chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 46-year-old male subject who was vaccinated with ENGERIX-B (GlaxoSmithKline) for prophylaxis. The subject's medical history included mental retardation and seizure disorder. On an unspecified date in 1983 the subject received "the hepatitis B vaccination series" with an unspecified number of doses of hepatitis B vaccine (unknown manufacturer). On an unspecified date after 1983 and before November 2005, a hepatitis B surface antibody titer was positive. The healthcare professional reported that, "for some unknown reason," the subject again was vaccinated with three subsequent doses of Engerix-B on an unspecified date in November 2005, an unspecified date after November 2005 and on or before 04 May 2006, and 04 May 2006. On 16 November 2006, 6 months after vaccination with the last dose of Engerix-B, a hepatitis B surface antibody titer was negative. Follow-up information received on 26 February 2007 indicated that there was no change in the subject's seroconversion. The subject was receiving multiple concurrent medications at the time of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Injection site nodule, Laboratory test normal, Smear cervix abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/7/2008; 4/7/2008. Information has been received through the Merck pregnancy registry through a health professional concerning an 18 year old female with a history of Herpes simplex, a positive Human Papillomavirus test and sports induced asthma, who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (Lot # 657736/0389U). On 21-MAY-2007, the patient developed a bump on her left arm at the injection site.  The bump on her arm resolved without treatment.  On 12-JUL-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of Gardasil (Lot # 658100/0525U).  On an unspecified date the patient found out she was pregnant (LMP approximately 01-MAR-2007).  On 16-AUG-2007, the patient reported the pregnancy at an office visit. On 17-AUG-2007, the patient had a serum alpha-fetoprotein test which was negative. On 30-NOV-2007, the patient had an ultrasound for screening. Prenatal screening tests (not specified) were normal.  Concomitant medications include VALTREX to prevent a Herpes simplex outbreak at the time of delivery.  Additional information has been requested. Follow up information indicated that on 02-Jan-2008, the patient delivered a normal female baby at 39 weeks from the LMP. The baby weighed 2267 grams and had an apgar score of 8/9. It was also reported that the baby "size was less than dates." No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/7/2008; 4/7/2008. Information has been received through the Merck pregnancy registry through a health professional concerning an 18 year old female with a history of Herpes simplex, a positive Human Papillomavirus test and sports induced asthma, who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (Lot # 657736/0389U). On 21-MAY-2007, the patient developed a bump on her left arm at the injection site.  The bump on her arm resolved without treatment.  On 12-JUL-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of Gardasil (Lot # 658100/0525U).  On an unspecified date the patient found out she was pregnant (LMP approximately 01-MAR-2007).  On 16-AUG-2007, the patient reported the pregnancy at an office visit. On 17-AUG-2007, the patient had a serum alpha-fetoprotein test which was negative. On 30-NOV-2007, the patient had an ultrasound for screening. Prenatal screening tests (not specified) were normal.  Concomitant medications include VALTREX to prevent a Herpes simplex outbreak at the time of delivery.  Additional information has been requested. Follow up information indicated that on 02-Jan-2008, the patient delivered a normal female baby at 39 weeks from the LMP. The baby weighed 2267 grams and had an apgar score of 8/9. It was also reported that the baby "size was less than dates." No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 05-Sep-2007 was vaccinated with Gardasil.  In September 2007, the patient reported that she had developed hives.  At one point the patient reported hives and then the patient was complaining of hives so it is not clear if she still had hives.  No other information was reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced welts at the injection site that lasted for about a month. The patient's outcome was not reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate schedule of drug administration in a subject of unspecified age and gender who was vaccinated with Engerix-B (GlaxoSmithKline) and hepatitis B vaccine. The subject's medical history included heart disease. Concurrent medical conditions included hypertension. Concurrent medications included Clonidine, Flopen, Isodine, Aspirin and HCTZ. On an unspecified date, prior to 22 January 2007, the subject received an unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced a "really sore" arm. At the time of reporting, the outcome of the event was unspecified. On 22 January 2007, the subject received the 3rd dose of Engerix-B (unknown, left arm) approximately 60 days early. The subject was supposed to receive the vaccination in March 2007. The subject was supposed to have blood work performed, but she requested vaccination for Hepatitis B.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma conjunctival
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 25-Jun-2007 was vaccinated with her first dose of Gardasil (lot # as reported "5234U").  On 16-Aug-2007 the patient was vaccinated with her second dose of Gardasil (lot # as reported "802UU").  On approximately 06-Sep-2007 the patient experienced conjuctival squamous papilloma.  Subsequently, the patient recovered from conjuctival squamous papilloma.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a female subject aged between 50 and 59 years old was vaccinated with Engerix-B (GlaxoSmithKline). Concurrent medical conditions included hemodialysis. On either 02 January 2007 or 03 January 2007, the subject received "possibly the 3rd last dose" of the Engerix-B series. On an unspecified date after 02 January 2007 or 03 January 2007 and before 23 January 2007, 1 week after  vaccination with Engerix-B, the subject tested positive for hepatitis B antigens. The outcome of the event was not reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a subject of unspecified age and gender who was vaccinated with Engerix-B ( GlaxoSmithKline) for prophylaxis. On an unspecified date before 23 January 2007, the subject received unspecified dose of Engerix-B. On an unspecified date on or before 23 January 2007, at an unspecified time after vaccination with Engerix-B, the subject tested positive for hepatitis B surface antigen. The outcome of the event was not reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a subject of unspecified age and gender who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  On an unspecified date before 23 January 2007, the subject received unspecified dose of Engerix-B.  On an unspecified date on or before 23 January 2007, at an unspecified time after vaccination with Engerix-B, the subject tested positive for hepatitis B surface antigen.  The outcome of the event was not reported.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a health professional concerning a 20 year old Hispanic female with a history of being positive for papilloma viral infection, who on 03-Nov-2007 was vaccinated with a 0.5mL dose of Gardasil.  Subsequently, the patient was pregnant.  The patient's last menstrual period was 21-Sep-2007 and her estimated delivery date was 27-Jun-2008.  The patient had one previous pregnancy and one full term delivery.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described th occurrence of rash in a 23-year-old male subject who was vaccinated with ENGERIX B vaccine. Concurrent medical conditions included mononucleosis. On an unspecified date, the subject received the 1st dose of ENGERIX B, the subject experienced rash, fever and dizziness. The subject had mononucleosis at the time of vaccination with ENGERIX B, so the physician was unsure if the symptoms were from the vaccine or from the pre-existing condition. The reporting physician stated that she had not seen the subject since the onset of the events, nor did she know when the subjects received the ENGERIX B dose, as he was vaccinated at another facility. At the time of reporting, the outcome of the events was unspecified.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture negative, Hypovolaemic shock, Renal failure acute, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 9 week old male with no pertinent medical history or allergies who on 13-Dec-2007 was vaccinated orally with a first dose of Rotateq (lot #657519/1129U).  Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), Hib conj vaccine (unspecified carrier) (manufacturer unknown), Prevnar and poliovirus vaccine (manufacturer unknown).  On an unspecified date (in approximately December 2007), the patient experienced renal failure, vomiting, diarrhea and a low grade fever.  The patient presented to the emergency room (patient not admitted to the hospital, in ER only) and was given "a bolus".  Blood and urine cultures were performed, results were not reported.  The patient's outcome was not reported.  There was no product quality complaint involved.  No further information was provided.  Upon internal review the patient's renal failure was determined to be an other important medical event.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture, Culture urine, Diarrhoea, Pyrexia, Renal failure
Clinical narrative: Information has been received from a physician concerning an approximately 9 week old male with no pertinent medical history or allergies who on 13-Dec-2007 was vaccinated orally with a first dose of Rotateq (lot #657519/1129U).  Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), Hib conj vaccine (unspecified carrier) (manufacturer unknown), Prevnar and poliovirus vaccine (manufacturer unknown).  On an unspecified date (in approximately December 2007), the patient experienced renal failure, vomiting, diarrhea and a low grade fever.  The patient presented to the emergency room (patient not admitted to the hospital, in ER only) and was given "a bolus".  Blood and urine cultures were performed, results were not reported.  The patient's outcome was not reported.  There was no product quality complaint involved.  No further information was provided.  Upon internal review the patient's renal failure was determined to be an other important medical event.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 9 week old male with no pertinent medical history or allergies who on 13-Dec-2007 was vaccinated orally with a first dose of Rotateq (lot #657519/1129U).  Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), Hib conj vaccine (unspecified carrier) (manufacturer unknown), Prevnar and poliovirus vaccine (manufacturer unknown).  On an unspecified date (in approximately December 2007), the patient experienced renal failure, vomiting, diarrhea and a low grade fever.  The patient presented to the emergency room (patient not admitted to the hospital, in ER only) and was given "a bolus".  Blood and urine cultures were performed, results were not reported.  The patient's outcome was not reported.  There was no product quality complaint involved.  No further information was provided.  Upon internal review the patient's renal failure was determined to be an other important medical event.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Hyperhidrosis, Lethargy, Pyrexia, Urinary incontinence
Clinical narrative: On day 8 after the vaccine he was very lethargic. Then he got sick. That night he had an extraordinary high fever which broke. He urinated all over himself and the bed and was covered in sweat. I called the Ped office listed above to record the reaction.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Coeliac disease, Milk allergy, Otitis media, Rhinitis allergic, Rhinorrhoea
Clinical narrative: Vaccination given in left thigh.  Pt had repeated ear infections following vaccination, treatment was two Rocephin shots to the left thigh.  Pt dragged left leg until 10 mos when started crawling, then started cruising at 12 mos but would not put weight on left leg.  Walked at 17 months.  Currently has gluten and milk allergies, speech delays.  1/18/08 Reviewed pcp medical records which reveal patient experienced good health on 8/23/06.  9/20/06 dx w/GERD & bilateral OM.  Rocephin 500 mg given IM in right thigh.  10/24 dx w/GERD, runny nose, possible allergic rhinitis, TMs w/effusions.  11/25/06 dx w/URI & serous otitis media.  12/5 fine papular rash all over, dx w/yeast allergic rash.  1/13/07 dx w/URI & otitis media.  Rocephin 500 mg given IM in right thigh.  OM persisted & referred to allergist.  2/8/07 allergist dx w/no food allergy by skin testing; recurrent rhinits etiology unclear; eustachan tube dysfunction secondary to rhinitis; suspect mile acute sinusitis related to rhinitis. Tx w/oral steroids, oral antibiotic & nasal steroids.  Returned to pcp 4/10/07 & dx w/tonsillitis/URI.  Developed otitis media by 4/23/07.  6/11/07 patient on gluten free diet & doing better.  7/27/07 dx/tonsillitis & adenitis.  Vax record confirms vax as reported. Follow-up: Child was well and healthy before this event, and nothing but sick afterward.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder developmental, Weight bearing difficulty
Clinical narrative: Vaccination given in left thigh.  Pt had repeated ear infections following vaccination, treatment was two Rocephin shots to the left thigh.  Pt dragged left leg until 10 mos when started crawling, then started cruising at 12 mos but would not put weight on left leg.  Walked at 17 months.  Currently has gluten and milk allergies, speech delays.  1/18/08 Reviewed pcp medical records which reveal patient experienced good health on 8/23/06.  9/20/06 dx w/GERD & bilateral OM.  Rocephin 500 mg given IM in right thigh.  10/24 dx w/GERD, runny nose, possible allergic rhinitis, TMs w/effusions.  11/25/06 dx w/URI & serous otitis media.  12/5 fine papular rash all over, dx w/yeast allergic rash.  1/13/07 dx w/URI & otitis media.  Rocephin 500 mg given IM in right thigh.  OM persisted & referred to allergist.  2/8/07 allergist dx w/no food allergy by skin testing; recurrent rhinits etiology unclear; eustachan tube dysfunction secondary to rhinitis; suspect mile acute sinusitis related to rhinitis. Tx w/oral steroids, oral antibiotic & nasal steroids.  Returned to pcp 4/10/07 & dx w/tonsillitis/URI.  Developed otitis media by 4/23/07.  6/11/07 patient on gluten free diet & doing better.  7/27/07 dx/tonsillitis & adenitis.  Vax record confirms vax as reported. Follow-up: Child was well and healthy before this event, and nothing but sick afterward.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Chills, Dermatitis bullous, Full blood count normal, Idiopathic thrombocytopenic purpura, Laboratory test normal
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Liver function test normal, Malaise, Mononucleosis heterophile test negative, Productive cough, Pyrexia
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Skin lesion
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Activities of daily living impaired, Arthralgia, Blood chloride decreased, Blood glucose increased, Blood potassium decreased
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Blood product transfusion, Chills, Coagulation test normal, Cough, Dyspnoea
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Epistaxis, Fatigue, Full blood count abnormal, Haemoptysis, Headache
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Increased upper airway secretion, Influenza like illness, Lip haemorrhage, Liver function test normal, Lymphocyte percentage decreased
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Malaise, Monocyte count increased, Myalgia, Nasal congestion, Neutrophil count increased
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Neutrophil percentage increased, Night sweats, Platelet count decreased, Platelet transfusion, Pneumonia
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pyrexia, Rhinorrhoea, Skin discolouration, Throat irritation, Thrombocytopenia
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 36.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: White blood cell count increased
Clinical narrative: Patient received FluMist vaccination on 5 Nov 07.  Patient was asymptomatic until 7-10 days later when developed malaise. Patient took 100mg acetaminophen q6h for 4 days then symptoms changed to fever, chills and productive cough treated with OTC items.  On 6 Dec 07 patient appeared for medical treatment after noticing hemorrhagic bullous lesion on his lips and oral mucosa on 5 Dec, and petechiae on legs on 4 Dec.  Labs showed platelet count of zero, which was confirmed.  Patient was diagnosed with suspected ITP with possible relation to vaccine and evacuated to medical center.  8/15/08 Reviewed medical reccords of 12/5/07-6/10/2008. FINAL DX: Idiopathic thrombocytopenia purpura assoc w/flumist vaccine. Records reveal patient experienced arthralgias, myalgias & fatigue approx 1 week s/p vaccination; HA, fever, chills & night sweats 10 days s/p vaccination; nasal congestion, post nasal drip, throat tickling, hacking cough w/SOB 2 weeks s/p vaccination; & dark spots on lower lip & legs, nosebleed, bleeding from lip lesion & productive bloody cough & extensive petechiae 1 month s/p vaccination.  Dx w/pneumonia intially but CBC revealed thrombocytopenia w/a platelet count of 0.  Admitted & tx w/steroids.  Transferred to higher level of care & tx w/platelet transfusion & IVIG.  Gradually improved & transferred to hospital on continued steroids.  Improved & d/c to home w/continued heme/onc f/u w/serial labs.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: Pt received Hep A & Menactra on the afternoon of 15JAN08.  Reported swelling, warmth, redness and itching around site on morning of 17JAN08.  Pt reports symptoms begining evening of the 15JAN08.  Pt reports that symptoms have worsened slightly from this time until the morning of 17JAN08.  Pt reports scratching at the site.  On assessment right upper arm appearing to have mild swelling with red, warm area of approximately 6-7cm in diameter.  Pt denies any fevers or other symptoms. Site also assessed by physician and determined to be localized skin reaction.  Pt instructed to use hydrocortisone cream and Benadryl to help control itching at site as well as cool compresses.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Swollen, red and itchy eyes~taking Benadryl.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient received smallpox vaccination on 5Jan08 and became pregnant approximately 2 days later.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Blood culture, Chest X-ray, Computerised tomogram, Convulsion, Culture urine
Clinical narrative: After receiving the Flu vaccine, my son developed a fever about 5-7 hrs. later.  At 4 hours later his eyes and nose began running and he was cranky.  Throughout the night of 1/15-1/16 his fever continued to rise.  At 12:20pm on 1/16 he had a seizure due to rapid rise from fever.  His limbs turned blue, became rigid, had difficulty breathing.  Had CT scan, x-ray, blood, and urine test.  He is continued being treated with Motrin and Tylenol at a higher dosage.  He needs to go in for follow up chest x-rays-has developed an URI.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Cyanosis, Dyspnoea, Irritability, Lacrimation increased, Muscle rigidity
Clinical narrative: After receiving the Flu vaccine, my son developed a fever about 5-7 hrs. later.  At 4 hours later his eyes and nose began running and he was cranky.  Throughout the night of 1/15-1/16 his fever continued to rise.  At 12:20pm on 1/16 he had a seizure due to rapid rise from fever.  His limbs turned blue, became rigid, had difficulty breathing.  Had CT scan, x-ray, blood, and urine test.  He is continued being treated with Motrin and Tylenol at a higher dosage.  He needs to go in for follow up chest x-rays-has developed an URI.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: After receiving the Flu vaccine, my son developed a fever about 5-7 hrs. later.  At 4 hours later his eyes and nose began running and he was cranky.  Throughout the night of 1/15-1/16 his fever continued to rise.  At 12:20pm on 1/16 he had a seizure due to rapid rise from fever.  His limbs turned blue, became rigid, had difficulty breathing.  Had CT scan, x-ray, blood, and urine test.  He is continued being treated with Motrin and Tylenol at a higher dosage.  He needs to go in for follow up chest x-rays-has developed an URI.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Wrong technique in drug usage process
Clinical narrative: Patient reported that vaccine was administered via IM injection to the dorsogluteal region two months ago and has resulted in a "hole" or depression of the tissue at the injection site.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Crying, Oedema peripheral, Swelling
Clinical narrative: Patient cried all day Friday after shots. Then he went to sleep at 7PM. Patient woke up crying, and continued to cry while feeding. Patient slept through the night. Then woke up Saturday morning and went back to sleep at 11AM. Patient woke up crying and stopped breathing upon arrival to hospital with swollen legs & arms. Transported via car. Patient was transferred. 1/18/08 Reviewed vax record which confirms RO dose & lot as reported. 3/5/08 Reviewed hospital medical records of 1/7-1/15/2008 which reveal patient experienced lethargy, hypothermia, apnea & respiratory failure.   Had been seen in outlying ER where rectal temp was 92.3 & O2 sats was 82%.  Parent admitted to feeding large amounts of H2O in addition to formula.  Intubated in outlying ER, septic w/u initiated & started on IV antibiotics prior to transfer.  Admitted to PICU where exam revealed small thin patient w/coarse breath sounds, cool periphery & lethargy. Consults done: ophthalmology, endocrine, PICU, nutrition & MSW.  Extubated w/o & restarted feeds w/o difficulty.  Progressed well & d/c to care of maternal cousin to f/u w/pcp & endocrine. FINAL DX: failure to thrive; hyponatremia; hypothermia; & respiratory failure. 3/7/08 Reviewed ER medical records of 1/6/2008 which reveal patient experienced cough, lethargy, listless, apnea spells, accessory muscle use, retractions, decreased air movement & breathing difficulty.  Pulse ox 85%.  Rectal temp 92.3.  LP done. Tx w/IVF, IV antibiotics & intubated prior to transfer to higher level of care. ER Final DX: fever, sepsis, hyponatremia, hypotension, bradycardia.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site discomfort, No reaction on previous exposure to drug, Pain in extremity, Paraesthesia
Clinical narrative: "Approximately 1/3/08 she received her 3rd Gardasil injection in the left deltoid shoulder area.  She said it felt a little more uncomfortable than usual, felt just ill inside, like the fluid going into her arm.  Since that time, she has had progressive pain extending down the entire arm with some tingling generalized in the arm and hands.  Pain in a broad area.  She denies any skin changes over the site, no constitutional symptoms during the last symptoms.  She denies any generalized reaction to prior injections or to any immunizations in the past that she can recall.  She has pain with resistant abduction and external rotation.  No treatment at this time."
Age: 31.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthma
Clinical narrative: Seriousness criteria: other-medically significant.  Initial report was received from a health care provider on 03 January 2008.  A 31-year-old male patient had received Imovax Rabies vaccine, lot number K1120 and Rabies Immune Globulin (manufacturer not reported) during an emergency room visit for a possible rabies exposure following a cat bite in 1996.  The dates of product administration, and routes/sites of vaccination were not reported.  Following treatment, the patient was diagnosed with asthma; the dates of diagnosis and onset of symptoms and the patient's medical history were not provided.  It was not reported if the cat had been confirmed rabid or if testing results were available.  No further information had been provided at the time of the report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Facial palsy, Rash
Clinical narrative: Information has been received from a physician concerning a female "in her 60's" with a history of shingles who in 2007 "sometime before Christmas", was vaccinated with 0.65 ml of Zostavax. Prior to vaccination the patient had had symptoms of shingles and was given an antiviral and returned to clinic after one week to show that the rashes went away. The physician administered the vaccination with Zostavax, during the time that the patient showed that the rashes were already gone, "to boost the patient's immunity". One week after receiving Zostavax the patient returned to clinic with symptoms of "bell's palsy" on the same side of her face that she had previously had the rashes. The patient was given a steroid by the physician, and after a few days complained of pain in her face. At the time of reporting the physician noted that the patient's symptoms have improved, but she has "not returned back to normal yet". The lot number was not available. Lab diagnostics studies were not performed. There was no product quality complaint. Upon internal review the event of Bell's Palsy was considered as a other medically important event (OME). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning an approximately 77 year old female ("late 70's") who was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently the patient developed Guillain-Barre C3 A9 syndrome and was hospitalized.  The patient was released from the hospital and was noted to be "now doing better".  There was no product quality complaint.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Allergy test, Anaphylactic reaction, Dysphagia, Lip swelling
Clinical narrative: Information has been received from a health professional concerning an 8 year old male with Epstein's anomaly (congenital heart disease) (previously reported as no pertinent medical history) and unknown allergies, who was vaccinated IM (previously reported as SC) at 2:00 PM with a second 0.5 ml dose of Varivax (Oka/Merck) (lot number: 658178-1013U). There was no illness at the time of vaccination. Concomitant therapy included "other vaccines" such as Havrix. On 12-SEP-2007, following vaccination the patient experienced an anaphylactic reaction. The patient was treated with epinephrine as an intervention. It was noted that this was a life threatening event. The outcome is reported as recovered "within 24 hours". There was no product quality complaint. The reporter considered the anaphylactic reaction to be an other important medical event. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. Follow-up information stated that the patient was seen by the physician for testing of allergies to any vaccine additives but these results were not available at the time. The vaccine was administered by the patient's primary care doctor. Follow-up information was requested. Follow-up information received stated that on 12-SEP-2007 at 2:15 PM the patient experienced lip swelling followed by complaints of difficulty swallowing. Required epinephrine SC and oral steroids. There was no illness at time of vaccination. No other information. Lip swelling and difficulty swallowing were considered to be other medical event by the reporter.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 4 month old male who, "approximately two weeks ago," on approximately 01-Jan-2008, was vaccinated with a dose of Rotateq.  Subsequently in January 2008, the patient experienced bloody stools.  The patient was sent to the emergency room and was observed not to have had intussusception.  It was reported that the bloody stool was still being observed even two weeks thereafter, not as bad, but still happening.  It was not known if the patient would continue the series of Rotateq at the six month visit.  Upon internal review, the patient's bloody stools were considered to be other important medical events.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 27-DEC-2007 was vaccinated with the third dose of Rotateq.  On 04-JAN-2008 the patient experienced intussusception and was hospitalized for an unspecified period of time.  The patient had a "contrast enema" performed on an unknown date, results not reported.  Subsequently, the patient recovered from intussusception.  Upon internal review, intussusception is considered an other important medical event.  No product quality complaint reported.  Additional information has been requested.  01/22/2008 Vax record received and updated in database. 01/29/2008 MR received for DOS 01/4-5/2008 with DX:  Intussusception.  Child presented to ER with 1 day hx of diarrhea with screaming and abdominal pain. Reduced by Barium Enema. Pt tolerating diet and D/Cd next day.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Laboratory test, Oedema peripheral, Pain, Pain of skin
Clinical narrative: Information has been received from a 31 year old female consumer with a history of a right shoulder condition and a cyst on her stomach cord who in October 2007, was vaccinated with a dose of Pneumovax 23 while she was hospitalized for double pneumonia. Concomitant therapy included influenza virus vaccine (unspecified) administered on the same day, hormonal contraceptives (unspecified), estrogens (unspecified), trazodone hydrochloride (TRAZADONE) and rizatriptan benzoate (MAXALT). On 04-DEC-2007 around 4:00 pm, the patient went to her physician's office and received another dose of Pneumovax 23. On 05-DEC-2007 around 5:30 am, the patient woke up and her arm was swollen. Then later on that day around 1:30 pm she started to get a fever that went up to 103.2, chills, her skin hurt, her swollen arm got worse, and her body ached all over and she had red blotches on her arm as well. Later that night, the patient went to the hospital and was admitted for about three days. It was reported that the chills, fever, body aches and her hurting skin went away, but her arm is still a little bit swollen and it hurts when she touches it. No product quality complaint was involved. No further information is available.