chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Gait disturbance, Impaired work ability, Laboratory test normal, Myalgia
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested.  In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient in her late teens (exact age and gender unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, the patient experienced diarrhea.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently the patient "had alot of anxiety and passed out."  At the time of the report, the patient's outcome was unknown.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently the patient experienced "had alot of anxiety and passed out."  At the time of the report, the patient's outcome was unknown.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Allergy test positive, Anti-thyroid antibody positive, Antinuclear antibody negative, Band neutrophil count
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Basophil count normal, CSF monocyte count decreased, DNA antibody, Drug hypersensitivity, Eosinophil count decreased
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Food allergy, Haematocrit normal, Haemoglobin increased, Helicobacter pylori identification test negative, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Lymphocyte count decreased, Lymphocyte morphology abnormal, Mean cell volume normal, Monocyte count decreased
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neutrophil count decreased, Platelet count normal, Rash macular, Red blood cell count increased, Red cell distribution width normal
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urine ketone body present, Urticaria, White blood cell count decreased
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergies to peanuts and penicillin, who on 22-AUG-2007 was vaccinated with a second dose of Gardasil (Lot# 658554/0928U).  It was noted she received her first dose of Gardasil on 05-JUN-2007.  Concomitant therapy included RITALIN LA.  On 22-AUG-2007 the patient developed itching, swelling, and blotchiness at the injection site.  The patient also developed blotchiness on the patient's wrist bilaterally and on her abdomen.  No hives or shortness of breath noted.  The patient sought unspecified medical attention.  On 23-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who , on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, almost immediately after receiving the vaccination, the patient became very lightheaded. The patient became no lightheaded that she had to be held up by her mother, but did not faint. The patient did not seek medical attention. The patient recovered within five minutes after vaccine administered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Mass, Overdose, Pain in extremity, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a nurse who was vaccinated with a dose of Gardasil. Subsequently, the patient was inadvertently vaccinated with a another dose of Gardasil instead of Vaqta (manufacturer unknown). The patient developed  a bump and pain in her arm. There were no laboratory or diagnostic tests performed. The patient sought medical attention from the physician. At the time of the report the patients outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling of body temperature change, Flushing, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a first and second dose of Gardasil. Concomitant therapy included ADVIL. The nurse reported that the patient had flushing around her ears throughout her body shortly after the first injection. After the second dose of Gardasil, she noticed spells of being hot and cold and had a fever and thought it was a urinary tract infection. Unspecified medical attention was sought by the patients. The patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pruritus, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 22-AUG-2007 was vaccinated by injection with the first 0.5 mL dose of Gardasil. On 22-AUG-2007, after the patient received her first dose of Gardasil experienced "anaphylactic reactions including swelling of the throat." The patient sought unspecified medical attention. Subsequently, the patient recovered from anaphylactic reactions and swelling of the throat. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow-up it was reported by the physician concerning a 19 year old female with no illness at the time of vaccination and no pre-existing allergies, birth defects, or medical conditions whose reported weight was 130 pounds and whose reported height was 66 inches who on 22-AUG-2007at 3:00 p.m., was vaccinated by injection into the left arm with the first 0.5 mL dose of GARDASIL, (lot # 686094/05240). It was reported that 15 minutes after the vaccine was administered the patient had throat swelling, itching, vomiting x 1. The patient was treated for "anaphylaxis" with SOLU-MEDROL, BENADRYL and prednisone. There was no decrease in blood pressure (BP) and no changes in respiratory status. The patient recovered on 22-AUG-2007. The reporter determined the patient's anaphylactic reaction to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. in addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 07-JUN-2007 was vaccinated with Gardasil. (Lot # 655620/0171U). It was reported that on 07-JUN-2007, a few hours after she was given Gardasil, the patient had a fever, chills and fatigue. The patient recovered one week after she was given the vaccine. The patient spoke with the nurse regarding her fever, chills and fatigue. No other information was available from the nurse. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female patient with no medical history who on 06-JUN-2007, was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot# 657622/0388U). Concomitant therapy included penicillin (unspecified). On that same day, the patient developed itch from head to toe, swelling of her hands and feet and quarter sized welts all over body. The patient was seen in the emergency room for evaluation. On 15-AUG-2007, the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot# 658488/0930U). On that same day, the patient developed the itch all over her body, but did not experience any of the other previous reactions. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no medical history or allergies who on 18-MAY-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included vitamins (unspecified). On 18-JUL-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 654535/0960F). On 18-JUL-2007, the patient had experienced generalized achiness with joint pains. Unspecified medical attention was sought. It was reported that the patient was to be seen in the office on 21-AUG-2007. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 20-AUG-2007, was vaccinated IM with a first dose of Gardasil (Lot to be determined). Concomitant therapy included a dose of (Havrix). On approximately 22-AUG-2007 "about 2 days later", the patient developed a rash on her legs. It was reported that the patient's mother called and reported that the rash had spread all over the patient's entire body. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoacusis
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 22-AUG-2007, was vaccinated with a first dose of Gardasil (Lot To be determined). A couple of hours after receiving the vaccine the patient experienced dizziness was lightheaded and had "muffled hearing". Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. It was reported that the patient was scheduled to see her allergist to be tested for an allergy to yeast. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no medical history or allergies who within the last 3 months date was vaccinated with a dose of Gardasil. There was no concomitant medication. "Within the last week" it was reported that the patient had a positive pap smear test after receiving the first doses of the vaccine. The vaccinations were believed to be administered within the last 3 months. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Pyrexia, Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her third dose of Gardasil. Subsequently the patient experienced "hot-cold fever" and lower back pain. The physician believed these symptoms to be related to a urinary tract infection. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from an emergency room physician concerning a 19 year old female who on 15-AUG-2007 was vaccinated with a dose of Gardasil. On 22-AUG-2007 the patient was seen in the emergency room for severe arm pain in the arm where the vaccination was received. The physician reported there was no sign of infection and no specific treatment was advised. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date was vaccinated with a dose of Gardasil. Subsequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a nurse concerning a patient  a 17 year old, who, on an unspecified date was vaccinated with GARDASIL (lot # 857622/0388U). Susequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outocme was unknown. No product quality complaint was involved. Additional informatoin has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date was vaccinated with a dose of Gardasil. Subsequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Transient ischaemic attack
Clinical narrative: Information has been received from a pharmacist and technician concerning a 66 year old female with allergic reaction to quinolones and no reported medical history who on 05-SEP-2007 was vaccinated with Zostavax (lot # 658085/0882U). Concomitant therapy included a steroid injection and other unspecified medications. On 07-SEP-2007 the patient experienced fever, swelling and redness at the injection site. The patient sought the medical attention of the pharmacist. On 14-SEP-2007 the patient contacted the pharmacy and reported that she was admitted to the hospital on 11-SEP-2007 for a "mini-stroke". She was released on 13-SEP-2007. The patient is recovering from her events. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 55-year-old male who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently, the patient experienced swelling and redness at and around the injection site. The patient was hospitalized because it was possibly thought to be cellulitis. No outcome reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Haematochezia, Mucous stools, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Information has been received from a physician concerning her 8-week-old son who on 16-AUG-2007 was vaccinated with the first dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Prevnar, Pediarix and a dose of Hib (manufacturer unknown). The physician reported that on 16-AUG-2007, her son developed a slight fever which she treated with acetaminophen (TYLENOL). On 18-AUG-2007, at 1900, the patient started crying and passed three stools with blood in them (not fresh) which looked coagulated with some mucous. The boy was taken to the Emergency Room (ER) where an ultrasound was negative for intussusception. No tests were done on the stool and no other laboratory tests were performed. At the time of this report, the outcome was unknown. Upon internal review three stools with blood was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface positive in an infant subject of unspecified gender who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. On an unspecified date in 2007 the subject received 1st dose (birth dose) of Engerix B. The infant was tested for hepatitis B surface antigen 5 days later and tested positive. The circumstances for why the infant was tested were not known by the reporter. The infant believed to have been tested while hospitalized for an unknown reason. No other information was known at the time of reporting. The outcome of the event was unspecified.
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Brain oedema, Discomfort, Hypoaesthesia, Hypokinesia
Clinical narrative: On 11 SEP 2007 a product liability litigation was received from a lawyer. The following information was provided: A female patient who is the plaintiff received three doses of RabAvert on 13 SEP 2005, 20 SEP 2005 and on 4 OCT 2005. It was reported that as a direct and proximate result of the vaccinations the patient sustained permanent and disabling personal injuries (interval unknown) including, but not limited to, swelling of the brain, numbness, nerve damage and was thereby caused to sustain serious, permanent, and debilitating body injuries. She developed severe and irreversible damage to her nerves and nervous system, she was caused to suffer from severe and permanent muscular and neurological damage and the use, function and movement of portions of her body have been permanently impaired. She had severe discomfort, pain, and mental anguish. As a direct result of her injuries the patient's ability to work, labor, earn wages, and enjoy the ordinary pursuits of life has been seriously and permanently impaired or destroyed. The patient had to undergo necessary extensive hospitalization and therapeutic are and treatment. Defendants are the manufacturer for failure to adequately warn prescribers, administrators and all other health care providers of the risk of permanent side effects caused by RabAvert and the registered nurse who administered the vaccines for medical malpractice. Causality: not related. Although only limited information is provided and exact diagnosis of the patient's disease and onset latency are not provided causality has been excluded. Swelling of brain is a serious, immediate medical intervention requiring disease of different aetiology. It has never been observed in association with use of inactivated vaccines and there is no plausible pathomechanism that could explain this disease as result of vaccination.
Sex: F
Vaccine: RAB
Symptoms: Nerve injury, Pain
Clinical narrative: On 11 SEP 2007 a product liability litigation was received from a lawyer. The following information was provided: A female patient who is the plaintiff received three doses of RabAvert on 13 SEP 2005, 20 SEP 2005 and on 4 OCT 2005. It was reported that as a direct and proximate result of the vaccinations the patient sustained permanent and disabling personal injuries (interval unknown) including, but not limited to, swelling of the brain, numbness, nerve damage and was thereby caused to sustain serious, permanent, and debilitating body injuries. She developed severe and irreversible damage to her nerves and nervous system, she was caused to suffer from severe and permanent muscular and neurological damage and the use, function and movement of portions of her body have been permanently impaired. She had severe discomfort, pain, and mental anguish. As a direct result of her injuries the patient's ability to work, labor, earn wages, and enjoy the ordinary pursuits of life has been seriously and permanently impaired or destroyed. The patient had to undergo necessary extensive hospitalization and therapeutic are and treatment. Defendants are the manufacturer for failure to adequately warn prescribers, administrators and all other health care providers of the risk of permanent side effects caused by RabAvert and the registered nurse who administered the vaccines for medical malpractice. Causality: not related. Although only limited information is provided and exact diagnosis of the patient's disease and onset latency are not provided causality has been excluded. Swelling of brain is a serious, immediate medical intervention requiring disease of different aetiology. It has never been observed in association with use of inactivated vaccines and there is no plausible pathomechanism that could explain this disease as result of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis. The subject was not a patient of the reporter. The reporter was informed of this by another healthcare professional. On an unspecified date the subject inadvertently received an unspecified dose of Engerix B (intravenous). The subject experienced wrong route of administration as the dose was given intravenously and the correct route is intramuscular. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Blood glucose normal, Blood thyroid stimulating hormone normal
Clinical narrative: On 13 August, he received the smallpox vaccine (3 jabs) in his left arm. Noted around day 7-10 post-vaccine that he did perspire more than usual, but denies fever or chills. Around 23 August, service member reports the onset of a headache that started at the top of his head and radiated to the back of his head and was associated with neck pain. He described this pain as "sharp" and rates its intensity level as a level 8/10 using a pain intensity scale of 0 (= no pain) and 10 (= worst pain ever experienced). He denies associated nausea, vomiting or photophobia. He did not self treat his headache, but reports it had resolved around 24 August. On 24 August, service member awoke with a sharp, constant chest pain "across whole chest and ...went to my shoulders, elbows (Left >right) and teeth". He rates the pain intensity as 9/10. The pain was worse while laying down and with deep breaths. He denies experiencing shortness of breath, palpitations, nausea or vomiting, and peripheral edema. He went to the clinic shortly after awakening. An ECG, CXR, Echocardiogram and lab work were completed. He was treated with Indocin and within 2 hours, his pain intensity had decreased to about 4-5/10. With continued Indocin, his shoulder and elbow pain completely resolved by the next day and his chest pain diminished to a level 3/10. By August 27th, his chest only hurt with deep breaths or if his heart rate increased. Currently (9/4/07), service member denies chest pain except with increased heart rate after minimal exertion and if he delays his indocin doses. These episodes are described as sharp pain lasting < 1 minute and rated as a pain intensity level of 2-3/10. He notes his heart rate increases with minimal exertion such as climbing 1 flight of stairs. Also, feels "winded" after minimal exertion; described like being winded after running on a PT test. His energy level is described as being about 80% of his baseline prior to August 2007.  09/24/2007 VAERS report submitted with MR attached.  Pt noted increased diaphoresis on approx the 7th day s/p vaccine.  On 8/23/07 pt developed headache with associated neck pain.  On 8/24 pt developed sharp, constant chest pain radiating into the shoulders, elbows, and teeth awakening pt from sleep.  Pain increased while laying flat and with inspiration.  Events happend overseas so further records unavailable. DX: Pericarditis likely related to smallpox vaccine. F/U 9/4/007 where pt reports occ chest pain with increased HR after minimal exertion.  Feels winded after minimal exertion. Energy level decreased to 80%.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Electrocardiogram ST-T change, Haematocrit normal
Clinical narrative: On 13 August, he received the smallpox vaccine (3 jabs) in his left arm. Noted around day 7-10 post-vaccine that he did perspire more than usual, but denies fever or chills. Around 23 August, service member reports the onset of a headache that started at the top of his head and radiated to the back of his head and was associated with neck pain. He described this pain as "sharp" and rates its intensity level as a level 8/10 using a pain intensity scale of 0 (= no pain) and 10 (= worst pain ever experienced). He denies associated nausea, vomiting or photophobia. He did not self treat his headache, but reports it had resolved around 24 August. On 24 August, service member awoke with a sharp, constant chest pain "across whole chest and ...went to my shoulders, elbows (Left >right) and teeth". He rates the pain intensity as 9/10. The pain was worse while laying down and with deep breaths. He denies experiencing shortness of breath, palpitations, nausea or vomiting, and peripheral edema. He went to the clinic shortly after awakening. An ECG, CXR, Echocardiogram and lab work were completed. He was treated with Indocin and within 2 hours, his pain intensity had decreased to about 4-5/10. With continued Indocin, his shoulder and elbow pain completely resolved by the next day and his chest pain diminished to a level 3/10. By August 27th, his chest only hurt with deep breaths or if his heart rate increased. Currently (9/4/07), service member denies chest pain except with increased heart rate after minimal exertion and if he delays his indocin doses. These episodes are described as sharp pain lasting < 1 minute and rated as a pain intensity level of 2-3/10. He notes his heart rate increases with minimal exertion such as climbing 1 flight of stairs. Also, feels "winded" after minimal exertion; described like being winded after running on a PT test. His energy level is described as being about 80% of his baseline prior to August 2007.  09/24/2007 VAERS report submitted with MR attached.  Pt noted increased diaphoresis on approx the 7th day s/p vaccine.  On 8/23/07 pt developed headache with associated neck pain.  On 8/24 pt developed sharp, constant chest pain radiating into the shoulders, elbows, and teeth awakening pt from sleep.  Pain increased while laying flat and with inspiration.  Events happend overseas so further records unavailable. DX: Pericarditis likely related to smallpox vaccine. F/U 9/4/007 where pt reports occ chest pain with increased HR after minimal exertion.  Feels winded after minimal exertion. Energy level decreased to 80%.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Haemoglobin normal, Headache, Heart rate increased, Hyperhidrosis, Neck pain
Clinical narrative: On 13 August, he received the smallpox vaccine (3 jabs) in his left arm. Noted around day 7-10 post-vaccine that he did perspire more than usual, but denies fever or chills. Around 23 August, service member reports the onset of a headache that started at the top of his head and radiated to the back of his head and was associated with neck pain. He described this pain as "sharp" and rates its intensity level as a level 8/10 using a pain intensity scale of 0 (= no pain) and 10 (= worst pain ever experienced). He denies associated nausea, vomiting or photophobia. He did not self treat his headache, but reports it had resolved around 24 August. On 24 August, service member awoke with a sharp, constant chest pain "across whole chest and ...went to my shoulders, elbows (Left >right) and teeth". He rates the pain intensity as 9/10. The pain was worse while laying down and with deep breaths. He denies experiencing shortness of breath, palpitations, nausea or vomiting, and peripheral edema. He went to the clinic shortly after awakening. An ECG, CXR, Echocardiogram and lab work were completed. He was treated with Indocin and within 2 hours, his pain intensity had decreased to about 4-5/10. With continued Indocin, his shoulder and elbow pain completely resolved by the next day and his chest pain diminished to a level 3/10. By August 27th, his chest only hurt with deep breaths or if his heart rate increased. Currently (9/4/07), service member denies chest pain except with increased heart rate after minimal exertion and if he delays his indocin doses. These episodes are described as sharp pain lasting < 1 minute and rated as a pain intensity level of 2-3/10. He notes his heart rate increases with minimal exertion such as climbing 1 flight of stairs. Also, feels "winded" after minimal exertion; described like being winded after running on a PT test. His energy level is described as being about 80% of his baseline prior to August 2007.  09/24/2007 VAERS report submitted with MR attached.  Pt noted increased diaphoresis on approx the 7th day s/p vaccine.  On 8/23/07 pt developed headache with associated neck pain.  On 8/24 pt developed sharp, constant chest pain radiating into the shoulders, elbows, and teeth awakening pt from sleep.  Pain increased while laying flat and with inspiration.  Events happend overseas so further records unavailable. DX: Pericarditis likely related to smallpox vaccine. F/U 9/4/007 where pt reports occ chest pain with increased HR after minimal exertion.  Feels winded after minimal exertion. Energy level decreased to 80%.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Troponin I increased
Clinical narrative: On 13 August, he received the smallpox vaccine (3 jabs) in his left arm. Noted around day 7-10 post-vaccine that he did perspire more than usual, but denies fever or chills. Around 23 August, service member reports the onset of a headache that started at the top of his head and radiated to the back of his head and was associated with neck pain. He described this pain as "sharp" and rates its intensity level as a level 8/10 using a pain intensity scale of 0 (= no pain) and 10 (= worst pain ever experienced). He denies associated nausea, vomiting or photophobia. He did not self treat his headache, but reports it had resolved around 24 August. On 24 August, service member awoke with a sharp, constant chest pain "across whole chest and ...went to my shoulders, elbows (Left >right) and teeth". He rates the pain intensity as 9/10. The pain was worse while laying down and with deep breaths. He denies experiencing shortness of breath, palpitations, nausea or vomiting, and peripheral edema. He went to the clinic shortly after awakening. An ECG, CXR, Echocardiogram and lab work were completed. He was treated with Indocin and within 2 hours, his pain intensity had decreased to about 4-5/10. With continued Indocin, his shoulder and elbow pain completely resolved by the next day and his chest pain diminished to a level 3/10. By August 27th, his chest only hurt with deep breaths or if his heart rate increased. Currently (9/4/07), service member denies chest pain except with increased heart rate after minimal exertion and if he delays his indocin doses. These episodes are described as sharp pain lasting < 1 minute and rated as a pain intensity level of 2-3/10. He notes his heart rate increases with minimal exertion such as climbing 1 flight of stairs. Also, feels "winded" after minimal exertion; described like being winded after running on a PT test. His energy level is described as being about 80% of his baseline prior to August 2007.  09/24/2007 VAERS report submitted with MR attached.  Pt noted increased diaphoresis on approx the 7th day s/p vaccine.  On 8/23/07 pt developed headache with associated neck pain.  On 8/24 pt developed sharp, constant chest pain radiating into the shoulders, elbows, and teeth awakening pt from sleep.  Pain increased while laying flat and with inspiration.  Events happend overseas so further records unavailable. DX: Pericarditis likely related to smallpox vaccine. F/U 9/4/007 where pt reports occ chest pain with increased HR after minimal exertion.  Feels winded after minimal exertion. Energy level decreased to 80%.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest pain, Dyspnoea, Echocardiogram abnormal, Headache
Clinical narrative: Description: Headache, SOB and chest pains 9 days following his primary smallpox vaccination. The pains were located in his left chest and radiated into his neck and left arm. He described them 'like someone sitting on my chest'. He had 2 episodes with the second episode so severe '10/10' on the PAS that he sought medical care. He admitted to a civilian hospital medicated for pain and  was discharged with complete resolution of his symptoms on 6 June 06. Symptom: Chest Pain Start; 06/02/2006 End: 06/03/2006 Comment: 2 episodes; 1 lasted @ 30 minutes; 2nd with pains 10/10 on PAS.  09/24/2007  VAERS report received with medical records attached. Link requested to 291063.  No further records available as event happened overseas and pt was treated in a foreign hospital. Patient experienced  headache and chest pain radiating into the L neck and arm x2 episodes on 6/2/06. Experienced SOB on 2nd episode. Seen in clinic and transfered to hospital due to an abnormal EKG.  DX: Myopericarditis in temporal association with smallpox vaccine. F/U 9/2007 with report that stamina and energy not back to pre AE levels.  Recovery time post exercise is greater as well. Occasional mild chest pains.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Neck pain, Troponin increased
Clinical narrative: Description: Headache, SOB and chest pains 9 days following his primary smallpox vaccination. The pains were located in his left chest and radiated into his neck and left arm. He described them 'like someone sitting on my chest'. He had 2 episodes with the second episode so severe '10/10' on the PAS that he sought medical care. He admitted to a civilian hospital medicated for pain and  was discharged with complete resolution of his symptoms on 6 June 06. Symptom: Chest Pain Start; 06/02/2006 End: 06/03/2006 Comment: 2 episodes; 1 lasted @ 30 minutes; 2nd with pains 10/10 on PAS.  09/24/2007  VAERS report received with medical records attached. Link requested to 291063.  No further records available as event happened overseas and pt was treated in a foreign hospital. Patient experienced  headache and chest pain radiating into the L neck and arm x2 episodes on 6/2/06. Experienced SOB on 2nd episode. Seen in clinic and transfered to hospital due to an abnormal EKG.  DX: Myopericarditis in temporal association with smallpox vaccine. F/U 9/2007 with report that stamina and energy not back to pre AE levels.  Recovery time post exercise is greater as well. Occasional mild chest pains.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arteriogram coronary, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Description: Headache, SOB and chest pains 9 days following his primary smallpox vaccination. The pains were located in his left chest and radiated into his neck and left arm. He described them 'like someone sitting on my chest'. He had 2 episodes with the second episode so severe '10/10' on the PAS that he sought medical care. He admitted to a civilian hospital medicated for pain and  was discharged with complete resolution of his symptoms on 6 June 06. Symptom: Chest Pain Start; 06/02/2006 End: 06/03/2006 Comment: 2 episodes; 1 lasted @ 30 minutes; 2nd with pains 10/10 on PAS.  09/24/2007  VAERS report received with medical records attached. Link requested to 291063.  No further records available as event happened overseas and pt was treated in a foreign hospital. Patient experienced  headache and chest pain radiating into the L neck and arm x2 episodes on 6/2/06. Experienced SOB on 2nd episode. Seen in clinic and transfered to hospital due to an abnormal EKG.  DX: Myopericarditis in temporal association with smallpox vaccine. F/U 9/2007 with report that stamina and energy not back to pre AE levels.  Recovery time post exercise is greater as well. Occasional mild chest pains.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Chest pain, Dyspnoea, Echocardiogram abnormal, Headache
Clinical narrative: Chest pain for 2 hours.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Neck pain, Troponin increased
Clinical narrative: Chest pain for 2 hours.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arteriogram coronary, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Chest pain for 2 hours.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Metabolic function test normal, Nuclear magnetic resonance imaging normal, Obsessive-compulsive disorder, Streptococcal identification test
Clinical narrative: 2 weeks following vaccination first symptoms of obsessive-compulsive disorder appeared in patient. According to psychiatrist following patient, it's very likely vaccine triggered the disease.  12/17/2007 MR received for DOS 01/8-17/2007 with D/C Dx:  Obsessive Compulsive disorder.   In September 2006 pt began having intrusive thoughts about being unclean and needing to wash.  Pt washing hands ~12x/day for 5-10 minutes, and symptoms cause pt great psychic stress. Pt having difficulty concentrating and school performance had declined. (+) depressive sx. Pt to f/u as outpt  Per 60 day follow up: Patient is still on medications and strict care of the psychiatrist. Receives psychotherapy.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis normal
Clinical narrative: 2 weeks following vaccination first symptoms of obsessive-compulsive disorder appeared in patient. According to psychiatrist following patient, it's very likely vaccine triggered the disease.  12/17/2007 MR received for DOS 01/8-17/2007 with D/C Dx:  Obsessive Compulsive disorder.   In September 2006 pt began having intrusive thoughts about being unclean and needing to wash.  Pt washing hands ~12x/day for 5-10 minutes, and symptoms cause pt great psychic stress. Pt having difficulty concentrating and school performance had declined. (+) depressive sx. Pt to f/u as outpt  Per 60 day follow up: Patient is still on medications and strict care of the psychiatrist. Receives psychotherapy.
Age: 1.31
Sex: F
Vaccine: HIBV, MMR
Symptoms: Autism, Blood phosphorus decreased, Blood test abnormal, Ear infection, Ear tube insertion
Clinical narrative: Between 2 - 3 years had ear infections and tubes in ears. Very sensitive to sounds, would cover ears. Years of different treatments for autistic behaviours. Then started with a doctor. Started vitamins, supplements and a lot of tests. Recent tests provided showing very high strep in blood. She has never had strep.  9/25/2007 VAERS report received with medical records and vax record attached.  TC to parent for additional info.  Parent is unable to give AE onset date "sometime between age 2-3". Medical records from MD reveal Dx:  Unspecified Disorder of Immune mechanism. Obsessive-Compulsive Disorder.  Autoimmune Disease NOC. Encephalopathy unspecified.  DX of Autism on vax record. Per 60 day follow up: She is severly autistic. Follow-up: Patient is severely autistic with major deficits in language and social skills. We continue to see obsessive/compulsive issues. Patient will never be able to live alone. She will always need a caregivers.
Age: 1.31
Sex: F
Vaccine: HIBV, MMR
Symptoms: Hyperacusis, Streptococcal bacteraemia, Toxicologic test normal
Clinical narrative: Between 2 - 3 years had ear infections and tubes in ears. Very sensitive to sounds, would cover ears. Years of different treatments for autistic behaviours. Then started with a doctor. Started vitamins, supplements and a lot of tests. Recent tests provided showing very high strep in blood. She has never had strep.  9/25/2007 VAERS report received with medical records and vax record attached.  TC to parent for additional info.  Parent is unable to give AE onset date "sometime between age 2-3". Medical records from MD reveal Dx:  Unspecified Disorder of Immune mechanism. Obsessive-Compulsive Disorder.  Autoimmune Disease NOC. Encephalopathy unspecified.  DX of Autism on vax record. Per 60 day follow up: She is severly autistic. Follow-up: Patient is severely autistic with major deficits in language and social skills. We continue to see obsessive/compulsive issues. Patient will never be able to live alone. She will always need a caregivers.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Culture throat negative, Petechiae, Pharyngolaryngeal pain, Platelet count decreased, Purpura
Clinical narrative: 8-16-07 Petechiae and purpura noted by patient along with a sore throat. Throat culture done, result (4 d later) was negative AB strep. Because of low platelet count, admitted to hospital. Dx: ITP, Rx IVIG x 2 with later increase in platelet count.  10/01/2007 MR received for hospital DOS 8/16-18/2007 for D/C DX: Immune Thrombocytopenic Purpura.  Pt presented initially to PCP with c/o rash, excessive bleeding following a knee laceration, spontaneous nosebleed, and a new purple rash in the mouth.  PCP noted petechiae and  wet purpura on exam and labs done with a platelet count of 1000.  Sent to ER for eval. PE (+) for petechiae over entire body, palpable bruises as well as non-raised bruises, pharyngeal purpura and several lacerations. Discharge to F/U with hematologist.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: White blood cell count decreased
Clinical narrative: 8-16-07 Petechiae and purpura noted by patient along with a sore throat. Throat culture done, result (4 d later) was negative AB strep. Because of low platelet count, admitted to hospital. Dx: ITP, Rx IVIG x 2 with later increase in platelet count.  10/01/2007 MR received for hospital DOS 8/16-18/2007 for D/C DX: Immune Thrombocytopenic Purpura.  Pt presented initially to PCP with c/o rash, excessive bleeding following a knee laceration, spontaneous nosebleed, and a new purple rash in the mouth.  PCP noted petechiae and  wet purpura on exam and labs done with a platelet count of 1000.  Sent to ER for eval. PE (+) for petechiae over entire body, palpable bruises as well as non-raised bruises, pharyngeal purpura and several lacerations. Discharge to F/U with hematologist.
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Pericardial effusion
Clinical narrative: Polyarthralgia and pericardial effusion.  10/17/2007 MR received for DOS 9/16-20/2007 for D/C DX Pericardial Effusion.  Pt presented  with several day hx of joint pain and shortness of breath associated with burning in her throat, also coughing and weakness.  Temp 100.4'F upon eval. PE (+) for JVD Pt had an US guided pericardiocentesis with drain placement.  Drain removed once drainage was <5cc.