chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Dysarthria, Multiple sclerosis
Clinical narrative: It was reported that a male pt was vaccinated with the hep b vaccine recombinant series. It was reported that approx. one month the first injection the pt started to slur his words, which turned out to be his first symptoms of multiple sclerosis. The pt, as well as his neurologist, were unsure whether the hep b vaccination series had anything to do with the multiple sclerosis. It was noted that the pt grew up in another country so he may have been at risk but that this could never been determined. Follow-up information from the pt indicated that he received the first and second doses of the hep b vaccine. At the time he was a school bus driver at risk of hepatitis according to the school district. After the first dose he started slurring his words. He received the second dose on time. He was 46 years old. The pt retired in November 1990. He went to the hospital and indicated that the doctors were stumped. The following tests were performed: heavy metal tests, an EVP test, an MRI, lumbar puncture, CT scan and several other blood tests. None were conclusive for MS, but the pt indicated that they were leaning in that direction. Since that time the pt has had 8 MRIs and approx. the same number of other tests. He stated that he does not present clinically like a normal MS because his tests are not definitive by themselves. At no time did the doctors suggest that the hepatitis b vaccine was the trigger. The pt reported that they were adamant that it was not the MS trigger. The pt agreed with their conclusion given the research he has done. Upon internal review, multiple sclerosis was determined to be an other important medical event. Additional info has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a 27 year old female with spironalactone allergy who on 05/16/2001 was vaccinated IM in the right deltoid with a first dose of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 0517/2001 the pt experienced rash and a "hive type reaction" on her trunk, arms, and face. It was reported that the pt treated her hives with Benadryl. It was noted that the pt has not had this type of reaction before. It was reported that the reaction continued until 05/21/2001 (4 days) and that the pt recovered from this experience. It was indicated that on 06/13/2001 the pt received a first dose IM in the right deltoid of hep a virus vaccine inactivated and on 06/28/2001 the pt received a second dose IM in the left deltoid of hep b vaccine recombinant. It was noted that there was no reaction after the second dose of hep b vaccine recombinant. No further info is available.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Lethargy, Rash
Clinical narrative: Information has been received from a physician concerning a 21 day old female infant who was full term at birth with no known allergies who on 06/10/2001 was vaccinated with hep  b vaccine recombinant. On approximately 06/10/2001 the pt had symptoms of a rash and lethargy. The infant was hospitalized on 06/12/2001 to rule out sepsis. It was reported that "up to now all the culture results have been negative." It was noted that the infant remains in the hospital with an intermittent rash. Follow-up info has been received from the physician and indicated that she was the pt's intern and is no longer a part of this pt's care; therefore, she does not have access to the infant's medical records. Additional info has been requested.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 10 year old male who was vaccinated with one dose of hep b vaccine recombinant. Approximately two weeks after the vaccination, the child developed an unexplained case of hives over his body. Unspecified medical attention was sought. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Information has been received from a nurse concerning an 11 year old female who was vaccinated with a second dose of hep b vaccine. One week post vaccination, the pt developed mild Bell's palsy. The pt sought unspecified medical attention. Additional info has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a 38 year old female with an allergy to an unspecified cardiac medication who on 06/14/2001 was vaccinated with a first dose of hep b vaccine recombinant. On 06/14/2001 the pt reported that injection site arm bothered her. On 06/15/2001 the pt developed redness, soreness, swelling from her shoulder to her hand on injection site arm and a fever. On 06/16/2001 the pt developed a swollen node in axillary area the size of a golf ball. Subsequently, the next day the node was the size of a pea and the other symptoms had resolved. Unspecified medical attention was sought. As of 06/22/2001 the pt felt fine. Additional info has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Headache, Nausea, Pruritus
Clinical narrative: Information has been received from a registered pharmacist concerning a 36 year old female with no significant medical history who on 06/29/2001 was vaccinated with a first dose of "thiomersal free" hep b vaccine recombinant in the left deltoid. There was no concomitant medications, additional vaccines nor any recent immunizations. The pt was not ill at the time of the vaccination. On 06/29/2001 at 1015H, approximately one hour after the vaccination, the pt developed nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on her arms, and headache. She was taken to the ER and treated in the ER with injectable Benadryl. She was also started on a course of prednisone and vistaril. The pt was not admitted to the hospital, but was kept in the ER for several hours for observation and discharged that same day. As of 07/02/2001, the pt recovered from her experiences. Upon internal review nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on the arms, and headache were determined to be other important medical events. No further info is available.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a registered pharmacist concerning a 36 year old female with no significant medical history who on 06/29/2001 was vaccinated with a first dose of "thiomersal free" hep b vaccine recombinant in the left deltoid. There was no concomitant medications, additional vaccines nor any recent immunizations. The pt was not ill at the time of the vaccination. On 06/29/2001 at 1015H, approximately one hour after the vaccination, the pt developed nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on her arms, and headache. She was taken to the ER and treated in the ER with injectable Benadryl. She was also started on a course of prednisone and vistaril. The pt was not admitted to the hospital, but was kept in the ER for several hours for observation and discharged that same day. As of 07/02/2001, the pt recovered from her experiences. Upon internal review nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on the arms, and headache were determined to be other important medical events. No further info is available.
Sex: U
Vaccine: HEP
Symptoms: Crying
Clinical narrative: Information has been received from a health professional concerning an infant pt who in approximately 1998, was vaccinated with one dose of hep b vaccine recombinant. It was reported that the pt had "inconsolable crying, as a baby, due to hep b vaccine recombinant." Upon follow-up, the registered nurse communicated that "the pt you are referring to was reported 3 years ago." No further info is available.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site pain, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 26 year old female with asthma, septra allergy, penicillin allergy, food allergy, insect sting allergy, and dust allergy who on 06/29/2001 was vaccinated with a first dose of "thiomersal free" hep b vaccine recombinant in the left deltoid. There were no concomitant medications, additional vaccines, nor any recent immunizations. The pt was not ill at the time of the vaccination. On 06/29/2001 at 11:00, approximately one hour and fortyfive mins post vaccination, the pt developed pain in the arm of the injection, numbness in her left arm down to her fingers in her left hand, and swelling in her left arm down to her fingers in her left hand. The pt was taken to the ER and was given pain medication for her symptoms. She was discharged from the ER, and as of 06/02/2001 had recovered from her experiences. No further info is available.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 10 year old female child who was vaccinated with a first dose of hep b vaccine recombinant. Subsequently the pt broke out in itchy hives. The child was vaccinated with a second dose of hep b vaccine recombinant. Subsequently the child had more hives and the itching was reported to be more intense. Unspecified medical attention was sought. Additional info has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Influenza like illness, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old white female medical assistant with a history of thyroid dysfunction and no known drug allergies who on 06/01/2001 at 16:00 was vaccinated with the right beceps with a first dose of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 06/02/2001, the pt developed hive-like rash on her groin, trunk and inner thigh. The pt also experienced flu-like symptoms with headache and had intense itching. The pt sought unspecified medical attention. The pt was given Benadryl and pt recovered from the experience. It was reported that the vaccine was improperly stored. For a month, the refrigerator was being unplugged for a few hours or days each time prior to administration of the vaccine. The attending physician was not sure if the symptoms were from the vaccine or the improper temperature excursions. No further info is avaialble.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Abdominal pain upper, Influenza like illness, Malaise, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female with a septra allergy who on 07/05/2001 was vaccinated with hep b vaccine recombinant. There was no illness at the time of vaccination. On 07/08/2001 the pt experienced a sore throat, runny nose and generally did not feel well. It was reported that she also experienced a low grade fever, uper abdominal pain, cramps, vomiting and flu-like symptoms. A strep culture was done which was negative. Unspecified medical attention was sought. The pt has recovered.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Information has been received from a health professional concerning an 18 year old white female with a septra allergy who on 07/05/2001 was vaccinated with hep b vaccine recombinant. There was no illness at the time of vaccination. On 07/08/2001 the pt experienced a sore throat, runny nose and generally did not feel well. It was reported that she also experienced a low grade fever, uper abdominal pain, cramps, vomiting and flu-like symptoms. A strep culture was done which was negative. Unspecified medical attention was sought. The pt has recovered.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: Information has been received from a health professional concerning an 18 year old female, with a history of cystitis cystica, no known allergies, and urinary tract infection at the time of vaccination. On 07/11/2001 was vaccinated with the first dose of hep b vaccine recombinant IM in the left deltoid, following a physical examination. Concomitant therapy, that day, included the first TB test (tubersol) administered in the right forearm. There was no other concomitant medication. Two hours later, at 4pm on 07/11/2001, the pt experienced lightheadedness and dizziness, didn't feel well and thought she may pass out. She complained of feeling "weak and drained." The pt sought unspecified medical attention. It was reported that she did not require any hospitalization or further check-up. It was noted that she "felt better later on that evening." Subsequently, the symptoms resolved and the pt recovered on 07/12/2001. It was noted that neither the pt or a sibling experienced any adverse events following prior vaccinations. No further info is available.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Fatigue, Headache, Leukocytosis, Liver function test abnormal
Clinical narrative: Information has been received from a health professional concerning a "petite" 18 year old white female, with no medical history, known allergies, or known illness at the time of vaccination who on 30 May 2001 was vaccinated with the first 5 mcg dose of hepatitis b vaccine recombinant (yeast) (lot #635516/0426K [previously reported as lot #637847/1654K]), administered IM in the left deltoid following a physical exam. Concomitant therapy, that day, included the first TB test (one dose of tuberculin purified protein derivative) (TUBERSOL) (lot # C0824AA), administered in the left forearm. There was no other concomitant medication. Approximately 1 week later, on 06 JUN 2001 complaints of a headache, epigastric discomfort, feeling very weak, drained (fatigue), and "was sick" (malaise). Her mother reported that she got "very sick" and was "tired and run down". At that time, Epstein-Barr virus (EBV) panel was negative. The patient's symptoms continued for three weeks post vaccination. Blood work was re-drawn. Subsequently she tested positive for EBV and CMV. At that point in time, she was noted to have increased liver function tests (10 times normal) and evelated white blood count. Eight weeks post-vaccination, lab work was normal, she had no further symptoms, and she recovered. The treating physician assumed the initial symptoms were possibly from vaccination, as EBV panel was negative, and then the patient was exposed to EBV and CMV and had subsequent mono syndrome. It was also reported that another patient was vaccinated with hepatitis b vaccine recombinant (yeast), from the same lot (637847/1654K), and experienced similar events. The reporter expressed a concern with the lot. The records of testing prior to release of this lot (637847/1654K) have been checked by Biological Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Information has been received from a health professional concerning a "petite" 18 year old white female, with no medical history, known allergies, or known illness at the time of vaccination who on 30 May 2001 was vaccinated with the first 5 mcg dose of hepatitis b vaccine recombinant (yeast) (lot #635516/0426K [previously reported as lot #637847/1654K]), administered IM in the left deltoid following a physical exam. Concomitant therapy, that day, included the first TB test (one dose of tuberculin purified protein derivative) (TUBERSOL) (lot # C0824AA), administered in the left forearm. There was no other concomitant medication. Approximately 1 week later, on 06 JUN 2001 complaints of a headache, epigastric discomfort, feeling very weak, drained (fatigue), and "was sick" (malaise). Her mother reported that she got "very sick" and was "tired and run down". At that time, Epstein-Barr virus (EBV) panel was negative. The patient's symptoms continued for three weeks post vaccination. Blood work was re-drawn. Subsequently she tested positive for EBV and CMV. At that point in time, she was noted to have increased liver function tests (10 times normal) and evelated white blood count. Eight weeks post-vaccination, lab work was normal, she had no further symptoms, and she recovered. The treating physician assumed the initial symptoms were possibly from vaccination, as EBV panel was negative, and then the patient was exposed to EBV and CMV and had subsequent mono syndrome. It was also reported that another patient was vaccinated with hepatitis b vaccine recombinant (yeast), from the same lot (637847/1654K), and experienced similar events. The reporter expressed a concern with the lot. The records of testing prior to release of this lot (637847/1654K) have been checked by Biological Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a newborn 2 day old white female who on 12 JUL 2001 was vaccinated with a dose of hepatitis B vaccine recombinant (yeast) (Lot # 640031/0411L). Within one hour of being injected the patient developed "bumps" all over her body that looked like mosquito bites on her arms and one hour later the "bumps" disappeared. The physician reported that the patient recovered and that her experience was non-serious. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Information has been received from a female consumer (demographics unknown) who on 09 JUL 2001 was vaccinated with the first dose of hepatitis b vaccine recombinant (yeast) (Lot # 0327C - invalid). Approximately one half hour later, the patient developed an extreme headache, paine, felt weak, was very sensitive to light, and reported that her body felt like it was in slow motion. She reported that the physician gave her a shot, for pain, in the hip and that "this did help with some of the pain". She requested information about the vaccine and whether or not she should receive the next dose. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Photosensitivity reaction
Clinical narrative: Information has been received from a female consumer (demographics unknown) who on 09 JUL 2001 was vaccinated with the first dose of hepatitis b vaccine recombinant (yeast) (Lot # 0327C - invalid). Approximately one half hour later, the patient developed an extreme headache, paine, felt weak, was very sensitive to light, and reported that her body felt like it was in slow motion. She reported that the physician gave her a shot, for pain, in the hip and that "this did help with some of the pain". She requested information about the vaccine and whether or not she should receive the next dose. The patient sought unspecified medical attention. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue, Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a health professional concerning a 54 year old white female with a banana allergy and a penicillin allergy and a history of pallor and lightheadedness who on 12 JUL 2001 at 4 pm was vaccinated IM in the left deltoind (while sitting down) with a 1.0 mL second dose of hepatitis b vaccine recombinant (yeast) (lot # 639854/0672L). There were no illnesses at the time of vaccination or known adverse events following prior vaccinations. Immediately after being vaccinated (at 16:05) the patient complained of "feeling faint" and became quite pale. She sat quietly for a short time, took a walk, and reclined on the exercise mat for approximately 10 minutes. She drank a glass of grape juice and then stated she "felt better." Normal color had returned to her face and she stood and ambulated without apparent difficulty. She remained at the facility for observation another 10 minutes and then left. The patient stated that the first dose of hepatitis b vaccine recombinant (yeast) (MSD) had not produced any feelings of "faintness." it was reported that the patient recalled being "stiff" and perhaps more tired than usual for two days after the injection. It was reported that the injection site remained unremarkable and no respiratory distress was noted. It was noted that the patient has had the same feelings of feeling faint (lightheadedness) and pallor in the past when she donated blood. Follow up information has been received from the health professional reporting that the events resolved and that no adverse symptoms continue. No further information is available.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male child with no known allergies who on approximately 27 JUN 2001 was vaccinated with a first dose of Hepatitis B vaccine recombinant (yeast). On approximately 28 JUN 2001, 24-48 hours post dose, the child broke out in an itchy rash all over the trunk of his body. It was reported that the nurse said "it looks like an allergic reaction, but it is not hives." It was noted that the rash still persists. Unspecified medical attention was sought. Follow up information has been received and indicated that the reporter determined that the rash and the itchy allergic reaction were not related to the therapy with Hepatitis B vaccine recombinant (yeast). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Neuropathy, Sensory disturbance
Clinical narrative: Information has been received from a physician concerning a 44 year old female with intervertebral disc disorder. On 04/18/2001, the pt was vaccinated with hep b vaccine recombinant, polio, diphteria, tetanus and hep a. On 05/323/2001, the pt was vaccinated with the second dose hep b vaccine. On 07/13/2001, the p developed generalize sensory neuropathy described as
Age: 1.8
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 22 month old caucasian female with no past medical history and no known drug allergies who on 17 JUL 2001 was vaccinated with the third dose of hepatitis b vaccine recombinant (yeast) in the deltoid. There was no concomitant medication or illness at the time of vaccination. The physician reported that the patient was vaccinated by another physician from the same office and returned two days later, on 19 JUL 2001, with an injection site reaction. The site was hot, tender, red and about 2" x 3" in size. The patient had painful swelling of the deltoid muscle, about 5 cm across, with erythema and warmth. The patient sought unspecified medical attention. It was reported that the patient recovered on 21 JUL 2001. No further information is expected.
Sex: M
Vaccine: HEP
Symptoms: Angioneurotic oedema, Liver function test abnormal, Urticaria
Clinical narrative: Information has been received from a physician concerning a male with hepatic function abnormality (elevated liver function tests before his needle stick) and a history of needle stick in approximately July 1998. Subsequently, the patient was vaccinated prophylactically with one dose of hepatitis b vaccine recombinant (yeast) and hepatitis b immunoglobulin. In approximately November 1998, 4-5 months later, the patient was placed on zidovudine for prophylaxis (dosage, route, and duration not provided). The physician reported that since July 1998, the patient had developed angioedema and urticaria that had lasted 3 years. It was indicated that the patient had sought medical attention. No further information was provided. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Hypokinesia, Injection site pain, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female who on 24 JUL 2001 was vaccinated with Hepatitis B vaccine recombinant (yeast) 1 ml intramuscularly. On 25 JUL 2001 the patient developed soreness at the injection site. The patient stated that she cannot lift the affected arm all the way up and the arm feels heavy. Unspecified medical attention was sought. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 44 year old white female with no past medical history and no known drug allergies who received the complete series of Hepatitis B vaccine recombinant (yeast) "sometime in the past". The medical assistant reported that in approximately July 2001, a titer did not detect seroconversion. On 26 JUL 2001, the patient received an additional dose of Hepatitis B vaccine recombinant (yeast) (Lot # 638713/1820K) IM in the left arm. There were no illnesses at the time of vaccination. On 27 JUL 2001, the patient experienced an injection site reaction of redness, tenderness and swelling. The patient also experienced nausea and fatigue. Unspecified medical attention was sought. The medical assistant reported that the patient put aspirin crushed up, mixed with water on her arm "to take the fever out." The patient also put ice on her arm. The patient's pain and redness lasted approximately five days. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Nausea
Clinical narrative: Information has been received from a health professional concerning a 44 year old white female with no past medical history and no known drug allergies who received the complete series of Hepatitis B vaccine recombinant (yeast) "sometime in the past". The medical assistant reported that in approximately July 2001, a titer did not detect seroconversion. On 26 JUL 2001, the patient received an additional dose of Hepatitis B vaccine recombinant (yeast) (Lot # 638713/1820K) IM in the left arm. There were no illnesses at the time of vaccination. On 27 JUL 2001, the patient experienced an injection site reaction of redness, tenderness and swelling. The patient also experienced nausea and fatigue. Unspecified medical attention was sought. The medical assistant reported that the patient put aspirin crushed up, mixed with water on her arm "to take the fever out." The patient also put ice on her arm. The patient's pain and redness lasted approximately five days. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female who on 31 JUL 2001 was vaccinated with hepatitis b vaccine recombinant (yeast) in her upper right arm. A few days later, in August 2001, the patient experienced itching and developed a mild rash on her lower right arm only. The patient sought unspecified medical attention. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Fatigue, Influenza like illness, Malaise, Mononucleosis syndrome
Clinical narrative: Information has been received from a 43 year old male pharmacist with no known allergies or past medical history who on 07/16/2001 at 8:30am was vaccinated with the first dose of hep b vaccine recombinant IM in the left arm. There were no concomitant therapies. On 07/18/2001, the pt developed malaise, exhaustion, night sweat, fever of 102 F., cough, sore throat and general flu like symptoms. On 07/19/2001, the pt tested positive and diagnosed with mononucleosis. The symptoms were attributed to the Epstein-Barr virus. On 09/15/2001, the pt recovered from the mononucleosis. Additional info is not expected.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Night sweats, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a 43 year old male pharmacist with no known allergies or past medical history who on 07/16/2001 at 8:30am was vaccinated with the first dose of hep b vaccine recombinant IM in the left arm. There were no concomitant therapies. On 07/18/2001, the pt developed malaise, exhaustion, night sweat, fever of 102 F., cough, sore throat and general flu like symptoms. On 07/19/2001, the pt tested positive and diagnosed with mononucleosis. The symptoms were attributed to the Epstein-Barr virus. On 09/15/2001, the pt recovered from the mononucleosis. Additional info is not expected.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hypokinesia, Pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 36 year old male ER physician with no past medical history who in approx. the "1990's" was vaccinated wtih a series of hep b vaccine recombinant. Subsequently, the physician had a negative titer. In approximately the 1990's the physician was administered a booster dose of hep b vaccine recombinant. Subsequently, the physician had a positive titer. It was reported that in July 2001 the physician "was exposed to body fluids and a titer was negative." On 07/06/2001 the physician, at the age of 47 years old, was administered a second booster dose in the upper left deltoid of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 07/08/2001, two days after vaccination, the pt developed an ache in his left upper arm/shoulder and had difficulty raising his arm. It was noted that the shoulder pain lasted 3-4 weeks, and that the pt was improving and now had a full range of motion. Additional info has been requested.
Sex: F
Vaccine: HEP, YF
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from Glaxo Smith Kline for Engerix B and was assigned manufacturer control number 20010170491. A physician reported an event concerning a female adult patient with no known allergies who on 09 JUL 2001 was vaccinated with a second dose of hepatitis b vaccine recombinant (yeast). Concomitant therapy included a first dose of yellow fever virus vaccine live (YF-VAX). On 09 JUL 2001, approximately 45 minutes after the immunization, the patient experienced numbness and tingling of the palate. It was reported that the sensation came in waves of decreasing intensity and that it resolved "hours later" that night. It was reported that the patient had no adverse experience following her first injection of hepatitis b vaccine recombinant (yeast) (Engerix B). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Asthenia, Fatigue, Feeling abnormal
Clinical narrative: Information has been received from a 33 year old female with no past medical history and no known drug allergies who on 15 AUG 2001 was vaccinated with a dose of hepatitis b vaccine recombinant (yeast). Concomitant therapy that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD) and varicella virus vaccine live (site unknown) (MSD). Other concomitant therapy included unspecified steroids (manufacturer unknown). After being vaccinated, the patient began feeling tired and her head was "feeling heavy". It was reported that the patient's symptoms were "decreasing" since she received the vaccines. The patient sought unspecified medical attention. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal oedema, Rash, Tachycardia
Clinical narrative: Information has been received from a physician concerning a 42 year old female with a penicillin allergy and a bee sting allergy who on 02 MAY 2001 was vaccinated at her place of employment with a dose of hepatitis b vaccine recombinant (yeast) (lot # 630591/1735J). There were no concomitant medications or current illnesses. On approximately 02 MAY 2001, "not long after" vaccination, the patient experienced throat swelling and a rash. It was reported that the patient self-administered epinephrine (EPIPEN). The patient presented to an urgent care facility with an elevated pulse without angioedema or wheezing. The patient was administered IM diphenhydramine hyrochloride (Benadryl) and methylprednisolone sodium succinate (Solumedrol). It was noted that the patient recovered from her experience. The physician expressed a concern with the lot. No further information was available. Upon internal review, throat swelling was determined to be an other important medical event. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Loss of consciousness
Clinical narrative: Information has been received from a pharmacist concerning a 12 year old female, with a history of asthma and no known allergies, who on 08/28/2001 was vaccinated with the first dose of hep b vaccine recombinant. There was no concomitant medication. Immediately after vaccination, on 08/28/2001, the pt passed out and experienced a severe headache, that lasted a few minutes, at the same time. The pt sought unspecified medical attention. Additional info has been requested.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an 11 year old male with no known allergies who in approximately 2001, was vaccinated in the left deltoid with hep b vaccine recombinant. Concomitant therapy included a dose in the right deltoid of hep a vaccine. Other concomitant therapy included Concerta. It was reported on 08/31/2001 that the pt "now" has a rash all over the body. Unspecified medical attention was sought. Additional info has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with a codeine allergy who on 07/24/2001 was vaccinated with the first dose of hep b vaccine recombinant IM in the left deltoid at 4pm. On the same day at 4:30pm, she experienced numbness in the left arm, swelling from shoulder to fingers and the arm was very tender to touch. Ice was applied and the pt took diphenhydramine hydrochloride (Benadryl). The pt recovered by 07/26/2001 from her experience. Additional info has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hypoaesthesia, Injection site oedema, Myalgia, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning an approximately 24 year old female pt with a history of Guillain Barre syndrome and latex sensitivity who in 2000 was vaccinated with a three dose series of hep b vaccine. Subsequently, in approximately 2001, the pt had a negative anti-HBs titer. On 08/14/2001 was vaccinated with a booster dose of hep b vaccine recombinant. On 08/14/2001 the pt developed a very sore arm, injection site swelling in the arm, tingling and numbness in her fingers and a very high fever of 105 F. The pt was seen on 08/29/2001, for a follow-up, and her only complaints were some tingling and numbness in her fingers. The pt also told the nurse that "she always develops a fever after receiving a vaccination." Unspecified medical attention was sought. Additional info has been requested. Follow up info indicated that the pt has a history of "similar reactions to previous vaccines." It was also noted that she was paralyzed for 4.5 months from the neck down as a child and "subsequently develops fever with all vaccines." It was reported that the pt fuly recovered on 8/14/01.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning an approximately 24 year old female pt with a history of Guillain Barre syndrome and latex sensitivity who in 2000 was vaccinated with a three dose series of hep b vaccine. Subsequently, in approximately 2001, the pt had a negative anti-HBs titer. On 08/14/2001 was vaccinated with a booster dose of hep b vaccine recombinant. On 08/14/2001 the pt developed a very sore arm, injection site swelling in the arm, tingling and numbness in her fingers and a very high fever of 105 F. The pt was seen on 08/29/2001, for a follow-up, and her only complaints were some tingling and numbness in her fingers. The pt also told the nurse that "she always develops a fever after receiving a vaccination." Unspecified medical attention was sought. Additional info has been requested. Follow up info indicated that the pt has a history of "similar reactions to previous vaccines." It was also noted that she was paralyzed for 4.5 months from the neck down as a child and "subsequently develops fever with all vaccines." It was reported that the pt fuly recovered on 8/14/01.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Cognitive disorder, Confusional state, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female hospital employee who in approximately august 2001 experienced a lack of response after being vaccinated with a series of hep b vaccine recombinant. On 08/24/2001, the pt was vaccinated in the left arm with a booster dose of hep b vaccine recombinant. Subsequently, the pt developed shortness of breath, a fever of 99.4 F, confusion, change in cognitive status, lightheadedness and nausea. It was reported that pt also had numbness in her left arm. The pt was taken to the ER and was treated with an IV antihistamine. It was noted that the pt was not hospitalized. She was released from the ER. Subsequently, the pt recovered from shortness of breath, fever of 99.4 F, confusion, change in cognitive status, lightheadedness, nausea and numbness in left arm. It was reported that "now her only complaints are some alteration in cognitive status (some forgetfulness) and tightness and pressure in her neck." It was noted that her physician had her on restricted work, with no lifting allowed. Additionally, pt's alteration in cognitive status and tightness and pressure in her neck persisted. The pt's shortness of breath was considered by the reporter to be immediately life threatening. The tightness and pressure in her neck was considered by the reporter to be disabling. Additional info has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old female hospital employee who in approximately august 2001 experienced a lack of response after being vaccinated with a series of hep b vaccine recombinant. On 08/24/2001, the pt was vaccinated in the left arm with a booster dose of hep b vaccine recombinant. Subsequently, the pt developed shortness of breath, a fever of 99.4 F, confusion, change in cognitive status, lightheadedness and nausea. It was reported that pt also had numbness in her left arm. The pt was taken to the ER and was treated with an IV antihistamine. It was noted that the pt was not hospitalized. She was released from the ER. Subsequently, the pt recovered from shortness of breath, fever of 99.4 F, confusion, change in cognitive status, lightheadedness, nausea and numbness in left arm. It was reported that "now her only complaints are some alteration in cognitive status (some forgetfulness) and tightness and pressure in her neck." It was noted that her physician had her on restricted work, with no lifting allowed. Additionally, pt's alteration in cognitive status and tightness and pressure in her neck persisted. The pt's shortness of breath was considered by the reporter to be immediately life threatening. The tightness and pressure in her neck was considered by the reporter to be disabling. Additional info has been requested.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Lethargy
Clinical narrative: Information has been received on 09/10/2001 from a registered nurse concerning a female hospital volunteer who was vaccinated with the first, second, and third dose of hep b vaccine recombinant. The pt reported that after receiving the second dose she had been feeling tired since her first dose. After the third dose the pt became so tired that "she could not function enough to do her volunteer work." It was reported that the pt became "extremely lethargic." The pt sought unspecified medical attention. Additional info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 year old "healthy" female with migraines, chronic nausea and allergies to Ceclor, sulfa and bees who on 09/14/2001 at 4pm was vaccinated with a 2nd dose of hep B vaccine recombinant IM in the left deltoid. There was no concomitant medication. On 09/15/2001, the pt developed a red, raised arthus reaction that was 4 inches in diameter on her left arm. It was noted that the pt's whole shoulder was affected. The pt reported that the area is sore and swelling and worsening daily. Follow-up info from a registered nurse and the pt's medical records noted that the pt developed redness, swelling and tenderness to the left deltoid area. It was also noted as a large, red, raised, tender, hard area at the site of the hep B vaccine and as a questionable allergic reaction. The pt was seen in the physician's office on 09/19/2001 and an examination of the left deltoid revealed a slightly erythematous area. The swelling was noted to be down, it was less indurated and was still tender, although not as bad as it was the day before. The assessment was "an arthus-like reaction to the hep vaccine, somewhat unusual." It was noted that the outcome was unknown and there were no further complaints from the pts. It was also noted that the pt had chronic nausea according to the mother. It was reported that this seemed to have preceded the immunization. It was noted that at first they thought it might have been something else like the pt's migraines, but clearly that is not the problem. The assessment was chronic nausea probably gastroesophageal reflux and a set of gastroesophageal reflux disease instructions were give to the pt and her gastroenterology. The pt tolerated the first dose without reaction. No further info is available.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Information has been received from a woman in a physician's office concerning a 12 year old "healthy" female with migraines, chronic nausea and allergies to Ceclor, sulfa and bees who on 09/14/2001 at 4pm was vaccinated with a 2nd dose of hep B vaccine recombinant IM in the left deltoid. There was no concomitant medication. On 09/15/2001, the pt developed a red, raised arthus reaction that was 4 inches in diameter on her left arm. It was noted that the pt's whole shoulder was affected. The pt reported that the area is sore and swelling and worsening daily. Follow-up info from a registered nurse and the pt's medical records noted that the pt developed redness, swelling and tenderness to the left deltoid area. It was also noted as a large, red, raised, tender, hard area at the site of the hep B vaccine and as a questionable allergic reaction. The pt was seen in the physician's office on 09/19/2001 and an examination of the left deltoid revealed a slightly erythematous area. The swelling was noted to be down, it was less indurated and was still tender, although not as bad as it was the day before. The assessment was "an arthus-like reaction to the hep vaccine, somewhat unusual." It was noted that the outcome was unknown and there were no further complaints from the pts. It was also noted that the pt had chronic nausea according to the mother. It was reported that this seemed to have preceded the immunization. It was noted that at first they thought it might have been something else like the pt's migraines, but clearly that is not the problem. The assessment was chronic nausea probably gastroesophageal reflux and a set of gastroesophageal reflux disease instructions were give to the pt and her gastroenterology. The pt tolerated the first dose without reaction. No further info is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Hypernatraemia, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Eye disorder, Hypernatraemia, Hypoglycaemia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.