chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Laboratory test abnormal, Otitis media, Petechiae, Pneumonia
Clinical narrative: information has been rec'd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 945-950, Oct 2001) concerning a 21 mth old male pt with history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at one year of age. Concomitant therapy included an unspecified immunosuppressive medication at the time of infection. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review the pt's infection (pneumococcal bacteremia) was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. The risk factors for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplantation (range 3 to 48 months). Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae/purpura. In 25% of episodes patients had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01102590,01104800,01104802, and 01104803). A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.75
Sex: M
Vaccine: PPV
Symptoms: Purpura, Pyrexia
Clinical narrative: information has been rec'd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 945-950, Oct 2001) concerning a 21 mth old male pt with history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at one year of age. Concomitant therapy included an unspecified immunosuppressive medication at the time of infection. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review the pt's infection (pneumococcal bacteremia) was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. The risk factors for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplantation (range 3 to 48 months). Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae/purpura. In 25% of episodes patients had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01102590,01104800,01104802, and 01104803). A copy of the published article is attached as further documentation of the patient's experience.
Age: 3.75
Sex: M
Vaccine: PPV
Symptoms: Laboratory test abnormal, Otitis media, Petechiae, Pneumonia, Purpura
Clinical narrative: information has been received from a literature article titled invasive pneumococcal infections ins pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal 20(10); 946-950, Oct 01) concerning an approximately 45 month old male pt with a history of a cardiac transplant, bacteremia with serotype 19F seen on a blood culture, pressure equalization tube placement for recurrent otitis media and a brief cardiopulmonary arrest during the tube placement. The pt was vaccinated with one dose of pneumococcal vaccine 23 polyvalent after his 1st infection (bacteremia) at 21 months of age. Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. 2 yrs later, the pt developed a bacteremia with serogroup 9V. It was noted that the isolates were susceptible to penicillin and ceftriaxone. The pt was not taking anti microbial prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pt's receiving their care at a hospital form3/90 to 11/00 that were reviewed for cases of invasive bacterial infection caused by S pneumoniae that occurred after transplantation. The risk factor for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range, 3 to 48 months) Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia / purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medication at the time of infection including cyclosporin. Azathioprine, systemic corticosteriods and mycophenolate mofetil.  It was also noted that four other patients were vaccinated with on dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 0110259,01104800, 01104801, and 01104802). A copy of the published article is attached as further documentation of the pt's experience. This report is considered to be an "Other Important Medical Event".
Age: 3.75
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: information has been received from a literature article titled invasive pneumococcal infections ins pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal 20(10); 946-950, Oct 01) concerning an approximately 45 month old male pt with a history of a cardiac transplant, bacteremia with serotype 19F seen on a blood culture, pressure equalization tube placement for recurrent otitis media and a brief cardiopulmonary arrest during the tube placement. The pt was vaccinated with one dose of pneumococcal vaccine 23 polyvalent after his 1st infection (bacteremia) at 21 months of age. Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. 2 yrs later, the pt developed a bacteremia with serogroup 9V. It was noted that the isolates were susceptible to penicillin and ceftriaxone. The pt was not taking anti microbial prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pt's receiving their care at a hospital form3/90 to 11/00 that were reviewed for cases of invasive bacterial infection caused by S pneumoniae that occurred after transplantation. The risk factor for the development of invasive pneumococcal disease included african-american race, transplantation at age <32 yrs and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range, 3 to 48 months) Fever >101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia / purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All pt's were taking immunosuppressive medication at the time of infection including cyclosporin. Azathioprine, systemic corticosteriods and mycophenolate mofetil.  It was also noted that four other patients were vaccinated with on dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 0110259,01104800, 01104801, and 01104802). A copy of the published article is attached as further documentation of the pt's experience. This report is considered to be an "Other Important Medical Event".
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Laboratory test abnormal, Otitis media, Petechiae, Pneumonia
Clinical narrative: Information has been received from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 946-950,10/01 concerning an approximately 5 year old female pt with a history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at the age of 42 months (3.5 years). Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. almost 2 yrs later the pt developed a bacteremia with serogroup 14. Upon internal review, pt's bacteremia was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. the pt's involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age < 32 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range 3 to 48 months). Fever >101F was the presenting sign/ symptoms in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae, purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All patients were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other pt's were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01104800, 01104801, 01104802, and 01104803) A copy of the published article is attached as further documentation of the pt's experience.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Purpura, Pyrexia
Clinical narrative: Information has been received from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant pt's (Pediatric Infectious Disease Journal; 20(10): 946-950,10/01 concerning an approximately 5 year old female pt with a history of a cardiac transplant who was vaccinated with one dose of pneumococcal vaccine 23 polyvalent at the age of 42 months (3.5 years). Concomitant therapy included an unspecified immunosuppressive medications at the time of infection. almost 2 yrs later the pt developed a bacteremia with serogroup 14. Upon internal review, pt's bacteremia was considered to be an other important medical event. It was noted that this information was rec'd from medical records of all cardiac transplant pt's receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S pneumoniae that occurred after transplantation. the pt's involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age < 32 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the first infection occurred at median age of 20 months post transplant (range 3 to 48 months). Fever >101F was the presenting sign/ symptoms in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechiae, purpura. In 25% of episodes pt's had received a course of oral anti microbial therapy within 30 days before their invasive disease. All patients were taking immunosuppressive medications at the time of infection including cyclosporin, azathioprine, systemic corticosteriods and mycophenolate mofetil. It was also noted that four other pt's were vaccinated with one dose of pneumococcal vaccine 23 polyvalent and developed similar events (WAES# 01104800, 01104801, 01104802, and 01104803) A copy of the published article is attached as further documentation of the pt's experience.
Age: 1.6
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Otitis media
Clinical narrative: Info has been recvd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant patients concerning an over 2-year-old female pt who recvd vax at 19 mos of age. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review, the pt's infection was considered to be an other important medical event. F/U states: The pt also developed otitis media with the 1st episode. It was noticed that both isolates were susceptible to penicillin and ceftriaxone. The pt was not taking prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pts receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S. pneumonia that occurred after transplantation. The pts involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age less than 12 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the 1st infection occurred at median age of 30 months post/transplant (range 3 to 48 months). Fever over 101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia/purpura. In 25% of episodes pts had received a course of oral antimicrobial therapy within 30 days before their invasive disease. All pts were taking immunosuppressive medications at the time of infection including cyclosporin, axathioprine, systemic corticosteroids and mycophenolate mofetil. It was also noted that 3 other pts were vaccinated with 1 dose of pneumoncoccal vaccine 23 polyvalent and developed similiar events (WAES01102590, 01104801 and 01104802). No further information is available. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES01104802 is a duplicate of WAES01104800. Therefore, WAES01104802 is being deleted from our files and the reports consolidated into 01104800. WAES01104802 was previously submitted to the FDA on 11/1/01.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Joint swelling, Nerve injury, Pain, Photosensitivity reaction
Clinical narrative: Information has been received from an RN concerning a 48 year old Hispanic female dietary aide who on 6/25/01 (also reported as 6/27/01 and 6/22/01), sometime in the PM, was vaccinated IM in the LA with a 3rd dose of Hep-B vaccine recombinant (yeast) (lot NDC0006-4775-00, also reported as lot 637691/1454K). On 6/27/01 (also reported as 6/26/01), at approx. 14:00, the pt experienced pain in the joints (wrists, arms, and knees), joint swelling and had a rash. It was reported that the pt was sent to the ER and was treated with Benadryl and prednisone and was released. It was noted that the pt continues to have mild symptoms for which workman's compensation will not cover. Follow-up info has been received from an RN which indicated that there might have been a temperature stability issue with the product due to the wholesaler and their shipping methods. It was noted that the vaccine was packed on an ice pack and "it took at least 3 days to arrive". Addition follow-up has been received on 10/22/01 from an RN which indicated that the pt had not completely recovered from the experience. It was reported that the pt also experienced "nerve damage", aches, could not go out into the sun for a long period of time and could not work in the heat (pt did kitchen work). The pt's aches and pain in joints, joint swelling, photosensitivity, head sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and "Other Important Medical Events". Additional information has been requested. Follow-up information has been received on 10/29/01 from an RN which indicated the pt was "fine". It was noted that she was still having a problem going out in the sun for long periods of time and that she could not work in the kitchen because of the heat. It was reported that the pt had not been dx'd with any other disorder and that the problem was both sunlight and heat. Follow-u[ info received from a registered nurse indicated that the pt had not recovered from her experience. The pt's aches and pain in joints (wrists, arms, and knees, joint swelling, photosensitivity, heat sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and other important medical events (OMIC). Additional info has been requested.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from an RN concerning a 48 year old Hispanic female dietary aide who on 6/25/01 (also reported as 6/27/01 and 6/22/01), sometime in the PM, was vaccinated IM in the LA with a 3rd dose of Hep-B vaccine recombinant (yeast) (lot NDC0006-4775-00, also reported as lot 637691/1454K). On 6/27/01 (also reported as 6/26/01), at approx. 14:00, the pt experienced pain in the joints (wrists, arms, and knees), joint swelling and had a rash. It was reported that the pt was sent to the ER and was treated with Benadryl and prednisone and was released. It was noted that the pt continues to have mild symptoms for which workman's compensation will not cover. Follow-up info has been received from an RN which indicated that there might have been a temperature stability issue with the product due to the wholesaler and their shipping methods. It was noted that the vaccine was packed on an ice pack and "it took at least 3 days to arrive". Addition follow-up has been received on 10/22/01 from an RN which indicated that the pt had not completely recovered from the experience. It was reported that the pt also experienced "nerve damage", aches, could not go out into the sun for a long period of time and could not work in the heat (pt did kitchen work). The pt's aches and pain in joints, joint swelling, photosensitivity, head sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and "Other Important Medical Events". Additional information has been requested. Follow-up information has been received on 10/29/01 from an RN which indicated the pt was "fine". It was noted that she was still having a problem going out in the sun for long periods of time and that she could not work in the kitchen because of the heat. It was reported that the pt had not been dx'd with any other disorder and that the problem was both sunlight and heat. Follow-u[ info received from a registered nurse indicated that the pt had not recovered from her experience. The pt's aches and pain in joints (wrists, arms, and knees, joint swelling, photosensitivity, heat sensitivity and "nerve damage" were considered by the reporter to be immediately life threatening and other important medical events (OMIC). Additional info has been requested.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV, PPV
Symptoms: Cellulitis, Cough, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received on 10/23/01 from a health professional concerning a 53 year old female who on 10/11/01 was vaccinated with "the standard dose", 0.5ml, of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) and 1 dose of influenza virus vaccine. On 10/15/01, the pt went to the MD's office with a local reaction that was described as an area at the injection site that was swollen, red and hot. The pt also had symptoms of a sinus infection, with a cough and a fever. She was dx'd with cellulitis and was prescribed Augmentin for the sinus infection and the cellulitis, Atuss and Medrol. It was noted that the pt "is fine now" and has fully recovered. The reporter noted that the practice had been administering the pneumococcal vaccine 23 polyvalent vaccine for years and they have never had a problem. It was also noted that another pt (WAES 01106301) who was vaccinated from the same lot developed similar events. The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the vaccine until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the CDC and was released. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states the pt was also prescribed Augmentin for the sinus infection.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV, PPV
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Information has been received on 10/23/01 from a health professional concerning a 53 year old female who on 10/11/01 was vaccinated with "the standard dose", 0.5ml, of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) and 1 dose of influenza virus vaccine. On 10/15/01, the pt went to the MD's office with a local reaction that was described as an area at the injection site that was swollen, red and hot. The pt also had symptoms of a sinus infection, with a cough and a fever. She was dx'd with cellulitis and was prescribed Augmentin for the sinus infection and the cellulitis, Atuss and Medrol. It was noted that the pt "is fine now" and has fully recovered. The reporter noted that the practice had been administering the pneumococcal vaccine 23 polyvalent vaccine for years and they have never had a problem. It was also noted that another pt (WAES 01106301) who was vaccinated from the same lot developed similar events. The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the vaccine until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the CDC and was released. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states the pt was also prescribed Augmentin for the sinus infection.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received on 10/23/01 from a health professional concerning a 53 year old female who on 10/11/01 was vaccinated with "the standard dose", 0.5ml, of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) and 1 dose of influenza virus vaccine. On 10/15/01, the pt went to the MD's office with a local reaction that was described as an area at the injection site that was swollen, red and hot. The pt also had symptoms of a sinus infection, with a cough and a fever. She was dx'd with cellulitis and was prescribed Augmentin for the sinus infection and the cellulitis, Atuss and Medrol. It was noted that the pt "is fine now" and has fully recovered. The reporter noted that the practice had been administering the pneumococcal vaccine 23 polyvalent vaccine for years and they have never had a problem. It was also noted that another pt (WAES 01106301) who was vaccinated from the same lot developed similar events. The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the vaccine until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the CDC and was released. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states the pt was also prescribed Augmentin for the sinus infection.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Anaemia, Fibromyalgia, Gastrointestinal disorder, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: This report was received from the pt and has not been verified by a physician or other healthcare professional. The pt reported that she had no adverse experience following receipt of her 1st injection of Engerix-B on an unknown date in 1995. One month later, also in 1995, the pt reportedly received her 2nd injection of Engerix-B. The pt reported that, approx. 1 month following the 2nd injection, her "stomach bothered (her) for at least 6 months". She also "began noticing muscle aches". The pt reported that she now has anemia, fibromyalgia and "possibly rheumatoid arthritis or lupus". She stated that she experienced "constant inflammation". She reported that she has seen a physician for these events; she did not specify the treatment of these events. She stated, "all of these symptoms may not be attributed to the Engerix-B vaccine, but most began shortly after the 2nd injection". She also reported that she received the 3rd injection of Engerix-B on an unspecified date. The unspecified stomach problem resolved after "at least 6 months". The outcome of the muscle aches was not specified. As of 10/22/01, the anemia, fibromyalgia, possible rheumatoid arthritis and possible lupus were reportedly ongoing. Possible lupus is considered "Medically Serious".
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 75 year old female who on 10/25/95 and 10/18/01 was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/18/01, a few hours, post vax, the pt returned with a reaction that was described as a very swollen injection site that was as hard as a rock. The pt was dx'd with cellulitis and on 10/18/01, she was put on treatment with oral cephalexin and prednisone. The pt was seen in the office on 10/20/01 and was doing better. The pt was seen 3 more times, the last on 10/27/01 and had fully recovered. The reporter noted that the practice had been administering the vaccine for years and they have never had a problem. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: It was also noted that another pt who was vaccinated from the same lot developed a similar events (WAES01103264). The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the (pneumococcal vaccine 23 polyvalent) until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by CMP Compliane and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information from the health professional noted that the physician wanted to exchange this lot for a new lot number. Upon internal review, the pt's cellulitis was considered to be an other important medical event. No further info is available.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 75 year old female who on 10/25/95 and 10/18/01 was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/18/01, a few hours, post vax, the pt returned with a reaction that was described as a very swollen injection site that was as hard as a rock. The pt was dx'd with cellulitis and on 10/18/01, she was put on treatment with oral cephalexin and prednisone. The pt was seen in the office on 10/20/01 and was doing better. The pt was seen 3 more times, the last on 10/27/01 and had fully recovered. The reporter noted that the practice had been administering the vaccine for years and they have never had a problem. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: It was also noted that another pt who was vaccinated from the same lot developed a similar events (WAES01103264). The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the (pneumococcal vaccine 23 polyvalent) until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by CMP Compliane and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information from the health professional noted that the physician wanted to exchange this lot for a new lot number. Upon internal review, the pt's cellulitis was considered to be an other important medical event. No further info is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: ITP that responded to IVIG.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Epistaxis, Eye haemorrhage, Gingival bleeding, Petechiae
Clinical narrative: The pt was covered in large bruises all over her body. She had a nose bleed and petechia all over her body including eye area and bleeding gums. She was treated in ER and then transferred to the hospital for an overnight stay and treated with IV and Renrho. Diagnosed with thrombocytopenia
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Aphasia, Autism, Coma, Somnolence
Clinical narrative: Pt stopped talking, become spacey and stopped responding. per doc 212752 patient has never developed appropriate speech language communication. He was right on track before the vaccines. His intestinal system is still messed-up and he is now on undergoing treatment to rid his body of mercury and other toxins. *F/UP report on 3/21/03: Autistic Sx's, Severe language loss.*
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Pt had 3 seizures on 10/29/01 and was hospitalized.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Monocytosis, Nausea, Pain
Clinical narrative: Pt developed a fever of 102.4F max, several rigors, headache, nausea and severe achiness in the left arm. Treatment: Tamiflu, droperidol, Toradol and Tylenol. Pt felt better at discharge. Dx'd with viral illness (monocytosis).
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Pt developed a fever of 102.4F max, several rigors, headache, nausea and severe achiness in the left arm. Treatment: Tamiflu, droperidol, Toradol and Tylenol. Pt felt better at discharge. Dx'd with viral illness (monocytosis).
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Adrenocortical insufficiency chronic, Cardiac arrest, Chest pain, Coma, Hypothyroidism
Clinical narrative: On 10/14/99, I woke up feeling horrible with heaviness in my chest and pain when breathing. That afternoon I was taken by EMS to the ER and was examined and released with a dx of pneumonia and was given prescriptions for Biaxin and Vicodin. The next day, 10/15/99, I felt worse and again was taken by EMS to the ER and within hours of arrival at the hospital, my heart stopped. I had a pericardial effusion (tamponade). My heart stopped 3 X, once for 20 minutes. My kidneys failed and I went into a coma. My parents came to the hospital and they were told that I was most likely going to die. My family and friends prepared themselves for my death. I spent a total of 3 weeks in the hospital, much of it in ICU, experiencing a myriad of heart problems, kidney dialysis and miscellaneous invasive procedures. After release from the hospital, I did not get better. I was re-admitted to the same hospital on 11/18/99. After 4 days of testing, I was dx'd with Addison's Disease and Hypothyroidism. When I received the medication for these conditions, I felt better and went home. I was off of work from mid 10/99 until 1/00. On 1/21/00, I again felt heaviness in my chest and went to ER. I was immediately admitted and surgery was later performed. I had a pericardial window and 600cc of fluid drained. I missed more work. On 3/13/00, I went to ER and was dx'd with pericarditis, although there was no fluid build up due to the pericardial window. From 3/00 to present, I have had recurrent pericarditis. It occurs regularly and is very painful. I now have 3 autoimmune conditions that I did not have prior to receipt of the anthrax vaccinations. My Rheumatologist is considering putting me on Methotrexate, as well, for Prednisone sparing purposes. I have gained 50 pounds and am quite obese as a result of the continuous steroid use. I am experiencing early onset menopause due to my endocrine problems.  The annual follow up states that, "I will have autoimmune problems for the rest of my life as a result of these vaccinations: Addison's disease, autoimmune hypothyroidism and recurrent pericarditis. I had none of these conditions prior to the anthrax shots. My life expectancy has been shortened."
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Immune system disorder, Menopause, Obesity, Pericardial effusion, Pericarditis
Clinical narrative: On 10/14/99, I woke up feeling horrible with heaviness in my chest and pain when breathing. That afternoon I was taken by EMS to the ER and was examined and released with a dx of pneumonia and was given prescriptions for Biaxin and Vicodin. The next day, 10/15/99, I felt worse and again was taken by EMS to the ER and within hours of arrival at the hospital, my heart stopped. I had a pericardial effusion (tamponade). My heart stopped 3 X, once for 20 minutes. My kidneys failed and I went into a coma. My parents came to the hospital and they were told that I was most likely going to die. My family and friends prepared themselves for my death. I spent a total of 3 weeks in the hospital, much of it in ICU, experiencing a myriad of heart problems, kidney dialysis and miscellaneous invasive procedures. After release from the hospital, I did not get better. I was re-admitted to the same hospital on 11/18/99. After 4 days of testing, I was dx'd with Addison's Disease and Hypothyroidism. When I received the medication for these conditions, I felt better and went home. I was off of work from mid 10/99 until 1/00. On 1/21/00, I again felt heaviness in my chest and went to ER. I was immediately admitted and surgery was later performed. I had a pericardial window and 600cc of fluid drained. I missed more work. On 3/13/00, I went to ER and was dx'd with pericarditis, although there was no fluid build up due to the pericardial window. From 3/00 to present, I have had recurrent pericarditis. It occurs regularly and is very painful. I now have 3 autoimmune conditions that I did not have prior to receipt of the anthrax vaccinations. My Rheumatologist is considering putting me on Methotrexate, as well, for Prednisone sparing purposes. I have gained 50 pounds and am quite obese as a result of the continuous steroid use. I am experiencing early onset menopause due to my endocrine problems.  The annual follow up states that, "I will have autoimmune problems for the rest of my life as a result of these vaccinations: Addison's disease, autoimmune hypothyroidism and recurrent pericarditis. I had none of these conditions prior to the anthrax shots. My life expectancy has been shortened."
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Pneumonia, Renal failure
Clinical narrative: On 10/14/99, I woke up feeling horrible with heaviness in my chest and pain when breathing. That afternoon I was taken by EMS to the ER and was examined and released with a dx of pneumonia and was given prescriptions for Biaxin and Vicodin. The next day, 10/15/99, I felt worse and again was taken by EMS to the ER and within hours of arrival at the hospital, my heart stopped. I had a pericardial effusion (tamponade). My heart stopped 3 X, once for 20 minutes. My kidneys failed and I went into a coma. My parents came to the hospital and they were told that I was most likely going to die. My family and friends prepared themselves for my death. I spent a total of 3 weeks in the hospital, much of it in ICU, experiencing a myriad of heart problems, kidney dialysis and miscellaneous invasive procedures. After release from the hospital, I did not get better. I was re-admitted to the same hospital on 11/18/99. After 4 days of testing, I was dx'd with Addison's Disease and Hypothyroidism. When I received the medication for these conditions, I felt better and went home. I was off of work from mid 10/99 until 1/00. On 1/21/00, I again felt heaviness in my chest and went to ER. I was immediately admitted and surgery was later performed. I had a pericardial window and 600cc of fluid drained. I missed more work. On 3/13/00, I went to ER and was dx'd with pericarditis, although there was no fluid build up due to the pericardial window. From 3/00 to present, I have had recurrent pericarditis. It occurs regularly and is very painful. I now have 3 autoimmune conditions that I did not have prior to receipt of the anthrax vaccinations. My Rheumatologist is considering putting me on Methotrexate, as well, for Prednisone sparing purposes. I have gained 50 pounds and am quite obese as a result of the continuous steroid use. I am experiencing early onset menopause due to my endocrine problems.  The annual follow up states that, "I will have autoimmune problems for the rest of my life as a result of these vaccinations: Addison's disease, autoimmune hypothyroidism and recurrent pericarditis. I had none of these conditions prior to the anthrax shots. My life expectancy has been shortened."
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Fibromyalgia, Influenza like illness, Laboratory test abnormal, Rheumatoid arthritis
Clinical narrative: Two and a half years ago I had 2 Lyme vaccinations on 02/19/1999 and 03/19/1999. Since then I have developed auto-immune arthritis in all of my joints. The annual follow up states, "I still don't know if my low-grade inflammatory process and elevated rheumatoid factor all due to the vaccine, but I still have those problems and occasional "flu-like" symptoms that mimic fibromyalgia, as well as moderate inflammation joint changes.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid factor
Clinical narrative: Two and a half years ago I had 2 Lyme vaccinations on 02/19/1999 and 03/19/1999. Since then I have developed auto-immune arthritis in all of my joints. The annual follow up states, "I still don't know if my low-grade inflammatory process and elevated rheumatoid factor all due to the vaccine, but I still have those problems and occasional "flu-like" symptoms that mimic fibromyalgia, as well as moderate inflammation joint changes.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Dementia, Pneumonia, Respiratory failure
Clinical narrative: The patient rapidly developed respiratory failure with oxygen desaturation days after receving the vaccination. Annual follow up states that pt did not recover. Replied to your letter dated 06/26/02 by fax on 07/17/02. Death certificate sent, as requested. Annual follow up on 11/25/03: "It is unknown if the patient recovered from the adverse event." Death Certificate Info: Immediate cause: Pneumonia. Underlying cause: Advanced Dementia. Significant Conditions: Diabetes Follow up on 06/01/2004: states it is unknown if the pt recovered from the adverse event.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Pneumonia, Respiratory failure
Clinical narrative: The patient rapidly developed respiratory failure and oxygen desaturation days after vaccination. Transferred to hospital. Per F/U on 6/25/02: immediate cause of death; respiratory failure and pneumonia.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: The patient became lightheaded and dizzy 4 hours post vax. The patient experienced nausea and vomiting during the night, which abated by the next morning.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Post vax, the patient experienced local erythema and pain on the right deltoid.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced swelling, pain, and a fever at the injection site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cough, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Fatigue, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Nausea, Pain, Paraesthesia, Pharyngolaryngeal pain
Clinical narrative: Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder pain, Sneezing
Clinical narrative: Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Post vax, the patient experienced injection site erythema, pain and edema. The patient was treated wtih cool compress and NSAID.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Post vax the patient developed redness, swelling, heat and pain at the injection site.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash erythematous, Rash macular
Clinical narrative: Post vax the patient was brought to the office with a rash. There were multiple macules 1mm, red raised areas surrounding 1 1/2 cm clearing surrounding the injection site. The site itself had redness, warmth and swelling. The patient was treated with Claritin.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Post vax the patient's arm was swollen from the injection site down to the elbow. The patient was treated with Benadryl.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Post vax, the patient developed a fever, fatigue, myalgia, nausea, loose stools and chills.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain
Clinical narrative: Post vax, the patient developed pain in the left arm radiating up to the neck. The patient was treated with ice.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: The patient experienced a fever, chills, myalgia, nausea and fatigue after vaccination.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Patient presented 24 hours after flu shot with a headache, fever of 100.6 and myalgia.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia
Clinical narrative: Post vaccination the patient developed aching in all joints, especially arms and no energy.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: After vaccination on 10/23/2001 the patient developed pruritis and a rash all over his body, except his face. The patient was treated with Benadryl.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Staff ARNP here received flu shot and had anaphylactic reaction. 2 other staff members had allergic reaction (itching).
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Eye irritation, Swelling face, Throat tightness
Clinical narrative: Staff ARNP here received flu shot and had anaphylactic reaction. 2 other staff members had allergic reaction (itching).
Age: 20.0
Sex: F
Vaccine: RAB, YF
Symptoms: Abdominal pain, Dry throat, Dyspnoea
Clinical narrative: Approximately 1 hr and 45 minutes after vaccinations pt phoned the clinic with complaint of abdominal pain,scratchy throat, and SOB. client was advised to call 911 for transport to ER. At 14:50  P/C to client . RE: status she advised she was driving to Er. At 15:00 client phoned from ER where she is receiving treatment.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever, irritable for three days.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Vomiting the same day PCV, DTaP and HiB were given. Phenergan supp 1/4 gid and Tylenol.
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Rash macular
Clinical narrative: Macular rash coalescing to form a patch mostly chest and abdomen.