chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Lethargy, Vomiting
Clinical narrative: Patient had Rotateq on 9/29/06 and 12/8/06 and was diagnosed with intussusception on 12/20/06. Patient's symptoms were vomiting and lethargy.  It was reduced with a barium enema.  She is undergoing a UGI with small bowel follow through today to rule out malrotation.  2/5/07 Received medical records from hospital which reveal patient experienced vomiting & lethargy for 5 days & was admitted to hospital 12/20/06-12/21/06.  Exam revealed patient was dehydrated.  IS was suspected, successfully reduced & patient was admitted for overnight observation s/p reduction due to possibility of malrotation or mobile cecum.  Ped surgery consult done FINAL DX: Intussusception, reduced by BE.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: REDNESS SWELLING AND PAIN AT SITE OF INJECTION LARGE WEAL MEASURING 7X 8CM AT SITE OF INJECTION NAUSEA VOMITING FEVER AND CHILLS
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria, Vomiting
Clinical narrative: REDNESS SWELLING AND PAIN AT SITE OF INJECTION LARGE WEAL MEASURING 7X 8CM AT SITE OF INJECTION NAUSEA VOMITING FEVER AND CHILLS
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Coordination abnormal, Feeling abnormal, Feeling hot, Headache, Muscle contractions involuntary
Clinical narrative: Reported warmth of right upper extremity after vaccine given.  States "feeling weird" within 24 hrs. of vaccine.  On 12/20, approx. 1923 hrs. presented to the ER with twitching, fasciculations of the facial muscles, ataxia, vertigo, severe headaches with photophobia and "feeling weird".
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Muscle twitching, Photophobia, Vertigo
Clinical narrative: Reported warmth of right upper extremity after vaccine given.  States "feeling weird" within 24 hrs. of vaccine.  On 12/20, approx. 1923 hrs. presented to the ER with twitching, fasciculations of the facial muscles, ataxia, vertigo, severe headaches with photophobia and "feeling weird".
Age: 47.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, FLU3, HEPAB, TDAP
Symptoms: Asthenia, CSF test abnormal, Demyelination, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Initial information received from Centers for Disease Control and Prevention on 14 November 2006. A 47 year old female patient received a dose of Adacel, lot number C2384AA, a dose of Fluzone SV2006-2005 USP, lot number U1763AA, and a dose of Twinrix (lot number AHABB079BA) on 05 December 2005. Concomitant medication included Rhinocort. 35 days post vaccination, on 11 January 2006, the patient developed asthenia, paresthesias, urinary incontinence, fecal incontinence, and decreased reflexes. She also had injection site inflammation at an unspecified injection site. The patient was admitted to the hospital on 13 January 2006 with acute inflammatory demyelinating polyneuropathy. A lumbar puncture showed albumino-cytologic dissociation. The patient was diagnosed with Guillain Barre Syndrome. No information was provided regarding treatment. The patient recovered from the events on 24 February 2006. The reporter of this case considered the events to be life threatening. Relevant Test/Laboratory Data: LP results showed albumino-cytologic dissociation.
Age: 47.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, FLU3, HEPAB, TDAP
Symptoms: Inflammation, Laboratory test abnormal, Paraesthesia, Polyneuropathy
Clinical narrative: Initial information received from Centers for Disease Control and Prevention on 14 November 2006. A 47 year old female patient received a dose of Adacel, lot number C2384AA, a dose of Fluzone SV2006-2005 USP, lot number U1763AA, and a dose of Twinrix (lot number AHABB079BA) on 05 December 2005. Concomitant medication included Rhinocort. 35 days post vaccination, on 11 January 2006, the patient developed asthenia, paresthesias, urinary incontinence, fecal incontinence, and decreased reflexes. She also had injection site inflammation at an unspecified injection site. The patient was admitted to the hospital on 13 January 2006 with acute inflammatory demyelinating polyneuropathy. A lumbar puncture showed albumino-cytologic dissociation. The patient was diagnosed with Guillain Barre Syndrome. No information was provided regarding treatment. The patient recovered from the events on 24 February 2006. The reporter of this case considered the events to be life threatening. Relevant Test/Laboratory Data: LP results showed albumino-cytologic dissociation.
Age: 47.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP, FLU3, HEPAB, TDAP
Symptoms: Guillain-Barre syndrome, Injection site inflammation, Laboratory test abnormal
Clinical narrative: Initial information received from Centers for Disease Control and Prevention on 14 November 2006. A 47 year old female patient received a dose of Adacel, lot number C2384AA, a dose of Fluzone SV2006-2005 USP, lot number U1763AA, and a dose of Twinrix (lot number AHABB079BA) on 05 December 2005. Concomitant medication included Rhinocort. 35 days post vaccination, on 11 January 2006, the patient developed asthenia, paresthesias, urinary incontinence, fecal incontinence, and decreased reflexes. She also had injection site inflammation at an unspecified injection site. The patient was admitted to the hospital on 13 January 2006 with acute inflammatory demyelinating polyneuropathy. A lumbar puncture showed albumino-cytologic dissociation. The patient was diagnosed with Guillain Barre Syndrome. No information was provided regarding treatment. The patient recovered from the events on 24 February 2006. The reporter of this case considered the events to be life threatening. Relevant Test/Laboratory Data: LP results showed albumino-cytologic dissociation.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Bacterial infection, Dyspnoea, Guillain-Barre syndrome, Headache
Clinical narrative: A 37 year old male patient, who is a medical doctor, had received a dose of Adacel, lot number C2456AA, on 08 May 2006. The route and site of administration were not reported. The patient had received the Adacel vaccine for a pertusis outbreak. One day post immunization, the patient experienced several days of odd sensation of both feet along with weakness of his arms and legs, but mostly weakness of his legs. Reportedly, he had dyspnea and a bacterial infection. Per hospital records received by the CDC, the patient had a headache, low back pain, radiating to bilateral thighs, numbness and tingling of his arms and legs for three days. He also had difficulty walking and climbing stairs. He was unable to run or walk fast (patient is regular runner). He was sent to the emergency room to rule out Guillain Bare syndrome. In the emergency room the patient's 02 sats were 92% on room air. The patient was treated and released to follow up as an outpatient. Diagnostics and treatments received were not reported. At an unspecified amount of time later, the patient was evaluated by a neurologist. An MRI revealed disc bulges. The patient had nerve conduction studies which showed findings consistent with demyelinative neuropathy compatible with GBS. The patient was diagnosed with GBS two week post immunization. He was treated and permitted to work only eight hours a day. At the time of this report, the recovery states of the patient was unknown. 60 day Follow-up Information 01-AUG-2006: Per neurology no functional deficits as of 7/5/06 but residual absent reflexes expected to improve.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: A 37 year old male patient, who is a medical doctor, had received a dose of Adacel, lot number C2456AA, on 08 May 2006. The route and site of administration were not reported. The patient had received the Adacel vaccine for a pertusis outbreak. One day post immunization, the patient experienced several days of odd sensation of both feet along with weakness of his arms and legs, but mostly weakness of his legs. Reportedly, he had dyspnea and a bacterial infection. Per hospital records received by the CDC, the patient had a headache, low back pain, radiating to bilateral thighs, numbness and tingling of his arms and legs for three days. He also had difficulty walking and climbing stairs. He was unable to run or walk fast (patient is regular runner). He was sent to the emergency room to rule out Guillain Bare syndrome. In the emergency room the patient's 02 sats were 92% on room air. The patient was treated and released to follow up as an outpatient. Diagnostics and treatments received were not reported. At an unspecified amount of time later, the patient was evaluated by a neurologist. An MRI revealed disc bulges. The patient had nerve conduction studies which showed findings consistent with demyelinative neuropathy compatible with GBS. The patient was diagnosed with GBS two week post immunization. He was treated and permitted to work only eight hours a day. At the time of this report, the recovery states of the patient was unknown. 60 day Follow-up Information 01-AUG-2006: Per neurology no functional deficits as of 7/5/06 but residual absent reflexes expected to improve.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, Areflexia, Back pain, Bacterial infection
Clinical narrative: A 37 year old male patient, who is a medical doctor, had received a dose of Adacel, lot number C2456AA, on 08 May 2006. The route and site of administration were not reported. The patient had received the Adacel vaccine for a pertusis outbreak. One day post immunization, the patient experienced several days of odd sensation of both feet along with weakness of his arms and legs, but mostly weakness of his legs. Reportedly, he had dyspnea and a bacterial infection. Per hospital records received by the CDC, the patient had a headache, low back pain, radiating to bilateral thighs, numbness and tingling of his arms and legs for three days. He also had difficulty walking and climbing stairs. He was unable to run or walk fast (patient is regular runner). He was sent to the emergency room to rule out Guillain Bare syndrome. In the emergency room the patient's 02 sats were 92% on room air. The patient was treated and released to follow up as an outpatient. Diagnostics and treatments received were not reported. At an unspecified amount of time later, the patient was evaluated by a neurologist. An MRI revealed disc bulges. The patient had nerve conduction studies which showed findings consistent with demyelinative neuropathy compatible with GBS. The patient was diagnosed with GBS two week post immunization. He was treated and permitted to work only eight hours a day. At the time of this report, the recovery states of the patient was unknown. 60 day Follow-up Information 01-AUG-2006: Per neurology no functional deficits as of 7/5/06 but residual absent reflexes expected to improve.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: A 37 year old male patient, who is a medical doctor, had received a dose of Adacel, lot number C2456AA, on 08 May 2006. The route and site of administration were not reported. The patient had received the Adacel vaccine for a pertusis outbreak. One day post immunization, the patient experienced several days of odd sensation of both feet along with weakness of his arms and legs, but mostly weakness of his legs. Reportedly, he had dyspnea and a bacterial infection. Per hospital records received by the CDC, the patient had a headache, low back pain, radiating to bilateral thighs, numbness and tingling of his arms and legs for three days. He also had difficulty walking and climbing stairs. He was unable to run or walk fast (patient is regular runner). He was sent to the emergency room to rule out Guillain Bare syndrome. In the emergency room the patient's 02 sats were 92% on room air. The patient was treated and released to follow up as an outpatient. Diagnostics and treatments received were not reported. At an unspecified amount of time later, the patient was evaluated by a neurologist. An MRI revealed disc bulges. The patient had nerve conduction studies which showed findings consistent with demyelinative neuropathy compatible with GBS. The patient was diagnosed with GBS two week post immunization. He was treated and permitted to work only eight hours a day. At the time of this report, the recovery states of the patient was unknown. 60 day Follow-up Information 01-AUG-2006: Per neurology no functional deficits as of 7/5/06 but residual absent reflexes expected to improve.
Age: 37.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Intervertebral disc protrusion, Muscular weakness, Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal
Clinical narrative: A 37 year old male patient, who is a medical doctor, had received a dose of Adacel, lot number C2456AA, on 08 May 2006. The route and site of administration were not reported. The patient had received the Adacel vaccine for a pertusis outbreak. One day post immunization, the patient experienced several days of odd sensation of both feet along with weakness of his arms and legs, but mostly weakness of his legs. Reportedly, he had dyspnea and a bacterial infection. Per hospital records received by the CDC, the patient had a headache, low back pain, radiating to bilateral thighs, numbness and tingling of his arms and legs for three days. He also had difficulty walking and climbing stairs. He was unable to run or walk fast (patient is regular runner). He was sent to the emergency room to rule out Guillain Bare syndrome. In the emergency room the patient's 02 sats were 92% on room air. The patient was treated and released to follow up as an outpatient. Diagnostics and treatments received were not reported. At an unspecified amount of time later, the patient was evaluated by a neurologist. An MRI revealed disc bulges. The patient had nerve conduction studies which showed findings consistent with demyelinative neuropathy compatible with GBS. The patient was diagnosed with GBS two week post immunization. He was treated and permitted to work only eight hours a day. At the time of this report, the recovery states of the patient was unknown. 60 day Follow-up Information 01-AUG-2006: Per neurology no functional deficits as of 7/5/06 but residual absent reflexes expected to improve.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Blood immunoglobulin G, Blood immunoglobulin M, CSF glucose, CSF protein
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Gait disturbance, Gastroenteritis, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hyporeflexia, Joint range of motion decreased, Laboratory test, Paraesthesia, Pharyngitis
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pharyngolaryngeal pain, Red blood cell count decreased, White blood cell count
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia, Muscle tightness
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Paraesthesia, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Initial report received on 14 November 2006. From medical records received, a 60-year-old male patient, with a past medical history of eczema and high cholesterol, and who had been exposed to gastrointestinal, had received a dose of ADACEL, lot number C2384AA, on 07 July 2006. The route and site of administration was not reported. The patient was taking Aspirin 81 mg, Lipitor, vitamin E, and vitamin C at the time of the vaccination. Eleven days post immunization, the patient returned to the physician's office complaining of a four day history of sore throat, and weakness in both of his legs. A quick strep test was performed, but the results were not reported. Physical examination that day revealed absent patellular to ankles. Deep tendon reflexes (DTR), but his leg extension, and plantar flexion were all within normal limits, and he was able to walk on his toes without difficulty. The patient was diagnosed with Guillain Barre Syndrome and acute pharynigitis. Other diagnostics and treatments received were not provided. The following day, the patient woke up and noted tingling and weakness in his hands, and he dropped a bar of soap several times while showering. He continued to have difficulty walking and raising his arm (right worse than left) above his head due to weakness. The patient was also experienced numbness in his toes and finger tips as well as "tightness" in his calves and thighs. The patient was hospitalized that day for the acute onset of progression weakness. On examination in the hospital, the patient denied any shortness of breath, recent tick bites, bowel or blacker incontinence, headache, loss of vision, blurred vision, diplopia, dysarthria, dysphasia, lightheadedness, vertigo, tinnitus, hearing difficulty, difficulties producing of comprehending aspect, fever, chills, night sweats, recent weight loss or gain, cough, chest pain or tightness, palpitations, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel or bladder habits, dysuria, arthralgia, or myalgias. His physicial/neurological scan was within normal limits with a 2+ radial pulse, and foot inversion and eversion 4/5 bilaterally. Diagnostics performed and treatments received were not reported. The patient was discharged from the hospital to an extended care facility on 05 August 2003, 19 days after admission. At the time of this report, the patient's recovery status was unknown.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, HEPA, MNQ, TDAP, HEPA, MNQ, TDAP
Symptoms: Facial palsy
Clinical narrative: A 15-year female patient had received a dose of Menactra, lot number U2004AA, a dose of Adacel, lot not reported, and a dose of another manufacturer's hepatitis A vaccine on 07/Jul/2006. The route and site of administration were not provided for any of the vacciens. The trade name and manufacturer was not reporter for the Hepatitis A vaccine. One day post-vaccination, the patient developed Bell's palsy right-side. The patient was seen by a neurologist as an outpatient on 27/Jul/2006, who indicated that the patient had been treated with Prednisone for seven days,and Valtrex for ten days. On 27/Jul/2006, the patient had non-serious by the agency. The recovery status of the patient is unknown.
Age: 13.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Pain
Clinical narrative: Initial report received on 09/21/2006 from a health care provider. A 13 year old male patient, with a history of ADHD, had received a left deltoid injection of Adacel, lot number C2384AA, on 18 Sep 2006. At an unknown amount of time post vaccination, the patient developed redness and tenderness at the injection site the size of an orange. He was examined by a physician on 21 Sep 2006 an diagnosed with cellulitis. He was treated with cold compresses and Benadryl. The size of the needle used in administration was a 25 gauge, one inch needle. At the time of this report, the patient had not recovered. Follow up information received on 26 October 2006. The patient received Adacel intramuscularly. His symptoms started on 19 September 2006 and lasted 4 days. The diagnosis of cellulitis was clinical and no diagnostic testing was done. He was treated with Keflex 500 mg bid x 10 days, cold compresses and Benadryl. The patient has recovered.
Age: 13.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Injection site erythema, Tenderness
Clinical narrative: Initial report received on 09/21/2006 from a health care provider. A 13 year old male patient, with a history of ADHD, had received a left deltoid injection of Adacel, lot number C2384AA, on 18 Sep 2006. At an unknown amount of time post vaccination, the patient developed redness and tenderness at the injection site the size of an orange. He was examined by a physician on 21 Sep 2006 an diagnosed with cellulitis. He was treated with cold compresses and Benadryl. The size of the needle used in administration was a 25 gauge, one inch needle. At the time of this report, the patient had not recovered. Follow up information received on 26 October 2006. The patient received Adacel intramuscularly. His symptoms started on 19 September 2006 and lasted 4 days. The diagnosis of cellulitis was clinical and no diagnostic testing was done. He was treated with Keflex 500 mg bid x 10 days, cold compresses and Benadryl. The patient has recovered.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash in a 81-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) and pneumococcal vaccine for prophylaxis. The subject's medical history included sulfa allergy. Concurrent medications included Fluconazole (Diflucan) and Cephalexin. On 05 October 2006 at 10:49 am, the subject received a dose of Fluarix (0.5 ml, right arm). On 05 October 2006, the subject received 2nd dose of Pneumococcal vaccine (unknown). In the evening of 05 October 2006, the same day as vaccination with Fluarix and Pneumococcal vaccine, the subject experienced rash on her abdomen, under her breast, and under her neck. The subject was scheduled to see her physician on the day of reporting. At the time of reporting the event was unresolved. The pharmacist considered the event was possibility related to vaccination with Fluarix and Pneumococcal vaccine.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash in a 81-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) and pneumococcal vaccine for prophylaxis. The subject's medical history included sulfa allergy. Concurrent medications included Fluconazole (Diflucan) and Cephalexin. On 05 October 2006 at 10:49 am, the subject received a dose of Fluarix (0.5 ml, right arm). On 05 October 2006, the subject received 2nd dose of Pneumococcal vaccine (unknown). In the evening of 05 October 2006, the same day as vaccination with Fluarix and Pneumococcal vaccine, the subject experienced rash on her abdomen, under her breast, and under her neck. The subject was scheduled to see her physician on the day of reporting. At the time of reporting the event was unresolved. The pharmacist considered the event was possibility related to vaccination with Fluarix and Pneumococcal vaccine.
Age: 69.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP, HEP, HEPA, TDAP, TYP
Symptoms: Herpes zoster, Pain, Rash, Urticaria, Viral infection
Clinical narrative: Initial report received from a nurse on 18 October 2006. A 69 year old, female patient developed lesions, hives, and pain, 8 hours after she received Adacel (lot number C2557AA) intramuscularly, in the left arm and Typhim Vi (lot number Z0122-2) intra muscularly, in the right arm. The patient also received Havrix (lot number AHABV109CA), intra muscularly, in the right arm and Hep B intra muscularly in the left arm. She received the vaccines at 10:00am and adverse events began at 6:00pm. The patient noted the vaccines lowered her immune system. She was exposed to a child in the waiting room (FRI) and broke out with shingles on Sun. The adverse events occurred unilaterally, on the left arm and neck. The patient recovered.
Age: 69.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP, HEP, HEPA, TDAP, TYP
Symptoms: Herpes zoster, Immune system disorder, Pain, Skin ulcer, Urticaria
Clinical narrative: Initial report received from a nurse on 18 October 2006. A 69 year old, female patient developed lesions, hives, and pain, 8 hours after she received Adacel (lot number C2557AA) intramuscularly, in the left arm and Typhim Vi (lot number Z0122-2) intra muscularly, in the right arm. The patient also received Havrix (lot number AHABV109CA), intra muscularly, in the right arm and Hep B intra muscularly in the left arm. She received the vaccines at 10:00am and adverse events began at 6:00pm. The patient noted the vaccines lowered her immune system. She was exposed to a child in the waiting room (FRI) and broke out with shingles on Sun. The adverse events occurred unilaterally, on the left arm and neck. The patient recovered.
Age: 69.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP, HEP, HEPA, TDAP, TYP
Symptoms: Viral infection
Clinical narrative: Initial report received from a nurse on 18 October 2006. A 69 year old, female patient developed lesions, hives, and pain, 8 hours after she received Adacel (lot number C2557AA) intramuscularly, in the left arm and Typhim Vi (lot number Z0122-2) intra muscularly, in the right arm. The patient also received Havrix (lot number AHABV109CA), intra muscularly, in the right arm and Hep B intra muscularly in the left arm. She received the vaccines at 10:00am and adverse events began at 6:00pm. The patient noted the vaccines lowered her immune system. She was exposed to a child in the waiting room (FRI) and broke out with shingles on Sun. The adverse events occurred unilaterally, on the left arm and neck. The patient recovered.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule
Clinical narrative: Initial report received from a physician in the USA on 01 November 2006. A 32 year old, female patient developed an injection site reaction. 3cm tender nodule subdermal, after she received an injection of Adacel (lot number C2609AA, route of administration not reported) in the left deltoid on 15 September 2006. The onset of the reaction was 19 September 2006. She did not have any illnesses at the time of vaccination. There were no relevant diagnostic tests or laboratory data. By 20 October 2006, the nodule decreased 25mm. At the time of the report, the patient recovered.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site nodule, Injection site reaction
Clinical narrative: Initial report received from a physician in the USA on 01 November 2006. A 32 year old, female patient developed an injection site reaction. 3cm tender nodule subdermal, after she received an injection of Adacel (lot number C2609AA, route of administration not reported) in the left deltoid on 15 September 2006. The onset of the reaction was 19 September 2006. She did not have any illnesses at the time of vaccination. There were no relevant diagnostic tests or laboratory data. By 20 October 2006, the nodule decreased 25mm. At the time of the report, the patient recovered.
Age: 87.0
Sex: M
Vaccine: DTP, TDAP
Symptoms: Cellulitis, White blood cell count increased
Clinical narrative: Initial report received from a health professional in USA, on 17 November 2006. An 87 year old male patient, received 03 November 2006, Adacel (lot number C2609AA), into the left deltoid (sode and route of administration not reported). On 04 November 2006, a day after vaccination , the patient experienced cellulitis (severe) and needed Emergency Room doctor visit. The patient was given Levofloxacin (Leverqual and Mcretasone (Elscon)). The patient had recovered. On 18 October 2006, the patient had received influenza vaccine (lot number 71211) into the left deltoid. It was his yearly vaccination. The patient did not receive Adacel before.
Age: 87.0
Sex: M
Vaccine: DTP, TDAP
Symptoms: Cellulitis, Laboratory test abnormal, Medication error
Clinical narrative: Initial report received from a health professional in USA, on 17 November 2006. An 87 year old male patient, received 03 November 2006, Adacel (lot number C2609AA), into the left deltoid (sode and route of administration not reported). On 04 November 2006, a day after vaccination , the patient experienced cellulitis (severe) and needed Emergency Room doctor visit. The patient was given Levofloxacin (Leverqual and Mcretasone (Elscon)). The patient had recovered. On 18 October 2006, the patient had received influenza vaccine (lot number 71211) into the left deltoid. It was his yearly vaccination. The patient did not receive Adacel before.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of joint pain in a 43-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Medical history included right hand dominant athletic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Oral contraceptive (Oral contraceptives). On 02 November 2006 the subject received a dose of Fluarix in the left deltoid. On 02 November 2006 less than one day after vaccination with Fluarix the subject experienced joint pain "that felt as though the injection was given in the interarticular joint." The subject was seen by a physician and referred to an orthopedic specialist for physical therapy. The subject must work at home because of the pain. The healthcare provider considered the event was disabling. At the time of reporting, 28 November 2006, the event was worse.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of joint pain in a 43-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Medical history included right hand dominant athletic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Oral contraceptive (Oral contraceptives). On 02 November 2006 the subject received a dose of Fluarix in the left deltoid. On 02 November 2006 less than one day after vaccination with Fluarix the subject experienced joint pain "that felt as though the injection was given in the interarticular joint." The subject was seen by a physician and referred to an orthopedic specialist for physical therapy. The subject must work at home because of the pain. The healthcare provider considered the event was disabling. At the time of reporting, 28 November 2006, the event was worse.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Laboratory test abnormal, Myocarditis, Pericarditis
Clinical narrative: This 20 year old AD reports receiving his primary Smallpox vaccination on 12 December 2006. He reported a typical site reaction with no untowards adverse events until he was awakened from sleep around midnight on 20 December 2006. He awoke with a severe stabbing midsternal chest pain as if "someone stabbed a stake in my heart". The pain spread across the chest up both shoulders into his neck, ears, back of neck, into the head and eyes.  He placed the pain as a 15/10 pain scale. He got up, unable to find a position of comfort but things eased if he was upright. He attempted to sleep but awoke hourly with reoccurring pain if lying down. He did not take any medication for this discomfort. He reported to work that am and was sent to the base medical unit where he was transferred via ambulance to the area hospital.  He stated paramedics gave him IV morphine in route which helped his pain. He was evaluated by the ER for several hours and released back to base approximately 1430 12/21/06 where he attempted to sleep/rest. A few hours later he awoke again with the pain in "full force". He returned to the ER where a repeat cardiac evaluation showed EKG with elevated ST segments, elevated troponin level at 9, CPKMB at 34 with a CXR showing mild cardiomegly (per MD consult with another MD 12/22/06).  He was admitted to ICU for myopericarditis.    This interview was briefly obtained via phone with the patient in ICU. He was complaining of 8/10 chest pain despite 8-9 mg morphine over the last hour as ineffective. He reports taking some green pills also for inflammation at 1100hr 12/22/06. Since the onset of chest pain the best he felt was in the ambulance and ER prior to his first discharge.  He has had minimal relief up to this point.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Cardiomegaly, Chest pain, Electrocardiogram ST segment elevation, Insomnia
Clinical narrative: This 20 year old AD reports receiving his primary Smallpox vaccination on 12 December 2006. He reported a typical site reaction with no untowards adverse events until he was awakened from sleep around midnight on 20 December 2006. He awoke with a severe stabbing midsternal chest pain as if "someone stabbed a stake in my heart". The pain spread across the chest up both shoulders into his neck, ears, back of neck, into the head and eyes.  He placed the pain as a 15/10 pain scale. He got up, unable to find a position of comfort but things eased if he was upright. He attempted to sleep but awoke hourly with reoccurring pain if lying down. He did not take any medication for this discomfort. He reported to work that am and was sent to the base medical unit where he was transferred via ambulance to the area hospital.  He stated paramedics gave him IV morphine in route which helped his pain. He was evaluated by the ER for several hours and released back to base approximately 1430 12/21/06 where he attempted to sleep/rest. A few hours later he awoke again with the pain in "full force". He returned to the ER where a repeat cardiac evaluation showed EKG with elevated ST segments, elevated troponin level at 9, CPKMB at 34 with a CXR showing mild cardiomegly (per MD consult with another MD 12/22/06).  He was admitted to ICU for myopericarditis.    This interview was briefly obtained via phone with the patient in ICU. He was complaining of 8/10 chest pain despite 8-9 mg morphine over the last hour as ineffective. He reports taking some green pills also for inflammation at 1100hr 12/22/06. Since the onset of chest pain the best he felt was in the ambulance and ER prior to his first discharge.  He has had minimal relief up to this point.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test abnormal, Pain, Pericarditis
Clinical narrative: This 20 year old AD reports receiving his primary Smallpox vaccination on 12 December 2006. He reported a typical site reaction with no untowards adverse events until he was awakened from sleep around midnight on 20 December 2006. He awoke with a severe stabbing midsternal chest pain as if "someone stabbed a stake in my heart". The pain spread across the chest up both shoulders into his neck, ears, back of neck, into the head and eyes.  He placed the pain as a 15/10 pain scale. He got up, unable to find a position of comfort but things eased if he was upright. He attempted to sleep but awoke hourly with reoccurring pain if lying down. He did not take any medication for this discomfort. He reported to work that am and was sent to the base medical unit where he was transferred via ambulance to the area hospital.  He stated paramedics gave him IV morphine in route which helped his pain. He was evaluated by the ER for several hours and released back to base approximately 1430 12/21/06 where he attempted to sleep/rest. A few hours later he awoke again with the pain in "full force". He returned to the ER where a repeat cardiac evaluation showed EKG with elevated ST segments, elevated troponin level at 9, CPKMB at 34 with a CXR showing mild cardiomegly (per MD consult with another MD 12/22/06).  He was admitted to ICU for myopericarditis.    This interview was briefly obtained via phone with the patient in ICU. He was complaining of 8/10 chest pain despite 8-9 mg morphine over the last hour as ineffective. He reports taking some green pills also for inflammation at 1100hr 12/22/06. Since the onset of chest pain the best he felt was in the ambulance and ER prior to his first discharge.  He has had minimal relief up to this point.