chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, PPV
Symptoms: Pneumonia, Posture abnormal, Productive cough, Radiculopathy, Sensory disturbance
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 339758). An 18-year-old male patient, who had no concurrent illnesses, or pre-existing medical history, had received a dose of MENACTRA (lot number U2572AA); a subcutaneous injection of MMR II, manufacturer Merck (lot number 0916X); and a dose of PNEUMOVAX, manufacturer Merck (lot number AHABB128AB) on 03 September 2008. The patient had received multiple vaccines in basic training. The patient presented on 20 September 2008 with complaint of a 10 day history of numbness of the toes initially thought to be due to his boots and was dismissed. At an unspecified amount of time later, the patient returned for evaluation with continued numbness that now was in both legs. He also complained of a productive cough and it was noted he had recent close contact with person/or persons with pneumonia. The patient was diagnosed at that time with Community Acquired Pneumonia and was started on antibiotics (traded name not provided). Several days later the patient developed tingling in his fingertips and legs with painful cramping in the calves. The patient was unable to walk up stairs and was having difficulty due to arm weakness. He was referred to the hospital for evaluation on 24 September 2008 and was hospitalized for seven days. During hospitalization, physical examination revealed abnormal sensation, reduced motor strength, abnormal gait and stance, and diminished or absent DTRs. The patient was diagnosed with GBS (GUILLAIN BARRE syndrome) following EMG/NCS testing. He was treated with IVIG with some improvement and was subsequently able to walk with a walker. Relevant diagnostic test and laboratory data revealed elevated protein in spinal fluid, and positive EMG/NCV. A chest x-ray was positive for right lung apex consolidation. EMG/NCS was positive for generalized sensorimotor polyradiculopathy with mixed axonal and acquired demyelinating features. CSF (cerebral spinal fluid) showed protein 179 and culture and gram stain revealed WBC 18.7, 7% lymphs, and 85.9% neutrophils. Urine protein SSA was high at 5. As of December 2008, the patient had fatigue and continued numbness, pain and spasm in his arms and legs. The service member was discharged permanently from the military. At the time of this report, the patient's recovery status was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the network and determined to meet the proposed case definition of GUILLAIN-BARRE Syndrome, with a level 1 of diagnostic certainty. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, PPV
Symptoms: Walking aid user
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 08 September 2009 and follow-up information on 16 September 2009 (VAERS number 339758). An 18-year-old male patient, who had no concurrent illnesses, or pre-existing medical history, had received a dose of MENACTRA (lot number U2572AA); a subcutaneous injection of MMR II, manufacturer Merck (lot number 0916X); and a dose of PNEUMOVAX, manufacturer Merck (lot number AHABB128AB) on 03 September 2008. The patient had received multiple vaccines in basic training. The patient presented on 20 September 2008 with complaint of a 10 day history of numbness of the toes initially thought to be due to his boots and was dismissed. At an unspecified amount of time later, the patient returned for evaluation with continued numbness that now was in both legs. He also complained of a productive cough and it was noted he had recent close contact with person/or persons with pneumonia. The patient was diagnosed at that time with Community Acquired Pneumonia and was started on antibiotics (traded name not provided). Several days later the patient developed tingling in his fingertips and legs with painful cramping in the calves. The patient was unable to walk up stairs and was having difficulty due to arm weakness. He was referred to the hospital for evaluation on 24 September 2008 and was hospitalized for seven days. During hospitalization, physical examination revealed abnormal sensation, reduced motor strength, abnormal gait and stance, and diminished or absent DTRs. The patient was diagnosed with GBS (GUILLAIN BARRE syndrome) following EMG/NCS testing. He was treated with IVIG with some improvement and was subsequently able to walk with a walker. Relevant diagnostic test and laboratory data revealed elevated protein in spinal fluid, and positive EMG/NCV. A chest x-ray was positive for right lung apex consolidation. EMG/NCS was positive for generalized sensorimotor polyradiculopathy with mixed axonal and acquired demyelinating features. CSF (cerebral spinal fluid) showed protein 179 and culture and gram stain revealed WBC 18.7, 7% lymphs, and 85.9% neutrophils. Urine protein SSA was high at 5. As of December 2008, the patient had fatigue and continued numbness, pain and spasm in his arms and legs. The service member was discharged permanently from the military. At the time of this report, the patient's recovery status was unknown. From the additional information received on 16 September 2009 from the CDC, this case was evaluated by the network and determined to meet the proposed case definition of GUILLAIN-BARRE Syndrome, with a level 1 of diagnostic certainty. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Areflexia, Arthralgia, Asthenia, Axonal neuropathy, Blood immunoglobulin A decreased
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 09 September 2009 and follow-up information on 16 September 2009 (VAERS number 339882). A 12-year-old male patient, with a history of mild cold symptoms, received an intramuscular left arm injection of MENACTRA (lot number U2531AA), and a fourth left arm intramuscular injection of Fluzone (lot number U2500SAA) on 30 October 2007. On 20 November 2007, 21 days post- vaccination,  he developed left foot drop with an inability to move his toes, resulting in a limping gate. Genetic testing was negative for CMT. EMG and nerve conduction studies were consistent with axonal neuropathy and possible chronic inflammatory neuropathy. CSF protein was 58, serum IgA 58 (low). DEXA was positive for osteoporosis and osteopenia. He was seen by his primary physician in February 2008 with ankle pain, and was referred to an orthopedist and neurologist at that time. In May 2008 he developed right foot drop, and a physical exam on 01 June 2008 showed decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. Deep tendon reflexes were absent in the lower extremities. On 21 July 2008 he was admitted to the hospital for IVIG; he developed a headache following treatment. He was discharged on 24 July 2008 on Prednisone, and was to follow-up with his neurologist as an outpatient. Diagnosis at the time of discharge was chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Additional treatment included wearing foot and ankle braces to assist with ambulation. On 06 October 2008 the patient was noted to have some muscle wasting, and on 24 December 2008 he developed a hand tremor. Some improvement in strength was noted. The reporter noted that the event resulted in permanent disability. Outcome was not reported. From additional information received on 16 September 2009 from the CDC, this case was evaluated and confirmed to be CIDP.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Bone densitometry, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Disability, Electromyogram abnormal
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 09 September 2009 and follow-up information on 16 September 2009 (VAERS number 339882). A 12-year-old male patient, with a history of mild cold symptoms, received an intramuscular left arm injection of MENACTRA (lot number U2531AA), and a fourth left arm intramuscular injection of Fluzone (lot number U2500SAA) on 30 October 2007. On 20 November 2007, 21 days post- vaccination,  he developed left foot drop with an inability to move his toes, resulting in a limping gate. Genetic testing was negative for CMT. EMG and nerve conduction studies were consistent with axonal neuropathy and possible chronic inflammatory neuropathy. CSF protein was 58, serum IgA 58 (low). DEXA was positive for osteoporosis and osteopenia. He was seen by his primary physician in February 2008 with ankle pain, and was referred to an orthopedist and neurologist at that time. In May 2008 he developed right foot drop, and a physical exam on 01 June 2008 showed decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. Deep tendon reflexes were absent in the lower extremities. On 21 July 2008 he was admitted to the hospital for IVIG; he developed a headache following treatment. He was discharged on 24 July 2008 on Prednisone, and was to follow-up with his neurologist as an outpatient. Diagnosis at the time of discharge was chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Additional treatment included wearing foot and ankle braces to assist with ambulation. On 06 October 2008 the patient was noted to have some muscle wasting, and on 24 December 2008 he developed a hand tremor. Some improvement in strength was noted. The reporter noted that the event resulted in permanent disability. Outcome was not reported. From additional information received on 16 September 2009 from the CDC, this case was evaluated and confirmed to be CIDP.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Gait disturbance, Headache, Immunoglobulin therapy, Movement disorder, Muscle atrophy
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 09 September 2009 and follow-up information on 16 September 2009 (VAERS number 339882). A 12-year-old male patient, with a history of mild cold symptoms, received an intramuscular left arm injection of MENACTRA (lot number U2531AA), and a fourth left arm intramuscular injection of Fluzone (lot number U2500SAA) on 30 October 2007. On 20 November 2007, 21 days post- vaccination,  he developed left foot drop with an inability to move his toes, resulting in a limping gate. Genetic testing was negative for CMT. EMG and nerve conduction studies were consistent with axonal neuropathy and possible chronic inflammatory neuropathy. CSF protein was 58, serum IgA 58 (low). DEXA was positive for osteoporosis and osteopenia. He was seen by his primary physician in February 2008 with ankle pain, and was referred to an orthopedist and neurologist at that time. In May 2008 he developed right foot drop, and a physical exam on 01 June 2008 showed decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. Deep tendon reflexes were absent in the lower extremities. On 21 July 2008 he was admitted to the hospital for IVIG; he developed a headache following treatment. He was discharged on 24 July 2008 on Prednisone, and was to follow-up with his neurologist as an outpatient. Diagnosis at the time of discharge was chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Additional treatment included wearing foot and ankle braces to assist with ambulation. On 06 October 2008 the patient was noted to have some muscle wasting, and on 24 December 2008 he developed a hand tremor. Some improvement in strength was noted. The reporter noted that the event resulted in permanent disability. Outcome was not reported. From additional information received on 16 September 2009 from the CDC, this case was evaluated and confirmed to be CIDP.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Nerve conduction studies abnormal, Osteopenia, Osteoporosis, Peroneal nerve palsy, Tremor
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (CDC) on 09 September 2009 and follow-up information on 16 September 2009 (VAERS number 339882). A 12-year-old male patient, with a history of mild cold symptoms, received an intramuscular left arm injection of MENACTRA (lot number U2531AA), and a fourth left arm intramuscular injection of Fluzone (lot number U2500SAA) on 30 October 2007. On 20 November 2007, 21 days post- vaccination,  he developed left foot drop with an inability to move his toes, resulting in a limping gate. Genetic testing was negative for CMT. EMG and nerve conduction studies were consistent with axonal neuropathy and possible chronic inflammatory neuropathy. CSF protein was 58, serum IgA 58 (low). DEXA was positive for osteoporosis and osteopenia. He was seen by his primary physician in February 2008 with ankle pain, and was referred to an orthopedist and neurologist at that time. In May 2008 he developed right foot drop, and a physical exam on 01 June 2008 showed decreased strength on plantar/dorsiflexion bilaterally and difficulty with gait and stance. Deep tendon reflexes were absent in the lower extremities. On 21 July 2008 he was admitted to the hospital for IVIG; he developed a headache following treatment. He was discharged on 24 July 2008 on Prednisone, and was to follow-up with his neurologist as an outpatient. Diagnosis at the time of discharge was chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Additional treatment included wearing foot and ankle braces to assist with ambulation. On 06 October 2008 the patient was noted to have some muscle wasting, and on 24 December 2008 he developed a hand tremor. Some improvement in strength was noted. The reporter noted that the event resulted in permanent disability. Outcome was not reported. From additional information received on 16 September 2009 from the CDC, this case was evaluated and confirmed to be CIDP.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, Antiphospholipid antibodies negative, CSF test normal, Computerised tomogram abnormal, Muscular weakness
Clinical narrative: Initial information was received on 10 April 2009 from the FDA, VAERS number 340675. An 11 year old female patient received MENACTRA (lot number not provided) and DTAP (manufacturer not provided) on 12 January 2009. Ten days post vaccination, the patient developed Acute Disseminated Encephalomyelitis. Recovery status was not reported. Per the FDA, this case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Follow-up information was extracted from the VAERS database via QSCAN on 19 May 2009 (VAERS ID number 340675). On 12 January 2009, the patient had received a first dose intramuscular injection of MENACTRA (lot number not reported), and a first dose intramuscular injection ADACEL (lot number not reported). On 22 January 2009 (also reported as ten days following vaccination), the patient began to experience pain and progressive weakness of her left arm and left leg. She was seen at the emergency room on 25 January 2009 with complaints of left sided weakness over the last several days and was subsequently admitted. A MRI of the brain and spine showed areas of demyelination of the cervical spine and brain. CSF studies had been negative for infection, autoimmune diseases and multiple sclerosis. The patient received a neurological consult assessment on 26 January 2009 which noted: ADEM probably associated with MENACTRA. The remainder of the report narrative was incomplete and ended as follows: "Radiographic studies indicated white matter disease in cervi". This report also contained coding for "antiphospholipid antibodies negative" which was not mentioned in the case narrative. This seriousness for this event was also considered to be life threatening and the patient's outcome was reported as recovered (date not reported). Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Pain in extremity
Clinical narrative: Initial information was received on 10 April 2009 from the FDA, VAERS number 340675. An 11 year old female patient received MENACTRA (lot number not provided) and DTAP (manufacturer not provided) on 12 January 2009. Ten days post vaccination, the patient developed Acute Disseminated Encephalomyelitis. Recovery status was not reported. Per the FDA, this case meets the agency probable or confirmed ADEM case definition of diagnostic certainty for level 1 or 2. Follow-up information was extracted from the VAERS database via QSCAN on 19 May 2009 (VAERS ID number 340675). On 12 January 2009, the patient had received a first dose intramuscular injection of MENACTRA (lot number not reported), and a first dose intramuscular injection ADACEL (lot number not reported). On 22 January 2009 (also reported as ten days following vaccination), the patient began to experience pain and progressive weakness of her left arm and left leg. She was seen at the emergency room on 25 January 2009 with complaints of left sided weakness over the last several days and was subsequently admitted. A MRI of the brain and spine showed areas of demyelination of the cervical spine and brain. CSF studies had been negative for infection, autoimmune diseases and multiple sclerosis. The patient received a neurological consult assessment on 26 January 2009 which noted: ADEM probably associated with MENACTRA. The remainder of the report narrative was incomplete and ended as follows: "Radiographic studies indicated white matter disease in cervi". This report also contained coding for "antiphospholipid antibodies negative" which was not mentioned in the case narrative. This seriousness for this event was also considered to be life threatening and the patient's outcome was reported as recovered (date not reported). Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Body temperature increased, Chest discomfort, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: This non serious case was received on 28 April 2009 from a health care professional. A 17 year old female patient with asthma, penicillin and CEFZIL allergies received MENACTRA (lot number U2869AA) intramuscularly in the right deltoid, PNEUMOVAX (manufacturer Merck, lot number 1287-X) intramuscularly in the right deltoid, VARIVAX (manufacturer Merck, lot number 1753X) intramuscularly in the left deltoid, BOOSTRIX (manufacturer GSK, lot number AC52B039AA) intramuscularly in the left deltoid on 23 April 2009 in the AM. Concomitant therapy included albuterol, ADVAIR, ZYRTEC, PROVENTIL, and AMOXIL. On 23 April 2009 in the PM the patient developed an immediate, red, swollen right deltoid. She later developed nausea, vomiting, diarrhea, and had a temperature of 101.6. She was seen in the emergency room and treated with ZOFRAN intravenously. On 23 April 2009 labs included: WBC 18, sed rate 44. On 25 April 2009 patient was seen by her physician and labs included: WBC 15.8, sed rate 46. Her arm was still red, but less swollen. her temperature was 98.6. She continued to complain of nausea, sore throat, and chest tightness, but no vomiting. She was to be seen on 28 April 2009. The patient's recovery status was unknown. Follow up information received on 04 June 2009 from a health care professional. According to medical records from 28 April 2009 office visit, the patient developed a right swollen and painful arm where she received MENACTRA and PNEUMOVAX. The patient also developed sweats, a fever, diarrhea, vomiting, fatigue, and aches. RST and influenza screens have been negative. The patient was 75% back to normal, but the patient was still tired. WBC were 15,000 and dropped to 12,000 and then 7,000 over the past 3 days. The ESR had gone up from 44 to 46 to 69 on 27 April 2009. The physician reported that the patient's fatigue had improved and that it was almost certainly an immunization reaction, probably MENACTRA. The physician is avoiding more labs for the time being and will monitor her progress. The patient will return if she does not improve. The patient's mother she is a registered nurse was in agreement. Follow-up information received on 29 June 2009 from a health care professional. The patient had no concurrent illness at the time of vaccinations on 23 April 2009. The patient had received the MENACTRA, PNEUMOVAX 23, BOOSTRIX and VARIVAX vaccines on 23 April 2009 at 11:00 am. Per the reporter, the adverse events occurred the evening of 23 April 2009 or early morning on 24 April 2009. The result of the Sed rate completed on 25 April 2009 was confirmed by the reporter to be 44. On 27 April 2009 additional laboratory data revealed WBC 12.2 and Sed rate 46. The patient was seen for evaluation on the following dates: 25, 27 and 28 April 2009. The final diagnosis was considered as immunization reaction. The patient recovered; however, the recovery date was not provided. List of Documents held by Sender: medical records.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Immunisation reaction, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This non serious case was received on 28 April 2009 from a health care professional. A 17 year old female patient with asthma, penicillin and CEFZIL allergies received MENACTRA (lot number U2869AA) intramuscularly in the right deltoid, PNEUMOVAX (manufacturer Merck, lot number 1287-X) intramuscularly in the right deltoid, VARIVAX (manufacturer Merck, lot number 1753X) intramuscularly in the left deltoid, BOOSTRIX (manufacturer GSK, lot number AC52B039AA) intramuscularly in the left deltoid on 23 April 2009 in the AM. Concomitant therapy included albuterol, ADVAIR, ZYRTEC, PROVENTIL, and AMOXIL. On 23 April 2009 in the PM the patient developed an immediate, red, swollen right deltoid. She later developed nausea, vomiting, diarrhea, and had a temperature of 101.6. She was seen in the emergency room and treated with ZOFRAN intravenously. On 23 April 2009 labs included: WBC 18, sed rate 44. On 25 April 2009 patient was seen by her physician and labs included: WBC 15.8, sed rate 46. Her arm was still red, but less swollen. her temperature was 98.6. She continued to complain of nausea, sore throat, and chest tightness, but no vomiting. She was to be seen on 28 April 2009. The patient's recovery status was unknown. Follow up information received on 04 June 2009 from a health care professional. According to medical records from 28 April 2009 office visit, the patient developed a right swollen and painful arm where she received MENACTRA and PNEUMOVAX. The patient also developed sweats, a fever, diarrhea, vomiting, fatigue, and aches. RST and influenza screens have been negative. The patient was 75% back to normal, but the patient was still tired. WBC were 15,000 and dropped to 12,000 and then 7,000 over the past 3 days. The ESR had gone up from 44 to 46 to 69 on 27 April 2009. The physician reported that the patient's fatigue had improved and that it was almost certainly an immunization reaction, probably MENACTRA. The physician is avoiding more labs for the time being and will monitor her progress. The patient will return if she does not improve. The patient's mother she is a registered nurse was in agreement. Follow-up information received on 29 June 2009 from a health care professional. The patient had no concurrent illness at the time of vaccinations on 23 April 2009. The patient had received the MENACTRA, PNEUMOVAX 23, BOOSTRIX and VARIVAX vaccines on 23 April 2009 at 11:00 am. Per the reporter, the adverse events occurred the evening of 23 April 2009 or early morning on 24 April 2009. The result of the Sed rate completed on 25 April 2009 was confirmed by the reporter to be 44. On 27 April 2009 additional laboratory data revealed WBC 12.2 and Sed rate 46. The patient was seen for evaluation on the following dates: 25, 27 and 28 April 2009. The final diagnosis was considered as immunization reaction. The patient recovered; however, the recovery date was not provided. List of Documents held by Sender: medical records.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Red blood cell sedimentation rate increased, Vomiting
Clinical narrative: This non serious case was received on 28 April 2009 from a health care professional. A 17 year old female patient with asthma, penicillin and CEFZIL allergies received MENACTRA (lot number U2869AA) intramuscularly in the right deltoid, PNEUMOVAX (manufacturer Merck, lot number 1287-X) intramuscularly in the right deltoid, VARIVAX (manufacturer Merck, lot number 1753X) intramuscularly in the left deltoid, BOOSTRIX (manufacturer GSK, lot number AC52B039AA) intramuscularly in the left deltoid on 23 April 2009 in the AM. Concomitant therapy included albuterol, ADVAIR, ZYRTEC, PROVENTIL, and AMOXIL. On 23 April 2009 in the PM the patient developed an immediate, red, swollen right deltoid. She later developed nausea, vomiting, diarrhea, and had a temperature of 101.6. She was seen in the emergency room and treated with ZOFRAN intravenously. On 23 April 2009 labs included: WBC 18, sed rate 44. On 25 April 2009 patient was seen by her physician and labs included: WBC 15.8, sed rate 46. Her arm was still red, but less swollen. her temperature was 98.6. She continued to complain of nausea, sore throat, and chest tightness, but no vomiting. She was to be seen on 28 April 2009. The patient's recovery status was unknown. Follow up information received on 04 June 2009 from a health care professional. According to medical records from 28 April 2009 office visit, the patient developed a right swollen and painful arm where she received MENACTRA and PNEUMOVAX. The patient also developed sweats, a fever, diarrhea, vomiting, fatigue, and aches. RST and influenza screens have been negative. The patient was 75% back to normal, but the patient was still tired. WBC were 15,000 and dropped to 12,000 and then 7,000 over the past 3 days. The ESR had gone up from 44 to 46 to 69 on 27 April 2009. The physician reported that the patient's fatigue had improved and that it was almost certainly an immunization reaction, probably MENACTRA. The physician is avoiding more labs for the time being and will monitor her progress. The patient will return if she does not improve. The patient's mother she is a registered nurse was in agreement. Follow-up information received on 29 June 2009 from a health care professional. The patient had no concurrent illness at the time of vaccinations on 23 April 2009. The patient had received the MENACTRA, PNEUMOVAX 23, BOOSTRIX and VARIVAX vaccines on 23 April 2009 at 11:00 am. Per the reporter, the adverse events occurred the evening of 23 April 2009 or early morning on 24 April 2009. The result of the Sed rate completed on 25 April 2009 was confirmed by the reporter to be 44. On 27 April 2009 additional laboratory data revealed WBC 12.2 and Sed rate 46. The patient was seen for evaluation on the following dates: 25, 27 and 28 April 2009. The final diagnosis was considered as immunization reaction. The patient recovered; however, the recovery date was not provided. List of Documents held by Sender: medical records.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: This non serious case was received on 28 April 2009 from a health care professional. A 17 year old female patient with asthma, penicillin and CEFZIL allergies received MENACTRA (lot number U2869AA) intramuscularly in the right deltoid, PNEUMOVAX (manufacturer Merck, lot number 1287-X) intramuscularly in the right deltoid, VARIVAX (manufacturer Merck, lot number 1753X) intramuscularly in the left deltoid, BOOSTRIX (manufacturer GSK, lot number AC52B039AA) intramuscularly in the left deltoid on 23 April 2009 in the AM. Concomitant therapy included albuterol, ADVAIR, ZYRTEC, PROVENTIL, and AMOXIL. On 23 April 2009 in the PM the patient developed an immediate, red, swollen right deltoid. She later developed nausea, vomiting, diarrhea, and had a temperature of 101.6. She was seen in the emergency room and treated with ZOFRAN intravenously. On 23 April 2009 labs included: WBC 18, sed rate 44. On 25 April 2009 patient was seen by her physician and labs included: WBC 15.8, sed rate 46. Her arm was still red, but less swollen. her temperature was 98.6. She continued to complain of nausea, sore throat, and chest tightness, but no vomiting. She was to be seen on 28 April 2009. The patient's recovery status was unknown. Follow up information received on 04 June 2009 from a health care professional. According to medical records from 28 April 2009 office visit, the patient developed a right swollen and painful arm where she received MENACTRA and PNEUMOVAX. The patient also developed sweats, a fever, diarrhea, vomiting, fatigue, and aches. RST and influenza screens have been negative. The patient was 75% back to normal, but the patient was still tired. WBC were 15,000 and dropped to 12,000 and then 7,000 over the past 3 days. The ESR had gone up from 44 to 46 to 69 on 27 April 2009. The physician reported that the patient's fatigue had improved and that it was almost certainly an immunization reaction, probably MENACTRA. The physician is avoiding more labs for the time being and will monitor her progress. The patient will return if she does not improve. The patient's mother she is a registered nurse was in agreement. Follow-up information received on 29 June 2009 from a health care professional. The patient had no concurrent illness at the time of vaccinations on 23 April 2009. The patient had received the MENACTRA, PNEUMOVAX 23, BOOSTRIX and VARIVAX vaccines on 23 April 2009 at 11:00 am. Per the reporter, the adverse events occurred the evening of 23 April 2009 or early morning on 24 April 2009. The result of the Sed rate completed on 25 April 2009 was confirmed by the reporter to be 44. On 27 April 2009 additional laboratory data revealed WBC 12.2 and Sed rate 46. The patient was seen for evaluation on the following dates: 25, 27 and 28 April 2009. The final diagnosis was considered as immunization reaction. The patient recovered; however, the recovery date was not provided. List of Documents held by Sender: medical records.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This non serious case was received on 03 April 2009 from a health care professional. An 18 year old female patient received MENACTRA (lot number U2868AA) and Hepatitis A (lot number and manufacturer not reported) both received in the deltoid on 30 March 2009. The specific site of administration was not known, however the patient believed she received MENACTRA in the right deltoid. On 31 March 2009 the patient developed redness, swelling, soreness in the arm. The patient was seen on 01 April 2009 at the physician's office and reported that the patient's right upper arm was red six inches around the injection site, swollen, tender to touch, and there as a decrease in motion where she was unable to lift arm above her head with pain, and her right forearm became pink. The patient was treated with Augmentin, hot, and cold packs for possible cellulitis. Follow up information was received on 04 June 2009 from a health care professional who reported that the patient has a history of Von-Willebrand's Disease. The patient received Vagta, hepatitis A vaccine (manufacturer Merck, lot number 1297X) on 20 March 2009. Per the reporter, the patient's arm in which the MENACTRA was administered was not clearly stated in their records. The patient's area of localized erythema diagnostic tests completed. The reporter spoke with the patient's father on 03 April 2009 and the patient was recovered at that time. Follow-up information was received from the health professional on 19 June 2009. The cellulitis was noted to be diagnosed by clinical diagnosis and response to therapy. Per the reporter, the administering nurse believed that the Hepatitis A vaccine had been given in the right arm, however there was some confusion in the patient records.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Cellulitis, Hypokinesia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non serious case was received on 03 April 2009 from a health care professional. An 18 year old female patient received MENACTRA (lot number U2868AA) and Hepatitis A (lot number and manufacturer not reported) both received in the deltoid on 30 March 2009. The specific site of administration was not known, however the patient believed she received MENACTRA in the right deltoid. On 31 March 2009 the patient developed redness, swelling, soreness in the arm. The patient was seen on 01 April 2009 at the physician's office and reported that the patient's right upper arm was red six inches around the injection site, swollen, tender to touch, and there as a decrease in motion where she was unable to lift arm above her head with pain, and her right forearm became pink. The patient was treated with Augmentin, hot, and cold packs for possible cellulitis. Follow up information was received on 04 June 2009 from a health care professional who reported that the patient has a history of Von-Willebrand's Disease. The patient received Vagta, hepatitis A vaccine (manufacturer Merck, lot number 1297X) on 20 March 2009. Per the reporter, the patient's arm in which the MENACTRA was administered was not clearly stated in their records. The patient's area of localized erythema diagnostic tests completed. The reporter spoke with the patient's father on 03 April 2009 and the patient was recovered at that time. Follow-up information was received from the health professional on 19 June 2009. The cellulitis was noted to be diagnosed by clinical diagnosis and response to therapy. Per the reporter, the administering nurse believed that the Hepatitis A vaccine had been given in the right arm, however there was some confusion in the patient records.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Malaise, Pain in extremity, Von Willebrand's disease
Clinical narrative: This non serious case was received on 03 April 2009 from a health care professional. An 18 year old female patient received MENACTRA (lot number U2868AA) and Hepatitis A (lot number and manufacturer not reported) both received in the deltoid on 30 March 2009. The specific site of administration was not known, however the patient believed she received MENACTRA in the right deltoid. On 31 March 2009 the patient developed redness, swelling, soreness in the arm. The patient was seen on 01 April 2009 at the physician's office and reported that the patient's right upper arm was red six inches around the injection site, swollen, tender to touch, and there as a decrease in motion where she was unable to lift arm above her head with pain, and her right forearm became pink. The patient was treated with Augmentin, hot, and cold packs for possible cellulitis. Follow up information was received on 04 June 2009 from a health care professional who reported that the patient has a history of Von-Willebrand's Disease. The patient received Vagta, hepatitis A vaccine (manufacturer Merck, lot number 1297X) on 20 March 2009. Per the reporter, the patient's arm in which the MENACTRA was administered was not clearly stated in their records. The patient's area of localized erythema diagnostic tests completed. The reporter spoke with the patient's father on 03 April 2009 and the patient was recovered at that time. Follow-up information was received from the health professional on 19 June 2009. The cellulitis was noted to be diagnosed by clinical diagnosis and response to therapy. Per the reporter, the administering nurse believed that the Hepatitis A vaccine had been given in the right arm, however there was some confusion in the patient records.
Age: 13.0
Sex: F
Vaccine: MNQ, TTOX
Symptoms: Decreased appetite, Fatigue, Insomnia, Loss of consciousness, Pallor
Clinical narrative: This serious case was received on 23 April 2009 from a consumer (patient's mother). A 13 year old female patient with a history of asthma and gastric reflux received MENACTRA (lot number not reported) and tetanus booster (manufacturer not reported) on 20 April 2009. Concomitant therapy included Albuterol inhaler as needed. Five minutes post vaccination following administration of the second vaccine, the patient passed out momentarily, length of time was not reported. Since then, the patient has been tired, sleeping longer than usual, has a decreased appetite, and is pale. Recovery status was not reported. Follow-up information was recovered 13 May 2009 from a health care professional who stated that the patient was not a patient at their facility. The reporter provided contact information for another physician (with the same last name) and suggested that the patient may be a client at the office. No additional relevant information was provided at the time of the report. This follow-up information is not submitted as a 15-day follow-up report to the health authorities. List of documents held by sender none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Back pain, Computerised tomogram normal, Diarrhoea, Full blood count normal, Headache
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Laboratory test normal, Lumbar puncture normal, Myalgia, Nausea, Neck pain
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Back pain, Computerised tomogram head, Diarrhoea, Full blood count normal, Headache
Clinical narrative: Initial report received on 21 July 2009 from VAERS (reference number 350415) whose initial reporter was a health care professional. An 18 year old female patient with an allergy to codeine received ADACEL (lot number C3031AA) intramuscularly in the left arm and MENACTRA (lot number U2689AA) intramuscularly in the right arm on 19 June 2009 at 2:00 PM. On 20 June 2009 the patient developed severe headache, myalgia, back pain, lower extremity pain, neck pain, paresthesias, nausea, vomiting, and diarrhea. The patient was subsequently hospitalized for one day. Head CT, LP, CBC, and other labs were normal. The patient was not recovered at the time of the report. Follow-up information was received on 16 November 2009 from a health care professional. As per the reporter, the information for this case was reviewed and there is no additional information at this time. Follow-up information was received from another health care professional on 19 November 2009. This reporter also had no additional information to provide at this time. List of Documents held by Sender: none.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Areflexia, Asthenia, Ataxia, Autoantibody positive, Back pain
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Diplopia, Dysarthria, Facial nerve disorder, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Headache, Hyporeflexia, Immunoglobulin therapy, Lumbar puncture normal, Migraine
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Miller Fisher syndrome, Muscular weakness, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.