chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Convulsion, Dyspnoea, Erythema, Skin discolouration
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 month old male patient who turned blue and subsequently experienced a generalized seizure on 11-Jan-2006. On 06-Jan-2006, at 4 months of age, the patient received the second dose of Prevnar, along with a dose of Pediarix (diphtheria/tetanus/acellular pertussis/hepatitis B vaccine/polio virus inactivated) and a dose of Act-Hib (haemophilus B conjugate vaccine (tetanus)). The patient's concurrent illness includes hemangioma of skin (port wine stain on face). Indication for Prevnar was immunization. Product was administered on 06-Jan-2006. dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Th child's mother reported that on 11-Jan-2006, her infant son turned blue (skin discoloration) and was resuscitated by her. The infant was then seen by the physician and later admitted to the hospital for a generalized seizure (convulsion). Laboratory tests were performed: EEG and MRI results were negative. The child was hospitalized for 2 days. No medications were administered to the infant while hospitalized. The physician noted that the infant "had no reaction with first Prevnar dose" and no previous neurological issues were known. No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Rash papular
Clinical narrative: Rash began on torso on AM of 1-3-06.  Denies itch.  Rash is describe crops of pink papules-some vesicles-some spots on neck, near ears.  No oral lesions.  Placto documentation.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash, Rash papular
Clinical narrative: On 1-3-06 discrete papules appeared on torso, itchy, increased rash on torso, flanks, groin, one spot inside cheek, spots on neck, ears, many with vesicles.  Photo documentation taken for chest.
Age: 20.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Pyrexia
Clinical narrative: From initial information received on 05/27/2005 from a patients parent regarding an adverse event, it was reported that a 19 year old male patient received a dose of Menomune A/C/Y/W 135 vaccine, lot number unknown, administered in the arm on 05/25/2005. To days later on May 27 2005, the patient wake up with a red, flat race on his face and a slight fever. The patients family physician was called. At the time of this report, the patient had not recovered from these events.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Back pain, Musculoskeletal stiffness, Pyrexia, Skin exfoliation, Swelling
Clinical narrative: Initial report received from patient's parent on 08/15/2005.  An 18 year old female patient with a medical history of exercise induced Asthma, had received a subcutaneous injection of Menomune, lot number unknown, in July 2004.  Four to six hours later, the patient developed a stiff neck and back and a fever.  Her hands and feet became extremely swollen and the skin peeled off of them.  As per the reporter, the patient recovered from these events.
Age: 47.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Meningitis, Musculoskeletal stiffness
Clinical narrative: From initial information received on 12/17/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a dose of Fluzone, administered in the right deltoid and a dose of Menumune, administered in the left arm on 12/06/2004.  Routes of administration were not reported.  Ten days later, on 12/16/2004, the patient developed gastrointestinal upset, nausea, vomiting, diarrhea, severe generalized aching, aching behind the eyes and a headache.  In addition, she developed neck and spine stiffness.  The patient also felt feverish, but no temperature was taken.  Reportedly, the patient previously received flu vaccinations, but no reactions were reported.  Per the reporter, the patient has not recovered from these events.  Followup information received on 08/25/2005.  The patient received fluzone intramuscularly and received menomune subcutaneously.  Per the reporter, the patient recovered completely and was only ill for several days.  The patient previously told the reporter that she had Meningitis when working in a hospital and when she became ill after the shots, she was feeling like she did at the time of the meningitis - stiff neck and back, headache, etc.  To the reporter's knowledge, the patient did not have any other pre-existing conditions and was not on any other medications.  No lab tests were done or treatment given.  The reporter was unable to contact the patient further.
Age: 47.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: From initial information received on 12/17/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a dose of Fluzone, administered in the right deltoid and a dose of Menumune, administered in the left arm on 12/06/2004.  Routes of administration were not reported.  Ten days later, on 12/16/2004, the patient developed gastrointestinal upset, nausea, vomiting, diarrhea, severe generalized aching, aching behind the eyes and a headache.  In addition, she developed neck and spine stiffness.  The patient also felt feverish, but no temperature was taken.  Reportedly, the patient previously received flu vaccinations, but no reactions were reported.  Per the reporter, the patient has not recovered from these events.  Followup information received on 08/25/2005.  The patient received fluzone intramuscularly and received menomune subcutaneously.  Per the reporter, the patient recovered completely and was only ill for several days.  The patient previously told the reporter that she had Meningitis when working in a hospital and when she became ill after the shots, she was feeling like she did at the time of the meningitis - stiff neck and back, headache, etc.  To the reporter's knowledge, the patient did not have any other pre-existing conditions and was not on any other medications.  No lab tests were done or treatment given.  The reporter was unable to contact the patient further.
Age: 40.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Myalgia, Pharyngolaryngeal pain, Rash maculo-papular
Clinical narrative: Initial report received from a healthcare professional in the USA on 08/15/2005.  A 39 year old male patient developed with myalgia, headache, sore throat and a macular papular pink colored rash on torso and upper shoulder, 1 day after receiving the injection of menomune on 08/12/2005.  The patient had received vaccine due to possible exposure.  The patient required doctor visit.  At the time of reporting, the patient did not recover.  The symptoms still persisted.
Age: 24.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Initial report received on 08/17/2005 from a healthcare professional.  A 24 year old female patient received a first dose of Menomune, administered intramuscularly in error in the left deltoid on 08/11/2005.  That same day the subject developed large diffuse hives and itching that became progressively worse over the next 72 hours.  She was subsequently taken to the emergency room by her Mother and treated with Benadryl and a five day steroid taper pack.  At the time of this report the patient had recovered from these events.  Followup information received on 11/10/2005.  The reporter records hives in the illness at time of vaccination box of the VAERS form.  Further information is not expected.  At the time of this report, the patient had recovered.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: A 19 year old female patient received a subcutaneous injection of Menomune, in the left arm on 09/07/2005.  Four days later she complained of severe pain and stiffness in the back of the neck area.  No fever, headache or other illness was reported with this event.  It was not reported if this patient had received any treatment for this event.  The patient has a pre-existing history of codeine allergy and was not taking any other medications at the time of the report.  The patient has not recovered from these events.  Followup information received on 10/28/2005.  The patient had no adverse event following prior vaccinations.  The patient had no other vaccinations within 4 weeks of receiving Menomune.  The duration of the neck stiffness was 3 days.  No diagnostic tests or labs were performed.  The patient did not require treatment and did not seek medical attention.  The patient recovered.  No further information is expected.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site induration, Pruritus, Swelling
Clinical narrative: 7.5 cm x 5.0 cm erythema, 10.5 cm x 7.0 cm induration, began swelling day 2-3, itching began day 6.  PT currently being followed by TMC; following to r/o cellulitis.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Received Adult Hepatitis B at approximately 8:05 am. Returned to health department at 9:00 am with complaint of arm swelling, rash, and itching. Red rash noted on lower arm with slight edema. No rash noted at site of injection although area was itching.  No signs or symptoms of respiratory distress. Was advised to take Benadryl and to go to the Emergency Room if symptoms worsen.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Received smallpox vaccine 2/25/03.  Had the expected mild side effects such as fatigue and headache on day 5 - 8, and tender lymph nodes (under arms) day 6 - 9.  Had a normal take response.  Approximately 8 months later (when weather got cold) developed Raynaud's syndrome.  Approximately 2 years after vaccination developed malaise, myalgias, neuropathy, joint pain, and was diagnosed with systemic lupus erythematosis.  Because this is a multifactorial and progressive disease, and they are not sure of the cause, I thought I should report this in case others have had similar problems.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Myalgia, Neuralgia, Neuropathy, Raynaud's phenomenon, Systemic lupus erythematosus
Clinical narrative: Received smallpox vaccine 2/25/03.  Had the expected mild side effects such as fatigue and headache on day 5 - 8, and tender lymph nodes (under arms) day 6 - 9.  Had a normal take response.  Approximately 8 months later (when weather got cold) developed Raynaud's syndrome.  Approximately 2 years after vaccination developed malaise, myalgias, neuropathy, joint pain, and was diagnosed with systemic lupus erythematosis.  Because this is a multifactorial and progressive disease, and they are not sure of the cause, I thought I should report this in case others have had similar problems.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received tetanus vaccine on 1/13/05 in Right deltoid. Stated that on 1/19/06 she developed edema, tenderness and warmth to touch of right upper arm and erythema at injection site. Referred to hospital on 1/20/06 for further evaluation and was prescribed Augmentin 875 mg. PO BID x 10 days and advised to apply cool compresses PRN.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Apraxia, Cold sweat, Electroencephalogram abnormal, Epilepsy, Grand mal convulsion
Clinical narrative: A) One of the vaccines given was expired at the time of administration. It was lot number 1001460 of DTaP. It expired Jun 11 2000. We just recently learned of this problem. B) The parents reported on Aug 26 2000 that their child had developed recurrent vomiting. Initially they felt it began one week after the injections. On Sep 8 2000 they reported the first episode occured 4 days after the injection. On Sep 28 2000, they reported it began on Jul 29 2000. Now they report within a day of the vaccine the child appeared ill. The recurrent vomiting was initially diagnosed as cyclic vomiting although he had an abnormal EEG. He had no response to Verapamil and then developed a grand mal seizure and was diagnosed with partial complex seizures. He developed difficulties in school and was then diagnosed as having oculomotor apraxia and a learning disorder as well. Of course, when the parents were informed of the expiration-problem, they were concerned that this may have been the cause of his neurologic concerns. - 2/1/06 Review of medical records essentially confirms the cyclic vomiting and abnormal EEG (9/2000 notes and test results), and subsequent development of seizures (2003 MRI listed reason for test as 'seizure'). Additional symptoms noted at time of AE onset, but not on VAERS report, include pale, clammy, headache, and fuzzy vision. Information received from 60 day follow up states patient has persistent epileptic activity. Patient remains on anticonvulsant therapy & had a seizure unprovoked 6 weeks ago.  Has continued learning disorder that eresged with seizure disorder August 2000.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Medication error, Mental impairment, Pallor, Vision blurred
Clinical narrative: A) One of the vaccines given was expired at the time of administration. It was lot number 1001460 of DTaP. It expired Jun 11 2000. We just recently learned of this problem. B) The parents reported on Aug 26 2000 that their child had developed recurrent vomiting. Initially they felt it began one week after the injections. On Sep 8 2000 they reported the first episode occured 4 days after the injection. On Sep 28 2000, they reported it began on Jul 29 2000. Now they report within a day of the vaccine the child appeared ill. The recurrent vomiting was initially diagnosed as cyclic vomiting although he had an abnormal EEG. He had no response to Verapamil and then developed a grand mal seizure and was diagnosed with partial complex seizures. He developed difficulties in school and was then diagnosed as having oculomotor apraxia and a learning disorder as well. Of course, when the parents were informed of the expiration-problem, they were concerned that this may have been the cause of his neurologic concerns. - 2/1/06 Review of medical records essentially confirms the cyclic vomiting and abnormal EEG (9/2000 notes and test results), and subsequent development of seizures (2003 MRI listed reason for test as 'seizure'). Additional symptoms noted at time of AE onset, but not on VAERS report, include pale, clammy, headache, and fuzzy vision. Information received from 60 day follow up states patient has persistent epileptic activity. Patient remains on anticonvulsant therapy & had a seizure unprovoked 6 weeks ago.  Has continued learning disorder that eresged with seizure disorder August 2000.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: A) One of the vaccines given was expired at the time of administration. It was lot number 1001460 of DTaP. It expired Jun 11 2000. We just recently learned of this problem. B) The parents reported on Aug 26 2000 that their child had developed recurrent vomiting. Initially they felt it began one week after the injections. On Sep 8 2000 they reported the first episode occured 4 days after the injection. On Sep 28 2000, they reported it began on Jul 29 2000. Now they report within a day of the vaccine the child appeared ill. The recurrent vomiting was initially diagnosed as cyclic vomiting although he had an abnormal EEG. He had no response to Verapamil and then developed a grand mal seizure and was diagnosed with partial complex seizures. He developed difficulties in school and was then diagnosed as having oculomotor apraxia and a learning disorder as well. Of course, when the parents were informed of the expiration-problem, they were concerned that this may have been the cause of his neurologic concerns. - 2/1/06 Review of medical records essentially confirms the cyclic vomiting and abnormal EEG (9/2000 notes and test results), and subsequent development of seizures (2003 MRI listed reason for test as 'seizure'). Additional symptoms noted at time of AE onset, but not on VAERS report, include pale, clammy, headache, and fuzzy vision. Information received from 60 day follow up states patient has persistent epileptic activity. Patient remains on anticonvulsant therapy & had a seizure unprovoked 6 weeks ago.  Has continued learning disorder that eresged with seizure disorder August 2000.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, CSF test abnormal, Cerebellar ataxia, Coordination abnormal, Speech disorder
Clinical narrative: Progressive loss of balance, ataxia and speech abnormal. Lumbar puncture and clinical picture Guillain Barre. Ruled out intracranial lesion/process, metabolic, etc. From Discharge summary, discharge summary states celebellar ataxia, GBS disproven, WBCs found in CSF.
Age: 1.63
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC
Symptoms: Flushing, Otitis media, Rash, Upper respiratory tract infection
Clinical narrative: Rash on face, facial flushing the day after vaccines given.  Received Benadryl orally.  Also concurrent upper respiratory infection, otitis media.
Age: 56.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Flu shot given in left arm on 1/11/06 at 6:15pm.  3hrs later extreme vertigo and dizziness. Unable to function or drive a car.  Today (1/12/06) still very dizzy and nausea.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria 1/6/06
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Erythematous measles like rash on face, trunk, palms and soles.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Right lower area of thigh red and swollen knot size of dime.  Related to Pneumo vaccine.  Had mom apply warm compress with a steroid cream (topicort).
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Grandmother reports uncontrollable screaming more than an hour.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Described a varicella type rash six years after receiving varicella vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Right leg swollen red, warm to touch
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Injection site swelling
Clinical narrative: 6cm x 4cm erythema.  Swollen R thigh at injection site (treatment-Orapred)
Age: 1.01
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Skin rash >5D.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Prolonged crying post injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Went to ER 01/04/2006 notice left thigh swollen yesterday afternoon 01/03/2006. Area redness 6 inches x 4 inches. Left thigh 1-2 inches bigger than right thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Went to ER 01/04/2006 notice left thigh swollen yesterday afternoon 01/03/2006. Area redness 6 inches x 4 inches. Left thigh 1-2 inches bigger than right thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Rash on left thigh 403/4 inches wheal with erythema and with heat. low grade fever 99.4 TX Orapred.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Rash on left thigh 403/4 inches wheal with erythema and with heat. low grade fever 99.4 TX Orapred.
Age: 1.83
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Injection site induration, Skin ulcer
Clinical narrative: No fevers, indurated, erythematous, warm, irregular lesions, RX cephalexin 250 mg x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site induration, Injection site oedema
Clinical narrative: Swelling, indurated area, warm to touch approx 4 cm diameter. Treated with Cephalexin 250 mg TID x 7 days.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site induration
Clinical narrative: 7x9 cm area of erythema and induration developed on the day after injection. No treatment except cold compress.
Age: 1.52
Sex: M
Vaccine: DTAP, IPV
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Received DPaT and polio at 11:15 am developed fever around 7:30pm and had grand mal seizure. 911 called and seizure had stopped by time 911 arrived (seizure later about 5 minutes). Seen in ER. Exam neg and all blood work neg. Family history of febrile seizures.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Medication error
Clinical narrative: No harm done, Pediarix given instead of DTap ordered.
Age: 0.75
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Erythema, Injection site induration
Clinical narrative: Vaccines IPV/DTAP administered 1/18/06. Redness, induration returned today. No systemic, signs/symptoms. H/O redness/induration _______ _____ _______after 12 9/12/05.
Age: 1.27
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Convulsion, Opisthotonus
Clinical narrative: Seizure like activity (arching etc) x 9 secs LOC x 7 minutes.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Flushing, Hypoaesthesia, Injection site reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of lower limb numbness in a 20 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). On 02 November 2004, the patient received the first dose of Engerix-B in the left arm. At an unspecified period of time following the administration of Engerix-B, on 02 November 2004, the patient experienced lower limb numbness, tingling, chills, flushing, dizziness, malaise, and an injection site reaction characterized as soreness. The events resolved on an unspecified date in November 2004. The nurse considered the events to possible be related to vaccination with Engerix-B.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Paraesthesia
Clinical narrative: This case was reported by a nurse and described the occurrence of lower limb numbness in a 20 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). On 02 November 2004, the patient received the first dose of Engerix-B in the left arm. At an unspecified period of time following the administration of Engerix-B, on 02 November 2004, the patient experienced lower limb numbness, tingling, chills, flushing, dizziness, malaise, and an injection site reaction characterized as soreness. The events resolved on an unspecified date in November 2004. The nurse considered the events to possible be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported by a health professional to a sales representative and described the occurrence of multiple sclerosis in an adult female patient who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date in 2002, the patient received the first dose of Engerix-B. Approximately two years following the administration of Engerix-B., on an unspecified date in 2004, the patient developed multiple sclerosis. The outcome of the event was not reported. The health professional considered the multiple sclerosis to probably be related to vaccination with Engerix-B. Multiple sclerosis was assesses as medically serious by manufacturer (OMIC).
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of welts in a 34 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). On 26 October 2004, the patient received the first dose of Engerix-B. On "the afternoon of 29 November 2004," the patient received the second dose of Engerix-B in the left arm (lot AHBVB034BA). "The evening" of 29 November 2004, the patient experienced "small, red, raised welts that started on the ankles and spread to the whole body." The patient was seen at a physician's office on 30 November 2004 and was prescribed desloratadine (Clarinex). The welts were ongoing at the time of initial reporting. The nurse considered the welts to probably be related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: This case was reported by a nurse and described the occurrence of allergy to thimerosal in a patient who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date, the patient received the third dose of Engerix-B. At an unspecified time following the third administration of Engerix-B, on an unspecified date, the patient experienced itching. the patient was seen at a physician's office for "allergy testing." The results of the allergy testing indicated that the patient had an allergy to thimerosal. The outcomes of the allergy to thimerosal and itching were not reported.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Hypertension
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of an exacerbation of hypertension in a 52 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). The patient's past medical history included hypertension, joint pain and acid reflux. Concurrent medications included verapamil and hydrochlorothiazide for hypertension, naproxen for joint pain, sertraline (Zoloft) for an unspecified indication, and lansoprazole (Prevacid) for acid reflux. On 09 November 2004, the patient received the first dose of Engerix-B (lot ENG5588A4). Approximately one day following the administration of Engerix-B, on 10 November 2004, the patient experienced exacerbation of hypertension with a blood pressure of 172/105 mm HG. The patient was seen at a physician's office and the hypertension resolved on an unspecified date on or before 02 December 2004. The immunization series with Engerix-B was discontinued. The nurse practitioner considered the hypertension unlikely to be related to vaccination with Engerix-B. She reported that she suspects, "the naproxen taken at the time of the event caused the increased blood pressure."
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: This case was reported by a nurse and described a 37 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three dose of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 45 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 01 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 24 year old male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 55 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On unspecified dates in 2004, the patient received three doses of Engerix-B (lot number not specified). Subsequently on 08 October 2004, a hepatitis B surface antibody titer was negative. The nurse considered the event to probably be related to the use of Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a physician and described a patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On an unspecified date, the patient received the 3rd dose of Engerix-B. At an unspecified time following the third administration of Engerix-B, on an unspecified date, a hepatitis B surface antibody titer was "Negative."
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 38 year old male patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix-B). The nurse reported that the patient "is not overweight and is not a smoker." On 25 February 2004 and 25 March 2004, the patient received the first two dose of Engerix-B (lot ENG5401A2). On 02 September 2004, the patient received a dose of hepatitis B immunization series. Approximately eight weeks after the third dose of hepatitis B vaccine, on 29 October 2004, a hepatitis B surface antibody titer was negative. As of 11 January 2004, no adverse event had occurred.
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of generalized rash in a patient who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date, the patient received the 1st dose of Engerix-B. At an unspecified time following the first administration of Engerix-B, on an unspecified date, the patient experienced a "generalized rash." The outcome of the event was not reported.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Injection site reaction, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of decreased movement of the arm in a 26 year old female patient who received hepatitis B vaccine recombinant (Engerix-B). On 16 November 2004, the patient received an injection of influenza virus vaccine (Fluzone). On 28 December 2004, the patient received the second dose of Engerix-B in the left arm (lot AHBVB034BB). At an unspecified time following the second dose of Engerix-B, on 28 December 2004, the patient experienced "reduced movement" of the left arm, a fever of 98.8 degrees Fahrenheit, and an injection site reaction characterized as soreness and warmth. The patient was seen at a physician's office. The events resolved on 04 January 2005.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described a 72 year old female patient who tested positive for hepatitis B surface antigen following the administration of hepatitis B vaccine recombinant (Engerix-B). The patient's medical history was notable for renal failure (cause not specified) requiring hemodialysis. On 03 January 2005, the patient received the second 40-mcg dose of Engerix-B (lot AHBVA068AA). The dose was administered as two separate 20-mcg injections in the right and the left deltoids. Approximately two days after receipt of Engerix-B, on 05 January 2005, the nurse reported that a "hepatitis B surface antigen titer was positive. The patient was tested again on 17 January 2005 and the hepatitis B surface antigen titer was negative. The nurse considered the event to be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported by a consumer and described the occurrence of multiple sclerosis in an adult female patient who received hepatitis B vaccine recombinant (Engerix-B). The consumer reported that "two women" developed multiple sclerosis following the administration of Engerix-B, however, patient identifiers were not provided. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Engerix-B (dose number not provided). At an unspecified time following the administration of Engerix-B, on an unspecified date, the patient experienced multiple sclerosis. The outcome of the event was not reported. Report received via manufacturer. Multiple sclerosis was assessed as medically serious by manufacturer (OMIC).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of headache in a 39 year old female patient who received an expired dosed of hepatitis B vaccine recombinant (Engerix-B). The reporter is the patient. On 12 January 2005, the patient received the third dose of Engerix-B (lot ENG537A4). The expiration date for this lot of Engerix-B is 13 May 2004. At an unspecified time following the administration of the third dose of Engerix-B, on 12 January 2005, the patient experienced a headache. The headache was ongoing at the time of initial reporting, 12 January 2005.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Eye disorder, Hypersensitivity, Laboratory test abnormal, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of an allergic reaction in a 45 year old male subject who received hepatitis B vaccine recombinant (Engerix-B). The subject smoked three cigarettes per day. Medical history included HIV positivity, contact dermatitis, bipolar disorder, "transgendering" and allergies to Soma, morphine, and novocaine. The subject's concurrent medications include Combivir and efavirenz (Sustiva) to treat HIV infection, clorazepate dipotassium (Tranxene) and fluxoetine hydrochloride (Prozac) to treat bipolar disorder, and conjugated estrogens (Premarin) and spironolactone (Aldactone) for "transgendering." On an unspecified date in 2001, the subject received the "hepatitis B vaccination series." The manufacturer for the hepatitis B vaccine was not provided. Approximately three years after the third dose of hepatitis B vaccine, on an unspecified date in October 2004, a hepatitis B surface antibody titer indicated that the subject was "non-immune." On 15 December 2004, the subject received a dose of Engerix-B as the 4th dose of hepatitis B vaccine. Approximately one day later, on 16 December 2004, the subject experienced swelling below the eyes, an itchy scalp and a rash on his arms. The subject was seen at a physician's office. The physician state that the subject, "had no lip swelling or dyspnea." The subject was diagnosed with "an allergic reaction to hepatitis B vaccine" and was treated with diphenhydramine hydrochloride (Benadryl). Immunization with Engerix-B was discontinued. The allergic reaction resolved on 17 December 2004. The reporting physician considered the allergic reaction to possibly be related to vaccination with Engerix-B.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of an allergic reaction in a 45 year old male subject who received hepatitis B vaccine recombinant (Engerix-B). The subject smoked three cigarettes per day. Medical history included HIV positivity, contact dermatitis, bipolar disorder, "transgendering" and allergies to Soma, morphine, and novocaine. The subject's concurrent medications include Combivir and efavirenz (Sustiva) to treat HIV infection, clorazepate dipotassium (Tranxene) and fluxoetine hydrochloride (Prozac) to treat bipolar disorder, and conjugated estrogens (Premarin) and spironolactone (Aldactone) for "transgendering." On an unspecified date in 2001, the subject received the "hepatitis B vaccination series." The manufacturer for the hepatitis B vaccine was not provided. Approximately three years after the third dose of hepatitis B vaccine, on an unspecified date in October 2004, a hepatitis B surface antibody titer indicated that the subject was "non-immune." On 15 December 2004, the subject received a dose of Engerix-B as the 4th dose of hepatitis B vaccine. Approximately one day later, on 16 December 2004, the subject experienced swelling below the eyes, an itchy scalp and a rash on his arms. The subject was seen at a physician's office. The physician state that the subject, "had no lip swelling or dyspnea." The subject was diagnosed with "an allergic reaction to hepatitis B vaccine" and was treated with diphenhydramine hydrochloride (Benadryl). Immunization with Engerix-B was discontinued. The allergic reaction resolved on 17 December 2004. The reporting physician considered the allergic reaction to possibly be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Skin burning sensation
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix-B). On 19 November 2004, the patient received the 1st dose of Engerix-B in the right arm (lot ENG5595BC-incorrect lot number). At an unspecified time following the first administration of Engerix-B, on 19 November 2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 19 November 2004. The nurse reported that, "the vaccine had just been removed from the refrigerator prior to the injection and it was cold." The nurse considered the injection site reaction to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Skin burning sensation
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix-B). On 10 November 2004, the patient received the 1st dose of Engerix-B in the left arm (lot ENG5595BC-incorrect lot number). At an unspecified time following the first administration of Engerix-B, on 10 November 2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 10 November 2004. The nurse reported that, "the vaccine had just been removed from the refrigerator prior to the injection and it was cold." The nurse considered the injection site reaction to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Injection site inflammation
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix B). On 11/19/2004, the patient received th e1st dose of Engerix B in the left arm (lot ENG5595BC incorrect lot number). At an unspecified time following the first administration of Engerix B, on 11/19/2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 11/19/2004. The nurse reported that, the vaccine had just been removed from the refrigerator prior to the injection and it was cold. The nurse considered the injection site reaction to probably be related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Thermal burn
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site burning in a female patient who received hepatitis B vaccine recombinant (Engerix B). On 11/19/2004, the patient received the 1st dose of Engerix B in the left arm (lot ENG5595BC incorrect lot number). At an unspecified time following the first administration of Engerix B, on 11/19/2004, the patient experienced an injection site reaction characterized as burning. The events resolved on 11/19/2004. The nurse reported that,, the vaccine had just been removed from the refrigerator prior to the injection and it was cold. the nurse considered the injection site reaction to probably be related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction, Thermal burn
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of an injection site reaction in a patient who received hepatitis B vaccine recombinant Engerix B. The nurse reported that quite a few patients experienced an injection site reaction following the administration of Engerix B, however, patient identifiers were not provided. On an unspecified date, the patient received a dose of Engerix B (lot AHBVB004BA, dose number not provided). At an unspecified time following the administration of Engerix B, on the same day, the patient experienced an infection site reaction characterized as burning. the outcome of the event was not reported. The nurse stated that the injection site burning occurred with this particular lot of Engerix B. She also reported that this practice, had not had a problem with other prefilled syringes of Engerix B they have used in the past. The nurse considered the injection site burning to possibly be related to vaccination with Engerix B.
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a nurse and described a 70 year old female patient who received hepatitis B vaccine recombinant (Engerix B) and subsequently tested positive for hepatitis B surface antigen. The patients past medical history included hypertension and renal failure (cause not specified) requiring hemodialysis. Concurrent medications included Vitamins and unspecified Blood pressure medication. On January 3 2005, the patient received the 2nd dose of Engerix B. Approximately 2 days following the second dose of Engerix B, on Jan 5 2005, a blood test was positive for hepatitis B surface antigen. the event resolved on 01/24/2005. The nurse considered the event to be related to Engerix B and due to receiving Engerix B, 2 days prior to hepatitis B surface antigen testing.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal, Hepatic enzyme increased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of elevated liver enzymes in a 38 year old male patient who received hepatitis B vaccine recombinant (Engerix B). On July 27 2004, the patient received the third dose of Engerix B (lot ENG5589A4). The pharmacist reported that at an unspecified time following the third administration of Engerix B, on or before 2/09/2005, routine laboratory testing showed slightly elevated liver enzymes. The event was on going at the time of initial reporting, 2/09/2005. Elevated liver enzymes was assessed as medically serious by manufacturer (OMIC).
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site tingling in an adult patient who received hepatitis B vaccine recombinant (Engerix B). The pharmacist reported that three patient experienced injection site tingling following the administration of Engerix B, however, patient identifiers were not provided. On 2/10/2005, the patient received the 2nd dose of Engerix B (lot ENG5588AH incorrect lot). The site of injection of Engerix B was not reported. At an unspecified time following the second administration of Engerix B, on 02/10/2005, the patient experienced an injection site reaction characterized as tingling. The outcome of the injection site reaction was not reported. The reporting pharmacist considered the injection site reaction to probably be related to vaccination with Engerix B.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Neck pain, Pyrexia
Clinical narrative: This case was reported by a physicians assistant and described the occurrence of pain in a 36 year old male patient who received hepatitis B vaccine recombinant (Engerix B). On 02/11/2005 the patient received the first dose of Engerix B in the left arm (Lot AHBVA062AA). At an unspecified time following the administration of Engerix B, on 02/11/2005, the patient experienced neck pain, elbow pain and fever. The fever resolved on 02/12/2005. The neck pain and elbow pain were on going at the time of initial reporting, 02/15/2005.
Sex: U
Vaccine: HEP
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of Flu like symptoms in an adult patient who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date, the patient received a dose of Engerix B (lot and dose number not specified). At an unspecified time later, the patient experienced flu like symptoms. The outcome of the event is unknown.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a doctor of philosophy an described a patient who had a decreased antibody response to immunization with hepatitis b recombinant (Engerix B). The report has not been verified by a physician or other health care professional. On unspecified dates, the patient received an unspecified number of doses of Engerix B. Subsequently, on an unspecified date, a hepatitis B surface antibody titer was low titer.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 45 year old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix B) immunization series. On June 4 2004, July 7 2004, and Dec 7 2004, the patient received three dosed of Engerix B (lot numbers ENG5540A2, ENG555B2, and AHBVA064AA respectively). Subsequently on 2/25/2005, a hepatitis B surface antibody titer was negative. The nurse considered the event to be unrelated to vaccination with Engerix B.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Influenza like illness, Myalgia, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of flu like feeling in a 43 year old male patient who received hepatitis B vaccine recombinant (Engerix B). The patient had no pre existing medical conditions and no allergies. The patient was not receiving any concurrent medications. On 01/31/2005, the patient received the first dose of Engerix B in the left deltoid (lot AHBVB034BB). Approximately two to three hours following the administration of Engerix B, on 01/31/2005, the patient experienced a flu like feeling, muscle and body aches and fatigue. The events resolved on 02/01/2005. In the nurse's opinion, the events were related to vaccination with Engerix B.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 33 year old male patient who received hepatitis B vaccine recombinant (Engerix B). The patient had no preexisting medical conditions. The patient was not receiving any concurrent medications. On an unspecified date in August 2004, the patient received the first dose of Engerix B. At an unspecified time following the first dose of Engerix B, on an unspecified date in 2004, the patient experienced a rash. The rash resolved on an unspecified date in 2004. On an unspecified date in 2004, the patient received the second dose of Engerix B. At an unspecified date in 2004, the patient experienced a rash. The rash resolved on an unspecified date. On March 3 2005, the patient received the third dose of Engerix B in the left arm (lot AHBVB030AA). On an unspecified date in March 2005, on or before March 8 2005, the patient again experienced a rash. The nurse described the rash as a much more substantial rash on his forehead and left cheek, looks like hives. The patient was seen by a dermatologist. The rash was ongoing at the time of initial reporting, 3/08/2005.