chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Rash papular
Clinical narrative: The pt received Varivax vaccination on 02/07/2002. She started with papules on legs on 02/28/2002 (phone conversation) did not set blisters or scabs. Multiple raised erythematous plaques, papules.
Age: 6.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash papular
Clinical narrative: Skin shows multi red papules, few with vesicles, few with crusting over trunk, scattered on face and upper extremities and legs. Prescribed Acyclovir 2 Tsp x 5 days fluids.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Rash papular, Rash vesicular
Clinical narrative: Itchy rash 4 days ago few lesions on abdomen and mid chest, more lesions over next 2 days over scalp and lower legs. Skin shows 20 red papules, few with vesicles and low grade fever.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Itchy rash 4 days ago few lesions on abdomen and mid chest, more lesions over next 2 days over scalp and lower legs. Skin shows 20 red papules, few with vesicles and low grade fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Mom brought child in with red swollen and not to touch left upper arm deltoid area. Advised her to take him to the doctor's office. Dr stated that it was a reaction to the DTaP.
Age: 11.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Urticaria
Clinical narrative: Redness and a nodule on left thigh at site of DTAP. A large wheal, 1/2 dollar-sized appeared later the same day and continued X 3 days.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Screaming
Clinical narrative: Constant non-stop crying for 3 hours.
Age: 1.3
Sex: M
Vaccine: DTP, OPV
Symptoms: Infection
Clinical narrative: On 3/4/02, dx'd chickenpox disease and Rx'd Benadryl.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Hypotonia, Listless
Clinical narrative: Vaccines given on 2/26/02 and on 3/2/02 the pt had a sudden onset febrile seizure and was listless and limp for 45 minutes.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling of arm started by morning after and by evening had a low-grade temperature, headache and dizziness. The next day, the MD ordered Prednisone 20mg bid (1st dose given at 10:30) by 13:30, headache and dizziness were gone. Today, 2/6/02, he feels fine other that arm still swollen and red.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Soreness and swelling of arm started by morning after and by evening had a low-grade temperature, headache and dizziness. The next day, the MD ordered Prednisone 20mg bid (1st dose given at 10:30) by 13:30, headache and dizziness were gone. Today, 2/6/02, he feels fine other that arm still swollen and red.
Age: 5.6
Sex: M
Vaccine: DTAP, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mild 5-6 spots on back and face. Varicella vaccine failure.
Age: 1.75
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Infection
Clinical narrative: Varicella-like rash, 10 days after varicella vaccine.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3.7mm long X 4mm erythema at site of injection in left deltoid. No hardness but warmth noted at site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling of right thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Coma, Convulsion, Eye movement disorder, Salivary hypersecretion, Sinusitis
Clinical narrative: Received DTAP, MMR and IPV on 3/5/02; pt tolerated well initially. Mom was sleeping with child. She awoke at 06:00 on 3/7/02 and child was convulsing. Eyes rolled back and was foaming at the mouth. Called 911. Convulsions lasted about 1 1/2 minutes. Child was unresponsive about 40-45 minutes. She was taken by EMS to the hospital and gradually awakened. Mom reports she is fine today.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Eye oedema
Clinical narrative: Erytema / edema of both eyes with urticarial lesions noted @ back, no respiratory distress. treated with Benadryl (25 mg PO every Q X 1 with good results, no lesions noted, decrease in swelling/erythema of both eyes.
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Coma, Convulsion, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Mother reported one event of seizure activity 24-25 hrs post vaccination. Event reported as stiffness/rigidity of muscles, eyes rolled back and unresponsive x 1 min duration. Taken by mother To ER for evaluation.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: A report was received on 02/28/2002, concerning a 77 year old male pt who experienced shortness of breath 2 days after receiving Fluvirin vaccine on 10/09/1998. The event was considered medically important. The causality was stated to be possibly related. No further info was provided.
Age: 51.0
Sex: M
Vaccine: FLUX, HEPA, TYP
Symptoms: Rash, Skin nodule
Clinical narrative: Report describes rash in a 51 year old male who received hep a vaccine (havrix). The vaccinee's allergies were not specified. prior to vaccination with havrix, the vaccinee had experienced similar rash episodes without etiology. concomitant vaccines:typhoid and flu. On 02/23/2001, the vaccinee received his first dose of Havrix, and a dose of typhoid vaccine and flu vaccine. Four days later, on 02/27/2001, he developed a raised rash, firm with nodules and clusters on hands and feet and legs. As of 03/02/2001, the outcome of the event is unknown.
Age: 9.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Back pain, Chest pain, Urticaria, Wheezing
Clinical narrative: Report described chest pain in a 9 year old female who received hep A vaccine. This report was received from the vaccinee's mother and has not been verified by a physician or other healthcare professional. Allergies and medical history were not specified. On 10/19/2000, the vaccinee received the unspecified dose of typhoid vaccine. In the morning of 10/27/2000, the vaccinee received the unspecified dose of hep A vaccine and yellow fever vaccine. Reportedly, sometime later that afternoon, the pt experienced wheezing, chest pain, back pain, and hives. The physician prescribed her diphenhydramine hydrochloride (Benadryl). As of 03/02/2001, the outcome of the adverse events was unknown.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Report described chest tightness in a 50 year old male who received hep A vaccine. This report was received from a director of clinical development and has not been confirmed by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were not specified. On 03/14/2001, the vaccinee received his second right deltoid dose of havrix. "Within two minutes," post vaccination, the vaccinee felt dizzy, nauseous, faint and had fluctuating blood pressure. He then complained of chest tightness and numbness and tingling. The vaccinee was placed on an examination table and given oxygen. 911 was called. the vaccinee was taken via ambulance to the hospital ER, where he was discharged. As of 03/20/2001 the outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Report described chest tightness in a 50 year old male who received hep A vaccine. This report was received from a director of clinical development and has not been confirmed by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were not specified. On 03/14/2001, the vaccinee received his second right deltoid dose of havrix. "Within two minutes," post vaccination, the vaccinee felt dizzy, nauseous, faint and had fluctuating blood pressure. He then complained of chest tightness and numbness and tingling. The vaccinee was placed on an examination table and given oxygen. 911 was called. the vaccinee was taken via ambulance to the hospital ER, where he was discharged. As of 03/20/2001 the outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Report described hives in a 49 year old female who received hep A vaccine. Reportedly, the vaccinee had no allergies or medical history. She took no concomitant medications and there was no illness at the time of vaccination. The vaccinee stated that she had never had hives before this occurrence. On 02/16/2001, the vaccinee received her first IM dose of Havrix. Within 24 hrs post vaccination, she experienced hives over her whole body. She received Benadryl starting on 02/17/2001. She was seen by the physician on 03/24/2001, and then started to take Benadryl daily. The reporter stated that the hives were of moderate intensity. As of 04/20/2001, the outcome of the event was ogoing.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site oedema, Injection site reaction
Clinical narrative: Report described swelling at the injection site in a 54 year old female who received hep A vaccine. This report was received from a corpsman and has not been verified by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were unknown. On 04/11/2001, the vaccinee received her first SQ dose of Havrix. Post vaccination, she reported swelling from shoulder to elbow of the injection arm. The arm circumference was not measured. The reporter stated that the pt's arm was blowing up like a balloon. The pt had self-treated with ice on 04/11/2001. At the time of the report, the pt was being seen by a physician, who probably was going to give her a steroid injection for the swelling. As of 04/12/2001, the outcome of the event was unknown.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Dysuria, Erectile dysfunction, Hypoaesthesia, Malaise
Clinical narrative: Report describes erectile dysfunction in a 41 year old male who received hep A vaccine. The pt was allergic to PCN. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Havrix, and Hep B. The vaccinating physician reported that the pt experienced chills and did not feel well in the evening of 04/25/2001. Three days post immunization, on 04/28/2001, the pt reported general achiness, numbness, and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, a rash, and a small perioral ulcer. Viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C reactive protein were performed. The physician prescribed acyclovir and referred the pt to an infectious disease specialist.  On 05/16/2001, the pt's father reported that his son developed a generalized red raised rash; itching; flushed face, nausea, fever and mouth blisters within four hours of immunization on 04/25/2001. Several days later, the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and possible nerve damage. The urologist reportedly prescribed Levaquin. On 05/18/2001, the pt's father reported that his son's condition has worsened. He stated that his son had sexual dysfunction due to numbness in his penis. He also reported that the pts facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt now will suffer with a loss of income, too. On 05/18/2001, the pt stated," I am having a reaction to one or both of your vaccines. I am having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face, vague malaise, a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved and the pt's condition had worsened, per the pt's father. On 05/31/2001, the internist found the condition of the pt to be normal except for the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak, the pt subsequently felt better for awhile. When he stopped taking Medro DosePak his symptoms returned.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Nausea, Oral mucosal blistering, Pain, Pallor, Paraesthesia
Clinical narrative: Report describes erectile dysfunction in a 41 year old male who received hep A vaccine. The pt was allergic to PCN. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Havrix, and Hep B. The vaccinating physician reported that the pt experienced chills and did not feel well in the evening of 04/25/2001. Three days post immunization, on 04/28/2001, the pt reported general achiness, numbness, and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, a rash, and a small perioral ulcer. Viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C reactive protein were performed. The physician prescribed acyclovir and referred the pt to an infectious disease specialist.  On 05/16/2001, the pt's father reported that his son developed a generalized red raised rash; itching; flushed face, nausea, fever and mouth blisters within four hours of immunization on 04/25/2001. Several days later, the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and possible nerve damage. The urologist reportedly prescribed Levaquin. On 05/18/2001, the pt's father reported that his son's condition has worsened. He stated that his son had sexual dysfunction due to numbness in his penis. He also reported that the pts facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt now will suffer with a loss of income, too. On 05/18/2001, the pt stated," I am having a reaction to one or both of your vaccines. I am having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face, vague malaise, a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved and the pt's condition had worsened, per the pt's father. On 05/31/2001, the internist found the condition of the pt to be normal except for the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak, the pt subsequently felt better for awhile. When he stopped taking Medro DosePak his symptoms returned.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pruritus, Pyrexia, Rash, Sexual dysfunction, Urticaria
Clinical narrative: Report describes erectile dysfunction in a 41 year old male who received hep A vaccine. The pt was allergic to PCN. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Havrix, and Hep B. The vaccinating physician reported that the pt experienced chills and did not feel well in the evening of 04/25/2001. Three days post immunization, on 04/28/2001, the pt reported general achiness, numbness, and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, a rash, and a small perioral ulcer. Viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C reactive protein were performed. The physician prescribed acyclovir and referred the pt to an infectious disease specialist.  On 05/16/2001, the pt's father reported that his son developed a generalized red raised rash; itching; flushed face, nausea, fever and mouth blisters within four hours of immunization on 04/25/2001. Several days later, the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and possible nerve damage. The urologist reportedly prescribed Levaquin. On 05/18/2001, the pt's father reported that his son's condition has worsened. He stated that his son had sexual dysfunction due to numbness in his penis. He also reported that the pts facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt now will suffer with a loss of income, too. On 05/18/2001, the pt stated," I am having a reaction to one or both of your vaccines. I am having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face, vague malaise, a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved and the pt's condition had worsened, per the pt's father. On 05/31/2001, the internist found the condition of the pt to be normal except for the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak, the pt subsequently felt better for awhile. When he stopped taking Medro DosePak his symptoms returned.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Report described rash in a male vaccinee of unspecified age who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other healthcare professiona. Allergies, medical history, and concomitant medications were not specified. On 05/14/2001, the vaccinee received his second "adult" dose of Havrix. On 05/15/2001, he experienced a rash at the inejection site, chest, and trunk. As of 05/15/2001, the adverse event was unresolved.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Report described weak legs in a 34 year old female who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The vaccinee's allergies are not specified. She took no concomitant vaccines. She hs hep B. On 05/25/2001 13:00, the vaccinee received a left arm dose of Havrix, it is unknown whether she received previous doses of Havrix, On 05/25/2001 15:00, the vaccinee started experiencing light-headedness and dizziness. The vaccinee stated that her lefts were very weak. As of 05/25/2001, the outcome of the adverse events was unresolved.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea
Clinical narrative: Report described "feeling like he could not breathe" in a 20 year old male who received hep A vaccine. This report was received from a "consumer" and has not been verified by a physician or other health care professional. Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received a dose of Havrix, it was not known whether he had received previous doses of Havrix. Subsequently, the vaccinee felt like he couldn't breathe. As of 06/04/2001, the outcome of the adverse event was unknown.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Abdominal pain, Discomfort
Clinical narrative: Report described abdominal pain in a 51 year old male who received hep A vaccine. Allergies and concomitant medications were not specified. Per the vaccinee's daughter, the vaccinee 'was having problems before in this area (liver).' There was no illness at the time of vaccination. Per the reporter, the vaccinee denied any problems prior to the administration of Havrix, and hep B vaccine recombinant (Engerix-B). this report has been submitted by the reporter also to the Centers for Disease Control. On 03/26/2001 15:30, the vaccinee received his first IM dose of Havrix, his first 20mcg IM dose of Engerix-B and a .5 cc IM dose of tetanus-diphtheria vaccine. Fortyeight hours following vaccination, the vaccinee complained of pain in liver. This symptom was subsequently reported as abdominal pain right side under rib. Two weeks later, the vaccinee was seen by a physician. The vacinee ha ddiscomfort at this time. A CT scan, and a liver enzymes study on approx. 04/13/2000 were normal. No durgs were used to treat the adverse event. The abdominal pain resolved in nine days, on 04/23/2001. The reporting nurse stated that the abdominal pain was moderate in intensity and possibly related to Engerix-B. The physician recommended that the vaccinee not continue with follow-up vaccines. As of 06/20/2001, the event resolved.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Syncope vasovagal
Clinical narrative: Report 2001014964-1 described possible vasovagal reaction in a 9-year old female who received hepatitis A vaccine, inactivated (Havrix)  Allergies, medical history, and concomitant medications were not specified.   On 15 June 2001, the vaccines received her first left arm 720 EL. U dose of Havrix via a Tip Lok  syringes with a 5/8 inch 25 gauge needle. The vaccinee fainted within three minutes of receiving the immunization. the reporter stated that "they suspect vasovagal". Emergency care (NOS) was administered at the emergency room. As of 20 June 2001, the patient was "improved"
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope, Syncope vasovagal
Clinical narrative: Report described possible vasovagal reaction in a 7 year old female who received hep A vacccine. Allergies, medical history, and concomitant medications were not specified. On 06/15/2001, the vaccinee received her first left arm dose of Havrix. The vaccinee fainted within three minutes of receiving the immunization. The reporter stated that "they suspect vasovagal." Emergency care was administered at the ER. As of 06/20/2001, the pt was "improved."
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Report described rash on palms of hands in a male vaccinee of unspecified age who received hep A vaccine. Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received his first dose of Havrix. Two days prost-vaccination, he developed a rash on the palms of his hands. As of 06/20/2001, the outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Insomnia, Pain, Pruritus
Clinical narrative: Report described stinging (sensation) in a 36 year old female who received hep A vaccine. The vaccinee reportedly was allergic to codeine, nuts, pollen, and animals. She had asthma. She received QVar 40 and Beconase, Combivent, and dietary supplement. On 06/28/2001, the vaccinee received a left arm dose of Havrix, a dose of typhus vaccine, and a dose of yellow fever vaccine. It was not known whether she had received previous doses of Havrix, typhus vaccine or yellow fever vaccine. On 06/29/2001 she was seen by the health care provider complaining of "crawling, itchy bug-like feeling all over," stinging below the skin surface "like nerve endings being burned," and insomnia "due to the former." She did not have hives. She was treated with Benadryl orally, which helped her sleep. As of 07/03/2001, the events were "improved."
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Tenderness
Clinical narrative: Report described sore skin (arms) in a 60 year old vacinee who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee denied medical history and allergies. She received progesterone and acetaminophen as needed. On 09/03/1999, the vaccinee received her first dose of hep A vaccine without adverse event. On 03/26/2001, the vaccinee received the second dose of hep A vaccine. On 03/27/2001, the vaccinee reportedly experienced sore skin in her armpits extending 2-4 inches down her arms. She reportedly discontinued deoderants "without success." As of 07/11/2001, the event was unresolved.
Sex: U
Vaccine: HEPA
Symptoms: Rash erythematous
Clinical narrative: Report 2001018585-1 described red raised projections in a vaccinee of  unspecified age and gender who received hepatitis a vaccine inactivated (Havrix). Allergies, medical history, and concomitant medications were not specified. On  an unspecified date, the vaccinee received her first dose of Havrix. Subsequently, she experienced a 5 X 3 (units unspecified) area of red raised projections. As of 31 July 2001, the outcome of the event was unknown.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Report described blisters (injection site) in a 30 year old female who received hep A vaccine. The vaccinee was allergic to PCN and had asthma. She received no concomitant medications. On 08/03/2001 the vaccinee received her first left deltoid "adult" dose of Havrix. On 08/06/2001, she experienced erythema and blisters slightly below the injection site. As of 08/13/2001, the symptoms had not completely resolved.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood bilirubin increased
Clinical narrative: Report described elevated bilirubin in a 33 year old male who received hep A vaccine. This report was received from the vaccinee's wife and has not been verified by a physician or other health care professional. The vacinee's allergies, and medical history were not specified. In August 2000, the vaccinee reportedly received a subcutaneous injection of Havrix and an injection of hep B vaccine. It was not known whether the vaccinee ha dreceived previous doses of Havrix or hep B vaccine. Reportedly, the vaccinee subseuently developd an elevated bilirubin level, which he has currently. The consumer consulted a health care professional regarding the adverse event. Havrix was discontinued. As of 08/17/2001, the outcome of the adverse event was ongoing.
Sex: M
Vaccine: HEPA
Symptoms: Headache, Nausea
Clinical narrative: Report describes headache in a male vaccinee of unspecified age who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On 10/30/1998, the vaccinee received his first injection of Havrix. An unspecified time post-immunization, he experienced a "violent" headache with nausea and felt "as if he was going out of his mind." The headache resolved after three or four days. The nausea and feeling tat he "was going out of his mind" resolved after an unspecified period of time. The vaccinee reportedly attributed these events to a "thimerosal reaction." The Havrix immunization series was discontinued.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Joint swelling
Clinical narrative: Report 2001027578-1 describes soft tissue swelling at the dorsum of each wrist in a 9-year-old female who received hepatitis a vaccine inactivated (Havrix) and hepatitis B vaccine recombinant (Engerix-B).  (Please see 2001027578-2 for the Engerix-B report.)  Medical history, concurrent conditions, and concurrent medications were not specified. On 07 November 2001, the vaccinee received an injection of havrix into one deltoid and an ingection of Engerix-B into the other deltoid. It was not known if she had received previous injections of Havrix or Engerix-B. Approximately one hour post-immunization, the vaccinee experienced soft tissue swelling at the dorsum of each wrist. The vaccinee was sent to a clinic for evaluation. There was no redness, pain, or fever. The vaccinee was seen again in the clinic on 15 November 2001. There was no change, and swelling was still present
Age: 24.0
Sex: M
Vaccine: HEPA, RAB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Report describes fever in a 24 year old male who received an injection of hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee had no adverse experiences following receipt of prior immunizations. On 04/10/2001, the vaccinee received his first injection of Havrix and his first injection of rabies vaccine. The rabies vaccine was administered for pre-exposure prophylaxis. On 04/13/2001, three days post-immunization, the vaccinee experienced a fever of 104 degrees F., nausea, and vomiting. The events resolved in six to eight hours. The vaccinee subsequently received a second injection of Imovax without adverse event.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vertigo, Vomiting
Clinical narrative: Report describes vomiting in a 32 year old female who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were unspecified. On 12/07/2001, the vaccinee received her first injection of Havrix. One hour later, she began experiencing abdominal pain and cramping, nausea, vomiting, vertigo, and diarrhea. On 12/11/2001, the vaccinee was seen in the ER for these symptoms. In the ER, unspecified blood analyses were performed, which were negative. The vaccinee received unspecified fluids and Tigan. A stool sample analysis was performed to test for Clostridium difficle. The result of this analysis was unknown at this time. As of 12/20/2001, the outcomes of the events were unknown.
Age: 6.0
Sex: M
Vaccine: DTP, HEP, HEPA
Symptoms: Myalgia
Clinical narrative: Report 2002000429-1 describes a sore arm in a 6 year old male who received hepatitis A vaccine inactivated (Havrix).   Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee received hepatitis B vaccine (brand unspecified) and diptheria, tetanus, and pertussis vaccine (brand unspecified) in the left arm. On 26 December 2001, the vaccinee receive an injection of Havrix in the right arm. It was not known if the vaccinee had received previous doses of Havrix. The injection of Havrix may have inadvertently been administered intravenously. The medical assistant was administering the Havrix injection to a"heavy" 6 year old male, who was fighting her and was very combative. She inserted the needle, drew back on the syringe and discovered blood in the syringe. The vaccinee continued to be combative,and the medical assistant gave the injection where she had aspirated blood. The vaccinee's parent reported that the vaccinee's right arm was sore. As of 07 January 2002, the outcome of the event was unknown.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Pinpoint papular rash on back from one axillary line to the other, between T4 & L1 and on right arm between mid-humerus and mid-forearm. Rare lesions on legs. No pustules or vesicles or itching. Too early to tell if recovered.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Child received vaccine on 1/28/02. Parent covered vaccine site with a bandage for 2 weeks due to "had a few chickenpox at the site". Mother states did not change bandage every day and the bandage got wet. Mother called on 2/11/02 and stated that the site was bout the size of a quarter, red and slight raised. Didn't hurt child. Called mother back on 2/12/02 and she states it is a much smaller red area and less red area.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: The pt experienced pain at the injection site, starting 30 minutes, post vax. Pain has lasted nearly 2 months. Pain is not continuous. Pt has no other symptoms. Pt stated she had pain after dose #2 on 7/25/01, lasting approx. 2 1/2 months. Vaccine administrator was not aware until after injection was given.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Screaming
Clinical narrative: Infant cried unconsolably for 5 hours after receiving vacccines.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Encephalitis, Influenza like illness
Clinical narrative: It was reported that a 47 year old male pt received a Fluzone SV vaccination on 10/19/2001 at a hospital. Reportedly 6 weeks later, the pt developed cognitive changes and had "flu-like" illness at end of December. On 01/21/2002, pt was admitted to intensive care unit at hospital. The reported diagnosis was acute disseminating encephalomyelitis(ADEM), unresolved, pt remains hospitalized.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Coordination abnormal, Dizziness, Drug level increased, Drug toxicity, Dysarthria
Clinical narrative: A female 14 years and 11 months of age, was admitted to a local hospital because of ataxia and increasing lethargy. She had been treated since the age of 2 with carbamazepine for partial complex seizures. During the first 8 years of treatment, there were 23 measurements of serum carbamazepine had remained constant since she was 9 years of age. Because of persistent seizures at 13 years of age, gabapentin was added to her treatment program. The addition of gabapentin was associated with a decrease in seizure frequency of serum carbamazepine levels remained stable (range-8.2-12.4 ug/mL). During routine follow-up, 3 months before admission, seizures were well controlled. Weight was stable at 46.5kg and a serum carbamazepine level was 12.4. The child was continued on Tegretol XR 400mg in the AM and 600mg at night plus gabapentin 600mg 3 X daily. Thirteen days before hospitalization, the pt received the inactivated influenza vaccine Fluzone. The vaccine was well tolerated and no changes were made in the child's medication. On the day of admission, the child awoke, complained of nausea and subsequently vomited. She became dizzy and slept for 3 hours. On awakening, she was unsteady and had slurred speech. She became lethargic and poorly responsive. In the local ER, her serum carbamazepine level was 27.5 ug/mL and a urine drug screen was (+) for tricyclic antidepressants and cocaine. Tests of liver function were nml. The pt was intubated, transferred to an ICU and maintained on a ventilator for 19 hours. She received IV fluids and activated charcoal. Nine hours, after admission, her carbamazepine level was 24.5 ug/mL and levels continued to fall over the remainder of the hospitalization. A serum carbamazepine level, 4 days after admission was 9.1 ug/mL. At her last follow-up, 7 months later, the pt was seizure free and asymptomatic on her former dose of carbamazepine and gabapentin.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoxia, Lethargy, Nausea, Vomiting
Clinical narrative: A female 14 years and 11 months of age, was admitted to a local hospital because of ataxia and increasing lethargy. She had been treated since the age of 2 with carbamazepine for partial complex seizures. During the first 8 years of treatment, there were 23 measurements of serum carbamazepine had remained constant since she was 9 years of age. Because of persistent seizures at 13 years of age, gabapentin was added to her treatment program. The addition of gabapentin was associated with a decrease in seizure frequency of serum carbamazepine levels remained stable (range-8.2-12.4 ug/mL). During routine follow-up, 3 months before admission, seizures were well controlled. Weight was stable at 46.5kg and a serum carbamazepine level was 12.4. The child was continued on Tegretol XR 400mg in the AM and 600mg at night plus gabapentin 600mg 3 X daily. Thirteen days before hospitalization, the pt received the inactivated influenza vaccine Fluzone. The vaccine was well tolerated and no changes were made in the child's medication. On the day of admission, the child awoke, complained of nausea and subsequently vomited. She became dizzy and slept for 3 hours. On awakening, she was unsteady and had slurred speech. She became lethargic and poorly responsive. In the local ER, her serum carbamazepine level was 27.5 ug/mL and a urine drug screen was (+) for tricyclic antidepressants and cocaine. Tests of liver function were nml. The pt was intubated, transferred to an ICU and maintained on a ventilator for 19 hours. She received IV fluids and activated charcoal. Nine hours, after admission, her carbamazepine level was 24.5 ug/mL and levels continued to fall over the remainder of the hospitalization. A serum carbamazepine level, 4 days after admission was 9.1 ug/mL. At her last follow-up, 7 months later, the pt was seizure free and asymptomatic on her former dose of carbamazepine and gabapentin.
Age: 2.5
Sex: M
Vaccine: HIBV, MMR
Symptoms: Autism
Clinical narrative: Autistic; regressed in development; several treatments. Note: Pediatric office said that lot number was not reported on IPV and DPT given on 4/9/01.
Age: 1.3
Sex: F
Vaccine: DTPHIB, MMR
Symptoms: Aphasia, Convulsion, Face oedema, Mental retardation severity unspecified, Neurodevelopmental disorder
Clinical narrative: Two days, post vax, the pt developed a high fever of 104F and used acetaminophen. She had a rash and swelling along the jaw line with a gradual loss of previously acquired language. Diagnosed with seizures and pervasive developmental delay.
Age: 1.3
Sex: F
Vaccine: DTPHIB, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Two days, post vax, the pt developed a high fever of 104F and used acetaminophen. She had a rash and swelling along the jaw line with a gradual loss of previously acquired language. Diagnosed with seizures and pervasive developmental delay.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Azotaemia, Haemolytic uraemic syndrome, Microcytic anaemia, Renal failure acute, Thrombocytopenia
Clinical narrative: Immunized on 2/26/02. Developed hemolytic, uremic syndrome on 3/1/02. (Atypical presentation/course ) requiring emergency dialysis.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Urine abnormality
Clinical narrative: Immunized on 2/26/02. Developed hemolytic, uremic syndrome on 3/1/02. (Atypical presentation/course ) requiring emergency dialysis.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Aminoaciduria, Convulsion, Electroencephalogram abnormal, Epilepsy, Hypertonia
Clinical narrative: The pt is a 53 day old male who was transferred here after he began to be ill at 20:00 last night with increased irritability and a high-pitched cry. That evening they also noted some rhythmic lip smacking and twitching of the right side of his face. They brought him to ER and they were sent home with the instructions to observe and return if there is any problems. Throughout the night and morning, the pt continued to have intermittent seizures that increased to the point where he was having them every 5-10 minutes and they lasted less than 1 minute. This afternoon they brought him to ER and there, the physician witnessed twitching of the right eye, eye deviation to the right, twitching to the right side of the mouth which eventually progressed to twitching of the entire body. He was given Ativan IV, continued to have twitching and then was given Versed and then was loaded with fosphenytoin. Labs and LP were done there and then the pt was transferred via helicopter. During transfer the pt had another episode of seizure activity with left facial twitching progressing to include the left arm and leg. When pt was given 2nd dose of fosphenytoin, he remained hemo-dynamically stable and arrives in our PICU. Admit to PICU; fluids, electrolytes and nutrition. We will place on D10 quarter-normal saline with 10meq/liter of K at maintenance. We will allow ad lib Isomil when he is awake. CSF looked good but we will treat with acyclovir because of the history of the father having a cold sore. The parents had also noticed that the pt had a decrease in po intake. On arrival to PICU, the pt was lethargic. Dysconjugate gaze is noted. The seizure activity seems to have resolved and the infant has a high Dilantin level, I would not recommend any additional anticonvulsant meds at this time. If seizures recur, we will treat acutely with Versed or Ativan and load with phenobarbital, monitoring respiratory status closely. In the next exam by another physician at home; he has some weakness of neck flexors with full head lag on pull to sit. Recommended avoiding pertussis vaccine and continue current mediations.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Irritability, Lethargy, Muscle twitching, Muscular weakness, Oral intake reduced
Clinical narrative: The pt is a 53 day old male who was transferred here after he began to be ill at 20:00 last night with increased irritability and a high-pitched cry. That evening they also noted some rhythmic lip smacking and twitching of the right side of his face. They brought him to ER and they were sent home with the instructions to observe and return if there is any problems. Throughout the night and morning, the pt continued to have intermittent seizures that increased to the point where he was having them every 5-10 minutes and they lasted less than 1 minute. This afternoon they brought him to ER and there, the physician witnessed twitching of the right eye, eye deviation to the right, twitching to the right side of the mouth which eventually progressed to twitching of the entire body. He was given Ativan IV, continued to have twitching and then was given Versed and then was loaded with fosphenytoin. Labs and LP were done there and then the pt was transferred via helicopter. During transfer the pt had another episode of seizure activity with left facial twitching progressing to include the left arm and leg. When pt was given 2nd dose of fosphenytoin, he remained hemo-dynamically stable and arrives in our PICU. Admit to PICU; fluids, electrolytes and nutrition. We will place on D10 quarter-normal saline with 10meq/liter of K at maintenance. We will allow ad lib Isomil when he is awake. CSF looked good but we will treat with acyclovir because of the history of the father having a cold sore. The parents had also noticed that the pt had a decrease in po intake. On arrival to PICU, the pt was lethargic. Dysconjugate gaze is noted. The seizure activity seems to have resolved and the infant has a high Dilantin level, I would not recommend any additional anticonvulsant meds at this time. If seizures recur, we will treat acutely with Versed or Ativan and load with phenobarbital, monitoring respiratory status closely. In the next exam by another physician at home; he has some weakness of neck flexors with full head lag on pull to sit. Recommended avoiding pertussis vaccine and continue current mediations.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Prothrombin time prolonged, Screaming, Staring, Strabismus, Tardive dyskinesia
Clinical narrative: The pt is a 53 day old male who was transferred here after he began to be ill at 20:00 last night with increased irritability and a high-pitched cry. That evening they also noted some rhythmic lip smacking and twitching of the right side of his face. They brought him to ER and they were sent home with the instructions to observe and return if there is any problems. Throughout the night and morning, the pt continued to have intermittent seizures that increased to the point where he was having them every 5-10 minutes and they lasted less than 1 minute. This afternoon they brought him to ER and there, the physician witnessed twitching of the right eye, eye deviation to the right, twitching to the right side of the mouth which eventually progressed to twitching of the entire body. He was given Ativan IV, continued to have twitching and then was given Versed and then was loaded with fosphenytoin. Labs and LP were done there and then the pt was transferred via helicopter. During transfer the pt had another episode of seizure activity with left facial twitching progressing to include the left arm and leg. When pt was given 2nd dose of fosphenytoin, he remained hemo-dynamically stable and arrives in our PICU. Admit to PICU; fluids, electrolytes and nutrition. We will place on D10 quarter-normal saline with 10meq/liter of K at maintenance. We will allow ad lib Isomil when he is awake. CSF looked good but we will treat with acyclovir because of the history of the father having a cold sore. The parents had also noticed that the pt had a decrease in po intake. On arrival to PICU, the pt was lethargic. Dysconjugate gaze is noted. The seizure activity seems to have resolved and the infant has a high Dilantin level, I would not recommend any additional anticonvulsant meds at this time. If seizures recur, we will treat acutely with Versed or Ativan and load with phenobarbital, monitoring respiratory status closely. In the next exam by another physician at home; he has some weakness of neck flexors with full head lag on pull to sit. Recommended avoiding pertussis vaccine and continue current mediations.
Age: 57.0
Sex: F
Vaccine: FLU3, HEPA, IPV, TYP, FLU3, HEPA, IPV, TYP
Symptoms: Depressed level of consciousness, Encephalitis, Headache, Respiratory distress, Speech disorder
Clinical narrative: Pt complained of headache and respiratory distress and then soon went "coma" per her husband on 12/20/01 and impaired consciousness and speech at the end of February. Final dx: "viral encephalitis".
Age: 57.0
Sex: F
Vaccine: FLU3, HEPA, IPV, TYP, FLU3, HEPA, IPV, TYP
Symptoms: Coma, Encephalitis, Respiratory distress, Speech disorder
Clinical narrative: Pt complained of headache and respiratory distress and then soon went "coma" per her husband on 12/20/01 and impaired consciousness and speech at the end of February. Final dx: "viral encephalitis".
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paralysis
Clinical narrative: On 10/30/01, the pt received Fluvirin into his left upper arm and 3 day later, on 11/2/01, the pt experienced an inability to move his right arm and right leg for 70 minutes. The pt's right arm and leg went numb also. The reporter indicated that the reaction involved persistent or significant disability or incapacity, due to the numbness and paralysis of the right arm and leg. The pt recovered on the same day. There was insufficient information to determine the reporter's causality assessment.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory distress
Clinical narrative: A report was received on 02/28/2002, concerning a 62 year old male pt who experienced respiratory distress which involved or prolonged hospitalization on 10/22/1998 after receiving fluvirin vaccine on 10/08/1998. It is not known if the pt had recovered at the time of reporting the event. The reporter has assessed the causality as possibly related. No more info was provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever of 102 deg. F (rectally) noted at 10pm with some redness and swelling in leg.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Four hours after DTap, PV7, IPV, and HIB vaccination, the pt had a screaming episode lasting 3 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Asthenia, Coma, Crying, Hypotonia, Hypoventilation
Clinical narrative: At 5:45 he was very white, appeared to be barely breathing and was limp. He did not respond to noise or physical stimulation. He was more responsive in ER but lethargic and had a weak cry. On 02/21/2002 mom said he was still pale and quieter than usual. Instructed to take into the physician's office. He was seen in the doctor's. Pt seems he has recovered but did have an adverse event.