chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy, Respiratory failure, Sepsis, Shock
Clinical narrative: This subject is a 67 year old female who was admitted to the hospital due to labored breathing while enrolled in a study. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine with the last dose administered on 10/22/03. The subject presented with labored breathing on 2/21/04, 122 days post immunization and was admitted to the hospital on the same day. The causality has not been assessed by the investigator. Additional info has been requested. Additional info received on 3/1/04. The laboured breathing was assessed by the investigator as unrelated to the study vaccine. Outcome is unknown at this time. Additional info received 3/9/04. Subject was admitted to hospital on 2/21/04 with acute cholecystitis, septic shock, CHF, respiratory failure, labored breathing. Subject was on a respirator. Subject died on 3/5/04, 13 days after admission and 135 days post immunization. Additional info received 3/10/04. Subject received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Additional info received on 3/11/04. The acute cholecystitis, septic shock, CHF, respiratory failure were reported by the investigator as unrelated to the study vaccine. The death certificate received on 3/22/04 states COPD. The medical record received on 3/22/04 states neuropathy, GERD, ulcers and hypothyroidism. The hospital discharge summary received on 3/23/04 states hypotension, SOB, decreased po intake and elevated liver enzymes. Follow up on 03/24/04: "Copy of death certificate: Cause of death: Sepsis syndrome-cholecystitic. Other significant conditions contributing in death but not resulting in the underlying cause of death is advanced COPD."
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Medication error, Pain
Clinical narrative: Information has been received though the pregnancy registry from a 23 year old female medical student with tuberculosis and no other medical history or allergies who on 2/14/04 was vaccinated with a second dose of varicella virus vaccine live. On 2/16/04, the student reported that she is currently eight weeks pregnant. Concomitant vaccinations received while pregnant included a dose of MMR II, a dose of hep B vaccine, a dose of IPOL and a dose of meningococcal vaccine. Concomitant medication included isoniazid for tuberculosis. The reporter noted that her physician is her father. She also noted that she experienced arm pain after vaccination with varicella virus vaccine live. Unspecified medical attention was sought and a prescription drug was not required. No diagnostic lab tests were performed. A product quality complaint was not involved. Additional info was received from the reporter which indicated that she had terminated her pregnancy. Additional info has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a 57 year old female pt with no allergies and no history, who on 1/8/02 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included "AVIPRO" Avapro, Topril, Toprol XL and Orthopresfest. The pt reported that she did not know the dosage of the vaccine or the lot number. She reported that on the same day as the vaccine (1/8/02), she experienced a temp of 103 deg. Over the next three days the pt's temp got as high as 106 deg and she went to see her physician. There was no treatment required for the adverse event and there were no lab or diagnostic tests performed. The pt reported that she "felt terrible" during the time her temp was so high. The pt reported that her temp was back to normal a few days later and she completely recovered. There was no product quality complaint reported. The pt felt that her temp of 103 deg and "felt terrible" were life-threatening and disabling. Additional info has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Dyspnoea, Pallor
Clinical narrative: Parents report 3 episodes of turning pale and needing stimulation to breathe/apnea lasted approximately 5-10 seconds. Transported by EMS to hospital and admitted for 23 hours of observation.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Asthenia, Hypoxia, Lethargy, Loss of consciousness
Clinical narrative: Parents report 3 episodes of turning pale and needing stimulation to breathe/apnea lasted approximately 5-10 seconds. Transported by EMS to hospital and admitted for 23 hours of observation.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pallor
Clinical narrative: Parents report 3 episodes of turning pale and needing stimulation to breathe/apnea lasted approximately 5-10 seconds. Transported by EMS to hospital and admitted for 23 hours of observation.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Red, hot and swollen.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Rt arm red, hot and swollen.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: R upper arm red and swollen, hot to touch 2/24/04 3 pm.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Parotitis
Clinical narrative: Patient developed consistent Parotitis with Mumps, Received vaccine 2/19/04, developed Parotitis 3/8/04.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Headache, Malaise, Pruritus, Rash papular, Rash pustular
Clinical narrative: Papules, pustules, malaise, headache, pruritis- started 3/11/04- papules appeared 3/12/04 treated with antihistamines
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site mass, Rash papular
Clinical narrative: Right thigh with firm lump at IZ site. Local pink discrete & confluent papular rash extending laterally (to left thigh) and distally to IZ site.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure, for 1 minute approximately. Treatment antibiotic from Tuesday 3/2/04 to 3/5/04. Pt had EEG, MRI, spinal fluid. Hospital record rec'd. CSF drawn during the 3/2/04 admission was normal. This record notes a statement from mother indicating that child's temp was 101F in PMD's office the day prior to admission when she rec'd. these immunizations. In the ER, temp was 100.9F. She was treated empirically w/ cefotaxime as well as with Tylenol. There were no further seizures while the child was hospitalized. She was discharged to home on day 4 w/ a DGX of new onset seizures and w/ with instruction for PMD to withhold future DTaP.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Swelling, heat & redness to left deltoid for 2 days. No visible symptoms on this date. Continue with residual soreness today per patient.
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Carbuncle
Clinical narrative: Carbuncle right thigh. Keflex 250 mg/ 5 ml. sig: 2 ml QID X 10 days. Warm compresses as needed.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Received pneumovax 3/9/04. Later that night had swelling + redness in left upper arm. Came for urgent care appt 3/10/04- left arm early cellulitis- received ceftriaxone 1g IM, Keflex 500 mg, TIDX 7 d, + tylenol #3 for pain
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Mild pox on face, body, legs and hairline. No mediation, Aveena bath, Calamine lotion + Benadryl PRN. Pt received vaccine at another PMD manufacturer & lot # unavailable to us.
Age: 1.8
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Developed 4" X 4" cellulitis around injection site
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling
Clinical narrative: Right arm swollen and injection site increase in local temperature. Treatment tylenol and Benadryl 8cc q 4 (deg) PRN.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Had Td  3-1-04- reaction that evening 3-1-04 severe itching, redness + slightly swollen + warm to touch at site left deltoid. Pt put Benadryl on area. Pt seen 3-10-04 at doctor's office. Area still red (approx 6 inches, 4-5 inches wide)
Age: 2.9
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/ redness 4X3 cm diam. L deltoid at site of injection. No systemic rx.
Age: 1.2
Sex: M
Vaccine: HIBV, IPV, MMR
Symptoms: Conjunctivitis, Pyrexia
Clinical narrative: 3-10-04 phone call from mom has pink eye but developed fever 3-8-04 in the evening. Low grade 100-101 degree. No other symptoms voiced -
Age: 15.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Injection site erythema, Pain, Paraesthesia
Clinical narrative: 2/9/04 Pt. received Td in left arm, HAV in right arm. Developed pain in both arms the next day. Pain was worse in right arm. Also developed tingling in right arm. Slight erythema over injection site. Right intense pain on exertion. Rx with ibuprofen. Pain persisted. Seen by neurology 2/20. Bilateral pain radiating from shoulders into arms with some parathesias which were positional and associated with exertion. Rx: Prednisone X 100 days, Tylenol
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: c/o pain in both arms and both legs
Age: 1.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling and warmth left upper thigh
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling erythema of injection site right arm 3-4" diameter, decreased swelling of upper arm
Age: 1.25
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Anaphylactic reaction, Cough, Face oedema, Urticaria
Clinical narrative: Anaphylatic reaction. Coughing, Hives, Swelling on face. given shot of Epi .27cc subq.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Shortly after receiving 1 yr immunizations, pt. began developing hives on face and trunk. 12.5mg benadryl + 20 mg orapred were given. Pt observed + d/c when condition improved. Script for epi pen jr + additional dose of 12.5 mg benedryl given for PRN use. time observed 35 min.
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Aggression, Autism, Mental retardation severity unspecified, Sleep disorder
Clinical narrative: Autism, retardation, behavioral problems, aggression, self mutilation, sleep disorder.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP
Symptoms: Apnoea
Clinical narrative: This report concerns a 2 month old male patient who on 6/13/01 was vaccinated IM in the left thigh with a first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant vaccination on 1/13/01 included first doses of Streptococcus pneumoniae vaccine given IM in the left thigh, poliovirus vaccine given SC in the right thigh and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid given IM in the right thigh. On 6/13/01, approximately one hour after being put to bed that evening, the patient was found not breathing. Subsequently, the patient died. Follow up information indicated that reporter information was not provided. No further information is anticipated. The case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP
Symptoms: Unevaluable event
Clinical narrative: This report concerns a 2 month old male patient who on 6/13/01 was vaccinated IM in the left thigh with a first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant vaccination on 1/13/01 included first doses of Streptococcus pneumoniae vaccine given IM in the left thigh, poliovirus vaccine given SC in the right thigh and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid given IM in the right thigh. On 6/13/01, approximately one hour after being put to bed that evening, the patient was found not breathing. Subsequently, the patient died. Follow up information indicated that reporter information was not provided. No further information is anticipated. The case is closed.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Cellulitis, Face oedema, Injection site erythema, Injection site warmth
Clinical narrative: A mother reported that her 26 month old daughter received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed and developed cellulitis. This case was also reported by a nurse. The patient's medical history was notable for allergies to tomatoes and other unspecified foods, asthma, and febrile seizures. The patient underwent a tonsillectomy and adenoidectomy in February 2004. Concurrent medications included fluticasone and mometasone. On 3/2/04, the patient received the fourth dose of Infanrix (lot DTPA630A2) in her left thigh. On the same day, the patient received an injection of Haemophilus influenzae type B vaccine in the left thigh approximately one half inch apart from the Infanrix injection site. The mother reported that on the same day, the patient experienced injection site warmth and redness of approximately a quarter size. Approximately three days following the administration of Infanrix, on 3/5/04, the patient experienced a swollen face and was not acting right, and was seen at an emergency room. Examination revealed that the facial swelling had resolved and that the thigh was red. The mother also stated that the reaction site was larger than before, extending down and around the thigh. The patient was diagnosed with cellulitus and was treated with cephalexin and diphenhydramine. The patient's mother stated that as of 3/9/04, the local reactions have resolved but there is some discoloration at the injection site. The discoloration was described as, four inches long and goes half way around the front and back of the thigh. The patient's mother reported also, that as of 3/9/04, she noticed, a larger saddlebag on the left inner thigh compared to the right thigh. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number. The events were assessed as medically serious (OMIC). Follow up: This report was confirmed by a nurse with the following exceptions. The nurse stated that the injection site cellulitis accompanied by injection site warmth, discoloration and swollen thigh onet on 04MAR2004 and resolved on 09MAR2004. No biopsy was performed. The facial swelling and not feeling well resolved (date of resolution not provided). The nurse felt that the events jeopardized the patient or required intervention to prevent a serious outcome.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Skin discolouration, Swelling
Clinical narrative: A mother reported that her 26 month old daughter received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed and developed cellulitis. This case was also reported by a nurse. The patient's medical history was notable for allergies to tomatoes and other unspecified foods, asthma, and febrile seizures. The patient underwent a tonsillectomy and adenoidectomy in February 2004. Concurrent medications included fluticasone and mometasone. On 3/2/04, the patient received the fourth dose of Infanrix (lot DTPA630A2) in her left thigh. On the same day, the patient received an injection of Haemophilus influenzae type B vaccine in the left thigh approximately one half inch apart from the Infanrix injection site. The mother reported that on the same day, the patient experienced injection site warmth and redness of approximately a quarter size. Approximately three days following the administration of Infanrix, on 3/5/04, the patient experienced a swollen face and was not acting right, and was seen at an emergency room. Examination revealed that the facial swelling had resolved and that the thigh was red. The mother also stated that the reaction site was larger than before, extending down and around the thigh. The patient was diagnosed with cellulitus and was treated with cephalexin and diphenhydramine. The patient's mother stated that as of 3/9/04, the local reactions have resolved but there is some discoloration at the injection site. The discoloration was described as, four inches long and goes half way around the front and back of the thigh. The patient's mother reported also, that as of 3/9/04, she noticed, a larger saddlebag on the left inner thigh compared to the right thigh. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number. The events were assessed as medically serious (OMIC). Follow up: This report was confirmed by a nurse with the following exceptions. The nurse stated that the injection site cellulitis accompanied by injection site warmth, discoloration and swollen thigh onet on 04MAR2004 and resolved on 09MAR2004. No biopsy was performed. The facial swelling and not feeling well resolved (date of resolution not provided). The nurse felt that the events jeopardized the patient or required intervention to prevent a serious outcome.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Face oedema, Flushing, Stridor
Clinical narrative: About 30 minutes after vaccinations, had anaphylactic reaction, facial swelling, wheezing, SOB, flushing. Taken to ER and had IV epinephrine, IV Benadryl, Solumedrol and Albuterol nebulization. Discharged from ER that day. Nurse follow up on 05/18/04 states: Stridor, tachycardiac.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: About 30 minutes after vaccinations, had anaphylactic reaction, facial swelling, wheezing, SOB, flushing. Taken to ER and had IV epinephrine, IV Benadryl, Solumedrol and Albuterol nebulization. Discharged from ER that day. Nurse follow up on 05/18/04 states: Stridor, tachycardiac.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Cognitive disorder, Fatigue, Joint swelling
Clinical narrative: Arthritis and joint pain/swelling, cognitive impairment, extreme fatigue, others. This pt developed severe fibromyalgia and chronic fatigue syndrome with symptoms developing with 6 weeks of Lymerix vaccinations. She has been very ill since. I take this from her history but do not have records close to the event.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Developed fever of 103.9 on the night of 3/11/04. Parents took to the ER; started having seizure there (tonic/clonic). Had seizure for at least 1 hour. Was intubated and transferred to another hospital.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Pericardial effusion, Pericarditis
Clinical narrative: Chest pain with exertion and deep inspirations. Suspected pericarditis, pericardial effusion. EKG A's included P-wave inversions and ST depression which resolved with symptoms resolving.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Rash erythematous
Clinical narrative: Patient received smallpox vaccine LUE (Good to go no issues) last week. yesterday 16 Mar 04 after received Anthrax vaccine RVP. Awoke this morning 17 Mar 04 with erythematous macules non-pruritic on anterior chest and upper back. Possibly small satellite lesion (2) on upper back (LUE). No dyspnea. No edema. Patient was...: he had protein shake and asparagus last night. Treated with motrin and pseudoephedrine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal polyps, Sinusitis
Clinical narrative: Chronic sinusitis & new diag. nasal polyp following influenza vaccine.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Approx-5:30 pm LPN received a call from mother stating that the child had been excessively crying non-stop since receiving immunization at 2 pm- mother states she gave tylenol at 3:30 pm but two relictivated. Mother instructed to bring child to clinic for further medical evaluation- child no longer crying (sleeping in clinic).
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Eye disorder, Rash erythematous, Skin discolouration
Clinical narrative: No signs mild rash began on 3/14/04 by 3/15/04 he had bigger red splotches covering his entire body also eyes were blackened. No fever
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: Developed red, but swollen area below injection site of DT after 24 hours
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Skin ulcer
Clinical narrative: 16 days after receiving Varicella vaccine child developed varicella rash- child has had intermittal lesions since receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site swelling, Tenderness
Clinical narrative: Left deltoid with redness, swelling, warmth and tenderness at injection site (approx 10 cm erythema and induration)
Age: 38.0
Sex: M
Vaccine: HEP, TTOX, TYP
Symptoms: Blister, Contusion, Erythema, Feeling hot
Clinical narrative: Pt reported to clinic with immunization reaction concern. Pt had a fluid filled blister to left deltoid area with some bruising and redness and area warm to touch. Medical officer notified. No tx done.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Cyanosis, Influenza like illness, Pain, Paraesthesia, Peripheral coldness
Clinical narrative: Peripheral coldness, Paraesthesia, Cyanosis, Pyrexia, Influenza like illness, Pain. This case was reported by a nurse practitioner and described the occurrence of cold, tingling, blue extremities in a 20-year old female patient who received hepatitis inactivated and hepatitis B recombinant vaccine (Twinrix). The patient had no known drug allergies and was healthy at the time of administration of Twinrix. On 12 December 2003, the patient received the first dose of Twinrix (lot HAB235A4). At an unspecified time following administration of Twinrix, on 12 December 2003, the patient developed cold, tingly, bluish extremities, a feverish feeling, flu-like symptoms, and achiness. That same day, she was seen at the student health service. As of 12 December 2003, the events were unresolved.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Pyrexia
Clinical narrative: Peripheral coldness, Paraesthesia, Cyanosis, Pyrexia, Influenza like illness, Pain. This case was reported by a nurse practitioner and described the occurrence of cold, tingling, blue extremities in a 20-year old female patient who received hepatitis inactivated and hepatitis B recombinant vaccine (Twinrix). The patient had no known drug allergies and was healthy at the time of administration of Twinrix. On 12 December 2003, the patient received the first dose of Twinrix (lot HAB235A4). At an unspecified time following administration of Twinrix, on 12 December 2003, the patient developed cold, tingly, bluish extremities, a feverish feeling, flu-like symptoms, and achiness. That same day, she was seen at the student health service. As of 12 December 2003, the events were unresolved.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood lactic acid increased, Laboratory test abnormal
Clinical narrative: Blood lactate dehydrogenase increased. This case was reported by a physician and described the occurrence of elevated lactate dehydrogenase in a 39 year old male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix) for prophylaxis. The patient was described as "healthy". On an unspecified date in November 2003, the patient received the second dose of Twinrix. Approximately three weeks later, on 04 December 2003, the patient underwent "routine lab work." The lab results revealed "elevated" lactate dehydrogenase. As of 27 January 2004, the event was unresolved. The physician considered the elevated lactate dehydrogenase to be possibly related to vaccination with Twinrix.
Sex: F
Vaccine: HEPAB
Symptoms: Ear pain
Clinical narrative: This case was reported by a physician and described the occurrence of ear pain in his wife who received hepatitis A inactivated and hepatitis B recombinant vaccine. On 10/27/03, the patient received the first dose of Twinrix. On an unspecified date in December 2003, approximately seven weeks later, the patient developed ear pain and was hospitalized. As of 12/22/03, the event was unresolved. The reporting physician considered the earaches to be unrelated to vaccination with Twinrix.
Sex: F
Vaccine: HEPAB
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: Hepatitis B antibody negative. This case was reported by a consumer and described a female patient who did not respond to the hepatitis B component of immunization with hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). A physician or other health care professional has not verified this report. The patient's past medical history included hepatitis C. Concurrent medications included carvedilol, aspirin, frusmedie, paroxetinel, metoclopramide, venlafaxine, simvastatin, fluticasone propionate+salmeterol xinafoate, memetasone and Combivent. On an unspecified date, the patient received the third dose of Twinrix. Subsequently, on 16 January 2004, the patient underwent a "blood test."  The resulting hepatitis B surface antibody titer indicated that, "the Twinrix vaccine did not provide coverage for hepatitis B."
Sex: M
Vaccine: HEPAB
Symptoms: Liver function test abnormal
Clinical narrative: Liver function test abnormal. This case was reported by a pharmacist and described the occurrence of elevated liver function tests (NOS) in an adult male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). At an unspecified date prior to receipt of Twinrix, liver function tests were "normal". On an unspecified date, the patient received the first dose of Twinrix. At an unspecified time following the first administration of Twinrix, liver function tests (NOS) "went up to 150." On an unspecified date, the patient received the second dose of Twinrix. At an unspecified time following the second administration of Twinrix, liver function tests (NOS) "went up to 500." The outcome of the events in unknown. Comment: Exacerbation of elevated liver function tests and increased liver function tests were assessed as medically serious by GSK.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Medication error, Pain
Clinical narrative: Pain in extremity, Medication error. This case was reported by a nurse practitioner and described the occurrence of a sore arm in a 37 year old male patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). On 05 February 2004, the patient received the first dose of Twinrix in his arm. On the same day, the patient experienced a sore arm. The outcome of the sore arm was unknown. Approxiamately for days later, on 09 February 2004, the patient inadvertently received the second dose of Twinrix (lot HAB276A6). This is sooner than the recommended interval of one month between the first and second doses On 09 February 2004, the patient also received measles, mumps and rubella virus vaccine (MMRII, Merk).
Age: 38.0
Sex: F
Vaccine: FLUX, HEPAB, IPV, TD, TYP
Symptoms: Arthralgia
Clinical narrative: Arthralgia. This case was reported by a nurse practitioner and described the occurrence of generalized arthralgia in a 38 year old female patient who received hepatitis A inactivaed & hepatitis B recombinant vaccine (Twinrix). On 04 February 2004 the patient received the 1st dose of Twinrix. On the same day, the patient received injections of Influenza virus vaccine (manufacturer unknown), Typhoid vaccine (Typhim Vi, Aventis Pasteur), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur), and Tetanus and diptheria toxoid vaccine (Aventis Pasteur). Approximately four days later on 08 February 2004, the patient experienced generalized arthralgia. The patient was treated with ibuprofen (Advil) without relief. As of 10 Febrary 2004, the event remained unresolved.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain, Chest pain, Diarrhoea, Dyspnoea, Gastroenteritis
Clinical narrative: This is a 38 year old who received a non-primary smallpox vaccination 01/12/2004. He states that he had body aches and did not feel good in general for about 3 weeks, but resolved without development of other problems. He states that he had minimal response to his smallpox vaccine. He was deployed on 02/12/2004.  On 29 February 2004 he began to experience severe stomach cramps, diarrhea and nausea. He was seen in medical and told that he had a viral gastroenteritis that was going around. He also experienced night sweats, but does not feel that he had a fever.  On 03 Mar 2004 upon waking was experiencing substernal chest pain (5/10), shortness of breath and numbness in his left arm. He tried to stretch it out, but after 30 minutes had no success. He went to the medical tent he was placed on oxygen, intravenous fluids and aspirin. The physician did not think he had a heart attack because he could walk ~ 100 yards without difficulty. He was however, transferred via ambulance to the Emergency Department.   At the emergency department, he was given sublingual nitroglycerin which helped the pain (0-1/10). His shortness of breath also improved. Labs and electrocardiogram were obtained. It revealed He was then admitted to the Coronary Care Unit for further evaluation and treatment. He was placed on IV nitroglycerin drip. He remained in until approximately 1600 hours that day.  He was then transferred to another hospital after experiencing a second "attack" at about 1300 hours.   At the hospital, they continued medication regimine, completed an echocardiogram. He remained at Landstahl until 03/06/04 when he was transferred to another hospital.  He continued supportive care. On 03/07/04 he had a repeat echocardiogram. He was scheduled for a coronary angiography, but it was postponed until 03/10/04. The study showed all of his major coronary arteries to be clean. He was discharged on 03/11/04 and placed in medical hold until 03/15/04 after re-evaluation with cardiology. He's final diagnosis was myopericarditis in temporal association with smallpox vaccination and viral illness.  Nurse follow up on 05/27/04 states: "Complete."
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Hypoaesthesia, Laboratory test abnormal, Malaise, Nausea, Night sweats
Clinical narrative: This is a 38 year old who received a non-primary smallpox vaccination 01/12/2004. He states that he had body aches and did not feel good in general for about 3 weeks, but resolved without development of other problems. He states that he had minimal response to his smallpox vaccine. He was deployed on 02/12/2004.  On 29 February 2004 he began to experience severe stomach cramps, diarrhea and nausea. He was seen in medical and told that he had a viral gastroenteritis that was going around. He also experienced night sweats, but does not feel that he had a fever.  On 03 Mar 2004 upon waking was experiencing substernal chest pain (5/10), shortness of breath and numbness in his left arm. He tried to stretch it out, but after 30 minutes had no success. He went to the medical tent he was placed on oxygen, intravenous fluids and aspirin. The physician did not think he had a heart attack because he could walk ~ 100 yards without difficulty. He was however, transferred via ambulance to the Emergency Department.   At the emergency department, he was given sublingual nitroglycerin which helped the pain (0-1/10). His shortness of breath also improved. Labs and electrocardiogram were obtained. It revealed He was then admitted to the Coronary Care Unit for further evaluation and treatment. He was placed on IV nitroglycerin drip. He remained in until approximately 1600 hours that day.  He was then transferred to another hospital after experiencing a second "attack" at about 1300 hours.   At the hospital, they continued medication regimine, completed an echocardiogram. He remained at Landstahl until 03/06/04 when he was transferred to another hospital.  He continued supportive care. On 03/07/04 he had a repeat echocardiogram. He was scheduled for a coronary angiography, but it was postponed until 03/10/04. The study showed all of his major coronary arteries to be clean. He was discharged on 03/11/04 and placed in medical hold until 03/15/04 after re-evaluation with cardiology. He's final diagnosis was myopericarditis in temporal association with smallpox vaccination and viral illness.  Nurse follow up on 05/27/04 states: "Complete."
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Pericarditis
Clinical narrative: This is a 38 year old who received a non-primary smallpox vaccination 01/12/2004. He states that he had body aches and did not feel good in general for about 3 weeks, but resolved without development of other problems. He states that he had minimal response to his smallpox vaccine. He was deployed on 02/12/2004.  On 29 February 2004 he began to experience severe stomach cramps, diarrhea and nausea. He was seen in medical and told that he had a viral gastroenteritis that was going around. He also experienced night sweats, but does not feel that he had a fever.  On 03 Mar 2004 upon waking was experiencing substernal chest pain (5/10), shortness of breath and numbness in his left arm. He tried to stretch it out, but after 30 minutes had no success. He went to the medical tent he was placed on oxygen, intravenous fluids and aspirin. The physician did not think he had a heart attack because he could walk ~ 100 yards without difficulty. He was however, transferred via ambulance to the Emergency Department.   At the emergency department, he was given sublingual nitroglycerin which helped the pain (0-1/10). His shortness of breath also improved. Labs and electrocardiogram were obtained. It revealed He was then admitted to the Coronary Care Unit for further evaluation and treatment. He was placed on IV nitroglycerin drip. He remained in until approximately 1600 hours that day.  He was then transferred to another hospital after experiencing a second "attack" at about 1300 hours.   At the hospital, they continued medication regimine, completed an echocardiogram. He remained at Landstahl until 03/06/04 when he was transferred to another hospital.  He continued supportive care. On 03/07/04 he had a repeat echocardiogram. He was scheduled for a coronary angiography, but it was postponed until 03/10/04. The study showed all of his major coronary arteries to be clean. He was discharged on 03/11/04 and placed in medical hold until 03/15/04 after re-evaluation with cardiology. He's final diagnosis was myopericarditis in temporal association with smallpox vaccination and viral illness.  Nurse follow up on 05/27/04 states: "Complete."
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Anaphylactic reaction, Chest discomfort, Laryngospasm, Urticaria
Clinical narrative: Anaphylactic Reaction: Laryngealspasm, chest tightness, globus sensation and Urticaria
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Swelling, itching and Mild erythema at vaccine site for approximately 4 days.  Naprosyn 500mg and Allegra 180 mg
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Hyperaesthesia, Rash, Rash macular
Clinical narrative: Client received Hep A injection 03/10/04 around noon. States last pm between 6:30-7pm noticed blotching back left hand. Then both hands from 1st knuckles up to elbows began hurting and felt very sensitive. Also noted right side callar bone felt very sensitive. This am noticed rash on both thighs-no itching no respiratory symptoms-only symptoms as described. Has been getting immunizations to travel out of country.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Red rash to chest, under arms, it back, it face, raised temp of 101. Seen by physician on 030504.
Age: 0.3
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Psychomotor hyperactivity
Clinical narrative: Patient has been diagnosed with Early Onset BiPolar Disorder.  Within 24 hours of receiving his MMR2 vaccination, we noted a marked change in hyperactive, impulsive and aggressive behaviors.  In the following 3 months, his medication (Risperdal) needed to be increased 3 times, to the point where we no longer felt it was effective.  Within 6 months, we found it necessary to change his medications altogether (Abilify, Trileptal).  We feel that the 9 week long (Aug 1 - late September, 2003) manic cycle that he experience is directly correlated to the immunization, considering there were not other external factors that could have influenced such a drastic change.  During this same time, intervention had to be sought in an effort to prevent him from being dismissed (expelled) from pre-school for excessive aggressive incidents.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis bullous, Infection
Clinical narrative: PATIENT NOW HAS CHICKEN POX- DATE OF ONSET 03-17-04
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Atelectasis, Jaundice, Lethargy, Nasal congestion
Clinical narrative: Patient began snorting and flaring her nostrils while breathing about 1 1/2 hours after vaccine, nurses assured us it was normal.  Jaundice and lethargy  began to set in around the same time and again we were told it was common and to have her checked by the peds the next day if it was worse.  We were discharged to home where she continued to display above symptoms.  around 3:45 am on 01/18/2002 she stopped breathing, CPR was performed by her father and then the paramedics arrived, she was taken by ambulance to hospital ER where she was pronounced dead at 4:31 a.m.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Petechiae, Sepsis
Clinical narrative: Patient began snorting and flaring her nostrils while breathing about 1 1/2 hours after vaccine, nurses assured us it was normal.  Jaundice and lethargy  began to set in around the same time and again we were told it was common and to have her checked by the peds the next day if it was worse.  We were discharged to home where she continued to display above symptoms.  around 3:45 am on 01/18/2002 she stopped breathing, CPR was performed by her father and then the paramedics arrived, she was taken by ambulance to hospital ER where she was pronounced dead at 4:31 a.m.
Age: 26.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Aggression, Bacterial infection, Balance disorder, Convulsion, Coordination abnormal
Clinical narrative: Patient (pt) is a 26 year old male who received both typhoid and flu vaccine on 23-10-03. He felt fine the first wk and then at the end of October he had a knot in his throat, bad taste in his mouth and throat pain. Went to the doctor and was given amoxicillin for Strept- throat. States that the amoxicillin helped his throat. One week after the amoxicillin he started to notice a problem with blurred vision, dizziness and problems with balance. States it was constant and not associated with activity. Because of the dizziness and problems with his balance he was having problems playing basketball. Also had a headache. Described as constant, "hurting bad" and located in the frontal area of his head. Never had headaches like this before. He returned to the medic and was given meclizine for the dizziness. He tried it for 1 wk without any improvement so he returned to clinic. The clinic arranged for him to go for a MRI and further evaluation. MRI  revealed a cerebellar lesion vs. demyelinating disease. He was then given steroids and pt noted improvement in dizziness and stated that his blurred vision cleared. States headaches went away when his vision improved. Pt arrived at hospital on Dec 23 and stated he was taken off his steroids. While at home on Jan 2, 2004 he had a seizure witnessed by his cousin. Pt reported that his cousin said that he started shaking and fell to the floor. Pt did bite his lip. No incontinence noted and pt has no recall of event.  Pt was transported where he was admitted for evaluation. Pt states he has no prior history of seizures.  Hospital records indicated that when he was admitted he had mental status changes with combative behavior and a fever of 102.8. Intubation was required to complete medical workup. Initially started on Rocephin, Vancomycin and Acyclovir for empiric treatment of meningitis. Because blood and CSF were negative, the antibiotics were discontinued. Pt was discharged on January 7, 2004 with a normal gait, strength and appropriate mental status. Follow up as out patient with repeat MRI and Cerebral Spinal Fluid Analysis. March 18, 2004: Pt states he is doing well and feels there is an improvement in his condition. Only problem now is that he has occasional spasms on his right side of his body lasting 5-10 seconds. Spasms do not interfere with activity and he is not falling. He also complains of brief periods of dizziness during spasms. He is now hoping to resume some form of physical activity. Nurse follow up on 05/18/04: Cerebellar lesion, nystagmus, ataxia.
Age: 26.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Delirium, Dizziness, Dysgeusia, Electroencephalogram abnormal, Headache
Clinical narrative: Patient (pt) is a 26 year old male who received both typhoid and flu vaccine on 23-10-03. He felt fine the first wk and then at the end of October he had a knot in his throat, bad taste in his mouth and throat pain. Went to the doctor and was given amoxicillin for Strept- throat. States that the amoxicillin helped his throat. One week after the amoxicillin he started to notice a problem with blurred vision, dizziness and problems with balance. States it was constant and not associated with activity. Because of the dizziness and problems with his balance he was having problems playing basketball. Also had a headache. Described as constant, "hurting bad" and located in the frontal area of his head. Never had headaches like this before. He returned to the medic and was given meclizine for the dizziness. He tried it for 1 wk without any improvement so he returned to clinic. The clinic arranged for him to go for a MRI and further evaluation. MRI  revealed a cerebellar lesion vs. demyelinating disease. He was then given steroids and pt noted improvement in dizziness and stated that his blurred vision cleared. States headaches went away when his vision improved. Pt arrived at hospital on Dec 23 and stated he was taken off his steroids. While at home on Jan 2, 2004 he had a seizure witnessed by his cousin. Pt reported that his cousin said that he started shaking and fell to the floor. Pt did bite his lip. No incontinence noted and pt has no recall of event.  Pt was transported where he was admitted for evaluation. Pt states he has no prior history of seizures.  Hospital records indicated that when he was admitted he had mental status changes with combative behavior and a fever of 102.8. Intubation was required to complete medical workup. Initially started on Rocephin, Vancomycin and Acyclovir for empiric treatment of meningitis. Because blood and CSF were negative, the antibiotics were discontinued. Pt was discharged on January 7, 2004 with a normal gait, strength and appropriate mental status. Follow up as out patient with repeat MRI and Cerebral Spinal Fluid Analysis. March 18, 2004: Pt states he is doing well and feels there is an improvement in his condition. Only problem now is that he has occasional spasms on his right side of his body lasting 5-10 seconds. Spasms do not interfere with activity and he is not falling. He also complains of brief periods of dizziness during spasms. He is now hoping to resume some form of physical activity. Nurse follow up on 05/18/04: Cerebellar lesion, nystagmus, ataxia.
Age: 26.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Injury, Laboratory test abnormal, Mental impairment, Muscle spasms, Nystagmus
Clinical narrative: Patient (pt) is a 26 year old male who received both typhoid and flu vaccine on 23-10-03. He felt fine the first wk and then at the end of October he had a knot in his throat, bad taste in his mouth and throat pain. Went to the doctor and was given amoxicillin for Strept- throat. States that the amoxicillin helped his throat. One week after the amoxicillin he started to notice a problem with blurred vision, dizziness and problems with balance. States it was constant and not associated with activity. Because of the dizziness and problems with his balance he was having problems playing basketball. Also had a headache. Described as constant, "hurting bad" and located in the frontal area of his head. Never had headaches like this before. He returned to the medic and was given meclizine for the dizziness. He tried it for 1 wk without any improvement so he returned to clinic. The clinic arranged for him to go for a MRI and further evaluation. MRI  revealed a cerebellar lesion vs. demyelinating disease. He was then given steroids and pt noted improvement in dizziness and stated that his blurred vision cleared. States headaches went away when his vision improved. Pt arrived at hospital on Dec 23 and stated he was taken off his steroids. While at home on Jan 2, 2004 he had a seizure witnessed by his cousin. Pt reported that his cousin said that he started shaking and fell to the floor. Pt did bite his lip. No incontinence noted and pt has no recall of event.  Pt was transported where he was admitted for evaluation. Pt states he has no prior history of seizures.  Hospital records indicated that when he was admitted he had mental status changes with combative behavior and a fever of 102.8. Intubation was required to complete medical workup. Initially started on Rocephin, Vancomycin and Acyclovir for empiric treatment of meningitis. Because blood and CSF were negative, the antibiotics were discontinued. Pt was discharged on January 7, 2004 with a normal gait, strength and appropriate mental status. Follow up as out patient with repeat MRI and Cerebral Spinal Fluid Analysis. March 18, 2004: Pt states he is doing well and feels there is an improvement in his condition. Only problem now is that he has occasional spasms on his right side of his body lasting 5-10 seconds. Spasms do not interfere with activity and he is not falling. He also complains of brief periods of dizziness during spasms. He is now hoping to resume some form of physical activity. Nurse follow up on 05/18/04: Cerebellar lesion, nystagmus, ataxia.