist eluded to problems with the HPV virus and that this should go away and did not need to get MRI. She spent seven weeks straight with a headache and weakness that is unparalleled. She missed a minimum of six days of school due to exhaustion and headache. During those seven weeks she had constant headache, weakness, severe lethargy, nausea and vomiting. She almost missed making her basketball team that she had been working out for every day of the months because she could not even function on the lowest level.  12/2/08 Reviewed ER medical records of 11/05/2008. FINAL DX: chronic HA & fatigue. Records reveal patient experienced HA x 6 weeks & had developed chills, nasal drainage, nausea, decreased appetite.  Had completed antibiotic course recently for sinusitis.  Had been seen in urgent care & referred to ER for MRI of brain.  Phone consult w/neuro who recommended CT scan instead & outpatient f/u.  12/5/08 Reviewed PCP & neuro medical records. FINAL DX: protracted HA related to immunizations or URI.   Records reveal patient experienced usual state of good health on day of vaccination.  Neuro consult done 11/18/08 for protracted HA.  Had HA, fatigue, intermittent weakness & nausea day starting day after vaccination.  Also experienced URI & rhinorrhea.  Neuro exam was WNL.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pregnancy test, Presyncope, Viral test, Vomiting
Clinical narrative: My 16 year old daughter was given GARDASIL injection #1 on 9/24/08 along with MENACTRA and TdaP.  Immediately she was nauseated. One week later she developed a headache that would not go away for seven weeks. We went to a doctor after hours and received a shot of TORADOL which did not stop the pain, they began orders for MRI of the head. Two days later she almost passed out in the shower and was so weak she could not walk up the stairs at home. I took her to the ER where they did blood tests ruling out diabetes, mono, infection, virus etc. 11/5/08. They did a head CT which showed nothing. They gave IMITREX which made the headache worse. We were referred to a neurologist and would need an MRI which we could not get done because of insurance problems, but ultimately the neurologist eluded to problems with the HPV virus and that this should go away and did not need to get MRI. She spent seven weeks straight with a headache and weakness that is unparalleled. She missed a minimum of six days of school due to exhaustion and headache. During those seven weeks she had constant headache, weakness, severe lethargy, nausea and vomiting. She almost missed making her basketball team that she had been working out for every day of the months because she could not even function on the lowest level.  12/2/08 Reviewed ER medical records of 11/05/2008. FINAL DX: chronic HA & fatigue. Records reveal patient experienced HA x 6 weeks & had developed chills, nasal drainage, nausea, decreased appetite.  Had completed antibiotic course recently for sinusitis.  Had been seen in urgent care & referred to ER for MRI of brain.  Phone consult w/neuro who recommended CT scan instead & outpatient f/u.  12/5/08 Reviewed PCP & neuro medical records. FINAL DX: protracted HA related to immunizations or URI.   Records reveal patient experienced usual state of good health on day of vaccination.  Neuro consult done 11/18/08 for protracted HA.  Had HA, fatigue, intermittent weakness & nausea day starting day after vaccination.  Also experienced URI & rhinorrhea.  Neuro exam was WNL.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Skin lesion
Clinical narrative: (R) deltoid- small elliptical bullous lesions.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of fatigue in a 30-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline, HEPATITIS B vaccine.  A physician or other health care professional has not verified this report.  Concurrent medications included Acyclovir.  On 13 September 2007 at 15:00 the subject received the first dose of TWINRIX (unknown, left arm), which was administered prior to traveling to a foreign country.  Upon his arrival in a foreign country, the subject believed that he may have been exposed to hepatitis B, and presented to a medical facility.  On 23 September 2007, the subject received a dose of Hepatitis B vaccine (which the subject believed to be a GlaxoSmithKline product although this was not confirmed).  The subject considered this vaccination to be a "possible duplicate first-in-series" dose of hepatitis B vaccine.  On the same date, 23 September 2007, the subject received a dose of hepatitis B immunoglobulin at what he considered to be a possible subtherapeutic dose.  On 24 September 2007, eleven days after vaccination with TWINRIX and one day after receiving hepatitis B vaccine and hepatitis B immunoglobulin, the subject developed fatigue.  At the time of reporting, the fatigue was unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Swelling
Clinical narrative: This case was reporting by a healthcare professional and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with TWINRIX, GlaxoSmithKine.  On an unspecified date the subject received an unspecified dose of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced swelling.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with TWINRIX, GlaxoSmithKline.  On an unspecified dates the subject received 3 doses of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced not responding to therapy.  Laboratory results revealed that the subject was not immune.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a physician via a sales representative, and described the occurrence of hepatitis B antibody negative in an adult male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On unspecified dates between approximately 2005 and the time of reporting in October 2007, the subject received the first and second doses of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced hepatitis B antibody negative.  According to the physician, the subject had been vaccinated with TWINRIX "twice in the past two years" and hepatitis B titers continued to be negative.  At the time of reporting the events were unresolved.  The physician considered the events were unrelated to vaccination with TWINRIX.
Sex: U
Vaccine: HEPAB
Symptoms: Blood test abnormal, Pharmaceutical product complaint
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of abnormal blood test results in 22,000 adult subjects, both male and female, who were vaccinated with TWINRIX.  Beginning in September 2007, the subjects received their third dose of TWINRIX (unknown).  Between September 2007 and the time of reporting on 17 October 2007, the subjects underwent unspecified blood tests that yielded abnormal results.  The blood tests for each subject were performed one week after the third dose of TWINRIX, and the abnormal blood test results prevented the subjects from future blood donation.  The blood test was manufactured by Abbott, and reportedly had increased sensitivity over "their testing in the past".  The reporting physician believed that there was "some quality issue or formulation change with the TWINRIX vaccine that is causing these test results, since they have used TWINRIX for years and never seen these test results until September 2007" (product complaint).  At the time of reporting the events were unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain, Sensation of heaviness
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of arm heavy in a subject of unspecified gender and noted not to be pediatric who was vaccinated with TWINRIX, GlaxoSmithKline.  The healthcare professional reported to the sales representative that, "patients" experienced adverse events following receipt of vaccination with TWINRIX, however, a specific number of subjects was not reported.  On 21 November 2007, the healthcare professional indicated that "within the past month" the subject received unspecified dose of TWINRIX (1 ml, unknown, unknown arm).  The date of administration of TWINRIX was not provided.  In 2007, less than one month after vaccination with TWINRIX, the subject experienced heaviness in the arm, injection site burning, and injection site pain.  The healthcare professional indicated a product complaint reporting that the office was concerned there was a quality assurance issue with the TWINRIX.  The healthcare professional noted that there have been no changes in administration technique, needles, or individuals giving the vaccine and that the office has never had reports of this before.  The healthcare professional reported the events and product complaints with lot numbers AHABB107AA and AHABB107BA.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Age: 48.0
Sex: M
Vaccine: HEPAB
Symptoms: Antibody test abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of decreased therapeutic response in a 48-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has no verified this report. Concurrent medications included LIPITOR. On unspecified dates he subject received three doses of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced decreased therapeutic response. On an unspecified date following vaccination, a laboratory test to check for titers was performed. On 2 November 2007, the subject was informed that the results were lower than expected. The subject was not aware if hepatitis A or hepatitis B or both results were lower then expected. Medical attention was not required. The subject also noted that he was not sure if the product was TWINRIX, but believes that it is. At the time of reporting the outcome of the event was unspecified.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), MMR vaccine (Merck). Relevant medical history included a previous vaccination with ADACEL on 26 November 2007. One day after the subject received ADACEL, she experienced fever and chills. This was the first vaccine that the subject had ever received. Not previously vaccinated with any of the childhood vaccines. Concurrent medical conditions included allergy to alum. On 30 November 2007, the subject received 1st dose of TWINRIX (1 ml, intramuscular, right arm) and 1st dose of MMR vaccine (subcutaneous, right arm). Three to four hours after vaccination with MMR vaccine and TWINRIX, the subject experienced nausea, vomting and fever. Medical attention was not required. It was reported that the immunization series was delayed. At the time of reporting the event were resolved.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline).  Concurrent vaccination included MMR vaccine (Merck) administered on 30 November 2007, subcutaneously, in the right arm.  Previous vaccination included ADACEL (TDAP) given on 26 November 2007 in the left arm.  The subject experienced chills and fever one day following vaccination with ADACEL.  These events were said to have resolved.  On 30 November 2007 the subject received 1st dose of TWINRIX at 1.0 ml, intramuscularly in the right arm.  On 30 November 2007 (at 19:30), about 3 to 4 hours after vaccination with TWINRIX (and MMR vaccine), the subject experienced nausea, vomiting and fever.  The events reportedly resolved by 02 December 2007.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Diarrhoea, Erythema, Fatigue, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of soreness (generalized) in a 39-year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  The subject's medical history included hepatitis A and typhoid.  Concurrent medical conditions included epilepsy.  Concurrent medications included Levetiracetam (Keppra).  On an unspecified date the subject received 1st dose, 2nd dose of TWINRIX and on 11 December 2007 at 09:00 the subject received 3rd dose of TWINRIX (1 ml, left arm).  At an unspecified time after vaccination with the first and second dose of TWINRIX, the subject experienced tiredness.  On 11 December 2007 in the early afternoon following vaccination with the third dose of TWINRIX, the subject experienced soreness all over and in the evening she experienced tiredness.  In the morning of 12 December 2007, one day after vaccination with TWINRIX, she experienced cheeks that were beet red, fever, tingling from waist down, tingling on her cheeks, two episodes of diarrhea and increased thirst.  She also reported that she has been so tired that she was unable to get out of bed.  The reporter noted that the soreness, tiredness, tingling from the waist down and tingling on her cheeks improved.  The diarrhea and the beet red cheeks resolved.  The tiredness that she experienced following the first two doses also resolved in a couple of days.  At the time of reporting the outcome of the fever, increased thirst and inability to get out of bed were unspecified.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Paraesthesia, Pyrexia, Thirst
Clinical narrative: This case was reported by a consumer and described the occurrence of soreness (generalized) in a 39-year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  The subject's medical history included hepatitis A and typhoid.  Concurrent medical conditions included epilepsy.  Concurrent medications included Levetiracetam (Keppra).  On an unspecified date the subject received 1st dose, 2nd dose of TWINRIX and on 11 December 2007 at 09:00 the subject received 3rd dose of TWINRIX (1 ml, left arm).  At an unspecified time after vaccination with the first and second dose of TWINRIX, the subject experienced tiredness.  On 11 December 2007 in the early afternoon following vaccination with the third dose of TWINRIX, the subject experienced soreness all over and in the evening she experienced tiredness.  In the morning of 12 December 2007, one day after vaccination with TWINRIX, she experienced cheeks that were beet red, fever, tingling from waist down, tingling on her cheeks, two episodes of diarrhea and increased thirst.  She also reported that she has been so tired that she was unable to get out of bed.  The reporter noted that the soreness, tiredness, tingling from the waist down and tingling on her cheeks improved.  The diarrhea and the beet red cheeks resolved.  The tiredness that she experienced following the first two doses also resolved in a couple of days.  At the time of reporting the outcome of the fever, increased thirst and inability to get out of bed were unspecified.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug eruption, Inappropriate schedule of drug administration, Pruritus, Rash maculo-papular, Rash papular
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of maculopapular rash in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. Previous vaccination included TWINRIX (GlaxoSmithKline) given in December 2007 (around the 25th). Concurrent medications included allergy medication, blood pressure medication, and anti-hypercholesterolaemic. The subject had a history of allergies, high cholesterol and high blood pressure. On 2 January 2008 the subject received 2nd dose of TWINRIX at 1.0 ml following the accelerated dosing schedule. Sometime between the time the subject received the 2nd dose of TWINRIX and the day of reporting, 07 January 2008, the subject developed a maculopapular rash on his shin. The physician was unsure if the event was due to TWINRIX or if the subject suffers from "winter skin," meaning itchy skin due to winter weather. At the time of reporting the event was unresolved. On 09 January 2008, follow-up was received by the physician. It was reported that the subject experienced a papular rash on his legs after receiving the second dose of TWINRIX. Later on 09 January 2008, further follow-up was provided by the physician. concurrent vaccinations included TWINRIX that was received on 19 December 2007 and YELLOW FEVER vaccine given with either the first or second TWINRIX dose. concurrent medications were noted to include LIPITOR, SINGULAIR, VERAPAMIL and  AIRBORN. Medical history included a sulfa allergy and mild asthma. No history of adverse events following previous vaccinations. The physician reported that the 65 year old male subject received the second dose of TWINRIX on 02 January 2008 in his left arm at 10:30 Am. On 02 January 2008, 24 hours after receiving the second dose (accelerated dosing schedule), the subject developed a maculopapular rash on his shins (from the knee to the ankle). The subject was seen in the physician's office and the physician stated that the rash looks like a drug rash. The subject also experienced inappropriate schedule of vaccine administered. At the time of reporting, the outcome of the rash was unresolved. The physician considered that it was unknown if the events were related to the use of TWINRIX.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Pharyngeal oedema, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lip swelling in a 51-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included TWINRIX; given on an unspecified date. On 3 January 2008, the subject received 2nd dose of TWINRIX (1 ml, left arm). On 3 January 2008, less than one day after vaccination with TWINRIX, the subject experienced lip swelling, rash of arm and chest and felt like his throat was swelling up. The subject was treated with antihistamine and the adverse events improved. The following day still was swollen and the rash was still present. On 05 January 2008, the event were resolved.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody abnormal, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 55-year-old male subject not responding to therapy following vaccination with TWINRIX for prophylaxis. On an unknown date, the subject completed a series of TWINRIX. A second three dose series of TWINRIX was started in March 2007. The 3rd dose of the second series was administered in September 2007. On month following administration of the 3rd dose of TWINRIX, on 30 October 2007, a titer was taken and showed that the subject was responding to therapy. He was hepatitis A antibody negative and had a hepatitis B antibody level of less than 0.1. At the time of reporting, the subject's lack of response to therapy was unresolved. Follow-up information received on 31 January 2008 indicated that the subject received a series of hepatitis immunizations several years ago.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Body temperature increased, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of viral illness in a 20-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 15 January 2008, the subject received 1st dose of TWINRIX (1 ml). Six days after vaccination with TWINRIX, on 21 January 2008, the subject experienced influenza-like symptoms, low grade fever, headache, nausea and vomiting. The subject's mother had contacted the primary care physician and stated that the physician believed that it was a viral illness. The mother questioned whether the events could have been caused by the TWINRIX. At the time of reporting, the outcome of the events were unspecified. Follow-up received via the pharmacist on 20 February 2008. She reported that the events resolved and she considered that they were not serious. It was also noted that the vaccination series was going to be delayed as the subject wanted to wait until summer to continue. She noted that the events were possibly related to the use of TWINRIX.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of viral illness in a 20-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 15 January 2008, the subject received 1st dose of TWINRIX (1 ml). Six days after vaccination with TWINRIX, on 21 January 2008, the subject experienced influenza-like symptoms, low grade fever, headache, nausea and vomiting. The subject's mother had contacted the primary care physician and stated that the physician believed that it was a viral illness. The mother questioned whether the events could have been caused by the TWINRIX. At the time of reporting, the outcome of the events were unspecified. Follow-up received via the pharmacist on 20 February 2008. She reported that the events resolved and she considered that they were not serious. It was also noted that the vaccination series was going to be delayed as the subject wanted to wait until summer to continue. She noted that the events were possibly related to the use of TWINRIX.