chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema
Clinical narrative: Left deltoid area swollen. No redness, no limited range of motion.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Feeling hot, Injection site oedema, Pyrexia
Clinical narrative: Mother reports took child to ER 1/15/05 PM for cellulitis lt upper arm, red swollen warm some fever also had a scratch on very upper arm, mom states unsure cause of cellulitis but find out which vaccines on left arm in case anything else happens. Was given antibiotics and applied warm clothes, much better now.
Age: 31.0
Sex: M
Vaccine: MEA, MMR
Symptoms: Unevaluable event
Clinical narrative: On 1/12/2005 pt received an MMR vaccination and a measles vaccination indifferent arms. After being called on 01/18/2005 by the person reviewing paperwork, the pt was called and notified. Pt stated he had not experienced any adverse reactions and was in usual health.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Developed hives (urticaria) 1 hr after immunizations. Also had ingested chocolate prior to vaccine administration which causes rashes.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Administered Hib#4, Prevnar#4, varicella#1, MMR #1, Within 1 minute child was covered with a red rash all over body.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash pustular
Clinical narrative: Generalized pustular lesions with heaviest concentration on left shoulder and arm and anterior bilat thighs. Referred for dermatology eval. Treated with antihistamine for pruritis.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Dyspnoea, Headache, Tremor
Clinical narrative: A 42 year old female patient experienced tremors, anxiety, shortness of breath and a headache while receiving RabAvert. The patient received intramuscular RabAvert in 4 doses from 06/11/02 to 06/26/02, as well as recombinant immune globulin in tow intra muscular injections on 06/11/02 and a Diphtheria Tetanus Toxoid intramuscular injection on 06/11/02. The subject had a history of gastric reflux disease and had recently sustained a dog bite. Concomitant medication consisted of Regelan. On 06/26/02 approximately 24 hours after the 4th injection of RabAvert, the patient reported tremors of her hands, neck and jaw. She also complained of shaky anxious feeling in her chest with some shortness of breath. On 07/11/02, she had a visit with her internist and reported that a headache occurred for approximately 24 hours after each dose of RabAvert. The tremors were reported as continuing at that time. The patient's medications were adjusted at the time and the tremors ceased within 24 hours. On 07/10/02, a rabies vaccine adsorbed titer was reported as high and additional RabAvert was held. The subject was considered recovered as of 08/06/02.
Age: 11.0
Sex: M
Vaccine: JEV, RAB
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: A 10 year old male patient had injection site redness, swelling and itching following treatment with RabAvert. His medical history included asthma. The patient had also received an injection of RabAvert at 9:30 p.m. for the first time that same day. That same day, the patient developed a local reaction of 10 cm of redness at the injection, with swelling and itching. These symptoms reportedly resolved.
Age: 1.52
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Apnoea, Convulsion, Cyanosis, Febrile convulsion, Pyrexia
Clinical narrative: From initial information received on 1/12/05 from a registered nurse regarding an adverse event occurring in the USA it was reported that an 18 month old male patient received his fourth dose of ACTHIB, lot number UE436AA, administered in the left thigh; a third dose of IPOL, lot number X1189, administered in the right thigh; and a fourth dose of TRIPEDIA, lot number U1290CA, administered in the right thigh at 10 AM on 1/10/05. The routes of administration were not reported. At 11 PM the same evening, the patient developed a fever of 104.2 degrees F and then experienced a generalized seizure at 1 AM on the morning of 1/11/05. The duration of the seizure was reported as minutes. The patient was not breathing and his lips turned blue. His parents called 911 and administered Epipen Jr in case the symptoms were related to the patient's peanut allergy. The child was taken to the ER and diagnosed as having had a febrile seizure. No testing was done in the ER. The patient recovered from these events. These events were considered life-threatening as per the reporter.  From additional information received on 07/Feb/2005 from a registered nurse. It was reported that all vaccines given on 10/Jan/2005 were administered intramuscularly by a certified medical assistant. It was also reported that the only symptom noted at the well child visit was eczema. Per the reporter, the child was treated at home by the ambulance crew with EPIPEN Jr and oxygen. The patient was transported to the hospital for evaluation and treatment. In the emergency room, he was given TYLENOL for his temperature. He was discharged to home and instructed to follow up with his primary care physician and to take TYLENOL as needed. He was seen by a his primary care physician on 11/Jan/2005 and was advised to alternate TYLENOL and ibuprofen for 48 hours. The patient was examined the following day by the emergency room physician as a follow up visit. There were no signs of his illness except mild diarrhea. The doctor recommended to hold TYLENOL/ADVIL treatment and observe the child. The patient's parents were educated regarding treatment for a febrile seizure. The child's physician will determine whether the child should receive pertussis at the age of five. The reporter also stated that there were no concerns regarding previous vaccines administered. No additional information is expected. This case is considered closed.
Age: 1.52
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Apnoea, Cyanosis, Eczema, Febrile convulsion, Pyrexia
Clinical narrative: From initial information received on 1/12/05 from a registered nurse regarding an adverse event occurring in the USA it was reported that an 18 month old male patient received his fourth dose of ACTHIB, lot number UE436AA, administered in the left thigh; a third dose of IPOL, lot number X1189, administered in the right thigh; and a fourth dose of TRIPEDIA, lot number U1290CA, administered in the right thigh at 10 AM on 1/10/05. The routes of administration were not reported. At 11 PM the same evening, the patient developed a fever of 104.2 degrees F and then experienced a generalized seizure at 1 AM on the morning of 1/11/05. The duration of the seizure was reported as minutes. The patient was not breathing and his lips turned blue. His parents called 911 and administered Epipen Jr in case the symptoms were related to the patient's peanut allergy. The child was taken to the ER and diagnosed as having had a febrile seizure. No testing was done in the ER. The patient recovered from these events. These events were considered life-threatening as per the reporter.  From additional information received on 07/Feb/2005 from a registered nurse. It was reported that all vaccines given on 10/Jan/2005 were administered intramuscularly by a certified medical assistant. It was also reported that the only symptom noted at the well child visit was eczema. Per the reporter, the child was treated at home by the ambulance crew with EPIPEN Jr and oxygen. The patient was transported to the hospital for evaluation and treatment. In the emergency room, he was given TYLENOL for his temperature. He was discharged to home and instructed to follow up with his primary care physician and to take TYLENOL as needed. He was seen by a his primary care physician on 11/Jan/2005 and was advised to alternate TYLENOL and ibuprofen for 48 hours. The patient was examined the following day by the emergency room physician as a follow up visit. There were no signs of his illness except mild diarrhea. The doctor recommended to hold TYLENOL/ADVIL treatment and observe the child. The patient's parents were educated regarding treatment for a febrile seizure. The child's physician will determine whether the child should receive pertussis at the age of five. The reporter also stated that there were no concerns regarding previous vaccines administered. No additional information is expected. This case is considered closed.
Sex: U
Vaccine: RAB
Symptoms: Immune system disorder, Laboratory test abnormal
Clinical narrative: A report was received that of a total number of people immunized with RabAvert as either a booster or pre-exposure prophylaxis, a large percentage of theses individuals did not have protective rabies antibody titer levels at tow years after immunization. We received additional information. Of a total 58 patients, 27 had initial DIA (dot immunobinding assay) test indication inadequate titers for antirabies protection in 2004 after primary series or booster vaccination in 2002 for pre exposure prophylaxis. An additional 13 patients had border line values. As the tests were performed with an unrecommended system, retesting was preformed using RFFIT ( rapid fluorescent focus inhibition test), as recommended. Upon retesting of all 58 patients, all but two had adequate antibody titers. One of these had received the primary series in the Philippines in the 1970's and had received on booster in 2002. He will be revaccinated. The other person had received the primary series in 2002 and showed neutralizing antibody level of ,1:5. This person will be boostered. Assessment: unchanged. OMIC
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Dyspnoea, Facial palsy, Hemiparesis, Hemiplegia, Injury
Clinical narrative: A 26 year old male patient (UA) experienced a neuroparalysis after receiving RabAvert therapy for post exposure prophylaxis. The patient received RabAvert in five doses beginning 05/03/04 and completing 06/03/04. He has no past medical history or concomitant medications. The patient suffered a dogbite on his hand on 04/30/04. On 05/0304, he presented to the emergency room and RabAvert therapy and human rabies immune globulin (HRIG) were initiated. A "routine blood test" at that time and rabies titer were negative. On 05/04/04, one day after the first dose of RabAvert and HRIG, the patient developed increased salivation and muscle twitching. In June 2004 the patient was seen again in the emergency department for the same symptoms, was told he may be suffering from stress and anxiety and he was released without treatment. The symptoms increased and later in June 2004, he developed swelling, weakness and slight paralysis on the right side of his body including his leg, arm, face and lip. The partial paralysis is described as a tightness on the right side of his body, aching of the muscles on the right side and weakness of the right side of his body. He also had a right lip droop, a right eye that "hurts to close", muscle jerking, weakness on the right side of his body and face, right side arm and leg swelling, decreased control of the right side of his face and difficulty breathing. He had no difficulty ambulating. The patient saw a neurologist on 07/08/04 and was told his reflexes were elevated and he was given a working diagnosis of a 7th cranial nerve problem versus encephalitis. The neurologist has scheduled him for an MRI and wants to do a computed tomography, electroencephalogram, lumbar puncture and more blood testing. Treatment was initiated with Prednisone in tapering doses and Valtrex as of 07/08/04. OMIC
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Muscle twitching, Myalgia, Neurological examination abnormal, Neurological symptom, Salivary hypersecretion
Clinical narrative: A 26 year old male patient (UA) experienced a neuroparalysis after receiving RabAvert therapy for post exposure prophylaxis. The patient received RabAvert in five doses beginning 05/03/04 and completing 06/03/04. He has no past medical history or concomitant medications. The patient suffered a dogbite on his hand on 04/30/04. On 05/0304, he presented to the emergency room and RabAvert therapy and human rabies immune globulin (HRIG) were initiated. A "routine blood test" at that time and rabies titer were negative. On 05/04/04, one day after the first dose of RabAvert and HRIG, the patient developed increased salivation and muscle twitching. In June 2004 the patient was seen again in the emergency department for the same symptoms, was told he may be suffering from stress and anxiety and he was released without treatment. The symptoms increased and later in June 2004, he developed swelling, weakness and slight paralysis on the right side of his body including his leg, arm, face and lip. The partial paralysis is described as a tightness on the right side of his body, aching of the muscles on the right side and weakness of the right side of his body. He also had a right lip droop, a right eye that "hurts to close", muscle jerking, weakness on the right side of his body and face, right side arm and leg swelling, decreased control of the right side of his face and difficulty breathing. He had no difficulty ambulating. The patient saw a neurologist on 07/08/04 and was told his reflexes were elevated and he was given a working diagnosis of a 7th cranial nerve problem versus encephalitis. The neurologist has scheduled him for an MRI and wants to do a computed tomography, electroencephalogram, lumbar puncture and more blood testing. Treatment was initiated with Prednisone in tapering doses and Valtrex as of 07/08/04. OMIC
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Swelling
Clinical narrative: A 26 year old male patient (UA) experienced a neuroparalysis after receiving RabAvert therapy for post exposure prophylaxis. The patient received RabAvert in five doses beginning 05/03/04 and completing 06/03/04. He has no past medical history or concomitant medications. The patient suffered a dogbite on his hand on 04/30/04. On 05/0304, he presented to the emergency room and RabAvert therapy and human rabies immune globulin (HRIG) were initiated. A "routine blood test" at that time and rabies titer were negative. On 05/04/04, one day after the first dose of RabAvert and HRIG, the patient developed increased salivation and muscle twitching. In June 2004 the patient was seen again in the emergency department for the same symptoms, was told he may be suffering from stress and anxiety and he was released without treatment. The symptoms increased and later in June 2004, he developed swelling, weakness and slight paralysis on the right side of his body including his leg, arm, face and lip. The partial paralysis is described as a tightness on the right side of his body, aching of the muscles on the right side and weakness of the right side of his body. He also had a right lip droop, a right eye that "hurts to close", muscle jerking, weakness on the right side of his body and face, right side arm and leg swelling, decreased control of the right side of his face and difficulty breathing. He had no difficulty ambulating. The patient saw a neurologist on 07/08/04 and was told his reflexes were elevated and he was given a working diagnosis of a 7th cranial nerve problem versus encephalitis. The neurologist has scheduled him for an MRI and wants to do a computed tomography, electroencephalogram, lumbar puncture and more blood testing. Treatment was initiated with Prednisone in tapering doses and Valtrex as of 07/08/04. OMIC
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Drug ineffective
Clinical narrative: A 56 year old male pt experienced inadequate rabies antibody titers while receiving RabAvert therapy. The pt received an initial series of RabAvert in 2002 for pre exposure prophylaxis along with a Hep B vaccination series. He was administered a booster series of RabAvert injections on 13Jan04, 20Jan04 and 13Feb04 for pre exposure prophylaxis. The pt had no past medical history and takes no concomitant medications. On 28Jun04 an enzyme linked immunosorbent assay (ELISA) test was performed with a result of less than 0.5. The physician assigned to his work area and was informed that the level indicated an inadequate antibody titer. The treatment plan was for the pt to have another RabAvert booster and then a Rapid Fluorescent Focus Inhibition Test (RFFIT) will be performed.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Hypoaesthesia, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: A 24 year old female patient experienced injection site reaction and acute neurological symptoms after treatment with RabAvert for pre-exposure prophylaxis. The patient received three doses of RabAvert on day 0, 3, and 28 (dates unspecified). Her past medical history and concomitant medications were unspecified. The patient tolerated her first and second dose (day 0 and 3) of RabAvert with minimal injection site reaction of localized tenderness and redness lasting for 2 days following each vaccination. Within 10 minutes after her third vaccination (day 28), the patient complained of numbness and tingling in hands, going up both arms, then down to her knees, along with myalgia and joint pain. No cardiovascular or respiratory symptoms were noted.  The acute neurological symptoms were treated with epinephrine, Benadryl, and Solu-Medrol. Her symptoms progressed and she was unable to lift her legs off the bed. A neurology consult was obtained and resulted in non-specific conclusion. The neurologist noted that the patient's symptom did not follow a specific dermatome distribution. The patient was admitted for overnight observation. Her symptoms resolved by the next morning and she was discharged home.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Injection site reaction, Myalgia, Nervous system disorder, Paraesthesia
Clinical narrative: A 24 year old female patient experienced injection site reaction and acute neurological symptoms after treatment with RabAvert for pre-exposure prophylaxis. The patient received three doses of RabAvert on day 0, 3, and 28 (dates unspecified). Her past medical history and concomitant medications were unspecified. The patient tolerated her first and second dose (day 0 and 3) of RabAvert with minimal injection site reaction of localized tenderness and redness lasting for 2 days following each vaccination. Within 10 minutes after her third vaccination (day 28), the patient complained of numbness and tingling in hands, going up both arms, then down to her knees, along with myalgia and joint pain. No cardiovascular or respiratory symptoms were noted.  The acute neurological symptoms were treated with epinephrine, Benadryl, and Solu-Medrol. Her symptoms progressed and she was unable to lift her legs off the bed. A neurology consult was obtained and resulted in non-specific conclusion. The neurologist noted that the patient's symptom did not follow a specific dermatome distribution. The patient was admitted for overnight observation. Her symptoms resolved by the next morning and she was discharged home.
Sex: M
Vaccine: RAB
Symptoms: Injury, Pruritus, Rash
Clinical narrative: 5A Male pt developed generalized rash and pruritus following prophylactic vaccination and inoculation against rabies. He was being treated for an animal bite from a dog that had been bitten by a raccoon. The pt received RabAvert on 03Nov03, and HRIG on 04Nov03. He received HRIG on 03Nov03 as well. He developed a full body rash with pruritus on 04Nov03. It was unk if the rash had resolved at the time of the report.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Pruritus, Rash, Rash papular
Clinical narrative: A 20 year old female pt developed a full body rash following RabAvert admin. She received her first dose of RabAvert on an unk date and the second dose on 17Nov03. Concomitant medication included oral contraceptives. The pt has no past medical or surgical history. No adverse events were reported after the first dose of RabAvert. On 19Nov03, two days after the second RabAvert dose, she developed a full body rash with severe itching. The rash was described as red and papular and present on her back, arms and most dense on the abdomen and upper thighs. Steroids were given for treatment. Follow up received 13Jan04: the first dose of RabAvert was given on 10Oct03 and the second dose on 17Oct03. She developed an intensely itchy rash on her lower abdomen and legs on 19Oct03. Three to four weeks later, the event resolved.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Hypoaesthesia, Lethargy, Nausea, Paraesthesia
Clinical narrative: A 20 year old female pt received her first dose of RabAvert for preexposure series into left deltoid on 02Dec03. Approx 1-1.5 hours later, she c/o nausea, lethargy, tingling left arm, left side of chest, numbness left arm which lasted about 3 hours (particularly nausea). Observation during this time found pt to be in no acute distress (NAD) and neuro exam to be within normal limits. The pt left the clinic with only mild paraesthesia left arm. Additional information received on 03Dec03: The pt was contacted by her health care provider on 03Dec03. The pt stated she had completely recovered.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Agitation, Asthenia, Dizziness, Headache
Clinical narrative: A 13 year old male pt experienced limb pain and numbness, weakness, agitation, faintness, headache, stomach ache and fever after receiving RabAvert therapy. The pt received four doses of RabAvert (lot 323011, expiration date Apr06), the first on 20Nov03, second on 24Nov03, third on 28Nov03 and the fourth on 05Dec03. On 20Nov03 after his first dose of RabAvert in the left gluteus, he experienced left arm pain and numbness which resolved prior to leaving the physician office. On 24Nov03 he received his second RabAvert dose in the deltoid and BayGam around the site of the wound and the rest in the right gluteus. The pt was to received BayRab but BayGam was administered instead. On 25Nov03 he felt rather bad with weakness, sort of hyper, kind of faint feeling, headache and stomach ache. Fever developed in the evening and he did not feel well. He required no treatment medications or medical intervention and was fully recovered on 26Nov03. On 28Nov03 he received his third RabAvert dose and BayRab. That day he experienced agitation which was resolved by the next morning. Follow up received 30Dec03 and 02Jan04: Additional information provided by the physicians office. Site of wound: finger. The fifth dose of RabAvert given 19Dec03 with no adverse reactions. All RabAvert doses were 1ml, administered IM. On 11Dec03 the Rabies Antibody titer: 5.17 (norm: >or=0.50 post vaccine). The pt has recovered completely.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Injection site pain, Malaise, Medication error, Psychomotor hyperactivity
Clinical narrative: A 13 year old male pt experienced limb pain and numbness, weakness, agitation, faintness, headache, stomach ache and fever after receiving RabAvert therapy. The pt received four doses of RabAvert (lot 323011, expiration date Apr06), the first on 20Nov03, second on 24Nov03, third on 28Nov03 and the fourth on 05Dec03. On 20Nov03 after his first dose of RabAvert in the left gluteus, he experienced left arm pain and numbness which resolved prior to leaving the physician office. On 24Nov03 he received his second RabAvert dose in the deltoid and BayGam around the site of the wound and the rest in the right gluteus. The pt was to received BayRab but BayGam was administered instead. On 25Nov03 he felt rather bad with weakness, sort of hyper, kind of faint feeling, headache and stomach ache. Fever developed in the evening and he did not feel well. He required no treatment medications or medical intervention and was fully recovered on 26Nov03. On 28Nov03 he received his third RabAvert dose and BayRab. That day he experienced agitation which was resolved by the next morning. Follow up received 30Dec03 and 02Jan04: Additional information provided by the physicians office. Site of wound: finger. The fifth dose of RabAvert given 19Dec03 with no adverse reactions. All RabAvert doses were 1ml, administered IM. On 11Dec03 the Rabies Antibody titer: 5.17 (norm: >or=0.50 post vaccine). The pt has recovered completely.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A 13 year old male pt experienced limb pain and numbness, weakness, agitation, faintness, headache, stomach ache and fever after receiving RabAvert therapy. The pt received four doses of RabAvert (lot 323011, expiration date Apr06), the first on 20Nov03, second on 24Nov03, third on 28Nov03 and the fourth on 05Dec03. On 20Nov03 after his first dose of RabAvert in the left gluteus, he experienced left arm pain and numbness which resolved prior to leaving the physician office. On 24Nov03 he received his second RabAvert dose in the deltoid and BayGam around the site of the wound and the rest in the right gluteus. The pt was to received BayRab but BayGam was administered instead. On 25Nov03 he felt rather bad with weakness, sort of hyper, kind of faint feeling, headache and stomach ache. Fever developed in the evening and he did not feel well. He required no treatment medications or medical intervention and was fully recovered on 26Nov03. On 28Nov03 he received his third RabAvert dose and BayRab. That day he experienced agitation which was resolved by the next morning. Follow up received 30Dec03 and 02Jan04: Additional information provided by the physicians office. Site of wound: finger. The fifth dose of RabAvert given 19Dec03 with no adverse reactions. All RabAvert doses were 1ml, administered IM. On 11Dec03 the Rabies Antibody titer: 5.17 (norm: >or=0.50 post vaccine). The pt has recovered completely.
Age: 59.0
Sex: F
Vaccine: RAB, YF
Symptoms: Arthralgia, Arthropathy, Dysphagia, Mouth ulceration, Tongue oedema
Clinical narrative: A 50 year old female patient experienced swelling of the tongue, difficulty swallowing and small ulcerations on her tongue, approximately 5 days after the 2nd dose of RabAvert. On day 9 after the second dose, the patient suffered severe pain and inflammation of the right hip for 2 days. The patient received the second of RabAvert 1ml intramuscularly on 11/19/03 with a yellow fever vaccine. On 11/1/03, the first dose of RabAvert was given with oral typhoid fever capsules, Hepatitis A vaccine and Engerix (Hepatitis B vaccine) without any problems. Follow up received 12/17/03: Early on 11/19/03, the day of the second RabAvert dose, the patient had an extensive orthodontic appointment involving both upper and lower teeth and jaws to complete the correction of temporomandibular joint dysfunction. The ulcer type lesions described in her mouth were merely reddening sore spots resulting from the dental work. She explained the difficulty in swallowing and a swollen tongue was "soreness/dryness" due to frequent suctioning. The patient added after her 11/19/03 vaccinations, she sent to out of town and slept on a sofa. The only medication she took for the hip pain was Ibuprofen. Claims she has completely recovered from all the symptoms and did not associate them with her vaccinations nor did she seek or need medical care. The patient indicated she did not associate the symptoms she experienced with any of her vaccinations. Follow up received on 01/23/04: The patient received her third and final RabAvert vaccination along with a Polio booster and a Yellow fever vaccination without any problems on 12/22/03.
Age: 59.0
Sex: F
Vaccine: RAB, YF
Symptoms: Tongue ulceration
Clinical narrative: A 50 year old female patient experienced swelling of the tongue, difficulty swallowing and small ulcerations on her tongue, approximately 5 days after the 2nd dose of RabAvert. On day 9 after the second dose, the patient suffered severe pain and inflammation of the right hip for 2 days. The patient received the second of RabAvert 1ml intramuscularly on 11/19/03 with a yellow fever vaccine. On 11/1/03, the first dose of RabAvert was given with oral typhoid fever capsules, Hepatitis A vaccine and Engerix (Hepatitis B vaccine) without any problems. Follow up received 12/17/03: Early on 11/19/03, the day of the second RabAvert dose, the patient had an extensive orthodontic appointment involving both upper and lower teeth and jaws to complete the correction of temporomandibular joint dysfunction. The ulcer type lesions described in her mouth were merely reddening sore spots resulting from the dental work. She explained the difficulty in swallowing and a swollen tongue was "soreness/dryness" due to frequent suctioning. The patient added after her 11/19/03 vaccinations, she sent to out of town and slept on a sofa. The only medication she took for the hip pain was Ibuprofen. Claims she has completely recovered from all the symptoms and did not associate them with her vaccinations nor did she seek or need medical care. The patient indicated she did not associate the symptoms she experienced with any of her vaccinations. Follow up received on 01/23/04: The patient received her third and final RabAvert vaccination along with a Polio booster and a Yellow fever vaccination without any problems on 12/22/03.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: A 26 year old female patient experienced faintness, lightheadedness, headache and nausea, one hour after receiving RabAvert. Two hours later, the patient returned to see the nurse with complaints of sweating. At that time she had no fever, shortness of breath or change in blood pressure, but was flushed. The patient was a veterinary student who was getting pre exposure prophylaxis. The patient received the second of three doses of RabAvert on 02/02/04. No further details are available at this time.
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Hypokinesia, Injection site pain
Clinical narrative: A female pt developed pain in the left deltoid and shoulder and numbness in the shoulder area after receiving RabAvert. The pt received five dose of RabAvert for post exposure prophylaxis. She complained of pain following injection into her left deltoid. Subsequently, doses three and four were administered into the gluteal area. Pain and numbness were also noted in the shoulder area, which had persisted for one year after RabAvert injections. The reporting physician stated the events were not related to RabAvert. He noted the subject may have a mechanical problem with her arm, causing the symptoms.
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: A 16 year old female pt experienced post exertional fatigue (with symptoms being very tired and needing to sleep more), headache, swollen glands, and shortness of breath after receiving RabAvert for post exposure vaccination (a bat in the house). Concomitant medications included Imovax, human immunoglobulins anti rabies (HRIG), and oral contraceptives. The pt reported the events one day after receiving the fourth dose of rabies vaccine on 19Feb04. The pt received her first dose of rabies vaccine (IMOVAX) and human immunoglobulin anti rabies (HRIG) on 05Feb04. The three subsequent doses on 08Feb04, 12Feb04 and 19Feb04 were with RabAvert. The physician assessed the events as being related to the drug. Follow up information received on 17Mar04: The onset latency for fatigue was changed from 13 days to 1 day. The onset latency for headache, lymphadenopathy and dyspnea was changed from 15 days to 12 days. On 19Feb04 headache, swollen glands and shortness of breath were reported.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Dysgeusia, Injection site pain, Injury, Paraesthesia, Sinus congestion
Clinical narrative: A female pt with exposure to rabies through a dog bite, developed pain in the right and left hip after vaccination with RabAvert. Concomitant medications included Elavil and Diovan. The pt described taking a rabies vaccine which may have been RabAvert about one and a half years ago for exposure to rabies through a dog bite. She was treated with five shots the first day and then received at least four more over approx a month. The end of the course was Jul02. In Aug02, she began to notice pain in both of her hips, which lasted about four to five months and spontaneously remitted. Also around Aug02, she developed an extremely salty taste and a feeling of dripping into her throat. The pt had seen a dentist, periodontist, primary care physician, neurologist and ear, nose and throat specialists. She has had a brain MRI, sinus scans, salivary gland biopsy and kidney tests all of which were normal or negative. The pt also complained of intermittent tingling of legs and feet that lasts a few minutes.  Follow up received 24May04: The pt is a 55 year old female with a past medical history of hypertension and allergy to penicillin, tetracycline, Minocin, Ampicillin and tetanus. The pt received a dog bite on 24Jun02. On 24Jun02, she was administered RabAvert with immunoglobulin and prescribed erythromycin. Subsequent vaccination dates were administered on 27Jun02, 01Jul03, 08Jul02 and 22Jul02. On 08Jul02, the subject received 0.5ml RabAvert IM and on all other dates a 1 mL injection was administered IM. On 01Jul02 no adverse reactions had been reported but it was noted the pt's right calf was bruised. On 08Jul02, the pt's leg wound seemed better with less bruising. She complained of stomach upset with erythromycin. Approx two to three weeks later after the last dose, she noted arthritic symptoms in the joints which were more prominent on the hip area. Work up results for Lyme's disease and Sjogrens disease were negative. Laboratory results for thyroid and urinalysis and MRI of the hip were negative. About four months later, the arthritic symptoms in the hip abated but the salty taste remained.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Abscess, Anaphylactic reaction, Headache, Liver function test abnormal, Malaise
Clinical narrative: A 58 year old female pt was given RabAvert approx two years ago for a dog bite. Past medical history was significant for allergy to antibiotics. The pt had asked her physician if the RabAvert contained antibiotics. The pt also stated that she told the doctor she had a history of allergy to all antibiotics. After the first immunization on 10Apr02, she did not feel right. After the second injection, she developed an anaphylactic reaction and was seen by an immunologist who told her to discontinue the series. At some point after that, the pt developed immune symptoms which have continued to the present, including headache, abnormal liver function tests, and open sores that wont heal. She was being followed by an immunologist at the time of the report.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Injection site oedema, Lymphadenitis, Rhinorrhoea
Clinical narrative: A 44 year old female pt experienced severe lymphadenitis of the left axilla and a swollen left arm after receiving her second dose of RabAvert for prophylactic vaccination. The pt received her first dose on 24Feb04 with no reported problems. She received her second dose on 03Mar04 and within twenty four hours the pt experienced the lymphatic problems along with a runny nose. The symptoms resolved within three to four days with no further complaints. No further details were currently available at the time of the report. Follow Up received 30Apr04: The physician reported the pt experienced pain and swelling of injection site that extended to the axilla. He provided the injection route (IM) and dates. Three doses given two weeks and three weeks apart, starting 24Feb04, 03Mar04 and 23Mar04. The pt had a complete recovery.
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Diarrhoea, Headache, Influenza like illness
Clinical narrative: A female pt (age unspecified) experienced headache, belly ache, and mild diarrhea after receiving RabAvert for post exposure vaccination. Less than forty eight hours after receiving her first dose of RabAvert on 16Mar04, she experienced flu symptoms of headache, bellyache and mild diarrhea. The symptoms were ongoing at the time of the report.
Sex: F
Vaccine: RAB
Symptoms: Visual disturbance
Clinical narrative: A female pt developed lightening flashes in her eyes following a RabAvert booster vaccination. The pt received a booster vaccination on 30Mar04. On 01Apr04, the pt experienced lightning flashes, increased disturbances from overhead lights, television watching and computer screens. Followed up received 15Apr04: Pt/Reporter provided additional information regarding the numbers of booster injections and the dates. The pt had received three sets (two each booster injections) within the prior six months. The first set of booster injections started on 03Nov03, the second set on 04Feb04 and the final set begin on 30Mar04. The reporter did not know the lot numbers. The pt's relevant medical history included breath cancer, now in remission for greater than eighteen years. The flash vision continued with rare frequency.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Headache, Listless, Neck pain, Pharyngolaryngeal pain
Clinical narrative: A 4 year old male pt with exposure to a bat, developed fever, neck pain, sore throat, headache, stomach ache and listlessness following treatment with RabAvert. He received on dose of RabAvert. No visible bites had been seen on the child however, post exposure prophylaxis was started by the local ER staff. On 02Apr04, the pt had two immunizations of Imovax in the arm. Three days later (day 3), he had another dose in the arm. Prior to getting the third dose (day 7), the pt was switched to RabAvert. IM RabAvert was given. On 09Apr04, the pt developed a fever (102F) and stated his neck hurt, he complained of a sore throat, headache, stomach hurting and was listless according to parents. The pt's mother telephoned the pediatrician who said to observe. The next day the pt was perkier, but continued to not be himself. The pt was planned to received the entire series at the pediatrician's office despite the adverse events. Follow up received 10May04: The pt has no symptoms or complaints from previous vaccines or the possible exposure. He received his third rabies vaccine with RabAvert, 1mL, IM in the right deltoid on 09Apr04. Twenty-four hours later, he recovered from the events.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A 4 year old male pt with exposure to a bat, developed fever, neck pain, sore throat, headache, stomach ache and listlessness following treatment with RabAvert. He received on dose of RabAvert. No visible bites had been seen on the child however, post exposure prophylaxis was started by the local ER staff. On 02Apr04, the pt had two immunizations of Imovax in the arm. Three days later (day 3), he had another dose in the arm. Prior to getting the third dose (day 7), the pt was switched to RabAvert. IM RabAvert was given. On 09Apr04, the pt developed a fever (102F) and stated his neck hurt, he complained of a sore throat, headache, stomach hurting and was listless according to parents. The pt's mother telephoned the pediatrician who said to observe. The next day the pt was perkier, but continued to not be himself. The pt was planned to received the entire series at the pediatrician's office despite the adverse events. Follow up received 10May04: The pt has no symptoms or complaints from previous vaccines or the possible exposure. He received his third rabies vaccine with RabAvert, 1mL, IM in the right deltoid on 09Apr04. Twenty-four hours later, he recovered from the events.
Age: 1.58
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: A 19 month old female pt exposed to a bat, developed a fever following treatment with RabAvert. On day 0, the pt received one immunization in the buttock and one in the arm. On day three, she received another vaccination in the buttock. Both vaccinations were Imovax. RabAvert was initiated on day 7 and the pt developed a fever of 102 degrees F. The next day, the mother reported that the pt was fine. Follow Up received 10May04: The pt had no symptoms or complaints from previous vaccines or the possible exposure. She received her third rabies vaccine with RabAvert, 1mL, Im on the right thigh on 09Apr04. She became febrile, tired and lethargic. Twenty four hours later, she recovered.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: A female of unk age developed localized injection site tenderness, generalized muscle aches, fever, chills, headache, nausea, and low back pain after immunization with RabAvert. After receiving the second dose of a 3 dose series immunization of RabAvert on day 7th of immunization, 22Apr04, the pt complained of the aforementioned symptoms. Currently, adverse experiences are persisting, and limited information is available. Additional information received: 04May04 in additional to the initial reported adverse events, pt also experienced fatigue. Pt's medical history included possible allergic reaction to childhood immunization. Further clarification of events were obtained. Pt received first dose of RabAvert on 14Apr04 followed by second dose on 22Apr04. Twenty four hours post immunization, on 23Apr04, the pt experienced the aforementioned symptoms. Pt received treatment with Advil, and all adverse drug reactions were completely resolved on 25Apr04. Pt was to received final immunization later.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pyrexia, Tenderness
Clinical narrative: A female of unk age developed localized injection site tenderness, generalized muscle aches, fever, chills, headache, nausea, and low back pain after immunization with RabAvert. After receiving the second dose of a 3 dose series immunization of RabAvert on day 7th of immunization, 22Apr04, the pt complained of the aforementioned symptoms. Currently, adverse experiences are persisting, and limited information is available. Additional information received: 04May04 in additional to the initial reported adverse events, pt also experienced fatigue. Pt's medical history included possible allergic reaction to childhood immunization. Further clarification of events were obtained. Pt received first dose of RabAvert on 14Apr04 followed by second dose on 22Apr04. Twenty four hours post immunization, on 23Apr04, the pt experienced the aforementioned symptoms. Pt received treatment with Advil, and all adverse drug reactions were completely resolved on 25Apr04. Pt was to received final immunization later.
Age: 4.0
Sex: M
Vaccine: RAB
Symptoms: Lethargy, Musculoskeletal stiffness, Neck pain, Pyrexia, Vomiting
Clinical narrative: A 4 year old boy developed a fever after receiving his third RabAvert immunization. The mother of the pt described finding the child holding a bat, that later tested positive for rabies. On 03May04, the pt started post exposure prophylaxis therapy. Eight hours after the third immunization with RabAvert, the pt developed a fever 99.8 F, vomited once and complained of a stiff neck. The pt was taken to ER, where a complete blood count was drawn, analyzed and found to be normal. He was released home. Later the mother remembered she had forgotten to give the pt Tylenol after the third immunization, which she had done previously for the first two immunizations. In addition, she realized the pt had fallen asleep in his father's lap in a strange position and awakened with a complaint of a stiff neck. Follow up received 21May04: The pt is doing fine. He is scheduled for his final vaccination 28May04. Follow up received 18Oct04: The mother reported additional events of lethargy, sore neck and described the previously reported fever as high temperature. The lot number was provided. The date of 03May04 of the first RabAvert injection could not be verified.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Bursitis, Myalgia, Neck pain
Clinical narrative: A 44 year old male experienced myalgia, arthralgia, or bursitis after receiving his second immunization of RabAvert for preexposure prophylaxis. The pt received his first dose of RabAvert (1ml, IM) on 10May04, followed by a second dose (1ml, IM) on 17May04. The pt's medical history was non-contributory. He had no known drug allergies and was not on any concomitant medications. On 10May04, the pt received his first vaccination with RabAvert and tolerated without any difficulties. On 17May04, one hour and twenty minutes and administration of the second dose of RabAvert, the pt complained of pain in his neck, right shoulder, and upper spine area. The pt was rated as a 2 out of 10 on a pain scale (1 least painful, 10 most painful). On the evening of 17May04, the pt had increased to a 10 out of 10. On 20May04, the pt was medically assessed and was prescribed Ibuprofen for treatment. At this time, the pt had improved to 2 out of 10 on the pain scale. The pt's physician felt that the pain was myalgia, arthralgia, or bursitis due to RabAvert.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Malaise, Myalgia, Pyrexia, Tenderness
Clinical narrative: A 38 year old female pt developed muscle pain, low grade fever, aches and malaise after receiving RabAvert therapy for prophylactic vaccination. The pt received the first dose of RabAvert 1ml IM on 21May04. Within twenty four hours of receiving the RabAvert, the pt developed local muscle pain, low grade fever (99.9F), general aches and malaise. On 25May04, the pt noticed that her supraclavicular lymph nodes were tender, swollen and enlarged 2-3cm in size. No additional information was available at the time of the report. Follow up received 22Jun04: The pt's date of birth was 21Feb04. Events began approx twenty four hours after receiving the second dose. Lymphadenopathy Subclavicular on the same side (left ) of the last injection was noted. Several other lymph nodes were noted and enlarged in the same general area and all were tender. The event subsided over a few weeks. The pt did not received the third and final dose in the series. Lot numbers nor expiration dates were provided.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Fatigue, Injury, Muscle spasms, Muscular weakness
Clinical narrative: A 52 year old female pt developed increased muscle weakness and fatigue, muscle spasms and pain on inspiration after receiving RabAvert therapy. The pt received RabAvert on the following dates: 21May04, 24May04, 28May04 and 04Jun04. Past medical history consisted of systemic lupus erythematous and hypertension. The pt also has a history of weakness, fatigue and muscle spasms at night, prior to starting RabAvert. About one month ago and prior to the 1st RabAvert injection, the pt developed pain on inspiration described as it hurt to breathe, self treated with two days of penicillin she already had at home. Concomitant medications included Plaquinil, Dextra, Spironolactone and Topral (Topral discontinued two weeks ago). The pt sustained a bite from a feral kitten and was treated with 4 out of 5 doses of RabAvert at a clinic with a fifth dose scheduled, as well as planned testing for a titer. The pt experienced increased weakness and fatigue after starting RabAvert as well as muscle spasms in her arms and legs. The weakness and fatigue are described as a rubbery, pre flu-like achiness. The muscle spasms occur occasionally and are described as not severe and like flutters. They are now occurring under the left shoulder blade and on her left side. The difficulty breathing, described as hurts to breathe, had reoccurred a few days prior to the report. An initial visit to see her rheumatologist for this problem was planned for the following day. The events had not improved at the time of this report.