chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP, HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported by a nurse and described the occurrence of multiple sclerosis symptoms in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On 24 October 2005, the subject received the 1st dose of Engerix-B (lot AHBVB076BA). On 24 October 2005, the subject also received live attenuated MMR II (strain not specified). On 02 December 2005 the subject received 2nd dose of Engerix-B (lot AHBVB172AA). On an unspecified date on or after 02 December 2005 and or before 04 May 2006, less than one year after vaccination with Engerix-B, the subject experienced multiple sclerosis like symptoms. The outcome of the event was not reported. Comment: Multiple sclerosis symptoms was assessed as medically serious.
Sex: F
Vaccine: HEP, HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported by a nurse and described the occurrence of multiple sclerosis symptoms in a female subject of unspecified age who was vaccinated with Engerix B for prophylaxis. On 24 October 2005, the subject received the 1st dose of Engerix B (lot AHBVB076BA). On 24 October 2005, the subject also received MMR II. On 02 December 2005 the subject received 2nd dose of Engerix B (lot AHBVB172AA). On an unspecified date on or after 02 December 2005 and on or before 04 May 2006, less than one year after vaccination with Engerix B, the subject experienced multiple sclerosis like symptoms. The outcome of the event was not reported. Comment: Multiple sclerosis symptoms was assessed as medically serious by manufacturer.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Tendonitis
Clinical narrative: On 11/16/06, the patient was given a flu shot at a clinic. She pointed to an area of the lower deltoid where she said the shot was given. She had family visit her after Christmas and was sleeping on the sofa. She developed pain and redness of left shoulder and was seen by an orthopedic surgeon, who did a left shoulder X ray which showed tendonitis. Dr said it was due to her sleeping on a sofa.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site right upper arm.
Age: 52.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Asthenia, Libido decreased
Clinical narrative: Joints ache, loss of energy, weakness, libido decrease.
Age: 1.53
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right thigh red, swollen, warm, RX'd Keflex
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Brief febrile convulsion within 12 hours of receiving Dtap, Hib, Prevnar, and Flu vaccine. 1/29/07  Received medical records from provider which included ER record.  Seen in ER on 1/10/07 for mouth twitching, eye twitching & rolling back lasting for approx 1 min & followed by a period of quietness.  Had cold/cough for few days prior to receiving vax & was running a fever of unknown value.  Temp in ER was 101.  Tx w/antipyretic & d/c to f/u by PCP next day.  At PCP office, 1/11 & no further fever or seizure activity noted. LABS: WBC 16.7. FINAL DX: Febrile seizure.
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: 5 mins after receiving Gardasil pt had vasovagal symptoms, lasted approx 5-10 min.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Malaise, Skin warm, Somnolence, Vomiting
Clinical narrative: 01/04/07 pt started getting sick around 2pm, her face was warm and flush, no recorded fever, threw up one time. Fell asleep until 5pm woke up ate a little dinner went back to sleep until next morning.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Full body Hives
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Full blood count, Pyrexia, Rash, Viral infection, White blood cell count decreased
Clinical narrative: On January 13, 2007, fever of 101.7 gave Tylenol 1 1/2 teaspoons every 6 hours. Fever continued until 1/16/2007. On 1/16/2007, no fever. On 1/17/2007, tool pt to Dr because she now has a rash on her chest up. Dr said it was a virus and that the rash was not chicken pox or shot.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on legs, face, trunk increased temp 100-103
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Cough, Injection site erythema, Injection site swelling, Petechiae
Clinical narrative: Had slight cough when vaccines administered 1/11/07. That night, temp increase 103 and stayed 103 through 1/16 alternating Tylenol and Motrin. Large 5cm raised red area left deltoid (Dtap) 1/13, to ER to Dr 1/16. Has petechiae on chest and small blisters also cough. 1/17 mother said arm and chest fading.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Had slight cough when vaccines administered 1/11/07. That night, temp increase 103 and stayed 103 through 1/16 alternating Tylenol and Motrin. Large 5cm raised red area left deltoid (Dtap) 1/13, to ER to Dr 1/16. Has petechiae on chest and small blisters also cough. 1/17 mother said arm and chest fading.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 01/16/2007 pt came to office stated went to ER c/o pain to left back of arm with swelling and redness told to have reaction to vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: In Am following vaccination, pt had left arm swelling, erythema from shoulder to elbow, Also low grade temp to 99.6 also pruritus and small maculo-papular rash at areas scratched. Pt given Polio #4 and Dtap #5 in left arm and MMR #2 in right arm. Pt seen on 12/27/06 symptoms resolving. Prescribed Benadryl 50.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Swelling, erythema, induration rt deltoid tender. Localized cellulitis Cephalexin 25 mg TID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Varicella
Clinical narrative: Varivax given 06/29/04, DX with chicken pox 01/03/07.
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Back pain, Chest discomfort, Headache
Clinical narrative: C/O chest tightness, pain in both feet, pain (cramping in calves( visual disturbances, weakness, headache, heavy feeling in his chest, pain in 1+ knee, back pain.
Sex: M
Vaccine: TD
Symptoms: Muscle spasms, Pain in extremity, Visual disturbance
Clinical narrative: C/O chest tightness, pain in both feet, pain (cramping in calves( visual disturbances, weakness, headache, heavy feeling in his chest, pain in 1+ knee, back pain.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Abasia, Headache, Lymphadenopathy, Pyrexia, Sensation of heaviness
Clinical narrative: High temp about 6 hours after after injection, Enlarged lymph nodes in groin and armpit (red), severe HA couldn't walk for approx 6-8 hours after legs felt very heavy for 2 days.
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Skin nodule
Clinical narrative: PT REPORTS THAT THE DAY AFTER RECEIVING TDAP VACCINE, THE LEFT SIDE OF HER NECK BECAME TIGHT AND SORE.  SHE NOTICED A "LUMP" ON HER LEFT COLLAR BONE WHICH IS EXAMINED BY THE RN AND FOUND TO BE AN ENLARGED CERVICAL LYMPH NODE.  NODE IS APPX 3MM AND TENDER TO PALPATION.  PT HAS BEEN INSTRUCTED TO WATCH NODE AND TO SEE MD SHOULD ENLARGEMENT PERSIST.  NO REDNESS OR SWELLING IS NOTED AT THE INJECTION SITE (LEFT DELTOID).
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Ear pain, Pyrexia, Varicella
Clinical narrative: History of chicken pox as a child in 1991. Received varicella vaccine 1/3/07 per college requirements. Broke out in multiple head to toe pox starting 1/6/07.  Pox in throat and fever of 101 degrees on 1/8/07. 1/12/07-Seen by PCP with negative strep throat screen. 1/14/07-C/O earache. 1/15/07-Seen again by PCP who noted pox on eardrum with exam.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Gait disturbance, Incorrect dose administered, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Received the DTaP vaccine on Tuesday Jan. 9, 2007 in the morning.  Within two hours he began running a low grade fever that lasted until the evening.   His upper leg became hot to the touch, swollen, and sore which lasted for 48 hours. The circumference was 12 3/4 inches compared to the other leg which was 11 1/2 inches.  He limped and complained of pain from Tuesday through Thursday.  By Friday, was walking normally but the leg was sore to the touch and still swollen.  On Saturday, January 13, a rash appeared on the affected leg.  The rash measured 3 inches in length and 1 1/8 inches wide.  It consisted of 19 distinct, red, raised "spots".  As of today, January 17, 2007, the spots are still visible although not as textured and are faded in color.   **Please note that from the research I have done, it is my understanding that the doctor ordered this vaccine out of schedule.  This was his 4th dose of DTaP. (He was on a delayed schedule due to previous adverse reations, although not this severe.) The third dose was given on 9-29-06.  This means that the 3rd and 4th doses were given only 3 months and 11 days apart.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Received the DTaP vaccine on Tuesday Jan. 9, 2007 in the morning.  Within two hours he began running a low grade fever that lasted until the evening.   His upper leg became hot to the touch, swollen, and sore which lasted for 48 hours. The circumference was 12 3/4 inches compared to the other leg which was 11 1/2 inches.  He limped and complained of pain from Tuesday through Thursday.  By Friday, was walking normally but the leg was sore to the touch and still swollen.  On Saturday, January 13, a rash appeared on the affected leg.  The rash measured 3 inches in length and 1 1/8 inches wide.  It consisted of 19 distinct, red, raised "spots".  As of today, January 17, 2007, the spots are still visible although not as textured and are faded in color.   **Please note that from the research I have done, it is my understanding that the doctor ordered this vaccine out of schedule.  This was his 4th dose of DTaP. (He was on a delayed schedule due to previous adverse reations, although not this severe.) The third dose was given on 9-29-06.  This means that the 3rd and 4th doses were given only 3 months and 11 days apart.
Age: 41.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Patient reports that the day after receiving TDAP vaccine she noticed a large painful swelling under her right arm with that area tight feeling.On examination by RN 4 days later a 15mm swelling tender to the touch was found in rt. axilla.No reddness or swelling noted at injection site(rt. deltoid).Patient was instructed to watch area and if worsens or does not resolve to see PMD.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Wheezing
Clinical narrative: Pt received inactivated Influenza vaccine, 0.5ml IM in the left deltoid at 1410 on 16 Jan 2007.  At approximately 1508, the pt came to the front clinic desk c/o wheezing/coughing.  I quickly notified Dr who came out and brought her to the back treatment room.  He listened to her lungs, thten requested us to perform a PFT on the patient.  After the PFT's were accomplished, she was administered a nebulizer treatment of Albuterol 5mg and Atrovent 0.05mg.  Following completion of the neb tx, Dr listened to her lungs again, and requested us to repeat the PFT.  After those results came up, the patient was still complaining of cough. Dr asked her several times if she had any other symptoms other than a cough, and this time she said she was having some chest tightness.  Dr ordered me to administer 0.3mg of Epinephrine IM.  I administered the Epi at 1542.  Following the dose of Epi we obtained vital signs.  After the second set of vital signs, the patient was given 40mg of Prednisone to decrease the chances of a latent phase reoccurrence of the reaction.  We observed the patient for an hour, she continued to improve, then when Dr felt confident enough about her condition, she was released to her husband who drove her home.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Given an Adult dose of Hepatitis B rather than the pediatric formulation.  No adverse effects have been noted.  CDC was notified and this nurse was told to fill this out per their request since an adolescent received an adult dose instead a pediatric one.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cyanosis, Hypersensitivity, Lip oedema, Pruritus
Clinical narrative: Mom called stated "my child is having an allergic reaction to shots.  His lips are turning blue and swelling.  He is itching like crazy." LPN instructed parent to take child to emergency room on 1-16-2007 at 17:40
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blister, Pain, Silver-Russell syndrome, Skin exfoliation, Skin irritation
Clinical narrative: Russell Silver's Syndrome. Blistering and peeling raw skin over all parts of the body, pain. 03/12/07-records received from PCP. Notes of 2/280/02 document diaper rash diffuse erythemetous areas. Continues with diaper rash 03/07/02. On 03/11/02-diaper rash continues now on trunk diffuse erythemeous macular papular leions on trunk, fac and anticubital spaces. No lymphadenopathy. 5/28/03-Chicken pox.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Gastric ulcer, Heat rash, Pruritus, Rash
Clinical narrative: Beginning 2 days after vaccination, minimal bilateral forearm pruritic blistering occurred. Over following 2-5 days, patient stratched blistered causing them to open and now rash appears to be resolving. No rashing on chest or face. No associated brusing, bleeding (epistasis or gingival), GI distress, fever or chills.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: pt stated post last vaccine admin. arm was hot to touch and sore
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: pt received vaccine at 1340, mom noticed hives at 1415, returned to clinic, seen by md at 1515, benadryl given at 1515, pt observed until 1600, reddness and elevation lessened, no further hives noted
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Pain, Paralysis, Plasmapheresis
Clinical narrative: Gullian [[name]] Syndrome, Partial paralysis, pain about 2-3 weeks after influenza vaccination patient received Plasmapheresis treatment.  2/5/07 Received medical records from hospital which reveal that patient experienced progressive weakness of her [[name]]s & tingling of the toes over a 4 week period along with weakness of the hands, bladder urgency & low back pain.  Admitted 12/18/2002-12/23/2002.  On exam she had [[name]] weakness & absent ankle jerk reflexes.   Tx w/plasmaphoresis x 4.  Improved & was d/c to home with f/u by neuro.   FINAL DX: Guillain [[name]] syndrome; hypothyroidism; HTN; & lumbago.
Age: 1.79
Sex: F
Vaccine: MMRV
Symptoms: Pallor, Pruritus, Rash, Rash erythematous, Rash generalised
Clinical narrative: Rash started on 1/16/07 on face and around ears. Spreading all over body, palms and sole, itchy. No fever. Rash erythematous hives, of varying size 3-4 inch to small macula, blanching, few have central cleaning, measle like rash. Medicated with Benadryl.
Age: 1.79
Sex: F
Vaccine: MMRV
Symptoms: Rash macular, Rash morbilliform, Urticaria
Clinical narrative: Rash started on 1/16/07 on face and around ears. Spreading all over body, palms and sole, itchy. No fever. Rash erythematous hives, of varying size 3-4 inch to small macula, blanching, few have central cleaning, measle like rash. Medicated with Benadryl.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Varivax given approx 30-40 minutes later fine red raised rash face, ears, neck shoulder. Epi and Benadryl given.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described an adult subject of unspecified gender who did not respond to immunization with Engerix B for prophylaxis. On an unspecified date before 13 November 2006 the subject received an unspecified dose of Engerix B. The healthcare professional reported that the subject received the full vaccine series. On an unspecified date on or before 13 November 2006, at an unspecified time after vaccination with Engerix B, a hepatitis B surface antibody titer indicated that the subject had no response to the vaccine.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described an adult subject of unspecified gender who did not respond to immunization with Engerix B for prophylaxis. On an unspecified date in 2006 the subject received an unspecified dose of Engerix B. The healthcare professional reported that the subject received the full vaccine series. On 25 October 2006, less than one year after vaccination with Engerix B, a hepatitis B surface antibody titer indicated that the subject had no response to the vaccine.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician and described a male subject of unspecified age who did not respond to immunization to Hepatitis B vaccine (Manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown). About three to four years later, on an unspecified date on or before 14 November 2006, a hepatitis B surface antibody titer was zero.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of a female subject aged between 60 and 69 years old testing hepatitis B surface antigen positive following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history and concurrent conditions were not reported. Concurrent medications included blood pressure medication. In October 2006 the subject received primary course of Engerix B at 40 mcg. Lot number and expiration date were not reported. In November 2006, following vaccination with Engerix B, the subject was tested and found to be hepatitis B surface antigen positive. The event was unresolved at the time of reporting.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of a male subject aged between 60 and 69 years old testing hepatitis B surface antigen positive following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history and concurrent conditions were not reported. Concurrent medications included blood pressure medications. In October 2006 the subject received primary course of Engerix B at 40 mcg. Lot number and expiration date were not reported. In November 2006, following vaccination with Engerix B, the subject was tested and found to be hepatitis B surface antigen positive. The event was unresolved at the time of reporting.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back disorder, Drug hypersensitivity, Drug ineffective, Fatigue
Clinical narrative: This case was reported by a nurse and described a 33 year old female subject who experienced the occurrence of hypaesthesia following vaccination with Engerix B for prophylaxis. Medical history and concurrent medications were unknown. On 10 May 2006, the subject received the 1st dose of Engerix B. Within twenty four hours, the subject experienced right sided dyesthesia, fever joint pain and fatigue. The subject was seen in the emergency room. Following consultation with a neurologist, results of a MRI of the brain was normal and the MRI of the cervical spine revealed a bulging disc between C5 and C6. An anti double stain DNA antibody test, laboratory test and urinalysis was normal. The symptoms improved. The Engerix B series was discontinued. The causality was unk. Follow up received on 19 December 2006 indicated the onset of events was 12 May 2006, two days following vaccination with Engerix B. Diagnostic results revealed a negative hepatitis B surface antibody. Hepatitis B series was not completed. The subject continues to have occasional dull aches. The physician considered the events to be a reaction to the hepatitis B vaccination as the diagnostic workup was negative. The subject had hepatitis B immunization in the past without problems.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described a 33 year old female subject who experienced the occurrence of hypaesthesia following vaccination with Engerix B for prophylaxis. Medical history and concurrent medications were unknown. On 10 May 2006, the subject received the 1st dose of Engerix B. Within twenty four hours, the subject experienced right sided dyesthesia, fever joint pain and fatigue. The subject was seen in the emergency room. Following consultation with a neurologist, results of a MRI of the brain was normal and the MRI of the cervical spine revealed a bulging disc between C5 and C6. An anti double stain DNA antibody test, laboratory test and urinalysis was normal. The symptoms improved. The Engerix B series was discontinued. The causality was unk. Follow up received on 19 December 2006 indicated the onset of events was 12 May 2006, two days following vaccination with Engerix B. Diagnostic results revealed a negative hepatitis B surface antibody. Hepatitis B series was not completed. The subject continues to have occasional dull aches. The physician considered the events to be a reaction to the hepatitis B vaccination as the diagnostic workup was negative. The subject had hepatitis B immunization in the past without problems.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Prophylaxis
Clinical narrative: Hepatitis B surface antigen positive.   This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject's medical history included hemodialysis. On an unspecified date the subject received unspecified dose of Engerix-B.  On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Prophylaxis
Clinical narrative: Hepatitis B surface antigen positive.  This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject's medical history included hemodialysis.  On an unspecified date the subject received unspecified dose of Engerix-B. On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
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 adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis.  The subject's medical history included hemodialysis.  On an unspecified date the subject received unspecified dose of Engerix-B. On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Prophylaxis, Vision blurred
Clinical narrative: Migraine, Vision blurred.  This case was reported by a healthcare professional and described the occurrence of migraine headache in a 25-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include migraine headache.  Her prior migraine was three months prior to the vaccination with Engerix-B.  The subject's migraines normally lasted only one day. The subject had no reported illness at the time of vaccination.  Co-suspect medication included medroxyprogesterone acetate (Depo Provera). On 09 May 2006, the subject received the 1st dose of Engerix-B (unknown, right arm).  On 10 May 2006, 24 hours after vaccination with Engerix-B, the subject experienced migraine headache and blurred vision.  At the time of reporting, the migraine headache was resolved. The outcome of the blurred vision was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive.  This case was reported by a physician and described a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B surface antigen.  The subject was a dialysis patient. On an unspecified date prior to receiving the Energix-B dosing series, the subject had a negative hepatitis B surface antigen blood test.  On an unspecified date at the end of September 2006, the subject received the 3rd dose of Engerix-B. On either 04 or 05 October 2006, a titre was drawn which showed a positive result for hepatitis B surface antigen.  No other information was reported.  At the time of reporting, the outcome was unknown.
Sex: U
Vaccine: HEP
Symptoms: Dialysis, Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive.  This case was reported by a physician and described a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B surface antigen.  The subject was a dialysis patient. On an unspecified date prior to receiving the Engerix-B dosing series, the subject had a negative hepatitis B surface antigen blood test. On an unspecified date at the end of September 2006, the subject received the 3rd dose of Engerix-B. On either 04 or 05 October 2006, a titre was drawn which showed a positive result of hepatitis B surface antigen. No other information was reported.  At the time of the reporting, the outcome was unknown.
Sex: U
Vaccine: HEP
Symptoms: Dialysis, Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive.  This case was reported by a physician and described a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B surface antigen.  The subject was a dialysis patient. On an unspecified date prior to receiving the Engerix-B dosing series, the subject had a negative hepatitis B surface antigen blood test.  On an unspecified date at the end of September 2006, the subject received the 3rd dose of Engerix-B. On either 04 or 05 October 2006, a titre was drawn which showed a positive result for hepatitis B surface antigen. No other information was reported.  At the time of reporting, the outcome was unknown.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Therapy non-responder. This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatititis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antibody titer was negative.  Relevant test results included [laboratory results/hospital investigations].  At the time of reporting the outcome of the event was was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Therapy non-responder. This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antibody titer was negative.  Relevant tests results included [laboratory results/hospital investigations]. At the time of reporting the outcome of the event was was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: Therapy non-responder.  This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B.  On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antibody titer was negative.  Relevant test results included [laboratory results/hospital investigations].  At the time of reporting the outcome of the event was was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a  hepatitis B surface antibody titer was negative. Relevant test results included (laboratory results/hospital investigations). At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described an adult male subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a  hepatitis B surface antibody titer was negative. Relevant test results included (laboratory results/hospital investigations). At the time of reporting the outcome of the event was unspecified.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 65-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history included heart transplant and hemodialysis. Concurrent medications included Epoetin alfa (Epogen), Paricalcitol (Zemplar), Venofer, Azathioprine (Imuran), Losarten potassium (Cozaar), Lisinopril, Cyclosporin (Neoral), Quetiapine fumarate (Seroquel), Diazepam, Clonidine, Docusate, Prednisone, Metoprolol succiante (Toprol) and Fioricet. On 04 September 2006, the subject received the 1st dose of Engerix-B. On 02 October 2006 the subject received 2nd dose of Engerix-B. On 04 October 2006, 2 days after vaccination with the 2nd dose of Engerix-B, a blood sample revealed that the subject was hepatitis B surface antigen positive and negative for hepatitis B core IgM, hepatitis B surface antibody, and hepatitis A virus antibody. A repeat blood test performed on 07 October 2006, again revealed that the subject was hepatitis B surface antigen positive and negative for hepatitis B IgM, hepatitis B surface antibody, and hepatitis A virus antibody. At the time of initial reporting, 09 October 2006, the event was ongoing. The healthcare professional considered the event was possibly related to vaccination with Engerix-B.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Hot flush, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 32-year-old male subject who was vaccinated with hepatitis B vaccine with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On 05 October 2006 the subject received unspecified dose of Engerix-B in the left arm. On 05 October 2006, less than one day after vaccination with Engerix-B, the subject experienced shortness of breath, hive and hot flash. The subject was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the events was not reported.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered, Yellow fever
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administered in a 47-year-old male subject was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. Concurrent medications included Tetanus vaccine. On 7 September 2006 the subject received 1st dose of Engerix-B at 0.5 ml and Havrix (dose number not specified) at ELISA units. At an unspecified after vaccination with Engerix-B and Havrix, the subject developed yellow fever. At the time of documenting this event, the healthcare professional noted that the lots of Engerix-B that were administered to the subject on 07 September 2006 were pediatric doses and not the adult dose. This was considered to be an inappropriate dose of drug administered as 1 ml of Engerix-B and 1440 ELISA units of Havrix are indicated for adult subjects. No additional information is available regarding this case.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse via another manufacturer and described the occurrence of headache in an adult female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The reporting nurse was also the subject. On an unspecified date on or prior to 13 October 2003, the subject received an unspecified dose of Engerix-B. At an unspecified time after vaccination with Engerix-B, the subject experienced headache, neck stiffness, and joint pain. As a result of the events, the subject sought medical attention. At the time of reporting, the subject was still experiencing symptoms. No further information was reported. The outcome was reported to be recovering with sequalae.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 23-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. There was no noted relevant medical history. Concurrent medications included amitripyline (Elavil). Concurrent conditions were not reported.  On 23 November 2005, the subject received 1st dose of Engerix-B. On 23 December 2006, the subject received 2nd dose of Engerix-B. On 23 May 2006, the subject received 3rd dose of Engerix-B. On 15 September 2006, approximately four months following 3rd dose of Engerix0B, the subject had a hepatitis B surface antibody titre drawn. The resulting level was 7.7 mIu/ml. This was considered to be a decreased therapeutic response. No additional details were known at the time of reporting. The outcome of the event was unknown. Follow-up information was received on 04 October 2006 via the reporter. The subject had no relevant medical history., concurrent conditions, or concurrent medications. The subject drank four to five servings of alcohol per month and did not use tobacco. The dose of Engerix-B given on 23 May 2006 was 20 mcg. It was planned to repeat the Engerix-B vaccine series. The nurse practitioner considered the events were related to Engerix-B. The nurse practitioner also considered the events could have been associated with lack of efficacy.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of left arm pain in a 47-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On 12 September 2006, the subject received an unspecified dose of Engerix-B (intramuscular, left arm). On 14 September 2006, two days after vaccination with Engerix-B, the subject experienced pain, numbness and tingling in the left arm. No other information was available at the time of reporting. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with Engerix-B.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 30-year-old female subject not responding to therapy following vaccination with hepatitis B  vaccine recombinant for prophylaxis. The subject was allergic to codeine and prochlorperazine (Compazine). There were no concomitant medications. On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of Hepatitis B vaccine. This completed a three dose series for hepatitis B. The dose, lot number and expiration dates for each administration were not provided. On a date on or before 24 July 2006, the subject, a nursing student, received a "surface antibody test" to do clinicals and the reading was 8.7. The subject was considered a non-responder and was not allowed by her school to participate in clinicals. Documentation received noted that the actual trade name of the Hepatitis B vaccine administered was not known. Manufacturer was notified in case the subject received Engerix-B. Follow-up regarding this case was received on 29 September 2006. On 24 July 2006, a hepatitis B surface antibody was 8.7 MIU/ml. On 07 September 2006, a hepatitis B surface antibody was negative. The reporting healthcare professional considered the event to be possibly related to vaccination with hepatitis B vaccine. At the time of reporting, the outcome was unknown.
Sex: U
Vaccine: HEP
Symptoms: Haemodialysis, Hepatitis B antibody negative
Clinical narrative: This case was reported by a nurse and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. Concurrent medical conditions included hemodialysis. On three unspecified dates on or prior to 30 August 2006, the subject received three doses of Engerix-B vaccine (40 mcg, unknown). The indicated dosing for Engerix-B in hemodialysis subjects is four doses of the vaccine, administered on a 0, 1, 2, and 6 month dosing schedule. After receiving the three doses of Engerix-B, the subject tested negative for antibody to hepatitis B. The nurse stated that she planned to administer an Engerix-B booster dose to the subject and check titer levels approximately six weeks after the booster was administered. No additional information was reported regarding this event. At the time of reporting the outcome of the event was was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Haemodialysis, Hepatitis B antibody negative, Hepatitis B surface antigen, Prophylaxis
Clinical narrative: This case was reported by a nurse and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. Concurrent medical conditions included hemodialysis. On three unspecified dates on or prior to 30 August 2006, the subject received three doses of Engerix-B in hemodialysis subjects is four doses of the vaccine, administered on a 0,1, 2, and 6 month dosing schedule. After receiving the three doses of Engerix-B, the subject tested negative for antibody to hepatitis B. The nurse stated that she planned to administer an Engerix-B booster dose to the subject and check titer levels approximately six weeks after the booster was administered. No additional information was reported regarding this event. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Prophylaxis, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a female subject of unspecified age who was inadvertently vaccinated with Engerix-B for prophylaxis. The pharmacist reported that, on 16 August 2006, "a nurse accidentally administered (the 1st dose of) Engerix-B to a patient subcutaneously thinking the vaccine was a tuberculosis vaccine." The recommended route of administration of Engerix-B is intramuscular. On either 16 August 2006 or 17 August 2006, less than one week after vaccination with Engerix-B, the subject experienced swelling injectiong site and injection site redness. The subject was seen at a physician's office. The vaccination course with Engerix-B was discontinued. The outcome of the events was not reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Vaccination failure
Clinical narrative: This case was reported by a nurse via a wholesaler sales representative and described the occurrence of low seroconversion to hepatitis b vaccine in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. It was thought that the subject completed the entire series of Engerix-b (vaccination dates not provided), but it was unclear. At an unspecified time after vaccination with Engerix-B, the subject's titer did not reach the correct level, and the subject developed possible lack of efficacy. At the time of reporting, the outcome of the events was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Vaccination failure
Clinical narrative: This case was reported by a nurse via a wholesaler sales representative and described the occurrence of low seroconversion to hepatitis b vaccine in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. It was thougth that the subject completed the entire series of Engerix-B (vaccination date not provided), but it was unclear. At an unspecified time after vaccination with Engerix-B, the subject's titer did not reach the correct level, and the subject developed possible lack of efficacy. At the time of reporting, the outcome of the events was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Vaccination failure
Clinical narrative: This case was reported by a nurse via a wholesaler sales representative and described the occurrence of low seroconversion to hepatitis b vaccine in subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. It was thought that the subject completed the entire series of Engerix-B (vaccination dates not provided), but it was unclear. At an unspecified time after vaccination with Engerix-B, the subject's titer did not reach the correct level, and the subject developed possible lack of efficacy. At the time of reporting, the outcome of the events was unspecified.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Blood cholesterol increased, Drug ineffective, Hepatitis B antibody negative, Hypothyroidism
Clinical narrative: This case was reported by a nurse and described a 57 year old female subject who did not respond to immunization to the Engerix-B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On 06 April 2005, the subject received the third dose of Engerix-B. The other two doses were given on 28 October 2004 and 28 September 2004. On 06 May 2006, one month after vaccination with Engerix-B, it was reported that the subject had a negative hepatitis B antibody titer. Further information was not reported.
Age: 35.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Hepatitis B antigen positive, Hepatitis B surface antigen positive, Medication error
Clinical narrative: This case was reported by a consumer and described the occurrence of "positive hepatitis B titre" in a 35 year old female subject who was vaccinated with Engerix-B for prophylaxis. A physician or other health care professional has not verified this report.  The subject's relevant medical history included arthritis. Concurrent medications included Motrin and Dyazide. On 01 May 2006 the subject received 1st dose of Engerix-B (1 ml, unknown lot number). On 01 May 2006, the subject received "some other (unspecified) vaccinations which she reports may have been mixed in the same syringe as Engerix-B. She reports 5cc volume of injection, not just 1cc for hepatitis B shot." This was considered to be a medication error. It is recommended that Engerix B be given in a separate syringe when concomitant administrations of other vaccines are required. At the time of reporting, the subject had not yet received a second dose of hepatitis B vaccine. On 10 August 2006, 101 days following the 1st dose of Engerix-B, "she had a titre drawn that was hepatitis B surface antigen positive." As a result, the subject has been denied entry into nursing school. She reported that she was going to a gastroenterologist for viral load testing. At the time of reporting the outcome of the event was unresolved. Follow up received on 30 August 2006 indicated that prior to vaccination with Engerix-B she had previously tested negative for hepatitis B in 2005 and her husband had tested negative as well. Viral load testing was negative but she reported that "it seems that an assay was positive at some point."
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described the occurrence of antigenemia in a 55 year old male subject who was vaccinated with Engerix-B for prophylaxis. Subject is currently a dialysis patient. Medical history included diabetes, cirrhosis,hypertension, alcoholism and athersclerosis. Concurrent medications included Lortab, Nephro-Vite, Plavix, Vytorin, and Amaryl. On or before July 25, 2006, the subject tested negative for hepatitis B. On 25 July 2006 at 16:30am, the subject received the initial dose of Engerix-B (40 mcg, left deltoid). On 27 July 2006, two days after vaccination with Engerix-B, the subject experienced antigenemia. At the time of reporting, the outcome of the event was unspecified.