chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Anxiety, Arthralgia, Back pain, Blood creatine phosphokinase increased, Chest pain
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Depression, Diabetes mellitus, Fasciitis, Fibromyalgia, Fracture
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Headache, Hypercholesterolaemia, Hypertension, Hypertrophy, Hypoaesthesia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Lung disorder, Memory impairment, Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Shoulder pain, Sleep apnoea syndrome, Sleep disorder, Tinnitus
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. PRESENT CONDITION: Patient has an unspecified, musculoskeletal pain syndrome temporally associated with the receipt of the anthrax vaccination series. For the past four years, he has experienced generalized pain that has been refractory to all medical regimens. He has been unable to perform to the minimum standards of the PFT for the past 2 years. His current disabilities have interfered with his ability to perform in his MOS. He has not participated in a deployment or field exercise secondary to his current medical condition and maintains a P3 profile. He currently has continuous generalized muscle pain and intermittent spasm in the arms, hands, back, chest, and legs. He walks with a cane for support at all times. He sleeps 3-4 hours/night and awakens non-refreshed. He often has cramping of muscles and painful numbness in feet, legs, and hands. He has short-term memory loss, and often forgets appointments or paying bills. His tinnitus is bilateral and continuous. His hypertension is controlled at 125/76. This service member's significant disabilities make it unlikely that he will meet the minimal physical standards for the military, attain the criteria for promotion or deploy rapidly to combat environment. He has reached maximum medical benefit at this time. He will need ongoing medical treatment and follow up for possible progression of clinical symptoms. CURRENT FUNCTIONAL STATUS: He experiences exacerbations and remissions in symptom severity but his overall level of functioning is extremely impaired. His is unable to run or walk briskly and cannot stand > 30 minutes. He cannot play sports. He has paresthesias and cramping of the hands, which impairs many activities and impairs his fine motor skills. Consequently, he cannot grip writing objects >3 minutes without cramping, or use tools for fine movement without losing grip strength. He is unable to play a musical instrument or type.  Diagnosis: 1) Multiple persistent physical symptoms related to service, etiology unspecified to varying degrees after exhaustive medical evaluation, including muscle biopsy. The following symptoms and/or previous diagnosed symptom-based syndromes are included in this category: shoulder, back, chest, joint, and headache pain, stinging and ringing in the ears, disordered sleep, tremor in his sleep, fatigue, and memory problems. 2) Fibromyalgia. 3) Obstructive Sleep Apnea. 4) Anxiety/Depression. 5) Right shoulder pain. 6) Low back pain. 7) Headache, Tension. 8) Tinnitus. 9) Hypercholesterolemia. 10) Elevated creatinine phosphokinase. 11) Sleep disorder. 12) Memory disorder. 13) Arthralgias. 14) Diabetes, Type II. 15) Plantar Fascitis. 16) Atypical chest pain. 17) History of mild left ventricular concentric hypertrophy. 18) History of Bronchitis.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Fatigue, Infection transmission via personal contact, Pharyngolaryngeal pain
Clinical narrative: This is a non serious case from a nurse in the USA of involving accidental exposure. The reported causality was not provided. This is a case of possible accidental exposure to FluMist. A parent called to report that she had developed sore throat, cough, weakness and fatigue with onset beginning the same day of administration (MEDI-0002477). While reporting her own adverse events she also stated that her 14 year old daughter also experienced sore throat, cough, weakness and fatigue beginning four days after the mother was vaccinated on Nov 10 2004. The child did not receive the vaccine and fully recovered on Nov 20 2004. Therefore, vaccine administration date, time and lot numbers are not applicable. Mar 04 2005 follow up information received from the reporter: confirmation that the patient never received FluMist.
Age: 21.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 21 year old female medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratch throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, Vaccine lot number
Age: 21.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 21 year old female medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratch throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, Vaccine lot number
Age: 64.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had accidental exposure (Unlabelled, USA) to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 64 year old female medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into there events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number
Age: 64.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had accidental exposure (Unlabelled, USA) to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 64 year old female medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into there events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number
Age: 34.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a health care professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 34 year old male medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number
Age: 34.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Pharyngolaryngeal pain
Clinical narrative: This is a non serious spontaneous case from a health care professional in the USA reporting that a medical support member had Accidental Exposure to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. A 34 year old male medical support member developed headache and scratch throat after accidental exposure during FluMist administration. Investigation into these events resulted in no definitive reason why the FluMist was responsible for these symptoms. HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes military personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Additional information received on Jan 05 2005 and Jan 19 2005 incorporated into above narrative. Additional information received on May 04 2005: patient name, gender and DOB, vaccine lot number
Age: 34.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pharyngitis, Pharyngolaryngeal pain, Rhinitis
Clinical narrative: MEDI 0002920 is not serious spontaneous case from a consumer or other non health professional in the USA of Runny Nose.The reporter causality is related to FluMist. This is a spontaneous case report sent by a consumer that refers to a male aged 33 years. He received FluMist on Feb 03 2005, the time was not recorded. On Feb 05 2005, the patient experienced a stuffed, runny nose, and cold symptoms. the time of onset was not reported. The reporter stated the events resolved in about a week. He used over the counter medicine for treatment and recovered. no further information available.
Age: 34.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Nasal congestion, Pharyngitis, Rhinitis, Rhinorrhoea
Clinical narrative: MEDI 0002920 is not serious spontaneous case from a consumer or other non health professional in the USA of Runny Nose.The reporter causality is related to FluMist. This is a spontaneous case report sent by a consumer that refers to a male aged 33 years. He received FluMist on Feb 03 2005, the time was not recorded. On Feb 05 2005, the patient experienced a stuffed, runny nose, and cold symptoms. the time of onset was not reported. The reporter stated the events resolved in about a week. He used over the counter medicine for treatment and recovered. no further information available.
Age: 24.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Fatigue, Irritability, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: This is a non serious case from a consumer in the USA involving nasal congestion. The reporter causality is not provided. A 24 year old female received FluMist on Jan 29 2005 and Experienced irritability, sneezing, runny nose for 2 days followed by 2 days of nasal congestion. it is unknown if the patient recovered from the reported symptoms. Reporter causality was not provided. Feb 28 2005 received additional information : demographics, vaccine date, events details and past med history. Oct 26, 2005 additional information added: patient's age and AE onset.
Age: 24.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Irritability, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: This is a non serious case from a consumer in the USA involving nasal congestion. The reporter causality is not provided. A 24 year old female received FluMist on Jan 29 2005 and Experienced irritability, sneezing, runny nose for 2 days followed by 2 days of nasal congestion. it is unknown if the patient recovered from the reported symptoms. Reporter causality was not provided. Feb 28 2005 received additional information : demographics, vaccine date, events details and past med history. Oct 26, 2005 additional information added: patient's age and AE onset.
Age: 18.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Arthralgia, Arthritis, Urticaria
Clinical narrative: This is not serious case from a physician in the USA of Urticaria. The reported causality was not provided to FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 18 years. She received FluMist on Feb 10 2005. The patients concomitant medication included drospirenone. The patient developed a flu like illness five days prior to FluMist vaccination. Sometime on Feb 15 2005 the patient developed an urticarial rash, On Feb 20 2005, she developed pain with walking and pain in many joints especially in her knees. She presented in the reporters office on Feb 24 2005 for initial consultation and was diagnosed with reactive arthritis. She received Toradol for treatment and ultra bet for pain. The reported stated he was not sure if the events were due to FluMist. Attempts to locate the vaccine facility and lot number have been unsuccessful. The reporter stated that the patient was lost to follow up. No further information is available. April 25 2005 additional information received from the reporter and incorporated in the narrative: Patients date of birth, confirmation that the reported vaccine facility was incorrect, and the patient was lost to follow up
Age: 18.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Arthralgia, Arthritis, Influenza like illness, Pain, Urticaria
Clinical narrative: This is not serious case from a physician in the USA of Urticaria. The reported causality was not provided to FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 18 years. She received FluMist on Feb 10 2005. The patients concomitant medication included drospirenone. The patient developed a flu like illness five days prior to FluMist vaccination. Sometime on Feb 15 2005 the patient developed an urticarial rash, On Feb 20 2005, she developed pain with walking and pain in many joints especially in her knees. She presented in the reporters office on Feb 24 2005 for initial consultation and was diagnosed with reactive arthritis. She received Toradol for treatment and ultra bet for pain. The reported stated he was not sure if the events were due to FluMist. Attempts to locate the vaccine facility and lot number have been unsuccessful. The reporter stated that the patient was lost to follow up. No further information is available. April 25 2005 additional information received from the reporter and incorporated in the narrative: Patients date of birth, confirmation that the reported vaccine facility was incorrect, and the patient was lost to follow up
Age: 18.0
Sex: M
Vaccine: ANTH, HEPAB, TYP
Symptoms: Injection site abscess, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Initially pt had repeat cycle of scab formation, no other sx's. Currently pt reports that vaccine site enlarges and itches monthly with pus. erythema, no ulceration. No regional lymphadenopathy, no constitutional sx's. Pt does not give a reason why he has waited till now to report these sx's.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Anorexia, Chills, Headache, Hypersensitivity, Malaise
Clinical narrative: The reporter causality is not provided to FLUMIST. A pharmacist reported loss of appetite, headach, severe myalgia, extreem malaise, low-grade fever, childs, and slight nasal congestion in a female patient after received a Flumist vaccination, This 10 year old female with a history of seasonal allergies received FluMist at the reporters pharmacy on Nov 12 2004. The reported onset date for the events was Nov 13 2004. The events continued for six days with the first four days more severe thatn the latter. The patient received acetaminophen and ibuprofen for treatment and recovered on Nov 18 2004
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Nasal congestion, Pyrexia
Clinical narrative: The reporter causality is not provided to FLUMIST. A pharmacist reported loss of appetite, headach, severe myalgia, extreem malaise, low-grade fever, childs, and slight nasal congestion in a female patient after received a Flumist vaccination, This 10 year old female with a history of seasonal allergies received FluMist at the reporters pharmacy on Nov 12 2004. The reported onset date for the events was Nov 13 2004. The events continued for six days with the first four days more severe thatn the latter. The patient received acetaminophen and ibuprofen for treatment and recovered on Nov 18 2004
Age: 49.8
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Chills, Headache, Influenza, Pain
Clinical narrative: The reporter causality is not provided. Case reference MEDI-0002521 is a spontaneous case report sent by consumer which refers to male aged 49 years. The male received FluMist on Nov 23 2004 at 4pm. ON Nov 25 2004, the male stated he was achy all over and had a headache, By the following day the reporter stated he had the full blown flu. On Nov 26 2004 he had light chills that became worse by Nov 27 2004. He stated his chills were so severe on Nov 27 2004 that he had to wear a coat while indoors. He used ibuprofen for treatment. By Dec 02 2004 all events excluding loss of appetite had resolved. The reporter stated his appetite returned on Dec 05 2004.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Influenza, Ocular hyperaemia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: This is a non serious spontaneous case from a physician in the USA who reports a patient tested positive for influenza A (Labeled,USA). The reporter did not provide causality between events and FluMist vaccination. On Nov 11 2004, a 6 year old male received FluMist intranasally and developed fever, sore throat, and stomach ache on the morning of Mar 19 2005. He went to an urgent care facility where he initiated amoxicillin treatment. On Mar 21 2005, the patient visited the doctor where he complained of fever, runny nose, and red eyes. A nasal swab was taken and tested for Influenza A and B. The patient tested positive for influenza A and he discontinued amoxicillin. The patient has improved but has not yet recovered.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: This is a non serious spontaneous case from a physician in the USA who reports a patient tested positive for influenza A (Labeled,USA). The reporter did not provide causality between events and FluMist vaccination. On Nov 11 2004, a 6 year old male received FluMist intranasally and developed fever, sore throat, and stomach ache on the morning of Mar 19 2005. He went to an urgent care facility where he initiated amoxicillin treatment. On Mar 21 2005, the patient visited the doctor where he complained of fever, runny nose, and red eyes. A nasal swab was taken and tested for Influenza A and B. The patient tested positive for influenza A and he discontinued amoxicillin. The patient has improved but has not yet recovered.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: The reporter determined that the symptoms were related to receipt of FluMist. A nurse at a military clinic reported that an adult patient received FluMist in January 2005. A few hours later, the patient experienced flu like symptoms. The reporter felt that the symptoms were related to FluMist but she did not think that it should be reported because it was an expected reaction. The patients demographic information was not recorded. It is also unknown if the patient recovered from the reported symptoms.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Skin discolouration, Tenderness, Urticaria
Clinical narrative: This is a non serious spontaneous case reported by a nurse in the USA of a 43 year old female who developed hives after receiving FluMist. The reported did not provide casual relationship to FluMist vaccine. A 43 year old female developed hives on both legs within 24 hours of receiving FluMist on Apr 12 2005. the patient had planned for a trip and decided to get the FluMist from a travel health office. Per the reporter, the patient proceeded with her travel plans even when the hives began to appear, However, she reported the event to the travel health office only upon coming back where she was advised to consult with her family physician. the patient is not allergic to eggs but claimed to be prone to skin sensitivity and getting sick easily. The patient did not report any doctor visits or hospitalizations related to this while she was abroad. She has not recovered from this event. The hives are resolving, but the sites were described as still tender and somewhat black and blue in color, Reporter causality was not provided.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: MEDI-0003483 is a non serious spontaneous case from a consumer in USA involving flu like symptoms. The reporter causality is not provided to FluMist. A 40 year old male received FluMist on Oct 27 2004 at 1:48 pm. 3-4 days after receiving the vaccine, patient experienced nasal congestion. On the 6th day, the patient felt worse with more flu like symptoms and felt that he developed full blown influenza, He complained of chest congestion, cough, muscle aches, fever and nausea. The patient called his doctor to inform him of his symptoms. He was advised to stay home and rest. His doctor reported the symptoms he developed to the Center for Disease (CDC). After a month, the patient fully recovered. He was then seen at his doctors office where a nasal swab was taken but he did not know what the result was. Per nurse at doctors office, there was no record on patients chart that a nasal swab was done at their office. The reporter felt the events are possibly related to FluMist, although he stated that he was also doing some paint jobs a few days after he received FluMist. The patient fully recovered. Additional information incorporated in narrative. AE onset date.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Pyrexia
Clinical narrative: MEDI-0003483 is a non serious spontaneous case from a consumer in USA involving flu like symptoms. The reporter causality is not provided to FluMist. A 40 year old male received FluMist on Oct 27 2004 at 1:48 pm. 3-4 days after receiving the vaccine, patient experienced nasal congestion. On the 6th day, the patient felt worse with more flu like symptoms and felt that he developed full blown influenza, He complained of chest congestion, cough, muscle aches, fever and nausea. The patient called his doctor to inform him of his symptoms. He was advised to stay home and rest. His doctor reported the symptoms he developed to the Center for Disease (CDC). After a month, the patient fully recovered. He was then seen at his doctors office where a nasal swab was taken but he did not know what the result was. Per nurse at doctors office, there was no record on patients chart that a nasal swab was done at their office. The reporter felt the events are possibly related to FluMist, although he stated that he was also doing some paint jobs a few days after he received FluMist. The patient fully recovered. Additional information incorporated in narrative. AE onset date.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: This is a not serious spontaneous case from a consumer other non health professional in the USA of Headache. The reporter causality is not provided to FluMist. A consumer reported headache, abdominal pain, 100 degree F temperature, vomiting, diarrhea, chills fatigue, muscle ache, and malaise in her husband three days after receiving the FluMist vaccine. The 37 year old male received FluMist on Nov 19 2004. On the Morning of Nov 22 2004, the patient awoke with a headache that became worse by the afternoon. He had chills severe fatigue that became worse in the evening. Later, on the evening of Nov 22 2004, he had general muscle aches, malaise, and abdominal pain. he began vomiting about 9:00 pm on Nov 22 2004. The reporter stated on Nov 23 2004, her husband felt a little better. He still had fatigue, minor diarrhea, and a mild headache. No further information is available.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Myalgia, Pyrexia, Vomiting
Clinical narrative: This is a not serious spontaneous case from a consumer other non health professional in the USA of Headache. The reporter causality is not provided to FluMist. A consumer reported headache, abdominal pain, 100 degree F temperature, vomiting, diarrhea, chills fatigue, muscle ache, and malaise in her husband three days after receiving the FluMist vaccine. The 37 year old male received FluMist on Nov 19 2004. On the Morning of Nov 22 2004, the patient awoke with a headache that became worse by the afternoon. He had chills severe fatigue that became worse in the evening. Later, on the evening of Nov 22 2004, he had general muscle aches, malaise, and abdominal pain. he began vomiting about 9:00 pm on Nov 22 2004. The reporter stated on Nov 23 2004, her husband felt a little better. He still had fatigue, minor diarrhea, and a mild headache. No further information is available.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Headache, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: This is a non serious spontaneous case from a registered pharmacist in the USA who experience a Nose Bleed after receiving FluMist. The reporter did not provide causality between events and FluMist vaccination. At 9:45 am on Nov 10 2004, a 33 year old female received FluMist intranasally and experienced headache, runny nose, and slight fever on Nov 11 2004. On Nov 12 2004, the patient experienced nasal congestion and on the same day her runny nose resolved. The nasal congestion was unresponsive to Flonase (fluticasone propionate) and Deconsal (guaifenesin/pseudoephedrine). Her headache was treated with Tylenol (acetaminophen). On Nov 20 2004, the nasal congestion was on going. On the evening of Nov 20 2004, the patient experienced a severe nose bleed. She is scheduled for an ENT visit in Nov 24 2004. The patient has been using Ocean nasal (sodium chloride) nasal since Nov 11 2004. The reporter did not provide causality between events and FluMist vaccination.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Nasal congestion, Otitis media, Rhinorrhoea
Clinical narrative: This is not serious spontaneous case from a nurse in the USA involving Red Face. The reporter causality is not related to FluMist. A nurse reported a red face, runny nose, ear infection, and nasal congestion in female patient 1 day after receiving her FluMist vaccine. This 5 year old girl with a history of allergies presented in the reporters office on Nov 08 2004 with an ear infection. The patient received an intramuscular injection of ceftriaxone sodium for treatment of the ear infection and she received the FluMist vaccine. On Nov 23 200, the patient had a runny nose and nasal congestion. On Nov 15 2004, the infant presented in the reporters office with an ear infection. The patients runny nose had improved but her face was red from nose to her lip. The reporter stated she did not know if the patients face was red due to rubbing her face or if it was red due to the blowing of her nose. No further information is available.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite, Headache, Photophobia, Pyrexia
Clinical narrative: Meningeal symptoms - headache, fever (100.8), photophobia, decreased appetite.
Age: 62.0
Sex: M
Vaccine: PPV, TD
Symptoms: Fatigue, Feeling hot, Oedema peripheral, Oedema peripheral, Pruritus
Clinical narrative: Received immunizations Friday. By Saturday evening, arm hot, swollen, tender. Went to ER due to SOB - received Nebulizer treatment and allergy meds and sent home. Sunday - swelling increased to hand; back to ER, admit. In hospital Sunday - Monday receiving IV Rocephin q 12, took 1 pain pill starting to improve. Fever presented Saturday and Sunday. Monday 5 PM, swelling and minimum fever - no SOB. Follow-up: Recipient describes bouts of pruritis in area of administration on arm. Recipient has been stricken with excessive fatigue since event. Physicians are investigating possible causes. Recipient will be participating in sleep study to rule out sleep apnea. Recipient has history of asthma. Recipient has not identified further swelling or range of motion problems since his hospitalization and treatment.
Age: 62.0
Sex: M
Vaccine: PPV, TD
Symptoms: Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Received immunizations Friday. By Saturday evening, arm hot, swollen, tender. Went to ER due to SOB - received Nebulizer treatment and allergy meds and sent home. Sunday - swelling increased to hand; back to ER, admit. In hospital Sunday - Monday receiving IV Rocephin q 12, took 1 pain pill starting to improve. Fever presented Saturday and Sunday. Monday 5 PM, swelling and minimum fever - no SOB. Follow-up: Recipient describes bouts of pruritis in area of administration on arm. Recipient has been stricken with excessive fatigue since event. Physicians are investigating possible causes. Recipient will be participating in sleep study to rule out sleep apnea. Recipient has history of asthma. Recipient has not identified further swelling or range of motion problems since his hospitalization and treatment.
Age: 62.0
Sex: F
Vaccine: HEPAB, TYP, YF, HEPAB, TYP, YF
Symptoms: Chest X-ray abnormal, Haematemesis, Influenza like illness, Pleurisy
Clinical narrative: An initial report was received in the USA from a health care professional on 7/29/05. A 62 year old female patient experienced flu-like symptoms six days after receiving a SC injection of YF-VAX, lot number UE500AA, in the right arm, an IM injection of TYPHIM Vi, lot number X0464-2 in the right deltoid, and HEPATITIS A AND B COMBO VACCINE, lot number AHABB029AB, in the left deltoid. All of these vaccines were the first doses received by the patient. She was diagnosed with pneumonia and pleurisy the following day on 7/26/05. She was also noted to be spitting up blood. She was treated with Tequin 400mg daily for 14 days and recovered. The patient had a past medical history of having pneumonia several times. The patient was referred to a pulmonologist whose name and address was also provided. (OMIC) Follow-up information received on 06/Sep/2005 from a health care provider. It was reported that the patient returned in September 2005. She reporter that she was very sick with high altitude sickness. She had DIAMOX to take, but her physician only wanted her to take half strength. When she returned to sea level she was much better, but was scheduled to follow-up with her pulmonologist in six months.
Age: 62.0
Sex: F
Vaccine: HEPAB, TYP, YF, HEPAB, TYP, YF
Symptoms: Haematemesis, Influenza like illness, Pleurisy, Pneumonia, Pyrexia
Clinical narrative: An initial report was received in the USA from a health care professional on 7/29/05. A 62 year old female patient experienced flu-like symptoms six days after receiving a SC injection of YF-VAX, lot number UE500AA, in the right arm, an IM injection of TYPHIM Vi, lot number X0464-2 in the right deltoid, and HEPATITIS A AND B COMBO VACCINE, lot number AHABB029AB, in the left deltoid. All of these vaccines were the first doses received by the patient. She was diagnosed with pneumonia and pleurisy the following day on 7/26/05. She was also noted to be spitting up blood. She was treated with Tequin 400mg daily for 14 days and recovered. The patient had a past medical history of having pneumonia several times. The patient was referred to a pulmonologist whose name and address was also provided. (OMIC) Follow-up information received on 06/Sep/2005 from a health care provider. It was reported that the patient returned in September 2005. She reporter that she was very sick with high altitude sickness. She had DIAMOX to take, but her physician only wanted her to take half strength. When she returned to sea level she was much better, but was scheduled to follow-up with her pulmonologist in six months.
Age: 62.0
Sex: F
Vaccine: HEPAB, TYP, YF, HEPAB, TYP, YF
Symptoms: Viral infection
Clinical narrative: An initial report was received in the USA from a health care professional on 7/29/05. A 62 year old female patient experienced flu-like symptoms six days after receiving a SC injection of YF-VAX, lot number UE500AA, in the right arm, an IM injection of TYPHIM Vi, lot number X0464-2 in the right deltoid, and HEPATITIS A AND B COMBO VACCINE, lot number AHABB029AB, in the left deltoid. All of these vaccines were the first doses received by the patient. She was diagnosed with pneumonia and pleurisy the following day on 7/26/05. She was also noted to be spitting up blood. She was treated with Tequin 400mg daily for 14 days and recovered. The patient had a past medical history of having pneumonia several times. The patient was referred to a pulmonologist whose name and address was also provided. (OMIC) Follow-up information received on 06/Sep/2005 from a health care provider. It was reported that the patient returned in September 2005. She reporter that she was very sick with high altitude sickness. She had DIAMOX to take, but her physician only wanted her to take half strength. When she returned to sea level she was much better, but was scheduled to follow-up with her pulmonologist in six months.
Age: 1.19
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Small lump with slightly reddened skin at site of injection, appeared 2 days after immunization in right thigh - pneumo conj.  Treated with warm compresses.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Erythema, Urticaria
Clinical narrative: Redness left arm, Urticaria reaction - also left face and forearm.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Redness, edema, pain to upper left arm - Cellulitis, symptomatic treatment and Keflex by mouth.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 103.9 and rash, no other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: On Monday 07/18/2005 child received immunizations with noted problems.  Mom stated on the next AM around 09:00AM she noted his left arm swollen, hot red, she then applied cold compress, the heat decreased then returned she called the health department at 11:00AM 07/19/2005 and was advised to continue with cold compresses and call childs pediatrician.  They advised Tylenol and continue cold compresses, called back and infant was better.