chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Patient complained of new rash that appeared in a cluster on the upper back right arm.  They appeared like blisters, and then they unroofed.  He also had itching of the scalp.  The rash on his arm was not itchy or painful. The rash is slowly resolving
Age: 36.0
Sex: M
Vaccine: HEPAB, MMR, RAB
Symptoms: Cyanosis, Dyskinesia, Loss of consciousness, Malaise, Muscle twitching
Clinical narrative: Pt stated he didn't feel good. slumped over and passed out. Ammonia smelling salts placed under pt. nose. pt twitches with Left arm jerking and Right head deviation. dusky coloring. eyes open and pupils dilated. Pt laid on floor. 911 called. Pt responsive after 30 seconds of above episode. Pt AOx3 Pulse and respiration WNL . EMS arrived appx 1015AM. VS retaken and WNL. EKG done and IV started by paramedics. Pt had nausea and small spit up and emesis at 10:25AM. Pt taken via EMS to Hospital at 10:30AM.
Age: 36.0
Sex: M
Vaccine: HEPAB, MMR, RAB
Symptoms: Mydriasis, Nausea, Vomiting
Clinical narrative: Pt stated he didn't feel good. slumped over and passed out. Ammonia smelling salts placed under pt. nose. pt twitches with Left arm jerking and Right head deviation. dusky coloring. eyes open and pupils dilated. Pt laid on floor. 911 called. Pt responsive after 30 seconds of above episode. Pt AOx3 Pulse and respiration WNL . EMS arrived appx 1015AM. VS retaken and WNL. EKG done and IV started by paramedics. Pt had nausea and small spit up and emesis at 10:25AM. Pt taken via EMS to Hospital at 10:30AM.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Pt presented to the Hospital with symptoms consistant with Guillain-Barre Syndrome. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal
Clinical narrative: Pt presented to the Hospital with symptoms consistant with Guillain-Barre Syndrome. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Pain in extremity
Clinical narrative: Right arm pain, mainly upper arm sore every day since vaccination, but no swelling, bruising, and has difficulty raising arm. At times throbbing pain for 3 weeks. Started day after. Unable to sleep on right side. Complained of being worse in AM. Saw Chiropractor 1/25 and will see again on 1/27 for ultrasound. Iced initially - now using heat and massage.
Age: 6.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR
Symptoms: Erythema, Oedema peripheral, Pain, Rash, Skin warm
Clinical narrative: Pt left arm was swollen from the shoulder down to his elbow. It was red and warn to the touch. Pt complained of pain when touched. Mom noted a rash that had cleared up by the time he was seen in the office. Pt was treated with Motrin and Benadryl prior to appt.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Nausea, Rash
Clinical narrative: Received vaccine on Thursday, 1-21-10 at rehab, went to living facility and on Saturday, 1-23-10, nausea and diarrhea, on Tues, 1-26-10, acne type breakout of rash on face. (Forehead & left cheek).
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Ataxia, CSF protein normal, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Pt presented to the Hospital with increased ataxia, tingling bilateral weakness, fever and neuropathy. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Lumbar puncture, Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: Pt presented to the Hospital with increased ataxia, tingling bilateral weakness, fever and neuropathy. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Pain at injection site, with subsequent numbness after 48 hours.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion, Electroencephalogram normal
Clinical narrative: Seizure.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Received ZOSTAVAX on 1/7/10. Developed large rash and pain on left arm.
Age: 63.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Swelling around eyes with internal itching of eyes.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness
Clinical narrative: Pt received H1N1 nasal mist appx 9:50am. When went back to class became faint. Removed from class, given juice and snack and felt better with good color. BP 112/56, Pulse 56.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: After receiving H1N1 nasal mist - had nausea and headache. Mom picked from school @ 11:15 am. Received imm appx 10:am. Mom states has low grade temp at this time (2:48 pm)
Age: 68.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Lyme disease
Clinical narrative: 12/11/09 Received H1N1 vaccine late same day developed aching joints. Seen by PMD 2/ 14 - aching joints - mainly hips shoulders, wrists - worse at night. Original D/X Lyme Disease  - R/X doxycycline x 11 days. Symptoms subsided while on meds after completion - aching returned. Saw PMD 1/26 - aching improved not gone. Given R/X for CELEBREX - may not take. No s/s other than aching joints.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) arm at injection site has induration of 4.5 cm diameter - Erythema size 7.5 cm diameter.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Client received a 4th Hep B Immunization 1/26/10 instead of an HPV #3. Client received the latter one day later 1-27-10.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Urticaria
Clinical narrative: Had shingles vaccine 12/10/09, broke out in hives on legs, arms, stomach and hands on 12/26/09. Was given MEDROL at emergency room at hospital for 7 days. Took about 2 weeks for hives to be completely gone. Had high blood pressure 200/100 and fast heart beat from meds and the vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance, Groin pain
Clinical narrative: Fever - 10/23 - 10/25 fever blister - 10/27 - tired x 7 days. 10/28 - awakened during night tingling - pain (L) great toe - 10/31 - limping - swelling (L) knee - during night noted severe pain - both thighs and knees - and knees - hips - unable to walk - walked to BR with assistance only. Felt faint x 2 - took TYLENOL for pain - by 9 am able to walk but still experienced severe pain in both hips, groin, knees - thighs - numbness and tingling in feet - (much difficulty walking) symptoms continued 11/1 - 11/2 able to walk with assistance of cane - pain less during day - symptoms returned at night 11/3 - 11/4 - pain severe in (L) groin - severe pain when turning over on bed at night - swelling in (L, knee less by 11/4 - improved by 11/7 - Saw NP in phys. office on 11/11 - determined severe reaction to flu vaccine - referred to rheumotologist. (awaiting appointment)  1/17/09 continue with pain in both knees - rt upper leg - this is 1st time I have receive flu vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint swelling, Oral herpes, Pain, Pain in extremity
Clinical narrative: Fever - 10/23 - 10/25 fever blister - 10/27 - tired x 7 days. 10/28 - awakened during night tingling - pain (L) great toe - 10/31 - limping - swelling (L) knee - during night noted severe pain - both thighs and knees - and knees - hips - unable to walk - walked to BR with assistance only. Felt faint x 2 - took TYLENOL for pain - by 9 am able to walk but still experienced severe pain in both hips, groin, knees - thighs - numbness and tingling in feet - (much difficulty walking) symptoms continued 11/1 - 11/2 able to walk with assistance of cane - pain less during day - symptoms returned at night 11/3 - 11/4 - pain severe in (L) groin - severe pain when turning over on bed at night - swelling in (L, knee less by 11/4 - improved by 11/7 - Saw NP in phys. office on 11/11 - determined severe reaction to flu vaccine - referred to rheumotologist. (awaiting appointment)  1/17/09 continue with pain in both knees - rt upper leg - this is 1st time I have receive flu vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia, Walking aid user
Clinical narrative: Fever - 10/23 - 10/25 fever blister - 10/27 - tired x 7 days. 10/28 - awakened during night tingling - pain (L) great toe - 10/31 - limping - swelling (L) knee - during night noted severe pain - both thighs and knees - and knees - hips - unable to walk - walked to BR with assistance only. Felt faint x 2 - took TYLENOL for pain - by 9 am able to walk but still experienced severe pain in both hips, groin, knees - thighs - numbness and tingling in feet - (much difficulty walking) symptoms continued 11/1 - 11/2 able to walk with assistance of cane - pain less during day - symptoms returned at night 11/3 - 11/4 - pain severe in (L) groin - severe pain when turning over on bed at night - swelling in (L, knee less by 11/4 - improved by 11/7 - Saw NP in phys. office on 11/11 - determined severe reaction to flu vaccine - referred to rheumotologist. (awaiting appointment)  1/17/09 continue with pain in both knees - rt upper leg - this is 1st time I have receive flu vaccine.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema
Clinical narrative: 1/2 cm area erythema at vaccine site. No induration / fluctuance. 1 day after vaccine.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Flushing
Clinical narrative: Bilateral arms, face flushed, reddened about 2 hours post receiving H1N1 shot. Patient was given vaccine at 12 noon. Given BENDARYL 25 mg p.o with relief. Denies exposure to any allergen.
Age: 63.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Pain, Pruritus
Clinical narrative: Pt had onset of headache within 1 hour. I call pt. approximately 4 hours later pt complaining of itching all over and "aches all over".
Age: 12.0
Sex: M
Vaccine: FLU(H1N1), FLU3, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Right arm redness around injection site 16 x 18 cm. Received Tdap and Flu vaccine in R arm, has never had Flu vaccine before, had Td and Dtap prior.
Age: 93.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hallucination
Clinical narrative: Hallucination - per pt daughter - she received MRI/lab tests @ ER - no result - hallucination started 1 - 2 hours after vaccination no treatment additionally @ ER
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, CSF protein increased, Electromyogram abnormal, Fall, Guillain-Barre syndrome
Clinical narrative: Pt presented to the Hospital with S/P Fall. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Hyporeflexia, Lumbar puncture
Clinical narrative: Pt presented to the Hospital with S/P Fall. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pallor
Clinical narrative: REDNESS, PALE, SWELLING AND A RASH SURROUNDING INJECTION SITE.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Contusion, Herpes zoster, Pain
Clinical narrative: Pt RTC the next day with bruises & pain on her R thigh & buttock area.  Then on 1/19/10 pt RTC to be seen @ the clinic, which at that time the provider find out that the patient developes shingles.
Age: 95.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cheilitis, Dysphonia, Erythema, Lip swelling, Oral discomfort
Clinical narrative: red swollen lower lip, slight hoarseness and sensation of burning in mouth.  Later approx 1:00 pm noted to have redness and swelling 3 inches below injection site.
Age: 95.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Swelling
Clinical narrative: red swollen lower lip, slight hoarseness and sensation of burning in mouth.  Later approx 1:00 pm noted to have redness and swelling 3 inches below injection site.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Insomnia, Nerve conduction studies, Pain in extremity, Paraesthesia
Clinical narrative: pain to his right arm by the shoulder. "Feels like pins and needles Right arm pain is really bad unable to sleep at night" states pt. "This started in the evening of 1/14/10 and I went to the emergency on the 17th of January" states pt I got pain meds nothing else then I called you on 1/21/10 when nothing was helping me. I sent him to his private MD and they began treatment
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Mass, Myalgia, Pain
Clinical narrative: Pain for 3 weeks reported on October 22, 2009. Pain is radiating muscle tenderness in the forearm, lump under the derma, Dr. told patient "you received an injection in the bursa area which caused the inflammation. She is getting physical therapy, antinflammatories, heat, exercises and light weight lifting.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain
Clinical narrative: Right arm has been aching ever since states patient. No numbness, tingling, she had good ROM, good color and pulse good flexion and extension of Right arm. After she saw her Doctor she told us that he felt the injection was to close to the shoulder. She was told to ice the arm and shoulder take anti-inflammatories for the next 4-6 weeks. If not better an MRI would need to be done. We have kept in touch with patient and as of January 27, 2010 she feels she is getting better and that she will call her Doctor and she what the next step will be. No MRI done as of this date.
Age: 9.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: On school bus ride home pt. felt some nausea, legs tingling and numb. No vomit or diarrhea. At time of ER visit, Pt. felt well. neg, physical exam. Probable Vasovagal reaction.
Age: 24.0
Sex: M
Vaccine: MNQ, PPV, TYP
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: Patient recieved typhoid lot # B1026 adminstered to left deltoid and Menactra lot # U2921AA, Pneumovax 23 to left deltoid on 01/20/2010. patient c/o of numbness to right arm two days later (01/22/2010) the morning of the 01/23/2010 patient went to ER. he was admited due to fever. Patient was discharged on 01/24/2010
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: FEVER, CHILL, MUSCLE PAIN, INJECTION SITE PAIN
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Feeling drunk, Hypoaesthesia, Hypoaesthesia oral, Mobility decreased
Clinical narrative: Arm with red rash, numb and unable to move. She stated she felt drunk. She denied SOB, VS were stable, and by the time EMS arrived, she was unable to move her other arm, and stated she felt like she was going to faint and her lips were numb.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash erythematous
Clinical narrative: Arm with red rash, numb and unable to move. She stated she felt drunk. She denied SOB, VS were stable, and by the time EMS arrived, she was unable to move her other arm, and stated she felt like she was going to faint and her lips were numb.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, & soreness, at the injection site.
Age: 66.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Acne, Chest X-ray normal, Cough, Ear pain, Headache
Clinical narrative: Felt like "2 major acne pimples" in nape of neck, then progressed to a "tight band" across the back of his head from ear to ear.  "Pimples" resolved, then pain went into right ear.  It was a throbbing pain, getting faster and more painful as time went on. 1 week later, he went to his physician assistant.  He ws given Tylenol #3 and Valium.  The tightness and ear pain resolved.  He soon (not a very good recollection of time frames) started a dry cough.  His lungs were clear. No nasal drainage or swelling in his lymph nodes. No fever reported.  He went on an eight day trip to family.  His granddaughter had an ear infection.  He came home yesterday.  Today his productive cough worsened, glands swollen, sinus drainage. Felt like he had a slight temperature yesterday.  He took a dose of Tylenol and went to see his PA.  He had a chest x-ray done with normal results.
Age: 66.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Lymphadenopathy, Pain, Pyrexia, Sinus operation
Clinical narrative: Felt like "2 major acne pimples" in nape of neck, then progressed to a "tight band" across the back of his head from ear to ear.  "Pimples" resolved, then pain went into right ear.  It was a throbbing pain, getting faster and more painful as time went on. 1 week later, he went to his physician assistant.  He ws given Tylenol #3 and Valium.  The tightness and ear pain resolved.  He soon (not a very good recollection of time frames) started a dry cough.  His lungs were clear. No nasal drainage or swelling in his lymph nodes. No fever reported.  He went on an eight day trip to family.  His granddaughter had an ear infection.  He came home yesterday.  Today his productive cough worsened, glands swollen, sinus drainage. Felt like he had a slight temperature yesterday.  He took a dose of Tylenol and went to see his PA.  He had a chest x-ray done with normal results.
Age: 6.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site swelling, Pain
Clinical narrative: Following night noticed about 4in, by 3in area of swelling around injection site.(may have occured earlier, just first noticed then)  Complaining of soreness.  Treated with heat then and ice the following day (per doctors instructions) and swelling is going down.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Claustrophobia, Dyspnoea
Clinical narrative: Intermittent SOB and tight chest, no more than 2 minutes, instantly cleared with going outside and getting "fresh air".  No residual cough or chest pain between episodes.  Getting less frequent with time.  Seen in the office on 1/27 and had normal exam.  Only one episode on 1/27 and felt more like claustrophobia than SOB.
Age: 59.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1), PPV
Symptoms: Blood pressure increased, Chills, Dyspnoea, Injection site erythema, Joint range of motion decreased
Clinical narrative: severe pain (10) in right arm from the shoulder to the fingers; described as continous, stabbing pain;  unable to lift arm; NO range of movement in the right arm; redness at the site of the injection; difficulty breathing;  elevated blood pressure (121/90);  chills; fever; nausea.  as of 1/27/2010; constant pain the arm and very limited range of motion
Age: 59.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1), PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: severe pain (10) in right arm from the shoulder to the fingers; described as continous, stabbing pain;  unable to lift arm; NO range of movement in the right arm; redness at the site of the injection; difficulty breathing;  elevated blood pressure (121/90);  chills; fever; nausea.  as of 1/27/2010; constant pain the arm and very limited range of motion
Age: 59.0
Sex: M
Vaccine: FLUX(H1N1), FLUX(H1N1), PPV
Symptoms: Dyspnoea, Injected limb mobility decreased, Injection site pain, Musculoskeletal chest pain
Clinical narrative: severe pain (10) in right arm from the shoulder to the fingers; described as continous, stabbing pain;  unable to lift arm; NO range of movement in the right arm; redness at the site of the injection; difficulty breathing;  elevated blood pressure (121/90);  chills; fever; nausea.  as of 1/27/2010; constant pain the arm and very limited range of motion
Age: 1.16
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Notice reaction redness/swollen on 01/26/2010. (L) Deltoid (KINRIX). Today notice 43mm x 43 mm rashes. Advised to apply ice and BENADRYL to reduce swelling.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Hypotension, Throat tightness
Clinical narrative: Initial health care professional report received on 12 Jan 2010: This patient was vaccinated with S-OIV Fluvirin; batch number unknown) on 06 Jan 2010 at 3:40 PM. After 10 minutes of vaccine administration, the patient experienced breathing difficulty, throat constriction and hypotension. As corrective measure, treatment with epinephrine was given. The patient's breathing improved and blood pressure increased to 152/70 (units not provided). The patient was taken to the local emergency room for follow-up but was not hospitalized. No outcome was provided for hypotension and throat constriction.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hepatitis B antibody positive, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in a 28-year-old female subject who was vaccinated with ENGERIX B. Concurrent medical conditions included depression. Concurrent vaccination included ADACEL given on 24 November 2008. There were no concurrent medications. On the afternoon of 24 November 2008 the subject received 1st dose of ENGERIX B at 1.0 ml in the right arm. On 25 November 2008, 1 day after vaccination with ENGERIX B, the subject had lab work done that showed her to be hepatitis b antigen positive. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 January 2009 indicated that the subject had/has no risk factors for hepatitis B and no signs of illness. The subject's physician plans to follow her antigen and antibody levels and to complete the three dose series of ENGERIX B. No additional information was provided and no additional information is expected.
Age: 28.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site haemorrhage, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of exacerbation of insomnia in a 28-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX. A physician or other health care professional has not verified this report. The subject's medical history included insomnia. Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown arm given on 30 October 2006. Concurrent medications included Unknown. On 30 October 2006, 30 November 2006 and 30 April 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown, unknown arm). On 30 April 2007 the subject received 2nd dose of Havrix (unknown, unknown arm). In May or June 2007, at an unspecified time after vaccination with Engerix B and Havrix, the subject experienced exacerbation of insomnia. On 30 October 2006 and 30 November 2006 after vaccination with Engerix B, the subject experienced injection hurt going in.  On 30 April 2007, after vaccination with Engerix B, the subject experienced injection hurt going in and injection site hemorrhage. The subject reported she has history of insomnia for years and reported that after her last dose of Havrix and Engerix B vaccines, she experienced a worsening of her insomnia. She did not know the brand names of the hepatitis A and hepatitis B vaccines, but when she consulted the Department of Health regarding this event, they referred her to GSK for information, thus she assumes they were GSK brands. She was vaccinated for prevention since her family member has a liver transplant due to hepatitis B virus. She noticed a worsening of her insomnia in either May or June 2007, a after her last doses of Havrix or Engerix B vaccines that were given 30 April 2007. She has seen her doctor for medication for her insomnia but she has not discussed with her doctor that the worsening of insomnia might be due to the vaccines. She only recently began to suspect the vaccines. Subject stated the worsening of insomnia has been disabling since cannot work but it has not been physically disabling. She has not been hospitalized for treatment. The subject also reported events with Engerix B, of injections hurt, especially the last dose, with the last dose, blood spurted out of the injection site. She thought this was due to the nurse being distracted as they were discussing politics at the time of the injection. The blood spurted out was just treated by covering the injection with a bandage. Both these events has resolved on unknown dates. At the time of reporting the outcome of exacerbation of insomnia was unresolved; injection hurt going in and injection site hemorrhage resolved on an unknown date.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of chronic diarrhea in a 41-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to gluten. Concurrent medications included PRILOSEC and MOTRIN. On 10 December 2008 at 10:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 10 December 2008, 4 hours after vaccination with ENGERIX B, the subject experienced chronic diarrhea. The subject developed chronic diarrhea four hours after receiving the ENGERIX B vaccine, which is still ongoing. The reported believed it is related to the yeast in the vaccine because the subject has a gluten allergy. At the time of reporting the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine recombinant (unknown manufacturer). Concurrent vaccination included combined diphtheria, tetanus, pertussis (A or W not known) vaccine (manufacturer unspecified) given on the same date as hepatitis B vaccine. On an unspecified date (from 1993 to 1997) the subject received unspecified dose of Hepatitis B vaccine. At an unspecified time after vaccination with hepatitis B, the subject experienced hives. At the time of reporting the event was resolved. The healthcare professional considered the event was resolved. The subject experienced hives. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with Hepatitis B vaccine. Follow-up information received via the reporter on 15 January 2009 indicated that they were not sure if the hepatitis B vaccine administered to the subject between 1993-1997 was GlaxoSmithKline vaccine as was originally reported. No additional information was provided.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via a sale representative and described the occurrence of not responding to therapy in a 22-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject receive 3rd dose of ENGERIX B to complete the three dose series. At an unspecified time later, the subjects titer was tested and found to be negative. The subject had not responded to therapy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Malaise, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle pain in a 37-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  There were no concurrent medications.  On 20 August 2008 the subject received 1st adult dose of ENGERIX B in the left arm.  An unspecified time after vaccination with ENGERIX B, the subject experienced muscle pain which resolved.  On 23 September 2008, the subject received a 2nd adult dose of ENGERIX B in the left arm.  Three hours after 2nd vaccination with ENGERIX B, the subject felt sick with flu like symptoms and had to leave work and go home.  These events were unresolved at the time of reporting.  Relationship of all the events to ENGERIX B was not specified.  It was noted that when the subject returned for her 3rd dose of ENGERIX B, it was not administered due to the above events.  Follow-up information received on 24 March 2009 indicated that following 1st dose of ENGERIX B (20 mcg) on 20 August 2008, the subject reported muscle pain, flu like symptoms and feeling sick.  These events resolved and were reportedly thought to be related to treatment with ENGERIX B.  Three hours following 2nd vaccination with ENGERIX B (20 mcg) on 23 September 2008, the subject developed muscle pain and flu like symptoms and had to go home.  The outcome of these events was not reported.  The reporter felt that these events were related to treatment with ENGERIX B.  Again it was noted that the 3rd dose of ENGERIX B was not given.
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult (between 18 and 50 years old) female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).   On 3 March 2009, between 08:30 and 11:30, the subject received 2nd dose of ENGERIX B and upon returning to her seat, the subject started to rub her arm where she was injected complaining of injection site pain and injection site burning.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were probably related to vaccination with ENERGIX B.  It was reported that ENGERIX B vials were used with Integra syringes and needles that were 25 gauge, 1 inch.  The reporter stated that these events occurred in 22 to 25 out of 30 students receiving their 2nd dose of ENGERIX B on 03 March 2009.  Both male and female.
Age: 10.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 10-year-old subject of unspecified gender who was vaccinated with HEPATITIS B vaccine and later ENGERIX B, (GlaxoSmithKline) as an adult.  On an unspecified date when the subject was 10 years old, he/she completed a HEPATITIS B vaccine series.  At an unspecified time later, when that subject started working, she was tested and found to have a negative titer.  As an adult, the subject repeated the HEPATITIS B series and received ENGERIX B.  The 3rd dose of ENGERIX B was administered in 2009.  One month following administration of the 3rd dose of ENGERIX B, the subject was tested again and the titer was negative.  The subject had not responded to therapy following both series of HEPATITIS B vaccination.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stomach cramps in a 18-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline). There were no concurrent medications. On 3 October 2007 the subject received 2nd dose of Engerix B at at 20 mcg in the left arm. On 3 October 2007, less than one day after vaccination with Engerix B, the subject experienced severe stomach cramps. It was not known how long the cramps lasted, but they reportedly resolved. The healthcare professional considered the event was possibly related to vaccination with Engerix B.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in an approximately 62-year-old female subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). In 2008, the subject received the complete HEPATITIS B vaccine series at her primary care office (dates of the primary HEPATITIS B vaccine doses were not known). Two months later, on 23 October 2008, after vaccination with HEPATITIS B vaccine, a titer was taken which showed non-protective HEPATITIS B titer of less than five, and the subject experienced decreased therapeutic response. Due to the non-protective titer, the reporter gave the subject an additional booster dose of HEPATITIS B vaccine and then two months later, on 05 March 2009, took another titer which was also below five (decreased therapeutic response). The reporter planned to give additional HEPATITIS B doses due to the continued low titer. Follow-up information received via the reporter on 17 March 2009 indicated that the 4th dose of HEPATITIS B vaccine administered was ENGERIX B. Additionally, the onset date of events was indicated as 09 October 2009 versus 23 October 2009. No additional information was provided.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with RECOMBIVAX HB, (manufacturer unspecified) for prophylaxis. In 1989 the subject received 1st and 2nd dose of RECOMBIVAX HB. She received a 3rd dose of RECOMBIVAX HB in 1994. Titers were tested on an unspecified date and the subject was found to be non-responsive. The outcome of the events was not reported.
Age: 55.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Anti-HBc antibody negative, Blood thyroid stimulating hormone normal, Gammopathy, Hepatitis A antibody negative, Hepatitis B antibody
Clinical narrative: This case was reported by a healthcare professional, who is the subject, and described the occurrence of not responding to therapy in a female subject aged between 50 and 59 years old who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified), Hepatitis A vaccine inactivated and TWINRIX. Previous and/or concurrent vaccination included PNEUMOVAX; non-GSK manufacturer given on 19 June 2007. On 19 June 2007, 19 July 2007 and 21 December 2007 the subject received 1st dose (left arm), 2nd dose (left arm) and 3rd dose of Hepatitis B vaccine (unknown, right arm) and had a negative titer (not responding to therapy). The subject also experienced drug dose administration interval too short between the 2nd and 3rd doses. On 21 June 2007 and 21 December 2007 the subject received unspecified dose of Hepatitis A vaccine (unknown) and had a negative titer (not responding to therapy). The Hepatitis A vaccine given on 21 December 2007 was given in a separate arm from the Hepatitis B vaccine given on that same day. The subject did not know which brand she received. On 25 August 2008 the subject received unspecified dose of TWINRIX (unknown) (extra dose administered). A titer was drawn on 17 December 2008 which was negative for Hepatitis A and Hepatitis B. On 9 January 2009 the subject received unspecified dose of TWINIRX (unknown) (extra dose administered). A titer was drawn on 25 February 2009 which was negative for Hepatitis A and Hepatitis B. Follow-up information was received from the subject on 13 April 2009. The subject reported that the events were unresolved. She considered the events were possibly related to TWINRIX. She considered that the events could have been associated with the following medical history/concurrent illnesses: Subject had a false positive HTLV-1 test in 1997, but cannot donate blood anymore, and on 22 March 2007, she was diagnosed with monoclonal gammopathy of uncertain significance, IgG kappa. Relevant laboratory results included: 08 May 2008: Hepatitis B Surface Antibody: less than 0.1 (reference range: 0.00-0.99): inconsistent with immunity. Hepatitis A Antibody, Total: Negative (reference range: negative); 17 December 2008: Hepatitis B Surface Antigen (HBsAg) Screen: Negative (reference range: negative). Hepatitis Be Antigen: Negative (reference range: negative). Hepatitis Be Antibody: Negative (reference range: negative). Hepatitis B Surface Antibody: 0.13 (reference range: 0.00-0.99): inconsistent with immunity; 25 February 2009: Hepatitis B Immunity Panel: Hepatitis B Core AB total: Non-reactive (reference range: non-reactive); Hepatitis B Surface Antibody QL: Non-reactive (reference range: non-reactive). Hepatitis A Antibody, Total: Non-reactive (reference range: non-reactive).
Age: 55.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Hepatitis B antibody negative, Hepatitis B antigen, Hepatitis B surface antigen negative, Inappropriate schedule of drug administration, Light chain analysis
Clinical narrative: This case was reported by a healthcare professional, who is the subject, and described the occurrence of not responding to therapy in a female subject aged between 50 and 59 years old who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified), Hepatitis A vaccine inactivated and TWINRIX. Previous and/or concurrent vaccination included PNEUMOVAX; non-GSK manufacturer given on 19 June 2007. On 19 June 2007, 19 July 2007 and 21 December 2007 the subject received 1st dose (left arm), 2nd dose (left arm) and 3rd dose of Hepatitis B vaccine (unknown, right arm) and had a negative titer (not responding to therapy). The subject also experienced drug dose administration interval too short between the 2nd and 3rd doses. On 21 June 2007 and 21 December 2007 the subject received unspecified dose of Hepatitis A vaccine (unknown) and had a negative titer (not responding to therapy). The Hepatitis A vaccine given on 21 December 2007 was given in a separate arm from the Hepatitis B vaccine given on that same day. The subject did not know which brand she received. On 25 August 2008 the subject received unspecified dose of TWINRIX (unknown) (extra dose administered). A titer was drawn on 17 December 2008 which was negative for Hepatitis A and Hepatitis B. On 9 January 2009 the subject received unspecified dose of TWINIRX (unknown) (extra dose administered). A titer was drawn on 25 February 2009 which was negative for Hepatitis A and Hepatitis B. Follow-up information was received from the subject on 13 April 2009. The subject reported that the events were unresolved. She considered the events were possibly related to TWINRIX. She considered that the events could have been associated with the following medical history/concurrent illnesses: Subject had a false positive HTLV-1 test in 1997, but cannot donate blood anymore, and on 22 March 2007, she was diagnosed with monoclonal gammopathy of uncertain significance, IgG kappa. Relevant laboratory results included: 08 May 2008: Hepatitis B Surface Antibody: less than 0.1 (reference range: 0.00-0.99): inconsistent with immunity. Hepatitis A Antibody, Total: Negative (reference range: negative); 17 December 2008: Hepatitis B Surface Antigen (HBsAg) Screen: Negative (reference range: negative). Hepatitis Be Antigen: Negative (reference range: negative). Hepatitis Be Antibody: Negative (reference range: negative). Hepatitis B Surface Antibody: 0.13 (reference range: 0.00-0.99): inconsistent with immunity; 25 February 2009: Hepatitis B Immunity Panel: Hepatitis B Core AB total: Non-reactive (reference range: non-reactive); Hepatitis B Surface Antibody QL: Non-reactive (reference range: non-reactive). Hepatitis A Antibody, Total: Non-reactive (reference range: non-reactive).
Age: 55.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Vitamin D
Clinical narrative: This case was reported by a healthcare professional, who is the subject, and described the occurrence of not responding to therapy in a female subject aged between 50 and 59 years old who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified), Hepatitis A vaccine inactivated and TWINRIX. Previous and/or concurrent vaccination included PNEUMOVAX; non-GSK manufacturer given on 19 June 2007. On 19 June 2007, 19 July 2007 and 21 December 2007 the subject received 1st dose (left arm), 2nd dose (left arm) and 3rd dose of Hepatitis B vaccine (unknown, right arm) and had a negative titer (not responding to therapy). The subject also experienced drug dose administration interval too short between the 2nd and 3rd doses. On 21 June 2007 and 21 December 2007 the subject received unspecified dose of Hepatitis A vaccine (unknown) and had a negative titer (not responding to therapy). The Hepatitis A vaccine given on 21 December 2007 was given in a separate arm from the Hepatitis B vaccine given on that same day. The subject did not know which brand she received. On 25 August 2008 the subject received unspecified dose of TWINRIX (unknown) (extra dose administered). A titer was drawn on 17 December 2008 which was negative for Hepatitis A and Hepatitis B. On 9 January 2009 the subject received unspecified dose of TWINIRX (unknown) (extra dose administered). A titer was drawn on 25 February 2009 which was negative for Hepatitis A and Hepatitis B. Follow-up information was received from the subject on 13 April 2009. The subject reported that the events were unresolved. She considered the events were possibly related to TWINRIX. She considered that the events could have been associated with the following medical history/concurrent illnesses: Subject had a false positive HTLV-1 test in 1997, but cannot donate blood anymore, and on 22 March 2007, she was diagnosed with monoclonal gammopathy of uncertain significance, IgG kappa. Relevant laboratory results included: 08 May 2008: Hepatitis B Surface Antibody: less than 0.1 (reference range: 0.00-0.99): inconsistent with immunity. Hepatitis A Antibody, Total: Negative (reference range: negative); 17 December 2008: Hepatitis B Surface Antigen (HBsAg) Screen: Negative (reference range: negative). Hepatitis Be Antigen: Negative (reference range: negative). Hepatitis Be Antibody: Negative (reference range: negative). Hepatitis B Surface Antibody: 0.13 (reference range: 0.00-0.99): inconsistent with immunity; 25 February 2009: Hepatitis B Immunity Panel: Hepatitis B Core AB total: Non-reactive (reference range: non-reactive); Hepatitis B Surface Antibody QL: Non-reactive (reference range: non-reactive). Hepatitis A Antibody, Total: Non-reactive (reference range: non-reactive).
Sex: U
Vaccine: HEP
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 B vaccine, (manufacturer unspecified). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine and experience not responding to therapy. The physician reported that employees in a clinical program at the hospital were non-responders to the hepatitis B vaccination series. It was unknown with hepatitis B vaccine the employees received. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of knee joint pain in a female aged between 30 and 39 years old who was vaccinated with HAVARIX, GlaxoSmithKline, ENGERIX B for prophylaxis. On an unspecified date the subject received a pediatric dose of HAVRIX (.5 ml, unknown) and experienced vaccine under dose. Dose number was unspecified. On an unspecified date the subject received a pediatric dose of ENGERIX B (.5 ml, unknown) and experienced vaccine under dose. Dose number was unspecified. In January 2009 the subject received unspecified dose of ENGERIX B (unknown). Two minutes after vaccination with ENGERIX B the subject experienced knee joint pain which resolved approximately two hours later. The healthcare professional considered the knee joint pain probably related to vaccination with ENGERIX B.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Adverse event, Hepatitis B antibody, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 48-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 5 September 2008, 3 October 2008 and 9 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg/mL, left deltoid). On 9 January 2009, the subject experienced drug dose administration interval too short. On 20 February 2009, 42 days after vaccination with the third dose of ENGERIX B, the subject experienced decreased therapeutic response. On 20 February 2009, hepatitis B surface antibody was low at 2.2. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778216A, A0778217A, A0778218A and A0778220A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB703AA, AHBVB584AA AND AHBVB670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hepatitis B antibody, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 42-year-old female subject who was vaccinated with GENERIX B, GlaxoSmithKline for prophylaxis. Previous and/or concurrent vaccination included ADACEL; Sanofi Pasteur MSD given on 29 August 2008. There were no concurrent medications. On 29 August 2008, 10 October 2008 and 14 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown, right deltoid, left deltoid and left deltoid, respectively). On 14 January 2009, the subject experienced drug dose administration interval too short. On 25 February 2009, 42 days after vaccination with  ENGERIX B, the subject experienced decreased therapeutic response. On 25 February 2009, hepatitis B surface antibody was low at 5.2. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot experienced this adverse event. The subjects received the dose on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778217A, A0778218A and A0778220A. Follow-up information was received on 14 May 2009 Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB073AA, AHBVB584AA and AHBVB670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.