chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Fluid replacement, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Joint range of motion decreased, Malaise
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Meningitis aseptic, Musculoskeletal pain, Nausea, Neck pain, Nuchal rigidity
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Ocular hyperaemia, Paraesthesia, Photophobia, Pyrexia, Vaccination complication
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vasodilatation, Wheezing
Clinical narrative: This serious event was received from an extraction of the VAERS database on 12 February 2009 (reference number 336301).  A 47-year-old male patient received intramuscular right arm injections of FLUZONE (lot number U2749AA) and PNEUMOVAX (Merck, lot number 0980X) on 10 December 2008.  The patient had a history of allergies to penicillin, CIPRO, and bee stings, and had previously been in a motor vehicle collision.  Medical history included hypertension, chronic obstructive pulmonary disease (COPD), alcohol abuse, tobacco abuse, anal fistula, H. pylori, and "temper".  On the evening of vaccination, the patient had pain in the right shoulder and fever up to 104 degrees Fahrenheit.  Over the next four days, he experienced a frontal headache and progressive pain, redness, and swelling at the injection site.  On 14 December 2008 he was admitted to the hospital with fever, headache, nuchal rigidity, photophobia, chills, malaise, fatigue, diaphoresis, eye pain and redness, cough, nausea, diarrhea, neck pain, dizziness, and tingling.  Physical exam was positive for bilateral injected dilated veins in the right chest.  The patient initially was started on antibiotics, however they were discontinued when a CSF culture was found to be negative.  He showed improvement after being treated with intravenous fluids and NSAIDs, and was discharged on 16 December 2008.  Discharge diagnosis was "adverse reaction to pneumococcal vaccine; aseptic meningitis; and local reaction at site of injection".
Age: 0.3
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Irritability, Vomiting
Clinical narrative: Initial information received on 15 January 2009 from a health care professional. A 3 month old male patient who was born pre term inadvertently received a first time dose of FLUZONE No Preservative 2008-2009 (lot number UT2782E) on 14 January 2009 instead of receiving "Synergist vaccine". On 15 January 2009 the patient was vomiting and crying. Recovery status was unknown. No further information was provided. Follow up information was received on 03 June 2009 from a health care professional. On 15 December 2008 the patient received first time doses of Pentacel (lot number reported as C2881AA and C3169AB) intramuscularly in the thigh, PREVNAR (lot number D06803) intramuscularly in the thigh and ROTATEQ (lot number 0594X) orally on 15 December 2008. On 15 January 2009, one day post FLUZONE administration, the patient experienced vomiting and excessive crying which lasted for one day and then the patient recovered. In addition, the patient received PENTACEL (lot number reported as C2881AA and C3189AB) intramuscularly in the left thigh, PREVNAR (lot number C54766) intramuscularly in the thigh, ROTATEQ (lot number 1472X) orally, and SYNAGIS (lot number 089021) intramuscularly in the right thigh on 12 February 2009. No further information was provided. Follow up information received on 18 June 2009 from a health care professional who reported that the patient did not have RSV or any other illness at the time of vaccination. The lot number for PENTACEL was reported as C3189AB. The patient received FLUZONE intramuscularly in the right thigh. The reporter confirmed that the patient did not experience any reactions after 12 February 2009. No further information was provided.
Age: 0.3
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Crying, Inappropriate schedule of drug administration, Vomiting, Wrong drug administered
Clinical narrative: Initial information received on 15 January 2009 from a health care professional. A 3 month old male patient who was born pre term inadvertently received a first time dose of FLUZONE No Preservative 2008-2009 (lot number UT2782E) on 14 January 2009 instead of receiving "Synergist vaccine". On 15 January 2009 the patient was vomiting and crying. Recovery status was unknown. No further information was provided. Follow up information was received on 03 June 2009 from a health care professional. On 15 December 2008 the patient received first time doses of Pentacel (lot number reported as C2881AA and C3169AB) intramuscularly in the thigh, PREVNAR (lot number D06803) intramuscularly in the thigh and ROTATEQ (lot number 0594X) orally on 15 December 2008. On 15 January 2009, one day post FLUZONE administration, the patient experienced vomiting and excessive crying which lasted for one day and then the patient recovered. In addition, the patient received PENTACEL (lot number reported as C2881AA and C3189AB) intramuscularly in the left thigh, PREVNAR (lot number C54766) intramuscularly in the thigh, ROTATEQ (lot number 1472X) orally, and SYNAGIS (lot number 089021) intramuscularly in the right thigh on 12 February 2009. No further information was provided. Follow up information received on 18 June 2009 from a health care professional who reported that the patient did not have RSV or any other illness at the time of vaccination. The lot number for PENTACEL was reported as C3189AB. The patient received FLUZONE intramuscularly in the right thigh. The reporter confirmed that the patient did not experience any reactions after 12 February 2009. No further information was provided.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Arthralgia, CSF pressure increased, Peroneal nerve palsy
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 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, 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 08 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Blood product transfusion, Bone densitometry, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Disability
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 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Dysstasia, Electromyogram abnormal, Gait disturbance, Gene mutation identification test negative, Headache
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 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Movement disorder, Muscle atrophy, Nerve conduction studies abnormal, Osteopenia, Osteoporosis
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 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Peroneal nerve palsy, Tremor
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 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 U2500AA) 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 gait. 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. 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 the additional information received on 16 September 2009 from the CDC, this case was evaluated by the Clinical Immunization Safety Assessment network (CISA) and confirmed to be CIDP. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 16 January 2009 from a  health professional. A 58 year old female, with a history of hypertension, hypercholesterolemia and an unspecified reaction to unspecified international travel medications, received an intramuscular left deltoid injection of FLUZONE (lot number 02769AA) on 20 November 2008 at 16:00. Several hours after vaccination, at 18:00 the injection site became red, raised, and warm to touch.  The area was the size of a 50 cent piece. Ice was applied to the area. Since 20 November 2008, the area sporadically becomes itchy. The patient scratches the area, it scabs over, heals, and then becomes very itchy again. At the time of the report, the patient had not recovered. Follow up information was received on 09 February 2009 from a health professional. The reporter stated that the patient had been administered influenza vaccines (manufacturer unknown) in the past, however the patient has never had this type of reaction before. The patient has not recovered and is awaiting an appointment with a dermatologist. No further information was reported. Follow up information received 06 April 2009 from a health care professional who received the case and no additional information to provide at the time of the report. Follow up information received on 13 May 2009 from a health care professional who stated that the patient was evaluated by a dermatologist on 08 May 2009. The dermatologist recommended that the patient apply hydrocortisone cream to decrease the reaction at the site. The doctor diagnosed the symptoms as a local reaction to the injection. The patient is still recovering from the reaction. Follow up information received on 08 July 2009 from a health care professional. The reporter stated that according to the patient she recovered from the local reaction between mid May and June. No other information was provided.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 16 January 2009 from a  health professional. A 58 year old female, with a history of hypertension, hypercholesterolemia and an unspecified reaction to unspecified international travel medications, received an intramuscular left deltoid injection of FLUZONE (lot number 02769AA) on 20 November 2008 at 16:00. Several hours after vaccination, at 18:00 the injection site became red, raised, and warm to touch.  The area was the size of a 50 cent piece. Ice was applied to the area. Since 20 November 2008, the area sporadically becomes itchy. The patient scratches the area, it scabs over, heals, and then becomes very itchy again. At the time of the report, the patient had not recovered. Follow up information was received on 09 February 2009 from a health professional. The reporter stated that the patient had been administered influenza vaccines (manufacturer unknown) in the past, however the patient has never had this type of reaction before. The patient has not recovered and is awaiting an appointment with a dermatologist. No further information was reported. Follow up information received 06 April 2009 from a health care professional who received the case and no additional information to provide at the time of the report. Follow up information received on 13 May 2009 from a health care professional who stated that the patient was evaluated by a dermatologist on 08 May 2009. The dermatologist recommended that the patient apply hydrocortisone cream to decrease the reaction at the site. The doctor diagnosed the symptoms as a local reaction to the injection. The patient is still recovering from the reaction. Follow up information received on 08 July 2009 from a health care professional. The reporter stated that according to the patient she recovered from the local reaction between mid May and June. No other information was provided.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Initial report received on 16 January 2009 from a  health professional. A 58 year old female, with a history of hypertension, hypercholesterolemia and an unspecified reaction to unspecified international travel medications, received an intramuscular left deltoid injection of FLUZONE (lot number 02769AA) on 20 November 2008 at 16:00. Several hours after vaccination, at 18:00 the injection site became red, raised, and warm to touch.  The area was the size of a 50 cent piece. Ice was applied to the area. Since 20 November 2008, the area sporadically becomes itchy. The patient scratches the area, it scabs over, heals, and then becomes very itchy again. At the time of the report, the patient had not recovered. Follow up information was received on 09 February 2009 from a health professional. The reporter stated that the patient had been administered influenza vaccines (manufacturer unknown) in the past, however the patient has never had this type of reaction before. The patient has not recovered and is awaiting an appointment with a dermatologist. No further information was reported. Follow up information received 06 April 2009 from a health care professional who received the case and no additional information to provide at the time of the report. Follow up information received on 13 May 2009 from a health care professional who stated that the patient was evaluated by a dermatologist on 08 May 2009. The dermatologist recommended that the patient apply hydrocortisone cream to decrease the reaction at the site. The doctor diagnosed the symptoms as a local reaction to the injection. The patient is still recovering from the reaction. Follow up information received on 08 July 2009 from a health care professional. The reporter stated that according to the patient she recovered from the local reaction between mid May and June. No other information was provided.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bacteraemia, Blood creatinine increased, Body temperature increased, C-reactive protein normal
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever on 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on MOTRIN, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and come back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to urgent care clinic for worsening of left knee pain. The pain was sharp, locate to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has been noted with application of (rest, ice, compression and elevation (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistent fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Headache, Incisional drainage, Joint swelling
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever on 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on MOTRIN, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and come back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to urgent care clinic for worsening of left knee pain. The pain was sharp, locate to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has been noted with application of (rest, ice, compression and elevation (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistent fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Nausea, Osteomyelitis, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever on 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on MOTRIN, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and come back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to urgent care clinic for worsening of left knee pain. The pain was sharp, locate to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has been noted with application of (rest, ice, compression and elevation (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistent fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin warm, Staphylococcal infection, Tenderness, Weight bearing difficulty
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever on 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on MOTRIN, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and come back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to urgent care clinic for worsening of left knee pain. The pain was sharp, locate to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has been noted with application of (rest, ice, compression and elevation (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistent fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood creatinine increased, Body temperature increased, C-reactive protein normal, Dizziness
Clinical narrative: Initial report received on 17 February 2009 from another manufacturer as part of a study. The following is a Verbatim per the report: "She is an 11-year-old female patient who presented to the urgent care clinic for worsening left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever on 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on MOTRIN, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and come back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to urgent care clinic for worsening of left knee pain. The pain was sharp, locate to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has been noted with application of (rest, ice, compression and elevation (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistent fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.