chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 24-month-old female subsequent to the administration of FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  On 23-Feb-2010, the patient was administered FLUMIST.  There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. No late occurring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 24-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product to a four-year-old male was received from a clinic administrator concerning a four-year-old male subsequent to the administration of FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  On 22-Feb-2010, the patient was administered FLUMIST.  There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Follow up - No late occuring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into narrative: information on late occurring adverse events.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 33 year-old male subject received the following vaccines on 8 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twelve days after vaccination, the subject was diagnosed with non-specific myocarditis. The subject was also diagnosed with unspecified disease of the pericardium 14 days after vaccination. The subject had a history of dizziness/fainting spells. On day 13 (21 March 2010), the following tests were performed: Troponin I, 12.3 (abnormal); electrocardiogram, normal; and echocardiogram, normal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-intervention) study. List of documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Encephalitis, Lumbar puncture abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 20 year-old male subject received ACAM2000 (lot number not reported) on 05 January 2009. Twenty days after vaccination, on 25 January 2009, the subject was diagnosed with encephalitis following immunization procedures. The subject has a history of abnormal electrocardiogram (date not provided). An MRI performed on 21 January 2009 was reported as normal. An echocardiogram performed on 22 January 2009 was normal. A lumbar puncture performed on 29 January 2009 was reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-intervention) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 21 year-old male subject received the following vaccines on 22 April 2009: ACAM200 (lot number not reported); TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Nineteen days after vaccination, the subject was diagnosed with acute pericarditis, unspecified. The subject had no significant medical history. On 04 May 2009 (12 days after vaccination), the subject had an electrocardiogram, an echocardiogram and a Troponin I. All were reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-intervention) study. List of documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericarditis, Troponin I
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 21 year-old male subject received the following vaccines on 22 April 2009: ACAM200 (lot number not reported); TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Nineteen days after vaccination, the subject was diagnosed with acute pericarditis, unspecified. The subject had no significant medical history. On 04 May 2009 (12 days after vaccination), the subject had an electrocardiogram, an echocardiogram and a Troponin I. All were reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-intervention) study. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase decreased, C-reactive protein increased, Chest pain, Myocarditis, Myoglobin blood increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 22-year-old male subject received the following vaccines on 14 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Eleven days after vaccination, the subject was diagnosed with non-specific myocarditis. The subject was also diagnosed with unspecified disease of the pericardium 12 days after vaccination. The subject had a history of headaches. A Troponin I, drawn on Day 12, was 5.4 (abnormal). The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, ANTH, SMALL
Symptoms: Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 22-year-old male subject received the following vaccines on 14 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Eleven days after vaccination, the subject was diagnosed with non-specific myocarditis. The subject was also diagnosed with unspecified disease of the pericardium 12 days after vaccination. The subject had a history of headaches. A Troponin I, drawn on Day 12, was 5.4 (abnormal). The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, ANTH, SMALL
Symptoms: Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 22-year-old male subject received the following vaccines on 14 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Eleven days after vaccination, the subject was diagnosed with non-specific myocarditis. The subject was also diagnosed with unspecified disease of the pericardium 12 days after vaccination. The subject had a history of headaches. A Troponin I, drawn on Day 12, was 5.4 (abnormal). The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Injection site induration, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt. went to clinic on 01/09/10 to receive H1N1 shot - almost immediately after arm was very sore. Pt describes pain to be unbearable, she could not button her shirt, her arm felt very heavy. Pt was seen by Dr and given tramadol - hcl tab 50 mg. Phone-in fro pain. Medicine caused vomiting. Vomiting was so projectile it knocked her dentures out her mouth. Pt. still had not recovered fully and has been doing therapy since February 2010.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Nuclear magnetic resonance imaging, Pain in extremity, Sensation of heaviness
Clinical narrative: Pt. went to clinic on 01/09/10 to receive H1N1 shot - almost immediately after arm was very sore. Pt describes pain to be unbearable, she could not button her shirt, her arm felt very heavy. Pt was seen by Dr and given tramadol - hcl tab 50 mg. Phone-in fro pain. Medicine caused vomiting. Vomiting was so projectile it knocked her dentures out her mouth. Pt. still had not recovered fully and has been doing therapy since February 2010.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Vomiting, X-ray
Clinical narrative: Pt. went to clinic on 01/09/10 to receive H1N1 shot - almost immediately after arm was very sore. Pt describes pain to be unbearable, she could not button her shirt, her arm felt very heavy. Pt was seen by Dr and given tramadol - hcl tab 50 mg. Phone-in fro pain. Medicine caused vomiting. Vomiting was so projectile it knocked her dentures out her mouth. Pt. still had not recovered fully and has been doing therapy since February 2010.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abdominal discomfort, Condition aggravated, Grip strength decreased, Pain in extremity, Pyrexia
Clinical narrative: Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands and concomitant medications included unspecified medications for neurological problems. A non-healthcare professional reported the patient's medical history included reflex sympathetic dystrophy (RSD) and an unspecified allergy to morphine. Concomitant medications included Ketamine and other unspecified medications. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Follow-up information was received on 05 April 2010 from a health care professional. Based upon this new information received it was determined this case meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient experienced an exacerbation of multifactorial chronic neuropathic pain following vaccination. Outcome was not recovered. According to the reporter, the patient died on 10 February 2010 of causes unrelated to the vaccine. The cause of death was not reported. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands and concomitant medications included unspecified medications for neurological problems. A non-healthcare professional reported the patient's medical history included reflex sympathetic dystrophy (RSD) and an unspecified allergy to morphine. Concomitant medications included Ketamine and other unspecified medications. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Follow-up information was received on 05 April 2010 from a health care professional. Based upon this new information received it was determined this case meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient experienced an exacerbation of multifactorial chronic neuropathic pain following vaccination. Outcome was not recovered. According to the reporter, the patient died on 10 February 2010 of causes unrelated to the vaccine. The cause of death was not reported. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abdominal discomfort, Condition aggravated, Death, Grip strength decreased, Neuralgia
Clinical narrative: Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands and concomitant medications included unspecified medications for neurological problems. A non-healthcare professional reported the patient's medical history included reflex sympathetic dystrophy (RSD) and an unspecified allergy to morphine. Concomitant medications included Ketamine and other unspecified medications. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Follow-up information was received on 05 April 2010 from a health care professional. Based upon this new information received it was determined this case meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient experienced an exacerbation of multifactorial chronic neuropathic pain following vaccination. Outcome was not recovered. According to the reporter, the patient died on 10 February 2010 of causes unrelated to the vaccine. The cause of death was not reported. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands and concomitant medications included unspecified medications for neurological problems. A non-healthcare professional reported the patient's medical history included reflex sympathetic dystrophy (RSD) and an unspecified allergy to morphine. Concomitant medications included Ketamine and other unspecified medications. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Follow-up information was received on 05 April 2010 from a health care professional. Based upon this new information received it was determined this case meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient experienced an exacerbation of multifactorial chronic neuropathic pain following vaccination. Outcome was not recovered. According to the reporter, the patient died on 10 February 2010 of causes unrelated to the vaccine. The cause of death was not reported. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Anaphylactic reaction, Cough, Drooling, Erythema, Headache
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Ocular hyperaemia, Rabies
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Swelling face, Urticaria
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cardiac monitoring, Cough, Drooling, Erythema, Headache
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Ocular hyperaemia, Rash
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Swelling face, Throat irritation, Urticaria
Clinical narrative: Initial case received on 07 April 2010 and 08 April 2010 from the mother of the patient. A 5 year old male patient received a left deltoid injection (route not reported) of DAPTACEL (lot number unknown) and a right deltoid injection (route not reported) of IPOL (lot number unknown) on 02 April 2010. Approximately 10 minutes after vaccinations on 02 April 2010, as the mother was putting her son in the car, he started to cough uncontrollably and drool at the mouth, repeatedly saying "this cough just won't go away, my throat." The mother returned the patient to the office immediately and the physician examined his throat and lungs. The coughing and drooling persisted, his head hurt, his face was "beat red" and his eyes were red. The physician called 911. In the office the patient received two nebulizer treatments and oxygen via nasal cannula. His oxygen saturation was 95%. The mother noticed a rash on the patient's chest and back and he was given 7.5 mL of BENADRYL. The physician attempted to give him oral prednisone, which he spit out. While in the ambulance on the way to the emergency room (ER) the mother noticed welts on her son's left arm. By the time the patient arrived at the ER, he was red from head to torso, his face was swollen and he had hives on his legs. The injection site on the left arm was red and swollen. In the ER he was placed on a cardiac monitor and was given a right thigh injection of epinephrine, BENADRYL and intravenous prednisone. Shortly thereafter, "things started slowing down" and the body rash faded and went away. The patient was discharged at approximately 8 pm on 02 April 2010. The patient had no illness at the time of the vaccinations. The mother noted that Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. As casamino acid is an acid hydrolysate of casein and casein is a milk protein, she was concerned that there were milk by-products in the vaccine because her son has a level 4 milk allergy. The patient recovered from the adverse events on an unspecified date. Documents held by sender: None.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of found dead in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk) and PREVNAR (non-gsk). Co-suspect medication included ZANTAC syrup for gastroesophageal reflux disease. Concurrent medical conditions included gastroesophageal reflux disease. Previous and/or concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given at in 2010. On 7 April 2010 at 10:20 the subject received 1st dose of PEDIARIX (.5 ml, unknown, left thigh), 1st dose of ACTHIB (unknown) and 1st dose of PREVNAR (unknown). On an unknown date, the patient started Ranitidine hydrochloride (oral) at .6 ml three times per day. On 8 April 2010, 1 day after vaccination with PEDIARIX, ACTHIB, PREVNAR, and unknown time after starting ZANTAC, the subject experienced found dead. The subject was found deceased in crib the morning following vaccine administration. The subject was covered with blankets. The subject died on 8 April 2010 from death nos. It was unknown whether an autopsy was performed. The patient was prescribed ZANTAC for reflux the day before death was pronounced. Unclear if ZANTAC was actually administered.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Resuscitation
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of found dead in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk) and PREVNAR (non-gsk). Co-suspect medication included ZANTAC syrup for gastroesophageal reflux disease. Concurrent medical conditions included gastroesophageal reflux disease. Previous and/or concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given at in 2010. On 7 April 2010 at 10:20 the subject received 1st dose of PEDIARIX (.5 ml, unknown, left thigh), 1st dose of ACTHIB (unknown) and 1st dose of PREVNAR (unknown). On an unknown date, the patient started Ranitidine hydrochloride (oral) at .6 ml three times per day. On 8 April 2010, 1 day after vaccination with PEDIARIX, ACTHIB, PREVNAR, and unknown time after starting ZANTAC, the subject experienced found dead. The subject was found deceased in crib the morning following vaccine administration. The subject was covered with blankets. The subject died on 8 April 2010 from death nos. It was unknown whether an autopsy was performed. The patient was prescribed ZANTAC for reflux the day before death was pronounced. Unclear if ZANTAC was actually administered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Auricular swelling, Lip swelling, Rash, Swollen tongue
Clinical narrative: facial rash, swollen lips and tongue and ears within 10 minutes after receiving vaccines
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration
Clinical narrative: 40mm area of induration at vaccination site on right upper arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site. Patient instructed to use ibuprofen and alternate warm/cold compresses.  To ER if breathing difficulty.  See in office if symptoms worsen.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Headache, Oedema peripheral, Pain
Clinical narrative: 2-3 hours after vaccination had swelling of arm and severe headache, crying in pain like sharp pain persistent for 1 day.  No history of migraine or previous headaches.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Alopecia, Antinuclear antibody positive, Arthralgia, Autoantibody negative, Back pain
Clinical narrative: This 41 year old female reported receipt of her primary DRYVAX on 25 June 2003. Three AVA vaccinations were administered on 06 Sept 2003, 22 Sept 2003, and 11 Oct 2003 with no remembered adverse events to either vaccine. During a routine physical 14 Nov 2003 (1 month post 3rd AVA vac), a CBC identified "mild microcytic anemia" (WBC 5.2 (nl), High 12; HCT 37 MCV 85; neut 47%; lymph 47%) otherwise normal). She admitted to being tired and a family history of hypothyroidism otherwise no complaints documented or remembered. Providers suggested diagnosis of "high probability thalassemia". On 20 June 2004 ( months post vaccination) she complain of 2 day hx of itchy scalp with tender scalp and hair loss (hx of similar hair loss at age 9-10), headaches (hx tension ha), increased fatigue, and cervical-aural lymphadenopathy. She was diagnosed with superficial cellulitis and given KEFLEX. F/u eval 6/28/04 dx tinea capitis (positive woods lamp) and given griseofulvin and selenium sulfide shampoo. By 7/3/04 her symptoms had not changed and she now reported fever of 102 F with night sweats. She was treated with ROCEPHIN 1 gm IM X 3 days. By 7/9/04 the lymphadenopathy was resolving; however she exhibited a new vesicular papular itchy rash to bilateral arms, face and oral thrush with a sore throat-diagnosed with possible allergic reaction to griseofulvin. Meds were stopped and she was treated with 7 day taper of Prednisone and given DIFLUCAN with resolution of symptoms except alopecia. While hair regrowth did occur, new sites would develop, dermatology referral:  2 punch biopsies showed "inflammatory scarring alopecia with features consistent with lupus erythematosus. Negative GMS fungal stain". She was diagnosed with discoid lupus 18 August 2004 and referred to internal medicine doe SLE. October 2004 (12 months post AVA#3 vac) repetitive monthly flare ups of alopecia, fevers, arthralgia was associated with onset of menstrual cycles. She was admitted by rheumatology October 6-12, 2004 with neutropenic fever (ANC 325 and c/o 2 week hx fevers>102F, chills, HA, fatigue, sore throat, mouth ulcers, arthralgia, chronic LBP). Symptoms resolved with supportive therapy. Features were noted to be suggestive of SLE or DLE converting to SLE with negative ANA, cytopenia, fever, adenopathy, arthralgia, and fatigue (see below labs). Rheumatology diagnosed ANA-negative SLE based on DLE lesions and organ symptomatology (cytopenia from 2004 to present day, she continues to be followed by rheumatology, PCP, dermatology, GYN, et at for re-flare of symptoms.  Follow-up - Patient's last name updated.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Biopsy bone marrow abnormal, Blood culture negative, Blood folate normal, Blood glucose normal, Blood immunoglobulin A normal
Clinical narrative: This 41 year old female reported receipt of her primary DRYVAX on 25 June 2003. Three AVA vaccinations were administered on 06 Sept 2003, 22 Sept 2003, and 11 Oct 2003 with no remembered adverse events to either vaccine. During a routine physical 14 Nov 2003 (1 month post 3rd AVA vac), a CBC identified "mild microcytic anemia" (WBC 5.2 (nl), High 12; HCT 37 MCV 85; neut 47%; lymph 47%) otherwise normal). She admitted to being tired and a family history of hypothyroidism otherwise no complaints documented or remembered. Providers suggested diagnosis of "high probability thalassemia". On 20 June 2004 ( months post vaccination) she complain of 2 day hx of itchy scalp with tender scalp and hair loss (hx of similar hair loss at age 9-10), headaches (hx tension ha), increased fatigue, and cervical-aural lymphadenopathy. She was diagnosed with superficial cellulitis and given KEFLEX. F/u eval 6/28/04 dx tinea capitis (positive woods lamp) and given griseofulvin and selenium sulfide shampoo. By 7/3/04 her symptoms had not changed and she now reported fever of 102 F with night sweats. She was treated with ROCEPHIN 1 gm IM X 3 days. By 7/9/04 the lymphadenopathy was resolving; however she exhibited a new vesicular papular itchy rash to bilateral arms, face and oral thrush with a sore throat-diagnosed with possible allergic reaction to griseofulvin. Meds were stopped and she was treated with 7 day taper of Prednisone and given DIFLUCAN with resolution of symptoms except alopecia. While hair regrowth did occur, new sites would develop, dermatology referral:  2 punch biopsies showed "inflammatory scarring alopecia with features consistent with lupus erythematosus. Negative GMS fungal stain". She was diagnosed with discoid lupus 18 August 2004 and referred to internal medicine doe SLE. October 2004 (12 months post AVA#3 vac) repetitive monthly flare ups of alopecia, fevers, arthralgia was associated with onset of menstrual cycles. She was admitted by rheumatology October 6-12, 2004 with neutropenic fever (ANC 325 and c/o 2 week hx fevers>102F, chills, HA, fatigue, sore throat, mouth ulcers, arthralgia, chronic LBP). Symptoms resolved with supportive therapy. Features were noted to be suggestive of SLE or DLE converting to SLE with negative ANA, cytopenia, fever, adenopathy, arthralgia, and fatigue (see below labs). Rheumatology diagnosed ANA-negative SLE based on DLE lesions and organ symptomatology (cytopenia from 2004 to present day, she continues to be followed by rheumatology, PCP, dermatology, GYN, et at for re-flare of symptoms.  Follow-up - Patient's last name updated.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood iron normal, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone normal
Clinical narrative: This 41 year old female reported receipt of her primary DRYVAX on 25 June 2003. Three AVA vaccinations were administered on 06 Sept 2003, 22 Sept 2003, and 11 Oct 2003 with no remembered adverse events to either vaccine. During a routine physical 14 Nov 2003 (1 month post 3rd AVA vac), a CBC identified "mild microcytic anemia" (WBC 5.2 (nl), High 12; HCT 37 MCV 85; neut 47%; lymph 47%) otherwise normal). She admitted to being tired and a family history of hypothyroidism otherwise no complaints documented or remembered. Providers suggested diagnosis of "high probability thalassemia". On 20 June 2004 ( months post vaccination) she complain of 2 day hx of itchy scalp with tender scalp and hair loss (hx of similar hair loss at age 9-10), headaches (hx tension ha), increased fatigue, and cervical-aural lymphadenopathy. She was diagnosed with superficial cellulitis and given KEFLEX. F/u eval 6/28/04 dx tinea capitis (positive woods lamp) and given griseofulvin and selenium sulfide shampoo. By 7/3/04 her symptoms had not changed and she now reported fever of 102 F with night sweats. She was treated with ROCEPHIN 1 gm IM X 3 days. By 7/9/04 the lymphadenopathy was resolving; however she exhibited a new vesicular papular itchy rash to bilateral arms, face and oral thrush with a sore throat-diagnosed with possible allergic reaction to griseofulvin. Meds were stopped and she was treated with 7 day taper of Prednisone and given DIFLUCAN with resolution of symptoms except alopecia. While hair regrowth did occur, new sites would develop, dermatology referral:  2 punch biopsies showed "inflammatory scarring alopecia with features consistent with lupus erythematosus. Negative GMS fungal stain". She was diagnosed with discoid lupus 18 August 2004 and referred to internal medicine doe SLE. October 2004 (12 months post AVA#3 vac) repetitive monthly flare ups of alopecia, fevers, arthralgia was associated with onset of menstrual cycles. She was admitted by rheumatology October 6-12, 2004 with neutropenic fever (ANC 325 and c/o 2 week hx fevers>102F, chills, HA, fatigue, sore throat, mouth ulcers, arthralgia, chronic LBP). Symptoms resolved with supportive therapy. Features were noted to be suggestive of SLE or DLE converting to SLE with negative ANA, cytopenia, fever, adenopathy, arthralgia, and fatigue (see below labs). Rheumatology diagnosed ANA-negative SLE based on DLE lesions and organ symptomatology (cytopenia from 2004 to present day, she continues to be followed by rheumatology, PCP, dermatology, GYN, et at for re-flare of symptoms.  Follow-up - Patient's last name updated.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: C-reactive protein normal, Cardiolipin antibody negative, Cellulitis, Chills, Complement factor C3 decreased
Clinical narrative: This 41 year old female reported receipt of her primary DRYVAX on 25 June 2003. Three AVA vaccinations were administered on 06 Sept 2003, 22 Sept 2003, and 11 Oct 2003 with no remembered adverse events to either vaccine. During a routine physical 14 Nov 2003 (1 month post 3rd AVA vac), a CBC identified "mild microcytic anemia" (WBC 5.2 (nl), High 12; HCT 37 MCV 85; neut 47%; lymph 47%) otherwise normal). She admitted to being tired and a family history of hypothyroidism otherwise no complaints documented or remembered. Providers suggested diagnosis of "high probability thalassemia". On 20 June 2004 ( months post vaccination) she complain of 2 day hx of itchy scalp with tender scalp and hair loss (hx of similar hair loss at age 9-10), headaches (hx tension ha), increased fatigue, and cervical-aural lymphadenopathy. She was diagnosed with superficial cellulitis and given KEFLEX. F/u eval 6/28/04 dx tinea capitis (positive woods lamp) and given griseofulvin and selenium sulfide shampoo. By 7/3/04 her symptoms had not changed and she now reported fever of 102 F with night sweats. She was treated with ROCEPHIN 1 gm IM X 3 days. By 7/9/04 the lymphadenopathy was resolving; however she exhibited a new vesicular papular itchy rash to bilateral arms, face and oral thrush with a sore throat-diagnosed with possible allergic reaction to griseofulvin. Meds were stopped and she was treated with 7 day taper of Prednisone and given DIFLUCAN with resolution of symptoms except alopecia. While hair regrowth did occur, new sites would develop, dermatology referral:  2 punch biopsies showed "inflammatory scarring alopecia with features consistent with lupus erythematosus. Negative GMS fungal stain". She was diagnosed with discoid lupus 18 August 2004 and referred to internal medicine doe SLE. October 2004 (12 months post AVA#3 vac) repetitive monthly flare ups of alopecia, fevers, arthralgia was associated with onset of menstrual cycles. She was admitted by rheumatology October 6-12, 2004 with neutropenic fever (ANC 325 and c/o 2 week hx fevers>102F, chills, HA, fatigue, sore throat, mouth ulcers, arthralgia, chronic LBP). Symptoms resolved with supportive therapy. Features were noted to be suggestive of SLE or DLE converting to SLE with negative ANA, cytopenia, fever, adenopathy, arthralgia, and fatigue (see below labs). Rheumatology diagnosed ANA-negative SLE based on DLE lesions and organ symptomatology (cytopenia from 2004 to present day, she continues to be followed by rheumatology, PCP, dermatology, GYN, et at for re-flare of symptoms.  Follow-up - Patient's last name updated.