chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: DTPHIB, HPV4
Symptoms: Blood iron, Blood test, Computerised tomogram, Full blood count, Influenza like illness
Clinical narrative: Began with flu like symptoms. Returned to doctor on Sat. 9/22 to be diagnosed with flu. Noticed on Oct 3 increased swelling ER visit lots of inconclusive tests. Returned to primary doctor to get a new diagnosis then back for blood work. ER again then admitted on Oct 4 for increased swelling around throat and heart. Test all coming back inconclusive. She was on her monthly cycle first since receiving the shot. 4/11/08-record received-DOS 10/4-10/507-Presented with 2-3 days history of edema with acute onset of bilateral lower extremity swelling. C/O slight shortness of breath and 15-19 pound weight gain in last 2 weeks. Head, neck and mandible swollen. Difficulty swallowing.
Age: 17.0
Sex: F
Vaccine: DTPHIB, HPV4
Symptoms: Laboratory test, Pharyngeal oedema, Thyroid function test, Urine analysis
Clinical narrative: Began with flu like symptoms. Returned to doctor on Sat. 9/22 to be diagnosed with flu. Noticed on Oct 3 increased swelling ER visit lots of inconclusive tests. Returned to primary doctor to get a new diagnosis then back for blood work. ER again then admitted on Oct 4 for increased swelling around throat and heart. Test all coming back inconclusive. She was on her monthly cycle first since receiving the shot. 4/11/08-record received-DOS 10/4-10/507-Presented with 2-3 days history of edema with acute onset of bilateral lower extremity swelling. C/O slight shortness of breath and 15-19 pound weight gain in last 2 weeks. Head, neck and mandible swollen. Difficulty swallowing.
Age: 34.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: LEFT ARM AROUND INJECTION SITE RED, SWOLLEN, WARM, PAINFUL.SHE HAD A PHYSICAL YESTERDAY AND THE DOCTOR ADVISED COOL COMPRESSES. I ADVISED HER TO DO THE SAME AND IF THE ARM SWELLS TO ELEVATE IT ON A PILLOW AND TAKE TYLENOL FOR PAIN ONE OR TWO TABLETS. IF SYMPTOMS BECOME WORSEN TO SEE HER PRIMARY CARE DOCTOR SUCH AS INCREASING PAIN,SWELLING,HEAT, WARMTH,REDNESS, DRAINAGE AND PUS AND A FOUL ODOR.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Injection site discomfort, Injection site erythema
Clinical narrative: 11/30/07- At approx 1:16 pm- Hepatitis B vaccine was given in Left deltoid, within 1 minute a firm nodule was palpated at the injection site, the pt noted mild discomfort,and there was erythema noted at the location of the left deltoid.  At approx 1:20 pm the Hepatitis A vaccine was given in the Right deltoid without discomfort, nodule noted, or erythema.  At approx 1:21 pm the patient reported that she did not feel good and felt like she was going to pass out.  The patient then leaned to the side in her chair.  Pt did not loose consciousness, but became diaphoretic, hypotensive, and bradycardic.  Epinephrine 0.3 mg was given and 911 was called.  Pt responded to epinephrine within 5 min.  Pt was taken to ER via ambulance for evaluation.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site nodule, Malaise
Clinical narrative: 11/30/07- At approx 1:16 pm- Hepatitis B vaccine was given in Left deltoid, within 1 minute a firm nodule was palpated at the injection site, the pt noted mild discomfort,and there was erythema noted at the location of the left deltoid.  At approx 1:20 pm the Hepatitis A vaccine was given in the Right deltoid without discomfort, nodule noted, or erythema.  At approx 1:21 pm the patient reported that she did not feel good and felt like she was going to pass out.  The patient then leaned to the side in her chair.  Pt did not loose consciousness, but became diaphoretic, hypotensive, and bradycardic.  Epinephrine 0.3 mg was given and 911 was called.  Pt responded to epinephrine within 5 min.  Pt was taken to ER via ambulance for evaluation.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: sl swelling of face night of vaccine admin. Hives the next day, increased in severity over next 2 days. Day one given Benadry, day 2 given Benadryl and Rx for steriods with relief. C/o hives and itching.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Patient returned to health center on 11/29/07 one day after receiving 6 month vaccines plus Flu vaccine.  All sites of administration with erythema and induration; Left thigh with greater degree of symptoms. Also fever since 4 am. Insertion sites less than one inch apart.  Cool compresses and gentle massage ordered to sites, along with body temperature monitoring.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Asthenia, Burning sensation, Cognitive disorder, Eyelid ptosis
Clinical narrative: Burning left-side after the first vaccination (10/16/06). It went away before the second vaccination. Painful right side after the second vaccination (11/15/06). Still have the pain(neuropathy) till date. In the spring of 2007, I started feeling unexplainably weakness(fatigue)and the left knee felt like there was no fluid in it. All I could hear was a cracking sound.Then in the summer, I couldn't hold anything with the left hand without dropping it. My right eye started drooping and I couldn't walk without being held. Also had breakouts and cognitive problems. My primary care doctor gave me Famvir for the breakouts. I was then admitted in the hospital in August 2007 where I was diagnosed with MS.  12/26/2007 MR received for DOS 8/06-10/2007 with D/C Dx:  Multiple Sclerosis.  Weakness 2' to above. Pt presented to PMD with c/o increasing weakness over previous 2 weeks, requiring assistance with walking.  Pt notes decrease in intensity of voice/speech and some drooping of L eyelid. Admitted for further testing.  Pt first noted sx (L sided weakness) following vaccines in Fall 2006 but sx resolved.  PE (+) for R eyelid ptosis. 3/5 motor weakness.  DTRs 3+ at the knees. Neuro consult for progressive L sided weakness in a setting of double vision/headaches.  DTRs 0-1 bilaterally on exam.  Pt txd with IV steroids. Strength and ambulation improved prior to d/c.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Full blood count, Gait disturbance, Hypokinesia, Injection site irritation
Clinical narrative: Burning left-side after the first vaccination (10/16/06). It went away before the second vaccination. Painful right side after the second vaccination (11/15/06). Still have the pain(neuropathy) till date. In the spring of 2007, I started feeling unexplainably weakness(fatigue)and the left knee felt like there was no fluid in it. All I could hear was a cracking sound.Then in the summer, I couldn't hold anything with the left hand without dropping it. My right eye started drooping and I couldn't walk without being held. Also had breakouts and cognitive problems. My primary care doctor gave me Famvir for the breakouts. I was then admitted in the hospital in August 2007 where I was diagnosed with MS.  12/26/2007 MR received for DOS 8/06-10/2007 with D/C Dx:  Multiple Sclerosis.  Weakness 2' to above. Pt presented to PMD with c/o increasing weakness over previous 2 weeks, requiring assistance with walking.  Pt notes decrease in intensity of voice/speech and some drooping of L eyelid. Admitted for further testing.  Pt first noted sx (L sided weakness) following vaccines in Fall 2006 but sx resolved.  PE (+) for R eyelid ptosis. 3/5 motor weakness.  DTRs 3+ at the knees. Neuro consult for progressive L sided weakness in a setting of double vision/headaches.  DTRs 0-1 bilaterally on exam.  Pt txd with IV steroids. Strength and ambulation improved prior to d/c.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Lumbar puncture, Lumbar puncture abnormal, Multiple sclerosis, Muscular weakness
Clinical narrative: Burning left-side after the first vaccination (10/16/06). It went away before the second vaccination. Painful right side after the second vaccination (11/15/06). Still have the pain(neuropathy) till date. In the spring of 2007, I started feeling unexplainably weakness(fatigue)and the left knee felt like there was no fluid in it. All I could hear was a cracking sound.Then in the summer, I couldn't hold anything with the left hand without dropping it. My right eye started drooping and I couldn't walk without being held. Also had breakouts and cognitive problems. My primary care doctor gave me Famvir for the breakouts. I was then admitted in the hospital in August 2007 where I was diagnosed with MS.  12/26/2007 MR received for DOS 8/06-10/2007 with D/C Dx:  Multiple Sclerosis.  Weakness 2' to above. Pt presented to PMD with c/o increasing weakness over previous 2 weeks, requiring assistance with walking.  Pt notes decrease in intensity of voice/speech and some drooping of L eyelid. Admitted for further testing.  Pt first noted sx (L sided weakness) following vaccines in Fall 2006 but sx resolved.  PE (+) for R eyelid ptosis. 3/5 motor weakness.  DTRs 3+ at the knees. Neuro consult for progressive L sided weakness in a setting of double vision/headaches.  DTRs 0-1 bilaterally on exam.  Pt txd with IV steroids. Strength and ambulation improved prior to d/c.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Neurological examination normal, Neuropathy, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain
Clinical narrative: Burning left-side after the first vaccination (10/16/06). It went away before the second vaccination. Painful right side after the second vaccination (11/15/06). Still have the pain(neuropathy) till date. In the spring of 2007, I started feeling unexplainably weakness(fatigue)and the left knee felt like there was no fluid in it. All I could hear was a cracking sound.Then in the summer, I couldn't hold anything with the left hand without dropping it. My right eye started drooping and I couldn't walk without being held. Also had breakouts and cognitive problems. My primary care doctor gave me Famvir for the breakouts. I was then admitted in the hospital in August 2007 where I was diagnosed with MS.  12/26/2007 MR received for DOS 8/06-10/2007 with D/C Dx:  Multiple Sclerosis.  Weakness 2' to above. Pt presented to PMD with c/o increasing weakness over previous 2 weeks, requiring assistance with walking.  Pt notes decrease in intensity of voice/speech and some drooping of L eyelid. Admitted for further testing.  Pt first noted sx (L sided weakness) following vaccines in Fall 2006 but sx resolved.  PE (+) for R eyelid ptosis. 3/5 motor weakness.  DTRs 3+ at the knees. Neuro consult for progressive L sided weakness in a setting of double vision/headaches.  DTRs 0-1 bilaterally on exam.  Pt txd with IV steroids. Strength and ambulation improved prior to d/c.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Burning left-side after the first vaccination (10/16/06). It went away before the second vaccination. Painful right side after the second vaccination (11/15/06). Still have the pain(neuropathy) till date. In the spring of 2007, I started feeling unexplainably weakness(fatigue)and the left knee felt like there was no fluid in it. All I could hear was a cracking sound.Then in the summer, I couldn't hold anything with the left hand without dropping it. My right eye started drooping and I couldn't walk without being held. Also had breakouts and cognitive problems. My primary care doctor gave me Famvir for the breakouts. I was then admitted in the hospital in August 2007 where I was diagnosed with MS.  12/26/2007 MR received for DOS 8/06-10/2007 with D/C Dx:  Multiple Sclerosis.  Weakness 2' to above. Pt presented to PMD with c/o increasing weakness over previous 2 weeks, requiring assistance with walking.  Pt notes decrease in intensity of voice/speech and some drooping of L eyelid. Admitted for further testing.  Pt first noted sx (L sided weakness) following vaccines in Fall 2006 but sx resolved.  PE (+) for R eyelid ptosis. 3/5 motor weakness.  DTRs 3+ at the knees. Neuro consult for progressive L sided weakness in a setting of double vision/headaches.  DTRs 0-1 bilaterally on exam.  Pt txd with IV steroids. Strength and ambulation improved prior to d/c.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: PT presented to the clinic with an adverse reaction to the smallpox vaccination. The Pt received the vaccination on the Nov 5, 2007. The following day the PT removed bandage before he showered and did not recover site. PT followed with medical clinic the following week. PT was told site was healed, but was instructed to wash bed sheets, recover site, and wear long sleeves to insure that vaccination would not spread. PT did not comply with recovering site. PT noticed red spots on arms on the 26th of November. PT flew on the 27th of November to another country. Upon arriving he noticed sores that began to form. PT called for an appointment on the 4th of December. PT was seen and provider verified that his smallpox has spread underneath his arms, down his arms, buttocks, back, and on the backside of his leg. PMT was contacted and a VAERS report was entered. PT was instructed that he most stay isolated in his room and that he most be careful not scratch. He was also instructed to wash his laundry to prevent further spreading. PT is to follow up with the medical provider in 3 days. Pt is also aware that he unable to fly until on sores have scabbed over.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Severe pain in deltoid region (at the site of injection) began within 2 hours of vaccination.  Pain has continued for more than a month with little improvement and consistent worsening. Swelling and pain at more than a month.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture, Discomfort, Erythema, Full blood count, Oedema peripheral
Clinical narrative: PATIENT DEVELOPED DIFFUSE SWELLING OF THE DELTOID WITH ONLY MINIMAL DISCOMFORT AND ERRYTHEMA.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate
Clinical narrative: PATIENT DEVELOPED DIFFUSE SWELLING OF THE DELTOID WITH ONLY MINIMAL DISCOMFORT AND ERRYTHEMA.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Recurring chills, headache, myalgias, arthralgias which started 1 day after receiving flu vaccine.  Sx persistent at 2 weeks.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood glucose increased, Injection site erythema
Clinical narrative: Redness around injection site, achy joints, elevated blood sugar beginning 11/28/07.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: I got the flu worse with the shot than without it.  I feel more work needs to be done with it before it is administered.  Every year it is the same problem.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Varicella like rash appeared near L shoulder 2-3 days after receiving Zostavax on 11/18/07.  The rash is pruritic.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Blister
Clinical narrative: 2 small blisters - one on each thigh. (R) thigh approx 1 inch from needle mark anterior. (L) lateral thigh, approx 2 inches from needle site. No redness, no signs of infection.
Age: 56.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Neck stiffness and headaches. 11/12/07 above pt was advised to see her regular MD for further eval and tx.
Age: 14.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bradycardia, Hypotonia, Oxygen saturation, Oxygen saturation decreased, Oxygen supplementation
Clinical narrative: 1-2 minutes after administration of both injections she became unresponsive to voice & smelling salts; pale; hypotonic in chair; bradycardic 38 bpm; pulse oximeter 90% - placed on oxygen via rebreather; placed on floor with legs elevated-epinephrine, Benadryl and solumedrol steroid IM-via EMS to hospital.
Age: 14.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: 1-2 minutes after administration of both injections she became unresponsive to voice & smelling salts; pale; hypotonic in chair; bradycardic 38 bpm; pulse oximeter 90% - placed on oxygen via rebreather; placed on floor with legs elevated-epinephrine, Benadryl and solumedrol steroid IM-via EMS to hospital.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Same day as shots developed fever, chills, body aches, swelling at sit of pneumovax.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large area of swelling and redness of the site of injection with itching.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction
Clinical narrative: Injection site reaction to Prevnar.  Patient has a dime size pinkish-red spot with a quarter size knot underneath at injection site.  Reaction started on 10/16/07 and still present on 10/18/07 in office.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Vomiting
Clinical narrative: Diarrhea up to 11 times 3 days after vaccination yesterday 10/17/07.  Diarrhea x 6.  Vomiting.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Influenza vaccine administered 10-20-07; 10-22-07 pt. presented in office with a 6cm x 7 1/2cm area of erythema L anterior thigh, no induration, no warmth or tenderness with palpation.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness (erythema) & edema at injection site within 24 hours of Varivax #2 given to R lateral upper arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia, Syncope
Clinical narrative: Fever, chills, syncope, pain & swelling at injection site.
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Swelling/erythema right thigh.  Prescription cold compress. Resolved by prescription.
Age: 19.0
Sex: F
Vaccine: HEPAB, MMR, TD
Symptoms: Drug exposure during pregnancy
Clinical narrative: None - patient 5 months pregnant and received MMR vaccine on 12/3/07.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 2 x 2 cm area of induration, swelling, mild tenderness at routine site left deltoid area.  Patient seen 12/1.  Recommended Tylenol or Moltrin, ice pack, Benadryl.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Reported 11/30/07. Sore swollen arm (L) site increased in size - hot and red - Pt describes decrease in use - told to see doctor or go to Urgent Care - went to clinic 11/30/07. Given Indocin - Lortab/Zithromax.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling & redness of L anterior thigh with swelling to knee & redness & warmth.  Improved 24 hours later.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Both arms and thighs have rash.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Gaze palsy, Sluggishness, Syncope
Clinical narrative: Patient had delayed immunization schedule and immunisation was being updated on 11-19-07 at around 2 PM. Patient got DTaP, IPV, MMR, and Hep A. While he was to step out of waiting room, he collapsed with eyes rolling backwards but no abnormal body movements. Patient was responding sluggishly but appropriately. Vital signs were normal.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: I broke out in hives within a day of getting the vaccine. These hives were mainly on the back of my thigh, buttocks and wrists. They persisted for about 3 days and I still have the residual bump but are no longer itchy.
Age: 72.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Given MMR on 11/21/07 (volunteer worker). Presented to hospital ER 11/24/07 with T 101, C/S V/D. W/U: CXR negative, WBC 5.38 with 80 seg bands, BC/UC negative. Seen in f/u 11/27/07 - sx slowly resolving.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Received DTaP, IPV in left arm - 11-26-07. Grandmother noticed arm swollen; took child to ER. Warm, tender to touch. ER doctor gave antibiotic. Pt seemed fine at HD this AM - arm swollen.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm at vaccine site red, swollen, warm to touch. Cold pack applied to site.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Joint stiffness, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: Soreness noted after receiving shot. 3 hours after receiving shot felt lymph nodes on (L) arm swelling. Next morning noticed stiffness in joints (shoulder). (L) arm, slight stiffness in (R) shoulder, felt tingling in (L) arm and fingers. No shortness of breath, alert.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pain
Clinical narrative: Left arm red three inches and a half measured.  Painful to touch & red.  Small blister at center of redness.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC
Symptoms: Pruritus, Rash
Clinical narrative: With Spanish interpreter mother states child had a rash, itching after immunization at pvt. Drs office.  Then mother states she was unsure of when child had problems after immunizations.  She has had immunizations at pvt. Dr, public clinic and other.  Inconclusive regarding when problems occurred.  Child has had immunizations of Hep B, DTaP, Hib, PCV, IPV, MMR and Varicella.
Age: 25.0
Sex: M
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Pt had lyme vaccination. After then
Age: 31.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of joint paint in a 31 year old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. There were no concurrent medications. The subject reported he had experienced headache and flu-like symptoms in the past with other vaccines. The subject received 1st dose of Twinrix in the summer of 2004. On 20 September 2006, the subject received 2nd dose of Twinrix (right arm). On 24 or 25 September 2006, 4-5 days after vaccination with Twinrix, the subject reported that his ankles, wrists, and elbows began to hurt and were swollen. He reported no visible bruises, however, his ankles and wrists felt as if they were bruised. He also reported his ankles, wrists, and the bottoms of his feet hurt when they were touched. The subject described the pain as a "nagging pain". On an unspecified date in September2006, after receiving Twinrix, the subject experienced fatigue, headache, flu-like symptoms, and his gums hurt. He described the fatigue as "extreme" and stated that "he felt as if he were 100 years old". The subject reported that when he ran for approximately 30 minutes on 09 October 2006, "the pain faded after running approximately 1/2 miles, however, it returned twice as bad after he showered and dressed". he stated he is usually pretty active but for the last few weeks, he has not been able to do much more than what he absolutely has to do to make it through the day. He reported walking has become easier. The subject was treated with Motrin twice a day. He reported "the bloodwork results were good". He is schedule to see his physician for a follow-up visit on 11 October 2006. At the time of reported, the flu-like symptoms, gums hurt and headache had resolved, but joint pain, swelling of joints, fatigue, and sensations of bruising were unresolved.
Age: 31.0
Sex: M
Vaccine: HEPAB
Symptoms: Joint swelling, Oral pain
Clinical narrative: This case was reported by a consumer and described the occurrence of joint paint in a 31 year old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. There were no concurrent medications. The subject reported he had experienced headache and flu-like symptoms in the past with other vaccines. The subject received 1st dose of Twinrix in the summer of 2004. On 20 September 2006, the subject received 2nd dose of Twinrix (right arm). On 24 or 25 September 2006, 4-5 days after vaccination with Twinrix, the subject reported that his ankles, wrists, and elbows began to hurt and were swollen. He reported no visible bruises, however, his ankles and wrists felt as if they were bruised. He also reported his ankles, wrists, and the bottoms of his feet hurt when they were touched. The subject described the pain as a "nagging pain". On an unspecified date in September2006, after receiving Twinrix, the subject experienced fatigue, headache, flu-like symptoms, and his gums hurt. He described the fatigue as "extreme" and stated that "he felt as if he were 100 years old". The subject reported that when he ran for approximately 30 minutes on 09 October 2006, "the pain faded after running approximately 1/2 miles, however, it returned twice as bad after he showered and dressed". he stated he is usually pretty active but for the last few weeks, he has not been able to do much more than what he absolutely has to do to make it through the day. He reported walking has become easier. The subject was treated with Motrin twice a day. He reported "the bloodwork results were good". He is schedule to see his physician for a follow-up visit on 11 October 2006. At the time of reported, the flu-like symptoms, gums hurt and headache had resolved, but joint pain, swelling of joints, fatigue, and sensations of bruising were unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described a subject of unspecified age and gender who did not respond to immunization with Twinrix for prophylaxis. On an unspecified date on or before 07 November 2006, the subject received unspecified dose of Twinrix. At an unspecified time after vaccination with Twinrix, on an unspecified date on or before 07 November 2006, serology tests for hepatitis A antibody and hepatitis B surface antibody were negative.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described a subject of unspecified age and gender who did not respond to immunizations with Twinrix for prophylaxis. On an unspecified date on or before 07 November 2006, the subject received unspecified dose of Twinrix. At an unspecified time after vaccination with Twinrix, on an unspecified date on or before 07 November 2006, serology tests for hepatitis A antibody and hepatitis B surface antibody were negative.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody positive
Clinical narrative: This case was reported by a healthcare professional and described a 35 year old male subject who tested positive for hepatitis B surface antigen following vaccination with hepatitis B vaccine for prophylaxis. The subject's medical history included positive hepatitis C. On 31 October 2006 the subject received unspecified dose of hepatitis B vaccine. On 01 November 2006, 1 day after vaccination with hepatitis B vaccine, the subject tested positive for hepatitis B surface antigen. On 31 October 2006, the subject also received an unspecified dose of hepatitis a vaccine. The outcome of the event was not reported. Follow-up was received from the healthcare professional on 19 December 2006. The subject received Twinrix rather than separate injections of hepatitis B vaccine and hepatitis A vaccine as initially reported. The subject received the 1st dose of Twinrix on 31 October 2006 and tested positive for hepatitis B surface antigen on 01 November 2006. The immunization series with Twinrix was delayed "until the follow-up blood work results were available." On 08 December 2006, a repeat test for hepatitis B surface antigen was negative and serology results for hepatitis B core IgM were negative.
Age: 75.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction in a 75 year old male subject who was vaccinated with Twinrix for prophylaxis. On an unspecified date in 2004, the subject received the first and only dose of Twinrix (1ml, unknown). On an unspecified date(s) in 2004, at an unspecified time after vaccination with Twinrix, the subject experienced a local reaction at the injection site that was red, swollen and tender. The subject reported that the events were severe. The immunization series was discontinued.  On an unspecified date(s) in 2004, the events were resolved. The healthcare professional considered the events were probably related to vaccination with Twinrix.
Sex: U
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of decreased therapeutic response [[name]] subject of unspecified age and gender who was vacc[[name]]ted with Twinrix for prophylaxis. Concurrent medical conditions included human immunodeficiency virus. On an unspecified date the subject received unspecified dose of Twinrix (unknown). At an unspecified time after vacc[[name]]tion with Twinrix, the subject experienced decreased therapeutic response. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis. Concurrent medical conditions included HIV positive status. On unspecified dates the subject received three separate doses of Twinrix (1ml for third dose, unreported dosing for first two doses). At an unspecified time after completing the third dose of Twinrix, the subject was found to not have responded to the hepatitis B portion of therapy. No diagnostic tests were reported. The reporter noted that no additional information was known regarding the subject and that the subject  may have been the physician's patient or may have seen the physician via consult. At the time of reporting the outcome of the event was unspecified.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Back pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of back pain in a 53 year old male subject who was vaccinated with Twinrix for prophylaxis. On 26 March 2007 at 16:00 the subject received 2nd dose of Twinrix (1ml, unknown, left arm). One hour after vaccination with Twinrix, the subject experienced back pain, radiating leg pain in both legs, leg stiffness and difficulty moving legs. At the time of reporting the events were unresolved.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 46 year old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent medical conditions included diabetes. Concurrent medications included Insulin, Atenolol, Spironolactone and "sifaxan". On 22 May 2006, the subject received 3rd dose of Twinrix (unknown). She received 1st and 2nd doses of Twinrix on unspecified dates. On an unspecified date in 2007, after completing the 3 dose Twinrix series, the subject did not respond to Twinrix therapy, as indicated by unspecified "titers that were drawn within the last month". As a result of not responding to therapy with Twinrix, the pharmacist reported that the subject's physician had written the subject a prescription for 40mcg of Engerix B. At the time of reporting the outcome of the event was unspecified.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a consumer and described the occurrence of a 46 year old female subject testing negative for  hepatitis B antibody's following vaccination with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included arm fracture. Concurrent medical conditions included cirrhosis, hypertension and type II diabetes. Concurrent medications included insulin and unknown medications. In January 2007, the subject received a dose of Twinrix, third in the series. Dates of 1st and 2nd administrations of Twinrix were not known. In February 2007, the subject tested negative for hepatitis B antibody's. At the time of reporting the outcome of the event was unspecified. Follow-up received via physician. The subject received the initial dose approximately June 2006. The reporter considered that the events were serious but did not indicate a serious criteria. The reporter stated that the events could have been associated with the history of cirrhosis. The reporter considered that the events were related to the use of Twinrix. The events were unresolved at the time of reporting.
Sex: U
Vaccine: HEPAB
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Twinrix (unknown). In 2006 at an unspecified time after vaccination with twinrix, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEPAB
Symptoms: Laboratory test, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a female subject of unspecified age who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  On an unspecified dates the subject received the Twinrix series (unknown).  At an unspecified time after vaccination with Twinrix, the subject experienced decreased therapeutic response.  On an unspecified date, post-vaccination titers were performed by a physician which revealed that the subject had not adequately responded to the Twinrix series.  The physician was considering additional Twinrix dose(s) to "boost" the subject's response.  The reporter did not know the timing of the titers after the completion of the vaccination series or if the "non-response" was to hepatitis A, hepatitis B, or both components.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Malaise
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of "got sick" in an adult male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  The healthcare professional reported on 26 April 2007 that she, "had heard from another practice" that a subject received unspecified dose of Twinrix "last year."  At an unspecified time after vaccination with Twinrix, the subject "got sick."  The healthcare professional also reported that this dose of Twinrix was "administered with the accelerated dosing schedule."  At the time of initial reporting, 26 April 2007, the outcome of the event was unspecified.  The healthcare professional considered the event to possibly be related to vaccination with Twinrix.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Balance disorder, Blood test normal, Computerised tomogram, Gait disturbance, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of numbness on one side of body in a 50-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The reporting consumer is the subject's boyfriend.  The subject was described as premenopausal.  Concurrent medications included Sertraline hydrochloride (Zoloft).  On 05 April 2007 the subject received the first dose of Twinrix (1 ml, unknown, left arm).  On 6 April 2007, 1 day after vaccination with Twinrix, the subject experienced numbness on the right side of her body, swelling in the lower right extremities, loss of balance, and walking difficulty.  The subject's numbness started in the lower extremities, but moved to the neck as well.  The numbness reportedly occurred on the right side only.  Additionally, she developed headache and blurred vision on an unspecified date.  She reported to a physician's office for unspecified medical attention.  Blood and urine tests and a computed axial tomography scan were reportedly "all negative".  The reporting consumer noted that the swelling of the lower right extremity was "particularly bad" in the subject's toes.  At the time of reporting the events were worse.  The vaccination course with Twinrix was discontinued.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Swelling, Urine analysis normal, Vision blurred
Clinical narrative: This case was reported by a consumer and described the occurrence of numbness on one side of body in a 50-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The reporting consumer is the subject's boyfriend.  The subject was described as premenopausal.  Concurrent medications included Sertraline hydrochloride (Zoloft).  On 05 April 2007 the subject received the first dose of Twinrix (1 ml, unknown, left arm).  On 6 April 2007, 1 day after vaccination with Twinrix, the subject experienced numbness on the right side of her body, swelling in the lower right extremities, loss of balance, and walking difficulty.  The subject's numbness started in the lower extremities, but moved to the neck as well.  The numbness reportedly occurred on the right side only.  Additionally, she developed headache and blurred vision on an unspecified date.  She reported to a physician's office for unspecified medical attention.  Blood and urine tests and a computed axial tomography scan were reportedly "all negative".  The reporting consumer noted that the swelling of the lower right extremity was "particularly bad" in the subject's toes.  At the time of reporting the events were worse.  The vaccination course with Twinrix was discontinued.
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Lethargy, Nausea, Weight increased
Clinical narrative: This case was reported by a consumer and described the occurrence of weight gain in an adult female subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Flagyl, taken at the time of the first vaccination with Twinrix. On 12 March 2007, September 206 and August 2006 the subject received 3rd dose, 2nd dose and 1st dose of Twinrix in the left arm. At an unspecified time after the 1st vaccination with Twinrix, the subject experienced weight gain, headache, lethargy and nausea. The weight gain continued with the 2nd and 3rd doses of Twinrix. No life style changes were reported. The exact amount of weight gained was not known by the subject. Headache and lethargy resolved at an unspecified time. The outcome of nausea was not reported. The subject reported that the 3rd dose of Twinrix was administered to her without being shaken first. This was reported as a medication error.
Sex: U
Vaccine: HEPAB
Symptoms: Antimicrobial susceptibility test, No therapeutic response
Clinical narrative: This case was reported by a nurse, via a sales representative, and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included HIV positive.  On unspecified dates, the subject received 3rd dose, 2nd dose and 1st dose of Twinrix, ("adult dose", unknown).  At an unspecified time after vaccination with 3 dose series of Twinrix, the subject experienced not responding to therapy.  The unspecified titers were possibly being drawn at six months.  The nurse reported that "several of their HIV positive patients did not respond to the 3 dose series of Twinrix", but did not provide a specific number of patients.  At the time of reporting the outcome of the event was unspecified.  The nurse considered the event was probably related to vaccination with Twinrix.
Sex: U
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The subject's medical history included human immunodeficiency virus.  On an unspecified date(s) the subject received the 1st, 2nd, and 3rd doses of Twinrix (unknown).  At an unspecified time after vaccination with Twinrix, the subject did not seroconvert.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Back pain, Chromaturia, Hepatitis B antibody negative, No therapeutic response, Pyrexia
Clinical narrative: This case was reported by an unknown source and described the occurrence of not responding to therapy in a male subject aged between 50 and 59 years old who was vaccinated with Twinrix for prophylaxis. Co-suspect vaccines included hepatitis B vaccine (unknown manufacturer). The subject's medical history included allergies, codeine allergy and gout. Concurrent medications included Allopurinol and Zyrtec. In the early 1990's, the subject received his first hepatitis B vaccination series. Three days following his first immunization with Twinrix in the early 1990's, the subject developed a low grade fever, lower back pain, and dark urine. The subject was examined by a physician, and reported that he was advised to complete the hepatitis B vaccination series. The symptoms resolved a few days after onset, and the subject subsequently completed the first hepatitis B vaccine series. In the early 1990's, on an unspecified date following completion of the first hepatitis B vaccine series, a hepatitis B titer was negative. In the late 1990's the subject again completed a hepatitis B vaccine series. In the late 1990's, on an unspecified date following completion of the second hepatitis B vaccine series, a hepatitis B titer was again negative. in 2005 the subject completed the vaccination series for Twinrix (unknown). Approximately 2 years after completion of the Twinrix vaccination series, a hepatitis B titer was again negative. At the time of reporting the event of not responding to therapy was unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Blood HIV RNA increased, CD4 lymphocytes decreased, No therapeutic response, Therapeutic response decreased
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in subjects of unspecified age and gender who were vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  The reporter noted that this event had occurred in "multiple" subjects, however the specific number was unknown.  Concurrent medical conditions included human immunodeficiency virus infection.  On unspecified dates the subjects received unspecified doses of Twinrix.  At an unspecified time after vaccination with Twinrix, the subjects experienced not responding to therapy and/or decreased therapeutic response (specifics of which were not described).  The reporter noted that this occurs when the subject has a high viral load (HIV) and/or low CD4 lymphocyte count.  The physician assesses titers at an unspecified time after vaccination with Twinrix; if the subject's titers show lack of response or incomplete response, further vaccination with Twinrix may be postponed until CD4 lymphocyte counts have increased.  The reporter noted that this depends on the individual subject and provider's judgment and that different providers manage this occurrence differently in the clinic.  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Adverse event
Clinical narrative: This case was reported by a physician and described the occurrence of unspecified event in a male subject of unspecified age who was vaccinated with Twinrix for prophylaxis. The reporting physician is also the subject. On an unspecified date in June 2007, the subject received the first dose of Twinrix (prefilled syringe, unknown). Within one month of vaccination with Twinrix, in June 2007, the subject experienced "an unspecified safety and quality issue with his dose and the lot of Twinrix". The physician reported that the Twinrix vaccine "was donated to a public health clinica by an unknown source." At the time of reporting the outcome of the event(s) was unspecified.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 66-year-old male subject who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received an unspecified dose of Twinrix (unknown). At an unspecified time after vaccination with Twinrix, the subject experienced not responding to therapy ("lack of antibodies"). At the time of reporting the outcome of the event was unspecified. Follow-up information received on 06 July 2007 indicated that a titre drawn 7 months post completion of the Twinrix series showed no hepatitis B antibodies. No additional information was provided regarding outcome.
Sex: U
Vaccine: HEPAB
Symptoms: Antimicrobial susceptibility test, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Twinrix (unknown).  At an unspecified time after vaccination with Twinrix, the subject experienced not responding to therapy.  The Twinrix series of vaccinations had been repeated two additional times and the titers were negative.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 12 July 2007.  There was no additional information regarding the event included in the follow-up information.
Sex: F
Vaccine: HEPAB
Symptoms: Blood immunoglobulin M, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis B surface antigen positive in an adult female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  On 30 May 2007 the subject received 1st dose of Twinrix (unknown).  Two weeks after vaccination with Twinrix, the subject tested positive for hepatitis B surface antigen and was negative for immunoglobulin M.  At the time of reporting the outcome of the event was unspecified.