chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Anaemia, Arthritis, Diarrhoea, Drug interaction, Drug level decreased
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Leukocytosis, Pain
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash, Vomiting
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Anorexia, Cellulitis, Chills, Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort, Malaise, Pain in extremity
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pruritus, Pyrexia, Rash, Skin discolouration, Tremor
Clinical narrative: 11-07-05 Vaccine. 11-08-05 - Noted redness, swelling, discomfort in right arm injection area, returned to Minute Clinic in pm and was checked by CNP on duty. She checked with her supervisor and then ordered Doxycycline orally. Took one and then could see that redness, etc. was progressing. Called internist on call that evening who advised me to take another Doxycycline and see Dr. in am if running a temp or feeling worse. That night, started running a 101 F temp, had severe shaking chills, felt very ill. Next morning went in to see Dr. who admitted me to hospital with cellulitis of right arm. 11-9-05 Admitted to hospital about noon and received Levaquin IV at 6 pm WBC at clinic 16,000+ and neutrophils elevated. Area about 6 cm by 8 cm and pain. 141-10-05 Right arm cellulitis progressing, temp down, received Levaquin IV at 6pm. Much pain in right arm area. 11-11-05 Cellulitis still progressing and antibiotic changed to Clindamycin IV every six hours. Feeling ill no appetite. 11-13-05 Progression of cellulitis continued Began to develop very itchy skin rash on trunk of body. Changed to Vancomycin IV every 24 hours. skin rash getting worse, and moderate diarrhea, hyperactive bowel sounds, very poor appetite. 11-14-05 Skin rash progressing and covering most of body, diarrhea continued. Cellulitis contained. 11-15-05 Home from hospital on oral Levaquin allergic skin reaction, etc. worse. 11-17-05 To clinic to see Dr. for severe itching and discoloration and darkening of skin on trunk, diarrhea. Taken off all antibiotics, cellulitis not progressing any more, pain less. Intense discomfort of skin. Antihistaminic prescribed. 11-18-05 Followup clinic visit - Finally not feeling worse. 11-22-05 As of this date, some discoloration of skin on trunk, mild rash on legs and arms, occasional episodes of itching, large area on right upper arm discolored, but no pain, redness. Still some digestive system upset, but appetite is returning. This is a record of the illness to the best of my memory of events.b joints 1/1/10 follow up- moderate arthritis in hips, feet & thumb joints;allergic to cipro;taking cipro for uti; strain of e. coli became resistant to cipro. also had mild itching of face.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, PNC
Symptoms: Injection site erythema, Loss of consciousness, Pyrexia
Clinical narrative: Child experienced fever, passed out. Mother took her to ER. Child's temp in ER was 104.8. Redness at site on right arm
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm was red and warm to touch. Has taken antibiotics since then ( 11/07/05 ) and redness has gone away after two days
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Pruritus
Clinical narrative: Reddened and itching area approx 6 cm diameter at injection site.
Age: 1.05
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Cough, Irritability, Pyrexia
Clinical narrative: Fever 102 degrees 2-4 days cough, irritability.
Age: 0.43
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Medication error
Clinical narrative: Pt received PPV 23 instead of PCV 7
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Atrial flutter, Chest discomfort, Dizziness, Dyspnoea, Nausea
Clinical narrative: Fluttering in the chest Nausea, Emesis Chest Tightness Shortness of Breath Lightheadedness
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Fluttering in the chest Nausea, Emesis Chest Tightness Shortness of Breath Lightheadedness
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Initial report received from a health care provider on Nov 16 2005. A 52 year old male patient with a medical history of migraines received a left deltoid injection of Fluzone SV 2005-2006, lot number U1772AA, on 10/13/2005. Route of administration was not reported. On approximately 11/11/2005, the patient developed numbness and tingling in his hands and feet that moved up the extremities and muscle weakness. On 11/14/2005, the patient was examined in an ER, and thereafter, admitted to the hospital. Admitting diagnosis was not reported. The results of a CT and MRI were unknown. At the time of this report, the patient continued to be hospitalized and not recovered.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Joint swelling, Oedema peripheral
Clinical narrative: A 57 year old female patient with no significant medical history, and who had received the flu vaccine for the past three years with no reaction, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U17622AA, in the left arm in 02/Nov/2005 at 12:15 pm. the next day the patient developed a headache that became more severe in nature on04/Nov/2005. ON 04/Nov/2005 she developed swelling in her hands, arms, legs and ankles. This was accompanied by pain the the joints. She went to the ER and was treated with steroids. The patient had recovered from these even at the time of this report.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Eye movement disorder, Loss of consciousness, Skin discolouration
Clinical narrative: Initial report received on 11/17/2005 from a health care professional. A 47 year old male patient with a history of passing out when giving blood, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1911AA, site not reported, on Nov 17 2005. Within minutes, his color turned green, his eye rolled back in his head and he became unconscious. the patients blood pressure 90/60 and he was sent to the ER for evaluation. Per the reporter, the patient did not have hives or difficulty breathing. The status of his recovery as the time of this report was not reported.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Haemoptysis, Malaise, Pyrexia
Clinical narrative: A nurse from a doctors office reported that a 9 year old female, with no previous medical history, experienced fever, cough and cough out blood, 4 days after she received FluMist vaccine on Oct 28 2005. On Nov 1 2005, the patient began to have fever. On Nov 2 2005, the patient felt worse and was coughing so much that she cough out a glob of blood. She was seen a physician who ordered that the patient use a mist tent. Per the reporter, as of Nov 10 2005, the patients mother has not called the doctors office nor has she brought patient back for follow up. The patients clinical outcome is unknown at the time of report. The reporter causality is not provided.
Age: 0.35
Sex: M
Vaccine: PNC
Symptoms: Abnormal behaviour, Balance disorder, Hyperacusis, Hyperaesthesia, Sensory disturbance
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the father of a male patient who received a second dose on Mar 11 2003 at 4 months of age. Within the first couple months of life (dates unspecified), the patient experienced high guard posture, sensitivity to touch and sound, was tactically defensive and had poor balance. The patients concurrent illness included food allergy reported as allergy to milk, asparagus, pineapple, oranges, apples, grapefruit, wheat products and eggs, and ear infections. Indication for Prevnar was immunization. Product was administered on Mar 11 2003. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. On Mar 11 2003, at 4 months the patient received a second dose of Prevnar. The child's father reported that within the first couple months of life (dates unspecified), his child displayed autistic symptoms, characterized by, high guard posture (posture abnormal), sensitive to touch (hyperaesthesia), sensitive to sound (hyperacusis), was tactically defensive (abnormal behavior) and had poor balance (balance disorder. However the father denied that his son was ever diagnosed as autistic and that his pediatrician felt that he is totally normal. As of Nov 17 2005, the father reported that the child's behaviors were resolved for the most part, as a result of identifying food allergies. No additional information was available at the time of this report.
Age: 59.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a medical assistant concerning a 59 year old white male who on Nov 9 2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23 polysaccharide vaccine (lot 650084/0605P). the patient also received influenza virus vaccine (unspecified) on the opposite arm. Concomitant therapy included salmeterol xinafoate (severent) and albuterol sulfate (+) ipratropium bromide (Combivent). On Nov 9 2005, the patient developed allergic reaction. On Nov 10 2005, the patient came to the clinic and was treated with antibiotics. The patient was reported as recovered. Allergic reaction was considered to be an other important medical event by the reporting medical assistant (OMIC). Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a physician concerning a 15 year old healthy female (who has had regular menstrual periods in the past) who was vaccinated SC with a 0.5 mL dose of Varivax. The pt had indicated that her LMP was on approximately 15-SEP-2005. The same day of vaccination, in September 2005, the physician did a pregnancy test, which came back positive. The physician noted that it was too soon to tell how far along in the gestation the pt was, or even what the pt will do about the pregnancy. Unspecified medical attention was sought. No further information was available. There was no product quality complaint. Follow up information indicated that the pt had an elective termination in October 2005, one month after finding out she was pregnant. The elective termination was considered to be an other important medical event (OMIC). No additional information is expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a licensed professional nurse LPN concerning a 55 year old female who on Nov 14 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Within 3 hours of the vaccination, on Nov 14 2005, the patient experienced an injection site reaction characterized by redness, swelling and warmth. Unspecified medical attention was sought. It was reported that the patients entire upper arm was affected and made it very difficult to raise her arm. The patient was treated with azithromycin Z Pak, diphenhydramine hydrochloride (Benadryl, steroids and cold compresses. At the time of this report the patients present status was unknown. No further information was provided. No product quality complaint was involved. The reporter considered the adverse events to be disabling. The reporter also considered the adverse events to be other important medical events (OMIC). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis, Incorrect route of drug administration, Shoulder pain, Swelling
Clinical narrative: Information has been received from a 73 year old frail female "resident" who on 02-Nov-2005 was vaccinated in the shoulder joint instead of intramuscular with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P) . On 02-Nov-2005 the patient developed pseudo sepsis arthritis. The patient had material removed from her should by a scope procedure. There was right shoulder swelling, pain, abduction and disability. The patient underwent a "joint tap" which had a white cell count greater than 100,000. The patient was reported as recovering. Pseudo sepsis arthritis was considered to be disabling and other important medical event (OMIC) by the patient. There was no product complaint involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis bacterial, Medication error
Clinical narrative: Information has been received from a 73 year old frail female "resident" who on 02-Nov-2005 was vaccinated in the shoulder joint instead of intramuscular with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P) . On 02-Nov-2005 the patient developed pseudo sepsis arthritis. The patient had material removed from her should by a scope procedure. There was right shoulder swelling, pain, abduction and disability. The patient underwent a "joint tap" which had a white cell count greater than 100,000. The patient was reported as recovering. Pseudo sepsis arthritis was considered to be disabling and other important medical event (OMIC) by the patient. There was no product complaint involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Injection site warmth, Swelling
Clinical narrative: Information has been received from a respiratory therapist concerning a female (age not provided) who on 10-Nov-2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649988/0629P). The patient also received influenza virus vaccine (unspecified) on the opposite arm. No reaction to the influenza virus vaccine was reported. On 10-Nov-2005, the patient developed a little swelling and heat at the injection site. Two hours later the entire arm was swollen and she was unable to drive. She was told by the physician to go to the emergency room (ER). On 11-Nov-2005, a friend drove her to the ER and she was treated there. The patient's outcome was not reported. A little swelling and heat at the injection site and swollen arm were considered to be other important medical events (OMIC) by the reporting respiratory therapist. There was no product quality complaint involved. The respiratory therapist also provided information regarding another patient's experience with pneumococcal 23v polysaccharide vaccine (WAES #0511USA01974,0511USA02334). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 62 year old female with hypertension and no allergies who on 10-Nov-2005 was vaccinated in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. (lot # 650082/0691P). Concomitant therapy included atorvastatin calcium (Lipitor) and clopidogrel bisulfate (Plavix). On 12-Nov-2005 the patient was seen by a physician and complained of redness and swelling at the site and under the arm. Diagnosis was no cellulitis, adverse reaction to vaccination. No laboratory tests were done and treatment ordered included hydroxyzine hydrochloride (Atarax). At the time of the report the patient was recovering. The patient's experience was considered an other important medical event (OMIC). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a physician concerning a 69-year-old female with a codeine allergy and gastroesophageal reflux disease and a history of rhinitis allergic who on 14-Nov-2005 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 651524/0605R). Concomitant therapy included rabeprazole sodium (Aciphex), estrogens, conjugated (Premarin), and a baby aspirin daily. On approximately 15-Nov-2005, 36 to 48 hours post vaccination, the patient experienced a cellulitis like reaction of swelling, redness, warmth. She was treated with a methylprednisolone (Medrol) dose pack. The outcome was reported as not recovered. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no product quality complaint involved. The reporter considered the event to be an other important medical event (OMIC) and disabling.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a physician concerning a 10 year old male who, "as an infant", in approximately 1995, was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient has developed autism. No product quality complaint was involved. No other information was provided. Autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Eye disorder, Headache, Migraine, Similar reaction on previous exposure to drug
Clinical narrative: Around 8:30 pt started with vomiting and c/o severe headache and what felt like "buzzing bees" in his head. Mom said his eyes were "funny looking" and was taken to ER where doctors had a hard time waking him up. Pt was then admitted. Per annual report-Reporter states possible diagnosis is pediatric migraine. No 2nd dose of flu vaccination will be administered.  Hospital report requested from Medical Center.  2/1/06 Review of medical records (neuro consult) Final impression: probable pediatric migraine, nothing suspicious for seizure.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Around 8:30 pt started with vomiting and c/o severe headache and what felt like "buzzing bees" in his head. Mom said his eyes were "funny looking" and was taken to ER where doctors had a hard time waking him up. Pt was then admitted. Per annual report-Reporter states possible diagnosis is pediatric migraine. No 2nd dose of flu vaccination will be administered.  Hospital report requested from Medical Center.  2/1/06 Review of medical records (neuro consult) Final impression: probable pediatric migraine, nothing suspicious for seizure.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Approximately 40 minutes after injection, patient returned to area where shots were being administered. He was very short of breath, pale, and diaphoretic. Complained of SOB and throat swelling. 911 was called immediately. Benadryl 50mg IM and EPI 1:1000 .3 SQ was administered immediately. Patient's symptoms improved prior to ambulance arrival. Patient transported to nearest hospital.   12/22/05 Reviewed medical records. Additional symptoms include flushing, nausea, chest pain, and felt faint/lightheaded. Treated with NTG, phenergan, morphine, and Lovenox (antithrombotic).
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Pharyngeal oedema
Clinical narrative: Approximately 40 minutes after injection, patient returned to area where shots were being administered. He was very short of breath, pale, and diaphoretic. Complained of SOB and throat swelling. 911 was called immediately. Benadryl 50mg IM and EPI 1:1000 .3 SQ was administered immediately. Patient's symptoms improved prior to ambulance arrival. Patient transported to nearest hospital.   12/22/05 Reviewed medical records. Additional symptoms include flushing, nausea, chest pain, and felt faint/lightheaded. Treated with NTG, phenergan, morphine, and Lovenox (antithrombotic).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiomyopathy, Electrocardiogram abnormal, Hyperhidrosis, Laboratory test abnormal, Myocarditis
Clinical narrative: Received 0.5ml Fluzone on 10/19/05. 10/20/05, experienced a non MI cardiac event with cardiomyopathy. Discharge summary states myocarditis, diaphoresis, nausea. msv
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Received 0.5ml Fluzone on 10/19/05. 10/20/05, experienced a non MI cardiac event with cardiomyopathy. Discharge summary states myocarditis, diaphoresis, nausea. msv
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness
Clinical narrative: Patient received FluMist. As she was driving home, she felt like she was going to pass out two times. Each lasted a few seconds, but patient had to pull over until the episode passed. (OMIC)
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of stiff neck in a 31-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. There were no concurrent medications. The subject had no pre-existing medical conditions. On 05 October 2005 the subject received 1st dose of Engerix-B in the right arm (lot 131AA-incomplete lot number) At an unspecified time following the administration of the 1st dose of Engerix-B, on an unspecified date in October  2005, the subject experienced a stiff neck. The stiff neck resolved on an unspecified data before the 2nd dose of Engerix-B. On an unspecified date in November 2005, before 17 November 2005, the subject received the 2nd dose of Engerix-B. At an unspecified time following the 2nd dose of Engerix-B, on an unspecified date in November 2005, the subject again experienced a stiff neck. The subject was hospitalized. At the time of initial reporting, 17 November 2005, the stiff neck was ongoing. The nurse considered the stiff neck to possibly be related to vaccination with Engerix-B.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of stiff neck in a 45-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. There were no concurrent medications. The subject had no pre-existing medical conditions. On 05 October 2005 the subject received 1st dose of Engerix-B in the right arm (lot 131AA-incomplete lot number). At an unspecified time following the administration of the 1st dose of Engerix-B, on an unspecified date in October 2005, the subject experienced a stiff neck. The stiff neck resolved on an unspecified date before the 2nd dose of Engerix-B. On an unspecified date in November 2005, before 17 November 2005, the subject received the 2nd dose of Engerix-B. At an unspecified time following the 2nd dose of Engerix-B, on an unspecified date in November 2005, the subject again experienced a stiff neck. The subject was hospitalized. The stiff neck resolved "about two to three days following the 2nd dose" of Engerix-B, on an unspecified date on or before 17 November 2005. The nurse considered the stiff neck to possibly be related to vaccination with Engerix-B.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cognitive disorder
Clinical narrative: This 18 month old male subject was enrolled in an open-label study for prophylaxis treatment of hepatitis A. On 02/28/2005, he received the 4th dose of combined diptheria, tetanus, acellular pertussis vaccine and Aventis Pasteur's haemophilus influenza type B vaccine. On 03/30/2005, he received the 1st dose of hepatitis A vaccine. On 05/24/2005, 95 days after the 4th dose of Infanrix, 85 days after the 4th dose of ActHIB, 55 days after the 1st dose of Mavrix, this 18 month old subject was observed to experience delayed expressive language abilities. On 10/26/2005, the child was evaluated with a cognitive delay of 11 months of age, receptive delay at 10 months level and expressive delay at 16 months level. The event was unresolved at time of reporting. After tests results, it was decided to withdraw the child from the study. The investigator considered that there was a reasonable possibility that the delayed expressive language abilities may have been caused by Infanrix, hemophilus influenza tetanus toxoid conjunate vaccine and hepatitis A vaccine. Further informations are awaited.
Age: 47.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acne, Arthralgia, Arthritis, Back pain, Blindness
Clinical narrative: Acid reflux, digestive, gastric, ulcer. skin acne,back pain, knee pain, arthritis and vision blind.
Age: 47.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Gastric ulcer, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux, digestive, gastric, ulcer. skin acne,back pain, knee pain, arthritis and vision blind.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pruritus, Pyrexia, Rash
Clinical narrative: Per patient, "Rash to left upper arm appeared 24 hours following flu shot. Rash warm to touch, and itchy. "Seen in Emp Health on 11/18/05; diffuse rash to abdomen, a febrile, with rash to left arm from shoulder to elbow. Denies other S/S.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: 2 hours after vaccine given came to health office complaining of itching at site. Redness, edema and warmth present.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Flu vaccine given at 3 pm. 4 pm noted itchy around right side of neck. Given Benadryl 25mg PO and then took Benadryl 25mg PO on arrival at her home. 5:00 pm call to employee, home safe, no further redness.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: About 8 hours after immunization, patient noted fever up to 104 degrees (oral), chills and headache. Also note "red rash" at immunization site. Sx improving using Tylenol.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Purpura
Clinical narrative: Approx 24 hrs after receiving Fluzone injection; pt developed a "strawberry-type "rash that appeared to look like "windburn". very pruritic. Area effected included injection site left deltoid, left face, neck and hairline. Pt denied any respiratory compromise or hives; denied fever. Benadryl topical helpful in alleviating itch. All S/S resolved 24 hrs after onset.
Age: 71.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Contusion, Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Dark purple bruise at administering site, extreme swelling and redness around the site, tithing and tenderness. Administered on Nov 17th symptoms on Nov 18th. Dr visit on Nov 21 - medication prescribed by Dr.
Age: 71.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Pruritus, Tenderness
Clinical narrative: Dark purple bruise at administering site, extreme swelling and redness around the site, tithing and tenderness. Administered on Nov 17th symptoms on Nov 18th. Dr visit on Nov 21 - medication prescribed by Dr.
Age: 71.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Erythema
Clinical narrative: Dark purple bruise at administering site, extreme swelling and redness around the site, tithing and tenderness. Administered on Nov 17th symptoms on Nov 18th. Dr visit on Nov 21 - medication prescribed by Dr.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pneumovax administered 11/21/05 in left upper arm. Received a phone call from patient on 11/22/05 that her arm was stiff and sore. Was advised to apply cold compresses for 48 hours. On 11/23/05 presented to office. Arm was significantly  red fro elbow to axilla area - completely around but not involving injection site area. Hot to touch. Most pronounce redness and heat was ulnar aspect above antecubital area at hands breadth in size.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal stiffness, Neck pain, Nuchal rigidity
Clinical narrative: Within 2 hours of receiving vaccine in left deltoid begin having neck pain and stiffness. Nuchal rigidity lasted over 24 hours. 11/21/05 now reports 2 days of weakness in arm.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Right leg swelling, redness through out thigh.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Onset of coughing 2 hrs post injection lasted 45 minutes, report build up of spectrum used inhaler 2 times with relief. Reports previous response with allergy shots. 11/22 completely better.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea
Clinical narrative: Nausea, shortness of breath, instructed patient to call 911, EMS saw patient, patient refused transport to hosp. Saw her own doctor.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Pain from neck, shoulder and upper arm. Shot was given in shoulder. I have used ice, heat and Tylenol. I am still having problems.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Haemangioma of skin, Injection site reaction, Rash pruritic
Clinical narrative: Per mother approx 24 hrs after receiving Fluzone injection, pt developed a "strawberry type rash" that looked like "wind-burn" that was very pruritic. Involved area included injection site left deltoid, left face, neck and hairline. No respiratory involvement or compromise, no fever. Benadryl topical very helpful in alleviating itch. All S/S resolved 24 hrs after onset.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Became very itchy after the shot.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of drug administration, Pain
Clinical narrative: The person who administered the flu vaccine injected it into the bursa of my left shoulder. It became so painful I had to have an injection of cortisone to relieve the pain two days later.
Age: 12.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Oedema, Tenderness
Clinical narrative: Local Rx right deltoid given Td and influenzae on 11/15/05 - tender, swollen 4" x 2"; no erythema, normothermia to palp injections were spaced 1/4" apart. Examined by myself on 11/17/05. Tx Q.I.D. Ibuprofen; Keflex 500 one PO B.I.D.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Individual reports pain at time of injection and return following AM. Individual reports left arm continues to hurt when using it or wt bearing. Denies any redness or swelling at site at site at any time- Physician thought tendon or ligament was inflamed - Rx'd Celebrex but individual refused to take due to concerns re side effects.
Age: 0.84
Sex: F
Vaccine: FLU3, HEP
Symptoms: Pyrexia
Clinical narrative: Child had immunizations at 10 AM 11/2/2005 - Fever started at 10:30 PM according to the ER on 11/03/2005 - Was 10:56 when they arrived in the ER at 4 am 11/4/2005 - CBC, BI culture done.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash on the body noted 11/15/2005 2 days after Flu shot and Pneumovax were given. New order; Benadryl q 6 hours PRN. Hydrocortisone to rash resolved 11/18/2005.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Weakness, tiredness and sleepy x 1 day.
Sex: M
Vaccine: FLUX
Symptoms: Eye irritation, Eyelid oedema, Ocular hyperaemia
Clinical narrative: Nurse did not swab site of injection before administration. Eyes became irritated and got progressively worse as if had stones in them; left eye had swelling and redness on left corner, right eye also irritated. Washed eyes; had some relief and went to sleep. later on noticed that had swelling on both eyes (bags on eyes) especially top lid of left eye. Puffiness on top and bottom lid reduced. Right now has watery eyes.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Pallor, Tachycardia
Clinical narrative: Employee's first influenza vaccine to date. CDC info sheet on influenza inactivated vaccine given and discussed. Employee denied sulfate allergy. Vaccine administered accordingly. Onset of tachycardia (130), increased BP, dizziness, and pale within 5-10 minutes of administration. Employee monitored on floor by co-workers. No medication given. Employee did not notify provider until 11/28/05 at 09:45. Advised employee not to take flu vaccine again.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: Facial rash thick, red, burning.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Cough, Dyspnoea, Wheezing
Clinical narrative: Approximately 2.5 to 3 hrs after vaccination, I started having trouble breathing with coughing and wheezing. (I was diagnosed as suffering from an asthma attack about 10 years ago after prolonged exposure to small dust particles from construction.  I have 1-2 incidents a year that require me to use an inhaler.)  At approximately 6 to 6:30p.m. I used the inhaler and gradually obtained relief beginning after about 20-30 minutes of using the inhaler. I did alert the nurse at the Health Unit where I work and where the vaccine was administered.  She noted that the time elapsed strongly supported the view that it was not a reaction to the vaccine and did not believe I needed to fill out this form and recommended I contact my doctor. I believe it was a reaction and submit it only for any value it may have in terms of tracking/evaluating. Thank you.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Patient complained of very red itchy site. Site had small white spot in the center surrounded by red itchy area 4-6mm in size. No pain or swelling. He showed area to his own doctor he was told he should still have the flu shot next year. Patient is concerned he would have an anaphlactic reaction next year. He is a retired Dr. At this time white spot is present redness is getting smaller. All this is as reported by patient.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Pruritus
Clinical narrative: Erythema, pruritis, warm to touch in an area 4" X 5" around the injection site. MD recommended OTC Diphenhydramine cream which was effective in decreasing symptoms.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reports pain and heat at injection site with swelling for 2 days after the injection. Pain radiated from top of left forearm to ring and middle finger of left hand. Took ASA for Pain.
Age: 0.88
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Feeling abnormal, Gait disturbance, Heart rate increased, Irritability
Clinical narrative: The most serious concern that took us to the emergency room, was his excellerated heartbeat and breathing along with his weakness and inability to walk.  He was given the vaccine approx. 10 am the morning of 11/25/05, and by noon, after he awoke his morning nap, he couldn't walk without falling down, and cried constantly for almost 24 hours.  Over the course of the day, he breathing became heavier and faster and his heart felt like it was going to explode.  His body was very lifeless and because of the weakness in his legs, required us to carry him constantly for almost 2 days.  He was taken to the ER at approx. 5:30 am on the 26th and sent home diagnosed as side effects of the vaccine.  Push liquids and tylenol for discomfort.  Today is Monday, although he's feeling better, he is still very weak and irritable.
Age: 0.88
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: The most serious concern that took us to the emergency room, was his excellerated heartbeat and breathing along with his weakness and inability to walk.  He was given the vaccine approx. 10 am the morning of 11/25/05, and by noon, after he awoke his morning nap, he couldn't walk without falling down, and cried constantly for almost 24 hours.  Over the course of the day, he breathing became heavier and faster and his heart felt like it was going to explode.  His body was very lifeless and because of the weakness in his legs, required us to carry him constantly for almost 2 days.  He was taken to the ER at approx. 5:30 am on the 26th and sent home diagnosed as side effects of the vaccine.  Push liquids and tylenol for discomfort.  Today is Monday, although he's feeling better, he is still very weak and irritable.
Age: 12.0
Sex: M
Vaccine: FLUN3, HEP
Symptoms: Rash, Rash macular
Clinical narrative: Mother called today. States son received FluMist 5 days ago, he has rash noted this am.  Rash is from head to toe, red dots, stomach most noted to be blotchy.  States no fever.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: seizure
Age: 5.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site abscess, Injection site erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: The site of the Smallpox vaccination was extremely red, festered, had some yellow pus-like substance emitting from it.  The pain was excrutiating. I remember crying for days. I believe I had a fever. I remember having a plastic cover put over it and someone at public health commenting that they might have to do it over, and my screaming so much that my mom said no. It did eventually scab over but I was reminded of it when I had radiation to remove a basal cell carcinoma in 1988.  I thought how much it reminded me of the vaccination.