chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site inflammation
Clinical narrative: Report 20000319041 describes burning (sensation) (injection arm) in a 40 year old female who received Engerix-B. Reportedly, the vaccinee had no medical history, allergies, concomitant medications, or illness at the time of vaccination. On 09/27/2000 15:00, the vaccinee received her second IM-left deltoid dose of Engerix-B. Approx. 15-20 minutes later, her injection arm started "burning." The reporter advised the vaccinee to apply an ice pack and to take acetaminophen (Tylenol). Vaccinee stated that symptoms subsided after approx. one hour. As of 10/25/2000, the outcome of the event is resolved.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Report 200031919-1 describes rash in a 50 year old female who received the Hepatitis b vaccine.  Reportedly, the vaccinee has no medical history, allergies, concomitant medications, or illness at the time of vaccination. On 26-Sep-00, 15;45, the vaccinee received her third IM-left deltoid dose of the Hepatitis-b vaccine.   Approximately thirty minutes later, she developed a fine rash around the injection site extending to the upper trunk.  As of 25-Oct-00, the outcome of the event is resolved.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Report 2000032248-1 describes injection site soreness in a 14 year old male  who received a hepatitis-b vaccine for prophylaxis of hepatitis-B.  The reporter denied allergies, medical history and concomitant medications.  On 27-SEP-00, the vaccinee received his first dose of a hepatitis-b vaccine.  On 28-SEP-00, he experienced injection site soreness.   No treatment was given. As of 30-Oct-oo, the outcome of the event is ongoing.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Report number 2000032613-1 describes injection site redness and swelling in a patient (age and gender not specified) who recieved one injection of hepatitis-b vaccine for prophylaxis. Concurrent conditions included an unspecified skin condition. Concurrent medications were not specified. Sometime in October 2000, the patient received the first injection of the a hepatitis-B vaccine in the left deltoid. Twenty-four hours later, the patient experienced a swollen and red left deltoid at the site of the injection. Treatment was not specified. The patient did not receive the  second injection. As of November 2000, the injection site reaction was ongoing.  The most recent information, received 10 January 2001, indicated that the patient was seen by a physician, who determined that the redness and swelling of the patient's left deltoid region was due to a long-standing skin condition unrelated to the hepatitis-b vaccine. The outcome of the redness and swelling was not provided.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Report 2000032935-1 describes vomiting in a 49 year old female who received a hepatitis-B vaccine. The vaccinee has no known drug allergies and no medical history. She takes conjugated estrogen/medoxyprogrestrone acetate. On 15-SEP-00 and 16-Oct-00, the vaccinee received her first and second 1 cc left deltoid doses of the hepatitis-B vaccine, respectively.  On 16-Oct-00, within a few hours post vaccination with the hepatitis-B vaccine, the vaccinee experienced nausea. By 17-Oct-00 AM, the vaccinee experienced nausea and vomiting and had a headache. On 18-Oct-00, the vaccinee had fever and chills for a total of two days. the vaccinee missed 1 1/2 days of work. By 23-Oct-oo, her symptoms had revealed. As of 10-Nov-00, the outcome of the events is resolved.
Age: 19.0
Sex: M
Vaccine: HEP, MEN
Symptoms: Abdominal discomfort, Dyspnoea, Pruritus
Clinical narrative: Report 200032956-1 describes the occurrence of difficulty swallowing in a 19 year old male who received hepatitis B vaccine for prophylaxis. This report was received from the patient's mother and has not been verified by a physician or other health care professional. Concurrent medical conditions included asthma. Concurrent mediations included meningococcal polysaccharide vaccine and albuterol as needed. The patient received an injection of the hepatitis-b vaccine in August, 2000. Two days post-immunization, he experienced itching of his legs. his mother treated him with diphenhydramine. Approximately 1 week post-immunization, he developed difficulty swallowing, shortness of breath and abdominal discomfort. He was not seen by a physican. His symptoms were slowly resolving as of 09 November 2000.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report 200003330-1 describes hives in an "adult" female who received a hepatitis-B vaccine. Allergies, medical history and concomitant mediations are not specified. On 11-May-00, the vaccinee received her first dose of the hepatitis-b vaccine. The vaccinee "broke-out with hives almost immediately". The hives persisted for "several months". The vaccinee was treated with corticosteroids (NOS) and antihistamines (NOS). As of 15-NOV-00, the outcome of the event is unknown.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling cold, Hot flush, Influenza like illness, Pain
Clinical narrative: Report 200033887-1 describes body aches in a 35-year old female who received hepatitis b vaccine. This report was received from the patient and has been verified by a physician or other health care professional.  Concurrent medical conditions included reflux sympathetic dystrophy. Concurrent medications included gabepentin , verpamil and setraline, all for the treatment of reflex sympathetic dystrophy. On 11/16/2000, the patient received her first dose of the hepatitis-B vaccine. She reported that, within one hour of immunization, she developed pain of her entire right arm, generalized body aches, dizziness and flu-like symptoms with hot and cold flashes. She was seen later that day by her physician, who reportedly made a diagnosis of allergic  reaction and prescribed a six-day course of methylprednisolone. As of 17 November 2000, the patient reported that she was slowly recovering.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Hypersensitivity, Rash
Clinical narrative: Report 2000033914-1 describes chest tightness in a 49-year-old female who received an injection of hepatitis B vaccine. Concurrent medical history included hypersensitivity to "many drugs", "too many to mention". No concurrent medications were taken at the time of immunization. The patient received her first dose of the hepatits-B vaccine on 04-August 2000. Within minutes of immunization, she developed chest tightness and a rash across her chest. She recovered within a 24 hours.
Sex: M
Vaccine: HEP
Symptoms: Coordination abnormal, Eye pain, Guillain-Barre syndrome, Hypoaesthesia, Paralysis
Clinical narrative: Report 2000033944-1 describes Guillian-Barre syndrome in an adult male (age not provided) who received an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions and medications were not provided. The patient received his first injection of Engerix-B on 10/17/2000. Two days later, he experienced "excruciating" eye pain, loss of sensation in his hands and feet, loss of coordination, and pain and numbness of his entire arm. He was seen by a nerologist. MRI, unspecified laboratory analyses, unspecified x-rays, and lumbar puncture were performed; no results of these examinations were provided. The neurologist made a diagnosis of "inflammatory polyneuropathy combined with history of vaccine." The pt had not recovered as of 11/20/2000. He was scheduled to receive and unspecified an approximately 11/27/2000, the pt became paralyzed from the waist down. He was hospitalized and a diagnosis of Guillian-Barre syndrome was made. He received intravenous immunoglobulin with no effect. He then received plasmapheresis with some improvement. he relapsed and received additional plasmapherresis treatments. In total, he underwent plasmapheresis 13 times. The most recent information, received from the pt on 04/10/2001, indicated that he was back to work on a limited basis. He continued to have no sensation in his feet or fingertips. He was experiencing tingling of his right ear and back, and pain in his lower back, hips, and legs. As a result of the additional information received on 04/10/2001, this case has been reclassified as serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: Report 20003415-1 describes hepatitis B in a vaccine of unspecified age and gender who received Engerix-B.  Allergies, medical history and concomitant medications are unspecified.  On an unspecified date, the vaccinee received the forth dose of Engerix-B. Following the forth dose of Engerix-B, he was found to be in a nonresponder, and subsequently the vaccinee contracted hepatitis B. As of 28-NOV-00, the outcome of the event is unknown
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Report 2000034593-1 describes maladministration (sprayed in eyes) in a 32 year-old female who received Engerix-B.  The vaccinee has no known drug allergies. Medical history and concomitant medications are unspecified.  On an unspecified date, the vaccinee ( medical assistant) was accidentally "sprayed in the eyes"  when Engerix-B was being administered to a child. Subsequently, the vaccinee experienced an ocular headache and numbness in the eyes.  As of 29-NOV-00, the outcome of the events is resolved.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Report 200034597 described maladministration (sprayed in eyes) in a 36 year old female who received Engerix-B.  The vaccinee has no known drug allergies. medical history and concomitant medications were not specified.  On an unspecified date, the vaccinee (medical assistant) was accidentally "sprayed in the eyes" when Engerix-B was being administered to a child. Subsequently, the vaccinee experienced an ocular headache. As of 29-NOV-00, the outcome of the event is resolved.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Rash papular
Clinical narrative: Report 2000034782-1 describes red papules (annular ring) at the injection site in a 15 year old female who received Engerix-B for prophylaxis of hepatitis-B.  The reporter denied allergies and medical history of the vaccinee. The vaccinee was started on an antibiotics (NOS) on 15-NOV-2000, the day when she received her second dose of Engerix-B.  On 09-OCT-00, the vaccinee received her first deltoid dose of Engerix-B without adverse event.  On 15-Nov-00, the vaccinee received her second right deltoid dose of Engerix-B.  On 16-Nov-00, she experienced red papules (annular ring) at the injection site.  No treatment was given.  As of 30-NOV-00, the outcome of the event is unresolved.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 200034925-1 describes a 48 year old female who did not seroconvert following receipt of three doses of hepatitis B vaccine.  Concurrent medical conditions included coronary artery disease, hypertension, and cancer of the cervix. Concurrent medications included an unspecified estrogen. The patient received injections of Engerix-B on 25 February 2000 (lot ENG3212A4), 25 March 2000 (lot ENG3350A4), and 25 August 2000 (lot ENG3212A4). Hepatitis b titers measured in November 2000 and on 04 January 2001 were negative. Hepatitis b titers measured on 11 january 2001 and 15 January 2001 were less than two. The reporter indicated that two patients were immunized with the same lots of Engerix-b on the same days. The other patient seroconverted.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: Report 2000035159-1 describes sleepiness in an11 year old female who received an injection of hepatitis b vaccine (Engerix-B).  The vaccinee had no concurrent medical conditions and was not taking concurrent medications. She received her first injection of Engerix-B on 28 September 2000. That evening, 2.5 hours post-immunization, she became very sleepy and went to bed early. She was well the next day. On October 2000, three days post-immunization, she "had a very tired day". She recovered without sequelae and without treatment. The vaccine provider considered the sleepiness to be possibly related to Engerix-B administration.  The vaccinee received her second injection of Rngrerix-B on 09-november-2000. she had no adverse experience following receipot of this dose.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA, TTOX
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Pruritus
Clinical narrative: Report 2000035164-1 describes an injection site lump in a 22 year-old female who received an injection  of hepatitis b vaccine (Engerix-B).  The vaccinee had no concurrent medical conditions and was taking no concurrent medications. She received her first injection of Engerix-B  on 17 may 2000; she had no adverse experience following receipt of this dose. She received her second dose of Engerix-B on 08 June 2000. She also received injections of tetanus toxoid (brand name unknown) and hepatitis A vaccine (brand name unknown) on 08 June 2000. Six hours post-immunization, she developed redness, itching, and swelling at the site of Engerix-B administration. The redness, itching, and swelling resolved after one week.  The vaccinee gradually developed a "marble-sized lump" at the Engerix-B injection site. The lump resolved after one month
Sex: M
Vaccine: HEP
Symptoms: Lymphoma
Clinical narrative: Report 2000035167-1 describes possible cutaneous T-cell lymphoma in a male (age not provided) who received an injection of hepatitis-b vaccine (brand name unknown). This report was received from the patient's father and has been confirmed by a physician.  Concurrent medical conditions and medications were not provided. A male received two doses of a hepatitis-b vaccine (brand name and dates of administration unknown). At some later, unspecified date, the patient was seen by a dermatologist. The dermatologist referred the patient for diagnosis and treatment to another dermatologist at a tertiary-care center. Results of a biospy performed by the second dermatologist "were not clear". A tentative diagnosis of possible cutaneous T-cell lymphoma was made. The first dermatologist reported that, in the absence of a definitive diagnosis, she considers this event to be possibly related to the administration of hepatitis b vaccine. She stated that, to her knowledge, the patient had not been hospitalized and was not disabled by this event.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Infection, Muscular weakness
Clinical narrative: Report 200035528-1 describes an unspecified infection in a 52 year old male who received hepatitis B vaccine.  Medical history is significant for type II diabetes meelitus, chronic renal insufficiency secondary to diabetes mellitus and requiring hemodialysis, peripheral neuropathy, hypertension and 6-vessel coronary artery bypass grafting. Concurrent medications included insulin 70/30 40 units twice daily, benazepril, rosiglitazone, amlodipine, furosemide, dialysis/stress vitamin supplement, aspirin, calcium carbonate, and vitamin E. This reporter stated that family history is significant for arthritis-like symptoms, numbness in feet, and carpal tunnel syndrome in this patient's daughter following injection receipt of the hepatitis b vaccine (see case 2000035544-1). The patient received his first injection of hepatitis-b vaccine on 15 October 2000. At some later date  (not specified), he experienced weakness in his lower extremities. The weakness continued to worsen.  The patient then developed an unspecified infection.   The patient received his second injection of hepatitis b vaccine on 22 November 2000. At  some later date (not specified), the patient experienced weakness and numbness in his arms. The reporting health care professional, who is also the patient's wife, stated that the patient "was fine until the second injection". She stated that the only reason for his rapid deterioration of health is the hepatitis-b vaccine. As of 12/06/2000, the infection, leg weakness, arm weakness, and arm numbness persisted.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody positive, Arthralgia, Arthritis, Carpal tunnel syndrome, Hypoaesthesia
Clinical narrative: Report 2000035544-1 describes carpal tunnel syndrome in an 18-year-old female who received hepatitis-B vaccine.  Medical history is significant for a positive anti-nuclear antibody titer and possible lupus erythematosus. Concurrent medications were not specified. The reporter stated the the family history is significant for leg weakness, unspecified infection, arm weakness and arm numbness in this patient's father following receipt of the hepatitis-B vaccine (see case 2000035528-1). The patient received her first injection of the hepatitis-B vaccine in July, 2000 (exact date not provided). At some later date (not specified), the patient experienced pain in all her joints and numbness in her feet.  She received her second injection of the hepatitis-B vaccine in September, 2000 (exact date not provided). At some later date (not specified), she developed arthritis-like symptoms. Reportedly, a diagnosis of carpal tunnel syndrome was made. As of 06 December 2000, the outcome of the event was unknown
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Systemic lupus erythematosus
Clinical narrative: Report 2000035544-1 describes carpal tunnel syndrome in an 18-year-old female who received hepatitis-B vaccine.  Medical history is significant for a positive anti-nuclear antibody titer and possible lupus erythematosus. Concurrent medications were not specified. The reporter stated the the family history is significant for leg weakness, unspecified infection, arm weakness and arm numbness in this patient's father following receipt of the hepatitis-B vaccine (see case 2000035528-1). The patient received her first injection of the hepatitis-B vaccine in July, 2000 (exact date not provided). At some later date (not specified), the patient experienced pain in all her joints and numbness in her feet.  She received her second injection of the hepatitis-B vaccine in September, 2000 (exact date not provided). At some later date (not specified), she developed arthritis-like symptoms. Reportedly, a diagnosis of carpal tunnel syndrome was made. As of 06 December 2000, the outcome of the event was unknown
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Report 2000035560-1 describes Bell's palsy in a 40-year-old female who received an injection of hepatitis B vaccine.  Concurrent conditions were not provided;  however, the vaccine has no known allergies. Concurrent medications were not provided. The vaccinee received an injection of the hepatitis-B vaccine at the place of employment that she developed Bell's palsy on 20 November 200, 24 days post immunization. The vaccinee reported that the diagnosis had been made by her physician. The Bell's palsy persisted as of 11 December 2000.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: Report 2000035606-1 describes flu-like symptoms in a 33 year old female who received the hepatitis-b vaccine for prophylaxis of hepatitis B.  Reportedly, the vaccinee denies having allergies or medical history. She denies taking concomitant medications  In July, 1999, August, 1999 and on 14-NOV-00 (left deltoid), the vaccinee received her first, second and third doses of the hepatitis-b vaccine, respectively. Since receiving her third dose of the hepatitis-b vaccine (starting on 14-NOV-00), the vaccinee experienced flu-like symptoms, fatigue and sore shoulder. As of 11-Dec-00, the outcome of the events is ongoing.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Report 2000035610-1 describes arm/shoulder swollen, hard and sore in a 22 year-old female who received the hepatitis vaccine for prophylaxis of hepatitis-B.  Reportedly, the vaccinee denies having allergies or medical history. She takes hormone NOS.  In Jul, 2000, the vaccinee received her first left deltoid dose of the hepatitis vaccine. Subsequently, her arm/shoulder was swollen, hard, and sore. As of 11-Dec-00, the outcome of the events is resolved.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: On an unspecified date, the pt received his 1st dose of Hep-B vaccine. Subsequently, his experienced rash and hives and was admitted to a mental health/residential/intermediate care facility. As of 1/30/01, the outcome of the event was unknown.
Sex: F
Vaccine: HEP
Symptoms: Pain, Urticaria
Clinical narrative: The vaccinee received an injection of Engerix-B in 1998 (exact date not specified). At some later, (unspecified time), she experienced "urtica (stinging)"; the site of the stinging was not specified. Outcome of the event was not provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: The vaccinee received an injection of Hep-B vaccine several days prior to 12/20/00 (exact date not provided) and sought medical attention on 12/20/00. She was treated with methylprednisolone (Medrol Dosepak). Outcome of the event was unknown as of 12/20/00. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Nausea, Tremor
Clinical narrative: Report 20010002601 describes shakes in a 16 year old female who received an injection of hep B vaccine Engerix-B. Concurrent medical conditions included possible asthma. Concurrent medications included cetirizine. The vaccinee received her first injection of Engerix-B on 11/08/1999. Within 15 mins of receiving the injection, she developed shakes, muscle aches, and nausea. She recovered after 48 hours without treatment.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site atrophy
Clinical narrative: Report 20010005861 describes left deltoid atrophy (injection site) in a 38 year old female who received hep B vaccine (brand unknown). Allergies and concomitant medications are not specified. The vaccinee experiences depression. In approx. 1997, the vaccinee received her first IM-left deltoid dose of hep B vaccine (brand unknown). Subsequently, in approx. 1997, she developed left deltoid atrophy. The muscle subsequently "came back." On an unspecified date, the vaccinee received her second dose of hep B vaccine (brand unknown). On an unspecified date, the vaccinee received her 3rd IM-gluteal dose of hep B vaccine (brand unknown). The vaccinee experienced continued atrophy of the left deltoid. On examinatiion, the physician noted a 4-5 cm area "dent" on left deltoid, good range of motion, and no pain. Per the physician, the vaccinee has "no" deltoid. Per reporting pharmacist, "possibly the adverse event is not related to the vaccine." As of 01/10/2001, the outcome of the event is ongoing.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Pruritus
Clinical narrative: On approx. 12/19/00, the pt received his 1st IM-deltoid dose of Engerix-B. "Hours later" he developed a red area with itching at the injection site. His pediatrician dx'd the area as a "spider bite". The pt's allergist indicated that the pt should not receive his 2nd dose at this time. As of 1/9/01, the outcome of the adverse event is ongoing.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness
Clinical narrative: On 5 Jul 00, the vaccinee received her first dose of Engerix-B. Within 48 hours, she experienced flu-like symptoms which resolved. On 7 Aug 00, the vaccinee received her second dose of Engerix-B. Within 48 hours, she again experienced flu-like symptoms which resolved. No treatment was given. As of 8 Jan 01, the outcome of the events is resolved.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Dyspnoea, Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: Report 20010013551 describes difficulty breathing in a 24 year old female who received an injection of hepatitis B vaccine (Engerix-B). This report was received from the pt and has not been verified by a physician or other health care professional. There were no concurrent medical conditions. The pt has no known drug allergies. Concurrent medications include an unspecified oral contraceptive. The pt received her first injection of Engerix-B on 11/08/2000. Approximately two weeks later, around 11/22/2000, she developed difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and tingling. The bilateral arm numbness and tingling resolved after one week. The facial redness and difficulty breathing and swallowing persisted, and she was seen by her physician on 01/06/2001. Erythrocyte sedimentation rate, rheumatoid factor, antinuclear antibody titer, and C-reactive protein measured on 01/03/2001 were reportedly "all elevated." The pt received her second injection of Engerix-B on 01/03/2001. Approximately two weeks later, around 01/17/2001, she again experienced difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and weakness. On 01/17/2001, she was seen by her physician, who reportedly made a diagnosis of "rule out serum sickness." The pt was treated with propoxyphene, promethazine 50 mg daily, fluticasone (Flovent), and salmeterol (Serevent). as of 01/17/2001, the events were ongoing.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Serum sickness
Clinical narrative: Report 20010013551 describes difficulty breathing in a 24 year old female who received an injection of hepatitis B vaccine (Engerix-B). This report was received from the pt and has not been verified by a physician or other health care professional. There were no concurrent medical conditions. The pt has no known drug allergies. Concurrent medications include an unspecified oral contraceptive. The pt received her first injection of Engerix-B on 11/08/2000. Approximately two weeks later, around 11/22/2000, she developed difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and tingling. The bilateral arm numbness and tingling resolved after one week. The facial redness and difficulty breathing and swallowing persisted, and she was seen by her physician on 01/06/2001. Erythrocyte sedimentation rate, rheumatoid factor, antinuclear antibody titer, and C-reactive protein measured on 01/03/2001 were reportedly "all elevated." The pt received her second injection of Engerix-B on 01/03/2001. Approximately two weeks later, around 01/17/2001, she again experienced difficulty breathing, difficulty swallowing, facial redness, and bilateral arm numbness and weakness. On 01/17/2001, she was seen by her physician, who reportedly made a diagnosis of "rule out serum sickness." The pt was treated with propoxyphene, promethazine 50 mg daily, fluticasone (Flovent), and salmeterol (Serevent). as of 01/17/2001, the events were ongoing.
Age: 0.8
Sex: F
Vaccine: HEP, PNC
Symptoms: Irritability
Clinical narrative: Report 20010014281 describes crankiness in a ten month old female who received Engerix-B. This report was received from the pt's mother and has not been verified by a physician or othe rhealth care provider. the vaccinee has no known drug allergies and no known medical history. she had a respiratory infection at the time of vaccination. Concomitant vaccine: Prevnar, administered on 01/18/2001. On 03/22/2000, 05/01/2000, 08/01/2000, and 01/18/2001, the vaccinee received her first, second, third, and fourth leg doses of Engerix-B, respectively. On 01/18/2001, post-vaccination, the vaccinee experienced crankiness. as of 01/18/2001, the outcome of the event is unknown.
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Ecchymosis, Flushing
Clinical narrative: Report 20010014811 describes shortness of breath in an "adult" vaccinee of unspecified age and gender. Allergies, medical history, and concomitant medications are not specified. On an unspecified date, following the unspecified dose of engerix-B, the vaccinee experienced flusing, ecchymosis and shortness of breath. As of 01/19/2001, the outcome of the events is unknown.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Report 2010017091 describes injection site redness and swelling in a vaccinee of unspecified age and gender who received hepatitis B vaccine (brand unspecified). Allergies and medical history were not specified. Concomitant vaccine: hepatitis A vaccine (brand unspecified) administered at the same time as hepatitis B vaccine (brand unspecified). On an unspecified date, the vaccinee received the unspecified dose of hepatitis B vaccine (brand unspecified). Subsequently, the vaccinee experienced injection site swelling and redness. As of 01/19/2001, the outcome of the events is unknown.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Report 20010018711 describes hives in an 11 year old male who received Engerix-B for prophylaxis of hepatitis B. The vaccine has no known drug allergies and denies having a medical history or taking concomitant medications. On 08/16/2000, the vaccinee received his first dose of Engerix-B. Post-vaccination, on 08/16/2000, he experienced hives and fever. An ER visit was required. the events resolved. On 09/20/2000, the vaccinee received his first done of Recombivax. Post-vaccination on 09/20/2000, he experienced fever and hives. The events resolved. As of 01/23/2001, the outcome of the events is resolved.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal
Clinical narrative: report 20010025331 describes an elevated level of alanine transaminase in a 46 year old male who received an injection of hepatitis B vaccine (Engerix-B). This report was received from the patient and has not been verified by a physician or othe rhealth care professional. concurrent medical conditions included "slight" hypertension. The pt has no known drug allergies. Concurrent medications included guanfacine (Tenex) 1mg twice daily, citalopram (Celexa) 20 mg daily, and dextroamphetamine (dextrostat) 15 mg daily. The pt received his first injection of Engerix-B on 01/24/2001. On 01/29/2001, his alanine trasaminase level was measured at 55 units/liter; this was determined to be an elevated measurement for this patient. As of 01/31/2001, the outcome of this event was unknown.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Report 20010029491 describes antigenemia in a pt (age and gender not provided) who received an injection of hepatitis B vaccine (EngerixB). This report was received from a nurse via a company representative. Concurrent medical conditions included renal failure treated with hemodialysis. concurrent medications were not specified. The pt received an unknown number of injections of Engerix-B on unspecified dates. At some later date, the pt was determined to have a positive hepatitis B surface antigen antibody titer. At another, later date, the pt was found to have a negative hepatitis B surface antigen antibody titer. A diagnosis of antigenemia was made. The reporter indicated that four patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Muscle atrophy, Pain, Paraesthesia
Clinical narrative: Report 20010029501 describes left deltoid muscle atrophy in a 36 year old female who received an injection of hepatitis B vaccine (Engerix-B). There were no concurrent medical conditions or medications. The pt had no known drug allergies. She received her first injection of Engerix-B on 01/23/2001, the vaccine was injected into her left deltoid. On 02/03/2001, 11 days post-immunization, she was seen in the emergency room with pain, numbness, and tingling of the left deltoid. Muscle atropy of the left deltoid was noted. she was treated with unspecified steroids. These evens persisted as of 02/05/2001.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Report 20010037371 describes sensitivity to alcohol (itching) in a 56 year old female who received Engerix-B for prophylaxis of hepatitis B. The vaccinee has no known drug allergies. Reportedly, she has no medical history and no concomitant medications. In approximately 1996, the vaccinee received her third IM left deltoid dose of Engerix-B. Subsequently, she developed a sensitivity to alcohol. Within seconds after having an alcoholic drink she experienced generalized itching. additionally, she is a nonresponder. As of 02/08/2001, the outcome of the events is ongoing.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Report 20010037831 describes rash in a 52 year old female who received Engerix-B for the prophylaxis of hepatitis B. The vaccinee has no known drug allergies. Her medical history includes hypertension and she takes blood pressure medication (NOS). On 02/09/2001, the vaccinee received her first left deltoid dose of Engerix-B. Post-vaccination, on 02/19/2001, she noticed a rash on her chest. No treatment was given, and Engerix-B was not discontinued. As of 02/12/2001, the outcome of the event is unknown.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Optic neuritis
Clinical narrative: Report 20010037851 describes optic neuritis in a 17 year old female who received hepatitis B vaccine (Engerix-B). Concurrent medical conditions included wheezing upon exposure to cold air. The pt has no known drug allergies. There were no concurrent medications. The pt received her first injection of Engerix-B in September 2000. No adverse experience was reported following this injection. She received her second injection of Engerix-B on 10/10/2000. On 12/15/2000, 66 days post-immunization, she fell asleep on the floor at the friend's house. The friend's father accidentally kicked her on the forehead while trying to step over her; there was no brusing or swelling noted on the forehead. About 15:30 that afternoon, she experienced painless loss of vision in her right eye. The neurologist noted that an eye examination in November 2000 was normal. On 12/18/2000, the pt was seen by her eye doctor, who made a diagnosis of optic neuritis. The pt was seen by a neurologist later that day. She reported nausea the morning of 12/18/2000. On examination, the neurologist noted that the disc in the pt's right eye was edematous with blurred margins and there were some hemorrhages medially. The rest of the examination  was normal. The neurologist made a diagnosis of optic neuritis. MRI of the brain and retrobulbar as normal. Erythrocyte sedimentation rate was 72 mm/hr. Antinuclear antibody titer and Lyme antibody titer by ELISA were negative. The pt was treated with high-dose methylprednisolone (SoluMedrol) and then prednisone. The most recent information, received on 03/06/2001, indicated that by 01/08/2001, the pt "had improvement in the vision from her right eye, though it is still not back to normal. She notices a loss of color in the vision, as well as clarity." The papilledema of the right eye had resolved. The neurologist stated, "she can expect further improvement." She was discharged from the neurologist's care on 01/08/2001. Optic neuritis is considered SB medically serious.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Report 20010038911 described vomiting, diarrhea, and general malaise in a 33 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of hepatitis B. The vaccinee is allergic to oysters. Reportedly she had no medical history and took no concomitant medications. On 01/02/2001, the vaccinee received her second 20 mcg IM dose of Engerix-B. Within twelve hours post-vaccination, the vaccinee experienced vomiting, general malaise, and diarrhea. Symptoms resolved on 01/02/2001. As of 03/13/2001, the outcome of the events is resolved. The reporter has reported these adverse events directly to VAERS.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea
Clinical narrative: Report 20010039091 described headache and nausea in a 42 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of hepatitis B. Reportedly, the vaccinee had no allergies or medical history. Reportedly, she took no concomitant medications. There was no illness at the time of vaccination. On 12/21/2000, the vaccinee received her first 20 mcg IM dose of Engerix-B. Post-vaccination, on 12/21/2000, the vaccinee experienced severe nausea and headache. These adverse events resolved on 12/21/2000. Engerix-B was stoped due to the adverse events. As of 03/13/2001, the outcome of the adverse events is resolved. The reporter has reported these adverse events directly to VAERS.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Upper respiratory tract infection
Clinical narrative: Report 20010039191 describes an upper respiratory infection in a 53 year old female who received hepatitis B vaccine (brand name unknown). This report was received from the pt and has not been verified by a physician or other health care professional. Medical history included yeast infections. Concurrent medical conditions and medications were not provided. The pt received her first injection of hepatitis B vaccine (brand name unknown) on 01/11/2001 at her place of employment. She had no adverse experience following receipt of this injection. The pt received her second injection of hepatitis B vaccine (brand name unknown) on 02/08/2001 at her place of employment. The pt stated that she "was fighting a cold" at the time of immunization. Later on 02/08/2001, she "got sicker." She experienced flu-like symptoms and stated that she had an "upper respiratory infection." The pt did not seek medical attention. Her symptoms persisted as of 02/13/2001.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Report 20010039331 describes a rash on a 1 month old male who received an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions and medications were not provided. The infant received his first injection of Engerix-B on 02/05/2001. On 02/06/2001, one day post-immunization, the infant developed a rash on his face, hands, neck, trunk, and knees. He was seen in the local ER on 02/08/2001. The outcome of this event is unknown.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Report 20010040181 describes injection site pain and injection site swelling in a 7 year old female who received Engerix-B. Allergies, medical history, and concomitant medications were denied. The vaccinee is Caucasian-Hispanic. On 01/09/2001, the vaccinee received her third left deltoid dose of Engerix-B. "Since receiving the injection," she experienced a painful left deltoid, and her left side was slightly larger than her right side. No erythema was reported. No treatment was given. As of 02/06/2001, the outcome of the adverse events is unresolved.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Shoulder pain
Clinical narrative: Report 20010042091 describes pain in the shoulders and neck of a 47 year old female who received an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions and medications were not specified. The pt received her first injection of Engerix-B vaccine on 01/25/2001. "A couple of days later" (exact date not provided), she experienced pain and stiffness across the back of her neck to the base of her skull, then both sides of her neck. The pain and stiffness persisted as of 02/16/2001. The pt planned to be evaluated by her physician.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Report 20010052541 describes elevation of AST and ALT in a 47 year old male who received hep B vaccine recombinant for prophylaxis of hep B. The vaccinee has no known drug allergies and denies having a medical history. The vaccinee received hep A vaccine on 02/02/2001. On 02/02/2001, the vaccinee received his first left deltoid dose of Engerix B. 13 days later, on 02/15/2001, he was found to have elevated AST and elevated ALT. No symptoms were reported. This event is considered to be serious. AS of 02/26/2001, the outcome of the adverse events is unsolved.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Laboratory test abnormal
Clinical narrative: Information has been received from a RN concerning a 33 year old female who was vaccinated with a first and second dose of varicella virus vaccine live on 05-FEB-2001 and 28-MAR-2001, respectively. The pt informed the RN that she tested positive for pregnancy with a home pregnancy test. Unspecified medical attention was sought. In follow up the RN reported that the pt had an uncomplicated first trimester spontaneous abortion. The RN reported that neither the physician nor the pt thought that there was any relationship between the exposure and the miscarriage. No further information is available.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Bacterial infection, Bronchiolitis, Coma, Cyanosis, Epiglottitis
Clinical narrative: Patient died approximately 28 hours after Hepatitis B injection. Manner of death, natural, Cause of Death-- SIDS Per F/U 3/27/02: final autopsy dx: Pulmonary edema, anterior thymic petechiae, reactive chronic inflammation; bronchioles, epiglottis. Lungs were heavy for agevand exuded copious fluid. She was found to be blue and unresponsive by her father at approx. 1:50 pm on 9/28/01, after he was awakened by a telephone call. At that time, he called 911 and attempted CPR while waiting for help to arrive. When EMS personnel attempted intubation, copious vomitus exuded from the tube and oral cavity. ER personnel continued ACLS protocols without success.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Petechiae, Pleural effusion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Patient died approximately 28 hours after Hepatitis B injection. Manner of death, natural, Cause of Death-- SIDS Per F/U 3/27/02: final autopsy dx: Pulmonary edema, anterior thymic petechiae, reactive chronic inflammation; bronchioles, epiglottis. Lungs were heavy for agevand exuded copious fluid. She was found to be blue and unresponsive by her father at approx. 1:50 pm on 9/28/01, after he was awakened by a telephone call. At that time, he called 911 and attempted CPR while waiting for help to arrive. When EMS personnel attempted intubation, copious vomitus exuded from the tube and oral cavity. ER personnel continued ACLS protocols without success.
Sex: F
Vaccine: PNC
Symptoms: Atelectasis, Cough, Haemoptysis
Clinical narrative: A physican reported that a female pediatric solid organ transplant pt received her first dose of Prevnar on 31-DEC-2001. On 08-JAN-2002, the child was hospitalized for a single episode of hemoptysis. The reported noted that within "the last several weeks" the child had developed an "intermittent" cough. A chest X-ray performed on admission was consistent with infiltrate or atelectasis. A second chest X-ray performed within 24 hours of admission showed "remarkable improvement suggesting atelectasis to be the cause of this radiographic abnormality." Other laboratory findings were unremarkable. The child "remained stable" and was discharged within 24 hours of admission. The reporter indicated that there was no obvious etiology to the hemoptysis and considered the events to be "definitely not related" to Prevnar administration. No further information was available at the date of this report. Follow up info was received from the physician on 2/22/02. The child's medical history includes Alagille syndrome and liver transplantation. Concomitant medications included Ditropan, Bactrim, and Prograf. The physician provided an event onset date of 1/8/02 and indicated that the child recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Grunting, Hypotonia, Pyrexia
Clinical narrative: The parent heard grunting noise at 02:30 AM on 1/19/02; jerking arms and legs rhythmically. Staring straight ahead. Parents state seizure lasted at least 15 minutes, possibly 20-30 minutes. Seemed flaccid and unresponsive for 10 minutes, then was back to normal self, smiling, nursing. Temperature in ambulance was 99.9F. Seen in ER. Child had another seizure on the way home from doctor's office; eyes focused to the right side and unresponsive. Pt went to hospital and was admitted for 24 hours.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Staring, Strabismus
Clinical narrative: The parent heard grunting noise at 02:30 AM on 1/19/02; jerking arms and legs rhythmically. Staring straight ahead. Parents state seizure lasted at least 15 minutes, possibly 20-30 minutes. Seemed flaccid and unresponsive for 10 minutes, then was back to normal self, smiling, nursing. Temperature in ambulance was 99.9F. Seen in ER. Child had another seizure on the way home from doctor's office; eyes focused to the right side and unresponsive. Pt went to hospital and was admitted for 24 hours.
Age: 0.4
Sex: M
Vaccine: DTPHIB, HEP, OPV
Symptoms: Autism, Screaming
Clinical narrative: Uncontrollable crying for 6 hours. Now pt is autistic from the thimerosal he received in all the vaccinations.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea
Clinical narrative: Within seconds, post vax, the pt had apnea and was arousable with stimulation but continued to have 4 other episodes and was admitted.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Atrial fibrillation, Cerebrovascular accident
Clinical narrative: No sign or symptom immediately but had a major stroke within 20 hours, post vax, with atrial fibrillation. Is in Rehab.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Dizziness, Ear pain, Headache, Injection site pain
Clinical narrative: On 11/1/01, the pt had immediate pain at the injection site with a headache and a fever of 104F. 6 hours, post vax, she had chills, continued headache, vomiting, ear pain, neck pain and felt faint. On 11/07/01, she saw a doctor and was hospitalized.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: On 11/1/01, the pt had immediate pain at the injection site with a headache and a fever of 104F. 6 hours, post vax, she had chills, continued headache, vomiting, ear pain, neck pain and felt faint. On 11/07/01, she saw a doctor and was hospitalized.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Rash
Clinical narrative: Onset of symptoms 3-4 hours after injection: gasping difficulty breathing, cyanotic lips, rash on upper back
Age: 28.0
Sex: M
Vaccine: FLU3, HEPA, TD, VARCEL
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: On 1/3/02 in morning , pt. noticed slight swelling of lymph nodes in his neck and slight sore throat. These 2 signs & symptoms continued to 1/4/02. Pt. denies fever, cough, nasal congestion, rash and general malaise. Advised to call physician if S/S increased.  1/7/02 spoke with pt. no swollen lymph nodes, no fever, but still has slight sore throat and nasal discharge
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Myalgia
Clinical narrative: Client phoned on 1-4-02 to report that td vaccine received on 11-27-01 caused reaction. States symptoms began one day after getting shot. Left elbow and shoulder very sore now. Having difficulty lifting with that arm. States that also had severe swelling with hardness & redness that lasted 2 weeks after shot given. Referred to PCP. Will do f/u next week with client. Advised using ice packs & OTC pain meds. to get symptoms relief.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: swelling around the eyes; hives and itching on body
Age: 1.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Roseola
Clinical narrative: Mom called from Idaho on her way back to Oregon. Son developed fever 4 days ago with runny nose, fever continuous. Mom notice this morning (1-11-02) a rash on torso and rash just starting on face. Mom thinks may be rosacea. Child not in daycare. Mom giving Motrin for fever. OHN informed could be vaccine reaction (MMR, Varicella) PHN advised if fever persist beyond 5 days to contact physician for evaluation. Mom agreed.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Lethargy, Pain, Vomiting
Clinical narrative: Within 1 hour of shot, I got very bodyaches & very tired. Approximately 4 hours later-vomiting stomach ache. this lasted 4 days; did not take any medicine-I just let it run its course.