chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Difficulty in walking, Influenza like illness, Injection site swelling
Clinical narrative: 56 year old female had warmth and edema at the injection site after each of the first four anthrax vaccines.  This was accompanied by axillary lymphadenopathy, generalized myalgias, stiff joints, and flu-like symptoms.  After the second dose, initiated pretreatment with an oral antihistamine and Advil for the subsequent doses.  After each of the first three doses she had symptoms for 3  4 days and then they completely resolved.  These symptoms did not affect her ability to do her job. On 8 Sep 03 she received the fourth dose of anthrax vaccine.  She developed all of the same symptoms as with previous doses.  On 11 Sep 03 she had worsening pain in her knees, L>R.  By the fourth day, both knees were inflamed, and edematous, L>R.  She could not walk up or down stairs or bear full weight on the left leg.  Her left knee began to "buckle" intermittently.  As a result, she tore the meniscus on the left.  She was diagnosed with arthritis by a civilian doctor after X-rays were taken.  A MRI was ordered and she was sent to an Orthopedic doctor.  The MRI was normal except for the arthritis.  She received three steroid injections into the knee joint without any change in symptoms.  By this time, her right knee was getting worse and she tore the meniscus on the right.  She has undergone arthroscopy on both knees which confirmed the arthritis diagnosis.  The left knee has subsequently been injected with synthetic cushioning which has also been ineffective in relieving the symptoms.  The pain varies from a level of 1 to 7 out of 10 on any given day.  Walking and going down stairs makes the pain worse.  To avoid worsening of pain, repositioning while sitting is frequently required.  Also, if she turns the wrong way in her sleep, the pain will wake her up.  She is currently taking Bextra 20 mg a day with some pain relief, but the pain never completely resolves.   On 20 Jul 04 She received anthrax dose #5.  She had redness and swelling at the injection site that measured approximately 10 cm and was accompanied by axillary lymphadenopathy.  The nodule that appeared at the injection site was present for approximately 2 months.
Age: 55.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Joint stiffness, Lymphadenopathy, Myalgia
Clinical narrative: 56 year old female had warmth and edema at the injection site after each of the first four anthrax vaccines.  This was accompanied by axillary lymphadenopathy, generalized myalgias, stiff joints, and flu-like symptoms.  After the second dose, initiated pretreatment with an oral antihistamine and Advil for the subsequent doses.  After each of the first three doses she had symptoms for 3  4 days and then they completely resolved.  These symptoms did not affect her ability to do her job. On 8 Sep 03 she received the fourth dose of anthrax vaccine.  She developed all of the same symptoms as with previous doses.  On 11 Sep 03 she had worsening pain in her knees, L>R.  By the fourth day, both knees were inflamed, and edematous, L>R.  She could not walk up or down stairs or bear full weight on the left leg.  Her left knee began to "buckle" intermittently.  As a result, she tore the meniscus on the left.  She was diagnosed with arthritis by a civilian doctor after X-rays were taken.  A MRI was ordered and she was sent to an Orthopedic doctor.  The MRI was normal except for the arthritis.  She received three steroid injections into the knee joint without any change in symptoms.  By this time, her right knee was getting worse and she tore the meniscus on the right.  She has undergone arthroscopy on both knees which confirmed the arthritis diagnosis.  The left knee has subsequently been injected with synthetic cushioning which has also been ineffective in relieving the symptoms.  The pain varies from a level of 1 to 7 out of 10 on any given day.  Walking and going down stairs makes the pain worse.  To avoid worsening of pain, repositioning while sitting is frequently required.  Also, if she turns the wrong way in her sleep, the pain will wake her up.  She is currently taking Bextra 20 mg a day with some pain relief, but the pain never completely resolves.   On 20 Jul 04 She received anthrax dose #5.  She had redness and swelling at the injection site that measured approximately 10 cm and was accompanied by axillary lymphadenopathy.  The nodule that appeared at the injection site was present for approximately 2 months.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Dyspnoea, Injection site erythema, Injection site induration, Oedema
Clinical narrative: Pneumonia vaccine administered afternoon of 10/12/04. Patient awoke at 3am 10/13/04 "gasping for air" and noticed small rash 3in. below inj site. Woke in A.M. with palm-sized erythema & hardness in same area. Took Zyrtec at that time. Presented to me at ~11A.M. 10/13/04 in no apparent respiratory distress. I told her to go to doctor asap for follow-up. Per pt: Bullseye at shot site 4 hrs later, 8 hrs after shot generalized rash on arm with swelling. Took Benadryl PO saw her allergist 10/13/04 who advised no additional medication-use ice to site of Pneumovax. Some progression of swelling rash thru 10/14. Better on 10/16/04, continues with brusing on arm, pain almost gone
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Pneumonia vaccine administered afternoon of 10/12/04. Patient awoke at 3am 10/13/04 "gasping for air" and noticed small rash 3in. below inj site. Woke in A.M. with palm-sized erythema & hardness in same area. Took Zyrtec at that time. Presented to me at ~11A.M. 10/13/04 in no apparent respiratory distress. I told her to go to doctor asap for follow-up. Per pt: Bullseye at shot site 4 hrs later, 8 hrs after shot generalized rash on arm with swelling. Took Benadryl PO saw her allergist 10/13/04 who advised no additional medication-use ice to site of Pneumovax. Some progression of swelling rash thru 10/14. Better on 10/16/04, continues with brusing on arm, pain almost gone
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Influenza like illness, Pyrexia
Clinical narrative: Tuesday Oct. 13 04 at 2:30 pm I received my Flu shot about 4 hrs later I began to have chills and then fever, felt weak. I covered up after lying down. After about 16 - 18 hrs the flu like symptoms subsided and I began to feel back to normal. Just wanted to submit this info for your benefit.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Urticaria over chest and back.  No respiratory distress.  Symptomatic care and referral to allergist recommended.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Eye irritation, Eye swelling, Eyelid oedema, Ocular hyperaemia
Clinical narrative: At approximately 9:15 am on 10/12/04 the flu vaccine was administered.  Patient states that as soon as she recieved the injection her right eye began to burn.  She did not notify the nurse because she did not realize it was due to the injection.  Her Grandfather took her to school after that.  During the school day the tissue around the right eye became red and began to swell.  When I came home from work at 6pm her eyelid above the eye was extremely swollen.  The tissue below the eye was also extremely swollen and dark.  I gave her 25mg of Benadryl at 6pm and another 25mg at 10pm.  The next morning,(10-13-04)the swelling around her eye came down but the tissue was still slightly swollen.  Underneath her eye the tissue became bruised.  I took her in to her Pediatrician to have the reaction documented in her chart.  As of today 10-14-04 the swelling is almost completely gone however the tissue underneath the right eye has a bruise approximately 2cm long and 0.5cm wide.
Age: 24.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. stated appx. 16 hours after injection the injection site on right arm became swollen, red, hot and tender to touch.  Pt. states he massaged the injection under warm water and used a warm compress to affected area off and on for 6-8 hours.  Next he placed ice packs on injection site for appx. 30 minutes every 4-6 hours.  Pt. took no medications as he was directed at time of injection.  Pt. has NKDA. circumference of upper arms was Right upper bicep 43.0 cm mid bicep 40.0 cm lower bicep 35.5cm erythema vertical 20 inches horizontal 24 inches left upper bicep 39.0 cm left mid bicep 37.0 cm left lower bicep32.5 cm Pt. was instructed by physician to take motrin every 6-8 hours, apply ice packs for 30 min. every 4-6 hours and apply corticaid cream as needed not to exceed twice a day.  If condition shows no signs of improvement in 48 hours to seek follow up with provider.
Age: 0.49
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, HIBV
Symptoms: Decreased appetite, Irritability, Pharyngitis
Clinical narrative: Mother called office 10/1/04 reaction to shot. Hib vaccine on 9/29/04. Temp 100.3 rectally. Extremely fussy. Mother states she couldn't get to office referred to ER 10/4/04. Spoke to mom. Tylenol given. Temp decreased. Tooth broke through. Did not go to ER.
Age: 0.49
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: Mother called office 10/1/04 reaction to shot. Hib vaccine on 9/29/04. Temp 100.3 rectally. Extremely fussy. Mother states she couldn't get to office referred to ER 10/4/04. Spoke to mom. Tylenol given. Temp decreased. Tooth broke through. Did not go to ER.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Cough, Injection site oedema, Injection site pain, Nasal congestion, Otitis media
Clinical narrative: Patient is a 23 year old male who received his first and only anthrax (AVA) immunization on 13 June 04. He noticed swelling at the back of his left arm for about 5 weeks. He stated that this swelling was about the size of an inch and that the area was hard. He now reports that if he raises his arms he can feel a knot in the area.  One week following his immunization he stated that he felt tired and that when he woke up it felt like his body was beat up. He found it difficult to run even though he was physically active prior to his AVA. He said that his muscles were stiff and that his whole body felt like it was weak. He noticed this feeling more in the mornings and would go away as the day progressed and if he would stretch. He reported that all of his muscles felt stiff at the same time. He stated that the stiffness still persists and that he has some relief from taking Motrin 600 mg twice daily. He also noticed nasal congestion at this time. He reported that he has a history of sinus problems but that it usually clears in about one week.   In the middle of July, while at the beach, he stated that he felt sick and that his arm was itchy at the injection site. He noticed swelling over the injection site about the size of a quarter. He stated he was exposed to the sun for about 1to 11/2 hrs and when he went inside the swelling went down; however, he felt a slight lump under the skin. He had 4 other repeat episodes so now he remains inside. His last episode was in mid August.   At the end of July he experienced chest congestion and has been sick ever since that time. He reports coughing with occasional yellow sputum production and denies fever. He reports that he now has wheezing when he runs, which he has never had before.  Also at the end of July he has been having headaches, which he notices every morning and that it usually clears by afternoon. Currently he experiences a slight pressure feeling in his head throughout the day. He stated the pain depends on what side he sleeps on; if he sleeps on the right he will have the discomfort on the right side. He also reports a popping sensation in his ears. He denies any problems with vision, nausea, vomiting, and fever. He reports that the areas over his eyes and especially under his eyes are tender to touch.  He also reports problems sleeping because he remains awake thinking about his head hurting.  He said that he first noticed problems sleeping about 1 week following his shot because he spends a lot of time thinking about things. He states that is tiredness is a result of his lack of sleep.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Respiratory disorder, Sinusitis
Clinical narrative: Patient is a 23 year old male who received his first and only anthrax (AVA) immunization on 13 June 04. He noticed swelling at the back of his left arm for about 5 weeks. He stated that this swelling was about the size of an inch and that the area was hard. He now reports that if he raises his arms he can feel a knot in the area.  One week following his immunization he stated that he felt tired and that when he woke up it felt like his body was beat up. He found it difficult to run even though he was physically active prior to his AVA. He said that his muscles were stiff and that his whole body felt like it was weak. He noticed this feeling more in the mornings and would go away as the day progressed and if he would stretch. He reported that all of his muscles felt stiff at the same time. He stated that the stiffness still persists and that he has some relief from taking Motrin 600 mg twice daily. He also noticed nasal congestion at this time. He reported that he has a history of sinus problems but that it usually clears in about one week.   In the middle of July, while at the beach, he stated that he felt sick and that his arm was itchy at the injection site. He noticed swelling over the injection site about the size of a quarter. He stated he was exposed to the sun for about 1to 11/2 hrs and when he went inside the swelling went down; however, he felt a slight lump under the skin. He had 4 other repeat episodes so now he remains inside. His last episode was in mid August.   At the end of July he experienced chest congestion and has been sick ever since that time. He reports coughing with occasional yellow sputum production and denies fever. He reports that he now has wheezing when he runs, which he has never had before.  Also at the end of July he has been having headaches, which he notices every morning and that it usually clears by afternoon. Currently he experiences a slight pressure feeling in his head throughout the day. He stated the pain depends on what side he sleeps on; if he sleeps on the right he will have the discomfort on the right side. He also reports a popping sensation in his ears. He denies any problems with vision, nausea, vomiting, and fever. He reports that the areas over his eyes and especially under his eyes are tender to touch.  He also reports problems sleeping because he remains awake thinking about his head hurting.  He said that he first noticed problems sleeping about 1 week following his shot because he spends a lot of time thinking about things. He states that is tiredness is a result of his lack of sleep.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Asthenia, Eye pain, Fatigue, Headache, Injection site hypersensitivity
Clinical narrative: Patient is a 23 year old male who received his first and only anthrax (AVA) immunization on 13 June 04. He noticed swelling at the back of his left arm for about 5 weeks. He stated that this swelling was about the size of an inch and that the area was hard. He now reports that if he raises his arms he can feel a knot in the area.  One week following his immunization he stated that he felt tired and that when he woke up it felt like his body was beat up. He found it difficult to run even though he was physically active prior to his AVA. He said that his muscles were stiff and that his whole body felt like it was weak. He noticed this feeling more in the mornings and would go away as the day progressed and if he would stretch. He reported that all of his muscles felt stiff at the same time. He stated that the stiffness still persists and that he has some relief from taking Motrin 600 mg twice daily. He also noticed nasal congestion at this time. He reported that he has a history of sinus problems but that it usually clears in about one week.   In the middle of July, while at the beach, he stated that he felt sick and that his arm was itchy at the injection site. He noticed swelling over the injection site about the size of a quarter. He stated he was exposed to the sun for about 1to 11/2 hrs and when he went inside the swelling went down; however, he felt a slight lump under the skin. He had 4 other repeat episodes so now he remains inside. His last episode was in mid August.   At the end of July he experienced chest congestion and has been sick ever since that time. He reports coughing with occasional yellow sputum production and denies fever. He reports that he now has wheezing when he runs, which he has never had before.  Also at the end of July he has been having headaches, which he notices every morning and that it usually clears by afternoon. Currently he experiences a slight pressure feeling in his head throughout the day. He stated the pain depends on what side he sleeps on; if he sleeps on the right he will have the discomfort on the right side. He also reports a popping sensation in his ears. He denies any problems with vision, nausea, vomiting, and fever. He reports that the areas over his eyes and especially under his eyes are tender to touch.  He also reports problems sleeping because he remains awake thinking about his head hurting.  He said that he first noticed problems sleeping about 1 week following his shot because he spends a lot of time thinking about things. He states that is tiredness is a result of his lack of sleep.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: Patient is a 23 year old male who received his first and only anthrax (AVA) immunization on 13 June 04. He noticed swelling at the back of his left arm for about 5 weeks. He stated that this swelling was about the size of an inch and that the area was hard. He now reports that if he raises his arms he can feel a knot in the area.  One week following his immunization he stated that he felt tired and that when he woke up it felt like his body was beat up. He found it difficult to run even though he was physically active prior to his AVA. He said that his muscles were stiff and that his whole body felt like it was weak. He noticed this feeling more in the mornings and would go away as the day progressed and if he would stretch. He reported that all of his muscles felt stiff at the same time. He stated that the stiffness still persists and that he has some relief from taking Motrin 600 mg twice daily. He also noticed nasal congestion at this time. He reported that he has a history of sinus problems but that it usually clears in about one week.   In the middle of July, while at the beach, he stated that he felt sick and that his arm was itchy at the injection site. He noticed swelling over the injection site about the size of a quarter. He stated he was exposed to the sun for about 1to 11/2 hrs and when he went inside the swelling went down; however, he felt a slight lump under the skin. He had 4 other repeat episodes so now he remains inside. His last episode was in mid August.   At the end of July he experienced chest congestion and has been sick ever since that time. He reports coughing with occasional yellow sputum production and denies fever. He reports that he now has wheezing when he runs, which he has never had before.  Also at the end of July he has been having headaches, which he notices every morning and that it usually clears by afternoon. Currently he experiences a slight pressure feeling in his head throughout the day. He stated the pain depends on what side he sleeps on; if he sleeps on the right he will have the discomfort on the right side. He also reports a popping sensation in his ears. He denies any problems with vision, nausea, vomiting, and fever. He reports that the areas over his eyes and especially under his eyes are tender to touch.  He also reports problems sleeping because he remains awake thinking about his head hurting.  He said that he first noticed problems sleeping about 1 week following his shot because he spends a lot of time thinking about things. He states that is tiredness is a result of his lack of sleep.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nausea, Pruritus, Sleep disorder, Wheezing
Clinical narrative: Patient is a 23 year old male who received his first and only anthrax (AVA) immunization on 13 June 04. He noticed swelling at the back of his left arm for about 5 weeks. He stated that this swelling was about the size of an inch and that the area was hard. He now reports that if he raises his arms he can feel a knot in the area.  One week following his immunization he stated that he felt tired and that when he woke up it felt like his body was beat up. He found it difficult to run even though he was physically active prior to his AVA. He said that his muscles were stiff and that his whole body felt like it was weak. He noticed this feeling more in the mornings and would go away as the day progressed and if he would stretch. He reported that all of his muscles felt stiff at the same time. He stated that the stiffness still persists and that he has some relief from taking Motrin 600 mg twice daily. He also noticed nasal congestion at this time. He reported that he has a history of sinus problems but that it usually clears in about one week.   In the middle of July, while at the beach, he stated that he felt sick and that his arm was itchy at the injection site. He noticed swelling over the injection site about the size of a quarter. He stated he was exposed to the sun for about 1to 11/2 hrs and when he went inside the swelling went down; however, he felt a slight lump under the skin. He had 4 other repeat episodes so now he remains inside. His last episode was in mid August.   At the end of July he experienced chest congestion and has been sick ever since that time. He reports coughing with occasional yellow sputum production and denies fever. He reports that he now has wheezing when he runs, which he has never had before.  Also at the end of July he has been having headaches, which he notices every morning and that it usually clears by afternoon. Currently he experiences a slight pressure feeling in his head throughout the day. He stated the pain depends on what side he sleeps on; if he sleeps on the right he will have the discomfort on the right side. He also reports a popping sensation in his ears. He denies any problems with vision, nausea, vomiting, and fever. He reports that the areas over his eyes and especially under his eyes are tender to touch.  He also reports problems sleeping because he remains awake thinking about his head hurting.  He said that he first noticed problems sleeping about 1 week following his shot because he spends a lot of time thinking about things. He states that is tiredness is a result of his lack of sleep.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: Pt admitted to ER with fish hook in right hand. She received a Tetanus booster in left deltoid area. Later in day patient felt pain in left arm and pain radiating into left chest. The discomfort became severe which progressed to fever and chills. Temp  38.7. Marked tenderness throughout cervical spizla, upper back, left shoulder, biceps, triceps.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Arthritis, Chest pain, Chills, Discomfort, Pain
Clinical narrative: Pt admitted to ER with fish hook in right hand. She received a Tetanus booster in left deltoid area. Later in day patient felt pain in left arm and pain radiating into left chest. The discomfort became severe which progressed to fever and chills. Temp  38.7. Marked tenderness throughout cervical spizla, upper back, left shoulder, biceps, triceps.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Pyrexia, Tenderness
Clinical narrative: Pt admitted to ER with fish hook in right hand. She received a Tetanus booster in left deltoid area. Later in day patient felt pain in left arm and pain radiating into left chest. The discomfort became severe which progressed to fever and chills. Temp  38.7. Marked tenderness throughout cervical spizla, upper back, left shoulder, biceps, triceps.
Age: 52.0
Sex: U
Vaccine: TD, TD, TD
Symptoms: Arthritis, Neck pain, Pain in jaw, Shoulder pain
Clinical narrative: Pt admitted to ER with fish hook in right hand. She received a Tetanus booster in left deltoid area. Later in day patient felt pain in left arm and pain radiating into left chest. The discomfort became severe which progressed to fever and chills. Temp  38.7. Marked tenderness throughout cervical spizla, upper back, left shoulder, biceps, triceps.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: From initial information received from a health care professional through a manufacturer's sales force representative on 10/6/04 regarding an adverse event occurring in the USA, it was reported that a child (no specific information provided), received INFLUENZA VACCINE on 9/17/04. The manufacturer, lot number, route and site of administration were not reported. Ten days later, on 9/27/04, the patient presented to the physician with bruising. Blood work was drawn and showed a decreased platelet count. The patient was subsequently diagnosed with idiopathic thrombocytopenia purpura. The patient's recovery status is currently unknown. From additional information received on 29Oct04 through a telephone call to the responsible physician, the office fax number was provided by a nurse at the facility. No additional information relevant information was provided for the adverse experience. This follow up information is not submitted to the health authorities. From additional information received on 22Nov04 from a health care professional, it was reported that the pt was a five year old male who received his fifth dose of Fluzone SV 2004-2005 USP vaccine, lot number U1383AA, administered IM in the arm on 16Sep04. Reportedly seven days later, on 23Sep04, the pt developed idiopathic thrombocytopenic purpura. The pt had no signs of the idiopathic thrombocytopenic purpura prior to the vaccination. His platelet count was 3,000. The pt reportedly recovered by 07Oct04. No further information is anticipated, this case is considered closed.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Joint swelling, Laboratory test abnormal, Oedema peripheral, Rheumatoid arthritis
Clinical narrative: This is a serious case from a consumer whose son developed JUVENILE RHEUMATOID ARTHRITIS, considered medically significant, after receiving FluMist (OMIC). The reporter did not provide causality between events and FluMist vaccine. A mother reports her son developed juvenile rheumatoid arthritis, considered medically significant, after receiving FluMist. On 23Dec03, a 12 year old male received FluMist and in mid January, his knee became swollen. When he was taken to the doctor they gave him a temporary diagnosis of juvenile rheumatoid arthritis. The JRA has progressed symmetrically into his hands, knees, toes, and jaw. He went back to the doctor in early September 2004. He had a positive ANA test and was diagnosed with polyarticulate JRA. The patient has not recovered. Lot number is unknown and additional information has been requested. Additional information received from mother on 26Oct04 incorporated into above narrative. Follow up 03/14/05: Patient has not recovered from the adverse event(s). Stiffness of joints with less swelling and pain his jaws. A VAERS follow up report was submitted in accordance with 21CFR600.80. 04/26/2005 Per the reporter, the patient continues to have swelling and pain in his joints but the severity is less.  The patietn's white blood cell count also dropped below normal.  The drop in WBC count is being attributed to his methotrexate intake.  The WBC count will be reported next week.  Currently, his WBC is 4.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 54 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine, it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room. It was also noted that the patient was hospitalized. At the time of the report, the patient had not recovered. The reporter expressed concern with lot 0740N. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 67.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 67 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a 67 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), on the same arm, which was administered on the same day.  On 09/29/04, the pt developed lymph node swelling and fever. The pt was seen in the ER. It was also noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a female patient in her late 60's who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a female pt in her late 60's who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a female patient in her late 60's who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a female pt in her late 60's who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 68.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 68 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a 68 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 68.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 68 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a 68 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), in the same arm, which was administered on the same day. On 09/29/04 the pt developed lymph node swelling and fever.  The pt was seen in the ER. It was noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 70 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "The pt was seen in the ER. It was also noted that the pt was hospitalized.  At the time of the report, the pt had not recovered. The reporter expressed concern with Lot # 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 70.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 70 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "The pt was seen in the ER. It was also noted that the pt was hospitalized.  At the time of the report, the pt had not recovered. The reporter expressed concern with Lot # 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Blood sodium decreased, Grand mal convulsion
Clinical narrative: Information has been received from a health professional concerning a 30 year old female dialysis patient with SLE and Sjogren's syndrome who is on the transplant list and no known allergies who on 8/25/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647029/0460P). Concomitant therapy included her regular medicines and epoetin alfa. Other concomitant therapy included a second dose of hepatitis B virus vaccine (lot # 644857/0370P). The first dose of hepatitis B virus vaccine (lot # 644857/0370P) was given on 7/30/04. On 9/21/04 the patient had a grand mal seizure at home. She went to the ER and had another seizure while in the ER. She was hospitalized and her sodium was low at 122. The sodium was replaced, but the patient had another seizure while hospitalized. All labs, including a CT scan and head MRI were completely normal. It was noted that the patient had a low hemoglobin recently due to a heavy vaginal bleeding, but that had been corrected. The patient has been released from the hospital and recovered with no sequelae. At this time, no one knows what caused the seizures. The patient has been placed on seizure precautions, medications and prednisone. She has also been removed from the transplant list. No product quality complaint was involved. No further information was provided. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 8 hours after IM injection of pneumovax, severe pain, swelling at site of injection. Requiring Vicodin, Benadryl, cold packs and rest. Symptoms abated after 72 hours.  Follow up on 10/14/04 states: "Per telephone follow up with MD reporter, the pt was temporarily disabled for 3 days due to her adverse events. There was NO permanent disability. She was treated and fully recovered. Required emergency room/doctor visit."
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Coordination abnormal, Gait disturbance, Somnolence, Vomiting
Clinical narrative: Increased sleep on 10/9. Patient slept most of the day. The following morning (10/10), patient awoke with emesis one time and around 2 PM, patient had ataxic gait that progressed to inability to stand.  Nurse follow up on 10/30/04 states: "anorexia."
Age: 0.63
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Laboratory test abnormal, Myoclonus
Clinical narrative: Myoclonic jerks to left arm and had evaluation for seizures.  Nurse follow up on 10/30/04 states: "benign myoclonus."
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Severe localized reaction to left arm (erythema, warmth)
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: 5x4 cm area redness, warmth and tenderness. Started Sunday 10/10 (received vaccine 10/9). Seen by PMD 10/11/2004. Treated with Keflex.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Confusional state, Dizziness, Erythema
Clinical narrative: Red reaction 13cm x 8cm, hot to touch with patient having nausea with vomiting. Pt also had two syncope episodes over. Pt had onset of red reaction to site, nausea with vomiting and syncope within 1 hr. Anaphylaxis reaction, MD Rx Benadryl Epi, Vistiril, Nomec PO meds.  Nurse follow up on 10/30/04 states: "Verbal record: anaphylaxis."  Nurse follow up on 11/01/04 states: "anaphylaxis; hypervent; confused; weak; dizzy."
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperventilation, Nausea, Syncope, Vomiting
Clinical narrative: Red reaction 13cm x 8cm, hot to touch with patient having nausea with vomiting. Pt also had two syncope episodes over. Pt had onset of red reaction to site, nausea with vomiting and syncope within 1 hr. Anaphylaxis reaction, MD Rx Benadryl Epi, Vistiril, Nomec PO meds.  Nurse follow up on 10/30/04 states: "Verbal record: anaphylaxis."  Nurse follow up on 11/01/04 states: "anaphylaxis; hypervent; confused; weak; dizzy."
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Diarrhoea, Head discomfort
Clinical narrative: Felt chills, cold, soon afterwards threw up once then diarrhea started (watery, 15 times thru Sunday) no fever at any time and then dissipated slightly. Head felt heavy. Less on Sunday. Monday felt better had a couple of meals, today diarrhea is trying to stop.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Insomnia, Pain
Clinical narrative: Pt complained of numbness in left arm starting around 2 hours after immunization. Still painful more than 1 week later causing loss of sleep.
Age: 1.59
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Diarrhoea, Erythema, Pain, Swelling, Vomiting
Clinical narrative: Pain, swelling, redness: left deltoid. 3 cm x 3.5 cm. ER visit due to vomiting , diarrhea. No exams.
Sex: F
Vaccine: HIBV, MMR
Symptoms: Erythema, Feeling hot, Immune system disorder, Injection site mass, Injection site pain
Clinical narrative: Pt received HIB and MMR immunizations in left thigh on 9/13/04. On 9/16/04 mom called clinic complaining that area was sore and had a lump which felt like a golf ball. The area also was warm to the touch. Mom and daughter came to clinic on 09/17/04 for follow up. Temp was 98 Lump was 4-5cm on left lateral thigh w/no discharge, slight erythema. Looked more like immune response than frank infection. The pt had full sensation down leg. Mom advised to use children's ibuprofen and RTC or ER if pt becomes febrile, stops eating, has N/V, or lump changes shape, color, or has discharge. As of 10/8/04, no further follow up has been needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Onset after shot on right deltoid on 10/05/04 per mother got worse over last 2 days with increased redness, swelling and warmth. No fever. Treating patient for cellulitis 10/7/04
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Approximately 27 hours after Td, pt developed muscle aches, muscle cramps and fever ranging from 103-105 orally; took 800 mg Motrin at 4:30pm, 7:30pm, 12AM, sxs gone by 12AM
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Arthropathy, Bone disorder, Condition aggravated, Deep vein thrombosis
Clinical narrative: After shot my arthritis got worse, resulting in having both knees replaced. Discharge Summary received on 3/07/2005 states DVT R Leg s/p total knee replacement. Medical Records received on 03/21/2005 states total R knee replacement due to severe DJD  degenerative joint disease. - 3/2/05 Medical records for 6/03 reviewed. Final diagnosis was 'DVT R LEG'. Chief complaint was 'fall, lac to head, no LOC". 3/3/05 Review of d/c summary confirms diagnosis of DJD and procedure of left total knee replacement.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Fall, Injury
Clinical narrative: After shot my arthritis got worse, resulting in having both knees replaced. Discharge Summary received on 3/07/2005 states DVT R Leg s/p total knee replacement. Medical Records received on 03/21/2005 states total R knee replacement due to severe DJD  degenerative joint disease. - 3/2/05 Medical records for 6/03 reviewed. Final diagnosis was 'DVT R LEG'. Chief complaint was 'fall, lac to head, no LOC". 3/3/05 Review of d/c summary confirms diagnosis of DJD and procedure of left total knee replacement.