chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Appendicectomy, Barium enema, Biopsy lymph gland, Intussusception, Surgery
Clinical narrative: Pt began vomiting 12/18/07 PM to ER 12/19/07. Dx with intussuseption. A barium enema was attempted, but did not reduce. Surgical bowel reduction was successful. An appendectomy was also performed.  02/01/2008 MR received for DOS 12/19-21/2007 with DX:  Intussusception. Pt presented with 1 day hx of vomiting (16 episodes).  Had bloody stool in ER. Attempted to reduce with Barium enema but unsuccessful.  Pt had exploratory lap with reduction of ileocolic intussusception, appendectomy, and biopsy of mesenteric lymph nodes.  Mesenteric lymph nodes noted to be enlarged in OR. D/C on POD #2
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Pt began vomiting 12/18/07 PM to ER 12/19/07. Dx with intussuseption. A barium enema was attempted, but did not reduce. Surgical bowel reduction was successful. An appendectomy was also performed.  02/01/2008 MR received for DOS 12/19-21/2007 with DX:  Intussusception. Pt presented with 1 day hx of vomiting (16 episodes).  Had bloody stool in ER. Attempted to reduce with Barium enema but unsuccessful.  Pt had exploratory lap with reduction of ileocolic intussusception, appendectomy, and biopsy of mesenteric lymph nodes.  Mesenteric lymph nodes noted to be enlarged in OR. D/C on POD #2
Age: 52.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Rash, Rash pruritic, Throat irritation
Clinical narrative: Developed itchy B-B size elongated bumps on arms & legs evening of 12-12-07.  Throat is scratchy but no difficulty breathing.  Bumps are not red.  Advised medical care.
Age: 1.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Irritability, Pyrexia, Rash generalised, Somnolence
Clinical narrative: 9 days after the vaccine, he was unusually fussy and sleepy and had a fever of 101 degrees F.  10 days after the vaccine, he woke up with a rash all over his body and a slight fever.  The rash has lasted from Monday morning and he still has it.  Today, Wednesday, his cheeks have been bright red, he has a slight fever, and the rash all over still.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: The 58 y/o pt presented first to the clinic on 1/9/08, for complaint of left upper arm pain following influenza vaccination on 12/13/07. On return visit on 1/16/08, she states that the pain has been decreased since last visit. The pain is still  located on the left deltoid area. The pain is dull ache pain in nature. She scored the pain at 2-3/10. The pain is slightly aggravated by elevating and moving the left arm. She denies any fever, chills.   She denies any sensation difficulties in her left arm and left hand. She also denies history of any insect bite and any injury in that area.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Cold sweat, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Cold sweats, loof of breath, severe fatigue, dizziness and upset stomach, vision problems and headache after receiving Hepatitis A & B vaccines.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Stomach discomfort, Visual disturbance
Clinical narrative: Cold sweats, loof of breath, severe fatigue, dizziness and upset stomach, vision problems and headache after receiving Hepatitis A & B vaccines.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Back pain, Cold sweat, Dizziness, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Nausea, muscle pain throught body especially in location where administered (rt arm) and lower back pain. Hot and cold sweat, dizziness/lightheadedness accompanied by migraine headache. Secondary reaction rash on shoulders and back.
Age: 48.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Migraine, Myalgia, Nausea, Rash
Clinical narrative: Nausea, muscle pain throught body especially in location where administered (rt arm) and lower back pain. Hot and cold sweat, dizziness/lightheadedness accompanied by migraine headache. Secondary reaction rash on shoulders and back.
Age: 49.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Back pain, Conjunctival haemorrhage, Hyperhidrosis, Lip swelling, Musculoskeletal pain
Clinical narrative: Received Yellow Fever, IPOL, Typhoid Vi on 1/11/08 at 2 pm.  Had fever, sweating, muscle, back and shoulder aching/pain for about 6 hours on night of 1/11/08. 1/14/08 developed subconjunctival hemorrhage and on 11/15 had itching of feet and swelling of lip that resolved with Benadryl.  Pt was advised to me PMD.
Age: 49.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Myalgia, Pruritus, Pyrexia
Clinical narrative: Received Yellow Fever, IPOL, Typhoid Vi on 1/11/08 at 2 pm.  Had fever, sweating, muscle, back and shoulder aching/pain for about 6 hours on night of 1/11/08. 1/14/08 developed subconjunctival hemorrhage and on 11/15 had itching of feet and swelling of lip that resolved with Benadryl.  Pt was advised to me PMD.
Age: 40.0
Sex: M
Vaccine: HEPAB, IPV, PPV, TDAP
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Vaccines administered on 1/4/08. Pt reported 'fever, reaction, cellulitis, and infection" via voice mail on 1/7/08. States he went to a ER at a different hospital over the weekend for treatment with antibiotics. Symptoms were reported in the (L) arm however additional vaccines were administered in the (R).  3/11/08 Reviewed hospital medical records for admission 1/7-1/9/2007. FINAL DX: streptococcal cellulits LUE & recent immunization LUE. Records reveal patient experienced fever, chills, nausea, pain, swelling, tenderness & red band like area in LUE w/decreased ROM beginning 1 day s/p vaccines.  Seen in ER on 1/6 & tx w/IV antibiotics & d/c home on oral antibiotics.  No improvement & returned for admission.  ID consult done.  Tx w/IV antibiotics & improved.  D/C to home on continued oral antibiotics & f/u by ID.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Nuclear magnetic resonance imaging abnormal, Restless legs syndrome, Sensation of heaviness
Clinical narrative: Heavy legs, restless legs, hypersensitivity which moved into her upper body days later (shoulders). No tx for this by her MD. Seen on 12/26/07. Dr. told pt it could have been a virus that got to her.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Hypotonia, Mydriasis, Retching
Clinical narrative: Child had an episode the morning after immunizations.  She called for help in her morning shower.  Mom found her sitting on floor.  She attempted to vomit.  Mom got her up.  She went limp for a few seconds.  Mom thought pupils were dilated.  No fever, no abdominal pain, no known seizure activity.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Musculoskeletal pain, X-ray limb
Clinical narrative: 1/2/08 - red vaccine 1/4/08 - painful left shoulder.  Swelling noted at injection site extending to left breast.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash to body that has spread, itching (Papular) - started on 1/14/08.  Benadryl 12.5mg, 1/2 - 3/4 tsp every 6 hours for itching.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site swelling, Skin warm, Swelling
Clinical narrative: Swelling with redness.  Size of baseball at injection site.  Warm to touch.  Ice bag, Benadryl, prednisone.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed Hives on body 20 minutes after receiving Influenza TIV and HPV immunizations.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Ocular hyperaemia, Pruritus
Clinical narrative: ITCHING, RED EYE, MUSCULAR PAIN.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood pressure decreased, Depressed level of consciousness, Heart rate decreased, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Within 2 minutes after receiving the Gardasil vaccine (subsequent to receiving Varivax) patient had a near syncopal episode while sitting in the chair.  Patient face totally lost color and she reported feeling numb in her lips and shaky in her extremities. Patient needed to be aroused. Pt was placed in the supine position and BP was 78/32 and pulse 45. It took 5-10 minutes to recover before patients color returned and repeat BP was 108/62 pulse 60.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pallor, Presyncope, Tremor
Clinical narrative: Within 2 minutes after receiving the Gardasil vaccine (subsequent to receiving Varivax) patient had a near syncopal episode while sitting in the chair.  Patient face totally lost color and she reported feeling numb in her lips and shaky in her extremities. Patient needed to be aroused. Pt was placed in the supine position and BP was 78/32 and pulse 45. It took 5-10 minutes to recover before patients color returned and repeat BP was 108/62 pulse 60.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Blood culture, Erythema, Eschar, Full blood count
Clinical narrative: 3.5 cm x 6 cm area of induration, erythema and warmth w/ numerous clustered vesicles and sm. eschar formation.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Skin warm
Clinical narrative: 3.5 cm x 6 cm area of induration, erythema and warmth w/ numerous clustered vesicles and sm. eschar formation.
Age: 48.0
Sex: M
Vaccine: ANTH, HEPAB
Symptoms: Amnesia, Bone pain
Clinical narrative: AMNEA OF DREAM, LOST OF MEMORY 1/30/08-records received-C/O chronic right shoulder pain due to complete rotator cuff tear, seen for pain management, irritability, inactive at home, behavior changes since return from deployment. Receiving physical therapy. Follow-up Information 30-APR-2008: HPB, Dreams Trouble, Bones Pain
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Headache, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: 20 HRS POST INJECTION CC RT ARM KNOT AT INJECTION SITE, ITCHING, SWELLING, SORENESS, AND TEMP 100 f; HEADACHE. SORENESS CONTINTUES ON 1-14; IRRITABLE; SYMPTOMS BEGINNING TO RESOLVE NOT GETTING WORSE.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling, Irritability
Clinical narrative: 20 HRS POST INJECTION CC RT ARM KNOT AT INJECTION SITE, ITCHING, SWELLING, SORENESS, AND TEMP 100 f; HEADACHE. SORENESS CONTINTUES ON 1-14; IRRITABLE; SYMPTOMS BEGINNING TO RESOLVE NOT GETTING WORSE.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Chills, Computerised tomogram, Fatigue, Hypercholesterolaemia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of loss of consciousness in a 54-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included hypercholesterolemia. previous vaccination included Engerix B (GlaxoSmithKline) given on 3 October 2006 and 3 November 2006. Concurrent medications included Zetia. On 7 April 2007 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm. On 9 April 2007, 2 days after vaccination with Engerix B, the subject experienced loss of consciousness for about 3 minutes and was vomiting. The subject was taken to the emergency room and released. Within two weeks, the subject developed a fever, an all over body rash, chills, swollen lymph nodes and extreme generalized fatigue. The subject reported that she was seen by multiple physicians and underwent many blood tests and Ct scans without any clear diagnosis. She was also treated with high dose Penicillin without benefit. The subject was unable to work starting 18 July 2007 due to her symptoms. It was documented that the subject was hospitalised at some point and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject stated that she began to notice improved functioning on 28 December 2007, when she noticed that she was not as fatigued when she climbed the stairs or when she would go to the store. Her fever was also resolving. She was diagnosed 11 January 2008 as having a reaction to hepatitis B vaccine. The reaction was described as systemic. Improvement was specifically reported for vomiting, rash and fever. All of these events with the addition of loss of consciousness were considered probably related to treatment with Engerix B.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Lymphadenopathy, Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of loss of consciousness in a 54-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included hypercholesterolemia. previous vaccination included Engerix B (GlaxoSmithKline) given on 3 October 2006 and 3 November 2006. Concurrent medications included Zetia. On 7 April 2007 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm. On 9 April 2007, 2 days after vaccination with Engerix B, the subject experienced loss of consciousness for about 3 minutes and was vomiting. The subject was taken to the emergency room and released. Within two weeks, the subject developed a fever, an all over body rash, chills, swollen lymph nodes and extreme generalized fatigue. The subject reported that she was seen by multiple physicians and underwent many blood tests and Ct scans without any clear diagnosis. She was also treated with high dose Penicillin without benefit. The subject was unable to work starting 18 July 2007 due to her symptoms. It was documented that the subject was hospitalised at some point and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject stated that she began to notice improved functioning on 28 December 2007, when she noticed that she was not as fatigued when she climbed the stairs or when she would go to the store. Her fever was also resolving. She was diagnosed 11 January 2008 as having a reaction to hepatitis B vaccine. The reaction was described as systemic. Improvement was specifically reported for vomiting, rash and fever. All of these events with the addition of loss of consciousness were considered probably related to treatment with Engerix B.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of loss of consciousness in a 54-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included hypercholesterolemia. previous vaccination included Engerix B (GlaxoSmithKline) given on 3 October 2006 and 3 November 2006. Concurrent medications included Zetia. On 7 April 2007 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm. On 9 April 2007, 2 days after vaccination with Engerix B, the subject experienced loss of consciousness for about 3 minutes and was vomiting. The subject was taken to the emergency room and released. Within two weeks, the subject developed a fever, an all over body rash, chills, swollen lymph nodes and extreme generalized fatigue. The subject reported that she was seen by multiple physicians and underwent many blood tests and Ct scans without any clear diagnosis. She was also treated with high dose Penicillin without benefit. The subject was unable to work starting 18 July 2007 due to her symptoms. It was documented that the subject was hospitalised at some point and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject stated that she began to notice improved functioning on 28 December 2007, when she noticed that she was not as fatigued when she climbed the stairs or when she would go to the store. Her fever was also resolving. She was diagnosed 11 January 2008 as having a reaction to hepatitis B vaccine. The reaction was described as systemic. Improvement was specifically reported for vomiting, rash and fever. All of these events with the addition of loss of consciousness were considered probably related to treatment with Engerix B.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Liver function test abnormal, 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, (Unknown manufacturer) for prophylaxis. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown manufacturer). At an unspecified time after vaccination with Hepatitis B vaccine series, the subject experienced not responding to therapy. Titers showed that the subject did not reach seroprotection level. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 11 January 2008 indicated that the subject was a male in his mid 30's. It was reported that he experienced elevated liver function tests. The onset of the event was not reported. The elevated liver function test were suggested to be related to alcohol use and his overweight condition. No outcome was provided.
Age: 0.37
Sex: F
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: No adverse event given prior to the recommended 6 months age range
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Left upper arm and shoulder swollen, red and warm.  Duracef, cool compress, Alevert 5 mg daily until swelling goes down in UCC.  Ok to substitute Benadryl per pkg directions.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Pyrexia, Swelling
Clinical narrative: Swollen left thigh, fever.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN3, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash, Rash macular
Clinical narrative: Skin rash/large red blotches on lower half of body.  Itching occurred 6-7 hours after vaccines given.  Parents administered Benadryl syrup by mouth.
Age: 22.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Arthralgia, Erythema, Fatigue, Influenza, Injection site erythema
Clinical narrative: Description: 22 y/o AD SM received primary SPV, typhoid, and Twinrix on 4 Dec 2007.  Noted the development of lymphadenopathy near the clavicle on 12/11 followed by erythema around the inoculation site migrating up the right neck and towards the axilla.  Patient also developed flu-like symptoms by 12/12/07.  Symptom: Lymphadenopathy, subclavicular.  Start: 12/11/2007.  Comment: Patient noted a lump around his clavicle.  Symptom: Flu-like symptoms <96 hours.  Start: 12/12/2007.  Comment: SM developed malaise, fatigue, aches in addition to his inoculation site concerns.  Symptom: Joint pain, isolated.  Start: 12/12/2007.  Comment: Bilateral knee pains reported during illness.
Age: 22.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Lymphadenopathy, Malaise, Mass, Pain
Clinical narrative: Description: 22 y/o AD SM received primary SPV, typhoid, and Twinrix on 4 Dec 2007.  Noted the development of lymphadenopathy near the clavicle on 12/11 followed by erythema around the inoculation site migrating up the right neck and towards the axilla.  Patient also developed flu-like symptoms by 12/12/07.  Symptom: Lymphadenopathy, subclavicular.  Start: 12/11/2007.  Comment: Patient noted a lump around his clavicle.  Symptom: Flu-like symptoms <96 hours.  Start: 12/12/2007.  Comment: SM developed malaise, fatigue, aches in addition to his inoculation site concerns.  Symptom: Joint pain, isolated.  Start: 12/12/2007.  Comment: Bilateral knee pains reported during illness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV, VARCEL
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: Patient received immunes on 1/2/08, patient taken to ER by mom for rash on both thighs where immunes were given on 1/4/08.  ER report states hives on both thighs.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Developmental delay, Mental retardation severity unspecified, Speech disorder
Clinical narrative: 2 1/2 year old very severely developmental delayed with mental Retardation also mom states language regression noted after vaccine. Now improved
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.  Prednisone and Benadryl.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Pt. presented to ER on 1/15/08, given Dx of cellulitis to upper outer R arm.  Tx clindamycin 300 mg TID PO x7d.  Presented at office 1/16/08 with 6x4 cm erythematous, hot area to upper outer R arm.  Pt never experienced SOB, wheezing.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Flushing, Pruritus, Throat irritation
Clinical narrative: Patient immediately became lightheaded and flushed.  Started complaining of itching, and "tickling in throat".  Became anxious.  Offered Epipen, she refused.  Patient taken to ED by POU.  Patient treated and released by ED.  ED gave EPI Benadryl injections.  Saline IV.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, No therapeutic response, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 50-year-old male subject who was vaccinated with Engerix B, Havrix A for prophylaxis. Previous and/or concurrent vaccination included influenza virus vaccine, manufacturer unspecified; right arm given on 17 November 2005. On 26 April 2005, 2 June 2005 and 17 November 2005 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown, left arm). On an unspecified date the subject received 1st dose of Havrix (unknown). On 8 November 2007, at an unspecified time after vaccination with Havrix, 2 years after vaccination with Engerix B, the subject experienced not responding to therapy, hepatitis b antibody negative and hepatitis a antibody negative. Titers for hepatitis B antibodies were less than 5m1U per ml. Titers for hepatitis A were not reported. The subject required medical attention in the physician's office. The subject is getting ready to travel and wanted to make sure they were protected against hepatitis A and hepatitis B. At the time of reporting the events were unresolved. The healthcare professional considered negative Hepatitis B antibody titers was probably related to vaccination with Engerix B. Causality was unknown for negative hepatitis A antibody titers.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Hepatitis B vaccine for prophylaxis. On an unspecified date the subject received primary course and booster dose of Hepatitis B vaccine (unknown manufacturer). At an unspecified time after vaccination with a complete series of Hepatitis B vaccine, the subject experienced not responding to therapy. The surface antibody titers were negative. A booster dose of hepatitis B was given and the titers are still negative. It is unknown when the titers were taken. Medical attention was required at the physician's office. At the time of reporting the outcome of the events was unspecified.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 61-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included renal failure (cause not specified) requiring hemodialysis, gastroesophageal reflux disease, hyperlipidemia and pancreatitis.  Concurrent medications included Levothroid, unspecified "renal capsules" and omeprazole.  Previous and/or concurrent vaccination included Engerix B (GlaxoSmithKline) given on 21 May 2007.  On 25 May 2007, 4 days after the subject received the first vaccination with Engerix B, the subject received the second dose of Engerix B (40 mcg, unknown arm) and experienced inappropriate schedule of drug administration.  On 23 October 2007, the subject received the third dose of Engerix B (40 mcg, unknown arm) and experienced injection site pain.  Medical attention was not required.  The vaccination series was delayed.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Engerix B.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 26-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 21 August 2007, the subject also underwent a PPD skin test.  On 21 August 2007 the subject received the first dose of Engerix B (1 ml, unknown).  On 21 August 2007, 1 hour after vaccination with Engerix B, the subject experienced headache, chills, nausea and myalgia.  Approximately five hours later, the subject took Aleve, followed by improvement of symptoms.  On 22 August 2007, approximately 24 hours following vaccination, the events were resolved.  The healthcare professional considered the events were probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of shoulder pain in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine for prophylaxis. In September 2007 the subject received 1st dose of Hepatitis B vaccine (unknown). In September 2007, less than one day after vaccination with Hepatitis B vaccine, the subject experienced shoulder pain. The patient required medical attention in the emergency room. It was unknown whether the subject was hospitalized or stayed overnight in the emergency room. At the time of reporting the event was unresolved. It is unknown if the subject had experienced any adverse events following previous vaccinations.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administration in an adult subject of unspecified gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the adult subject received unspecified dose of Engerix B at 10 mcg.  This was considered to be an inappropriate dose of drug administered as the subject received a pediatric dose of Engerix B.  The subject was also found to have not responded to therapy.  This event was not resolved at the time of reporting.  This inappropriate dosing occurred in an undetermined number of adult patients.  The lot numbers of Engerix B administered were AHBV6B5AB and AHBVB166AA.
Sex: F
Vaccine: HEP
Symptoms: Disturbance in attention, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of concentration difficulty in a female subject aged between 50 and 59 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 20 September 2007 the subject received the first dose of Engerix B (intramuscular, right deltoid).  The reporter noted that the subject "was skinny and had a very small deltoid muscle in which to inject the Engerix B".  On 20 September 2007, on the same day as vaccination with Engerix B, the subject experienced concentration difficulty, which resolved that same day.  On 21 September 2007, the subject experienced aching in the right arm, which resolved approximately one week later.  At the time of reporting the events were resolved.  The vaccination course with Engerix B was discontinued.  Follow-up received on 24 October 2007 via the healthcare professional.  The onset date of the earliest signs and symptoms was reported to be 30 August 2007.  She noted that the end date was questionably on 07 September 2007.  It was reported that concentration returned the next day and the arm was sore for one week.  The nurse noted that the outcome of the events improved and resolved.  She noted that the events were not related to the use of Engerix B and were not serious.  The nurse also reported that she had received an email from the subject.  The subject stated that "she had the devil's own job concentrating."  She also stated that her arm was fine until the next day and then it ached for at least a week.  Follow-up received on 25 October 2007 from the nurse indicated that the Engerix B start date of 20 September 2007 was in error.  She stated that the subject received Engerix B on 30 August 2007.  She reported that she did not know the specific date that the events resolved other than in September 2007.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Fatigue, Hypersomnia, Lethargy, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of tiredness in a 50-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 17 September 2007 the subject received the first dose of Engerix B (unknown, right arm). Following vaccination, on 17 September 2007, the subject experienced tiredness and lethargy, and vomited twice on her way home after receiving Engerix B. She subsequently slept "all day and evening the day of the injection", and on an unspecified date in September 2007 experienced lack of appetite. The events improved two days following vaccination, and were resolved at the time of this report. The vaccination course with Engerix B was discontinued. The reporter believed that the subject, who was also a nurse, "may have had previous hepatitis B vaccination in the past, even tough she did not report this... and that this history of previous injections may have contributed to these events." Follow-up received on 24 October 2007 from a healthcare professional. The subject had no adverse events following receipt of previous immunizations. The healthcare professional reported that, "I suspect that she [the subject] had [received previous doses of hepatitis B vaccine] but she was not forthcoming." The healthcare professional considered that the events were not related to vaccination with Engerix B and could have been associated with "possible booster dose rather than 1st injection" of Engerix B.
Age: 59.0
Sex: F
Vaccine: HEP, TTOX, YF
Symptoms: Asthenia, Headache, Hepatomegaly, Lymphadenopathy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 59-year-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccination included tetanus toxoid vaccine and yellow fever vaccine both given on 31 August 2007. Concurrent medications included Nexium. On 31 August 2007 the subject received 1st dose of Engerix B at 20 mcg. On 2 September 2007, 2 days after vaccination with Engerix B, the subject experienced headache which resolved after a few days. On 15 September 2007, the subject developed swollen glands and lower energy level. She was seen by her physician and told that her liver was swollen. At the time of reporting, swollen glands, low energy level and the swollen liver were unresolved. Causality was not reported.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm muscles in a male subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent vaccination included Vaqta (Merck) given on the same date as Engerix B.  Previous vaccination included Twinrix (GlaxoSmithKline).  On an unspecified date the subject received a dose of Engerix B (unknown) and a dose of Vaqta in place of the combination dose of Twinrix which was unavailable at the time of vaccination.  At an unspecified time after vaccination with Engerix B and Vaqta, the subject experienced sore arm muscles.  The subject stated that his arm muscles were sore for 23 days following administration of the vaccines and the event remained unresolved at the time of reporting.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a female subject of unknown age not responding to therapy following vaccination with hepatitis B vaccine recombinant (unknown manufacturer) for prophylaxis.  Approximately 10 to 15 years ago, the subject was vaccinated with an unspecified number of doses of hepatitis B vaccine.  At an unknown time, the subject was tested and the titer test showed to be non reactive.  The subject had not responded to therapy.  At the time of reporting the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Dermatitis allergic
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with Engerix B for prophylaxis. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject experienced allergic reaction and rash. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with Engerix B. ON 10 October 2007, follow-up received from the pharmacist noted that he had no contact from the subject. He had just been questioned by a physician.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Exposure to communicable disease, Gingival disorder, Hypersensitivity, Mucosal excoriation
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of raw throat in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 20 September 2007 the subject received the first dose of Engerix B (20 mcg, unknown).  On 21 September 2007, one day after vaccination with Engerix B, the subject experienced a raw throat, throat redness, and redness of the tongue.  He presented to his physician's office for medical attention on 24 September 2007.  At the time of reporting the outcome of the events was unspecified.  Follow up information was received on 25 September 2007 via the nurse, who reported that the subject was a 53-year-old male who was reportedly "exposed to illness through his job".  He received his first vaccination with Engerix B, administered in the left arm, on the morning of 20 September 2007.  The following day, 21 September 2007, the subject developed tongue excoriation, red gums, red throat, and burning when eating.  He also developed blisters under his tongue.  Upon examination, the subject's presentation was described as "similar to an oral herpes infection"; however, no diagnostic examinations had been performed to confirm any type of infection.  The subject was referred to a dermatologist for further evaluation.  At the time of this report, the tongue excoriation, red tongue and gums, and burning while eating were improved.  The outcome of the remaining events was not specified.  Follow-up received on 12 October 2007 via the healthcare professional indicated that the subject received the Engerix B vaccination in his left deltoid.  He was seen by a dermatologist on 04 October 2007 and it was determined that the subject experienced a hypersensitivity reaction and reacted to something in the vaccine.  It was decided to not give any more vaccinations to the subject.  The subject did not have any known allergies.  The events resolved on 30 September 2007.  The reporter noted that the events were not related to Engerix B however further notes from the reporter indicated that the subject was hypersensitive to something in the vaccine Engerix-B.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Pharyngeal erythema, Throat irritation, Tongue blistering, Tongue disorder
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of raw throat in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 20 September 2007 the subject received the first dose of Engerix B (20 mcg, unknown).  On 21 September 2007, one day after vaccination with Engerix B, the subject experienced a raw throat, throat redness, and redness of the tongue.  He presented to his physician's office for medical attention on 24 September 2007.  At the time of reporting the outcome of the events was unspecified.  Follow up information was received on 25 September 2007 via the nurse, who reported that the subject was a 53-year-old male who was reportedly "exposed to illness through his job".  He received his first vaccination with Engerix B, administered in the left arm, on the morning of 20 September 2007.  The following day, 21 September 2007, the subject developed tongue excoriation, red gums, red throat, and burning when eating.  He also developed blisters under his tongue.  Upon examination, the subject's presentation was described as "similar to an oral herpes infection"; however, no diagnostic examinations had been performed to confirm any type of infection.  The subject was referred to a dermatologist for further evaluation.  At the time of this report, the tongue excoriation, red tongue and gums, and burning while eating were improved.  The outcome of the remaining events was not specified.  Follow-up received on 12 October 2007 via the healthcare professional indicated that the subject received the Engerix B vaccination in his left deltoid.  He was seen by a dermatologist on 04 October 2007 and it was determined that the subject experienced a hypersensitivity reaction and reacted to something in the vaccine.  It was decided to not give any more vaccinations to the subject.  The subject did not have any known allergies.  The events resolved on 30 September 2007.  The reporter noted that the events were not related to Engerix B however further notes from the reporter indicated that the subject was hypersensitive to something in the vaccine Engerix-B.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Injection site swelling, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 61 year old male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included depression.  In 2003, the subject received Engerix B vaccination series.  On an unspecified date in 2007, approximately 4 years after vaccination with Engerix B vaccine, the subject experienced not responding to therapy.  Antibody titer was less than 5.  The vaccination series was repeated.  When the second dose of Engerix B was being administered, the medical assistant noticed blood in the needle and syringe upon withdrawal of the needle from the subject's arm.  A swollen area appeared at the injection site.  Two pediatric Engerix B vaccines were also used for one adult dose.  At the time of reporting the outcome of the events was unresolved.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis A antibody positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with Engerix B for prophylaxis. Concurrent medical conditions included dialysis. In August 2007 the subject received unspecified dose of Engerix B (unknown). In August 2007, 4 days after vaccination with Engerix B, the subject experienced not responding to therapy and lack of effect. Results revealed a positive hepatitis B surface antigen. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen positive, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis.  In August 2007 the subject received unspecified dose of Engerix B (unknown).  In August 2007, 4 days after vaccination with Engerix B, the subject experienced not responding to therapy and lack of effect.  Results revealed a positive hepatitis B surface antigen.  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B for prophylaxis.  On 26 July 2007, 27 April 2007 and 26 March 2007 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after completion of the Engerix B three dose series, the subject was tested and the titer test showed to be only equivacol.  The subject had not responded to therapy.  At the time of reporting the event was unresolved.
Sex: U
Vaccine: HEP
Symptoms: 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 an infant subject of unspecified gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date in 2007 the subject received 1st dose (birth dose) of Engerix B.  The infant was tested for hepatitis B surface antigen an unknown number of days later and tested positive.  The circumstances for why the infant was tested were not known by the reporter.  No other information was known at the time of reporting.  The outcome of the event was unspecified.  Follow-up information was received on 15 November 2007; just prior to receiving the second Engerix-B dose, the hepatitis B surface antigen was negative.  The subject's antigenemia resolved, dates were unknown.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 56-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. On 11 July 2007, 19 February 2007 and 11 January 2007 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown). On 11 September 2007, it was noted that the subject had not seroconverted or did not respond to therapy with Engerix B. At the time of reporting the event was unresolved.
Sex: U
Vaccine: HEP
Symptoms: Medication error, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject completed the Engerix B vaccine series.  It was reported that two pediatric Engerix B doses were given at each administration of the series so that the dose totaled 20 mcg/1 ml from two 10 mcg syringes (the adult Engerix B dose).  This was considered to be a medication error.  The subject was also tested and found to have not responded to therapy.  At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a gastroenterologist, via a sales representative, and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received the 3rd dose of Hepatitis B vaccine (unknown) to complete the series.  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 63-year-old female subject not responding to therapy following vaccination with Engerix B for prophylaxis. Concurrent medical conditions included hypertension, lumbosacral disc disease, multiple sclerosis, optic neuropathy and osteoporosis. Concurrent medications included Altace, Zoloft, Calcium, Magnesium and Zinc. On November 1998, 9 April 1998 and 6 March 1998 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B at 20 mcg to complete the three dose series. The subject was tested on 11 December 2006 and the titer was found to be negative. The subject had not responded to therapy with Engerix B given in 1998. At the time of reporting the event was unresolved.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 45-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified) for prophylaxis.  In 1992 the subject received three doses of Hepatitis B vaccine (unknown).  On 23 July 2007, 15 years after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy.  At the time of reporting the event was unresolved.  Follow-up received via the physician who indicated that the specific suspect drug continued to be unknown.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 20-year-old male subject who was vaccinated with Engerix B for prophylaxis. Previous and/or concurrent vaccination included diphtheria, tetanus, pertussis given on 2 August 2002 and live attenuated MMR given on 2 August 2002. There were no concurrent medications. On 2 August 2002, 4 September 2002, and 5 February 2003 the subject received the first, second, and third doses of Engerix B (unknown). On 7 August 2007, 4 years after vaccination with Engerix B, 5 years after vaccination with Engerix B, the subject experienced not responding to therapy. Approximately four and half years after completion of the Engerix B series, on 07 August 2007 and 16 August 2007, hepatitis B antibody titers were negative. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Haematoma, Oedema peripheral, Rash
Clinical narrative: This case was reported by a pharmacist consultant and described the occurrence of swelling arm in an adult female subject who was vaccinated with Engerix B for prophylaxis. On an unspecified date the subject received the third dose of Engerix B (1 ml, unknown). It was noted that no blood was aspirated prior to vaccination. At an unspecified time after vaccination with Engerix B, the subject experienced swelling of the arm and a rash. It was not specified whether the events were systemic or localized. The subject was evaluated in the emergency department and was diagnosed with a hematoma. At the time of reporting the outcome of the events were unspecified.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an adult female subject not responding to therapy following vaccination with Hepatitis B vaccine for prophylaxis. On August 2000, May 1999 and April 1999 the subject received 3rd dose, 2nd dose and 1st dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject was tested and found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified.